--- - solicitation_title: "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)" solicitation_number: PAS-22-196 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-06-21 open_date: 2022-12-05 close_date: 2025-09-08 application_due_date: - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 - 2025-01-05 - 2025-04-05 - 2025-09-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2230639 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAS-22-196.html current_status: open solicitation_topics: - topic_title: "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)" branch: National Institutes of Health topic_number: PAS-22-196 topic_description: | Recommendations and milestones for Alzheimer's disease (AD) and AD-related dementias (ADRD) research from the National Alzheimer’s Project Act and the 2015, 2018, 2019, and 2021 Alzheimer's Disease Research Summits present a wide range of research and development proposals which, if pursued, have the potential to reduce the human burden and healthcare costs associated with AD/ADRD. As part of the National Institute on Aging's (NIA) strategic plan to support the development of innovative strategies and therapies to prevent, diagnose, and treat AD/ADRD, this Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Innovation Research (SBIR) program. The aim of this FOA is to encourage research on, and the commercialization of, novel therapies, devices, products, and healthcare programs and practices to prevent the onset of AD/ADRD, and to reduce the burden that AD/ADRD places on individuals, their families, and society at large. Examples of research areas of interest include, but are not limited to, the following: Prevention: Behavioral, environmental, pharmacological, and nutritional interventions to prevent and/or remediate brain biochemical and/or neurophysiological changes caused by neurodegenerative diseases, including age-related sensory dysfunction, motor dysfunction, or age-related decrements in balance and postural control, gait performance, and mobility. Programs to support cognitive training to improve cognitive function in the elderly. Examples of topics appropriate for such programs include, but are not limited to, the following: Rapid development of novel, engaging, computer-based cognitive-training programs based on empirically-established approaches using cognitive training to target a specific neural system/functional domain; Augmentation of existing computerized cognitive interventions that can be individually tailored to engage, adapt, challenge, and optimize functional cognitive abilities to enhance cognitive functioning and performance of activities of daily living; and Development of interventions to remediate age-related cognitive decline, especially using technology platforms with wide acceptance among older adults. Diagnosis: Sensitive, specific, and standardized tests for diagnostic screening of mild cognitive impairment (MCI) and dementia, including the development of new, cost-effective, minimally-invasive biomarkers that could be used for screening in the general population and in community settings. In addition, this FOA encourages research that would identify new biomarkers that could serve as surrogate measures for disease progression in AD/ADRD. Other advances might include the development of new instrumentation, imaging technology, related devices, and software packages for use in visualizing neural activity during cognitive, emotional, motor, or sensory behavior in older adults. Biosensors and prosthetic devices, technologies, and related software development to aid in the assessment, diagnosis, and remediation of age-related cognitive decline. Machine-learning tools and cognitive batteries that can be integrated into Electronic Medical Records (EMR) for diagnosis of MCI and AD/ADRD. New approaches for the assessment of persons living with multiple chronic conditions in clinical practice, including development and validation of brief cognitive-screening measures. Treatment: Discovery, development, and/or evaluation of drugs and/or biological or natural products, including central nervous system delivery systems, to remediate age-related cognitive decline and treat the cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging. In addition, this FOA invitess research on therapies that might slow and/or reverse the course of AD/ADRD, or prevent them entirely through the application of systems-biology and systems-pharmacology approaches. Therapeutics addressing novel targets are of particular interest. Clinical trials to test the safety and efficacy of drug, nutritional, behavioral, cognitive, or other types of interventions to remediate age-related cognitive decline and treat cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging, as well as to slow and/or reverse the course of AD/ADRD or to prevent their onset. Care: New technologies for in-home use, or for coordination or delivery of services to sustain in-home living for individuals living with MCI or AD/ADRD. Examples include, but are not limited to, the following: Systems and devices to evaluate, monitor, improve, or adapt to changes in cognition; Improvements in health-service delivery; Improvements in the preservation of functional independence; Technologies supporting independent living and the conduct of everyday tasks at home; Provision of information to healthcare providers and family members enabling assessment of patient needs and/or intervention(s); and Promotion of effective communication and interaction between individuals living with dementia in the community or in institutional settings and their healthcare providers, friends, and family members. Assistive robotics technology that can support a person in order to maintain or improve their independence, safety, and well-being when diagnosed with AD/ADRD and alleviate the burden of care. Such efforts might include the development of socially-assistive robots that can support engagement, social participation, and leisure activities of patients living with MCI and AD/ADRD. Cost-effective technology to create dementia-friendly cities and environments for individuals diagnosed with AD/ADRD. This might include the development of alarm technology and tracking and location-monitoring devices to alert caregivers and others of the whereabouts of individuals living with AD/ADRD. Other advances might include innovative research to develop safer home environments, such as automatic shut-off valves for water (e.g. a sink could overflow when one forgets to turn off faucet) and electricity and gas (e.g. forgetting to turn off stove). Comprehensive telecare systems that can be used to support independence and personal safety of an individual living with AD/ADRD and other dementias. Such telecare systems might include community alarms, medication reminders, sensors for floods or extreme temperatures, detection of absence from normal activities (e.g. sitting in a chair, going to bed), fall detection, and unobtrusive sensors to monitor activities of daily living and vital signs that can be reported to a healthcare provider. Other advances might include the development of technology that would allow for in-place monitoring of individuals at all stages of AD/ADRD. Ideally, such information would be integrated with other patient-relevant data in EMR. Wearable, mobile, or other technology to enable direct, objective, and continuous data capture of everyday functions in individuals living with AD/ADRD. Recent reviews of relevant scientific literature revealed the presence of disparities of care between diverse racial and ethnic minority populations of individuals with AD/ADRD. To address such disparities, this FOA encourages research to develop educational training programs for physicians, nursing assistants, home-care aids, and long-term-care services. These programs would focus on training healthcare staff to provide culturally-appropriate care to the patient at the right time and in the right setting. Tools: Novel technologies to monitor, assist, or maintain daily functioning of older individuals living with AD/ADRD and other cognitive impairments. Manuals and training materials for existing evidence-based interventions that reduce the burden of caregiving for AD/ADRD caregivers which can be used by community-based agencies and/or healthcare organizations. A tool that could be sold to Medicare Advantage (MA) plans to allow them to accurately project future costs of caring for patients living with AD/ADRD and other forms of dementia. Such a tool would be based on incidence and cost data and would be capable of being tailored for use by participating MA plans to address the unique demographics and risk characteristics of its coverage pool. Technology and analytical tools to investigate genetic, epigenetic, transcriptomic, proteomic, metabolomic, and cell stress pathways in neurons and glia of the aging and AD/ADRD brain. Such efforts might include the development of molecular-imaging technology and/or chip-based technology for in-vitro and in-vivo analysis of gene, epigenome, proteostasis, lipidomics, and metabolomics and metabolic function in the normal aging brain and in AD/ADRD. Improved technology for the analysis of structural and functional brain connectivity at the cell, neural circuitry, and global network levels to define the trajectory of changes in brain structure and function in aging and AD/ADRD. Such technology might include the development of non-invasive methods and novel probes that monitor and manipulate the plasticity of neural circuits in the adult and aged nervous system. Further advances might include the development of novel markers of neural stem-cell function (e.g., proliferation, migration, and differentiation) as well as methods to assess the integration and function of stem cells in the aging and/or diseased nervous system. Chip-based tools modeling human AD/ADRD for applications in AD/ADRD drug screening and development. Development of novel therapeutics for the treatment of AD/ADRD has proven to be a lengthy, costly, and relatively unproductive process, with drug attrition rates of over 90%. Several studies have indicated the lack of appropriate preclinical AD/ADRD models as one of the barriers for successful development of AD/ADRD therapeutics. Although animal models of AD/ADRD have helped our understanding of AD/ADRD pathogenesis to some extent, key genes and proteins that are critical to the pathogenesis of this disease exhibit many inherent species-specific differences and, consequently, there is a critical need for translation platforms that can accurately and reproducibly mimic the AD/ADRD phenotype in vivo and be amenable to high-content screening and assay applications. Recent advances in stem-cell technology allow for successful generation of human neural-progenitor cells from skin cells of normal and AD/ADRD patients. This technology could be exploited to develop cell-type-specific AD/ADRD disease models by replicating AD/ADRD pathobiology on microfluidic chips. These chips could then provide a novel AD/ADRD model system that could be used in the translation process to: perform high-throughput screening for drug discovery and drug efficacy, develop in situ assays for measuring predictive biomarkers, and validate therapeutic target(s). Approaches using artificial intelligence to assist with recruitment and monitoring of study participants for clinical trials of treatments or preventives for AD/ADRD. Clinical Research Operations Management System NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified. sbir_topic_link: https://www.sbir.gov/node/2230641 subtopics: [ ] - solicitation_title: "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)" solicitation_number: PAS-22-197 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-06-21 open_date: 2022-12-05 close_date: 2025-09-06 application_due_date: - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 - 2025-01-06 - 2025-04-07 - 2025-09-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2230635 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAS-22-197.html current_status: open solicitation_topics: - topic_title: "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)" branch: National Institutes of Health topic_number: PAS-22-197 topic_description: | Recommendations and milestones for Alzheimer's disease (AD) and AD-related dementias (ADRD) research from the National Alzheimer’s Project Act and, the 2015, 2018, 2019, and 2021 Alzheimer's Disease Research Summits present a wide range of research and development proposals which, if pursued, have the potential to reduce the human burden and healthcare costs associated with AD/ADRD. As part of the National Institute on Aging's (NIA) strategic plan to support the development of innovative strategies and therapies to prevent, diagnose, and treat AD/ADRD, this Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Technology Transfer (STTR) program. The aim of this FOA is to encourage research on, and the commercialization of, novel therapies, devices, products, and healthcare programs and practices to prevent the onset of AD/ADRD, and to reduce the burden that AD/ADRD places on individuals, their families, and society at large. Examples of research areas of interest include, but are not limited to, the following: Prevention: Behavioral, environmental, pharmacological, and nutritional interventions to prevent and/or remediate brain biochemical and/or neurophysiological changes caused by neurodegenerative diseases, including age-related sensory dysfunction, motor dysfunction, or age-related decrements in balance and postural control, gait performance, and mobility. Programs to support cognitive training to improve cognitive function in the elderly. Examples of topics appropriate for such programs include, but are not limited to, the following: Rapid development of novel, engaging, computer-based cognitive-training programs based on empirically-established approaches using cognitive training to target a specific neural system/functional domain; Augmentation of existing computerized cognitive interventions that can be individually tailored to engage, adapt, challenge, and optimize functional cognitive abilities to enhance cognitive functioning and performance of activities of daily living; and Development of interventions to remediate age-related cognitive decline, especially using technology platforms with wide acceptance among older adults. Diagnosis: Sensitive, specific, and standardized tests for diagnostic screening of mild cognitive impairment (MCI) and dementia, including the development of new, cost-effective, minimally-invasive biomarkers that could be used for screening in the general population and in community settings. In addition, this FOA encourages research that would identify new biomarkers that could serve as surrogate measures for disease progression in AD/ADRD. Other advances might include the development of new instrumentation, imaging technology, related devices, and software packages for use in visualizing neural activity during cognitive, emotional, motor, or sensory behavior in older adults. Biosensors and prosthetic devices, technologies, and related software development to aid in the assessment, diagnosis, and remediation of age-related cognitive decline. Machine-learning tools and cognitive batteries that can be integrated into Electronic Medical Records (EMR) for diagnosis of MCI and AD/ADRD. New approaches for the assessment of persons living with multiple chronic conditions in clinical practice, including development and validation of brief cognitive-screening measures. Treatment: Discovery, development, and/or evaluation of drugs and/or biological or natural products, including central nervous system delivery systems, to remediate age-related cognitive decline and treat the cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging. In addition, this FOA invites research on therapies that might slow and/or reverse the course of AD/ADRD or prevent them entirely through the application of systems-biology and systems-pharmacology approaches. Therapeutics addressing novel targets are of particular interest. Clinical trials to test the safety and efficacy of drug, nutritional, behavioral, cognitive, or other types of interventions to remediate age-related cognitive decline and treat cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging, as well as to slow and/or reverse the course of AD/ADRD or to prevent their onset. Care: New technologies for in-home use or for coordination or delivery of services to sustain in-home living for individuals living with MCI or AD/ADRD. Examples include, but are not limited to, the following: Systems and devices to evaluate, monitor, improve, or adapt to changes in cognition; Improvements in health-service delivery; Improvements in the preservation of functional independence; Technologies supporting independent living and the conduct of everyday tasks at home; Provision of information to healthcare providers and family members enabling assessment of patient needs and/or intervention(s); and Promotion of effective communication and interaction between individuals living with dementia in the community or in institutional settings and their healthcare providers, friends, and family members. Assistive robotics technology that can support a person in order to maintain or improve their independence, safety, and well-being when diagnosed with AD/ADRD and alleviate the burden of care. Such efforts might include the development of socially-assistive robots that can support engagement, social participation, and leisure activities of patients living with MCI and AD/ADRD. Cost-effective technology to create dementia-friendly cities and environments for individuals diagnosed with AD/ADRD. This might include the development of alarm technology and tracking and location-monitoring devices to alert caregivers and others of the whereabouts of individuals living with AD/ADRD. Other advances might include innovative research to develop safer home environments, such as automatic shut-off valves for water (e.g. a sink could overflow when one forgets to turn off faucet) and electricity and gas (e.g. forgetting to turn off stove). Comprehensive telecare systems that can be used to support independence and personal safety of an individual living with AD/ADRD and other dementias. Such telecare systems might include community alarms, medication reminders, sensors for floods or extreme temperatures, detection of absence from normal activities (e.g. sitting in a chair, going to bed), fall detection, and unobtrusive sensors to monitor activities of daily living and vital signs that can be reported to a healthcare provider. Other advances might include the development of technology that would allow for in-place monitoring of individuals at all stages of AD/ADRD. Ideally, such information would be integrated with other patient-relevant data in EMR. Wearable, mobile, or other technology to enable direct, objective, and continuous data capture of everyday functions in individuals living with AD/ADRD. Recent reviews of relevant scientific literature revealed the presence of disparities of care between diverse racial and ethnic minority populations of individuals with AD/ADRD. To address such disparities, this FOA encourages research to develop educational training programs for physicians, nursing assistants, home-care aids, and long-term-care services. These programs would focus on training healthcare staff to provide culturally-appropriate care to the patient at the right time and in the right setting. Tools: Novel technologies to monitor, assist, or maintain daily functioning of older individuals living with AD/ADRD and other cognitive impairments. Manuals and training materials for existing evidence-based interventions that reduce the burden of caregiving for AD/ADRD caregivers which can be used by community-based agencies and/or healthcare organizations. A tool that could be sold to Medicare Advantage (MA) plans to allow them to accurately project future costs of caring for patients living with AD/ADRD and other forms of dementia. Such a tool would be based on incidence and cost data and would be capable of being tailored for use by participating MA plans to address the unique demographics and risk characteristics of its coverage pool. Technology and analytical tools to investigate genetic, epigenetic, transcriptomic, proteomic, metabolomic, and cell stress pathways in neurons and glia of the aging and AD/ADRD brain. Such efforts might include the development of molecular-imaging technology and/or chip-based technology for in-vitro and in-vivo analysis of gene, epigenome, proteostasis, lipidomics, and metabolomics and metabolic function in the normal aging brain and in AD/ADRD. Improved technology for the analysis of structural and functional brain connectivity at the cell, neural circuitry, and global network levels to define the trajectory of changes in brain structure and function in aging and AD/ADRD. Such technology might include the development of non-invasive methods and novel probes that monitor and manipulate the plasticity of neural circuits in the adult and aged nervous system. Further advances might include the development of novel markers of neural stem-cell function (e.g., proliferation, migration, and differentiation) as well as methods to assess the integration and function of stem cells in the aging and/or diseased nervous system. Chip-based tools modeling human AD/ADRD for applications in AD/ADRD drug screening and development. Development of novel therapeutics for the treatment of AD/ADRD has proven to be a lengthy, costly, and relatively unproductive process, with drug attrition rates of over 90%. Several studies have indicated the lack of appropriate preclinical AD/ADRD models as one of the barriers for successful development of AD/ADRD therapeutics. Although animal models of AD/ADRD have helped our understanding of AD/ADRD pathogenesis to some extent, key genes and proteins that are critical to the pathogenesis of this disease exhibit many inherent species-specific differences and, consequently, there is a critical need for translation platforms that can accurately and reproducibly mimic the AD/ADRD phenotype in vivo and be amenable to high-content screening and assay applications. Recent advances in stem-cell technology allow for successful generation of human neural-progenitor cells from skin cells of normal and AD/ADRD patients. This technology could be exploited to develop cell-type-specific AD/ADRD disease models by replicating AD/ADRD pathobiology on microfluidic chips. These chips could then provide a novel AD/ADRD model system that could be used in the translation process to: perform high-throughput screening for drug discovery and drug efficacy, develop in situ assays for measuring predictive biomarkers, and validate therapeutic target(s); Approaches using artificial intelligence to assist with recruitment and monitoring of study participants for clinical trials of treatments or preventives for AD/ADRD. Clinical Research Operations Management System NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified. sbir_topic_link: https://www.sbir.gov/node/2230637 subtopics: [ ] - solicitation_title: 'Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)' solicitation_number: PAR-23-032 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2022-10-27 open_date: 2022-12-05 close_date: 2025-09-05 application_due_date: - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 - 2025-01-06 - 2025-04-04 - 2025-09-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2265723 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-23-032.html current_status: open solicitation_topics: - topic_title: 'Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)' branch: National Institutes of Health topic_number: PAR-23-032 topic_description: | Purpose This Funding Opportunity Announcement (FOA) encourages the translation of technology and therapeutic innovations from academic and other non-profit research sectors to the marketplace to advance the development of diagnostic and prevention tools or treatments for musculoskeletal, rheumatic, or skin diseases. Small Business Concerns (SBCs) are encouraged to apply for this Small Business Innovation Research (SBIR) grant award to support late-stage translation of their work and move the lab technologies towards commercial dissemination. Applications to this FOA must describe partnerships and close collaboration between the original developers of these technologies and SBCs, which may be accomplished in a number of ways, including the use of multiple Program Directors/Principal Investigators and/or employing researchers from the original institutions in the SBCs. The NIAMS/NIH and other research sponsors have invested a significant amount of funds in developing new technologies to study musculoskeletal, rheumatic, and skin diseases from basic, translational, and clinical perspectives through a variety of mechanisms, such as the NIH R01, R15, R21, R61, and P50, as well as NIH Research Evaluation and Commercialization Hub (REACH) Awards. These investments have produced a large amount of intellectual property for new technologies including drug candidates, biomarkers, diagnostic tools, and tissue engineering products. Since commercialization of a new technology or a potentially new therapeutic is a complex process, academic investigators with a focus on theoretical and mechanistic studies may not have the capacity to translate lab technology concepts into products for clinical use. Consequently, these concepts for new technologies and drugs may slowly or never advance to commercial dissemination. This FOA is intended to utilize the NIH SBIR grant mechanism to move these innovations in NIAMS mission-relevant research from non-commercial laboratories into the commercial marketplace through collaborations between small businesses and non-commercial laboratories. Research Objectives and Scope This initiative will support late-stage pre-clinical studies on technology or therapy feasibility, and studies that are required for regulatory approval before clinical testing and making new lab technologies more practical for clinical use. Applications may include human subjects research; however, clinical trials are excluded. Applicants could propose to analyze samples from affected subjects and controls, conduct subject interviews, or other procedures of clinical research. For the purpose of this initiative, a late-stage translation is the continuation of previous research work that has shown promising data for development of a product. It is expected that the academic/non-profit labs have conducted mechanistic studies and obtained preliminary results that provide a strong premise to further develop the technology or therapy. The concept of a product should be well defined. NIAMS mission-relevant research topics include, but are not limited to: Development of therapies such as drugs, biologics, devices, cells, genes or behavioral interventions Development of innovative strategies for the delivery of drugs Biomarker studies focusing on changes in disease-associated biochemistry, imaging, physiology, or other measures that would facilitate screening and diagnosis Development of outcome measures and methodologies that would enhance future observational studies and clinical trials Development of 3D human tissue models for studying pathogenesis and/or testing new therapeutics Collaboration Between Academic/Non-profit Lab and SBCs Commercialization of academic/non-profit lab research results is normally supported by the Small Business Technology Transfer (STTR) program, in which the research institutions can significantly contribute to the research and development. This FOA specifically encourages late-stage translation to be completed mostly by the small businesses. A collaboration between academic/non-profit labs and SBCs is encouraged, and the academic/non-profit lab can perform a portion of the project in accordance with the SBIR policy. This initiative also encourages academic researchers, especially women and socially or economically disadvantaged persons, to participate in innovation and entrepreneurship. A technology transfer agreement between the research institution and the SBC should be in place. Milestones NIH emphasizes rigor and reproducibility of observed results. This FOA will support duplication of the critical experiments/tests in a new setting (e.g., a different device model, a 3D human tissue model) to demonstrate the feasibility of a technology for commercialization or to support FDA approval for clinical trial. Because development of a new technology or therapy is inherently high-risk, attrition is anticipated as projects move through the process. To help mitigate this risk, applications must propose one or more milestones associated with each of the research plan's objectives in each phase of the project. Milestones are goals that measure success and/or efficacy that can be used for go/no-go decision-making for the project, and should have quantitative success criteria and an associated rationale for each. Quantitative criteria should be robust and consistent with the state-of-the-art of the field. Details on methods, assumptions, experimental designs, and data analysis plans (if the results are quantitatively measured) should be included for each milestone. Each milestone must have a timeline and be incorporated into the overall project timeline, which should also be reflected in a Gantt chart. Applications Not Responsive to This FOA Examples of research that are not responsive to this FOA include: applications that propose research and development that is not originated from an academic/non-profit lab applications that propose to conduct intervention studies Non-responsive applications will be returned without review. sbir_topic_link: https://www.sbir.gov/node/2265725 subtopics: [ ] - solicitation_title: > Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed) solicitation_number: PAR-23-267 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-04-18 open_date: 2023-05-06 close_date: 2025-06-07 application_due_date: - 2023-06-06 - 2024-06-06 - 2025-06-06 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2388079 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-23-267.html current_status: open solicitation_topics: - topic_title: > Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (U43/U44 Clinical Trials Not Allowed) branch: National Institutes of Health topic_number: PAR-23-267 topic_description: | Purpose This Funding Opportunity Announcement (FOA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I and Phase II (Fast track and Direct to phase II) grant applications. The funding opportunity will utilize a U43/U44 cooperative agreement to support SBCs to propose the development of novel extracellular vesicle-based therapeutic platforms for use in regenerative medicine. This FOA is focused on the development of platforms associated with the production, manufacturing, and use, of native or engineered EVs as therapeutics. The EV products should have therapeutic applications in the area of tissue and organ repair in regenerative medicine.. Background Extracellular vesicles (EVs) are endogenous membrane-enclosed carriers of bioactive protein, lipids and nucleic acids that are used for intercellular communication. The term, extracellular vesicles, is a generic term used for particles released from the cell that are delimited by a lipid bilayer that cannot replicate. However, there are multiple EVs subpopulations that can be differentiated based on criteria, including: size, biogenesis, release pathways, cargo, and function. EVs are released by virtually all cell types and EV-based intercellular communication takes place during normal cell homeostasis, or as a consequence of pathological development. EVs can cross biological barriers, can be modified to load molecular drugs, have few known deleterious effects and are relatively non-immunogenic, and can maintain their activity during storage. Several NIH programs have supported studies to understand the biology of EVs, and exosomes, and their potential use as therapeutics and diagnostics. This includes the NIH Common Fund's Extracellular RNA Communication Program (https://commonfund.nih.gov/exrna, which aimed to develop novel tools and technologies for the isolation and analysis of single EVs. However, there are a number of challenges in the use of EVs as therapeutics, including, but is not limited to, the production of sufficient quantities of EVs for therapeutic use, labor-intensive EV isolation procedures that are often not compatible with large-scale GMP manufacturing, and non-specific EV isolation methodologies. The goal of regenerative medicine is to regain or restore damaged or lost function of tissues and organs. The NIH Common Fund's Regenerative Medicine program (https://commonfund.nih.gov/stemcells) concluded in 2020 and aimed to accelerate breakthroughs in the development of stem cell-based therapies for complex diseases. In addition to developing a clinical-grade, current good manufacturing practice (cGMP) iPSC line, this program established the Stem Cell Translation Laboratory (SCTL) (https://ncats.nih.gov/stemcell), within the NIH National Center for Advancing Translational Sciences (NCATS) with the goal of bringing induced pluripotent stem cell technologies closer to clinical applications. Despite these successes, major challenges remain in regenerative medicine, particularly in tissue regeneration and repair. There have been numerous studies demonstrating the ability of EVs as potential regenerative entities, particularly for their role in the repair and regeneration of various organs and tissue types. Recent studies have demonstrated that native EVs derived from stem cells, such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs), have inherent therapeutic potential. EVs are able to affect cell phenotype, recruitment, proliferation, and differentiation in a paracrine manner resulting in many potential applications in the field of regenerative medicine. Engineered EVs can be loaded with cargo such as small molecule therapeutics, genetic modifications, and surface markers modified for specific therapeutic targeting. Many diseases could benefit from novel EV-based therapeutics. However, this FOA will focus on tissue and organ repair, and wound healing within regenerative medicine to address current challenges in the field, and to harness the advances made in regenerative medicine from previously funded NIH programs. It is anticipated that the use of non-living cellular products, such as EVs, for applications in regenerative medicine will lead to better translation into the clinic. This Funding Opportunity Announcement (FOA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I and Phase II (Fast track and Direct to phase II) grant applications. The funding opportunity will utilize a U43/U44 cooperative agreement to support SBCs to propose the development of novel extracellular vesicle-based therapeutic platforms for use in regenerative medicine. This FOA is focused on the development of platforms associated with the production, manufacturing, and use, of native or engineered EVs as therapeutics. The EV products should have therapeutic applications in the area of tissue and organ repair in regenerative medicine. The goal for this funding opportunity is to support platform-oriented technology development associated with the production, manufacturing, and use, of EVs as therapeutics in regenerative medicine. Applications should focus on the large-scale GMP grade production and manufacturing challenges associated with the use of EVs as therapeutics. Specific Objectives The goal for this funding opportunity is to support platform-oriented technology development associated with the production, manufacturing, and use, of EVs as therapeutics in regenerative medicine. Applications should focus on the large-scale GMP grade production and manufacturing challenges associated with the use of EVs as therapeutics. EV therapeutics would include, but are not limited to: 1) direct EV therapy (stem cell-isolated EVs produced under GLP conditions, and stored as off-the-shelf therapies); 2) designer EVs (personalized to the individual patient’s needs). Cell source can significantly influence the EV manufacturing process. Cell sources used for EV production should be well-characterized and reproducible to ensure consistency across preparations. GMP production grade EV products should be assessed and well-characterized for attributes such as purity (and the presence of contaminating factors), EV biophysical properties, and EV content, as critical quality control measures. Specific program objectives include: 1) The demonstrated ability to utilize stem cells such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs), or individual patient cells, to create EVs for specific and targeted tissue and organ repair. 2) The demonstration of GMP grade production of EVs for therapeutic applications. 3) The demonstration of the ability to repair and/or replace diseased organs for a specific human disorder relevant to regenerative medicine. Priority will be given to applications focusing on tissue/organ repair, and wound healing. 4) The validation of therapeutic benefits in vivo or ex vivo for the technology proposed. Phase I applications should include initial proof of concept studies focusing on feasibility and therapeutic applications in regenerative medicine. Phase II applications should optimize, refine, and scale-up technology platforms for the production and manufacturing of EVs using well-characterized cell sources and production-grade EV products. The validation of therapeutic benefits is required for phase II applications. This FOA will prioritize IND enabling therapeutic platforms that have the ability to work toward regulatory approval and commercialization. Regulatory engagement with the Office of Tissues and Advanced Therapies (OTAT) at the FDA Center for Biologics Evaluation and Research (CBER) is recommended, particularly for phase 2 applications. Applications should address the expected commercial impact of the proposed technology platform. Applications Not Responsive to this FOA The following types of studies are not responsive to this FOA. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding. - Projects are focused on the generation of liposome or other nanoparticle-based therapeutics. - Therapeutic applications outside the area of regenerative medicine. All applications must include project milestones as detailed in Section IV.2 - Application and Submission Information. Applicants are encouraged to contact staff at NCATS per Agency Contacts below to ensure that their aims and objectives are in line with the goals of the FOA. sbir_topic_link: https://www.sbir.gov/node/2388453 subtopics: [ ] - solicitation_title: > Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed solicitation_number: PAR-23-268 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-04-18 open_date: 2023-05-06 close_date: 2025-06-07 application_due_date: - 2023-06-06 - 2024-06-06 - 2025-06-06 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2388455 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-23-268.html current_status: open solicitation_topics: - topic_title: > Industrialization and Translation of Extracellular Vesicles for use in Regenerative Medicine (UT1/UT2) Clinical Trial Not Allowed branch: National Institutes of Health topic_number: PAR-23-268 topic_description: | Purpose This Funding Opportunity Announcement (FOA) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I and Phase II (Fast track) grant applications. The funding opportunity will utilize a UT1/UT2 cooperative agreement to support SBCs to propose the development of novel extracellular vesicle (EV)-based therapeutic platforms for use in regenerative medicine. This FOA is focused on the development of platforms associated with the production, manufacturing, and use, of native or engineered EVs as therapeutics. The EV products should have therapeutic applications in the area of tissue and organ repair in regenerative medicine. Background Extracellular vesicles (EVs) are endogenous membrane-enclosed carriers of bioactive protein, lipids and nucleic acids that are used for intercellular communication. The term, extracellular vesicles, is generic term used for particles released from the cell that are delimited by a lipid bilayer that cannot replicate. However, there are multiple EVs subpopulations that can be differentiated based on a criteria including: size, biogenesis, release pathways, cargo, and function. EVs are released by virtually all cell types and EV-based intercellular communication take place during normal cell homeostasis, or as a consequence of pathological development. EVs can cross biological barriers, can be modified to load molecular drugs, have few known deleterious effects and are relatively non-immunogenic, and can maintain their activity during storage. Several NIH programs have supported studies to understand the biology of EVs, and exosomes, and their potential use as therapeutics and diagnostics. This includes the NIH Common Fund's Extracellular RNA Communication Program (https://commonfund.nih.gov/exrna) which aimed to develop novel tools and technologies for the isolation and analysis of single EVs. However, there are a number of challenges in the use of EVs as therapeutics. This includes (but is not limited to) the production of sufficient quantities of EVs for therapeutic use, labor-intensive EV isolation procedures that are often not compatible with large-scale GMP manufacturing, and non-specific EV isolation methodologies. The goal of regenerative medicine is to regain or restore damaged or lost function of tissues and organs. The NIH Common Fund's Regenerative Medicine program (https://commonfund.nih.gov/stemcells) concluded in 2020 and aimed to accelerate breakthroughs in the development of stem cell-based therapies for complex diseases. In addition to developing a clinical-grade, current good manufacturing practice (cGMP) iPSC line, this program established the Stem Cell Translation Laboratory (SCTL) (https://ncats.nih.gov/stemcell), within the NIH National Center for Advancing Translational Sciences (NCATS) with the goal of bringing induced pluripotent stem cell technologies closer to clinical applications. Despite these successes, major challenges remain in regenerative medicine, particularly in tissue regeneration and repair. There have been numerous studies demonstrating the ability of EVs as potential regenerative entities, particularly for their role in the repair and regeneration of various organs and tissue types. Recent studies have demonstrated that native EVs derived from stem cells, such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs), have inherent therapeutic potential. EVs are able to affect cell phenotype, recruitment, proliferation, and differentiation in a paracrine manner resulting in many potential applications in the field of regenerative medicine. Engineered EVs can be loaded with cargo such as small molecule therapeutics, genetic modifications, and surface markers modified for specific therapeutic targeting. Many diseases could benefit from novel EV-based therapeutics. However, this FOA will focus on tissue and organ repair, and wound healing within regenerative medicine to address current challenges in the field, and to harness the advances made in regenerative medicine from previously funded NIH programs. It is anticipated that the use non-living cellular products, such as EVs, for applications in regenerative medicine will lead to better translation into the clinic. Specific Objectives The goal for this funding opportunity is to support platform-oriented technology development associated with the production, manufacturing, and use, of EVs as therapeutics in regenerative medicine. Applications should focus on the large-scale GMP grade production and manufacturing challenges associated with the use of EVs as therapeutics. EV therapeutics would include, but are not limited to: 1) direct EV therapy (stem cell-isolated EVs produced under GLP conditions, and stored as off-the-shelf therapies); 2) designer EVs (personalized to the individual patient’s needs). Cell source can significantly influence the EV manufacturing process. Cell sources used for EV production should be well-characterized and reproducible to ensure consistency across preparations. GMP production grade EV products should be assessed and well-characterized for attributes such as purity (and the presence of contaminating factors), EV biophysical properties, and EV content, as critical quality control measures. Specific program objectives include: 1) The demonstrated ability to utilize stem cells such as mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs), or individual patient cells, to create EVs for specific and targeted tissue and organ repair. 2) The demonstration of GMP grade production of EVs for therapeutic applications. 3) The demonstration of the ability to repair and/or replace diseased organs for a specific human disorder relevant to regenerative medicine. Priority will be given to applications focusing on tissue/organ repair, and wound healing. 4) The validation of therapeutic benefits in vivo or ex vivo for the technology proposed. Phase I applications should include initial proof of concept studies focusing on feasibility and therapeutic applications in regenerative medicine. Phase II applications should optimize, refine, and scale-up technology platforms for the production and manufacturing of EVs using well-characterized cell sources and production-grade EV products. The validation of therapeutic benefits is required for phase II applications. This FOA will prioritize IND enabling therapeutic platforms that have the ability to work toward regulatory approval and commercialization. Regulatory engagement with the Office of Tissues and Advanced Therapies (OTAT) at the FDA Center for Biologics Evaluation and Research (CBER) is recommended, particularly for phase 2 applications. Applications should address the expected commercial impact of the proposed technology platform. Applications Not Responsive to this FOA The following types of studies are not responsive to this FOA. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding. - Projects are focused on the generation of liposome or other nanoparticle-based therapeutics. - Therapeutic applications outside the area of regenerative medicine. All applications must include project milestones as detailed in Section IV.2 - Application and Submission Information. Applicants are encouraged to contact staff at NCATS per Agency Contacts below to ensure that their aims and objectives are in line with the goals of the FOA. sbir_topic_link: https://www.sbir.gov/node/2388459 subtopics: [ ] - solicitation_title: > SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) solicitation_number: PAR-23-220 program: BOTH phase: Phase II agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-05 close_date: 2025-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 - 2025-01-05 - 2025-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443053 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-23-220.html current_status: open solicitation_topics: - topic_title: > SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) branch: National Institutes of Health topic_number: PAR-23-220 topic_description: | The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II and Phase IIB it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II or Phase IIB award, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR/STTR Phase II award and the commercialization stage. A number of NIH Institutes and Centers (ICs) participate in the Phase IIB program, which provides additional support to mitigate the funding gap with a second Phase II award. However, Phase IIB programs can be limited in the amount of outsourcing allowed and some projects require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, clinical trials). Some SBCs also require additional funding beyond the Phase IIB to commercialize a technology or attract third party funding. In addition, SBIR/STTR awards may not support activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships. The SBIR and STTR programs were reauthorized and extended through 2025 under Public Law 114-328, Section 1834, Public Law 115-232 and Public Law 117-183 including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This Notice of Funding Opportunity (NOFO) aims to implement the CRP Program at NIH. The goal of this NOFO is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs. This NOFO supports New “Type 1” Applications from recipient s with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months, including those that will be active at the requested start date. Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1. Phase II and Phase IIB recipient s with funding from a non-participating NIH Institute/Center should note that some NIH Institutes/Centers participate in the following: The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. See https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf for more information) The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) (PAR-23-219 ). Scientific/Technical Scope NIH ICs participating in this NOFO may accept applications based on any topic within their mission or based on specific topics. While general topic areas are listed below, applicants should read the specific interests of the ICs carefully prior to submission. Topic areas appropriate for this NOFO include, but are not limited to, the following: Technical Assistance: Development of a regulatory strategy, including assembling the documentation needed to support a meeting request, filing of Investigational New Drug (IND) or Investigational Device Exemption (IDE), or relevant marketing applications to the Food and Drug Administration (FDA) or other relevant US Regulatory Agency. Development of an intellectual property strategy, including analysis of the patent landscape in the US and abroad. Technical assistance associated with manufacturing, including industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs). Other technical assistance through a third-party technical assistance provider, including market research. Late Stage Research and Development Activities: Independent replication/confirmation of key studies. Systematic research on development and optimization of industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, batch compounding, dosage form production, in-process sampling, testing, process validation and related production requirements. Activities to bring the development process under Design and Quality Systems Control. Animal studies to develop surgical techniques relevant to a device. In vitro and animal testing to meet FDA recognized ISO/ASTM Standards. Optimization of the device design with respect to the human functional anatomy. Device, software, and firmware design verification and validation activities. GLP compliant large animal studies. Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical trials and eventual market approval. Process optimization and synthesis, including development of analytical methods to determine drug purity and development of a clinical trial formulation. IND/IDE enabling studies, including toxicology. Chemistry, Manufacturing, and Control (CMC) activities for IND-enabling pharmacology/toxicology tests. Pharmacokinetic/ADME (absorption, distribution, metabolism, excretion) studies. Tumorigenicity, immunogenicity, mutagenicity and teratogenicity evaluations. GMP manufacturing of clinical trial supplies. Optimization of delivery systems. Development and validation of biochemical assays required for clinical trials (e.g., pharmacokinetic, pharmacodynamic, and/or immunogenicity assays). Clinical studies and clinical trials (Note: not every Institute or Center at NIH supports clinical trials through this NOFO . Please see below the section of Interests of Specific Institutes/Centers). Unlike typical SBIR and STTR research and development grants or contracts, companies have the option of out-sourcing a significant portion of the work requested through the CRP, provided the expert services are appropriate for the work proposed and well justified in the application. The SBC should perform a substantive role in the oversight and management of the R&D proposed, including appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Therefore, NIH expects the SBC to request enough funds to enable management of the activities. The remainder of the funds can be distributed among the subcontractors, consultants and SBC depending on the type of work proposed. CRP awards cannot be used to pay filing fees associated with filing patents or FDA submissions. CRP applicants cannot request the separate Technical and Business Assistance (TABA) funding allowed in Phase I and II projects. Interests of Specific Institutes/Centers For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. National Institute on Alcohol Abuse and Alcoholism (NIAAA) The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will support proposed CRP projects that align with NIAAA's mission. Applicants are encouraged to contact the NIAAA Program Coordinator about anticipated activities, including possible human subjects research, prior to submission. For more information about NIAAA's SBIR/STTR program, please visit https://www.niaaa.nih.gov/research/niaaa-sbir. National Institute on Deafness and Other Communication Disorders (NIDCD) The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in CRP applications in the General Topic Areas listed above, provided their projects are within the NIDCD mission areas. NIDCD will only accept CRP applications from NIDCD SBIR and STTR Phase II or Phase IIB recipient s and may decline funding of any application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award early in the process of preparing a submission. Annual budget requests exceeding $1,750,000 total costs per year will not be accepted. National Eye Institute (NEI) The National Eye Institute (NEI) is interested in CRP applications from NEI Phase II SBIR-funded applicants in the General Topic Areas listed above, provided they are within the NEI mission. The NEI will only accept CRP applications from SBIR Phase II or SBIR Phase IIB recipient s, but NEI may decline funding of any application for programmatic or administrative reasons. Applicants who wish to submit CRP applications to the NEI are strongly encouraged to contact Scientific/Research staff. National Heart Lung and Blood Institute (NHLBI) The NHLBI will accept CRP applications from NHLBI Phase II and Phase IIB funded institutions, provided they are within the NHLBI mission. NHLBI also participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late-Stage Development (SB1, Clinical Trial Not Allowed) NOFO (PAR-23-219 ). National Institute of Mental Health (NIMH) The National Institute of Mental Health (NIMH) is interested in CRP applications from NIMH Phase II and Phase IIB funded applicants in the General Topic Areas listed above. NIMH will only support proposed CRP projects that are within the NIMH mission. For information about NIMH's Small Business Program, please visit http://www.nimh.nih.gov/funding/small-business-research-programs.shtml. See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. sbir_topic_link: https://www.sbir.gov/node/2443055 subtopics: [ ] - solicitation_title: > SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) solicitation_number: PAR-23-219 program: BOTH phase: Phase II agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-05 close_date: 2025-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 - 2025-01-05 - 2025-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443059 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-23-219.html current_status: open solicitation_topics: - topic_title: > SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) branch: National Institutes of Health topic_number: PAR-23-219 topic_description: | The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II and Phase IIB it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II or Phase IIB award, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR/STTR Phase II award and the commercialization stage. A number of NIH Institutes and Centers (ICs) participate in the Phase IIB program, which provides additional support to mitigate the funding gap with a second Phase II award. However, Phase IIB programs can be limited in the amount of outsourcing allowed and some projects require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, clinical trials). Some SBCs also require additional funding beyond the Phase IIB to commercialize a technology or attract third party funding. In addition, SBIR/STTR awards may not support activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships. The SBIR and STTR programs were reauthorized and extended through 2025 under Public Law 114-328, Section 1834, Public Law 115-232 and Public Law 117-183 including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This Notice of Funding Opportunity (NOFO) aims to implement the CRP Program at NIH. The goal of this NOFO is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs. This NOFO supports New “Type 1” Applications from recipients with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months, including those that will be active at the requested start date. Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1. Phase II and Phase IIB recipients with funding from a non-participating NIH Institute/Center should note that some NIH Institutes/Centers participate in the following: The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. See https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf for more information) The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Required) (PAR-23-220). Scientific/Technical Scope NIH ICs participating in this NOFO may accept applications based on any topic within their mission or based on specific topics. While general topic areas are listed below, applicants should read the specific interests of the ICs carefully prior to submission. This Notice of Funding Opportunity does not accept clinical trials. Topic areas appropriate for this NOFO include, but are not limited to, the following: Technical Assistance: Development of a regulatory strategy, including assembling the documentation needed to support a meeting request, filing of Investigational New Drug (IND) or Investigational Device Exemption (IDE), or relevant marketing applications to the Food and Drug Administration (FDA) or other relevant US Regulatory Agency. Development of an intellectual property strategy, including analysis of the patent landscape in the US and abroad. Technical assistance associated with manufacturing, including industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs). Other technical assistance through a third-party technical assistance provider, including market research. Late Stage Research and Development Activities: Independent replication/confirmation of key studies. Systematic research on development and optimization of industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, batch compounding, dosage form production, in-process sampling, testing, process validation and related production requirements. Activities to bring the development process under Design and Quality Systems Control. Animal studies to develop surgical techniques relevant to a device. In vitro and animal testing to meet FDA recognized ISO/ASTM Standards. Optimization of the device design with respect to the human functional anatomy. Device, software, and firmware design verification and validation activities. GLP compliant large animal studies. Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical trials and eventual market approval. Process optimization and synthesis, including development of analytical methods to determine drug purity and development of a clinical trial formulation. IND/IDE enabling studies, including toxicology. Chemistry, Manufacturing, and Control (CMC) activities for IND-enabling pharmacology/toxicology tests. Pharmacokinetic/ADME (absorption, distribution, metabolism, excretion) studies. Tumorigenicity, immunogenicity, mutagenicity and teratogenicity evaluations. GMP manufacturing of clinical trial supplies. Optimization of delivery systems. Development and validation of biochemical assays required for clinical trials (e.g., pharmacokinetic, pharmacodynamic, and/or immunogenicity assays). Valid applications can include either or both Technical Assistance and Late Stage Research and Development Activities. Unlike typical SBIR and STTR research and development grants or contracts, companies have the option of out-sourcing a significant portion of the work requested through the CRP, provided the expert services are appropriate for the work proposed and well justified in the application. The SBC should perform a substantive role in the oversight and management of the R&D proposed, including appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Therefore, NIH expects the SBC to request enough funds to enable management of the activities. The remainder of the funds can be distributed among the subcontractors, consultants and SBC depending on the type of work proposed. CRP awards cannot be used to pay filing fees associated with filing patents or FDA submissions. CRP applicants cannot request the separate Technical and Business Assistance (TABA) funding allowed in Phase I and II projects. Interests of Specific Institutes/Centers For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. National Institute on Alcohol Abuse and Alcoholism (NIAAA) The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will support proposed CRP projects that align with NIAAA's mission. Applicants are encouraged to contact the NIAAA Program Coordinator about anticipated activities, including possible human subjects research, prior to submission. For more information about NIAAA's SBIR/STTR program, please visit https://www.niaaa.nih.gov/research/niaaa-sbir. National Institute of Allergy and Infectious Diseases (NIAID) The National Institute of Allergy and Infectious Diseases (NIAID) welcomes CRP applications from recent Phase II/IIB recipient s that are within its mission but will not provide support for implementation of clinical trials under this FOA. NIAID will consider awards up to $1,000,000 per year for up to 3 years. NIAID is not participating in PAR-23-220 NIAID may decline funding of any CRP application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff named in the Phase II or IIB award early in the process of preparing a submission. Non-NIAID Phase II recipient s must contact NIAID ( Scientific/Research Contact(s) in Omnibus NOFA #/Link) prior to submission to confirm programmatic interest. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in CRP applications from NIAMS Phase II funded applicants, provided they are within the NIAMS mission. However, NIAMS will not accept applications that include clinical trials. Applicants who wish to submit clinical trial applications to the NIAMS are encouraged to utilize one of the NIAMS clinical trial funding opportunities, which can be found on the NIAMS webpage: http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp. National Institute of Biomedical Imaging and Bioengineering (NIBIB) The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in CRP applications from NIBIB Phase II funded applicants in the General Topic Areas listed above, provided they are within NIBIB’s mission and supported scientific program areas. NIBIB may decline funding of any application for programmatic or administrative reasons. Additionally, NIBIB will not support project periods of more than two years. Potential applicants are strongly encouraged to contact program staff early in the process of preparing a submission.Include text below if Phase IIB is an allowable application type; otherwise delete. National Cancer Institute (NCI) The National Cancer Institute (NCI) welcomes CRP applications from companies that have active or completed NCI SBIR (Phase II and Phase IIB) or STTR (Phase II) awards. Please note that NCI will provide funding support up to a maximum of $250,000 total costs (direct costs, indirect costs, and fee). Potential applicants are strongly encouraged to contact NCI SBIR Program staff to discuss prior to submission the CRP activities for which support will be requested. The NCI may decline funding of any application for reasons of program balance or budget. NCI does not participate in the SBIR/STTR Commercialization Readiness Pilot Program Technical Assistance and Late-Stage Development (SB1 Clinical Trial Required) NOFO (PAR-23-220 ). For SBIR/STTR Phase II recipient s in need of additional assistance for late-stage development and/or clinical trials, the NCI recommends its SBIR Phase IIB program (https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-034.html), which is published as a Request for Applications once per year, typically in the Spring. National Institute on Deafness and Other Communication Disorders (NIDCD) The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in CRP applications in the General Topic Areas listed above, provided their projects are within the NIDCD mission areas. NIDCD will only accept CRP applications from NIDCD SBIR and STTR Phase II or Phase IIB recipient s and may decline funding of any application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award early in the process of preparing a submission. Annual budget requests exceeding $1,750,000 total costs per year will not be accepted. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) The NIDDK invites NIDDK Phase II and Phase IIB recipient s to apply to the SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development, provided that the proposed research and development falls within NIDDK’s mission. For Phase II recipient s, especially those developing products that require clinical evaluation or approval by a Federal regulatory agency, the NIDDK strongly encourages potential applicants to apply to NIDDK’s Phase IIB program. The Phase IIB program, including budgetary guidance, is described in the current Program Descriptions and Research Topics document found at the NIH SEED SBIR and STTR Funding Opportunities page: https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities. Potential applicants are strongly encouraged to contact the NIDDK Program Officer for the Phase II or Phase IIB award early in the process of preparing an application. National Institute of Environmental Health Sciences (NIEHS) The National Institute of Environmental Health Sciences (NIEHS) is interested in CRP applications from NIEHS Phase II and Phase IIB funded applicants in the General Topic Areas listed above, provided they are within the NIEHS mission. For information about the NIEHS Small Business Program, please visit; https://www.niehs.nih.gov/research/supported/translational/sbir/index.cfm National Eye Institute (NEI) The National Eye Institute (NEI) is interested in CRP applications from NEI Phase II SBIR-funded applicants in the General Topic Areas listed above, provided they are within the NEI mission. The NEI will only accept CRP applications from SBIR Phase II or SBIR Phase IIB recipient s, but NEI may decline funding of any application for programmatic or administrative reasons. Applicants who wish to submit CRP applications to the NEI are strongly encouraged to contact Scientific/Research staff. National Heart Lung and Blood Institute (NHLBI) The NHLBI will accept CRP applications from NHLBI Phase II and Phase IIB funded institutions, provided they are within the NHLBI mission. NHLBI also participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late-Stage Development (SB1, Clinical Trial Required NOFO (PAR-23-220 ). National Human Genome Research Institute (NHGRI) The National Human Genome Research Institute (NHGRI) is interested in CRP applications from NHGRI Phase II funded applicants in the General Topic Areas listed above, except that NHGRI will not provide support for clinical trials in the CRP FOA. NHGRI will only support proposed CRP projects that are within the NHGRI mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. National Institute of Mental Health (NIMH) The National Institute of Mental Health (NIMH) is interested in CRP applications from NIMH Phase II and Phase IIB funded applicants in the General Topic Areas listed above. NIMH will only support proposed CRP projects that are within the NIMH mission. For information about NIMH's Small Business Program, please visit http://www.nimh.nih.gov/funding/small-business-research-programs.shtml National Institute for Neurological Disorders and Stroke (NINDS) The National Institute for Neurological Disorders and Stroke (NINDS) is interested in CRP applications from NINDS Phase II/IIB funded applicants in the General Topic Areas listed above, provided they are within the NINDS mission. NINDS may decline funding of any application for programmatic or administrative reasons. Please note that NINDS will provide funding support up to a maximum of $300,000 total costs (direct costs, indirect costs, and fee). Potential applicants are strongly encouraged to contact program staff early in the process of preparing a submission. National Center for Advancing Translational Sciences (NCATS) The National Center for Advancing Translational Sciences (NCATS) is interested in CRP applications from NCATS Phase II funded applicants, provided they are within the NCATS mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. Please note that NCATS will not accept applications that include clinical trials. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. National Institute of Dental and Craniofacial Research (NIDCR) NIDCR will consider CRP applications from previous NIDCR Phase II awardees in the General Topic Areas listed above except for those supporting clinical trial-related activities. The Institute might consider certain clinical trial planning activities as described in PAR-21-160 (see: https://grants.nih.gov/grants/guide/pa-files/PAR-21-160.html). Applicants considering projects involving any type of human subjects research are strongly encouraged to contact Scientific/Research staff for consultation before submission. sbir_topic_link: https://www.sbir.gov/node/2443061 subtopics: [ ] - solicitation_title: 'HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)' solicitation_number: RFA-NS-23-007 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-09-15 open_date: 2022-12-04 close_date: 2025-04-05 application_due_date: - 2023-01-04 - 2023-04-04 - 2023-09-04 - 2024-01-04 - 2024-04-04 - 2024-09-04 - 2025-01-03 - 2025-04-04 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2249301 solicitation_agency_url: > https://grants.nih.gov/grants/guide/RFA-files/RFA-NS-23-007.html current_status: open solicitation_topics: - topic_title: 'HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)' branch: National Institutes of Health topic_number: RFA-NS-23-007 topic_description: | Purpose The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) program. Specifically, this FOA is focused on applications directed at improving pain measurement and treatment. Background This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative—an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://heal.nih.gov. More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options are thus critically needed. Research Objectives A. Scientific/Technical Scope Applications received under this FOA should have a primary focus on enhancing pain management, such as through measurement of pain-related outcomes. Applications must fall within the scope of the HEAL Initiative, including but not limited to: Tools and technologies to better understand the biological underpinnings of chronic pain, including new screening tools and models focused on pain and the development of pain therapies Discovery and pre-clinical development of analgesic treatments with little or no addiction liability, including small molecules, biologicals, and devices Advancing new pain treatments with little or no addiction liability through the clinical pipeline Development of improved pain management strategies for acute and chronic pain conditions, including development of novel pain management technologies, devices, and objective pain measurement The following activities are not within scope of this FOA: Development of pain treatments with potential abuse liability, such as those targeting mu opioid mechanisms Methods to track or reduce opioid use other than through novel pain management solutions NIH-defined clinical trials to investigate novel pain management technologies While these activities are not within scope of this FOA, they may fall within scope of other funding opportunities through the HEAL Initiative and/or NIH STTR. For additional funding opportunities under the HEAL Initiative, please see: https://heal.nih.gov/funding/open. For additional funding opportunities under NIH STTR, please see: https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities. The NIH clinical trial definition can be found here: https://grants.nih.gov/policy/clinical-trials/definition.htm. B. NIH Institute and Center Interests and Guidance National Institute of Neurological Disorders and Stroke (NINDS) The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of new medications with little or no addiction liability, devices, and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) NIAMS supports research to develop therapies and technologies directed at enhanced pain management within the NIAMS mission. National Center for Complementary and Integrative Health (NCCIH) The National Center for Complementary and Integrative Health (NCCIH) will support research on development and optimization of technologies relevant to complementary and integrative health approaches and of nonpharmacological therapies for the management of acute or chronic pain conditions. Examples of research of interest relevant to this FOA include, but are not restricted to, natural products (e.g., herbs, prebiotic, probiotics, and selective medical diets), mind and body practices (e.g., acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), music/art therapies, and whole person pain management (e.g. the development of sensory/diagnostic devices or applications that utilize Artificial Intelligence/Machine Learning (AI/ML) to elucidate the physiological, biological, and psychological mechanisms of multicomponent interventions on whole person pain management) National Institute on Minority Health and Health Disparities (NIMHD) Areas of interest: The mission of NIMHD is to lead, conduct and support scientific research to improve minority health and reduce health disparities. In the context of this FOA, NIMHD is interested in applications that focus on (but not limited to) the following areas: Addressing the intersection of chronic pain management and opioid use disorder (OUD): the development of therapeutic strategies and technologies that improve pain management and result in the enhanced continuity of care of patients with chronic pain. Conducting research/subgroup analyses to identify most effective therapies, technologies, and/or interventions at reducing the need for Opioid pharmacotherapy for specific populations, including the medically underserved and other health disparity populations. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. National Institute of Biomedical Imaging and Bioengineering (NIBIB) The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas can be found at https://www.nibib.nih.gov/research-funding. NIBIB supports research from early stage technology development through first in human demonstrations and early feasibility clinical studies. National Institute of General Medical Sciences (NIGMS) NIGMS accepts applications directed at improving the treatment and management of pain in the peri-operative period, including the development of non-addictive drugs, devices and objectives measures of pain. NIGMS accepts applications on the development of strategies, methods, or new technologies to improve the delivery, monitoring, safety and efficacy of anesthesia. NIGMS also accepts applications relevant to pain management of burn injury. National Institute of Mental Health (NIMH) The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For this FOA, the NIMH is interested in supporting the development of digital health technologies associated with pain and serious mental illness (SMI) or suicide, with the goal to reduce premature SMI mortality and to reduce suicide associated with pain and suffering. Examples of technology priorities within those specific goals include: automated, real time assessments of behavior in naturalistic environments, intervention refinement and delivery, and service delivery. Office of Research Infrastructure Programs (ORIP) The Office of Research Infrastructure Programs (ORIP) will support applications proposing relevant technologies to advance the determination, measurement, and/or amelioration/treatment of pain, using appropriate non-clinical models. National Institute of Dental and Craniofacial Research (NIDCR) The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications directed at improving diagnosis, management, and treatment of painful disorders of the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain, and other conditions. Topics of interest include, but are not limited to, development of: new non-addictive medications, devices, technologies for objective pain measurement, screening tools and models focused on pain and development of pain therapies. Development of tools and technologies to better understand chronic orofacial pain conditions are also of interest to NIDCR. Investigators are encouraged to contact NIDCR program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute mission and strategic plan. National Center for Advancing Translational Sciences (NCATS) NCATS intends to fund applications that meet its mission. For a description of the NCATS SBIR/STTR research priorities see https://ncats.nih.gov/smallbusiness/priorities. National Library of Medicine (NLM) NLM intends to fund applications that meet its mission. For a description of the NLM SBIR/STTR research interest see https://www.nlm.nih.gov/ep/grantsbir.html. National Institute of Nursing Research (NINR) NINR supports research programs that are developing and refining technologies to improve symptom risk assessment and identify potential interventions, promote health outcomes in diverse and underserved populations, and/or foster health, prevent illness, and improve health-related quality of life across the lifespan. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NICHD is particularly interested in applications relevant to (a) persistent pain of women with endometriosis, chronic pelvic pain, vulvodynia/vestibulodynia, dysmenorrhea, and other gynecologic pain syndromes, (b) pain (acute and chronic) after minor and major surgical procedures, and (c) pain conditions (acute and chronic) in children, women of reproductive age, pregnant and lactating individuals, people with intellectual and physical disabilities, and health disparity populations (i.e. racial/ethnic groups, sexual and gender minorities, underserved rural and socioeconomically disadvantaged populations, people with limited English proficiency). sbir_topic_link: https://www.sbir.gov/node/2249303 subtopics: [ ] - solicitation_title: 'HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)' solicitation_number: RFA-NS-23-006 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-09-15 open_date: 2022-12-04 close_date: 2025-04-05 application_due_date: - 2023-01-04 - 2023-04-04 - 2023-09-04 - 2024-01-04 - 2024-04-04 - 2024-09-04 - 2025-01-03 - 2025-04-04 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2249297 solicitation_agency_url: > https://grants.nih.gov/grants/guide/RFA-files/RFA-NS-23-006.html current_status: open solicitation_topics: - topic_title: 'HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)' branch: National Institutes of Health topic_number: RFA-NS-23-006 topic_description: | Purpose The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. Specifically, this FOA is focused on applications directed at improving pain measurement and treatment. Background This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative—an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://heal.nih.gov. More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options are thus critically needed. Research Objectives A. Scientific/Technical Scope Applications received under this FOA should have a primary focus on enhancing pain management, such as through measurement of pain-related outcomes. Applications must fall within the scope of the HEAL Initiative, including but not limited to: Tools and technologies to better understand the biological underpinnings of chronic pain, including new screening tools and models focused on pain and the development of pain therapies Discovery and pre-clinical development of non-addictive pain analgesic treatments with little or no addiction liability, including small molecules, biologicals, and devices Advancing new pain treatments with little or no addiction liability through the clinical pipeline Development of improved pain management strategies for acute and chronic pain conditions, including development of novel pain management technologies and devices, and objective pain measurement The following activities are not within scope of this FOA: Development of pain treatments with potential abuse liability, such as those targeting mu opioid mechanisms Methods to track or reduce opioid use other than through novel pain management solutions NIH-defined clinical trials to investigate novel pain management technologies While these activities are not within scope of this FOA, they may fall within scope of other funding opportunities through the HEAL Initiative and/or NIH STTR. For additional funding opportunities under the HEAL Initiative, please see: https://heal.nih.gov/funding/open. For additional funding opportunities under NIH STTR, please see: https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities. The NIH clinical trial definition can be found here: https://grants.nih.gov/policy/clinical-trials/definition.htm. B. NIH Institute and Center Interests and Guidance National Institute of Neurological Disorders and Stroke (NINDS) The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of medications with little or no addiction liability, devices, and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) NIAMS supports research to develop therapies and technologies directed at enhanced pain management within the NIAMS mission. National Center for Complementary and Integrative Health (NCCIH) The National Center for Complementary and Integrative Health (NCCIH) will support research on development and optimization of technologies relevant to complementary and integrative health approaches and of nonpharmacological therapies for the management of acute or chronic pain conditions. Examples of research of interest relevant to this FOA include, but are not restricted to, natural products (e.g., herbs, prebiotic, probiotics, and selective medical diets), mind and body practices (e.g., acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), music/art therapies, and whole person pain management (e.g. the development of sensory/diagnostic devices or applications that utilize Artificial Intelligence/Machine Learning (AI/ML) to elucidate the physiological, biological, and psychological mechanisms of multicomponent interventions on whole person pain management) National Institute on Minority Health and Health Disparities (NIMHD) Areas of interest: The mission of NIMHD is to lead, conduct and support scientific research to improve minority health and reduce health disparities. In the context of this FOA, NIMHD is interested in applications that focus on (but not limited to) the following areas: Addressing the intersection of chronic pain management and opioid use disorder (OUD): the development of therapeutic strategies and technologies that improve pain management and result in the enhanced continuity of care of patients with chronic pain. Conducting research/subgroup analyses to identify most effective therapies, technologies, and/or interventions at reducing the need for Opioid pharmacotherapy for specific populations, including the medically underserved and other health disparity populations. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. National Institute of Biomedical Imaging and Bioengineering (NIBIB) The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas can be found at https://www.nibib.nih.gov/research-funding. NIBIB supports research from early stage technology development through first in human demonstrations and early feasibility clinical studies. National Institute of General Medical Sciences (NIGMS) NIGMS accepts applications directed at improving the treatment and management of pain in the peri-operative period, including the development of non-addictive drugs, devices and objectives measures of pain. NIGMS accepts applications on the development of strategies, methods, or new technologies to improve the delivery, monitoring, safety and efficacy of anesthesia. NIGMS also accepts applications relevant to pain management of burn injury. National Institute of Mental Health (NIMH) The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For this FOA, the NIMH is interested in supporting the development of digital health technologies associated with pain and serious mental illness (SMI) or suicide, with the goal to reduce premature SMI mortality and to reduce suicide associated with pain and suffering. Examples of technology priorities within those specific goals include: automated, real time assessments of behavior in naturalistic environments, intervention refinement and delivery, and service delivery. Office of Research Infrastructure Programs (ORIP) The Office of Research Infrastructure Programs (ORIP) will support applications proposing relevant technologies to advance the determination, measurement, and/or amelioration/treatment of pain, using appropriate non-clinical models. National Institute of Dental and Craniofacial Research (NIDCR) The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications directed at improving diagnosis, management, and treatment of painful disorders of the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain, and other conditions. Topics of interest include, but are not limited to, development of: new non-addictive medications, devices, technologies for objective pain measurement, screening tools and models focused on pain and development of pain therapies. Development of tools and technologies to better understand chronic orofacial pain conditions are also of interest to NIDCR. Investigators are encouraged to contact NIDCR program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute mission and strategic plan. National Center for Advancing Translational Sciences (NCATS) NCATS intends to fund applications that meet its mission. For a description of the NCATS SBIR/STTR research priorities see https://ncats.nih.gov/smallbusiness/priorities. National Library of Medicine (NLM) NLM intends to fund applications that meet its mission. For a description of the NLM SBIR/STTR research interest see https://www.nlm.nih.gov/ep/grantsbir.html National Institute of Nursing Research (NINR) NINR supports research programs that are developing and refining technologies to improve symptom risk assessment and identify potential interventions, promote health outcomes in diverse and underserved populations, and/or foster health, prevent illness, and improve health-related quality of life across the lifespan. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NICHD is particularly interested in applications relevant to (a) persistent pain of women with endometriosis, chronic pelvic pain, vulvodynia/vestibulodynia, dysmenorrhea, and other gynecologic pain syndromes, (b) pain (acute and chronic) after minor and major surgical procedures, and (c) pain conditions (acute and chronic) in children, women of reproductive age, pregnant and lactating individuals, people with intellectual and physical disabilities, and health disparity populations (i.e. racial/ethnic groups, sexual and gender minorities, underserved rural and socioeconomically disadvantaged populations, people with limited English proficiency). sbir_topic_link: https://www.sbir.gov/node/2249299 subtopics: [ ] - solicitation_title: 'Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)' solicitation_number: RFA-DA-23-021 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-03-28 open_date: 2022-07-15 close_date: 2025-02-15 application_due_date: - 2022-08-15 - 2023-02-14 - 2023-08-15 - 2024-02-14 - 2024-08-13 - 2025-02-14 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2199561 solicitation_agency_url: > https://grants.nih.gov/grants/guide/RFA-files/RFA-DA-23-021.html current_status: open solicitation_topics: - topic_title: 'Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)' branch: National Institutes of Health topic_number: RFA-DA-23-021 topic_description: | According to the Centers for Disease Control and Prevention (CDC), more than 100,000 deaths from overdose were reported from April 2020 to April 2021 alone. Data shows an increase in overdoses due to natural and semi-synthetic opioids, synthetic opioids, predominantly fentanyl, and psychostimulants, such as methamphetamine or cocaine. In fact, in the year ending in April 2021, fentanyl was the leading cause of death for adults ages 18-45, more than car accidents, suicide, COVID, and cancer. The scope and complexity of the current drug crisis are staggering, and there is an urgent need for a comprehensive effort to offer new medical products to the affected individuals, families, and communities. Scientific advances and product development based on those scientific advances can provide solutions to help overcome the crisis. For example, medical products regulated by the U.S. Food and Drug Administration (FDA), including pharmacotherapeutics and medical therapeutic and diagnostic devices, offer promising means to monitor, diagnose, and treat patients suffering from opioid use disorders (OUD) and stimulant use disorders (StUD). There are currently five pharmacotherapies approved by the U.S. Food and Drug Administration (FDA) for treating OUD and mitigation of opioid withdrawal symptoms: methadone, buprenorphine, extended-release naltrexone, naloxone, and lofexidine. While these effective medications exist, they are underutilized due, partly, to patient retention in treatment regimens, policy barriers that limit the prescription of medications approved for the treatment of OUD, and stigma around opioid agonist medications. Recent data from SAMHSA (2020) shows that only a minimal percentage of patients affected by substance use disorders, including OUD/StUD, receive any treatment. Moreover, given the diverse nature of OUD, patients may have limited responses to available medications, and additional options could benefit more patients. There are currently no FDA-approved medications for StUD, including cocaine or methamphetamine use disorders. Similarly, there are currently five medical devices intended for patients suffering from substance use disorders cleared by the FDA. The list includes percutaneous or transcutaneous nerve stimulation devices designed to reduce symptoms of opioid withdrawal in conjunction with standard medications. The FDA also approved software as medical device solutions, also known as digital therapeutics, intended to deliver behavioral therapy to SUD patients as an adjunct to clinician-supervised treatment. While these technologies offer essential solutions for patients affected by SUD, significant constraints still limit patients' access. Examples of such restrictions include lack of FDA-cleared devices with specific indications for patients affected by StUD, lack of devices intended as a stand-alone treatment, lack of devices approved for use in patients under 18 years of age, and reduced adoption due to limited payor reimbursement. Additionally, existing FDA-cleared diagnostic devices for OUD/StUD are limited, and there are no wearable devices intended to monitor or diagnose OUD/StUD. This funding opportunity announcement strives to contribute to the emergence of new solutions by seeking applications to conduct research and development activities for novel medical products which would address the needs of patients suffering from OUD/StUD. Investigators and developers of biomedical technologies that lead to the prevention, monitoring, diagnosis, and treatment of OUD/StUD are highly encouraged to apply. Applications received under this FOA may fall within two FDA-regulated technical/scientific areas: (1) pharmacotherapeutics (small molecules and biologics) and (2) medical therapeutic and diagnostic devices, including software as a medical device. Small business companies that developed currently marketed technologies or are developing technologies for different indications and are interested in demonstrating that their FDA-regulated product has a potential application in the OUD/StUD space are especially encouraged to apply. Area 1: OUD/StUD pharmacotherapeutics Projects proposed under Area 1 may include but are not limited to developing the following categories of pharmacotherapeutics for OUD/StUD: Small or large molecule agents. Biologics, including antibodies and therapeutic vaccines. Natural products. Longer-acting formulations of existing addiction medications. Longer-acting formulations of agonists or antagonists, e.g., longer-lasting naloxone formulations and new medications. Advanced drug delivery systems. Development and characterization of biomarkers. Pharmacotherapeutics modalities other than those listed above may also be considered. Applications may include the following activities and steps in the R&D process: Target identification or validation. Assay development, confirmation of hits, and hit to lead studies. Lead optimization of compound(s) or biologic(s). In vivo pharmacokinetic, pharmacodynamic, and toxicology studies. In vivo preclinical efficacy studies. Formulation development studies. Process development to support clinical manufacturing (e.g., scale-up feasibility). Other activities leading to the selection of a development candidate. Specific proposed objectives will vary among applications. Appropriate objectives in Area 1 include but are not necessarily limited to the following examples: Development of in vitro pharmacological assays that cover a broad range of targets, including receptors, ion channels, transporters, enzymes, and secondary messengers to identify lead compounds, to define the mechanism of action, and to identify off-target activities. Completion of in vivo preclinical efficacy studies. Demonstration of acceptable safety (e.g., toxicity in rodents and/or large animals). Manufacturing of acceptable clinical dosage form [e.g., meeting Good Manufacturing Practices (GMP) quality]. Clinical Proof of Concept (Phase I and/or Phase II clinical trials). Applicants should propose and conduct activities that will eventually lead to the filing of an Investigational New Drug (IND) application, as well as clinical studies to support the filing of either a New Drug Application (NDA) or a Biological License Application (BLA). Applications may include biomarkers that assess the probability of OUD/StUD or allow an assessment of the treatment trajectory in patients under treatment for OUD/StUD. Recently issued FDA guidance on OUD: “endpoints for demonstrating effectiveness of drugs for treatment guidance for industry” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-effectiveness-drugs-treatment-guidance-industry) is a valuable resource in guiding R&D activities. For OUD, the proposed drug product must have a clear advantage over existing competing products and a clearly defined path with the ultimate goal of commercialization. Therefore, applicants are encouraged to establish a Target Product Profile (TPP) for the proposed products (https://wayback.archive-it.org/7993/20190907022334/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/target-product-profile-strategic-development-process-tool). Area 2: Medical therapeutic and diagnostic devices, including software as a medical device Projects proposed under Area 2 may include, but are not necessarily limited to, research and development of the following categories of medical devices: Imaging technologies for investigating brain function and enhancing the diagnosis of OUD/StUD. Devices that directly diagnose and reduce craving and withdrawal symptoms or increase retention in outpatient therapies. Therapeutic devices (e.g., neuromodulation) intended to improve OUD/StUD treatment outcomes and recurrence prevention. Devices, including digital therapeutics, intended to identify and treat newborns exposed to opioids and stimulants, along with other drugs, to improve both short- and long-term developmental outcomes; novel approaches to managing neonatal abstinence syndrome (NAS). Devices intended for the treatment of pediatric patients (e.g., neonates, infants, adolescents) including use of extrapolation methods to treat pediatric patients following FDA’s pediatric extrapolation guidance:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/leveraging-existing-clinical-data-extrapolation-pediatric-uses-medical-devices. Devices, including digital therapeutics, with treatment indications for pregnant mothers suffering from OUD/StUD. In vitro diagnostic assays such as Point-of-Care analytical tools for blood, saliva, or urine (e.g., lab-on-a-chip biosensors that allow remote performance of chemical or biological assays outside of a laboratory environment). Stand-alone or adjunctive digital therapeutics (e.g., Software as a Medical Device, Software in Medical Device) focused on behavioral health interventions to diagnose, treat, prevent, and mitigate OUD/StUD. Devices, including wearables and connected digital therapeutics at point-of-care, intended to detect, diagnose, and treat opioid-induced respiratory depression. Data science and cloud-based technologies empowered by artificial intelligence intended to collect, integrate, analyze, and visualize multimodal data related to diagnosis/treatment of OUD/StUD, including disorder progression and risk of recurrence. Technologies that integrate sensors, wearables, environmental and social factors to analyze behavior patterns, social interactions, ecological momentary assessment of triggers, and identifying stress responses to personalize just-in-time treatment interventions. For projects in Area 2, applicants should propose activities that will lead to the successful filing of FDA premarket application for clearance/approval (e.g., 510(k) or DeNovo application, Premarket Approval (PMA) application). Such activities include early engagement with the FDA Center of Devices and Radiological Health (CDRH) via the presubmission program to receive feedback on proposed intended use, preclinical testing, and study design protocols. Please see for reference the FDA Q-submission guidance:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program. Additional specific proposed activities may include, but are not limited to, the following examples: Studies supporting an Investigational Device Exemption (IDE) application, where applicable, for significant risk devices (see https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application). Process development for manufacturing. Non-clinical safety studies (e.g., toxicology, biocompatibility, electromagnetic compatibility, electrical safety). Safety studies in animal models. Clinical trials. Non-Responsive Activities The following activities will be considered non-responsive: Applications solely focused on disorders other than OUD/StUD (e.g., Alcohol Use Disorders), as defined in the DSM-5. Applications pursuing non-FDA-regulated products. Applications pursuing FDA-regulated medical products for pain as a sole focus without addressing OUD/StUD monitoring, diagnosis, treatment, overdose prevention, and/or reversal. Words Matter Drug addiction is a chronic but treatable disorder with well-understood genetic and social contributors. NIDA encourages preferred language that accurately describes addiction and substance use in all submitted materials without perpetuating stigma and bias. Research shows that using person-first language—such as "person with a substance use disorder"—instead of "substance abuser" or "addict" can reduce negative associations and punitive attitudes among clinicians and researchers. Further, the term "substance abuse" has no clinical relevance, as it is no longer included in the DSM-5 terminology. Instead, NIDA encourages the use of "addiction" or "substance use disorders" or other specific terminology, such as "opioid use disorders," "cocaine use disorders," as included in the DSM-5. In addition to using person-first language, NIDA recommends avoiding the term "substance abuse" and its derivatives in favor of "use," "misuse," or "use disorder(s)" where appropriate. Similarly, "abuse potential" may be replaced with "addiction liability." NIDA encourages using the term "medications for opioid use disorder" (MOUD) instead of "medication-assisted treatment" (MAT) or "opioid substitution therapy" (OST) when referring to medications prescribed for the treatment of OUD. The term MOUD appropriately frames these life-saving medications as effective, frontline treatments. In contrast, the term MAT implies that medication should have a supplemental or temporary role in treatment. OST reinforces the misconception that MOUD "substitutes" one drug for another instead of supporting recovery. The terminology shift to MOUD aligns with the way other psychiatric medications are understood (e.g., antidepressants, antipsychotics) as critical tools central to a patient's treatment plan. These small but powerful substitutions may help address stigma in patients and study participants, which research shows reduces willingness to seek and accept treatment, among other adverse health outcomes. For more information on preferred language in addiction care, visit NIDAMED: https://www.drugabuse.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction. The SBIR program is a phased program. An overall objective of the SBIR program is to increase private sector commercialization of innovations derived from federally supported research and development. The main objective in SBIR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. In contrast, the SBIR Phase II objective is to continue the R&D efforts to advance the technology toward ultimate commercialization. Beyond the scope of this FOA, it is anticipated and encouraged that the outcomes of successful SBIR projects will help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly available product or service. This FOA invites four types of applications: Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and determine the quality of performance of the small business awardee organization before proceeding to Phase II. Phase II. The objective of Phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Therefore, NIDA evaluates that investigators have established technical and commercial feasibility in Phase I before deciding on Phase II support. Fast Track. In an NIH SBIR fast-track both Phase I and Phase II are submitted and reviewed as one application to reduce or eliminate the funding gap between phases. Fast-Track (Phase I/ Phase II) applications should include a clear rationale of the technical and commercial feasibility of the proposed approach and technology in the OUD/StUD area; demonstrate a high probability of commercialization; include clear, appropriate, measurable, clinically meaningful milestones to be achieved before initiating Phase II; and indicate potential Phase III support/interest (non-SBIR) from future commercialization partners. The objective of Phase II (as a part of Fast Track applications) is to continue the R&D efforts initiated in Phase I to advance technologies to potential commercialization. Projects proposed for Phase II are based on the results achieved in Phase I (or equivalent) and aim to demonstrate scientific and technical merit and commercial potential. Therefore, NIDA evaluates that investigators have established technical and commercial feasibility in Phase I and that proposed milestones are met before deciding on Phase II support. Direct to Phase II. NIH can issue a Direct to Phase II award for a small business that has already demonstrated scientific and technical merit and feasibility but has not received a Phase I award for that project. The NIH Direct to Phase II will accept Phase II submissions regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Small businesses eligible to submit Phase II applications for projects supported with a Phase I SBIR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. First-time applicants may submit a Phase I, Fast-Track, or Direct-to-Phase II application. Special Considerations National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential and dependence or addiction liability to human subjects. Therefore, potential applicants are encouraged to obtain and review these recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects. Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth concerning existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. For additional details, please see https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/points-to-consider-regarding-tobacco-industry-funding-nida-applicants. Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details. Establishment of a Standard delta-9-THC Unit to be used in Research: Applications proposing research on cannabis or its main psychotropic constituent delta-9-THC are required to measure and report results using a standard delta-9-THC unit in all applicable human subjects’ research. The goal is to increase the comparability across cannabis research studies. A standard delta-9-THC unit is defined as any formulation of cannabis plant material or extract that contains 5 milligrams of delta-9-THC. A justification should be provided for human research that does not propose to use the standard unit. Please see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-21-049.html for additional details. sbir_topic_link: https://www.sbir.gov/node/2199563 subtopics: [ ] - solicitation_title: > Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (U43/U44 Clinical Trial Optional) solicitation_number: PAR-22-102 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-01-21 open_date: 2022-02-28 close_date: 2024-12-05 application_due_date: - 2022-03-28 - 2022-12-05 - 2023-03-27 - 2023-12-04 - 2024-03-27 - 2024-12-04 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2146317 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-22-102.html current_status: open solicitation_topics: - topic_title: > Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (U43/U44 Clinical Trial Optional) branch: National Institutes of Health topic_number: PAR-22-102 topic_description: | Background Currently, there are only three medications (four formulations) approved by the FDA for the treatment of alcohol use disorder (AUD). The need for additional medications to treat those affected by AUD is urgently needed.In addition,alcohol misuseaffects virtually all tissues and is linked with dysfunction and failure of many organs and systems including the liver, heart, pancreas, lung, bone, and skeletal muscle, as well as digestive, vascular, endocrine, and immune systems.There are currently no FDA-approved therapies for alcohol-associated organ damage (AAOD) so effectivetherapies to prevent and treat AAOD are urgently needed. Purpose The purpose of this Funding Opportunity Announcement (FOA) is to provide support to SBC for the optimization, development, and translation of pharmaceutical research discoveries into new treatments for disorders that fall under the mission of NIAAA.The goal is to advance small molecules, natural products or biologics for AUD and AAOD through the drug development pipeline towards FDA approval and ultimately, commercialization. Due to the urgency of this public health need, projects supporting a lead compound with a robust body of background data in the basic science and early discovery phases to be poised for transition to the preclinical and clinical phases of medications development will be prioritized. Background data may include rigorous preclinical testing, sufficient bioactivity, stability, manufacturability, bioavailability, and in vivo efficacy and/or target engagement. Applications focusing solely on basic science research such as: novel target identification/validation, generation of new animal models, development/testing of new human laboratory models, assay development, new biomarkers, or mechanistic studies of the neurobiology of AUD are not considered responsive. By the end of the funding period, projects are expected to achieve milestones that significantly move the compound towards the next phase of drug development (e.g., pre-IND meeting, Investigational New Drug (IND) application). Women-owned and socially or economically disadvantaged small business are encouraged to apply. Research Objectives This FOA seeks applications that propose to advance the following classes of therapeutics beyond pre-clinical development by preparing to seek regulatory approval for future trials: small molecules, natural products, and biologics, which broadly include peptides, proteins, oligonucleotides, gene therapies, and cell therapies. Applicants are strongly encouraged to contact NIAAA Scientific/Research staff regarding the agent under development, to determine the fit for the FOA prior to submission Examples of responsive drug development activities and corresponding SBIR Phase assignment includes but is not limited to, Pre-clinical development – SBIR Phase I (Proof of Concept Phase) Chemistry, Manufacturing, and Control (CMC) activities (e.g., master and working banks development, purification development, CMC analytical development, formulation development, scale-up manufacturing or cGMP manufacturing) for IND-enabling pharmacology/toxicology tests Pharmacokinetic evaluations in species relevant for toxicology or human dose-prediction Preliminary safety such as safety pharmacology and/or dose-range finding toxicology Optimizing and/or validation of appropriate assays for pharmacokinetics, bioactivity (potency), target engagement markers or other assays to monitor safety to be used in human trials Drug interaction studies between medication and alcohol Further evaluation of compound safety/efficacy in established animal models, IND-enabling studies Pre-clinical development – SBIR Phase II (Research and Development) The Phase II can support more extensive IND-enabling development activities. IND-enabling toxicology, with toxicokinetics, if applicable Tumorigenicity evaluations particularly for gene therapies and cell therapies, if applicable Immunogenicity evaluations, if applicable Biodistribution studies, if applicable Large animal study to assess biocompatibility of means of clinical delivery of the candidate, if applicable Validation of appropriate assays such as for target engagement markers to enable human use IND and other regulatory submissions Clinical development – SBIR Phase I Evaluation of pharmacokinetics, preliminary safety, tolerability, alcohol interaction, dose-ranging, and/or initial efficacy in human subjects. Clinical development - SBIR Phase II For more advanced projects, a small early phase clinical trial can also be supported when feasible during the Phase II. Applications seeking to supportonlyearly-stage clinical trials with preliminary POC efficacy and safety data supported outside the SBIR/STTR program, may apply for a Direct to Phase II under this FOA. Small, early-phase clinical trials that are appropriate include: Proof-of-Concept Pilot studies Safety and Efficacy testing in a larger sample of human subjects Milestones Because therapy development is an inherently high-risk process, it is anticipated that there may be significant attrition as projects move through the therapy development process. Milestones are goals that are quantifiable for measuring success that can be used for go/no-go decision-making for the project, and should have quantitative criteria associated with them (see Section IV.2 for details). NIAAA intends to only move forward agents that are both efficacious and safe. Although the primary goals are to assess safety and toxicology, lack of evidence of a trend towards efficacy in the dose range where the candidate is safe can also be a consideration for discontinuation. U44 Phase I/II transition Applicants can submit separate Phase I (U43) or Phase II (U44) applications. However, if Phase I and Phase II are submitted together in one application (U44 Fast-Track), then an administrative review will be conducted by NIAAA Program staff to decide whether a project will be considered for transition from the Phase I to the Phase II. Phase II eligible projects must have a candidate that has been manufactured with satisfactory purity and stability, verified to have activity in vivo and/or in vitro as necessary, have bioavailability with a proper formulation, and have a good preliminary safety profile. Prior to commencement of the clinical trial (defined as first subject signature on an informed consent form), the applicant must provide the following to NIAAA for review and/or approval. Investigational Review Board (IRB) approval; IRB approved Study protocol and Informed Consent; FDA IND or IND waiver; New or revised/updated data and safety monitoring plan; Data and Safety Monitoring Board configuration and charter; Agreement with NIAAA staff on updated timeline, milestones and budget for clinical trial NIAAA approval of protocol and safety monitoring plan Quality and Compliance Requirements Since the goal of this program is to generate therapeutics which will be eligible for FDA approval, adherence to compliance and quality criteria is required. It is expected that all IND-enabling nonclinical studies will be performed in a manner consistent with Good Laboratory Practices (GLP). Investigational products should be produced under current Good Manufacturing Practices (cGMP). Bioassays such as pharmacokinetics, pharmacodynamics or immunogenicity should, when possible, be performed under GLP guidelines. All clinical trials must be performed following Good Clinical Practices (GCP) and be in accord with NIAAA Policy. Intellectual Property (IP) Since the ultimate goal of the SBIR/STTR program is to bring new therapies to the market/patients, the program strongly encourages the awardees and/or their collaborators to obtain and retain any IP developed around the therapy during the project period (see instructions on attachment of letters to address IP issues in Section IV.2). Awardees are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the therapy development process. PDs/PIs are expected to work closely with their institutional technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. For rare or ultra-rare diseases where commercialization may be challenging, applicants are encouraged to discuss alternative strategies with NIAAA Scientific/Research staff to get further guidance. Applications including the following types of studies will be considered non-responsive and will not be reviewed: Animal model development, basic research and studies of disease mechanisms, assay development Early research such as identifying and validating targets and generation of preliminary agents that are not suitable for human testing Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers. (NIAAA recognizes that target engagement markers developed under the Phase I may evolve into predictive markers for treatment trials, but it is not the intent of this FOA to develop predictive biomarkers.) Activities already performed utilizing other private or public funds to advance the agent HIV/AIDS related research studies sbir_topic_link: https://www.sbir.gov/node/2146319 subtopics: [ ] - solicitation_title: > Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (UT1/UT2 Clinical Trial Optional) solicitation_number: PAR-22-103 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2022-01-21 open_date: 2022-02-28 close_date: 2024-12-05 application_due_date: - 2022-03-28 - 2022-12-05 - 2023-03-27 - 2023-12-04 - 2024-03-27 - 2024-12-04 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2280855 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-22-103.html current_status: open solicitation_topics: - topic_title: > Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (UT1/UT2 Clinical Trial Optional) branch: National Institutes of Health topic_number: PAR-22-103 topic_description: | Background Currently, there are only three medications (four formulations) approved by the FDA for the treatment of alcohol use disorder (AUD). The need for additional medications to treat those affected by AUD is urgently needed.In addition,alcohol misuseaffects virtually all tissues and is linked with dysfunction and failure of many organs and systems including the liver, heart, pancreas, lung, bone, and skeletal muscle, as well as digestive, vascular, endocrine, and immune systems.There are currently no FDA-approved therapies for alcohol-associated organ damage (AAOD) so effectivetherapies to prevent and treat AAOD are urgently needed. Purpose The purpose of this Funding Opportunity Announcement (FOA) is to provide support to SBC for the optimization, development, and translation of pharmaceutical research discoveries into new treatments for disorders that fall under the mission of NIAAA.The goal is to advance small molecules, natural products or biologics for AUD and AAOD through the drug development pipeline towards FDA approval and ultimately, commercialization. Due to the urgency of this public health need, projects supporting a lead compound with a robust body of background data in the basic science and early discovery phases to be poised for transition to the preclinical and clinical phases of medications development will be prioritized. Background data may include rigorous preclinical testing, sufficient bioactivity, stability, manufacturability, bioavailability, and in vivo efficacy and/or target engagement. Applications focusing solely on basic science research such as: novel target identification/validation, generation of new animal models, development/testing of new human laboratory models, assay development, new biomarkers, or mechanistic studies of the neurobiology of AUD are not considered responsive. By the end of the funding period, projects are expected to achieve milestones that significantly move the compound towards the next phase of drug development (e.g., pre-IND meeting, Investigational New Drug (IND) application). Women-owned and socially or economically disadvantagedsmall business are encouraged to apply. Research Objectives This FOA seeks applications that propose to advance the following classes of therapeutics beyond pre-clinical development by preparing to seek regulatory approval for future trials: small molecules, natural products, and biologics, which broadly include peptides, proteins, oligonucleotides, gene therapies, and cell therapies. Applicants are strongly encouraged to contact NIAAA Scientific/Research staff regarding the agent under development, to determine the fit for the FOA prior to submission Examples of responsive drug development activities and corresponding STTR Phase assignment includes but is not limited to, Pre-clinical development – STTR Phase I (Proof of Concept Phase) -Chemistry, Manufacturing, and Control (CMC) activities (e.g., master and working banks development, purification development, CMC analytical development, formulation development, scale-up manufacturing or cGMP manufacturing) for IND-enabling pharmacology/toxicology tests Pharmacokinetic evaluations in species relevant for toxicology or human dose-prediction Preliminary safety such as safety pharmacology and/or dose-range finding toxicology Optimizing and/or validation of appropriate assays for pharmacokinetics, bioactivity (potency), target engagement markers or other assays to monitor safety to be used in human trials Drug interaction studies between medication and alcohol Further evaluation of compound safety/efficacy in established animal models, IND-enabling studies Pre-clinical development – STTR Phase II (Research and Development) The Phase II can support more extensive IND-enabling development activities. IND-enabling toxicology, with toxicokinetics, if applicable Tumorigenicity evaluations particularly for gene therapies and cell therapies, if applicable Immunogenicity evaluations, if applicable Biodistribution studies, if applicable Large animal study to assess biocompatibility of means of clinical delivery of the candidate, if applicable Validation of appropriate assays such as for target engagement markers to enable human use IND and other regulatory submissions Clinical development – STTR Phase I Evaluation of pharmacokinetics, preliminary safety, tolerability, alcohol interaction, dose-ranging, and/or initial efficacy in human subjects. Clinical development - STTR Phase II For more advanced projects, a small early phase clinical trial can also be supported when feasible during the Phase II. Applications seeking to supportonlyearly-stage clinical trials with preliminary POC efficacy and safety data supported outside the SBIR/STTR program, may apply for a Direct to Phase II under this FOA. Small, early-phase clinical trials that are appropriate include: Proof-of-Concept Pilot studies Safety and Efficacy testing in a larger sample of human subjects Milestones Because therapy development is an inherently high-risk process, it is anticipated that there may be significant attrition as projects move through the therapy development process. Milestones are goals that are quantifiable for measuring success that can be used for go/no-go decision-making for the project and should have quantitative criteria associated with them (see Section IV.2 for details). NIAAA intends to only move forward agents that are both efficacious and safe. Although the primary goals are to assess safety and toxicology, lack of evidence of a trend towards efficacy in the dose range where the candidate is safe can also be a consideration for discontinuation. UT2 Phase I/II transition Applicants can submit separate Phase I (UT1) or Phase II (UT2) applications. However, if Phase I and Phase II are submitted together in one application (UT2 Fast-Track), then an administrative review will be conducted by NIAAA Program staff to decide whether a project will be considered for transition from the Phase I to the Phase II. Phase II eligible projects must have a candidate that has been manufactured with satisfactory purity and stability, verified to have activity in vivo and/or in vitro as necessary, have bioavailability with a proper formulation, and have a good preliminary safety profile. Prior to commencement of the clinical trial (defined as first subject signature on an informed consent form), the applicant must provide the following to NIAAA for review and/or approval. Institutional Review Board (IRB) approval; IRB approved Study protocol and Informed Consent; FDA IND or IND waiver; New or revised/updated data and safety monitoring plan; Data and Safety Monitoring Board configuration and charter; Agreement with NIAAA staff on updated timeline, milestones and budget for clinical trial NIAAA approval of protocol and safety monitoring plan Quality and Compliance Requirements Since the goal of this program is to generate therapeutics which will be eligible for FDA approval, adherence to compliance and quality criteria is required. It is expected that all IND-enabling nonclinical studies will be performed in a manner consistent with Good Laboratory Practices (GLP). Investigational products should be produced under current Good Manufacturing Practices (cGMP). Bioassays such as pharmacokinetics, pharmacodynamics or immunogenicity should, when possible, be performed under GLP guidelines. All clinical trials must be performed following Good Clinical Practices (GCP) and be in accord with NIAAA Policy. Intellectual Property (IP) Since the ultimate goal of the SBIR/STTR program is to bring new therapies to the market/patients, the program strongly encourages the awardees and/or their collaborators to obtain and retain any IP developed around the therapy during the project period (see instructions on attachment of letters to address IP issues in Section IV.2). Awardees are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the therapy development process. PDs/PIs are expected to work closely with their institutional technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. For rare or ultra-rare diseases where commercialization may be challenging, applicants are encouraged to discuss alternative strategies with NIAAA Scientific/Research staff to get further guidance. Applications including the following types of studies will be considered non-responsive and will not be reviewed: Animal model development, basic research and studies of disease mechanisms, assay development Early research such as identifying and validating targets and generation of preliminary agents that are not suitable for human testing Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers. (NIAAA recognizes that target engagement markers developed under the Phase I may evolve into predictive markers for treatment trials, but it is not the intent of this FOA to develop predictive biomarkers.) Activities already performed utilizing other private or public funds to advance the agent HIV/AIDS related research studies sbir_topic_link: https://www.sbir.gov/node/2280857 subtopics: [ ] - solicitation_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R41/R42 Clinical Trial Not Allowed) solicitation_number: PAR-21-226 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-04-30 open_date: 2021-08-05 close_date: 2024-09-06 application_due_date: - 2021-09-06 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/1972473 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-21-226.html current_status: open solicitation_topics: - topic_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R41/R42 Clinical Trial Not Allowed) branch: National Institutes of Health topic_number: PAR-21-226 topic_description: | Many NIH-funded research projects rely on vertebrate and invertebrate animal models to study the basics of biology and physiology, to investigate pathological conditions, to examine disease mechanisms and treatments, and to design novel therapies and translational procedures. In this regard, ORIP plays a vital role through its support of research infrastructures and animal models of human diseases. With this FOA, ORIP encourages applications from small business concerns (SBCs) for Small Business Technology Transfer (STTR) projects to develop and implement novel tools and devices to improve animal welfare, to ease the management of individual animals and animal colonies, and to improve the monitoring and control of environmental conditions (e.g., temperature, humidity, vibrations, and ultrasonic noise) which affect outcomes and reproducibility in animal model research. Poor reproducibility of experiments that use animal models has negatively impacted biomedical research for many decades. The difficulty of improving reproducibility can be realized when considering the broad range of intrinsic factors (e.g., age, species, health status, and sex) and extrinsic factors (e.g., climate, illumination, physical restraints, odors, and noise) that can affect the physiological and biological response of animals. The variation of extrinsic factors between different animal facilities has been cited as a source of irreproducibility in animal research. Often, different laboratory animals require different environmental conditions for their optimal growth and well-being. Also, the amount and type of pathogens, or pollutants in a facility can influence the physiological response and welfare of animals. Even small differences in the handling and diets of animals can affect their physiological response. Accurate accounting for and monitoring of these factors can reduce variations between experiments and lead to improvements in animal model validations and translatability to human studies. To consistently maintain an optimal environment for research animals, there is a need for devices in animal facilities that can precisely and accurately monitor the environmental conditions, especially those that are challenging to account for such as humidity, vibrations, odors, and ultrasonic noise. Ideally, these devices will facilitate innovative and efficient operational procedures that utilize novel and green technologies to control and optimize the environmental conditions in animal facilities. Devices that can sensitively identify types and levels of various pathogens, allergens, and/or other pollutants are especially desired in environments supporting laboratory animals. The level and type of infectious agents and other contaminants are factors that often contribute to differences in the physiological response between animals in different colonies or animal research facilities. These factors are especially hard to account for when comparing and monitoring species in the same and/or different geographical locations. Additionally, needed are noninvasive or minimally invasive bio-logging devices for real-time monitoring of the behavior, food/water consumption, and bodily functions of animals. Such devices should be discreet, robust, easy to apply, and mobile, while being sensitive enough to register the physiology of different animals. Not only should these devices aid in the study and management of individual animals or entire colonies, but they should also lead to improvements in the performance of research protocols and data analysis. To implement such goals, there is a simultaneous need for new software that can combine data from different types of monitoring devices while being compatible with different data formats and linkable to existing databases. Novel devices and tools are also needed to help ease the process of handling and restraining of animals. These devices should reduce the stress to both the animals and researcher; stress is an experimental variable and must be minimized. Importantly, these devices should bring improvements in the efficiency of animal-handling practices and experimental procedures. Connecting diet, environmental conditions, and physiological measurements will provide a global picture of the health and life-history of individual animals and colonies. Properly accounting for these factors will further help to understand the effects of extrinsic factors on experimental outcomes. Innovation is an important component of productive engineering efforts; however, new ideas are not a sufficient factor for designing and building a useful tool or device. The concept of innovation in the context of engineering endeavors and non-hypothesis driven research should be understood broadly. For example, a technology which is well established in one field and adapted to a different field may open new research areas, enable novel research projects, improve experimental procedures, and have a wider impact than its original scope. These efforts are important for a broad class of animal models, including but not limited to widely used model organisms such as fruit fly, worm, mouse, rat, zebrafish, frog, rabbit, swine, and nonhuman primates amongst others. We emphasize that this FOA applies to invertebrate and vertebrate animals. Disease-specific devices are not covered under this FOA (e.g., glucose monitors, brain probes for specific neurological conditions, or cancer imaging tools). Nor are reagents and experimental protocols appropriate for this FOA. The development and implementation of novel tools and devices, and enhancement of existing equipment includes, but are not limited to, the following specific examples: Portable and robust software to help manage (including husbandry protocol procedures and assessment) and evaluate animal colonies; Reliable and discreet noninvasive or minimally invasive technology for the tracking and monitoring of animals, that either connect to or can easily communicate with existing formats and electronic management systems; Novel automated feeding systems, compatible with tagging and tracking devices to allow quantitation of feed consumption of individual animals; Devices and equipment to automate and support drug delivery by oral, subcutaneous, arterial, venous, or intracerebroventricular/intracerebral routes, and related methods to measure drug uptake and their technological implementation in species-specific devices; Robust and accurate devices for non-invasive measurement of physiological parameters such as heart rate and blood pressure in rodents and other model organisms used in research; Improved systems for the collection of multi-source data (including telemetric and extrinsic variables) and their analysis for comprehensive behavioral assessment of animal models; Better devices for phenotyping at the organismal as well as at the molecular levels; Safe and improved holding, restraining, and transfer devices for routine care, and for intra-facility transport such as large animal transfer chutes and nonhuman primate restraints; Better air and water filters for metabolic cages, aquaria, and other animal facility equipment; Better bedding materials (e.g., self-displaying levels of contaminants and microorganisms, odor-absorbent, recyclable) for animals; Better and easy to use tools and devices to measure levels of pathogens and contaminants in cages, aquaria, and animal facilities; Better devices/tools/equipment to sanitize and disinfect animal facilities and related equipment. Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application. sbir_topic_link: https://www.sbir.gov/node/1972475 subtopics: [ ] - solicitation_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) solicitation_number: PAR-21-225 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-04-30 open_date: 2021-08-06 close_date: 2024-09-06 application_due_date: - 2021-09-05 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 - 2024-09-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/1978901 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-21-225.html current_status: open solicitation_topics: - topic_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) branch: National Institutes of Health topic_number: PAR-21-225 topic_description: | Many NIH-funded research projects rely on vertebrate and invertebrate animal models to study the basics of biology and physiology, to investigate pathological conditions, to examine disease mechanisms and treatments, and to design novel therapies and translational procedures. In this regard, the Office of Research Infrastructure Programs (ORIP) plays a vital role through its support of research infrastructures and animal models of human diseases. With this FOA, ORIP encourages applications from small business concerns (SBCs) for Small Business Innovation Research (SBIR) projects to develop and implement novel tools and devices to improve animal welfare, to ease the management of individual animals and animal colonies, and to improve the monitoring and control of environmental conditions (e.g., temperature, humidity, vibrations, and ultrasonic noise) which affect outcomes and reproducibility in animal model research. Poor reproducibility of experiments that use animal models has negatively impacted biomedical research for many decades. The difficulty of improving reproducibility can be realized when considering the broad range of intrinsic factors (e.g., age, species, health status, and sex) and extrinsic factors (e.g., climate, illumination, physical restraints, odors, and noise) that can affect the physiological and biological response of animals. The variation of extrinsic factors between different animal facilities has been cited as a source of irreproducibility in animal research. Often, different laboratory animals require different environmental conditions for their optimal growth and well-being. Also, the amount and type of pathogens, or pollutants in a facility can influence the physiological response and welfare of animals. Even small differences in the handling and diets of animals can affect their physiological response. Accurate accounting for and monitoring of these factors can reduce variations between experiments and lead to improvements in animal model validations and translatability to human studies. To consistently maintain an optimal environment for research animals, there is a need for devices in animal facilities that can precisely and accurately monitor the environmental conditions, especially those that are challenging to account for such as humidity, vibrations, odors, and ultrasonic noise. Ideally, these devices will facilitate innovative and efficient operational procedures that utilize novel and green technologies to control and optimize the environmental conditions in animal facilities. Devices that can sensitively identify types and levels of various pathogens, allergens, and/or other pollutants are especially desired in environments supporting laboratory animals. The level and type of infectious agents and other contaminants are factors that often contribute to differences in the physiological response between animals in different colonies or animal research facilities. These factors are especially hard to account for when comparing and monitoring species in the same and/or different geographical locations. Additionally, needed are noninvasive or minimally invasive bio-logging devices for real-time monitoring of the behavior, food/water consumption, and bodily functions of animals. Such devices should be discreet, robust, easy to apply, and mobile, while being sensitive enough to register the physiology of different animals. Not only should these devices aid in the study and management of individual animals or entire colonies, but they should also lead to improvements in the performance of research protocols and data analysis. To implement such goals, there is a simultaneous need for new software that can combine data from different types of monitoring devices while being compatible with different data formats and linkable to existing databases. Novel devices and tools are also needed to help ease the process of handling and restraining of animals. These devices should reduce the stress to both the animals and researcher; stress is an experimental variable and must be minimized. Importantly, these devices should bring improvements in the efficiency of animal-handling practices and experimental procedures. Connecting diet, environmental conditions, and physiological measurements will provide a global picture of the health and life-history of individual animals and colonies. Properly accounting for these factors will further help to understand the effects of extrinsic factors on experimental outcomes. Innovation is an important component of productive engineering efforts; however, new ideas are not a sufficient factor for designing and building a useful tool or device. The concept of innovation in the context of engineering endeavors and non-hypothesis driven research should be understood broadly. For example, a technology which is well established in one field and adapted to a different field may open new research areas, enable novel research projects, improve experimental procedures, and have a wider impact than its original scope. These efforts are important for a broad class of animal models, including but not limited to widely used model organisms such as fruit fly, worm, mouse, rat, zebrafish, frog, rabbit, swine, and nonhuman primates amongst others. We emphasize that this FOA applies to invertebrate and vertebrate animals. Disease-specific devices are not covered under this FOA (e.g., glucose monitors, brain probes for specific neurological conditions, or cancer imaging tools). Nor are reagents and experimental protocols appropriate for this FOA. The development and implementation of novel tools and devices, and enhancement of existing equipment includes, but are not limited to, the following specific examples: Portable and robust software to help manage (including husbandry protocol procedures and assessment) and evaluate animal colonies; Reliable and discreet noninvasive or minimally invasive technology for the tracking and monitoring of animals, that either connect to or can easily communicate with existing formats and electronic management systems; Novel automated feeding systems, compatible with tagging and tracking devices to allow quantitation of feed consumption of individual animals; Devices and equipment to automate and support drug delivery by oral, subcutaneous, arterial, venous, or intracerebroventricular/intracerebral routes, and related methods to measure drug uptake and their technological implementation in species-specific devices; Robust and accurate devices for non-invasive measurement of physiological parameters such as heart rate and blood pressure in rodents and other model organism used in research; Improved systems for the collection of multi-source data (including telemetric and extrinsic variables) and their analysis for comprehensive behavioral assessment of animal models; Better devices for phenotyping at the organismal as well as at the molecular levels; Safe and improved holding, restraining, and transfer devices for routine care, and for intra-facility transport such as large animal transfer chutes and nonhuman primate restraints; Better air and water filters for metabolic cages, aquaria, and other animal facility equipment; Better bedding materials (e.g., self-displaying levels of contaminants and microorganisms, odor-absorbent, recyclable) for animals; Better and easy to use tools and devices to measure levels of pathogens and contaminants in cages, aquaria, and animal facilities; Better devices/tools/equipment to sanitize and disinfect animal facilities and related equipment. Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application. sbir_topic_link: https://www.sbir.gov/node/1978905 subtopics: [ ] - solicitation_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) solicitation_number: PAR-21-225 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-04-30 open_date: 2021-08-06 close_date: 2024-09-06 application_due_date: - 2021-09-06 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2142407 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-21-225.html current_status: open solicitation_topics: - topic_title: > Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed) branch: National Institutes of Health topic_number: PAR-21-225 topic_description: | Many NIH-funded research projects rely on vertebrate and invertebrate animal models to study the basics of biology and physiology, to investigate pathological conditions, to examine disease mechanisms and treatments, and to design novel therapies and translational procedures. In this regard, the Office of Research Infrastructure Programs (ORIP) plays a vital role through its support of research infrastructures and animal models of human diseases. With this FOA, ORIP encourages applications from small business concerns (SBCs) for Small Business Innovation Research (SBIR) projects to develop and implement novel tools and devices to improve animal welfare, to ease the management of individual animals and animal colonies, and to improve the monitoring and control of environmental conditions (e.g., temperature, humidity, vibrations, and ultrasonic noise) which affect outcomes and reproducibility in animal model research. Poor reproducibility of experiments that use animal models has negatively impacted biomedical research for many decades. The difficulty of improving reproducibility can be realized when considering the broad range of intrinsic factors (e.g., age, species, health status, and sex) and extrinsic factors (e.g., climate, illumination, physical restraints, odors, and noise) that can affect the physiological and biological response of animals. The variation of extrinsic factors between different animal facilities has been cited as a source of irreproducibility in animal research. Often, different laboratory animals require different environmental conditions for their optimal growth and well-being. Also, the amount and type of pathogens, or pollutants in a facility can influence the physiological response and welfare of animals. Even small differences in the handling and diets of animals can affect their physiological response. Accurate accounting for and monitoring of these factors can reduce variations between experiments and lead to improvements in animal model validations and translatability to human studies. To consistently maintain an optimal environment for research animals, there is a need for devices in animal facilities that can precisely and accurately monitor the environmental conditions, especially those that are challenging to account for such as humidity, vibrations, odors, and ultrasonic noise. Ideally, these devices will facilitate innovative and efficient operational procedures that utilize novel and green technologies to control and optimize the environmental conditions in animal facilities. Devices that can sensitively identify types and levels of various pathogens, allergens, and/or other pollutants are especially desired in environments supporting laboratory animals. The level and type of infectious agents and other contaminants are factors that often contribute to differences in the physiological response between animals in different colonies or animal research facilities. These factors are especially hard to account for when comparing and monitoring species in the same and/or different geographical locations. Additionally, needed are noninvasive or minimally invasive bio-logging devices for real-time monitoring of the behavior, food/water consumption, and bodily functions of animals. Such devices should be discreet, robust, easy to apply, and mobile, while being sensitive enough to register the physiology of different animals. Not only should these devices aid in the study and management of individual animals or entire colonies, but they should also lead to improvements in the performance of research protocols and data analysis. To implement such goals, there is a simultaneous need for new software that can combine data from different types of monitoring devices while being compatible with different data formats and linkable to existing databases. Novel devices and tools are also needed to help ease the process of handling and restraining of animals. These devices should reduce the stress to both the animals and researcher; stress is an experimental variable and must be minimized. Importantly, these devices should bring improvements in the efficiency of animal-handling practices and experimental procedures. Connecting diet, environmental conditions, and physiological measurements will provide a global picture of the health and life-history of individual animals and colonies. Properly accounting for these factors will further help to understand the effects of extrinsic factors on experimental outcomes. Innovation is an important component of productive engineering efforts; however, new ideas are not a sufficient factor for designing and building a useful tool or device. The concept of innovation in the context of engineering endeavors and non-hypothesis driven research should be understood broadly. For example, a technology which is well established in one field and adapted to a different field may open new research areas, enable novel research projects, improve experimental procedures, and have a wider impact than its original scope. These efforts are important for a broad class of animal models, including but not limited to widely used model organisms such as fruit fly, worm, mouse, rat, zebrafish, frog, rabbit, swine, and nonhuman primates amongst others. We emphasize that this FOA applies to invertebrate and vertebrate animals. Disease-specific devices are not covered under this FOA (e.g., glucose monitors, brain probes for specific neurological conditions, or cancer imaging tools). Nor are reagents and experimental protocols appropriate for this FOA. The development and implementation of novel tools and devices, and enhancement of existing equipment includes, but are not limited to, the following specific examples: Portable and robust software to help manage (including husbandry protocol procedures and assessment) and evaluate animal colonies; Reliable and discreet noninvasive or minimally invasive technology for the tracking and monitoring of animals, that either connect to or can easily communicate with existing formats and electronic management systems; Novel automated feeding systems, compatible with tagging and tracking devices to allow quantitation of feed consumption of individual animals; Devices and equipment to automate and support drug delivery by oral, subcutaneous, arterial, venous, or intracerebroventricular/intracerebral routes, and related methods to measure drug uptake and their technological implementation in species-specific devices; Robust and accurate devices for non-invasive measurement of physiological parameters such as heart rate and blood pressure in rodents and other model organism used in research; Improved systems for the collection of multi-source data (including telemetric and extrinsic variables) and their analysis for comprehensive behavioral assessment of animal models; Better devices for phenotyping at the organismal as well as at the molecular levels; Safe and improved holding, restraining, and transfer devices for routine care, and for intra-facility transport such as large animal transfer chutes and nonhuman primate restraints; Better air and water filters for metabolic cages, aquaria, and other animal facility equipment; Better bedding materials (e.g., self-displaying levels of contaminants and microorganisms, odor-absorbent, recyclable) for animals; Better and easy to use tools and devices to measure levels of pathogens and contaminants in cages, aquaria, and animal facilities; Better devices/tools/equipment to sanitize and disinfect animal facilities and related equipment. Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application. sbir_topic_link: https://www.sbir.gov/node/2142409 subtopics: [ ] - solicitation_title: 'Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)' solicitation_number: PAR-21-282 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-08-20 open_date: 2021-09-20 close_date: 2024-06-21 application_due_date: - 2021-10-20 - 2022-02-18 - 2022-06-20 - 2022-10-18 - 2023-02-21 - 2023-06-20 - 2023-10-18 - 2024-02-20 - 2024-06-20 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2075181 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-21-282.html current_status: open solicitation_topics: - topic_title: 'Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)' branch: National Institutes of Health topic_number: PAR-21-282 topic_description: | Blueprint MedTech The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to: Planning resources to support concept development, team building, needs assessment, and other early translational activities. Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring). Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues). Advice from industry experts (e.g., meetings with an external oversight committee). The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government. A. Overview The purpose of this Funding Opportunity Announcement (FOA) is to support SBCs in pursuing translational activities and clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported by this FOA include implementation of clinical prototype devices, non-clinical safety and effectiveness testing, design verification and validation activities. Additional activities include obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as support for a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. All projects will be submitted as SBIR Fast-Track applications. The Phase I project will support non-clinical translational device activities to obtain an IDE and IRB approval for an SR clinical study, or to obtain IRB approval for an NSR clinical study. The duration of SBIR Phase I project will depend on the maturity of the project at entry and can last up to two years. The Phase II project will support a clinical study and can last up to three years. The total project period (including both phases) must not exceed five years. Projects for which only a clinical phase is proposed are outside of the scope of this funding opportunity. Only Phase I projects that have met specific criteria (see below) will be eligible for transition to Phase II after NIH administrative review. Furthermore, ethical considerations are intrinsic to the responsible conduct of neuroscience research and the translation of neuroscience advances (scientific and technological) into clinical practice. It is expected the immediate next steps following completion of the clinical feasibility study supported under this cooperative agreement will be: a marketing application if only a clinical feasibility study or experience is needed to demonstrate the device is safe and effective. a larger clinical trial that will lead to a marketing application, or device design decisions made based on the information and data collected. This FOA will utilize a Small Business Innovation Research (SBIR) U44 cooperative agreement. As a cooperative agreement, this FOA supports milestone-driven projects and involves NIH program staff’s participation in negotiating project and milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program. An objective of the SBIR and STTR programs is to foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons and women-owned small businesses. This PAR encourages applications from diverse teams of investigators,including team members that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds B. Scope Projects must focus on a disorder that falls within the mission of participating NIH Blueprint Institutes and Centers. It is expected that devices within the scope of this program either: are very close to the 'final system' and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project; or have received Pre-Submission feedback from the FDA (see FDA/CDRH Q-Submission website and CDRH-learn website, Q-submissions for additional resources); or require early feasibility clinical data to inform the final device design or manufacturing processes. C. Entry criteria Applicants to the Blueprint MedTech program must include novel medical device technologies that will advance upon current neurotechnology (see non-responsive criteria below). Applicants should clearly define the current state of the art and highlight how their proposed technology will advance patient care. Responsive applications should propose medical devices, expected to be regulated by the FDA, with first-of-its-kind technologies, unique and novel intended use, new safety questions, and/or new regulatory questions. Responsive applications may also pivot and refine existing technologies toward new intended use and/or use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use). Proposed medical devices and their indications will likely follow De Novo or Premarket Approval (PMA) regulatory pathways. Medical devices with indications that may fit within an existing 510(k) pathway may also be accepted, as long as the application can demonstrate a clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates. Such devices should be reasonably expected to provide new clinically meaningful diagnostic or therapeutic options or improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations. It is recommended that applicants reach out to the NIH program staff listed at the bottom of this funding opportunity to discuss responsiveness criteria with respect to proposed technologies and indications. For entry to the program, projects should have: Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication. Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature. A compelling case for a successful IDE submission for an SR study, or IRB approval for an NSR study at the end of SBIR Phase I. Required regulatory approvals for clinical studies must be received prior to the start of the SBIR Phase II. Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying for funding through this grant mechanism. Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding will be expected to do so as the first milestone of the SBIR Phase I award. Funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback that is consistent with the likely success of the regulatory path to market and overall device development plan outlined in the grant application is received. In the event that FDA feedback is not consistent with the plans in the grant, program staff will evaluate the concerns and change of scope that would be needed and work with the investigators to determine the most appropriate course of action. Any remaining funds associated with the original award will not be released. D. Phases SBIR Phase I scope: Examples of studies that may be proposed during SBIR Phase I include, but are not limited to: Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval. Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards. GLP compliant large animal model safety and/or testing of an implanted device. Activities to become current Good Manufacturing Practice (cGMP) compliant. Activities to bring the development process under Design and Quality Systems Control. Studies addressing usability/acceptability. Device, software, firmware, and cybersecurity design verification and validation activities. Development of packaging, connectors, and other accessories necessary for the translation of this technology. Regulatory activities, including pre-submission meetings with FDA, IDE submission, or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HDE), Request for Risk Designation, 513(g) submission). SBIR Phase II scope: SBIR Phase II will support a clinical study that will lead to either: A marketing application if the clinical study is sufficient to demonstrate device safety and effectiveness for regulatory approval, or A larger clinical study that will lead to a marketing application; or Use of the clinical experience to inform device design decisions Examples of studies that may be proposed during SBIR Phase II include, but are not limited to: Optimization of the device design with respect to the human functional anatomy. Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical studies and eventual market approval. Studies of the key physiological variables that may impact the function of the device in humans. Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function E. Non-Responsive Activities Applications that include the following activities will be considered non-responsive and will be withdrawn and not reviewed: Animal model development: all in vivo models must be established and characterized, and available to the applicant; Efforts to develop neurotechnology for fundamental study of the nervous system; Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses; Projects focused on technologies for augmentation of healthy individuals; Delayed-onset clinical studies; Device technologies where the SBC does not have the needed intellectual property (IP) to enable further development/commercialization; Device technologies not regulated by the FDA. Applications that do not include the following will also be considered incomplete: The following other attahcments: Gantt Chart, Long-term care plan, Resource Checklist; A milestone plan; It is recommended that applicants reach out to the NIH program staff listed at the bottom of this funding opportunity to discuss responsiveness criteria with respect to proposed technology and indications F. Milestones Because device development is an inherently risky process, it is anticipated that there may be attrition as projects progress. Applications must propose one or more milestones for each objective in each year of the project. Milestones are goals that quantitatively measure success and efficacy that will be used for go/no-go decision-making for the project (see below for details). For each objective, provide details on methods, assumptions, experimental designs, and data and statistical analysis plans. Specify the quantitative criteria for measuring success and the rationale used to develop and justify the criteria identified. Quantitative criteria should be robust and consistent with the state-of-the-art in the field. Applicants are encouraged to read examples of milestones (e.g., https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/Devices-Milestones). NIH program staff will contact the applicant to discuss the project and any changes prior to funding the application, including negotiation of the proposed milestones. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Progress towards achievement of the final set of milestones will be evaluated yearly by NIH program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, funding for the project will be discontinued. In addition to milestones, the decision to continue funding will also be based on: a robust data package that allows for adequate interpretation of results (regardless of whether they have been captured in the milestones), overall progress, portfolio balance and program priorities, competitive landscape, and availability of funds. NIH encourages rigor and reproducibility of observed results. In some cases, conducting additional critical experiments will be important for NIH to have confidence in making a funding decision. SBIR Phase I to Phase II transition: An administrative review will be conducted by program staff, with potential input by independent consultants, to decide whether the Phase I project will be transitioned to the Phase II project based on the following: Successful achievement of the Phase I milestones; Likelihood of success in clinical testing; Competitive landscape; Program priorities and current portfolio balance (for funded projects, search NIH RePORTER https://projectreporter.nih.gov/); For significant risk studies, documentation of final or conditional approval of the IDE from the FDA; IRB approval(s); Submission of the final clinical protocol and supporting documents to NIH ; Feedback on activities involving human subjects obtained from the NIH Safety and Risk Assessment Committee (SARAC); Agreement on updated timeline, milestones and budget for the clinical study, and Availability of funds. G. Quality and Compliance Requirements The use of the Design Control and Quality Systems processes (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers) to the degree specified by the FDA is required. Intermediate steps in the Design Control process (e.g., design reviews, design verification, design validation, and design transfer activities) where appropriate, and IDE submission should be represented in the annual milestones. NIH recognizes that the degree to which Design Controls and Quality Systems processes are required by the FDA may vary substantially depending on the specific device. Investigators are encouraged to discuss these issues with the FDA and regulatory consultants prior to submitting an application so the extent to which these processes are required is clearly defined and verifiable in the application. Applicants should consider the Quality System requirements at the IDE stage (i.e., design controls) when preparing their device development activities. Applicants should consider Guidelines and Policies for Monitoring Clinical Research in the formation of a plan for data and safety monitoring as required by the appropriate IC. I. Pre-application Consultation As an U44 cooperative agreement, NIH program staff will be involved in the negotiation and execution of the project. When possible applicants are strongly encouraged to consult with NIH program staff early in the process of planning an application; this provides the opportunity for the SBC to receive further guidance on program scope, goals, and developing appropriate milestones. Applicants should contact program staff at least 12 weeks before a receipt date. J. Institute Statements of Interest Refer to Blueprint MedTech website for specific IC requirements and interest statements: sbir_topic_link: https://www.sbir.gov/node/2075185 subtopics: [ ] - solicitation_title: 'PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)' solicitation_number: PA-23-232 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-05 close_date: 2024-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443069 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PA-23-232.html current_status: open solicitation_topics: - topic_title: 'PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)' branch: National Institutes of Health topic_number: PA-23-232 topic_description: | The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization. National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives. The SBIR program, as established by law and reauthorized under Public Law 114-328, Section 1834, Public Law 115-232 and Public Law 117-183 ,is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting federal research and development needs; increase the private sector commercialization of innovations developed through federal research and development funding; and foster and encourage participation in innovation and entrepreneurship by women and socially or economically disadvantaged persons. The STTR program aims to foster technology transfer through cooperative research and development between small businesses and research institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3.2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0.45% to the STTR program. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. See Notice of NIH’s Interest in Diversity, NOT-OD-20-031. Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs (https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf). Purpose This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, Fast-Track, and Phase IIB grant applications. Small business applicants interested in submitting an SBIR grant application should submit to PA-23-230 or PA-23-231. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH Fast-Track: An NIH STTR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Phase IIB: Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIH Institutes and Centers (ICs) may allow small businesses who have been awarded a Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects. These renewals are typically offered for those projects that require extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, and behavioral interventions. Commercial potential (i.e. the probability that an application will result in a commercial product) will be a strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed Phase IIB project. Applicants are encouraged to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). Examples of third-party investors include, but are not limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase IIB project period. If applicable, the application should include letters of support from third-party investors. NIH ICs that accept Phase IIB applications, either through this SBIR NOFO or other specific NOFOs, are listed in the PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the NIH Targeted Funding Opportunities that allow Phase IIB applications. Specific Objectives The PHS 2023 -2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA represent scientific program areas that may be of interest to applicant small businesses in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to submit STTR grant applications in these areas. STTR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this NOFO. In addition to the general STTR solicitations, some awarding components have additional, specific NIH Targeted Funding Opportunities of potential interest to small businesses. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. All applications submitted to this Parent Notice of Funding Opportunity are not allowed to propose clinical trial(s). STTR applications that propose clinical trial(s) should be submitted to PA-23-233. Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program. sbir_topic_link: https://www.sbir.gov/node/2443071 subtopics: [ ] - solicitation_title: 'PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)' solicitation_number: PA-23-230 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-07 close_date: 2024-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443073 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PA-23-230.html current_status: open solicitation_topics: - topic_title: 'PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)' branch: National Institutes of Health topic_number: PA-23-230 topic_description: | The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization. National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives. The SBIR program, as established by law and reauthorized under Public Law 114-328, Section 1834, Public Law 115-232, and Public Law 117-183, is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting federal research and development needs; increase the private sector commercialization of innovations developed through federal research and development funding; and foster and encourage participation in innovation and entrepreneurship by women and socially or economically disadvantaged persons. The STTR program aims to foster technology transfer through cooperative research and development between small businesses and research institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3.2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0.45% to the STTR program. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. See Notice of NIH’s Interest in Diversity, NOT-OD-20-031. Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs (https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf). Purpose This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), Fast-Track (NIH only), and Phase IIB (NIH only) grant applications. Small business applicants interested in submitting an STTR grant application should submit to PA-23-232or PA-23-233. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH Fast-Track: An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Direct to Phase II: For small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, NIH can issue a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Direct to Phase II awards should be submitted as “New” applications and not continuations ("Renewal") of Phase I SBIR or STTR projects. NIH Phase IIB: Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIH Institutes and Centers (ICs) may allow small businesses who have been awarded a Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects. These renewals are typically offered for those projects that require extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, and behavioral interventions. Commercial potential (i.e. the probability that an application will result in a commercial product) will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed Phase IIB project. Applicants are encouraged to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). Examples of third-party investors include, but are not limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase IIB project period. If applicable, the application should include letters of support from third-party investors. NIH ICs that accept Phase IIB applications, either through this SBIR NOFOs or other specific NOFOs, are listed in the current PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the NIH Targeted Funding Opportunities that allow Phase IIB applications. Specific Objectives The PHS 2023 -2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA represent scientific program areas that may be of interest to applicant small businesses in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, or FDA awarding components identified in this NOFO are encouraged to submit SBIR grant applications in these areas. SBIR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this NOFO. In addition to the general SBIR solicitations, some awarding components have additional, specific NIH Targeted Funding Opportunities of potential interest to small businesses. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH, CDC, and FDA grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. All applications submitted to this Parent Notice of Funding Opportunity are not allowed to propose clinical trial(s). SBIR applications that propose clinical trial(s) should be submitted to PA-23-231 Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program. sbir_topic_link: https://www.sbir.gov/node/2443075 subtopics: [ ] - solicitation_title: 'PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)' solicitation_number: PA-23-231 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-05 close_date: 2024-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443077 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PA-23-231.html current_status: open solicitation_topics: - topic_title: 'PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)' branch: National Institutes of Health topic_number: PA-23-231 topic_description: | The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization. National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives. The SBIR program, as established by law and reauthorized under Public Law 114-328, Section 1834 Public Law 115-232, and Public Law 117-183, is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting federal research and development needs; increase the private sector commercialization of innovations developed through federal research and development funding; and foster and encourage participation in innovation and entrepreneurship by women and socially or economically disadvantaged persons. The STTR program aims to foster technology transfer through cooperative research and development between small businesses and research institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3.2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0.45% to the STTR program. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. See Notice of NIH’s Interest in Diversity, NOT-OD-20-031. Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs (https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf). Purpose This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), Fast-Track (NIH only), and Phase IIB (NIH only) grant applications. Small business applicants interested in submitting an STTR grant application should submit to PA-23-232 or PA-23-233. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH Fast-Track: An NIH SBIR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Direct to Phase II: For small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, NIH can issue a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Direct to Phase II awards should be submitted as “New” applications and not continuations ("Renewal") of Phase I SBIR or STTR projects. NIH Phase IIB: Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIH Institutes and Centers (ICs) may allow small businesses who have been awarded a Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects. These renewals are typically offered for those projects that require extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, and behavioral interventions. Commercial potential (i.e. the probability that an application will result in a commercial product) will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed Phase IIB project. Applicants are encouraged to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). Examples of third-party investors include, but are not limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase IIB project period. If applicable, the application should include letters of support from third-party investors. NIH ICs that accept Phase IIB applications, either through this SBIR NOFOs or other specific NOFOs, are listed in the current PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the NIH Targeted Funding Opportunities that allow Phase IIB applications. Specific Objectives The PHS 2023 -2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA represent scientific program areas that may be of interest to applicant small businesses in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH and CDC awarding components identified in this NOFO are encouraged to submit SBIR grant applications in these areas. SBIR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this NOFO. In addition to the general SBIR solicitations, some awarding components have additional, specific NIH Targeted Funding Opportunities of potential interest to small businesses. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH and CDC grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. All applications submitted to this Parent Notice of Funding Opportunity must propose clinical trial(s). SBIR applications that do not propose clinical trial(s) should be submitted to PA-23-230. Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program. See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. sbir_topic_link: https://www.sbir.gov/node/2443083 subtopics: [ ] - solicitation_title: 'Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)' solicitation_number: PAR-21-233 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-04-23 open_date: 2021-07-10 close_date: 2024-04-06 application_due_date: - 2021-08-10 - 2022-02-09 - 2022-08-09 - 2023-02-09 - 2023-08-09 - 2024-02-09 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/1966201 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-21-233.html current_status: open solicitation_topics: - topic_title: 'Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)' branch: National Institutes of Health topic_number: PAR-21-233 topic_description: | A. Overview Recent advances in biology offer unprecedented opportunities to discover new treatments for nervous system disorders. Biotherapeutic development, however, has inherent complexities with regards to characterization, manufacturing, delivery, and administration. Many academic laboratories and small business enterprises don’t have the full scope of expertise and resources available; this program seeks to bridge those gaps. For instance, all therapeutic candidates including biologics, must obtain the requisite toxicology and safety pharmacology data package and undergo regulatory review by the Food and Drug Administration (FDA). The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). To facilitate biotherapeutic discovery and development by the neuroscience community, the NIH Blueprint for Neuroscience Research established the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics), which includes biotechnology products and biologics-based therapies (e.g., peptides, proteins), gene (e.g., oligonucleotide- and viral-based) and cell therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies). Within this network, neuroscience researchers can utilize funding for discovery and development activities that can be conducted in their own laboratories in collaboration with NIH-funded consultants and optionally also access NIH contracted research organizations (CROs) that specialize in manufacturing, pharmacokinetics, toxicology, and Phase I clinical testing. A current list of BPN-Biologics contractors and consultants is available at: https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics/resources. This Funding Opportunity Announcement (FOA) invites applications from small business concerns for new BPN Biologics-based therapy projects. Applicants may propose to conduct all experimental activities in their own labs or collaborate with BPN-Biologics CROs on activities of their choice. A Program Director/Principal Investigator (PD/PI) with some, but not all, required expertise and resources may request funding to conduct studies in his or her own lab and collaborate with BPN-Biologics CROs on any remaining studies. By contrast, a PD/PI with limited experience in biologics development may opt to collaborate with all available BPN-Biologics CROs. Regardless, the Program PD/PI will be responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools. For each project funded under this FOA, the NIH will assemble a customized Lead Development Team (LDT). The LDT will be co-chaired by the PD/PI and a BPN-Biologics consultant and will include members of the PD/PI's team, additional BPN-Biologics consultants, and NIH staff. Projects are funded via a U44 Fast-Track cooperative agreement mechanism that is milestone-driven and involves the LDT’s participation in establishing the project plan, monitoring research progress, and setting appropriate go/no-go decision-making criteria. The LDT will develop an overall strategy for the project, including milestone proposals, plan studies to be conducted by BPN-Biologics contractors, and coordinate activities across different research sites. Progression from the U44 Phase I award to the U44 Phase II award will be based on administrative review and availability of funds (see Section D, Milestones). Potential applicants are strongly encouraged to read Frequently Asked Questions (FAQs) on the BPN-Biologics website (https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics/faqs) and contact NIH Scientific/Research staff and participating NIH Institutes/Centers prior to preparing an application to discuss how they may best utilize BPN-Biologics resources and whether their application fits the mission of a particular NIH IC. For this FOA, Phase I clinical testing, studies or trials refer to the common phases of a clinical trial. U44 Phase I and II refer to the project phases of the SBIR program. B. Scope BPN-Biologics is dedicated to the translation of biological therapeutics towards clinical testing by supporting the discovery and development of novel and promising biotherapeutic candidates for neurological diseases. This FOA is not designed to support discovery and development of small molecules (see Companion BPN Funding Opportunities). Applicants should contact NIH Scientific/Research staff regarding small peptides (less than 6 amino acids), natural products, and/or combination therapies to determine the fit for this FOA as well as suitability for discovery and development within the BPN. To be supported by this FOA, a project must focus on a single nervous system condition that falls within the mission of one of the participating Institutes or Centers. Please see Section C below for more information on the interests of the participating Institutes and Centers and alternative programs to consider. The overall objective is that all projects should reach the clinical trial stage (regardless of entry point) within a maximum of 5 years of BPN-Biologics funding and support. A schematic of this project structure is available on the BPN-Biologics website at: https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics/resources. Projects can enter at either: The Discovery stage to optimize a promising lead compound then transition into development with the goal on entering the clinic by the end of no later than the 5th year. Applications that propose entry with a Discovery stage biologic lead should include a Development work plan as well. or The Development stage to advance a single biologic candidate through Investigational New Drug (IND)-enabling toxicology studies, filing an IND package with the FDA, and an optional Phase I clinical trial. Potential applicants are strongly encouraged to contact NIH Scientific/Research staff prior to preparing an application. The following sections describe the Discovery and Development stages in more detail. General Entry Criteria: All projects must meet the following entry requirements: Identified one or more lead biologic agent(s) sufficiently profiled so that the parameters still to be optimized can be quantitatively specified. Established preliminary in vivo efficacy and target engagement data using agent(s) in relevant animal model(s). The agent(s) should show in vivo efficacy using clinically relevant outcome measures (e.g., biochemical, anatomical and/or functional, when possible) and in vivo target engagement (e.g., measurement of target binding or proximal downstream effects) at the clinically intended site of action, using sufficient experimental and statistical rigor in a relevant animal in vivo proof-of-concept model. Applications may be considered without an in vivo/ex vivo efficacy requirement if there is a clear rationale backed-up with compelling in vitro data. Demonstrated that the key in vitro and in vivo assays are suitable to drive the characterization and optimization of lead biologics in a rigorous fashion and are available in either the applicant’s or collaborator’s laboratories. The proposed approach is unlikely to be blocked by any legal (e.g., intellectual property) constraints to pursuing the proposed agent(s) and using the proposed assays and models for research purposes and/or commercial development. Discovery Stage Projects that require lead characterization and optimization to improve the potency and/or suitability for clinical testing will enter the BPN-Biologics at the Discovery stage. The BPN-Biologics supports a maximum of two years of lead optimization. Therefore, by the end of the U44 Phase I, the PD/PI should have identified a clinical candidate that meets the entry criteria for the Development stage (U44 Phase II). Examples of activities that can be supported during the Discovery (U44 Phase I) stage include, but are not limited to: Characterization of identity and properties (e.g., cell phenotype, aggregation, epitope mapping, glycosylation or other post-translational modification, number of unpaired cysteines, oxidation, deamination, isomerization, proteolytic sites, sequences, viscosity, stability) Optimization and/or qualification of appropriate assays for pharmacokinetic, target engagement markers, biodistribution, or other assays to monitor safety available to be used in the U44 Phase II Determination of optimal route of administration Lead optimization to improve effectiveness, diminish toxicity, and increase absorption (e.g., absorption, distribution, metabolism, and excretion (ADME)) Demonstration of adequate/stage-appropriate preliminary safety, such as safety pharmacology and/or dose-range finding toxicology Initial development of pharmacodynamic biomarker assay(s) The goal at the end of the Discovery stage is to select a clinical candidate with appropriate bioactivity, stability, manufacturability, and bioavailability by the intended route of administration for development. Other requirements include target engagement with defined minimal and optimal doses by the intended route of administration, other favorable properties consistent with the desired clinical application, and in vivo efficacy when applicable. Projects with only in vitro data need compelling data and rationale that the in vivo studies are not necessary or appropriate. Projects that meet this goal will enter Development in the U44 Phase II award, beginning with the preparatory activities listed below. Development Stage The Development stage includes all IND-enabling studies, cGMP synthesis of clinical trial material, and Phase I clinical testing. Applications for entry into the Development stage must have identified the candidate therapeutic. Entry Criteria for the development Stage: A strong body of data linking the putative therapeutic target to the proposed disease indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease is required. The proposed therapeutic should have rationally laid out biological activity by the planned route of administration with exposure levels for activity being achievable based on absorption, distribution, metabolism, and excretion (ADME) properties appropriate for the intended clinical use. Demonstration that the ability of the PD/PI's institution to develop and commercialize the proposed biologic is unlikely to be blocked or impeded by legal (e.g., intellectual property) constraints and that there is support from the institution to file and maintain the patents estate and necessary regulatory documents along with associated cost (see Other Attachments in Section IV). All applications proposing to enter at the Development stage will begin with a U44 Phase I award of up to two years, to prepare for the IND-enabling studies supported during the U44 Phase II award. Projects that began at the Discovery stage will conduct all Development stage preparatory and IND-enabling studies during their U44 Phase II. Development stage U44 Phase I activities can include, but are not limited to: Any remaining optimization activities as listed above, if needed Non-GLP toxicology studies (e.g., dose-range finding toxicology) Formulation Scale up manufacture Replication of in vivo studies in the same or a different animal model A pre-IND meeting with FDA, if not already conducted The following are general expectations for a project to initiate Development IND-enabling studies within BPN-Biologics: Dose-range finding (DRF) toxicology studies (rodent and non-rodent) have shown an acceptable safety margin Manufacturing-related development processes, including compound assay release criteria (e.g. potency and stability indicating) have been established Optimal delivery route has been determined Development Activities for the U44 Phase II award may include the following: cGMP manufacturing of material for IND-enabling and/or Phase I clinical testing IND-enabling safety pharmacology and toxicology studies to determine a basis for clinical dose extrapolation using a relevant animal model IND document preparation and filing with the FDA Phase I clinical trial (a single and/or multiple ascending dose study to characterize safety, PK, and PD) (See below for more information regarding clinical trials The goal by the end of the Development stage is to begin a first-in-human Phase I clinical trial. Note: Key studies should be sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the results, with detailed information available about study design, execution, analysis, and interpretation. BPN-Biologics contractors can conduct the preclinical safety studies, cGMP manufacturing, formulation and other activities required to prepare for human testing. BPN-Biologics contractors will provide data and reports in a format suitable for inclusion in an IND application and will assist in the development of the application. The Phase I clinical trial can also be conducted through BPN-Biologics contractors. The PD/PI's Institution will be responsible for assembly and submission of the IND application and scheduling regulatory meetings with the FDA, and therefore, should include support for this activity in their plan. NIH staff and consultants on the LDT must be included in all meetings with the FDA. Additional Information regarding Clinical Trials Applicants are strongly advised to discuss plans with NIH program staff prior to submitting their application to determine whether a clinical trial is feasible within the proposed funding timeframe and/or available BPN-Biologics contract resources. In the event that only diseased patients are expected to be enrolled, the applicants’ own clinical site(s) must be proposed. Clinical Trial Design: Single dose or single ascending dose treatment which may be placebo-controlled or open-label studies; multiple ascending dose may be requested only if agent has a short half-life. Clinical trial outcomes may include safety, tolerability, pharmacokinetics and pharmacodynamics, target engagement and target modulation endpoints. The development of the protocol and management of the Phase I trial will be performed by a Clinical Development Team (CDT), which will evolve from the LDT and include the PD/PI, clinical consultants identified by the PD/PI, and NIH staff. The protocol-selected supporting trial documents, and regulatory documents will be submitted to NIH for administrative review (including internal and external experts) prior to commencement of the clinical trial (defined as signing of first informed consent). Applications Not Responsive to this FOA Non-responsive applications include those that involve any of the following activities: Basic research and studies of disease mechanism Animal model development Early discovery research, such as identifying and validating targets and generation of preliminary agents that are not suitable for human testing Development of small molecule compounds (covered by PAR-20-122 and PAR-20-111) Development of diagnostics and medical devices Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers as well as PET ligands Stand-alone clinical trials Studies directed beyond first-in-human Phase I clinical testing Non-responsive applications will not be reviewed. C. NIH Institute and Center Interests and Guidance National Institute on Aging (NIA) NIA is interested in projects that will provide drug development expertise and infrastructure support to researchers interested in developing new biologics aimed at modifying the behavioral symptoms in Alzheimer's disease (AD), delaying the onset or slowing the progression of AD, mild cognitive impairment (MCI), other dementias of aging and age-related cognitive decline. Researchers who may have the necessary drug development expertise and access to infrastructure to advance small molecules to the clinic should consider submitting an application to the Alzheimer's Drug Development Program (PAR-18-820). Regarding therapeutic approaches, NIA is interested in traditional biotherapeutic modalities such as gene and immunotherapies and other modalities such as genome editing, gene silencing, and PROTAC. NIA and the AD scientific community recognize that one of the major challenges to the successful development of drugs for AD is the poor translation of preclinical efficacy from AD animal models to the clinic. Meta analyses of preclinical studies indicate that a key factor contributing to the poor predictive power of AD animal models is the lack of standards in the design, conduct, and data analyses. Therefore, to improve the quality and predictive value of animal model studies NIA urges applicants to follow best practices guidelines as summarized at: https://grants.nih.gov/reproducibility/module_1/presentation_html5.html. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Without a specific "receptor", alcohol has numerous molecular targets in the brain, and alcohol-seeking behavior and alcoholism are influenced by multiple neurotransmitter systems, neuromodulators, hormones, and signal transduction pathways. Many potential target sites for which new pharmaceuticals may be developed have, therefore, been identified. These include neurotransmitter systems related to opioids, serotonin, dopamine, glutamate, γ-aminobutyric acid (GABA), endocannabinoids, the hypothalamic-pituitary-adrenal (HPA) axis, adenosine, neuropeptide systems (for example, neuropeptide Y, corticotropin releasing factor), signal transduction pathways (such as protein kinase A and protein kinase C); and gene transcription factors (such as delta Fos B and cAMP response element-binding protein [CREB]). NIAAA is interested in research aimed to develop pharmaceuticals targeting new molecular sites to provide effective therapy to a broader spectrum of alcoholic individuals. Recent research has discovered specific genetic variants that may contribute to the risk for alcoholism and/or render alcohol dependent individuals responsive to specific therapeutic agent. NIAAA is interested in supporting research to develop pharmaceuticals targeting individuals with identified genotypic and phenotypic characteristics to improve efficacy and safety. Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the Alcohol Research Centers will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators. National Eye Institute (NEI) The National Eye Institute (NEI) interest in BPN-Biologics is to develop novel therapies to treat diseases and disorders of the visual system, especially blinding eye diseases such as cataracts, glaucoma, age-related macular degeneration, retinitis pigmentosa and other conditions. The NEI is also interested in other visual system disorders such as strabismus and amblyopia that could be treated with biologics-based interventions. Each project should have a well-defined endpoint, achievable within a five-year time frame, for developing a treatment for a specific disease or disorder of the visual system. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a novel therapeutic that can then be tested in a clinical trial. If successful, a project funded under this program may lead to filing an IND-directed toxicological study, and Phase I clinical testing. Investigators are encouraged to contact NEI program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute. National Institute of Dental and Craniofacial Research (NIDCR) NIDCR is interested in BPN Biologics development for craniofacial disorders and painful disorders of the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain and other conditions. Recent advances in genomics and phenotyping of subjects with orofacial pain conditions have expanded the scope of potential targets to treat these conditions. Receptor systems, ion channels, and pro- and anti-inflammatory molecules have been implicated in chronic pain. NIDCR is interested in supporting research that will lead to highly efficacious and specific pharmacological treatments of subjects with orofacial pain disorders. Awardees will be required to comply with the NIDCR Clinical Terms of Award for activities that involve human subjects research that have been determined by NIDCR to need additional oversight. Investigators are encouraged to contact NIDCR program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute mission and strategic plan. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) The NICHD is interested in supporting research aimed to develop novel pharmacotherapies for the treatment of developmental disorders, diseases and conditions in pediatric population. Investigators are strongly encouraged to discuss their research plans with NICHD Scientific/Research contact prior to submitting their application. National Institute of Mental Health (NIMH) NIMH supports neuroscience research to discover the causes of mental illness and to develop more effective and safe treatments. NIMH has interest in applications proposing the development of biologics as an approach for the treatment of mental disorders, including treatment-resistant depression, bipolar disorder, schizophrenia, PTSD, and autism spectrum disorder. Researchers with expertise and interest in advancing small molecules to the clinics should consider submitting an application to the BPN-small molecules Program (PAR-20-111 and PAR-20-122), small molecules projects at the early clinical trials phase should consider the NIMH SBIR/STTR Programs or the First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01) PAR-18-427. Investigators interested in the development of small molecule projects are also encouraged to review the following NIMH drug discovery FOAs: Drug Discovery for Nervous System Disorders PAR-19-147 (R01) and PAR-19-146 (R21), Assay development and screening for discovery of chemical probes or therapeutic agents PAR-20-271 (R01), Discovery of in vivo Chemical Probes for Novel Brain Targets PAR-21-029 (R01), Discovery of Cell-based Chemical Probes for Novel Brain Targets PAR-21-028 (R21), National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction PAR-20-118 (U01) and PAR-20-119 (U19). For this initiative, NIMH will only support projects entering the BPN-Biologics at the Discovery stage for monogenetic severe neurodevelopmental health disorders (e.g., Autism Spectrum Disorders). NIMH will not support projects entering the BPN-Biologics at the Development (IND enabling/GMP synthesis or Phase I trials) stage. NIMH is interested in gene-based therapies such as genome-editing modalities and viral gene deliveries. NIMH is not interested in therapies based on large biologic macromolecules, (e.g., proteins, antibodies, and peptides) or oligonucleotides. Investigators are strongly encouraged to discuss their research plans with NIMH Scientific/Research contact prior to submission to determine alignment of the planned studies with NIMH priorities and to assess whether this or other NIMH funding opportunities are most appropriate. Consistent with NIMH's Research Domain Criteria (RDoC) initiative, research projects directed towards ameliorating pathophysiology that is potentially more proximal to specific functional deficits (domains) than DSM diagnostic entities are encouraged. Additional information about the RDoC approach can be found at the RDoC website. High-quality and reproducible studies that are reported to the scientific community in a transparent manner are an essential cornerstone of the research enterprise. Attention to principles of study design and transparency are essential to enable reviewers, the scientific community, and NIH to assess the quality of scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility (http://grants.nih.gov/reproducibility/index.htm) NIMH has published a Note with guidelines and priorities for potential applicants considering animal neurobehavioral approaches in research relevant to mental illnesses, investigators are strongly to follow the guidelines summarized at NOT-MH-19-053 if proposing to include behavioral measures. Further information on NIMH research priorities can be found in the NIMH Strategic Research Plan and Interventions Workgroup Report. Applicants are strongly encouraged to discuss applications with NIMH staff listed in Section VII - Agency Contact(s)Scientific/Research Contacts. National Institute of Neurological Disorder sand Stroke (NINDS) Examples of diseases relevant to the research mission of the NINDS can be found at https://www.ninds.nih.gov/Disorders/All-Disorders. Applicants are encouraged to contact the NINDS to discuss disease areas of interest as this list is not exhaustive. This FOA serves as the primary support mechanism at NINDS for the optimization and development biologics and biotechnology products. Applicants seeking support for early drug discovery research are encouraged to review NINDS SBIR/STTR programs. Applicants seeking support only to conduct early stage clinical trials should consider applying for an NINDS Exploratory Clinical Trial, through PAR-18-618 (or its reissue), which provides additional flexibility in budget and time, as well as the option of including a phase II trial. The quality and reproducibility of both preclinical and clinical research depend on the rigor with which researchers conduct studies, control for potential bias, and report essential methodological details. Examples of critical elements of a well-designed study are summarized on the NINDS website http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf. NINDS urges applicants to this program to consider these elements when describing supporting data and proposed studies. National Center for Complementary and Integrative Health (NCCIH) NCCIH is interested in supporting research on development of novel biologics from natural products (e.g., venoms and conotoxins) and microbial and microbiome therapies to modulate symptoms on nervous system disorders including pain, sleep disorders, anxiety disorders, mild depression, and stress etc. Investigators are strongly encouraged to discuss their research plans with the NCCIH Scientific/Research contact prior to submitting their applications. National Institute on Drug Abuse (NIDA) Through participating in this FOA, NIDA aims to provide drug development expertise and infrastructure to support the addiction researchers interested in developing new biotherapeutics for substance use disorders (SUD). Projects focused on cocaine, methamphetamine and marijuana use disorders are of high priority for NIDA because there are currently no FDA-approved treatments for these indications. NIDA will only support projects to develop innovative pharmacological approaches entering the BPN-Biologics at the Discovery stage. Specifically, NIDA is interested in using the BPN-Biologics mechanism to support (academic) addiction researchers in the "lead optimization" stages. NIDA applicants are strongly encouraged to take full advantage of the opportunities the BPN-Biologics affords, including collaboration with BPN-Biologics consultants and NIH-supported contract research organizations (CROs) that specialize in pharmacokinetics, toxicology, and manufacturing. Researchers who possess the drug development expertise and access to the necessary infrastructure to advance biotherapeutics to the clinic, should consider submitting their applications to specialized NIDA-administered programs. Investigators are strongly encouraged to discuss their research plans with NIDA program staff prior to submission to determine alignment of the planned studies with NIDA's interest and priorities. NIDA staff will also provide help in assessing whether this or other NIDA funding opportunities would be the most appropriate. D. Milestones Because biotherapeutic discovery and development are inherently high risk, it is expected that there will be attrition as projects progress. Go/No-Go milestones will be established by the NIH with input from the LDTs at the start of each project and updated as needed. An administrative review will be conducted by NIH program staff, with technical input from an External Oversight Committee (composed of senior non-federal scientists who are not directly involved in BPN-Biologics projects), to assess milestone progress and recommend which projects will advance from the U44 Phase I to the Phase II and assess progress after each subsequent milestone based on: Successful achievement of milestones The overall feasibility of project advancement, considering data that may not have been captured in milestones Competitive landscape for the disease indication and biotherapeutic target Program priorities Availability of funds Note: If a funded project does not make satisfactory progress toward the agreed upon milestones at any stage during the funding period, access to BPN-Biologics contract resources and future year grant funding may be discontinued (see Section VI.2). Approval for commencement of a clinical trial (defined as signing of informed consent by first prospective subject) will include the following: Successful achievement of the defined preclinical development milestones; Submission of an IND with documentation for one of the following: 1) acceptance of clinical protocol by FDA; 2) elapse of the 30-day post filing waiting period without comment from the FDA; 3) completion of protocol changes or amendments requested by FDA. Submission of the clinical protocol and supporting documents to NIH for administrative review and notification of NIH approval; Agreement on updated timeline and milestones for the clinical trial. E. Quality and Compliance Requirements Since the goal of this program is to generate therapeutics which will be eligible for FDA approval, adherence to compliance and quality criteria is required. It is expected that all IND enabling nonclinical studies will be performed in a manner consistent with Good Laboratory Practices (GLP) and current FDA guidance. All clinical trials must be performed following Good Clinical Practices (GCP) and in accord with NIH Policy for Data and Safety Monitoring. Investigational products for use in clinical trials must be produced under current Good Manufacturing Practice (cGMP) practices. F. Intellectual Property (IP) Since the ultimate goal of this program is to bring new biotherapeutics to the market, the creation and protection of intellectual property (IP) that will make biologic drug candidates attractive to potential licensing and commercialization partners are a significant consideration in designing research strategies and prioritizing projects for funding. This program is structured so that the awardee institution retains their assignment of IP rights and gains assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biologic drug candidates developed in this program. It is expected that the awardee institution will take responsibility for patent filings, maintenance and licensing efforts toward eventual commercialization. The PD/PI is expected to work closely with technology transfer/business development officials at his or her institution to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. Award recipients will be encouraged to identify and foster relationships with potential licensing and commercialization partners early in the drug development process, consistent with the goals of the BPN-Biologics. sbir_topic_link: https://www.sbir.gov/node/1966203 subtopics: [ ] - solicitation_title: > NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional) solicitation_number: PAR-21-224 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-05-05 open_date: 2021-08-05 close_date: 2024-04-06 application_due_date: - 2021-09-06 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/1972469 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-21-224.html current_status: open solicitation_topics: - topic_title: > NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional) branch: National Institutes of Health topic_number: PAR-21-224 topic_description: | Purpose: To facilitate the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies, NINDS has formed the Neurology Network of Excellence in Clinical Trials (NeuroNEXT, www.NeuroNEXT.org). NeuroNEXT has a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC) and a group of 25 geographically distributed clinical sites. This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. A separate clinical trials network has been established and funded by NINDS to conduct clinical trials and biomarker studies for stroke treatment, prevention and recovery; thus NeuroNEXT has been established for the conduct of studies in neurological disorders other than stroke. NeuroNEXT provides a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network is not specific to one disease, it has the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. The network is designed to increase the efficiency of clinical trials, to facilitate patient recruitment and retention, to increase the quality of neuroscience clinical trials, and to enable public-private partnerships. This FOA uses the U44 cooperative agreement mechanism and is open to eligible applicants, as defined in Section III. Academic researchers may wish to consider applying through PAR-21-223"NeuroNEXT Clinical Trials (U01)". "NeuroNEXT Infrastructure Resource Access (X01)" or any reissue if they wish to gain access to the network infrastructure but do not require funds for trial costs. Since conducting the clinical trials needed for commercialization may be capital-intensive, this FOA encourages business relationships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. In particular, this FOA will give competitive preferences and funding priority to applications deemed likely to result in a commercial product as indicated by an applicant's ability to secure independent third-party funds. An objective of the SBIR and STTR programs is to foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons and women-owned small businesses. This PAR encourages applications from diverse teams of investigators, including team members that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds. Definitions: For this funding opportunity announcement, Phase I and II clinical studies or trials refer to the common phases of a clinical trial. SBIR Phase I and II refer to the project phases of the SBIR program. Scope of the Program: This FOA encourages Fast Track, Phase II, and Phase IIB SBIR applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Applications for drugs or biologics should be supported by compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it is expected to be of benefit in ameliorating a specific aspect of the disease. Neurologic diseases chosen for study must fall within the primary responsibility of NINDS (www.ninds.nih.gov/funding/areas/index.htm). Multi-site studies in stroke prevention, treatment and/or recovery are not appropriate for this FOA; those studies would be considered by NIH StrokeNet: http://www.nihstrokenet.org/. Separate clinical trial networks also exist for the conduct of studies in neurological emergencies (SIREN: https://siren.network/) and pain (EPPIC-NET: https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NINDS-Role-HEAL-Initiative/NINDS-Role-HEAL-Initiative-EPPIC). Studies on these topics should be directed to the dedicated networks. Studies primarily focused on biomarker validation may also apply to one of the NINDS Biomarker funding opportunities https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Biomarkers. Phase 1 clinical trials should be directed to the exploratory clinical trial FOA (PAR-18-420 and PAR-18-617). Phase 1b/2a trials requiring multi-center implementation can be considered under this FOA. Applications in rare diseases are encouraged while recognizing that available patient pools may not be adequate to meet the sample size requirements normally required to establish the efficacy of an intervention. NINDS acknowledges that innovative, non-traditional trial designs including adaptive designs may be appropriate in rare disease studies. While NeuroNEXT is primarily intended for exploratory trials, the network will consider Phase II/III trials in diseases with a US prevalence of under 5,000 persons. Examples of appropriate studies under this FOA include, but are not limited to, those designed to: Evaluate and optimize the dose, formulation, safety, tolerability or pharmacokinetics of an intervention in the target population. Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity, pharmacodynamic response, target engagement, dose-response trends) in a human "proof of concept" trial. Select or rank the best of two or more potential interventions or dosing regimens to be evaluated in a subsequent trial, based on tolerability, safety data, biological activity, or preliminary clinical efficacy (e.g., futility trials). Evaluate biological activity relative to clinical endpoints. Applications seeking to obtain data needed for pharmacometric modeling are encouraged, with the ultimate aim of enabling the optimal design of a future efficacy trial of an intervention. For medical devices, in addition to providing initial clinical safety data, appropriate studies are those that inform the next phase of development, usually by finalizing the device design, establishing operator technique, and/or finalizing the choice of study endpoints for the design of a pivotal clinical trial. Fast Track Studies should implement clear go-no go criteria for continuing to the next Phase II SBIR. When possible, all studies should also include go-no go criteria for proceeding to the next trial phase after the Phase II award. These should be biomarker-informed wherever possible. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-process-drug-development-tools-guidance-industry-and-fda-staff This FOA is not intended to support the conduct of a clinical trial where the primary aim is to confirm efficacy of a proposed intervention. Implementation: Applicants should make note of the following: (1) Applicants to this FOA will be required to incorporate the NeuroNEXT infrastructure (www.neuronext.org) into their proposed study. Additional (ad-hoc) sites may be proposed to fulfill specific study requirements. All applicants will be required to use the master clinical trial agreements and central IRB that have been established for NeuroNEXT. (2) Rationale: Exploratory trials primarily test hypotheses in relatively small programs so that the acceptable risk and uncertainty are higher than in later stage programs. Exploratory clinical trials must anchor their rationale in (1) an unmet medical need; (2) a plausible biological mechanism; (3) non-clinical (in vitro and/or in vivo) data; and/or (4) early clinical data. Their individual weight should be carefully assessed in the specific context of the application at hand.; there is no requirement to provide support from all four areas. However, supporting data should be robust enough to justify the proposed phase of study. Applicants should consider the limitations of those studies with regards to the scientific rigor guidelines published by NINDS (see https://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-023.html). Preclinical data (such as from animal studies) that do not sufficiently meet the rigor guidelines or are not sufficiently associated with the human condition may be inadequate to support the rationale for the study. (3) Secondary Aims: Issues of study feasibility and refinement of study procedures may be addressed as secondary aims in an exploratory clinical trial, but not as the primary aim. Examples of such secondary aims include, but are not limited to, the following: Determining the optimal measure (endpoint), its variability, and/or the optimal timing of outcome evaluations in the context of the intervention, Collecting information on the utility of questionnaires, rating scales, or biomarkers, For Early Feasibility or Traditional Feasibility studies of medical devices, issues of study feasibility and refinement of study procedures are expected to be addressed as primary aims in addition to providing initial clinical safety data at this stage. These may include: Identifying appropriate modifications to the procedure or device to enable a subsequent Pivotal study on a finalized system; Refining the intended use population; Developing and refining data collection procedures; Refining the non-clinical test plans or methodologies; and Developing subsequent clinical study protocols. (4) The NIH recognizes that devices can vary greatly in terms of basic form and function, physiological bases for therapy, degree of invasiveness, etc. Consequently, the appropriate pathway to market may require a traditional Feasibility and Pivotal study in support of an eventual Pre-Market Approval submission, or may require a more limited study to address specific issues in support of an FDA 510(k) or 510(k) De Novo submission. Clinical studies involving devices may utilize the entire NeuroNEXT Network, or a more limited subset of centers selected based on appropriate expertise for the given device. Investigators are encouraged to contact NINDS Scientific/Research Staff as early as possible to discuss how the NeuroNEXT network may best be utilized in support of their specific device project. NINDS anticipates that the majority of device projects utilizing NeuroNEXT will be traditional Feasibility Studies in order to best leverage the advantages of the network. A Traditional Feasibility Study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan a Pivotal Study. If an Early Feasibility Study is proposed, it should be designed in accordance with FDA's draft guidance, "Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies", to allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data while device design and operations are still in development. Early Feasibility and Traditional Feasibility study designs may include single-arm case series, on-off interventions (patients as own controls), device-device comparisons, comparisons to historic controls, comparisons to performance controls, or adaptive/Bayesian designs. (5) Rare Diseases: Applications in rare diseases are encouraged while recognizing that available patient pools may not be adequate to meet the sample size requirements normally required to establish the efficacy of an intervention. NINDS acknowledges that innovative, non-traditional trial designs including adaptive designs may be appropriate in rare disease studies. Regardless of the design it is especially important to ensure that the study design and statistical analysis plans will meet the stated objectives,and allow for the most efficient evaluation of the limited subjects. The application should clearly demonstrate recruitment feasibility at the participating sites and applicants are encouraged to fully engage patient advocacy groups or similar representatives of the affected disease community in study design, execution, and reporting. While NeuroNEXT is primarily intended for exploratory trials, the network will consider Phase 2/3 trials in diseases with a US prevalence of under 5,000 persons. (6) The award and continuation of funding are subject to milestones to be specified in the notice of grant award according to NINDS policies. (7) NIH Resources: As appropriate, applicants are encouraged to make use of the following resources for clinical research including: (a) Clinical and Translational Science Award (CTSA) program (https://ncats.nih.gov/ctsa); (b) NeuroQOL (http://www.neuroqol.org); (c) NIH Toolbox (http://www.nihtoolbox.org); (d) PROMIS (http://www.nihpromis.org); and (e) NINDS Common Data Elements (http://www.commondataelements.ninds.nih.gov). (8) Mobile Technologies: Applicants are encouraged to consider utilizing (at least experimentally) mobile technologies to facilitate data collection and protocol adherence on the part of research participants and study site staff. (9) For Biomarker Validation Studies, biomarkers are defined as a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Categories of biomarkers include: Susceptibility/risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamic/response, and safety. Biomarker studies should define their intended Context of Use (a statement that fully and clearly describes the way the biomarker will be used in future clinical trials). Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant. NINDS will provide guidance to potential applicants with input from NINDS Program Staff and the NeuroNEXT Executive Committee. Potential applicants are strongly encouraged to contact NINDS Scientific/Research Contacts (see Agency Contacts, Section VII) in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure before submitting an application. Pre-application consultation may include an introductory teleconference (at least 3 months prior to submission), followed by a conference call or in-person meeting with NINDS staff, as needed. Funding decisions will also be based on a study's fit for the network relative to other proposed and ongoing trials. Prior to grant award, awardees who do not have an exemption from the FDA must provide any additional FDA correspondence regarding the status of the protocol to the NINDS, especially if the trial has been placed under full or partial hold. sbir_topic_link: https://www.sbir.gov/node/1972471 subtopics: [ ] - solicitation_title: > NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required) solicitation_number: PAR-21-267 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-07-16 open_date: 2021-08-07 close_date: 2024-04-06 application_due_date: - 2021-09-05 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2033749 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-21-267.html current_status: open solicitation_topics: - topic_title: > NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required) branch: National Institutes of Health topic_number: PAR-21-267 topic_description: | Purpose NINDS is committed to advancing diagnostics and treatments for people burdened by neurological diseases, and the NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies and therapeutics for the diagnosis and treatment of neurological diseases. The SBIR/STTR Programs are structured in three phases. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business concern (SBC) will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. The development of medical biotechnology products is often impeded by a significant funding gap (known as the “Valley of Death”). In particular, the development of regulated products such as therapeutics and medical devices often requires several years and substantial capital investments, due in part to the high costs of clinical trials. This FOA supports applications from Small Business Concerns (SBCs) for exploratory clinical trials that contribute to the justification for a future trial to establish definitive efficacy (such as a Phase 3 clinical trial or a Pivotal device trial). This includes Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, as well as preliminary studies of surgical, behavioral or rehabilitation therapies. A wide range of trials at different stages of development are allowed, including first-in-human (as defined by the Food and Drug Administration), Phase 1 and 2 single-site studies, and Phase 2b multicenter studies in certain cases. Applications must aim to generate data that inform further clinical development of the proposed intervention or diagnostic, and in the case of FDA-regulated clinical trials applications must demonstrate readiness by including FDA approval of the proposed study. The earliest clinical studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing) or diagnostic. Midstage clinical studies will generally include randomization and blinding and should yield data that allow a clear go/no-go decision regarding whether the intervention should proceed to an efficacy trial. All applications must outline specific plans for future development in the event of promising results. This FOA is not intended to support the conduct of a clinical trial where the primary aim is to establish or confirm definitive efficacy. Applications to implement definitive efficacy trials (e.g., Phase 3 clinical trials of drugs or Pivotal device trials) should be submitted to NINDS Efficacy Clinical Trials (U01). Renewal applications of SBIR Phase II awards (i.e., SBIR Phase IIB) to conduct Phase I and II clinical studies should be submitted to NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44). The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. To achieve this goal, the FOA aims to facilitate the transition of clinical-stage projects to the commercialization stage by encouraging business relationships between NIH’s SBIR/STTR awardees and third-party investors and/or strategic partners. Definitions For this funding opportunity announcement Phase 1 and 2 clinical studies or trials refer to the common phases of a clinical trial. SBIR Phase I and II refer to the project phases of the SBIR program. Specific Objectives Scientific/Technical Scope Examples of appropriate studies under this FOA include, but are not limited to, those designed to: Evaluate and optimize the dose, formulation, safety, tolerability or pharmacokinetics of an intervention in healthy volunteers or the target population. Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., target engagement, dose-response trends, pharmacodynamic response) in a human "proof of concept" trial. Select or rank the best of two or more potential interventions or dosing regimens to be evaluated in a subsequent trial, based on tolerability, biological activity, or preliminary clinical efficacy (e.g., futility trials). For devices: Establish proof-of-principle and optimize techniques, operation, and usability of a device; inform the final device design decisions; and estimate the magnitude of treatment effect. NINDS recognizes that devices can differ greatly in terms of basic form and function, physiological bases for therapy, degree of invasiveness, etc. A Pivotal device study, for example, could potentially be used in support of an off-label indication of an existing market approved device, or to provide evidence for a novel device design in support of a Pre-Market Approval (PMA), Humanitarian Device Exemption (HDE), 510(k) or 510(k) De Novo submission. Due to the broad scope of possible medical devices and the varied nature of the regulatory path, investigators considering applications to evaluate devices are strongly encouraged to contact Scientific/Research Staff as early as possible to discuss these issues and determine the suitability of their project for this funding mechanism. This PAR encourages applications from diverse teams of investigators, including team members that are underrepresented in the biomedical, behavioral, or clinical research workforce. Fostering diversity by encouraging the participation of individuals from nationally underrepresented groups in the scientific research workforce is longstanding interest of Congress, and a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital (e.g., Public Law 114-329, American Innovation and Competitiveness Act of 2017, and Notice of NIH's Interest in Diversity, NOT-OD-20-031). Scientists and trainees from underrepresented backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Increasing participation by socially and economically disadvantaged and women-owned small businesses is also critical to the success of the SBIR and STTR programs.  Independent Third-Party Partners As significant funding is often needed to take regulated clinical projects to market beyond initial clinical studies, we encourage applicants to develop business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies initiated with NIH SBIR or STTR fundingThird-party partners include, but are not limited to, another company, a venture capital firm, an “angel” investor, a foundation, a university, a research institution, a state or local government, or any combination of the above. In light of these goals, the NINDS strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies. That said, NINDS recognizes that companies developing products that have small potential revenue streams or that target small patient populations face additional barriers to market entry that make them less attractive to investors and strategic partners at preclinical or early clinical stages of development. Many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations. For the purposes of this FOA, NINDS has defined small markets as development of novel products that: Address a rare disease, defined in the Rare Diseases Act of 2002 (Public Law 107-280) as a condition affecting fewer than 200,000 individuals in the United States; or Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year; or Target a young pediatric population defined as including neonates (0-28 days), infants ( sbir_topic_link: https://www.sbir.gov/node/2033753 subtopics: [ ] - solicitation_title: > NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) solicitation_number: PAR-21-265 program: SBIR phase: Phase II agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-07-16 open_date: 2021-08-05 close_date: 2024-04-06 application_due_date: - 2021-09-05 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2033755 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-21-265.html current_status: open solicitation_topics: - topic_title: > NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) branch: National Institutes of Health topic_number: PAR-21-265 topic_description: | Purpose NINDS is committed to advancing diagnostics and treatments for people burdened by neurological diseases, and the NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies and therapeutics for the diagnosis and treatment of neurological diseases. The SBIR/STTR Programs are structured in three phases. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business concern (SBC) will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. The development of medical biotechnology products is often impeded by a significant funding gap (known as the “Valley of Death”). To achieve commercialization, some projects initiated with SBIR or STTR funding require considerable grant-in-aid financing beyond the SBIR/STTR Phase II award to achieve follow-on investment or commercialization. In particular, the development of regulated products such as therapeutics and medical devices often requires several years and substantial capital investments, due in part to the high costs of clinical trials. This FOA supports SBIR Phase IIB applications from Small Business Concerns (SBCs) for clinical trials or clinical research that contribute to the justification for a future trial to establish efficacy (such as a Phase 3 trial or a Pivotal device trial). This includes Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, as well as preliminary studies of surgical, behavioral or rehabilitation therapies. A wide range of trials at different stages of development are allowed, including first-in-human (as defined by the Food and Drug Administration), Phase 1 and 2 single-site studies, and Phase 2b multicenter studies. Applications must aim to generate data that inform further clinical development of the proposed intervention or diagnostic. The earliest studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing) or diagnostic. Later-stage studies will generally include randomization and blinding and should yield data that allow a clear go/no-go decision regarding whether the intervention should proceed to an efficacy trial. All applications must outline specific plans for future development in the event of promising results. In addition, NINDS recognizes that companies developing products that have small potential revenue streams or that target small patient populations face additional barriers to market entry that make them less attractive to investors and strategic partners at preclinical or early clinical stages of development. Many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations. For the purposes of this FOA, NINDS has defined small markets as development of novel products that: Address a rare disease, defined in the Rare Diseases Act of 2002 (Public Law 107-280) as a condition affecting fewer than 200,000 individuals in the United States; or Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year; or Target a young pediatric population defined as including neonates (0-28 days), infants ( sbir_topic_link: https://www.sbir.gov/node/2033757 subtopics: [ ] - solicitation_title: > NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) solicitation_number: PAR-21-266 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-07-16 open_date: 2021-08-05 close_date: 2024-04-06 application_due_date: - 2021-09-05 - 2022-01-05 - 2022-04-05 - 2022-09-05 - 2023-01-05 - 2023-04-05 - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2033759 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PAR-21-266.html current_status: open solicitation_topics: - topic_title: > NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) branch: National Institutes of Health topic_number: PAR-21-266 topic_description: | Purpose NINDS is committed to advancing diagnostics and treatments for people burdened by neurological diseases, and the NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies and therapeutics for the diagnosis and treatment of neurological diseases. The SBIR/STTR Programs are structured in three phases. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business concern (SBC) will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. The development of medical biotechnology products is often impeded by a significant funding gap (known as the “Valley of Death”). In particular, the development of regulated products such as therapeutics and medical devices often requires several years and substantial capital investments, due in part to the high costs of clinical trials. This FOA supports applications from Small Business Concerns (SBCs) for exploratory clinical trials that contribute to the justification for a future trial to establish definitive efficacy (such as a Phase 3 clinical trial or a Pivotal device trial). This includes Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, as well as preliminary studies of surgical, behavioral or rehabilitation therapies. A wide range of trials at different stages of development are allowed, including first-in-human (as defined by the Food and Drug Administration), Phase 1 and 2 single-site studies, and Phase 2b multicenter studies in certain cases. Applications must aim to generate data that inform further clinical development of the proposed intervention or diagnostic, and in the case of FDA-regulated clinical trials applications must demonstrate readiness by including FDA approval of the proposed study. The earliest clinical studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing) or diagnostic. Midstage clinical studies will generally include randomization and blinding and should yield data that allow a clear go/no-go decision regarding whether the intervention should proceed to an efficacy trial. All applications must outline specific plans for future development in the event of promising results. This FOA is not intended to support the conduct of a clinical trial where the primary aim is to establish or confirm definitive efficacy. Applications to implement definitive efficacy trials (e.g., Phase 3 clinical trials of drugs or Pivotal device trials) should be submitted to NINDS Efficacy Clinical Trials (U01). Renewal applications of SBIR Phase II awards (i.e., SBIR Phase IIB) to conduct Phase I and II clinical studies should be submitted to NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44). The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. To achieve this goal, the FOA aims to facilitate the transition of clinical-stage projects to the commercialization stage by encouraging business relationships between NIH’s SBIR/STTR awardees and third-party investors and/or strategic partners. Definitions For this funding opportunity announcement Phase 1 and 2 clinical studies or trials refer to the common phases of a clinical trial. SBIR Phase I and II refer to the project phases of the SBIR program. Specific Objectives Scientific/Technical Scope Examples of appropriate studies under this FOA include, but are not limited to, those designed to: Evaluate and optimize the dose, formulation, safety, tolerability or pharmacokinetics of an intervention in healthy volunteers or the target population. Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., target engagement, dose-response trends, pharmacodynamic response) in a human "proof of concept" trial. Select or rank the best of two or more potential interventions or dosing regimens to be evaluated in a subsequent trial, based on tolerability, biological activity, or preliminary clinical efficacy (e.g., futility trials). For devices: Establish proof-of-principle and optimize techniques, operation, and usability of a device; inform the final device design decisions; and estimate the magnitude of treatment effect. NINDS recognizes that devices can differ greatly in terms of basic form and function, physiological bases for therapy, degree of invasiveness, etc. A Pivotal device study, for example, could potentially be used in support of an off-label indication of an existing market approved device, or to provide evidence for a novel device design in support of a Pre-Market Approval (PMA), Humanitarian Device Exemption (HDE), 510(k) or 510(k) De Novo submission. Due to the broad scope of possible medical devices and the varied nature of the regulatory path, investigators considering applications to evaluate devices are strongly encouraged to contact Scientific/Research Staff as early as possible to discuss these issues and determine the suitability of their project for this funding mechanism. This PAR encourages applications from diverse teams of investigators, including team members that are underrepresented in the biomedical, behavioral, or clinical research workforce Fostering diversity by encouraging the participation of individuals from nationally underrepresented groups in the scientific research workforce is longstanding interest of Congress, and a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital (e.g., Public Law 114-329, American Innovation and Competitiveness Act of 2017, and Notice of NIH's Interest in Diversity, NOT-OD-20-031). Scientists and trainees from underrepresented backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Increasingparticipation by socially andeconomically disadvantagedand women-owned small businesses isalsocritical to the success of the SBIR and STTR programs.  Independent Third-Party Partners As significant funding is often needed to take regulated clinical projects to market beyond initial clinical studies, we encourage applicants to develop business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies initiated with NIH SBIR or STTR funding. Third-party partners include, but are not limited to, another company, a venture capital firm, an “angel” investor, a foundation, a university, a research institution, a state or local government, or any combination of the above. In light of these goals, the NINDS strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies. That said, NINDS recognizes that companies developing products that have small potential revenue streams or that target small patient populations face additional barriers to market entry that make them less attractive to investors and strategic partners at preclinical or early clinical stages of development. Many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations. For the purposes of this FOA, NINDS has defined small markets as development of novel products that: Address a rare disease, defined in the Rare Diseases Act of 2002 (Public Law 107-280) as a condition affecting fewer than 200,000 individuals in the United States; or Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year; or Target a young pediatric population defined as including neonates (0-28 days), infants ( sbir_topic_link: https://www.sbir.gov/node/2033761 subtopics: [ ] - solicitation_title: 'Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)' solicitation_number: PAR-21-162 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-03-29 open_date: 2021-07-10 close_date: 2024-04-06 application_due_date: - 2021-08-10 - 2022-02-09 - 2022-08-09 - 2023-02-09 - 2023-08-09 - 2024-02-09 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2142411 solicitation_agency_url: https://grants.nih.gov/grants/guide/pa-files/PAR-21-162.html current_status: open solicitation_topics: - topic_title: 'Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)' branch: National Institutes of Health topic_number: PAR-21-162 topic_description: | A. Overview Recent advances in biology offer unprecedented opportunities to discover new treatments for nervous system disorders. Biotherapeutic development, however, has inherent complexities with regards to characterization, manufacturing, delivery, and administration. Many academic laboratories and small business enterprises don’t have the full scope of expertise and resources available; this program seeks to bridge those gaps. For instance, all therapeutic candidates including biologics, must obtain the requisite toxicology and safety pharmacology data package and undergo regulatory review by the Food and Drug Administration (FDA). The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). To facilitate biotherapeutic discovery and development by the neuroscience community, the NIH Blueprint for Neuroscience Research established the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics), which includes biotechnology products and biologics-based therapies (e.g., peptides, proteins), gene (e.g., oligonucleotide- and viral-based) and cell therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies). Within this network, neuroscience researchers can utilize funding for discovery and development activities that can be conducted in their own laboratories in collaboration with NIH-funded consultants and optionally also access NIH contracted research organizations (CROs) that specialize in manufacturing, pharmacokinetics, toxicology, and Phase I clinical testing. A current list of BPN-Biologics contractors and consultants is available at: https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-resources. This Funding Opportunity Announcement (FOA) invites applications from small business concerns for new BPN Biologics-based therapy projects. Applicants may propose to conduct all experimental activities in their own labs or collaborate with BPN-Biologics CROs on activities of their choice. A Program Director/Principal Investigator (PD/PI) with some, but not all, required expertise and resources may request funding to conduct studies in his or her own lab and collaborate with BPN-Biologics CROs on any remaining studies. By contrast, a PD/PI with limited experience in biologics development may opt to collaborate with all available BPN-Biologics CROs. Regardless, the Program PD/PI will be responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools. For each project funded under this FOA, the NIH will assemble a customized Lead Development Team (LDT). The LDT will be co-chaired by the PD/PI and a BPN-Biologics consultant and will include members of the PD/PI's team, additional BPN-Biologics consultants, and NIH staff. Projects are funded via a U44 Fast-Track cooperative agreement mechanism that is milestone-driven and involves the LDT’s participation in establishing the project plan, monitoring research progress, and setting appropriate go/no-go decision-making criteria. The LDT will develop an overall strategy for the project, including milestone proposals, plan studies to be conducted by BPN-Biologics contractors, and coordinate activities across different research sites. Progression from the U44 Phase I award to the U44 Phase II award will be based on administrative review and availability of funds (see Section D, Milestones). Potential applicants are strongly encouraged to read Frequently Asked Questions (FAQs) on the BPN-Biologics website (https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-frequently-asked-questions) and contact NIH Scientific/Research staff and participating NIH Institutes/Centers prior to preparing an application to discuss how they may best utilize BPN-Biologics resources and whether their application fits the mission of a particular NIH IC. For this FOA, Phase I clinical testing, studies or trials refer to the common phases of a clinical trial. U44 Phase I and II refer to the project phases of the SBIR program. B. Scope BPN-Biologics is dedicated to the translation of biological therapeutics towards clinical testing by supporting the discovery and development of novel and promising biotherapeutic candidates for neurological diseases. This FOA is not designed to support discovery and development of small molecules (see Companion BPN Funding Opportunities). Applicants should contact NIH Scientific/Research staff regarding small peptides (less than 6 amino acids), natural products, and/or combination therapies to determine the fit for this FOA as well as suitability for discovery and development within the BPN. To be supported by this FOA, a project must focus on a single nervous system condition that falls within the mission of one of the participating Institutes or Centers. Please see Section C below for more information on the interests of the participating Institutes and Centers and alternative programs to consider. The overall objective is that all projects should reach the clinical trial stage (regardless of entry point) within a maximum of 5 years of BPN-Biologics funding and support. A schematic of this project structure is available on the BPN-Biologics website at: https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-resources. Projects can enter at either: The Discovery stage to optimize a promising lead compound then transition into development with the goal on entering the clinic by the end of no later than the 5th year. Applications that propose entry with a Discovery stage biologic lead should include a Development work plan as well. or The Development stage to advance a single biologic candidate through Investigational New Drug (IND)-enabling toxicology studies, filing an IND package with the FDA, and an optional Phase I clinical trial. Potential applicants are strongly encouraged to contact NIH Scientific/Research staff prior to preparing an application. The following sections describe the Discovery and Development stages in more detail. General Entry Criteria: All projects must meet the following entry requirements: Identified one or more lead biologic agent(s) sufficiently profiled so that the parameters still to be optimized can be quantitatively specified. Established preliminary in vivo efficacy and target engagement data using agent(s) in relevant animal model(s). The agent(s) should show in vivo efficacy using clinically relevant outcome measures (e.g., biochemical, anatomical and/or functional, when possible) and in vivo target engagement (e.g., measurement of target binding or proximal downstream effects) at the clinically intended site of action, using sufficient experimental and statistical rigor in a relevant animal in vivo proof-of-concept model. Applications may be considered without an in vivo/ex vivo efficacy requirement if there is a clear rationale backed-up with compelling in vitro data. Demonstrated that the key in vitro and in vivo assays are suitable to drive the characterization and optimization of lead biologics in a rigorous fashion and are available in either the applicant’s or collaborator’s laboratories. The proposed approach is unlikely to be blocked by any legal (e.g., intellectual property) constraints to pursuing the proposed agent(s) and using the proposed assays and models for research purposes and/or commercial development. Discovery Stage Projects that require lead characterization and optimization to improve the potency and/or suitability for clinical testing will enter the BPN-Biologics at the Discovery stage. The BPN-Biologics supports a maximum of two years of lead optimization. Therefore, by the end of the U44 Phase I, the PD/PI should have identified a clinical candidate that meets the entry criteria for the Development stage (U44 Phase II). Examples of activities that can be supported during the Discovery (U44 Phase I) stage include, but are not limited to: Characterization of identity and properties (e.g., cell phenotype, aggregation, epitope mapping, glycosylation or other post-translational modification, number of unpaired cysteines, oxidation, deamination, isomerization, proteolytic sites, sequences, viscosity, stability) Optimization and/or qualification of appropriate assays for pharmacokinetic, target engagement markers, biodistribution, or other assays to monitor safety available to be used in the U44 Phase II Determination of optimal route of administration Lead optimization to improve effectiveness, diminish toxicity, and increase absorption (e.g., absorption, distribution, metabolism, and excretion (ADME)) Demonstration of adequate/stage-appropriate preliminary safety, such as safety pharmacology and/or dose-range finding toxicology Initial development of pharmacodynamic biomarker assay(s) The goal at the end of the Discovery stage is to select a clinical candidate with appropriate bioactivity, stability, manufacturability, and bioavailability by the intended route of administration for development. Other requirements include target engagement with defined minimal and optimal doses by the intended route of administration, other favorable properties consistent with the desired clinical application, and in vivo efficacy when applicable. Projects with only in vitro data need compelling data and rationale that the in vivo studies are not necessary or appropriate. Projects that meet this goal will enter Development in the U44 Phase II award, beginning with the preparatory activities listed below. Development Stage The Development stage includes all IND-enabling studies, cGMP synthesis of clinical trial material, and Phase I clinical testing. Applications for entry into the Development stage must have identified the candidate therapeutic. Entry Criteria for the development Stage: A strong body of data linking the putative therapeutic target to the proposed disease indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease is required. The proposed therapeutic should have rationally laid out biological activity by the planned route of administration with exposure levels for activity being achievable based on absorption, distribution, metabolism, and excretion (ADME) properties appropriate for the intended clinical use. Demonstration that the ability of the PD/PI's institution to develop and commercialize the proposed biologic is unlikely to be blocked or impeded by legal (e.g., intellectual property) constraints and that there is support from the institution to file and maintain the patents estate and necessary regulatory documents along with associated cost (see Other Attachments in Section IV). All applications proposing to enter at the Development stage will begin with a U44 Phase I award of up to two years, to prepare for the IND-enabling studies supported during the U44 Phase II award. Projects that began at the Discovery stage will conduct all Development stage preparatory and IND-enabling studies during their U44 Phase II. Development stage U44 Phase I activities can include, but are not limited to: Any remaining optimization activities as listed above, if needed Non-GLP toxicology studies (e.g., dose-range finding toxicology) Formulation Scale up manufacture Replication of in vivo studies in the same or a different animal model A pre-IND meeting with FDA, if not already conducted The following are general expectations for a project to initiate Development IND-enabling studies within BPN-Biologics: Dose-range finding (DRF) toxicology studies (rodent and non-rodent) have shown an acceptable safety margin Manufacturing-related development processes, including compound assay release criteria (e.g. potency and stability indicating) have been established Optimal delivery route has been determined Development Activities for the U44 Phase II award may include the following: cGMP manufacturing of material for IND-enabling and/or Phase I clinical testing IND-enabling safety pharmacology and toxicology studies to determine a basis for clinical dose extrapolation using a relevant animal model IND document preparation and filing with the FDA Phase I clinical trial (a single and/or multiple ascending dose study to characterize safety, PK, and PD) (See below for more information regarding clinical trials The goal by the end of the Development stage is to begin a first-in-human Phase I clinical trial. Note: Key studies should be sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the results, with detailed information available about study design, execution, analysis, and interpretation. BPN-Biologics contractors can conduct the preclinical safety studies, cGMP manufacturing, formulation and other activities required to prepare for human testing. BPN-Biologics contractors will provide data and reports in a format suitable for inclusion in an IND application and will assist in the development of the application. The Phase I clinical trial can also be conducted through BPN-Biologics contractors. The PD/PI's Institution will be responsible for assembly and submission of the IND application and scheduling regulatory meetings with the FDA, and therefore, should include support for this activity in their plan. NIH staff and consultants on the LDT must be included in all meetings with the FDA. Additional Information regarding Clinical Trials Applicants are strongly advised to discuss plans with NIH program staff prior to submitting their application to determine whether a clinical trial is feasible within the proposed funding timeframe and/or available BPN-Biologics contract resources. In the event that only diseased patients are expected to be enrolled, the applicants’ own clinical site(s) must be proposed. Clinical Trial Design: Single dose or single ascending dose treatment which may be placebo-controlled or open-label studies; multiple ascending dose may be requested only if agent has a short half-life. Clinical trial outcomes may include safety, tolerability, pharmacokinetics and pharmacodynamics, target engagement and target modulation endpoints. The development of the protocol and management of the Phase I trial will be performed by a Clinical Development Team (CDT), which will evolve from the LDT and include the PD/PI, clinical consultants identified by the PD/PI, and NIH staff. The protocol-selected supporting trial documents, and regulatory documents will be submitted to NIH for administrative review (including internal and external experts) prior to commencement of the clinical trial (defined as signing of first informed consent). Applications Not Responsive to this FOA Non-responsive applications include those that involve any of the following activities: Basic research and studies of disease mechanism Animal model development Early discovery research, such as identifying and validating targets and generation of preliminary agents that are not suitable for human testing Development of small molecule compounds (covered by PAR-20-122 and PAR-20-111) Development of diagnostics and medical devices Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers as well as PET ligands Stand-alone clinical trials Studies directed beyond first-in-human Phase I clinical testing Non-responsive applications will not be reviewed. C. NIH Institute and Center Interests and Guidance National Institute on Aging (NIA) NIA is interested in projects that will provide drug development expertise and infrastructure support to researchers interested in developing new biologics aimed at modifying the behavioral symptoms in Alzheimer's disease (AD), delaying the onset or slowing the progression of AD, mild cognitive impairment (MCI), other dementias of aging and age-related cognitive decline. Researchers who may have the necessary drug development expertise and access to infrastructure to advance small molecules to the clinic should consider submitting an application to the Alzheimer's Drug Development Program (PAR-18-820). Regarding therapeutic approaches, NIA is interested in traditional biotherapeutic modalities such as gene and immunotherapies and other modalities such as genome editing, gene silencing, and PROTAC. NIA and the AD scientific community recognize that one of the major challenges to the successful development of drugs for AD is the poor translation of preclinical efficacy from AD animal models to the clinic. Meta analyses of preclinical studies indicate that a key factor contributing to the poor predictive power of AD animal models is the lack of standards in the design, conduct, and data analyses. Therefore, to improve the quality and predictive value of animal model studies NIA urges applicants to follow best practices guidelines as summarized at: https://grants.nih.gov/reproducibility/module_1/presentation_html5.html. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Without a specific "receptor", alcohol has numerous molecular targets in the brain, and alcohol-seeking behavior and alcoholism are influenced by multiple neurotransmitter systems, neuromodulators, hormones, and signal transduction pathways. Many potential target sites for which new pharmaceuticals may be developed have, therefore, been identified. These include neurotransmitter systems related to opioids, serotonin, dopamine, glutamate, ?-aminobutyric acid (GABA), endocannabinoids, the hypothalamic-pituitary-adrenal (HPA) axis, adenosine, neuropeptide systems (for example, neuropeptide Y, corticotropin releasing factor), signal transduction pathways (such as protein kinase A and protein kinase C); and gene transcription factors (such as delta Fos B and cAMP response element-binding protein [CREB]). NIAAA is interested in research aimed to develop pharmaceuticals targeting new molecular sites to provide effective therapy to a broader spectrum of alcoholic individuals. Recent research has discovered specific genetic variants that may contribute to the risk for alcoholism and/or render alcohol dependent individuals responsive to specific therapeutic agent. NIAAA is interested in supporting research to develop pharmaceuticals targeting individuals with identified genotypic and phenotypic characteristics to improve efficacy and safety. Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the Alcohol Research Centers will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators. National Eye Institute (NEI) The National Eye Institute (NEI) interest in BPN-Biologics is to develop novel therapies to treat diseases and disorders of the visual system, especially blinding eye diseases such as cataracts, glaucoma, age-related macular degeneration, retinitis pigmentosa and other conditions. The NEI is also interested in other visual system disorders such as strabismus and amblyopia that could be treated with biologics-based interventions. Each project should have a well-defined endpoint, achievable within a five-year time frame, for developing a treatment for a specific disease or disorder of the visual system. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a novel therapeutic that can then be tested in a clinical trial. If successful, a project funded under this program may lead to filing an IND-directed toxicological study, and Phase I clinical testing. Investigators are encouraged to contact NEI program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute. National Institute of Dental and Craniofacial Research (NIDCR) NIDCR is interested in BPN Biologics development for craniofacial disorders and painful disorders of the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain and other conditions. Recent advances in genomics and phenotyping of subjects with orofacial pain conditions have expanded the scope of potential targets to treat these conditions. Receptor systems, ion channels, and pro- and anti-inflammatory molecules have been implicated in chronic pain. NIDCR is interested in supporting research that will lead to highly efficacious and specific pharmacological treatments of subjects with orofacial pain disorders. Awardees will be required to comply with the NIDCR Clinical Terms of Award for activities that involve human subjects research that have been determined by NIDCR to need additional oversight. Investigators are encouraged to contact NIDCR program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute mission and strategic plan. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) The NICHD is interested in supporting research aimed to develop novel pharmacotherapies for the treatment of developmental disorders, diseases and conditions in pediatric population. Investigators are strongly encouraged to discuss their research plans with NICHD Scientific/Research contact prior to submitting their application. National Institute of Mental Health (NIMH) NIMH supports neuroscience research to discover the causes of mental illness and to develop more effective and safe treatments. NIMH has interest in applications proposing the development of biologics as an approach for the treatment of mental disorders, including treatment-resistant depression, bipolar disorder, schizophrenia, PTSD, and autism spectrum disorder. Researchers with expertise and interest in advancing small molecules to the clinics should consider submitting an application to the BPN-small molecules Program (PAR-20-111 and PAR-20-122), small molecules projects at the early clinical trials phase should consider the NIMH SBIR/STTR Programs or the First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01) PAR-18-427. Investigators interested in the development of small molecule projects are also encouraged to review the following NIMH drug discovery FOAs: Drug Discovery for Nervous System Disorders PAR-19-147 (R01) and PAR-19-146 (R21), Assay development and screening for discovery of chemical probes or therapeutic agents PAR-20-271 (R01), Discovery of in vivo Chemical Probes for Novel Brain Targets PAR-21-029 (R01), Discovery of Cell-based Chemical Probes for Novel Brain Targets PAR-21-028 (R21), National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction PAR-20-118 (U01) and PAR-20-119 (U19). For this initiative, NIMH will only support projects entering the BPN-Biologics at the Discovery stage for monogenetic severe neurodevelopmental health disorders (e.g., Autism Spectrum Disorders). NIMH will not support projects entering the BPN-Biologics at the Development (IND enabling/GMP synthesis or Phase I trials) stage. NIMH is interested in gene-based therapies such as genome-editing modalities and viral gene deliveries. NIMH is not interested in therapies based on large biologic macromolecules, (e.g., proteins, antibodies, and peptides) or oligonucleotides. Investigators are strongly encouraged to discuss their research plans with NIMH Scientific/Research contact prior to submission to determine alignment of the planned studies with NIMH priorities and to assess whether this or other NIMH funding opportunities are most appropriate. Consistent with NIMH's Research Domain Criteria (RDoC) initiative, research projects directed towards ameliorating pathophysiology that is potentially more proximal to specific functional deficits (domains) than DSM diagnostic entities are encouraged. Additional information about the RDoC approach can be found at the RDoC website. High-quality and reproducible studies that are reported to the scientific community in a transparent manner are an essential cornerstone of the research enterprise. Attention to principles of study design and transparency are essential to enable reviewers, the scientific community, and NIH to assess the quality of scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility (http://grants.nih.gov/reproducibility/index.htm) NIMH has published a Note with guidelines and priorities for potential applicants considering animal neurobehavioral approaches in research relevant to mental illnesses, investigators are strongly to follow the guidelines summarized at NOT-MH-19-053 if proposing to include behavioral measures. Further information on NIMH research priorities can be found in the NIMH Strategic Research Plan and Interventions Workgroup Report. Applicants are strongly encouraged to discuss applications with NIMH staff listed in Section VII - Agency Contact(s)Scientific/Research Contacts. National Institute of Neurological Disorder sand Stroke (NINDS) Examples of diseases relevant to the research mission of the NINDS can be found at https://www.ninds.nih.gov/Disorders/All-Disorders. Applicants are encouraged to contact the NINDS to discuss disease areas of interest as this list is not exhaustive. This FOA serves as the primary support mechanism at NINDS for the optimization and development biologics and biotechnology products. Applicants seeking support for early drug discovery research are encouraged to review NINDS SBIR/STTR programs. Applicants seeking support only to conduct early stage clinical trials should consider applying for an NINDS Exploratory Clinical Trial, through PAR-18-618 (or its reissue), which provides additional flexibility in budget and time, as well as the option of including a phase II trial. The quality and reproducibility of both preclinical and clinical research depend on the rigor with which researchers conduct studies, control for potential bias, and report essential methodological details. Examples of critical elements of a well-designed study are summarized on the NINDS website http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf. NINDS urges applicants to this program to consider these elements when describing supporting data and proposed studies. National Center for Complementary and Integrative Health (NCCIH) NCCIH is interested in supporting research on development of novel biologics from natural products (e.g., venoms and conotoxins) and microbial and microbiome therapies to modulate symptoms on nervous system disorders including pain, sleep disorders, anxiety disorders, mild depression, and stress etc. Investigators are strongly encouraged to discuss their research plans with the NCCIH Scientific/Research contact prior to submitting their applications. National Institute on Drug Abuse (NIDA) Through participating in this FOA, NIDA aims to provide drug development expertise and infrastructure to support the addiction researchers interested in developing new biotherapeutics for substance use disorders (SUD). Projects focused on cocaine, methamphetamine and marijuana use disorders are of high priority for NIDA because there are currently no FDA-approved treatments for these indications. NIDA will only support projects to develop innovative pharmacological approaches entering the BPN-Biologics at the Discovery stage. Specifically, NIDA is interested in using the BPN-Biologics mechanism to support (academic) addiction researchers in the "lead optimization" stages. NIDA applicants are strongly encouraged to take full advantage of the opportunities the BPN-Biologics affords, including collaboration with BPN-Biologics consultants and NIH-supported contract research organizations (CROs) that specialize in pharmacokinetics, toxicology, and manufacturing. Researchers who possess the drug development expertise and access to the necessary infrastructure to advance biotherapeutics to the clinic, should consider submitting their applications to specialized NIDA-administered programs. Investigators are strongly encouraged to discuss their research plans with NIDA program staff prior to submission to determine alignment of the planned studies with NIDA's interest and priorities. NIDA staff will also provide help in assessing whether this or other NIDA funding opportunities would be the most appropriate. D. Milestones Because biotherapeutic discovery and development are inherently high risk, it is expected that there will be attrition as projects progress. Go/No-Go milestones will be established by the NIH with input from the LDTs at the start of each project and updated as needed. An administrative review will be conducted by NIH program staff, with technical input from an External Oversight Committee (composed of senior non-federal scientists who are not directly involved in BPN-Biologics projects), to assess milestone progress and recommend which projects will advance from the U44 Phase I to the Phase II and assess progress after each subsequent milestone based on: Successful achievement of milestones The overall feasibility of project advancement, considering data that may not have been captured in milestones Competitive landscape for the disease indication and biotherapeutic target Program priorities Availability of funds Note: If a funded project does not make satisfactory progress toward the agreed upon milestones at any stage during the funding period, access to BPN-Biologics contract resources and future year grant funding may be discontinued (see Section VI.2). Approval for commencement of a clinical trial (defined as signing of informed consent by first prospective subject) will include the following: Successful achievement of the defined preclinical development milestones; Submission of an IND with documentation for one of the following: 1) acceptance of clinical protocol by FDA; 2) elapse of the 30-day post filing waiting period without comment from the FDA; 3) completion of protocol changes or amendments requested by FDA. Submission of the clinical protocol and supporting documents to NIH for administrative review and notification of NIH approval; Agreement on updated timeline and milestones for the clinical trial. E. Quality and Compliance Requirements Since the goal of this program is to generate therapeutics which will be eligible for FDA approval, adherence to compliance and quality criteria is required. It is expected that all IND enabling nonclinical studies will be performed in a manner consistent with Good Laboratory Practices (GLP) and current FDA guidance. All clinical trials must be performed following Good Clinical Practices (GCP) and in accord with NIH Policy for Data and Safety Monitoring. Investigational products for use in clinical trials must be produced under current Good Manufacturing Practice (cGMP) practices. F. Intellectual Property (IP) Since the ultimate goal of this program is to bring new biotherapeutics to the market, the creation and protection of intellectual property (IP) that will make biologic drug candidates attractive to potential licensing and commercialization partners are a significant consideration in designing research strategies and prioritizing projects for funding. This program is structured so that the awardee institution retains their assignment of IP rights and gains assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biologic drug candidates developed in this program. It is expected that the awardee institution will take responsibility for patent filings, maintenance and licensing efforts toward eventual commercialization. The PD/PI is expected to work closely with technology transfer/business development officials at his or her institution to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. Award recipients will be encouraged to identify and foster relationships with potential licensing and commercialization partners early in the drug development process, consistent with the goals of the BPN-Biologics. sbir_topic_link: https://www.sbir.gov/node/2142413 subtopics: [ ] - solicitation_title: 'PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)' solicitation_number: PA-23-233 program: STTR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2023" release_date: 2023-07-12 open_date: 2023-08-05 close_date: 2024-04-06 application_due_date: - 2023-09-05 - 2024-01-05 - 2024-04-05 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2443063 solicitation_agency_url: https://grants.nih.gov/grants/guide/PA-files/PA-23-233.html current_status: open solicitation_topics: - topic_title: 'PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)' branch: National Institutes of Health topic_number: PA-23-233 topic_description: | The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America's Seed Fund, are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization. National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives. The SBIR program, as established by law and reauthorized under Public Law 114-328, Section 1834, Public Law 115-232, and Public Law 117-183, is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting federal research and development needs; increase the private sector commercialization of innovations developed through federal research and development funding; and foster and encourage participation in innovation and entrepreneurship by women and socially or economically disadvantaged persons. The STTR program aims to foster technology transfer through cooperative research and development between small businesses and research institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3.2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0.45% to the STTR program. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. See Notice of NIH’s Interest in Diversity, NOT-OD-20-031. Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs (https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf). Purpose This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, Fast-Track, and Phase IIB grant applications. Small business applicants interested in submitting an SBIR grant application should submit to PA-23-230 or PA-23-231. SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH Fast-Track: An NIH STTR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Phase IIB: Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIH Institutes and Centers (ICs) may allow small businesses who have been awarded a Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects. These renewals are typically offered for those projects that require extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, and behavioral interventions. Commercial potential (i.e. the probability that an application will result in a commercial product) will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed Phase IIB project. Applicants are encouraged to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). Examples of third-party investors include, but are not limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase IIB project period. If applicable, the application should include letters of support from third-party investors. NIH ICs that accept Phase IIB applications, either through this SBIR NOFOor other specific NOFOs, are listed in the PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the NIH Targeted Funding Opportunities that allow Phase IIB applications. Specific Objectives The PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA represent scientific program areas that may be of interest to applicant small businesses in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to submit STTR grant applications in these areas. STTR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this NOFO. In addition to the general STTR solicitations, some awarding components have additional, specific NIH Targeted Funding Opportunities of potential interest to small businesses. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. All applications submitted to this Parent Notice of Funding Opportunity must propose clinical trial(s). STTR applications that do not propose clinical trial(s) should be submitted to PA-23-232. Further information about the SBIR and STTR programs can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program. See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. sbir_topic_link: https://www.sbir.gov/node/2443065 subtopics: [ ] - solicitation_title: > NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) solicitation_number: RFA-HL-23-008 program: SBIR phase: Phase II agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2021-11-16 open_date: 2022-01-28 close_date: 2024-02-29 application_due_date: - 2022-02-28 - 2023-02-28 - 2024-02-28 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2100569 solicitation_agency_url: > https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-008.html current_status: open solicitation_topics: - topic_title: > NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) branch: National Institutes of Health topic_number: RFA-HL-23-008 topic_description: | Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease.? It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III, a Small Business Concern (SBC) will be able to launch a product commercially with non-SBIR funds. However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the validation studies required to obtain regulatory approval and launch a product. In particular, the development of therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process. Companies developing products that have small potential revenue streams or target small patient populations face additional barriers to market entry that make them less attractive at preclinical or early clinical stages of development to investors and strategic partners. In addition, many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations. Thus, despite the extensive R&D performed on such products during Phase II projects, the results are often insufficient to attract the substantial private investment needed for the eventual commercialization of the product. Many small businesses therefore become cash-starved before reaching the next critical milestone along the path toward commercialization.? Hence, this FOA is designed to address this funding gap between the end of the SBIR or STTR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development. A number of public and private organizations recognize the challenges associated with this funding gap and are taking steps to provide additional resources to advance a greater number of promising early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but are also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the preclinical stages of development, and some of these firms have established technology incubators to provide development support, including regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. In the rare disease area, patient advocacy groups and foundations have organized to accelerate progress in the development of treatments for their disease. Such programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.?It is anticipated that funding by third-party investors will be predicated on significant due diligence, thus encouraging awardees to formulate credible business plans for product commercialization. In addition, it is expected that third-party investors will maintain an active role in supporting the awardee during the product development phase and during pursuit of follow-on funding for commercialization. Specific Objectives for SBIR Phase IIB Small Market Award Applications A. Independent Third-Party Investor Funds This FOA specifically encourages business relationships between applicant SBCs and third-party investors/strategic partners who can provide financing to help accelerate the commercialization of promising new products whose development was initiated with SBIR funding. Applicants are expected to leverage their previous SBIR support, as well as the opportunity to compete for additional NHLBI funding under this FOA, to attract and negotiate third-party financing needed to advance a product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed one-third of the total amount of the NHLBI funds being requested over the entire Phase IIB Small Market Award project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. If a Phase IIB Small Market Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Finance Plan submitted as part of the application) will become a term of award as described in Section VI.1 Award Notices. It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NHLBI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in commercializing emerging biomedical technologies addressing rare diseases or young pediatric populations, as well as engaging with the patient advocacy groups and foundations that focus on the indication of the developing technology.?Applicants are encouraged to explore existing resources and groups to engage with the relevant communities, such as the?NCATS Genetic and Rare Diseases Information Center (GARD), the?NCATS Therapeutics for Rare and Neglected Diseases (TRND) program, the?National Organization for Rare Disorders (NORD),?FasterCures, and the?Patient-Centered Outcomes Research Institute(PCORI). B. Scientific/Technical Scope The technical and commercial objectives described in the SBIR Phase IIB Small Market Award application MUST represent an extension of the development efforts that were pursued in a previously funded SBIR or STTR Phase II award. It is essential that significant progress was accomplished during the current/preceding SBIR or STTR Phase II project and that the proposed product has significant commercial potential. Applicants are expected to demonstrate that the proposed product has a clear advantage over existing and/or competing products and to define an appropriate path toward ultimate product commercialization. This FOA is specifically designed to provide additional support for products that require ultimate approval/clearance by a Federal regulatory agency and those that are small markets or for rare diseases. In these circumstances, it is critically important for Federal investment to de-risk investment by third parties. Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under this FOA, proposed projects MUST be relevant to the NHLBI mission. Applicants are strongly encouraged to contact the NHLBI Scientific/Research Contact (listed in Section VII) to discuss whether their proposed project meets this criterion. The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on products related to the?mission?of the NHLBI. The NHLBI program priority areas for technology development research are listed below. NCATS intends to co-fund applications that meet the NCATS mission to develop innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients. Additionally, NCATS is interested in co-funding applications that address rare diseases, and in particular, that can help speed the development of treatments for multiple rare diseases. For a description of the NCATS SBIR/STTR research priorities, please refer to?http://ncats.nih.gov/smallbusiness/priorities. The NHLBI program priority areas for technology development research include: Blood Diseases and Resources areas: In vitro diagnostic devices and therapeutic biologics, devices, and drugs for rare diseases, and diseases affecting young children and neonates, including, but not limited to: coagulation and other laboratory based assays; transfusion/infusion and non-transfusion/non-infusion treatments for bleeding complications in acquired and inherited bleeding disorders; point of care diagnostics for Sickle Cell Disease and other hemoglobinopathies to facilitate testing in low resource settings to provide earlier diagnosis and access to medical interventions; devices that facilitate transfusion of small volumes of blood components; and long-term, indwelling catheters for transfusion, blood sample collection or medication administration that provide very low thrombosis/infection risk. Other blood disease and resource areas may be proposed, as areas of interest are not limited to those listed. Cardiovascular Diseases areas: Diagnostics, therapeutics (including cell and gene therapies), or instruments for treating congenital or acquired heart disease in young pediatric populations, including heart pumps and valves, atrial septal defect closure devices, surgical tools, and devices for cardiac catheterization; diagnostics and therapies for rare arrhythmias (such as LQTS-1, -2, and -3, Brugada's, and Timothy's syndromes) and lipid disorders (such as lecithin-cholesterol acyltransferase or lipoprotein deficiencies or genetic diseases such as Pompedisease); technologies, instruments, and therapeutics for heart (and lung) transplantation, including devices for perfusion of donor organs and technologies for less invasive tissue biopsies and detection of organ rejection. Other cardiovascular disease areas may be proposed, as areas of interest are not limited to those listed. Lung Diseases areas: Diagnostics and therapeutics for rare lung diseases and those affecting young pediatric populations, including, but not limited to: respiratory distress syndrome, cystic fibrosis, adult and pediatric pulmonary arterial hypertension, adult and childhood interstitial lung diseases, lymphangioleiomyomatosis, and sarcoidosis. Examples include, but are not limited to, noninvasive monitoring of cardiopulmonary function for neonates and young children, portable imaging systems compatible with Intensive Care Unit environments, therapies to prevent bronchopulmonary dysplasia, improved aerosol delivery devices for young children, portable home diagnostic and treatment devices for sleep disordered breathing in young pediatric populations. Other lung disease areas may be proposed, as areas of interest are not limited to those listed. Examples of appropriate development activities to be proposed under this FOA include, but are not limited to, the following areas: For projects pertaining to the development of therapeutics - Applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application or clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA). For projects pertaining to imaging technologies, interventional devices, and in vivo diagnostics - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE) application, or an Investigational Device Exemption (IDE) application. For projects pertaining to ex vivo or in vitro diagnostics, prognostics, and screening tests - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE) application, an Investigational New Drug (IND) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay. NHLBI expects that activities to be pursued under this FOA should address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology. Specific activities to be proposed will vary among applications. C. Plan for Full Commercialization (all applications) The goal of the SBIR Phase IIB Small Market Award is to advance SBIR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Small Market Award project period) that outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be developed as part of the Commercialization Plan. The full commercialization plan for the product should extend beyond the period of SBIR funding. Applicants are encouraged to leverage other available Federal resources where appropriate, including existing FDA incentives to increase and accelerate small market product development, such as Orphan Drug designation, Humanitarian Device Exemption, the Pediatric Exclusivity Provision, and the?Orphan Products Clinical Trials Grants Program?to assist with expenses related to clinical trials. Additional information about relevant FDA programs and resources may be found on the?Developing Products for Rare Diseases & Conditions?industry page. ? See?Section VIII. Other Information?for award authorities and regulations. Criteria for Complete, Compliant, and Responsive Applications Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:? Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period") Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract) Applications that do not propose a product under development with a primary indication that: Addresses a rare disease as defined in the Orphan Drug Act Amendment of 1984 as any disease or condition that affects fewer than 200,000 persons in the United States; OR qualifies as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year; OR targets a young pediatric population, defined as including neonates (0-28 days), infants ( sbir_topic_link: https://www.sbir.gov/node/2100575 subtopics: [ ] - solicitation_title: > NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) solicitation_number: RFA-HL-23-009 program: SBIR phase: Phase II agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2022" release_date: 2021-11-16 open_date: 2022-01-28 close_date: 2024-02-29 application_due_date: - 2022-02-28 - 2023-02-28 - 2024-02-28 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2100743 solicitation_agency_url: > https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-009.html current_status: open solicitation_topics: - topic_title: > NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) branch: National Institutes of Health topic_number: RFA-HL-23-009 topic_description: | Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease. It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III, an SBC will be able to launch a product commercially with non-SBIR funds. However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the validation studies required to obtain regulatory approval and launch a product. In particular, the development of therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs assciated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process. Thus, despite the extensive R&D performed on such products during Phase II projects, the results are often insufficient to attract the substantial private investment needed for the eventual commercialization of the product. Many small businesses, therefore, become cash-starved before reaching the next critical milestone along the path toward commercialization.? Hence, this FOA is designed to address this funding gap between the end of the SBIR or STTR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development. A number of public and private organizations have begun to recognize the challenges associated with this funding gap and are taking steps to provide additional resources to advance a greater number of promising early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but are also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the preclinical stages of development, and some of these firms have established technology incubators to provide development support, including regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. Such programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors. It is anticipated that funding by third-party investors will be predicated on significant due diligence, thus encouraging awardees to formulate credible business plans for product commercialization. In addition, it is expected that third-party investors will maintain an active role in supporting the awardee during the product development phase and during pursuit of follow-on funding for commercialization. Specific Objectives for SBIR Phase IIB Bridge Award Applications A. Independent Third-Party Investor Funds This FOA specifically encourages business relationships between applicant SBCs and third-party investors/strategic partners who can provide financing to help accelerate the commercialization of promising new products whose development was initiated with SBIR or STTR funding. Applicants are expected to leverage their previous SBIR or STTR support, as well as the opportunity to compete for additional NHLBI funding under this FOA, to attract and negotiate third-party financing needed to advance a product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NHLBI funds being requested over the entire Phase IIB Bridge Award project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. If a Phase IIB Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Finance Plan submitted as part of the application) will become a term of award as described in Section VI.1 Award Notices. It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NHLBI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in commercializing emerging biomedical technologies. B. Scientific/Technical Scope The technical and commercial objectives described in the SBIR Phase IIB Bridge Award application MUST represent an extension of the development efforts that were pursued in a previously funded SBIR or STTR Phase II award. It is essential that significant progress was accomplished during the current/preceding SBIR or STTR Phase II project and that the proposed product has significant commercial potential. Applicants are expected to demonstrate that the proposed product has a clear advantage over existing and/or competing products and to define an appropriate path toward ultimate product commercialization. This FOA is specifically designed to provide additional support for products that require ultimate approval/clearance by a Federal regulatory agency. Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under this FOA, proposed projects MUST be relevant to the NHLBI?mission. Applicants are strongly encouraged to contact the NHLBI to discuss whether their proposed project meets this criterion. The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood, and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on products related to the?mission?of the NHLBI. The NHLBI program priority areas for technology development research include: Cardiovascular Diseases areas:? heart failure, atherothrombosis, heart attack, high blood pressure, atrial fibrillation along with other atrial and ventricular arrhythmias, sudden cardiac death, adult and pediatric congenital heart disease, cardiovascular complications of diabetes, and obesity, acquired valve disease, cardiomyopathies, and peripheral vascular diseases. Lung Diseases areas:? asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, sleep-disordered breathing, critical care, and acute lung injury, developmental biology and pediatric pulmonary diseases, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis. Blood Diseases and Resources areas: sickle cell disease (SCD), the thalassemias, Fanconi anemia, Diamond-Blackfan anemia, and other bone marrow failure syndromes, iron chelation, fetal hemoglobin production, white blood cell disorders, myeloproliferative and myelodysplastic syndromes, hematopoietic stem cell transplantation and novel cell-based therapies, transfusion medicine (red blood cells, platelets, and plasma) and blood banking including technologies to store, process, and screen blood, thrombosis and hemostatic disorders including but not limited to idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, and coagulation factor deficiencies and disorders. Rare diseases: Please note that the companion NHLBI SBIR Phase IIB Small Market Awards funding opportunity,?RFA-HL-23-008, supports the development of products addressing rare and pediatric diseases. Applicants working with applications in this area are encouraged to consider this funding opportunity. Examples of appropriate development activities to be proposed under this FOA include, but are not limited to the following areas: For projects pertaining to the development of therapeutics - Applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application or clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA). For projects pertaining to imaging technologies, interventional devices, and in vivo diagnostics - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, or an Investigational Device Exemption (IDE) application. For projects pertaining to ex vivo or in vitro diagnostics, prognostics, and screening tests - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, an Investigational New Drug (IND) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay. NHLBI expects that activities to be pursued under this FOA will address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology. Specific activities to be proposed will vary among applications. C. Plan for Full Commercialization The goal of the SBIR Phase IIB Bridge Award is to advance SBIR or STTR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Bridge Award project period) that outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization plan for the product should extend beyond the period of SBIR funding. ?Criteria for Complete, Compliant, and Responsive Applications Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:? Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period") Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract) Applications that do not propose R&D that falls within the technical scope of this FOA as described under Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications) Applications that do not contain a Commercialization Plan that includes all sections (a-l) and the required elements for each section, as described under Section IV ("SBIR/STTR Information: Commercialization Plan") Applications that do not include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan"), and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments") sbir_topic_link: https://www.sbir.gov/node/2100745 subtopics: [ ] - solicitation_title: Translational Neural Devices (U44 Clinical Trial Optional) solicitation_number: RFA-NS-21-022 program: SBIR phase: BOTH agency: Department of Health and Human Services branch: National Institutes of Health solicitation_year: "2021" release_date: 2021-04-28 open_date: 2021-06-01 close_date: 2024-02-21 application_due_date: - 2021-07-01 - 2021-10-20 - 2022-02-18 - 2022-06-20 - 2022-10-18 - 2023-02-21 - 2023-06-19 - 2023-10-18 - 2024-02-20 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/1972523 solicitation_agency_url: > https://grants.nih.gov/grants/guide/RFA-files/RFA-NS-21-022.html current_status: open solicitation_topics: - topic_title: Translational Neural Devices (U44 Clinical Trial Optional) branch: National Institutes of Health topic_number: RFA-NS-21-022 topic_description: | A. Purpose The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. B. Overview This FOA supports non-clinical testing to enable IRB and/or FDA approval needed to conduct a small clinical study, and the subsequent study itself (e.g., Early Feasibility Study - https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103). All projects will be Fast-Track applications and have two phases. SBIR Phase I will support non-clinical translational device activities to obtain an IDE and IRB approval for an SR clinical study, or to obtain IRB approval for an NSR clinical study. The duration of SBIR Phase I will depend on the maturity of the project at entry. Phase II will support a small clinical study and can last up to three years, however, the total project period (including both phases) must not exceed five years. Projects for which only a clinical phase is proposed are outside of the scope of this funding opportunity. Only those SBIR Phase I projects that have met specific criteria (see below) will be eligible for transition to SBIR Phase II after NIH administrative review. Furthermore, ethical considerations are intrinsic to the responsible conduct of neuroscience research and the translation of neuroscience advances (scientific and technological) into clinical practice. It is expected the immediate next steps following completion of the small clinical study supported under this cooperative agreement will be: a marketing application if only a small clinical study or experience is needed to demonstrate the device is safe and effective. a larger clinical trial that will lead to a marketing application; or device design decisions made based on the information and data collected. As applicants must have comprehensive supporting data, innovation and impact will in part be judged on presenting a credible path towards U.S. regulatory submission/IRB approval at the end of the SBIR Phase I project period, and on the potential to advance the care of patients by addressing an unmet clinical need. This FOA will utilize a Small Business Innovation Research (SBIR) U44 cooperative agreement. As a cooperative agreement, this FOA supports milestone-driven projects and involves NIH program staff’s participation in negotiating project and milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program. Applicants are strongly advised to contact the Scientific/Research contact listed below prior to submission. C. Scope Projects must focus on a disorder that falls within the mission of NINDS. It is expected that devices within the scope of this program either: are very close to the 'final system' and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project; or have received Pre-Submission feedback from the FDA (see https://www.fda.gov/medical-devices/products-and-medical-procedures/neurological-devices and https://www.youtube.com/watch?v=u0zPKPLW2mU for helpful resources); or require early feasibility clinical data to inform the final device design or manufacturing processes; or are already approved, but are being used for a novel indication, target, or patient population. D. Entry criteria: For entry to the program, projects should have: Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication. Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature. A compelling case for a successful IDE submission for an SR study, or IRB approval for an NSR study at the end of SBIR Phase I. All regulatory approvals must be in place prior to the start of the SBIR Phase II. Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying for funding through this grant mechanism. Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding will be expected to do so as the first milestone during the first year of SBIR Phase I of the award. Funding will be restricted to a maximum of $100,000 in direct costs until FDA feedback that is consistent with the likely success of the regulatory path to market and overall device development plan outlined in the grant application is received. In the event that FDA feedback is not consistent with the plans in the grant, program staff will evaluate the concerns and change of scope that would be needed and work with the investigators to determine the most appropriate course of action. Any remaining funds associated with the original award will not be released. E. Phases SBIR Phase I scope: Examples of studies that may be proposed during SBIR Phase I include, but are not limited to: Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval. Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards. GLP compliant large animal model safety and/or testing of an implanted device. Activities to become current Good Manufacturing Practice (GMP) compliant. Activities to bring the development process under Design and Quality Systems Control, Device, software, and firmware design verification and validation activities. Development of packaging, connectors, and other accessories necessary for the translation of this technology. Regulatory activities, including pre-submission meetings with FDA, IDE submission, or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HED), Request for Risk Designation, 513(g) submission). A limited clinical experience is also allowable during SBIR Phase I if it is necessary to support the IDE submission for the small clinical study conducted in SBIR Phase II. Clinical studies in SBIR Phase I are out of scope if the planned SBIR Phase II small clinical study is NSR. SBIR Phase II scope: SBIR Phase II will support a small clinical study that will lead to either: A marketing application if only a small clinical trial or experience is needed to demonstrate the device is safe and effective, or A larger clinical trial that will lead to a marketing application; or A larger clinical study that will lead to a marketing application; or Use of the clinical experience to inform device design decisions Examples of studies that may be proposed during SBIR Phase II include, but are not limited to: Optimization of the device design with respect to the human functional anatomy. Identification of the most simple, reliable, and cost-effective device configuration for more. advanced clinical studies and eventual market approval. Basic proof-of-concept testing in human patients. Studies of the key physiological variables that may impact the function of the device in humans. Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function F. Non-Responsive Activities: Applications that include the following activities will be considered non-responsive and will be withdrawn and not reviewed: Basic research and studies of disease mechanisms; Animal model development: all in vivo models must be well established and characterized, and available to the applicant; Efforts to develop neurotechnology for fundamental study of the nervous system; Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are outside the scope of the present FOA; Delayed onset clinical studies Proposals lacking a clinical study protocol included with the submission Projects focused on technologies for augmentation of healthy individuals Applications that do not include all required attachments (e.g., Gantt Chart, Long-term care plan) Applications that do not include a neuroethics section as part of the human subjects protection attachment. G. Milestones Because device development is an inherently risky process, it is anticipated that there may be attrition as projects move through the process. Applications must propose one or more milestones associated with each objective in each year of the project. Milestones are goals that measure success and efficacy that will be used for go/no-go decision-making for the project and should have quantitative success criteria associated with them (see below for details). For each milestone, provide details on methods, assumptions, experimental designs, and data analysis plans (if the results are quantitatively measured). Specify the quantitative criteria for measuring success and the rationale used to develop and justify the quantitative criteria identified. Quantitative criteria should be robust and consistent with the state-of-the-art in the field. Applicants are encouraged to read examples of milestones (https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/Devices-Milestones). NIH program staff will contact the applicant to discuss, negotiate the proposed milestones and any changes suggested prior to funding the application. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Progress towards achievement of the final set of milestones will be evaluated yearly by NIH program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, funding for the project will be discontinued. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), overall progress, portfolio balance and program priorities, competitive landscape, and availability of funds. NIH encourages increasing the rigor and reproducibility of observed results. In some cases, conducting additional critical experiments will be important for NIH to have confidence in making a funding decision. SBIR Phase I to Phase II transition: An administrative review will be conducted by program staff, with potential input by independent consultants, to decide whether a SBIR Phase I project will be transitioned into SBIR Phase II based on the following: Successful achievement of the defined milestones for SBIR Phase I of the project; Likelihood of success in clinical testing; Competitive landscape; Program balance; Availability of funds; For significant risk studies, documentation of final or conditional approval of the IDE from the FDA; IRB approval(s); Submission of the final clinical protocol and supporting documents to NIH for administrative review, and notification of approval by NIH; Feedback on activities involving humans subjects obtained from the NINDS Safety and Risk Assessment Committee (SARAC); and Agreement on updated timeline, milestones and budget for the clinical study. H. Quality and Compliance Requirements The use of the Design Control and Quality Systems processes (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers) to the degree specified by the FDA is required. Intermediate steps in the Design Control process (e.g., design reviews, design verification, design validation, and design transfer activities) where appropriate, and IDE submission should be represented in the annual milestones. NIH recognizes that the degree to which Design Controls and Quality Systems processes are required by the FDA may vary substantially depending on the specific device. Investigators are encouraged to discuss these issues with the FDA and regulatory consultants prior to submitting an application so the extent to which these processes are required is clearly defined and verifiable in the application. Applicants should consider the Quality System requirements at the IDE stage (i.e., design controls) when preparing their device development activities. Applicants should consider Guidelines and Policies for Monitoring Clinical Research in the formation of a plan for data and safety monitoring as required by the appropriate IC. I. Intellectual Property (IP) Since the ultimate goal of this program is to bring new therapeutic and diagnostic devices to the market, the program strongly encourages the awardees and/or their collaborators to obtain and retain any IP developed around the device during the project period (see instructions on attachment or letters to address IP issues in Section IV). Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the device development process. The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. For rare or ultra- rare diseases where commercialization may be challenging, applicants are encouraged to discuss alternative strategies with Scientific/Research staff to get further guidance. J. Pre-application Consultation As an U44 cooperative agreement, NIH program staff will be involved in the negotiation and execution of the projects. Applicants are strongly encouraged to consult with NIH program staff when planning an application. Early contact provides an opportunity for staff to provide further guidance on program scope, goals, and developing appropriate milestones. When possible, applicants should contact program staff at least 12 weeks before a receipt date. K. Institute Statements of Interest The National Institute for Neurological Disorders and Stroke (NINDS) will support translational device applications relevant to its mission (https://www.ninds.nih.gov/About-NINDS/Who-We-Are) under this FOA. Applications for NINDS proposing pre-translational, pre-clinical, investigative research projects on deliberative optimization and development of devices for impacts in neurology and neuroscience should apply through the Bioengineering Research Grants (R01s: see PAR-19-158 and PAR-19-159). Applicants are expected to incorporate data elements from the NINDS Common Data Elements (CDE) Project in their data collection forms when appropriate (see https://www.commondataelements.ninds.nih.gov). sbir_topic_link: https://www.sbir.gov/node/1972525 subtopics: [ ] - solicitation_title: > DEPARTMENT OF HOMELAND SECURITY (DHS) SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM FY24 solicitation_number: "24.1" program: SBIR phase: Phase I agency: Department of Homeland Security branch: Science and Technology Directorate solicitation_year: "2024" release_date: 2023-11-08 open_date: 2023-12-15 close_date: 2024-01-17 application_due_date: - 2024-01-17 occurrence_number: "1" sbir_solicitation_link: https://www.sbir.gov/node/2476995 solicitation_agency_url: https://oip.dhs.gov/sbir/public current_status: open solicitation_topics: - topic_title: > Agnostic Detection of Synthetic Opioids and Other Illicit Drugs branch: Science and Technology Directorate topic_number: DHS241-001 topic_description: | In 2021 and 2022, the number of U.S. overdose-related deaths topped 100,000, with about two-thirds of those attributed to synthetic opioids, mainly fentanyl. Fentanyl's chemical scaffold is easily tweaked to alter its spectroscopic signature and evade detection while delivering similar psychoactive effects. Numerous fentanyl analogues have been identified in illicit drug products and associated with fatal overdoses. The Drug Enforcement Administration's temporary scheduling of fentanyl-related substances has mitigated the appearance of new analogues somewhat, but certain derivatives such as fluorofentanyl continue to be widespread. In addition, drug traffickers have turned to other classes of synthetic opioids such as nitazenes which can also be structurally modified into pharmaceutically active, uncontrolled derivatives. Currently, field detection devices cannot alert users to the presence of novel compounds unless the devices have been appropriately configured. For example, if the device is spectroscopic in nature, detection is based on predetermined libraries of specific spectral signatures associated with those substances. Libraries require updates as substances are identified to incorporate the new spectral information. If the substance has not been previously identified in the field, and has no entry in the library, the end-user will likely not receive any indication that a potentially dangerous fentanyl-related drug is present, until a sample of the seized material has been analyzed by a forensic laboratory. The difficulty is compounded by the fact that most illicit drug products encountered in the field are mixtures of multiple compounds, which may obscure the target compound's signature. This topic seeks innovative methods to develop the capability to alert field personnel, or personnel in a controlled environment, to untargeted fentanyl-related substances in the presence of other compounds. Note the proposed approach need not be spectroscopic; this was provided as an example of the complexity associated with detecting an unknown compound. The proposed solution should include the following requirements from a Tier 1 or Tier 2 approach: Tier 1: Handheld, battery operated detector. • Threshold performance would be classification of pure compounds that might not yet be included in standard libraries (e.g., suspected synthetic opioid, not necessarily the precise ID). Sample preparation should be minimal, no more than dissolution of sample into a solvent. Processing time should be no greater than 5 minutes. • Optimal performance would be classification of suspected narcotics that are present in low-dose forms (e.g., tablet formulations), say less than 1% composition by mass. Minimal sample preparation. Processing time should be no more than 1 minute. • Software solutions applied to existing hardware (such as an algorithm for a Raman detector) would be considered, with the same threshold and optimal requirements. Tier 2: Portable detector that is moveable by a single person without wheeled assistance. • The weight should be less than 40 pounds, 120 VAC power, and rugged enough to be moved without maintenance (e.g., optical realignment). • Threshold performance would be identification of pure or nearly pure unknowns without a previous library entry. Samples should have minimal preparation beyond dissolving into solution. Processing time should be less than 5 minutes. • Optimal performance would be identification of unknown narcotics, that is, new synthetic opioids, in cut mixtures, such as tablet formulations. Minimal sample prep, processing time should be less than 1 minute. • Detection limits for unknowns should be for at least 1% of the sample composition. Software solutions, such as AI/ML algorithms for existing instruments are also encouraged. sbir_topic_link: https://www.sbir.gov/node/2476999 subtopics: [ ] - topic_title: > Data Labeling and Curation at Scale (DLCS) for Machine Learning Algorithms branch: Science and Technology Directorate topic_number: DHS241-002 topic_description: | The DHS Science & Technology Directorate (S&T) laboratories and DHS component operational partners generate large volumes (up to 10,000 or more measurements per day) of data from test events, prototype demonstrations, or targeted stream of commerce (SoC) data collections. These data are incredibly valuable to DHS and our R&D partners to support the development of next-generation detection algorithms, like those used at airports for on-person and accessible property screening in order to detect explosives and prohibited items. Currently, any data that is collected must be hand-annotated and stored on physical hard disks. This process is extremely time and labor intensive, while limiting DHS's ability to develop curated data sets and share data with R&D partners. R&D partners must also accept the data in the formats and labels that were hand created, as DHS does not currently have the capability to rapidly re-annotate or reformat existing data sets. DHS is seeking innovative techniques to accelerate and bring additional flexibility to DHS's data collection, labeling, storing, and distribution processes. The current state of the art relies heavily on human labeling and knowing desired metadata and curation schemes a priori. Successful solutions will limit the amount of human intervention required to perform these tasks, instead relying on automatic software to process most routine activities. It is assumed that the provided solution may include certain commercial-off-the-shelf (COTS) modules, but the focus of the research should be on novel data ingestion, labeling, and curation techniques. COTS modules included should support Government approved cybersecurity standards such as FedRAMP approval and/or compliance with FIPS 104-3 specifications. Capabilities of particular interest include the ability to ingest interesting file formats such as Hierarchical Data Formats, Digital Imaging and Communications in Security (DICOS) (an adaption of Digital Imaging and Communications in Medicine), and other defined but unusual data types, and then processing the data to assess complexity, identify common features/defined labels, and generate ground truth data for these files. Areas of uncertainty may be flagged for human review at a future time (at which point the human-generated ground truth may be analyzed to enhance the automated tools). Once the data is stored, it should be able to be easily curated, reprocessed (e.g. change file formats or ground truth formats), and distributed as packaged data sets. A successful solution should be able to be scaled significantly to support long-term use by DHS. sbir_topic_link: https://www.sbir.gov/node/2477001 subtopics: [ ] - topic_title: 911 Voice-over-IP Telephone Dispatchable Location System branch: Science and Technology Directorate topic_number: DHS241-003 topic_description: | The Federal Communications Commission (FCC) requires Voice-over-IP (VoIP) telephone service providers to furnish a subscriber's verified street address, known as dispatchable location to the 911 community, when activating the VoIP service for subscribers. The dispatchable location information is associated with the VoIP number whenever a subscriber places a 911 call to request for emergency services. VoIP telephone equipment works when connected to the internet and therefore offers subscribers the flexibility to relocate their VoIP service from one address to another. Given VoIP service complements the mobile phone service, when there is a lack of cellular coverage at a home or business, VoIP can serve as an important backup to a cellphone when connecting to the 911 Emergency Call Center (ECC). A problem arises when a VoIP subscriber moves from one locality to another and fails to update the VoIP service provider with the new physical address that is necessary for dispatching emergency personnel. Calls placed by the VoIP subscriber to 911 will be routed to the wrong 911 ECC based on the outdated address record, resulting in lost time to dispatch emergency personnel. By one estimate, the state of California reported 1,687,529 calls were placed using VoIP to 911 ECC in 2022, or 6% of all 911 calls. Even a small fraction (assuming 5%) of the VoIP lines having issue with dispatchable location in the state of California would have resulted in tens of thousands of calls that would not be routed to the correct 911 ECC. DHS S&T has confirmed with the state of California Office of Emergency Services that VoIP 911 calls that were routed incorrectly due to lack of updated and verified dispatchable location remains an on-going challenge for 911 ECC. VoIP vendors and public safety need a solution to address the problem of maintaining updated and verified dispatchable locations. The proposed solution should enable the VoIP service providers to address the key requirement mandated by the FCC and provide a dispatchable address for VoIP subscribers’ access to 911 services. The service provider must identify whether the service is being used to call 911 from a different location than the Registered Location and, if so, either: (i) prompt the customer to provide a new Registered Location; or (ii) update the Registered Location without requiring additional action by the customer. The proposed solution should include the following requirements: • Determine dispatchable location for 911 services (e.g., using caller’s current GIS location). • Detect a change in physical location from which a subscriber's VoIP equipment is connecting to the internet for telecommunication services. • Adhere to all relevant regulations and standards (including those referenced below). • Privacy preserving – storing data. • Access management that provides authorized administrators ability to perform query and collect system performance data. • Interoperable with legacy 911 and NG911 systems for the purpose of supplying dispatchable location for the VoIP calls. • Meet a minimum availability of 99% of up time. • Access to the location database of the legacy 911 system, or if available, the NG911 system. sbir_topic_link: https://www.sbir.gov/node/2477003 subtopics: [ ] - topic_title: Software Defined Radio for Public Safety (SDR-PS) branch: Science and Technology Directorate topic_number: DHS241-004 topic_description: | Communication is paramount for first responders (firefighters, EMS, and law enforcement) to ensure effective mission response, coordination of resources, and ensure officer/agent safety during emergency operations. First responders, including officers of DHS Components (Customers and Border Protection, Federal Protective Service, Immigration and Customs Enforcement, US Coast Guard, US Secret Service, Transportation Security Administration, Federal Emergency Management Agency), often work in locations where access to network infrastructure is unavailable. For example, incident response in remote areas may be beyond the reach of existing network infrastructure. Additionally, during disasters or major incidents, networks may be congested or unavailable for use, resulting in a lack of communications. The current solution requires first responders to carry both land mobile radios (LMR) and broadband devices to allow operations on infrastructure (Cellular Networks). Although this solution offers resiliency, it is cumbersome and impractical to carry multiple devices. It also does not address all the critical communication needs during emergency responses. Another issue with the current solution is that traditional LMR radios are a long-term investment of at least 7-10 years and does not adapt as readily to changing technologies and advanced communications evolution. Industry defines software-defined radio (SDR) as a radio communication system where components that conventionally have been implemented using analog hardware, are instead implemented by means of software and digital hardware on a personal computer or embedded system. SDR can tune to different frequencies and process various signals, from FM radio to 5G, Wi-Fi, and Bluetooth. SDR enables flexibility, reconfigurability, and interoperability of wireless systems, as well as a lower cost and power consumption. This topic seeks a novel approach to SDR for public safety that addresses the needs of first responders while providing flexibility, reconfigurability, and interoperability to maximize the value of radio investments. The proposed SDR-PS solution should: • Support communications on and off network infrastructure. • Allow for critical transmission on multiple bands and systems due to failed infrastructure or severe congestion. o For example, operation could allow for transmitting alert or emergency messages on several bands and systems either in parallel or sequentially with location. • Allow operation over multiple modes (device-to-device meshing, provide range extension at fringe areas). • Address the critical communication needs of first responders, to include emergency broadcasts, multiple users and channels. • Consider where and what conditions the system must operate under; Extreme heat and cold, moisture, ruggedized to support: impact from dropped/tossed, scrapped, or heavy weight. • Allow for operations in ultra remote areas by providing range extension or operation from device-to-device in areas of no coverage to mixed mode (using device-to-device and device-to-infrastructure) in fringe coverage areas. • Support multiple open-standards (e.g., Institute of Electrical and Electronic Engineers (IEEE) mesh, LTE (3rd Generation Partnership Project standard including High Power UE)), 5G, Project 25 (P25), Digital Mobile Radio, Tetra). • Consider availability, supportability, scalability, and sustainability of source components. • Enable future-proofing and transitional technologies. • Be capable of upgrading via software (new capabilities, standards, or use cases of technologies). • Improve on the size, weight, and portability compared to existing communication devices. The required proposed solution objectives include: • Wide band transceivers to cover a range of 150MHz-6GHz (Spectrum flexibility). • Operate with high power (variable with up to 3Watts desired optionally up to 6 watts at very high frequency (VHF)). • Hardware abstraction (potential for future proofing loading by loading in any standard software-based communications standards to use the hardware platform). • Design and approach shall meet Federal Encryption Standards (AES 256 and FIPS compliance). • Battery capable of no less than 12 hours of continuous operations. • A ruggedized design to support field operations to include durability for abrasions, rainy environments, intrinsically safe, protection from five-foot drop, and exposure to extreme heat or cold (120 degrees F to minus 16 degrees F). • Lower cost is highly desired (ideal target costs should be less than $3k). sbir_topic_link: https://www.sbir.gov/node/2477005 subtopics: [ ] - topic_title: Video Analysis of Drug and Human Smuggling Activities branch: Science and Technology Directorate topic_number: DHS241-005 topic_description: | Within the United States Coast Guard (USCG), operators manually monitor shore-based video cameras to identify activities of interest or anomalous activities. It is critical to monitor these activities to support Coast Guard's migrant and drug interdiction missions along the US coastline. Manually monitoring these activities may cause the operators to experience fatigue and become less attentive throughout the day. While wearisome, activities of interest or anomalous activities may be missed in areas with high activity. Anomalous activities and activities of interest examples include but are not limited to: 1. An unusually large number of people on board a vessel. 2. A vessel that appears to have an unusual amount of weight on board. This can be inferred from a boat riding lower in the water or an unusually large wake behind the vessel. 3. A vessel that lands on shore. 4. People departing a vessel that landed on shore. 5. People jumping from a vessel and swimming to shore. 6. A person swimming in the water far offshore or crossing a sea border. 7. Unusual vessel activity for the type, time, and location. For example: a vessel in a location at night that stands out as unusual; or a person on the beach at night when the beach is closed. 8. A vessel docked at a location for an unusually long time, which can be an indicator that a vessel has been abandoned. There is a need for automated video analysis capabilities that alert operators to these activities of interest and anomalous activities for adjudication. In addition, the proposed solution would include human-machine teaming capabilities analyzing the videos and identifying potential migrant and drug interdiction activities. With video cameras or other sensors positioned in designated locations and analyzing activities, operators would still be monitoring but the technology would flag and alert them to the activities of interest in real-time that are worthy of further investigation. Algorithms developed shall be expected to provide capability using standard off the shelf cameras with a range up to 15 nm, including mid wave infrared and Visible Imaging Sensors. sbir_topic_link: https://www.sbir.gov/node/2477007 subtopics: [ ] - topic_title: > Enhancing Mobile Radiological/Nuclear (R/N) Detection Through Contextual Information branch: Countering Weapons of Mass Destruction topic_number: DHS241-006 topic_description: | Mobile R/N detection systems are currently available to federal, state, and local authorities for purchase and deployment to detect R/N materials and related threats. These systems are sensitive and provide some indication of the direction from the detector to the threat but can't positively locate that threat. Law enforcement personnel have to leave their vehicles carrying hand-portable systems to search for and locate the source of the radiation with only a general idea of where to look. Operators need a system that provides real-time three-dimensional mapping with R/N source localization and attribution in a compact mobile unit that can be used for monitoring along challenging pathways such as urban environments and between obstacles found in ports of entry. CWMD has worked with the Department of Energy’s Lawrence Berkeley National Lab to demonstrate the integration of Lidar and real-time video with a specialized mobile radiation detection system. The result was a customized solution that used Simultaneous Localization and Mapping (SLAM) to provide object detection and tracking, coupled with localization and attribution of R/N threats to a particular object in the scene, such as a vehicle or person. The system was highly dependent on the complex, specialized radiation detection system; it could not readily be transferred to another vehicle. If the vehicle breaks down or is involved in an accident, the integrated detection system it’s carrying is unusable until the vehicle can be repaired. This topic seeks innovative approaches to providing threat detection and localization through integration of contextual sensors with modular, commercially available mobile radiation detection systems. Offerors will use the detector in development of their contextual sensor integration system. The resulting system shall be capable of being quickly installed and readily shifted from one vehicle to another, as described below. System characteristics and requirements: • The system should consist of components that operators can install in an unmodified sport utility vehicle (SUV) in less than one hour. Installation shall not require personnel with specialized maintenance or information technology expertise. • The system should consist of components small enough to be carried by a single person, weighing 50 pounds or less, each. • The system shall weigh no more than 200 pounds total. • The components should include: o A vehicle-mounted radiation detection system that meets the requirements of IEEE N42.43-2021, IEEE Standard for Mobile Radiation Monitors Used for Homeland Security; o Contextual sensors; o Connections among the components; and o Output to a display that operators can use for near-real-time situational awareness. • The system should store data and alarms for analysis and transmission and provide options for data retention and automatic cleanup. • The user interface should include near real-time maps and images identifying the location of the threat, attribution to an object such as a vehicle within traffic, along with probable identification of the radioactive isotope. • Additional capabilities of interest would be: o Calculating distance to the radioactive source; o Providing a 3D rendering or point cloud with radiation overlay; o Producing, displaying, and storing 3D maps that cover multiple city blocks, o Calculating the source activity level; o Providing a mode for mapping activity of a distributed radioactive source to the 3D surroundings; and o Recognizing changes in the environment if a vehicle passes the same location twice. • It is preferred that the contextual sensing system and algorithms be interoperable with Commercial-Off-the-Shelf (COTS) or modified-COTS vehicle-mounted radiation detection systems. sbir_topic_link: https://www.sbir.gov/node/2477009 subtopics: [ ] - solicitation_title: DoD 23.4 SBIR Annual BAA solicitation_number: 23.4 SBIR Annual BAA program: SBIR phase: BOTH agency: Department of Defense branch: N/A solicitation_year: "2023" release_date: 2022-11-15 open_date: 2022-11-15 close_date: 2024-01-16 application_due_date: - 2024-01-16 occurrence_number: null sbir_solicitation_link: https://www.sbir.gov/node/2272819 solicitation_agency_url: https://www.defensesbirsttr.mil/ current_status: open solicitation_topics: - topic_title: 'AI/ML for Nitramine Recrystallization and Coating ' branch: Army topic_number: 'A234-001 ' topic_description: | OUSD (R&E) MODERNIZATION PRIORITY: Artificial Intelligence/Machine Learning TECHNOLOGY AREA(S): Information Systems TOPIC OBJECTIVE:  To develop a suite of probe technology and machine learning algorithms which can be used throughout the energetics manufacturing process to reduce cost and increase product consistency. TOPIC DESCRIPTION:  Currently, nitramine energetic materials have unacceptably high rework/scrap rates in a number of different munitions’ energetics manufacturing processes, such as dissolution, recrystallization, and slurry coating. This is largely due to the plant operators inability to control critical manufacturing parameters such as cooling water temperature, nitramine concentration, and solvent/antisolvent ratios. To further exacerbate the problem, munitions’ energetics manufacturing processes are poorly understood ‘black boxes,’ so the reason behind any deviation from spec is difficult to ascertain. We believe that by deploying a number of different measurement probes during various manufacturing steps, and analyzing the data via machine learning, we can dramatically reduce or even eliminate out of spec batches. The probes will collect data in real time as materials are manufactured, and the machine learning algorithms will provide nearly instantaneous recommendations to the plant operators on how to adjust their processes to target the desired properties. Beyond reducing out of spec batches, we would also like to reduce cost, environmental footprint (by mainly increasing energy efficiency and reducing solvent use), and increase throughput from existing lines. We believe in the long run, the insights gained for this program will enable easier transition of novel energetic formulations.   The purpose of this topic is to explore probe technology and machine learning algorithms that will be examined from the offerors and will be down selected based on time resolution, ruggedness, data output, safety, and suitability. There are two key steps for this technology to be successful. The first is the development and deployment of novel probes that produce large amounts of data in real time. The second is an advanced machine learning system that can take the probe readings and provide adjustments in real time during manufacturing to produce the desired product. PHASE I: Demonstrate proposed probe technology can produce the data required over the course of several manufacturing runs. The Phase I Base amount must not exceed $100,000 for a 6-month period of performance. PHASE II:  Implement the probes during the manufacturing process and collect data. Use data with machine learning algorithms. • Phase II Sequential: Expand the probes to more manufacturing lines, increasing the amount of data for machine learning systems. Direct and control energetics manufacturing based on machine learning recommendations to realize benefits PHASE III and DUAL USE APPLICATIONS:  Applying AI/ML to chemical manufacturing has a ton of commercial potential, although this specific topic is geared towards energetics; therefore, landing this topic at moderate dual-use potential for commercial capabilities. All HMX/RDX batches are currently examined via a multitude of techniques to determine if they are meet specifications. These include assessing purity, particle size, and thermal stability. This analysis can compared against the predictions of the machine learning algorithms and the measurements provided by the probes. We will also test the machine learning predictions against the predictions of crystallization modeling software, when appropriate.   KEYWORDS:    Probe; Algorithms; Machine Learning; Manufacturing process; Energetic materials; Energy   REFERENCES:  1. http://site.iugaza.edu.ps/ajubeh/files/2012/05/B00k-Mechanics-of-Materials-Mcgraw-2012-Ed6-978-0-07-338028-5.pdf 2. https://books.google.com/books/about/Particle_Size_Measurements.html?id=lLx4GzA-7AUC 3. https://books.google.com/books/about/Chemical_Reactor_Modeling.html?id=mrP6RNajRs0C sbir_topic_link: https://www.sbir.gov/node/2414665 subtopics: [ ] - topic_title: Non-Hydrofluorocarbon-Based Fire Extinguishing branch: Army topic_number: A234-002 topic_description: | OUSD (R&E) MODERNIZATION PRIORITY: General Warfighting Requirements TECHNOLOGY AREA(S): Materials; Battlespace TOPIC OBJECTIVE: The objective of this topic is to explore potential opportunities surrounding a non-HFC based fire extinguishing agent or system. This is needed for ground vehicle crew automatic fire extinguishing systems (AFES) to protect Soldiers and their equipment. TOPIC DESCRIPTION:  The Army relies on HFC-227ea for many of its safety-critical ground vehicle crew fire protection systems. However, production and import of hydrofluorocarbons (HFC) are now being phased down due to their high global warming potentials (GWP), as mandated by the Kigali Amendment to the Montreal Protocol and the American Innovation and Manufacturing (AIM) Act of 2020. Development and fielding of non-HFC fire extinguishing systems directly supports Executive Order 14008: Tackling the Climate Crisis at Home and Abroad as well as the Army Climate Strategy. Meanwhile Section 103 of the Consolidated Appropriations Act, 2021 (P.L. 116-260) calls for an 85% phasedown of the production and import of HFCs by 2036. i. Executive Order 14008: Tackling the Climate Crisis at Home and Abroad, 2021. https://www. federalregister.gov/documents/2021/02/01/2021-02177/ tackling-the-climate-crisis-at-home-and- abroad. ii. Department of the Army, Office of the Assistant Secretary of the Army for Installations, Energy and Environment. February 2022. United States Army Climate Strategy. Washington, DC. iii. Order 13990: Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, 2021. 2021-01765.pdf (govinfo.gov) Rather than relying on recovered HFCs or trying to establish a stockpile to address the impending shortages of these chemicals, our proposed strategy is to minimize, or eliminate, the Army’s uses of HFC-227ea for ground vehicle crew fire protection applications.   PHASE I:  Subscale proof of concept of extinguishing effectiveness. Once developed, the technology would be tested at the US Army Aberdeen Test Center in one of its full-scale testbeds for performance and safety. The Phase I Base amount must not exceed $250,000 for a 12-month period of performance. PHASE II:  Full scale system demonstrated and tested in laboratory environment • Phase II Sequential: Full scale system integrated and tested in vehicle • Phase II Enhancement: Toxicology assessment, resolve any issues, document PHASE III and DUAL USE APPLICATIONS:  While many different industries will need to eventually switch to non-HFC extinguishers in the coming years, there remains barriers to adoption and scaling. Once capabilities of the system have been established, it would be integrated onto a ground vehicle(s) and evaluated against the Army’s criteria.   KEYWORDS:    Non-HFC; Fire Extinguish; Ground combat vehicles; Soldier safety   REFERENCES:  1. https://www.congress.gov/committee-print/116th-congress/house-committee-print/42770 2. https://apps.dtic.mil/sti/citations/ADA517470#:~:text=Historically%20the%20US%20Army%20USA,of%20peacetime%20and%20combat%20fires. sbir_topic_link: https://www.sbir.gov/node/2272841 subtopics: [ ] - topic_title: Non-Refrigerant Based Cooling System for Cabin Cooling branch: Army topic_number: A234-003 topic_description: | OUSD (R&E) MODERNIZATION PRIORITY: General Warfighting Requirements TECHNOLOGY AREA(S): Materials TOPIC OBJECTIVE: The objective of this topic is to develop alternative air handling units or systems to cool the cabin area and/or electronics. TOPIC DESCRIPTION: This topic calls for selected proposer(s) to design a non-refrigerant based low Global Warming Potential (GWP) Hydrofluorocarbon (HFC) Hydrofluoroolefin (HFO) free cooling system. HFC 134a is being phased out globally due to its high global warming potential (GWP), the automotive industry has switched over to HFO-1234yf which is flammable and not suitable for current military system designs. The idea to design a non-refrigerant based cooling system directly supports the Army Climate Strategy. The HFC 134a phase down plan included in Section 103 of the Consolidated Appropriations Act, 2021 (P.L. 116-260) calls for a phase down of the production and import of HFC’s down to 15% of the current levels by 2036. Rather than trying to adapt military air conditioning system designs to address the flammability of HFO-1234yf, this design strategy is to eliminate the refrigerant loop altogether. A non-refrigerant based system would eliminate the need for the purchase and storage of refrigerants as well as the leakage issues of current systems. It would eliminate the need for large specialty equipment recovery machines which are required to maintain refrigerant systems, thus saving cost for Army wide infrastructure. PHASE I:  Quarter scale proof of concept version of cooling system. This would be tested in the Special Systems and Component Engineering (SSCE) laboratory in a thermal chamber for performance. The Phase I Base amount must not exceed $250,000 for a 12-month period of performance. PHASE II:  Full size breadboard system tested in laboratory environment • Phase II Sequential: Full size system installed in vehicle • Phase II Enhancement: Resolve any issues, document, demonstrate in-vehicle performance PHASE III and DUAL USE APPLICATIONS: As global regulations tighten around the kinds of refrigerants that can be used, all industries that require refrigeration in their operations will require a new, effective, and compliant refrigerant moving forward. However, widespread adoption and scalability remain concerns. This system would eventually be installed on a vehicle and evaluated for performance. KEYWORDS:    System cooling; Non-refrigerant; air conditioning; refrigerant loop   REFERENCES:  1. https://www.exair.com/solutions/cooling-solutions.html 2. https://tetech.com/peltier-thermoelectric-cooler-modules/ 3. https://thermoelectricsolutions.com/list-of-thermoelectric-peltier-manufactures-companies-suppliers/ sbir_topic_link: https://www.sbir.gov/node/2414667 subtopics: [ ] - topic_title: Diver Performance Monitoring System branch: Army topic_number: A234-004 topic_description: | OUSD (R&E) MODERNIZATION PRIORITY: Biotechnology TECHNOLOGY AREA(S): Sensors; Electronics; Information Systems OBJECTIVE: Develop a solution that monitors relevant physiological markers and can alert divers of predetermined thresholds on risk. This solution includes form factor developments, accurate biomarker readings from sensors, durability for fresh, chlorinated, and salt-water environments, and on device computing to activate alerts based on predetermined thresholds. DESCRIPTION: Despite significant safety and overwatch, fatalities of student divers occasionally occur during training, with causes unknown in some cases. It is necessary to accurately monitor student biomarkers to determine when to alert nearby instructors and safety divers as special operations diving safety is paramount. Technology enabling systems that can alert divers in multiple environments can provide another tool for the military to use to ensure safe operations in high risk, high stress environments. Desired capabilities are broken up into critical, essential, and enhancing to articulate the minimum acceptable capabilities up to fully desired capabilities for product development. Critical (essential needs/must have): ● Accurate measurement of the following vital signs in fresh and chlorinated environments o Heart rate tracking - Within 5 beats of clinical-grade device o Blood or tissue oxygen saturation - SpO2/StO2 (within 2-5% of clinical-grade device) ● Bluetooth and/or WiFi capabilities for transferring recorded data ● Capable of implementing compatibility with the USSOCOM Human Performance Data Management System (HPDMS), i.e. Smartabase (API) ● 24-hour continuous runtime ● Adequate storage to capture 24 hours of critical data Desired (strongly wanted features): ● Accurate measurement of the following vital signs in fresh, chlorinated and salad water o Heart rate tracking - Within 5 beats of clinical-grade device o Blood or tissue oxygen saturation - SpO2/StO2 (within 2-5% of clinical-grade device) ● Heart Rate Variability (HRV) o Sampling rate 500-1000Hz (can record data at a lower rate) ● Present real-time physiological data to the user on a wearable display ● Accurate measurement of water depth and ambient temperature (air or water) ● Ability to set alert thresholds (preferably by a dive instructor) o Instructors will edit thresholds in HPDMS ● Ability to alert the wearer o Instructors will have ability to toggle alert ● Ability to alert nearby divers underwater of the wearers alert condition ● Functional at depths up to 130ft ● Functional at water temperatures between 34O-100O F ● Accurate respiratory rate measurement in fresh, chlorinated, and saltwater environments Enhancing (increases value to the user): ● Skin temperature measurement in fresh, chlorinated, and saltwater environments ● Core temperature measurement in fresh, chlorinated, and saltwater environments ● Ability to measure any other parameters vendors deem important ● Any other additional features vendors propose as potentially useful Constraints: ● The device cannot interfere with training or other gear (BCD, dive computer, mask, etc.) ● The device shall minimize the use of buttons to display physiological parameters PHASE I: Design a proof-of-concept solution for a device capable of accurately monitoring physiological markers vendors conclude are necessary (e.g. heart rate, SpO2, etc.) which can alert divers and instructors on predetermined thresholds of risk. The design should include, but not limited to, accurate measurements of heart rate and SpO2 or StO2 (in dry, fresh, and chlorinated environments), Bluetooth and/or WiFi capabilities, battery life and memory for a 24-hour continuous runtime, and should be capable of interfacing with the Human Performance Data Management System (HPDMS), i.e. Smartabase (API). The device can be standalone or integrated with standard dive equipment. Other features, capabilities, and/or solutions not addressed in this solicitation that vendors determine will be beneficial to improving safety of Army divers are encouraged. Phase I will award $150,000 over a 3-month period of performance (PoP). The 3 month period will include several virtual sessions with TPOCs and an option to travel to San Diego to assist with refinement of a final presentation on month 3. The final presentation will take into account adjustments to approach, desire to work with other vendors to solve the proposed problem, and cost effectiveness of the solution. Proposals will be evaluated on a holistic basis based on their relevance, total cost, developmental timeline, ability to integrate into a system of systems, modularity, compatibility with open architecture, and any additional features the proposer includes. Companies can voluntarily participate in the Army Applications Laboratory (AAL) 12-week cohort program. The AAL cohort program is designed to solve specific Army modernization challenges on a compressed timeline. The cohort program matches qualified companies with Army problems owners to speed capability development, accelerate transition, and de-risk or inform requirements. This program is designed for businesses that own unique, applicable technology and are interested in growing a new line of business into the DoD. The cohort program will enhance technology development through the rapid exposure to Army stakeholders and the sustainment, maneuver, and robotics acquisition communities. Planned activities include a problem topic deep dive, a field week with Army sustainment and maneuver leaders and soldiers, hands-on experience with currently fielded military equipment and weapon systems, and stakeholder engagement from the requirements writer to acquisition manager to the end-user. An example cohort program for this topic is: Week 1 – Orientation and problem deep dive (virtual) Week 2 – Soldier Touchpoint (in-person at a military installation) Week 3-6 – Concept research and planning Week 7 – Mid-point concept design brief to stakeholders and SME roundtable discussion (virtual) Week 8-11 – Concept design refinement Week 12 – Final concept design brief to Army Senior Leaders (virtual) Cohort programming will be provided free of charge. Proposers that plan to participate in the cohort (if awarded a Phase I) are encouraged to include travel costs for one cohort trip, within the continental US, of 4-5 days each for in-person programming. In-person events may be substituted for virtual events depending on COVID-19 travel restrictions. Details will be provided to awardees under this topic at Phase I award. PHASE II: Demonstrate a prototype device capable of monitoring physiological markers, established in Phase I, which can alert divers on predetermined thresholds of risk. Vendors will have quarterly touchpoints with military stakeholders and develop said prototype to conform to listed parameters throughout the 21-month PoP. Soldier touchpoints will be provided free of charge. Proposers that plan to participate in the Soldier touchpoints (if awarded a Phase II) are encouraged to include travel costs for 7 touchpoints, within the continental US, of 1-2 days each for in-person events. It is incumbent on the vendor to provide proposed, iterative deliverables over the PoP (or sooner) to complete the identified solution. Vendors will interact with military diving experts prior to delivering physical solutions to combat divers. Potential solutions can iterate and the ability to test potential solutions with a military unit is available free of charge. Solutions will be evaluated in priority of critical, essential, and enhancing priorities. Access to military diving experts during the touchpoints for feedback is free of charge, and companies should include the estimated cost of travel (assume quarterly multi day trips to various dive training locations such as San Diego, Key West, Panama City, or Pensacola for set-up, iterative prototyping, final product delivery & testing) to these touchpoints in their budget. In addition to the Phase II deliverable of a prototype for extended Soldier touch points, companies will provide deliverable and final reports detailing performance and associated deliverables, any iterative adjustments based on user feedback, and final product details. The final report should also include plans to adopt the solution onto a military network with associated security protocols and logical access points. PHASE III: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives through the effort by improving the device and developing the technology to TRL 7 and document the final design. Companies will iterate on and deliver final prototypes, make modifications to adapt to the required COTS wearables as identified through extended Soldier touch points and create a viable prototype for combat divers in various underwater scenarios. Prototypes shall be in their final form factor, capable of being worn and used by divers, and may be subjected to environmental testing at the government’s discretion. Phase III deliverables include integration with USSOCOM Human Performance Data Management System (HPDMS), i.e. Smartabase (API), user documentation, and prototype(s) for demonstration and government-sponsored testing. WEBINAR DATE: Tuesday December 13, 2022 10:00 am CT To learn more about this topic, and ask questions of Army stakeholders involved in the project register for a webinar: https://diver-performance.eventbrite.com The Link to the video recording of the webinar will be posted in the DSIP portal in the days following. KEYWORDS: Human performance optimization, HPO, underwater sensors, under water, underwater, sensor, HP, high risk, high stress, combat diver, heart rate, SpO2, StO2 REFERENCES 1. Optimizing sampling rate of wrist-worn optical sensors for physiologic monitoring | Journal of Clinical and Translational Science | Cambridge Core 2. Wearable Pulse Oximeter for Swimming Pool Safety - PMC (nih.gov) 3. Frontiers | Using Underwater Pulse Oximetry in Freediving to Extreme Depths to Study Risk of Hypoxic Blackout and Diving Response Phases (frontiersin.org) 4. The Dewey Monitor: Pulse Oximetry can Warn of Hypoxia in an Immersed Rebreather Diver in Multiple Scenarios | SpringerLink 5. AAL | Resource Center 6. http://aal.army/assets/files/pdf/sbir-phase-1-template.pdf 7. http://aal.army/assets/files/pdf/sbir-optional-slide-template.pdf sbir_topic_link: https://www.sbir.gov/node/2414669 subtopics: [ ] - topic_title: > Holistic Health and Fitness Readiness Kit (H2H Readiness Kit) branch: Army topic_number: A234-005 topic_description: | OUSD (R&E) MODERNIZATION PRIORITY: Advanced Materials TECHNOLOGY AREA(S): Advanced Materials OBJECTIVE: Develop a solution to provide the requisite infrastructure for the Holistic Health and Fitness (H2F) Soldier Performance Readiness Center (SPRC). This facility has several critical requirements, but key innovation is focused on construction materials and techniques that drive the overall cost of the structure significantly below Army costs of ~$16M. Additionally, the solution should be developed with efficiency in maintenance and operating costs over a period of 25 years. This solution is to be implemented in the harshest climates of US Army installations ranging from heavy snow and wind to high heat and humidity. DESCRIPTION: The Army’s Holistic Health and Fitness Program is missioned to resource 110 brigades across the Army by FY2030 with people, equipment, and facilities. Specifically to facilities, H2F has designed and budgeted for SPRCs for each brigade at 43,189 square feet. Unfortunately due to traditional construction costs and requirements from existing construction contracts, the facility as designed has an unfeasible cost of over $16 million. Without a different solution in construction materials/techniques, the program office will need to continue forward with a facility of less than half the size. This equates individuals within brigades using the SPRC 2-3 times per week to only having access once every 10 days. In reference to human performance across all five domains of health and fitness (physical, mental, nutrition, sleep, and spiritual), the SPRC is the primary facility meant to service Soldiers for their holistic health, enable appropriate levels of readiness, and improve their human performance baseline to accomplish the mission. Key Capabilities include: Critical: - 43,183 sf minimum with 16ft clear ceiling height in Zone 3 of the Physical Training Area. - Must withstand wind gusts of 115 mph for minimum of 3 second gusts. - Must handle a minimum of 15-92 pounds per square foot of snow load on the roof, depending on final project site. - Must follow anti-terrorism force protection per UFC 04-010-01 02 (30 JUL 2022) - Must include a fire protection system for safety purposes, following UFC 3-600-01 (06 MAY 2021). - Must include costs for foundation preparation and installation. Unique approaches to foundation are encouraged. - Must have commercial internet established for low cost upkeep with end-user. - Energy efficiency ratings will meet or exceed traditional “brick & mortar” standards for environmental control. - Must include all plumbing and electrical connections for HVAC, hygiene (hand washing, drinking water stations, restrooms), and lighting. Desired: - 25-year warranty on major structural defects to include enclosure materials (roofing/siding). Enhancing: - 25-year warranty on defects in wiring, piping, and ductwork in the electrical, plumbing, heating, cooling, ventilating, and mechanical systems. - 3-year warranty on defects in workmanship and materials such as facility equipment, finishes, doors & windows. PHASE I: Design a proof-of-concept solution for a full scale prototype facility to service the required throughput in H2F designed programming. Other features, capabilities, and/or solutions not addressed in this solicitation that vendors determine will be beneficial to improving safety of Army Soldiers are encouraged. Phase I will award up to $200,000 over a 3-month period of performance (PoP). The 3 month period will include several virtual sessions with TPOCs and an option to travel to Fort Benning, GA to assist with refinement of a final presentation on month 3. The final presentation will take into account adjustments to approach, ability to innovate on semi-permanent/semi-portable techniques, and cost effectiveness of the solution. Proposals will be evaluated holistically based on their relevance, total cost, development timeline, material uses, foundational preparation and establishment, and additional features the proposer includes. Week 1 – Orientation and problem deep dive (virtual) Week 2 – Soldier Touchpoint (in-person at a military installation) Week 3-6 – Concept research and planning Week 7 – Mid-point concept design brief to stakeholders and SME roundtable discussion (virtual) Week 8-11 – Concept design refinement Week 12 – Final concept design brief to Army Senior Leaders (virtual) PHASE II: Demonstrate a full scale prototype facility, established in Phase I, to service the required throughput in H2F designed programming. Vendors will deploy to a specified site location (either Fort Drum, Fort Bragg, or Fort Benning), prepare the ground, build the foundation and structure for testing. The target timeline for this activity is the first 6 months of the PoP. Vendors will have direct interaction with units and facilities managers at the specified site throughout the PoP. Upon completion of the build, the facility will be tested with the associated operational brigade for 9 months to ensure effective construction and can withstand heavy throughput. If awarded for phase II, proposers are encouraged to include travel costs for the project development throughout the build, along with 3 quarterly touch points for operational unit feedback on the prototype. Assume 1-2 days for each in-person touch point at whichever location selected to perform (Fort Drum, Fort Bragg, or Fort Benning). Vendors will interact with military H2F professionals, leaders, and facilities experts at each installation. Solutions will be evaluated in priority of critical, desired, and enhancing priorities. Companies should include the estimated cost of travel for build and quarterly touchpoints at the specified location in their budget. In addition to the Phase II deliverable of a prototype for extended Soldier touch points, companies will provide deliverable and final reports detailing performance and associated deliverables, any iterative adjustments based on user feedback, and final product details. The final report should also include price structures, cost sheets itemized, and design documentation with any adjustments due to environmental considerations by location. PHASE III: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives through the effort by improving the sourcing, design, technique, or actual materials to develop the technology to Technology Readiness Level 7 and document the final design. Companies will deliver final prototypes, make modifications to adapt the facility to different environments, or customize the facility for specific unit needs. Prototypes are to be subjected to environmental testing at the government’s discretion. Phase III deliverables include final price structures, full scale prototype with final design documentation, and a cost sheet itemized for consideration. WEBINAR DATE: Wednesday Jan 11, 2023 11:00 am CT To learn more about this topic, and ask questions of Army stakeholders involved in the project register for a webinar: https://H2FReadinessKit.eventbrite.com The Link to the video recording of the webinar will be posted in the DSIP portal in the days following. KEYWORDS: Human performance optimization, HPO, construction, advanced materials, foundation, materials, utilities, structure, facility REFERENCES 1. SPRC Army Standard, 05 MAY 2021 https://mrsi.erdc.dren.mil/cos/hnc/sprc/ 2. SPRC Standard Design, 30 SEP 2021 https://rfpwizard.mrsi.erdc.dren.mil/MRSI/content/cos/hnc/sprc/Library/Standard%20Designs/Standard_Design_SPRC_Medium_Sept_2021.pdf 3. UFC 04-010-01 DoD Minimum Antiterrorism Standards for Buildings, with Change 2 https://www.wbdg.org/ffc/dod/unified-facilities-criteria-ufc/ufc-4-010-01 4. UFC 3-600-01 Fire Protection Engineering for Facilities, with Change 6, 06 MAY 2021 https://www.wbdg.org/ffc/dod/unified-facilities-criteria-ufc/ufc-3-600-01 5. https://www.nrel.gov/docs/fy22osti/82447.pdf sbir_topic_link: https://www.sbir.gov/node/2414671 subtopics: [ ] - topic_title: Wearable Radiation Sensors branch: Army topic_number: A234-006 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials TOPIC OBJECTIVE: The topic focuses on developing technology that will allow the radiation detection industry to develop and propose low-cost dose rate meters that is significantly smaller and better wearable than those based on current GM-tube. Smaller RADIACs (radiation detectors) will decrease the weight burden of equipment on its users, reducing fatigue and improving maneuverability. The impact of this topic will be lighter and smaller equipment that the wearer may carry. The scale has potential to be throughout the Army and other commercial platforms. TOPIC DESCRIPTION: The innovative approach of this topic is the focus on SWAP (size, weight, and power) in addition to performance. Since the 1920’s, Geiger-Muller tubes (GM tubes) have been the technology used in almost all military RADAICs. The current systems, UDR-13, UDR-14, and UDR-15, all use GM-tubes. While the GM tubes can offer the needed performance, they have major drawbacks that limit the reduction of SWAP. The GM tubes’ low sensitivity per volume and relatively high-power consumption will severely limit any SWAP reduction. If a new suitable technology is not matured and the JPD-S must use GM-tube technology, then the new JPD-S will be about the same size as the current 30-year-old UDR-13. Evolving ground-breaking technology such as solid-state gamma dose rate sensors offers the potential to greatly reduce the SWAP, with an overall objective of reducing SWAP by half. The potential end users of this technology may be the ground combat troops. Those RADIACs are deployed at one RADIAC per squad level (about 10 soldiers). The soldiers will rely on the JPD-S to provide accurate information about the radiation levels throughout the operational environment from response to disasters such as the Army’s response in Operation Tomodachi (the US support to Japan after the 2011 earthquake, tsunami, and nuclear power plant accident) to operations on the nuclear battlefield. Soldiers rely on their RADIACs to provide accurate information about the radiation level to help minimize and document exposures. PHASE I:  Starting in FY23, Phase I would be multiple awards for 6-month efforts focused on scientific, technical, commercial merit and feasibility of proposed solutions. If a performer proposed an existing detector, then the performer would need to demonstrate a clear path for temperature range and nuclear survivability. If a performer proposed a new sensor material, then the performer would need to demonstrate that the new sensor material can accurately measure radiation. PHASE II: Starting in FY 24, Phase II would be at least two awards focused on development of the technology, integration into a detector, and testing. JPEO would consider the possibility of a Phase II enhancement depending on the progress made by the performers in Phase II. PHASE III and DUAL USE APPLICATIONS:  In FY27, JPEO plans to start the program of record. Based on previous successes, JPEO plans to the following path: • Issue an RFP (request for proposal) requiring extensive data showing that their proposed equipment meets the needs of the Army and is low risk at that point plus an operating prototype • Select 3 to 5 prototypes for testing • Based on test results, down select to one system • Complete development • Conduct Development and operational test • Develop logistic (manuals, repair process, etc.) • Procure and field   KEYWORDS: Radiation detectors; RADAIC; ground combat troops; dose rate meter; meter   REFERENCES:  Fabjan, C. W. and Schopper, H. (eds.) 2020, Particle Physics Reference Library, Volume 2: Detectors for Particles and Radiation Krutul, K, et. al., “Radiation Hardness Studies of PIN-Diode Detectors Irradiated with Heavy Ions”, Acta Physica Polonica B Proceedings Supplement, Vol. 13 (2020) Menichelli, M., et. al., “Hydrogenated amorphous silicon detectors for particle detection, beam flux monitoring and dosimetry in high-dose radiation environment”, arXiv:2002.10848 [physics.ins-det] sbir_topic_link: https://www.sbir.gov/node/2414673 subtopics: [ ] - topic_title: > Artificial Intelligence (AI)/ Machine Learning (ML) Open Topic branch: Army topic_number: A234-007 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy TOPIC OBJECTIVE: The purpose of an Artificial Intelligence (AI)/ Machine Learning (ML) focused Open Topic is to bring potentially valuable small business innovations to the Army and create an opportunity to expand the relevance of the Army SBIR program to firms who do not normally compete for SBIR awards. TOPIC DESCRIPTION: This open topic is a Phase I submission only. The period of performance is a maximum of 3 months and a maximum funding limit of $150,000 per award. While the AI/ML Open Topic will accept proposals on any technical challenge requiring an AI/ML application, submissions addressing the following six out of eleven AI/ML TBT core priorities will be prioritized for award: • Synthetic data generation – production data applicable to a given situation that are not obtained by direct measurement. • Automated detection and prevention – automated systemic-based controls where they can stop threats automatically as well as predict the next attack for better future prevention. • Automated data label – quickly curate and label data for an AI model. • Biometrics – authentication is used in computer science as a form of identification and access control • Natural language technology – focused on programming computers to process and analyze large amounts of natural language data. • Supply chain resilience – automating risks and vulnerabilities within the supply chains to prevent major impacts. PHASE I:  The Phase 1 period of performance will be 3 months. Small businesses shall deliver a proof of technical feasibility at the end of the Period of Performance. Phase 1 submission materials: • 5-page technical volume for down-select • 8-slide commercialization plan; template provided in announcement. • A Statement of Work” is required outlining intermediate and final anticipated deliverables during the Phase 1 award period Post-Phase 1 Deliverables: • Small Business: A feasibility study to demonstrate the technical and commercial practicality of the concept to include an assessment of its technical readiness and potential applicability to military and commercial markets. • TPOC and Transition Partner: Commitment secured from TPOC and Transition Partner to associate with potential P2 work. PHASE II: Produce prototype solutions that will be easy to operate by a Soldier. These products will be provided to select Army units for further evaluation by the soldiers. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets. PHASE III and DUAL USE APPLICATIONS:  Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization. The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation. Based on soldier evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration.   KEYWORDS: Artificial Intelligence; Machine Learning; Open topic; automation; synthetic data generation; data labeling; supply chain resilience   REFERENCES:  https://www.armysbir.army.mil/topics/ sbir_topic_link: https://www.sbir.gov/node/2414675 subtopics: [ ] - topic_title: Army Tech Marketplace branch: Army topic_number: A234-008 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software, Integrated Network Systems-of-Systems and Trusted AI and Autonomy TOPIC OBJECTIVE: To develop, integrate and deploy a technology with a simple intuitive user interface to improve information exchange and the discovery of collaboration opportunities within the Army R&D and Acquisitions communities as well as between the Army and private sector technology providers and private sector technology integrators. The intent is to improve the transition of R&D-funded technologies into the Army enterprise. TOPIC DESCRIPTION: The Army research and development ecosystem does not have a simple, intuitive portal for Army research centers and acquisition offices to access information related to Army R&D investments, including technology capabilities, technology maturity level, milestone delivery schedules, etc. The lack of direct access to internal information and data limits internal Army awareness and analysis of potentially valuable technologies to support the Army enterprise. The result is a less robust use of R&D investments, missed collaborations and co-investments, and an overall decrease in the likelihood of critical technologies transitioning into the Army enterprise to support the Soldier. The Army Tech Marketplace is envisioned as a web-based knowledge management and collaboration platform with an intuitive user-friendly interface that enhances transparency and simplifies access to R&D-funded technologies for Army stakeholders and private sector innovators to share, retrieve, and analyze information, and collaborate. The Army Tech Marketplace should provide an artificial intelligence and data-fusion capability to assess the probability of technologies to transition, identify trends within the Army enterprise, and maximize the value of business intelligence data to support agile Army decision-making. This effort seeks to create a platform for sharing information at the appropriate level first between different Army offices and second with members of the innovation economy. The effort will prioritize an internal Army-focused side connecting R&D needs and gaps with funding and resource opportunities. Internally, it must be a common, IL4 secure space for the Army and eventually, Joint Service research centers, acquisitions, and SBIR programs to learn of cross-organizational activities, mitigate R&D risks by learning from others, and dynamically exploit opportunities for collaboration. It will also have a generally accessible, external-to-the-Army side connecting innovation economy firms with Army technology challenges and the Army Program Executive Offices working to address those challenges. Externally, the Army Tech Marketplace permits Army, Joint Services, and innovation economy members to appropriately share information, build relationships, and facilitate collaboration, contracts, and integration of innovations into the Army enterprise. Integral to the platform must be data analytics and artificial intelligence enabled tools to assist internal Army Tech Marketplace users to assess technologies and trends to improve interactions with external members, as well as leverage the total value of the data on the platform to improve Army Tech Marketplace operations. These capabilities should be accessed through a simple graphical intuitive user interface that can serve users of various proficiencies and knowledge. The platform should be vetted from both a software and usability standpoint. The following are the generalized steps required of the company performing this work to frame and inform their proof-of-concept deliverable: 1. Work with Army SBIR Program to align project goals, requirements, and roles. 2. Engage key stakeholders identified by Army SBIR Program to conduct problem framing and stakeholder mapping activities to engage, discover questions, clarify language, and develop instruments useful to the stakeholders. 3. Review and present findings on similar products and services that other military Services and private organizations use that may have similar or overlapping use cases. 4. Collaborate with Army SBIR Program to identify and outline a detailed project plan, timeline, goals, scoping, and discovery outline intended to form the basis of anticipated Phase 2 work. The following are success criteria for this effort: 1. Internal Army and External Innovation Economy: Separation within the platform of internal Army stakeholder site from external emerging technology accessible site. The internal, Army-only site must achieve DOD IL-4 to handle Army data up to Controlled Unclassified Information (CUI). The external, innovative economy-oriented side of the platform should achieve DOD IL 2 (Public or Non-Critical Mission Information). 2. Collaboration: Enable collaboration across multiple Army users and private sector innovation economy firms. 3. Ease of Use: An intuitive interface informed by a human-centered design approach that results in a layout and graphics requiring minimal familiarization for basic portal navigation. Must be easy to customize fields to provide flexibility and offer a simplified Search Engine. 4. Workflow: Process tracking, routing, reminders, and ability to assign follow-on tasks. 5. Platform Modularity: Build a modular platform capable of easy expansion in both scale of participants and the scope of capabilities. 6. Reporting & Accountability: The ability to easily retrieve data and insights and track progress on pre-determined metrics. Includes but not limited to reporting and dashboards or other business intelligence tools to help visualize the data. 7. Analytics: Offer data analytics and artificial intelligence enabled tools for trend analysis, customer discovery, and continuous improvement actions across the platform. 8. Lifecycle Cost: Respecting the platform’s modular approach, create a total lifecycle cost model to account for implementation, training, and ongoing licensing/support costs. PHASE I: Starting in FY23, Phase I would be for multiple awards of $200,000 each with a 4-month period focused on technical value, commercial merit, and feasibility of proposed solutions. At a minimum, the deliverable from Phase I would be a detailed technical presentation on the design and attributes of the proposed platform conforming to the eight success criteria listed in the Topic Description. PHASE II: In FY 23, an award would be made to refine the plan developed in Phase I and create a minimum viable platform for testing and evaluation by the Army Applied SBIR Program and its stakeholders employing the eight success criteria listed in this Topic Description. These criteria are subject to revision based on the results of the outcome of the Phase I effort. PHASE III DUAL USE APPLICATIONS: The proposed technology has potential use within the Army Small Business Innovation Research Program as well as other Army Research Centers and acquisition programs.   KEYWORDS: R&D; research and development; portal; Webpage integration; knowledge management; collaboration platform; innovation economy; tech marketplace; software; website   REFERENCES:  https://www.armysbir.army.mil/topics/ https://www.ausa.org/sites/default/files/SR-1990-A-Primer-on-Research-and-Development-in-the-US-Army.pdf sbir_topic_link: https://www.sbir.gov/node/2414677 subtopics: [ ] - topic_title: 'Casualty Care Training- Mixed Reality Manikin Solution for Female Soldier Survivability' branch: Army topic_number: A234-009 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care; Human-Machine Interfaces OBJECTIVE: Develop, demonstrate, and deliver solutions for enhanced female combat trauma mixed reality (MR) training manikin that incorporates open architecture utilizing high fidelity simulations for combat-trauma-related scenarios. DESCRIPTION: A study of the Army’s medical training literature found significant disregard for the anatomical and physiological differences between males and females resulting in lower survivability rates for female casualties in comparison to males: 35.9% vs 17% and 14.5% vs 12% (Operation Iraqi Freedom) (Cross, Johnson, Wenke, Bosse, & Ficke, 2011). The Army currently trains Soldiers using male manikins when teaching Tactical Combat Casualty Care (TCCC). The Army is looking to invest in technology that improves training to better care for Soldiers, specifically female Soldiers, on the battlefield and save lives at point of injury. Training using realistic, female anatomy can help reduce hesitation to provide treatment of battlefield injuries and reduce female deaths. The Army is seeking a solution for a hybrid training tool utilizing a combination of augmented reality, virtual reality, and physical manikins to address female combat casualty care. To build out the best-in-breed training solution, all components need to be open architecture with plug-and-play capabilities to develop modular training independent of gender or scenario. While medical training is extremely hands-on, and the ability to physically feel what is happening is critical in training, virtual training provides ease and modularity for creating different training scenarios and reduces the cost of training. Currently, trauma medical training is done in either virtual or physical training environments. There are limitations for both approaches but combining the two will increase training effectiveness and reduce costs overall. Current Army medical training is male-centric with significant gaps in female trauma care (Bell, Thomson, Mazzeo, & Pike, 2020). According to the Department of Defense Personnel and Readiness Report of 2019, 14.9% of the United States Army population is female (2019, p. 93). This effort will not only move the needle to address female needs on the battlefield for the military, but it will also have applications in the civilian sector, better preparing medical professionals for trauma cases. PHASE I: Design a proof-of-concept solution for an end-to-end system, or components of a system that effectively trains Soldiers utilizing an anatomically correct physical female manikin, physical task trainers, software simulators/trainers, and provides Soldier training feedback. Solutions will be evaluated based on a holistic view of factors including the ability to integrate designated Army open standards, cost of development, adaptability of solution based on individual Soldiers’ needs or scenarios, and any additional factors proposed. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed effort, and to determine the quality of performance of the awarded companies prior to providing further support in Phase II. Final deliverable will be a concept design presentation, proof of technology demonstration, and plans for follow-on Phase II work. Companies can voluntarily participate in the Army Applications Laboratory (AAL) 12-week cohort program. The AAL cohort program is designed to solve specific Army modernization challenges on a compressed timeline. The cohort program matches qualified companies with Army problem owners to speed capability development, accelerate transition, and de-risk or inform requirements. This program is designed for businesses that own unique, applicable technology and are interested in growing a new line of business through the DoD. The cohort program will enhance technology development through rapid exposure to Army stakeholders and the Army medical simulation community. Planned activities include a problem topic deep dive, a field week with Army leaders and Soldiers, hands-on experience with currently fielded military equipment, and stakeholder engagement from the requirements writer, to the acquisition manager, to the end-user. An example cohort program for this topic is: Week 1 – Orientation and problem deep-dive (virtual) Week 2 – Soldier Touchpoint (in-person at an Army installation) Week 3-6 – Concept research and planning Week 7 – Mid-point concept design brief to Army Senior Leaders and SME roundtable discussion (in-person at an Army installation) Week 8-11 – Concept design refinement Week 12 – Final concept design brief to Army Senior Leaders (in-person at an Army installation) Cohort programming will be provided free of charge. Proposers who plan to participate in the cohort (if awarded a Phase I) are encouraged to include travel costs for three cohort trips, within the continental US, for four to five days each for in-person programming. In-person events may be substituted for virtual events depending on COVID-19 travel restrictions. Details will be provided to awardees under this topic at Phase I award. PHASE II: Design a prototype demonstration for the continued development efforts initiated in Phase I. Prototypes should be capable of integration with existing Army systems or newly developed systems from other awardees. They should also showcase modularity and prove effective during simulated or operational demonstrations. Phase II deliverables include a demonstration and delivery of a Technology Readiness Level (TRL) 6 prototype for further Army evaluation, as well as quarterly and final reports detailing design and performance analysis of the prototype. Awardees may also be eligible for Phase IIb award after completion of Phase II period of performance. Phase IIb can extend the period of performance with additional funding and additional matching opportunities to finish building out solutions with the stakeholders’ discretion. PHASE III: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives through the effort. Companies may develop a manufacturing-ready product design, capable of integration with the existing or future system, and demonstrate technology integration. Low-rate production will occur as required. Companies will engage in laboratory or operational testing as required. Phase III deliverables include system-level integration technical data package, installation documentation, and system-level prototype for demonstration and government-sponsored testing WEBINAR DATE: Two Webinars will be conducted with this solicitation on Tuesday, 21 March: Webinar 1 (1500-1600 CST) and Thursday, 23 March: Webinar 2 (1200-1300 CST). Please register at: https://casualtycaretrainingwebinar.eventbrite.com KEYWORDS: Female Manikin, Combat Casualty Trauma, Combat Trauma Manikin, MOHSES, Augmented Reality Medical Training, Virtual Reality Medical Training, Open Architecture REFERENCES: Bell, E. Thomson, R., Mazzeo, M. Pike, W. (2020). Same injury, different outcome? Investigating hesitation while treating female casualties. Proceedings of the 2020 Interservice/Industry Training, Simulation, and Education Conference. https://media.defense.gov/2023/Mar/06/2003173353/-1/-1/1/BELL_THOMSON_CASUALTIES.PDF Cross, J. D., Johnson, A. E., Wenke, J. C., Bosse, M. J., & Ficke, J. R. (2011). Mortality in female war veterans of Operations Enduring Freedom and Iraqi Freedom. Clinical Orthopaedics and Related Research®, 469(7), 1956-1961.Retrieved November 21 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3111768/ MoHSES, the Advanced Modular Manikin Phase 2 Standards(2015). Retrieved November 3 from https://www.mohses.org/ Office of the Under Secretary for Personnel and Readiness Report, 2019. Retrieved October 2, 2019 from https://prhome.defense.gov/M-RA/Inside-M-RA/TFM/Reports/ Reed, A. M., Janak, J. C., Orman, J. A., & Hudak, S. J. (2018). Genitourinary injuries among female US service members during Operation Iraqi Freedom and Operation Enduring Freedom: findings from the Trauma Outcomes and Urogenital Health (TOUGH) project. Military Medicine, 183(7-8), e304-e309. https://pubmed.ncbi.nlm.nih.gov/29420771/ Sotomayor, T. M., Mazzeo M. V., Maraj, C. S., & Page, A. J. (2018). Saving female lives using simulation: elevating the training experience.. Launching Innovation Through Medical Modeling and Simulation Technologies, 6(4), 28 – 37. Retrieved October 2, 2019, from https://csiac.org/articles/saving-female-lives-using-simulation-elevating-the-training-experience/ sbir_topic_link: https://www.sbir.gov/node/2414679 subtopics: [ ] - topic_title: ' xTechSBIR Pacific Finalist Open Topic Competition' branch: Army topic_number: A234-P010 topic_description: | Critical Technical Area(s): Advanced Computing and Software; Integrated Network Systems-of-Systems; Renewable Energy Generation and Storage; Human-machine Interfaces OBJECTIVE: It has been noted that when it comes to conflict, America is often the “away team.” The U.S. is often fighting wars in areas thousands of miles from U.S. shores. This fact creates a “tyranny of distance,” meaning that, distance lessens military strength and increases the cost of conflicts. The impact of long distances can affect overall strategy, tactics, and logistics. Even with unrivaled capabilities, the ability to collect and understand intelligence can decay over distance. The supply chain is also heavily impacted, as distance increases, the time to provide supplies increases, supply routes can be contested, and even when supplies arrive safely, upkeep and maintenance are still a concern. These are just a few of the ways that distance impacts the effectiveness of our military overseas. The U.S. Army is interested in enabling technologies that could help overcome the “tyranny of distance”. Examples of technologies that address this issue include but are not limited to the following domains: • Logistics/Supply Chain: To ensure rapid resupply of material and aid. • Sustainment and Climate: To limit the need for resupply across geographically dispersed troops. • Communications: To ensure secured communication in degraded environments over extraordinary distances. • Internet of Things (IoT)/Sensing: To increase force control and introduce autonomous capabilities in Theater. • Information Advantage: To increase real-time situational awareness through information operations and a commons intelligence picture. DESCRIPTION: The U.S. Army would like to invite interested entities to participate in the xTech Small Business Innovation Research (SBIR) Pacific competition, a forum for eligible small businesses in the U.S. Pacific region to engage with the Army, earn prize money, participate in the accelerator program, and submit for a Phase I SBIR award. xTechSBIR Pacific offers an opportunity for eligible participants to pitch novel technology solutions directly to the Army addressing tyranny of distance challenges faced by the U.S. Pacific region. The U.S. Army Combat Capabilities Development Command (DEVCOM)-Pacific, U.S. Army Pacific (USAPAC), and Hawaii Technology Development Corporation (HTDC) in partnership with the Assistant Secretary of the Army (Acquisition, Logistics, and Technology) (ASA(ALT)), recognizes that the Army must enhance engagements with eligible small businesses by: (1) understanding the spectrum of ‘world-class’ technologies being developed commercially that may benefit the Army; (2) integrating the sector of commercial innovators into the Army’s Science and Technology (S&T) ecosystem; and (3) providing mentorship and expertise to accelerate, mature, and transition technologies of interest to the Army. The xTechSBIR Pacific competition will consist of three-rounds: (1) Call for concept white papers (2) Virtual Technology Pitch event and (3) Final Pitch event, awarding up to $800,000 in cash prizes to select eligible entities throughout the competition. Ultimately, up to 20 finalists will be selected from the virtual technology pitch event and will receive a cash prize of $20,000 each and an invitation to demonstrate their innovative technology solutions to Army challenges during the final pitch event. Up to 10 participants will be selected as the final winners of the competition upon conclusion of the finals pitch event and will receive an additional cash prize of $25,000 each and the opportunity to submit for a Phase I SBIR award of up to $250,000 each or a Direct to Phase II SBIR award of up to $1,900,000 each. Details on the prize structure are listed in this announcement. In addition to non-dilutive cash prizes, participants will have the opportunity to engage with Army partners through information sharing and networking opportunities. Finalists will be entered into the xTech Accelerator to receive intensive mentorship and access to networking events to help grow their companies for Army and commercial users. The efforts described in this notice are being pursued under the authorities of 10 U.S.C. § 4025 (formerly 2374a, Prizes for Advanced Technology Achievements) and 15 U.S.C. § 638 and 10 U.S.C. § 4003 (Prototype Projects) to award cash prizes and SBIR awards to only those eligible entities as described in this announcement. While the authority of this program is 10 U.S.C. § 4025, the xTechSBIR Pacific competition may generate interest by another U.S. Army, DOD or USG organization for a funding opportunity outside of this event. The interested organization may contact the participant to provide additional information which may or may not result in partnership opportunities. PHASE I: Companies will complete a feasibility study that demonstrates the firm’s competitive technical advantage relative to other commercial products (if other products exist) and develop concept plans for how the company’s technology can be applied to Army modernization priority areas. Studies should clearly detail and identify a firm’s technology at both the individual component and system levels, provide supporting literature for technical feasibility, highlight existing performance data, showcase the technology’s application opportunities to a broad base of customers outside the defense space, a market strategy for the commercial space, how the technology directly addresses the Army’s modernization area as well as include a technology development roadmap to demonstrate scientific and engineering viability. At the end of Phase I, the company will be required to provide a concept demonstration of their technology to demonstrate a high probability that continued design and development will result in a Phase II mature product. PHASE II: Produce prototype solutions that will be easy to operate by a Soldier. These products will be provided to select Army units for further evaluation by the soldiers. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets. PHASE III DUAL USE APPLICATIONS: Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization. The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation. Based on soldier evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration. REFERENCES: https://www.xtech.army.mil/competitions/ KEYWORDS: logistics; supply chain; climate; xTech; xTechSBIR Pacific; internet of things; information collection; data collection; sensing; communications sbir_topic_link: https://www.sbir.gov/node/2414681 subtopics: [ ] - topic_title: Conformable Hydrogen Storage branch: Army topic_number: A234-011 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Biotechnology TOPIC OBJECTIVE: The goal of this topic is to develop conformable hydrogen storage vessels that can store hydrogen at 700 bar (10,000 psi). TOPIC DESCRIPTION: As the Army moves towards electrifying its vehicle fleet, storing enough energy onboard vehicles to match or exceed their current performance is a challenge. While batteries have made great strides in recent decades, they remain heavy and cumbersome. A potential solution for heavy vehicles is hydrogen fuel cells. Fuel cells can provide the benefits of electrification (silent mobility, silent watch, export power, high torque on demand, etc.) while maintaining current vehicle range and allowing for refueling in the same amount of time as liquid fuels. One drawback of hydrogen fuel cells is storage of the hydrogen itself. Current solutions are bulky composite overwrapped pressure vessels (COPVs) that take up significant space. A potential solution is conformable tanks that can be designed to fit unusually shaped space claims, allowing for more energy to be stored in containers, on vehicles, or in other energy storage use cases. This technology has been developed and validated to 350 bar (5,000 psi) applications, but further work is required to meet the goal of 700 bar operating pressures. Evaluation of these tanks under military ballistic testing also revealed some potential areas of improvement for this technology. It is important to develop this technology as it will enable high energy density storage that can be refilled as quickly as current liquid fuels while enabling electrification technologies and reducing thermal and acoustic footprints for energy generation systems. Note: This technology uses emerging manufacturing techniques along with a unique design that allows for the hydrogen storage tank to fit the shape of any space claim, utilizing a higher percentage of empty space than the current state of the art. The materials used are also lower cost and have been optimized to meet the demanding requirements for vehicle use. PHASE I: This is a Direct to Phase II topic. To justify a Direct to Phase 2, the company should provide data showing a tank system made up of multiple segments (more than one) capable of 350 bar operations. At minimum, there should be data demonstrating the system can comply with proof testing and burst testing outlined in CSA/ANSI HGV 2. DIRECT TO PHASE II: Design a 700-bar system for vehicle use that qualifies applicable to HGV 2 standards identified by both TPOC and contractor. Demonstrate the performance of the system on an applicable vehicle system. Potential Phase II Sequential and Enhancement: Scale up the design of the 700-bar system for larger storage quantities. Undergo ballistic testing of the system with military specific ballistic threats. Incorporate lessons learned from previous testing and develop 700 bar systems for specific military vehicle applications. PHASE III DUAL USE APPLICATIONS: There is a multitude of industries that would benefit from improved hydrogen storage, with new use cases, like P2G tech, that will rely on hydrogen storage technology for operation. Efficient hydrogen storage will become a necessity as various industries, including transportation, metal refining, and chemical manufacturing, increase their hydrogen usage. The proposed technology has potential use within the Army Small Business Innovation Research Program as well as other Army Research Centers and acquisition programs.   KEYWORDS: Hydrogen; Storage; fuel; battlespace; tank; refuel point; electrification   REFERENCES:  1. Lithium Ion Battery, Clean Energy Institute, https://www.cei.washington.edu/education/science‐of‐solar/battery‐technology/ 2. Physical Hydrogen Storage, https://www.energy.gov/eere/fuelcells/physical‐hydrogen‐storage 3. Conformable Hydrogen Pressure Vessel, https://www.osti.gov/servlets/purl/1459184 4. Innovative pressurized hydrogen storage for integrated vehicle structures using composites, 5. https://www.compositesworld.com/news/innovative‐pressurized‐hydrogen‐storage‐for‐integrated‐vehicle‐structures‐using‐composites 6. Materials challenges to enable hydrogen deployment at scale by 2050, https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=0CCYQw7AJahcKEwjg37GFo_f7AhUAAAAAHQAAAAAQAw&url=https%3A%2F%2Fwww.royce.ac.uk%2Fcontent%2Fuploads%2F2021%2F06%2FRoyce‐Hydrogen‐Conformable‐Tanks-Summary.pdf&psig=AOvVaw1WyXFqJZkfpV3vNpk4zMmc&ust=1671044241186277 sbir_topic_link: https://www.sbir.gov/node/2414683 subtopics: [ ] - topic_title: Hydrogen Generator branch: Army topic_number: A234-012 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Biotechnology TOPIC OBJECTIVE: The purpose of this topic is to develop an on-demand hydrogen generation system that can be used to quickly refuel a vehicle in situations where its main fuel tank is empty. The end user for this system would be fuel cell system operators. In the event a fuel cell system depletes the main fuel tank and battery power (assuming a hybrid fuel cell/battery electric architecture), this system can be used to provide hydrogen to the fuel tank (or directly to the fuel cell) to allow the system to provide power and return to safety. The system would be sized to be portable while providing enough energy to travel back to base, similar to how jerrycans are currently used. TOPIC DESCRIPTION: As the Army moves towards more electrified platforms, new challenges arise, such as running out of fuel or energy while executing a mission. Current vehicles can be refueled quickly from a jerrycan, allowing them to travel to the refueling point. Fully electrified platforms are not as easily refueled on the side of the road, which puts both Soldiers and materiel in danger. As the Army explores electrification technologies, preparing for situations such as this are important to keep both Soldiers safe and protect next generation platforms. Hydrogen fuel cells are a potential electrification technology that can provide near-silent power and mobility for military vehicles while providing high torque with inherently scalable power and energy, capable of providing range beyond that of purely battery-powered electric vehicles. Hydrogen can also be refueled more quickly than batteries can charge, providing an opportunity to solve the problem of a fuel-depleted vehicle on a mission. Several technologies exist that can provide hydrogen on-demand from solid materials that can be easily and safely transported and stored. One such technology of interest is aluminum alloys that react with water to provide hydrogen. Note: Hydrogen generators that utilize aluminum alloy and water are like an extra fuel tank, but less volatile. Aluminum powder can be safely handled and stored as a solid material, unlike liquid fuel. Several recent advances in the technology allow for the material to be manufactured at scale from scrap aluminum, providing a large source of energy in an inexpensive manner (1, 2). Compared to domestically sourcing lithium for battery production (and in order to meet future energy needs), this technology provides significant energy density without requiring rare earth metals, while at the same time needing significantly less infrastructure be developed. When exposed to water, the alloys produce hydrogen rapidly and at pressure, allowing a vehicle to be fueled quickly while providing enough energy to travel back to safety or a refueling point. The system can be designed with safety at the forefront, incorporating pressure relief devices and intrinsically safe controls. PHASE I: It is important to note that this is a Direct to Phase II topic. To justify a Direct to Phase 2, This Direct to Phase 2 effort should have data demonstrating the operation of an aluminum-water hydrogen generation system. The data should show the flow rate of hydrogen from the system, pressure during operation, temperature of the system, the amount of aluminum and water used, and control over the reaction (data showing a controlled stop/start cycle of the reaction). The proposal should also demonstrate the hydrogen from the reaction is pure enough to operate a fuel cell by either providing performance data from a fuel cell connected to the system or analysis of the hydrogen purity. PHASE II: Design a hydrogen generation system that can be man-portable while providing a meaningful range for vehicles in the case that fuel is depleted. Manage the thermal performance of the system, reducing both the exterior touch temperature to safe levels and overall thermal signature. Fabricate and demonstrate such a system. Demonstrate aluminum alloy production capable of supporting the manufacturing of several systems. Testing required for this technology would include measuring the flow rate of hydrogen from the system, demonstrating that the system can operate at the designated pressure, maintaining a safe external touch temperature, and effectively removing heat from the reaction. PHASE III DUAL USE APPLICATIONS: There is high dual-use potential for hydrogen fuel cells, as users across industries continue to adopt this technology, especially in vehicles and industrial power. The high CAGR indicated rapid, significant projected growth across all sectors. Popular use cases for fuel cells in general include power generation for electric individual and mass transportation vehicles, industrial processes, data centers, and utilities, as well as residential heating. Hydrogen fuel cells can be used to build stacks, which can allow for modular power systems that can adapt to energy requirements based on the use case.The proposed technology has potential use within the Army Small Business Innovation Research Program as well as other Army Research Centers and acquisition programs.   KEYWORDS: Hydrogen; Storage; fuel; battlespace; tank; refuel point; electrification; generator; generation system; power supply   REFERENCES:  1. Using aluminum and water to make clean hydrogen fuel—when and where it’s needed, https://energy.mit.edu/news/using-aluminum-and-water-to-make-clean-hydrogen-fuel-when-and-where-its-needed/ 2. Nanogalvanic Aluminum Powder For Hydrogen Generation, https://www.arl.army.mil/wp-content/uploads/2019/11/AlNanogalvanicPowder-Marketing-Sheet.pdf 3. The production of hydrogen as an alternative energy carrier from aluminium waste, https://energsustainsoc.biomedcentral.com/articles/10.1186/s13705-017-0110-7 sbir_topic_link: https://www.sbir.gov/node/2414685 subtopics: [ ] - topic_title: Dual Band Imager branch: Army topic_number: A234-013 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber OBJECTIVE: The innovative approach of this topic is the focus on reduced SWAP (size, weight, and power) in addition to performance. DESCRIPTION: Missions require the use of multiple sensors in order to achieve specific objectives. The sensors used extended range imaging applications relies on antiquated technology resulting in extreme sensitivity to Size, Weight, and Power (SWaP). Current dismounted sensors configurations either necessitate separate imaging devices, or complex optical filtering schemes that increase system SWaP in order to maintain operational effectiveness in all environments. Lastly, imaging sensors allow for more advanced target discrimination against advanced threats in multiple bands, complex scenes and various atmospheric conditions. If multiple sensor bands can be imaged simultaneously on the same detector, lower SWaP and less sensitive subcomponent alignments (lower SWaP/environmental factors) is gained resulting in less complex systems. PHASE I: Phase I is anticipated 3 months to complete a System Design Review, covering systems trade analysis and optimization of performance vs anticipated SWaP, with the goals of phase II below as the basis. The final design will be illustrated with conceptual drawings and performance predictions to at the detector level to support system-level feasibility studies by the Government. Additional details/specifications to be provided to firm upon award. PHASE II: Phase II is anticipated sbir_topic_link: https://www.sbir.gov/node/2414687 subtopics: [ ] - topic_title: Sustainable Building Materials and Technologies Open Topic branch: Army topic_number: A234-P014 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials OBJECTIVE: The purpose of a Sustainable Building Materials and Technologies focused Open Topic is to bring potentially valuable small business innovations to the Army and create an opportunity to expand the relevance of the Army SBIR program to firms who do not normally compete for SBIR awards. Building materials and technologies are ubiquitously used by the Army CONUS and OCONUS, and account for a significant percentage of the overall Army carbon/climate footprint. This Sustainable Building Materials and Technologies topic seeks to address this carbon intensive aspect of military operations through disruptive materials, logistics, and technologies from a life-cycle assessment (LCA)perspective to meet the goals of the DoD Climate Adaptation plan and Army Climate Strategy. DESCRIPTION: This open topic is a Phase I or Direct to Phase II submission. For Phase I awards period of performance is a maximum of 6 months and a maximum funding limit of $250,000 per award. For Direct to Phase II awards period of performance is a maximum of 18 months and a maximum funding limit of $1,900,000 per award. While the Sustainable Building Materials and Technologies Open Topic will accept proposals on any technical challenge requiring an application to reduce lifecycle fossil fuel consumption and/or emissions, submissions addressing the applications of those technologies in enduring facilities and infrastructure on installations as well as low-logistics contingency construction applications will be prioritized along with efforts focused on the following technical areas: • Low-logistics indigenous materials utilization • Sustainability-centered materials-by-design • Scalable sustainable building material technologies • Forward waste utilization for sustainable low-logistics manufacturing • Low-energy bio-based building materials • Terrestrial carbon sequestration materials and technologies PHASE I: The Phase I period of performance will be 6 months. Small businesses shall deliver a proof of technical feasibility at the end of the Period of Performance. Phase I submission materials: • 5-page technical volume • 8-slide commercialization plan; template provided in announcement Post-Phase I Deliverables: • Small Business: A feasibility study to demonstrate the technical and commercial practicality of the concept to include an assessment of its technical readiness and potential applicability to both military and commercial markets. • Technical POC and Transition Partner: Commitment secured from TPOC and Transition Partner to associate with potential Phase II work. (Transition Partner is defined as an Army organization planning to integrate and fund the technology after SBIR funding has expired). Proposers interested in submitting a Direct to Phase II (DP2) proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above has been met and describes the potential military and/or commercial applications. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. PHASE II: Produce prototype solutions targeted toward construction and other Army sustainability requirements. These solutions should be vetted through standard testing procedures and modeling focused on mechanical /structural performance, lifecycle durability, lifecycle sustainability, and an understanding of lifecycle cost factors. Prototypes will focus on demonstrating technology at scale including requirements for design and specifications that can easily transition for adoption by the Army. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets. PHASE III DUAL USE APPLICATIONS: Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization. The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation. Based on technical evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration KEYWORDS: Clean Technology; Sustainable Construction; Open topic; Materials, Sustainability, Resilience; Emissions; Green; Environmental, Facilities, Buildings, Infrastructure REFERENCES:  https://www.armysbir.army.mil/topics/ sbir_topic_link: https://www.sbir.gov/node/2414689 subtopics: [ ] - topic_title: xTechPrime Finalist Open Topic Competition branch: Army topic_number: 'A234-P015 ' topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy; Advanced Computing and Software; Integrated Sensing and Cyber; Microelectronics; Integrated Network Systems-of-Systems; Renewable Energy Generation and Storage; Advanced Materials; Human-Machine Interfaces OBJECTIVE: xTechPrime is seeking novel, disruptive concepts and technology solutions with dual-use capabilities that can assist in tackling the Army’s current needs and apply to current Army concepts. The intent is to provide the Army with transformative technology solutions while enabling cost savings throughout the Army systems’ life cycle. Critical technology focus areas include Artificial Intelligence/Machine Learning (AI/ML); Autonomy; Climate and Clean Technologies; Immersive/Wearables; and Sensors. See attached document on the Valid Eval registration page for a list of the top Army SBIR Transition Broker Team topic areas. DESCRIPTION: The U.S. Army would like to invite interested entities to participate in the xTechPrime competition, a forum for eligible small businesses and technology integrators to form teams in order to bring forward innovative technology solutions to solve current Army needs. A technology integrator is defined for this competition as “any business outside of the selected small business in Part 1, who has directly worked with the U.S. government. They have experience managing at least one subcontractor and are responsible for ensuring that the work is completed as defined in the contract, this can include but is not limited to, other small businesses, Primes, and sole proprietors.” The xTechPrime competition will challenge small businesses to work together in teams with technology integrators to submit their innovative solutions that contribute to the Army’s current modernization goals. xTechPrime will assist in driving innovation, ultimately delivering novel, and often overlooked, technologies to the Army. Through the xTechPrime competition, the Army is encouraging collaboration between small businesses and technology integrators by providing an opportunity to form teams to compete for non-dilutive cash prizes and, for the original small business submitters, the potential for a Direct to Phase II SBIR contract award. The efforts described in this notice are being pursued under the authorities of 10 U.S.C. § 4025 (formerly 2374a) and 15 U.S.C. § 638 and 10 U.S.C. § 4022 (Prototype Projects) to award cash prizes and SBIRs to only those eligible entities as described in this announcement. The xTechPrime competition will serve as the proof-of-principle that is required to receive a Direct to Phase II SBIR award. While the authority of this program is 10 U.S.C. § 4025, the xTechPrime competition may generate interest by another DOD organization for a funding opportunity outside of this program (e.g., submission of a proposal under a Broad Agency Announcement). The interested DOD organization may contact the participant to provide additional information or ask for a request for proposal in a separate solicitation. PHASE I: This is a Direct to Phase II submission. In order for proposers to submit a Direct to Phase II (DP2) proposal, they must provide the justification documentation to substantiate that the scientific and technical merit and feasibility described above has been met and describes the potential military and/or commercial applications. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. PHASE II: Produce prototype solutions that will be easy to operate by a Soldier. These products will be provided to select Army units for further evaluation by the soldiers. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets. PHASE III DUAL USE APPLICATIONS: Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization. The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation. Based on soldier evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration. REFERENCES: https://www.xtech.army.mil/competitions/ KEYWORDS: logistics; supply chain; climate; xTech; xTechPrime; internet of things; information collection; data collection; sensing; communications; autonomy; artificial intelligence; sensors; AI/ML sbir_topic_link: https://www.sbir.gov/node/2414691 subtopics: [ ] - topic_title: 'Lethal Payloads for Small Unmanned Aerial Systems ' branch: Army topic_number: A234-016 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Air Platforms OBJECTIVE: Develop a lethal payload capability that can be employed on a Small Unmanned Aerial System (sUAS). The capability should employ munitions (ammunition or explosives) that are currently in the U.S. inventory and attach to one or more sUAS platforms on the Defense Innovation Unit (DIU) Blue UAS Cleared List, excluding the WingtraOne platform. DESCRIPTION: The ability to employ lethal payloads on existing sUAS is vital for future Army combat operations. Lethal payloads for sUAS will provide capabilities at the small unit level beyond the current use of sUAS, which focuses only on intelligence, surveillance, and reconnaissance (ISR) capabilities. Successful development of lethal payloads for sUAS would advance the U.S. Army’s modernization priorities and increase the lethality of its Infantry Brigade Combat Teams (IBCTs). Currently only one sUAS platform is fielded at the small unit level: the Short Range Reconnaissance (SRR) platform, fielded by Program Executive Office (PEO) Aviation and referred to commercially as the Skydio X2D. The SRR was developed to give infantry platoons a UAS platform for intelligence, surveillance, and reconnaissance. Under the SRR program there is currently no capability to employ the system as a lethal asset. The Defense Innovation Unit (DIU), under the Blue UAS program, has worked with vendors to vet and scale commercial UAS technology for the Department of Defense (DoD). This program consists of five lines of effort that curate, maintain, and improve a roster of policy-approved commercial UAS which suit the diverse needs of DoD users. This effort currently has vetted 16 different platforms for DoD use. Government labs are currently undertaking efforts to develop lethal UAS. These efforts include DEVCOM Armament Center’s latest payload for the SRR platform, which delivers an M67 fragmentation grenade as the munition. The design goals of this effort are the development of modular lethal payloads that can be employed by the current Program of Record SRR and/or any of the platforms on the DIU Blue UAS Cleared List excluding the WingtraOne platform. These payloads should: • Be attachable by Soldiers in the field • Employ ammunition or explosives currently in the Government inventory, allowing units to order through standard channels • Increase the lethal capability beyond that of the M67 fragmentation grenade-based solution currently in development • Integrate into the selected platform • Operate on the platform controller or include a simple system to initiate the payload (long term desire is for ATEK integration) • Be able to pass applicable safety testing • Be able to be made safe and dismounted from the platform if not detonated Primary obstacles to overcome for successful operation of lethal payloads for sUAS is the integration and control of the payload to the selected platform while maintaining safe flight of the platform. Cost should be considered in the SBIR proposals. PHASE I: Design a preliminary lethal payload for the Short Range Reconnaissance (SRR) platform or any sUAS platform from the DIU Blue UAS Cleared List, excluding the WingtraOne platform. Preliminary design should describe the selected sUAS platform(s) and munition(s), consist of a concept for physical attachment and electrical and software integration, and a description of the method of fire control. This topic is accepting Direct to Phase II (DP2) proposals only. Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described in above has been met and describes the potential commercial applications. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. PHASE II: Refine the preliminary design, produce, and deliver a prototype at Technology Readiness Level (TRL) 5 of a lethal payload for a sUAS platform. The system refinement should include mechanical and electrical integration into the selected platform, fire control, and targeting. Required Phase II deliverables include all necessary components (hardware and software) to integrate the payload to the platform, attachment of munitions, safe handling procedures for munitions, arming munitions, targeting or aiming, delivery of munition, making system safe, returning to operator, and removal of munitions and payload to be utilized again if not employed. The prototype will be demonstrated using a simulated, dummy, or inert munition at a vendor-provided, government-approved location to evaluate performance. The performer will provide the sUAS platform necessary to conduct the demonstration but is not required to deliver the sUAS platform to the Government. Additionally, the performer will deliver monthly progress reports describing all technical challenges, technical risk, and progress against the schedule, and a final technical report. PHASE III: The objective of Phase III, where appropriate, is to transition the technology to a U.S. Army Combat Capabilities Development Command (DEVCOM) lab for further development, or to a Program Executive Office (PEO) for potential acquisition pathways. Phase III goals may include live-fire demonstration of the technology at an appropriate test range, testing to applicable safety and airworthiness standards, end user touchpoints, and development of operator, maintenance, and safety instructions and training procedures. KEYWORDS: UAS, sUAS, Small Unmanned Aerial Systems, Blue UAS, SRR, Lethal Payloads REFERENCES: 1. DIU Blue UAS Cleared Drone List, https://www.diu.mil/blue-uas-cleared-list 2. DIU UAS Policy Guidance, https://www.diu.mil/blue-uas-policy 3. U.S. Army Weapon Systems Handbook, https://asc.army.mil/docs/wsh2/2020-2021-wsh.pdf sbir_topic_link: https://www.sbir.gov/node/2414693 subtopics: [ ] - topic_title: xTechSBIR Autonomy Finalist Open Topic Competition branch: Army topic_number: 'A234-P017 ' topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Autonomy; Advanced Materials OBJECTIVE: xTechSBIR Autonomy is seeking novel capabilities and technology solutions within the Autonomy space, that can assist in tackling the Army’s current and future needs, enabling new capabilities, improved performance, faster production, or cost savings for Army systems. Examples of technologies that address the issue include but are not limited to the following domains: • Novel Materials for Additive Manufacturing – The U.S. Army is interested in enabling technologies that could replace conventional subtractive production methods. Novel feedstocks and 3D printable materials can be used to produce parts more with increased efficiency and superior performance. • Future Additive Production Capabilities – The U.S. Army is seeking novel and unique additive production technologies. These may include revolutionary production capabilities, or improved processes that can increase efficiency to reduce cost, waste, and production time. • Additive Production Systems & Analysis – The U.S. Army is interested in solutions to produce parts through additive manufacturing with improved efficiency, reliability, and quality. These technologies may include: • Manufacturing Equipment for Expeditionary Environments – The U.S. Army manufacturers parts in harsh environments including deserts, high altitude locations, and the Arctic. Such environments may be remote with limited logistical support, and may experience high humidity, dust, sand, and temperatures below -50C. Expeditionary production equipment must survive being stored in extreme environments and may also be required to operate in difficult conditions. • Advanced and Convergent Manufacturing Capabilities - The U.S. Army is also interested in novel non-additive production methods and hybrid/convergent manufacturing capabilities that combine additive and subtractive processes. • Advanced Materials – The U.S. Army is seeking research and development in the areas of novel advanced materials. There is particular interest in materials that exhibit improved strength, durability, and performance at both extremely low and high temperatures. A wide variety of applications for advanced materials include personnel protection, aerospace, avionics, and hypersonic systems. DESCRIPTION: The U.S. Army would like to invite interested entities to participate in the xTech Small Business Innovation Research Autonomy competition, an opportunity for eligible small businesses to engage and pitch their novel technology solutions directly to the Department of Defense, earn prize money and potentially receive a Phase I SBIR award of up to $250,000 each. The Army recognizes that the DoD must enhance engagements with eligible small businesses, by: (1) understanding the spectrum of ‘world-class’ technologies being developed commercially that may benefit the DoD in the autonomy space; (2) integrating the sector of non-traditional innovators into the DoD Science and Technology (S&T) ecosystem; and (3) providing expertise and feedback to accelerate, mature, and transition technologies of interest to the DoD. The xTechSBIR Autonomy competition will consist of four-rounds: (1) Call for concept white papers; (2) Final Technology Pitch event; (3) Request for Phase I SBIR Proposal Submission; and (4) Request for Phase II SBIR Demonstration. The competition will be awarding up to $500,000 in cash prizes to select eligible entities throughout the competition. Ultimately, up to 20 winners will be selected from the technology pitch event round and will be invited to submit an application for a potential Phase I SBIR Proposal worth up to $250,000. Up to 20 companies will be selected to receive a Phase I SBIR award and then will be invited back after six months of award to conduct a live demonstration to a key panel of DoD experts. Details on the prize structure and phases, are listed in this announcement below. In addition to non-dilutive cash prizes, participants will have the opportunity to engage with U.S. DoD and winners from the Part 1: Concept White Paper round will be invited to conduct an in-person pitch at Grace’s Quarters in Maryland. The efforts described in this notice are being pursued under the authorities of 10 U.S.C. § 4025 (formerly 2374a, Prizes for Advanced Technology Achievements) to award cash prizes as described in this announcement and potential SBIR contracts (15 U.S. Code §638) to only those eligible and selected entities as described in this announcement. In addition, 10 U.S.C. § 4003 (Prototype Projects) can be utilized to award additional follow-on contracts for additional proof-of-concept or prototype development. While the authority of this program is 10 U.S.C. § 4025, the xTechSBIR Autonomy competition may generate interest by another U.S. Army, DoD or USG organization for a funding opportunity outside of this event. The interested organization may contact the participant to provide additional information which may or may not result in partnership opportunities. PHASE I: Companies will complete a feasibility study that demonstrates the firm’s competitive technical advantage relative to other commercial products (if other products exist) and develop concept plans for how the company’s technology can be applied to Army modernization priority areas. Studies should clearly detail and identify a firm’s technology at both the individual component and system levels, provide supporting literature for technical feasibility, highlight existing performance data, showcase the technology’s application opportunities to a broad base of customers outside the defense space, a market strategy for the commercial space, how the technology directly addresses the Army’s modernization area as well as include a technology development roadmap to demonstrate scientific and engineering viability. At the end of Phase I, the company will be required to provide a concept demonstration of their technology to demonstrate a high probability that continued design and development will result in a Phase II mature product. PHASE II: Produce prototype solutions that will be easy to operate by a Soldier. These products will be provided to select Army units for further evaluation by the soldiers. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets. PHASE III DUAL USE APPLICATIONS: Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization. The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation. Based on soldier evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration. REFERENCES: https://www.xtech.army.mil/competitions/ KEYWORDS: autonomy; manufacturing; additive manufacturing; xTech; xTechSBIR; 3D printing; additive fabrication; direct digital manufacturing; freeform fabrication; solid freeform fabrication; rapid manufacturing; rapid prototyping; expeditionary manufacturing; convergent manufacturing; additive production; advanced materials; advanced manufacturing; advanced manufacturing; sbir_topic_link: https://www.sbir.gov/node/2414695 subtopics: [ ] - topic_title: Digital Erasure of Sensitive FPGA Systems branch: Army topic_number: A234-018 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy; Advanced Computing and Software OBJECTIVE: Modern and future battlefields will see increasing use of automated platforms; however, single-use, leave-behind, or unattended U.S. military systems require sufficient protection against hardware and software components from being reverse engineered. Currently, there is not yet a cost-effective, adequate solution for this requirement. Practices such as traditional physical anti-tamper methods or warfighters having direct physical access to attempt platform destruction are not feasible for the new ecosystem of low-cost, high-count platforms. Conversely, digital erasure with its low barrier-to-entry, in terms of cost and implementation, is the suitable alternative. DESCRIPTION: Through reverse engineering techniques, adversaries can extract information stored in non-volatile memory from abandoned, misused, single-use, leave-behind, or unattended U.S. military systems. Furthermore, utilizing volatile memory storage (i.e., Random Access Memory, RAM) for a system’s Critical Program Information (CPI), proprietary information, or intellectual property (IP) is not an adequate design technique to ensure the information is unrecoverable as new, sophisticated techniques are able to “freeze” binary signatures etched onto the storage medium hardware. These capabilities enable adversaries and other nation-state actors to potentially modify, exploit, exfiltrate, or leverage U.S. military systems, including their design and information, risking Original Equipment Manufacturer (OEM) business advantages and the U.S. military’s technological superiority. However, systems designed with reconfigurable logic hardware (e.g., Field Programmable Gate Arrays, FPGAs) instead of Application Specific Integrated Circuits (ASICs) to execute system functions provides a hardware fabric that can be completely erased in order to protect sensitive designs and information from being reverse engineered. PHASE I: This is a Direct to Phase II topic (DP2). Small businesses, at the time of proposal, must have a solution capable of and, at the time of award, be able to demonstrate a proof-of-concept digital erasure solution capable of modifying the FPGA fabric to ensure the original data within memory is no longer recoverable. DIRECT TO PHASE II: As a Direct to Phase II, proposal submissions should include discussion on the following: • Demonstrate digital erasure functionality on commercial platforms/systems/controllers that, once activated by a trigger mechanism, will successfully erase the FPGA fabric in order to prevent data recovery through reverse engineering of the memory hardware. • Coordination with partners will reveal applications and preferred trigger mechanisms, thus the trigger functions themselves must be protected to mitigate the potential for adversaries to attack platforms through digitally erasing systems. • The developed tool will automatically implement digital erasure functionality onto FPGAs despite differences in vendors, components, interfaces, etc. to achieve platform-agnostic support. • To provide resiliency against reverse engineering, digital erasure function should erase FPGA fabric by writing randomized data to memory instead of writing only 0s or only 1s. • Optimization steps to reduce total erasure/overwrite times and resource utilization will be identified and implemented during development. • Streamline user experience and requirements both for warfighters to trigger digital erasure and for FPGA developers to implement digital erasure functionality. • Conduct commercialization strategy to integrate solution with existing toolchains and developer applications utilized by industry for FPGA development. • Solution testing and evaluation will be conducted through FPGA developer tools to digitally verify that the memory has been successfully erased, and later through performing simulated data remanence attacks, where the hardware is manipulated to retain memory states which are then analyzed, to provide realistic verification whether the original data can be recovered through sophisticated reverse engineering techniques after a memory erase. PHASE III DUAL USE APPLICATIONS: Data security is a top priority for organizations across all industries, which has companies rushing to adopt and implement the latest capabilities in data destruction and sanitation. The moderately high CAGR of 14.3% indicates sustained growth. Complete the maturation of the company’s technology developed in Phase II and produce prototypes to support further development and commercialization. KEYWORDS: Reconfigurable, Logic, Zeroize, Circuit, FPGA, System On A Chip, SoC, ASIC, Tamper, Data Assurance, Electronics, Microelectronics, Zeroization, Sanitization, Hardware, Memory REFERENCES: 1. NIST Special Publication 800-88: Guidelines for Media Sanitization, Revision 1 https://csrc.nist.gov/publications/detail/itl-bulletin/2015/02/nist-special-publication-800-88-revision-1-guidelines-for-media/final#:~:text=NIST%20has%20published%20an%20updated%20version%20of%20Special,on%20the%20categorization%20of%20confidentiality%20of%20their%20information 2. Lohrke, H., Tajik, S., Krachenfels, T., Boit, C., & Seifert, J. P. (2018). Key extraction using thermal laser stimulation: A case study on xilinx ultrascale fpgas. IACR Transactions on Cryptographic Hardware and Embedded Systems, 573-595. https://tches.iacr.org/index.php/TCHES/article/download/7287/6464/ 3. Courbon, F., Skorobogatov, S., & Woods, C. (2016, November). Direct charge measurement in floating gate transistors of flash EEPROM using scanning electron microscopy. In ISTFA 2016 (pp. 327-335). ASM International. https://aspace.repository.cam.ac.uk/bitstream/handle/1810/262365/Courbon_et_al2016-International_Symposium_for_Testing_and_Failure_Analysis-AM.pdf?sequence=1&isAllowed=y 4. Gupta, K., & Nisbet, A. (2016). Memory forensic data recovery utilising RAM cooling methods. https://ro.ecu.edu.au/cgi/viewcontent.cgi?article=1162&context=adf 5. Gutmann, P. (2001). Data remanence in semiconductor devices. In 10th USENIX Security Symposium (USENIX Security 01). https://www.usenix.org/events/sec01/full_papers/gutmann/gutmann_html 6. Skorobogatov, S. (2002). Low temperature data remanence in static RAM (No. UCAM-CL-TR-536). University of Cambridge, Computer Laboratory. https://www.cl.cam.ac.uk/techreports/UCAM-CL-TR536.pdf sbir_topic_link: https://www.sbir.gov/node/2414697 subtopics: [ ] - topic_title: 'xTech Search 7 SBIR Finalist Open Topic Competition ' branch: Army topic_number: A234-P019 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA: Trusted AI and Autonomy; Advanced Computing and Software; Emerging Threat Reduction   OBJECTIVE:  xTechSearch is seeking novel, disruptive concepts and technology solutions with dual-use capabilities that can assist in tackling the Army’s current needs and apply to current Army concepts. The intent is to provide the Army with transformative technology solutions while enabling cost savings throughout the Army systems’ life cycle. Critical technology focus areas include Artificial Intelligence / Machine Learning (AI/ML); Advanced Materials; Advanced Manufacturing; Autonomy; Cyber; Electronics; Human Performance; Immersive; Network Technologies; Position, Navigation and Timing (PNT); Power; Software Modernization; and Sensors. See attached document on the Valid Eval registration page for a list of the top Army Modernization Priorities and other critical Army Focus Areas.    DESCRIPTION: The xTechSearch competition strives to integrate small businesses into the Army’s S&T ecosystem by providing research opportunities with Army labs, including authorized access to the Army’s organic intellectual and technical capital. Participants will receive detailed feedback from Army and Department of Defense (DoD) stakeholders. Participants will have access to training, mentorship and other support infrastructure as they progress through the contest to determine how best to align their technology solutions with real users and buyers within the Army. Finalists will be entered into the xTech Accelerator to receive intensive mentorship and access to networking events to help grow their companies for Army and commercial users. xTechSearch is an opportunity for eligible participants to pitch novel technology solutions – a new application for an existing technology or an entirely new technology concept – to the Army.   PHASE I: Companies will complete a feasibility study that demonstrates the firm’s competitive technical advantage relative to other commercial products (if other products exist) and develop concept plans for how the company’s technology can be applied to Army modernization priority areas.  Studies should clearly detail and identify a firm’s technology at both the individual component and system levels, provide supporting literature for technical feasibility, highlight existing performance data, showcase the technology’s application opportunities to a broad base of customers outside the defense space, a market strategy for the commercial space, how the technology directly addresses the Army’s modernization area as well as include a technology development roadmap to demonstrate scientific and engineering viability.    At the end of Phase I, the company will be required to provide a concept demonstration of their technology to demonstrate a high probability that continued design and development will result in a Phase II mature product.    PHASE II: Produce prototype solutions that will be easy to operate by a Soldier.  These products will be provided to select Army units for further evaluation by the soldiers. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets.   PHASE III DUAL USE APPLICATIONS: Complete the maturation of the company’s technology developed in Phase II to TRL 6/7 and produce prototypes to support further development and commercialization.  The Army will evaluate each product in a realistic field environment and provide small solutions to stakeholders for further evaluation.  Based on soldier evaluations in the field, companies will be requested to update the previously delivered prototypes to meet final design configuration.    REFERENCES: https://www.xtechsearch.army.mil   KEYWORDS: AI/ML; Electronics; Human performance; open topic; prize competition; autonomy; dual-use   sbir_topic_link: https://www.sbir.gov/node/2464819 subtopics: [ ] - topic_title: 'DEEP-BIM: Dynamic Enhanced Environment Perception - Building Information Models ' branch: Army topic_number: A234-020 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy; Advanced Computing and Software   OBJECTIVE: The proposed topic is a Direct-to-Phase-II effort to develop and integrate advanced building model generation capabilities into the Defense Threat Reduction Agency (DTRA) Edge-Enhanced Mapping And Positioning System (E2MAPS) program.   DESCRIPTION: Charged with supporting operations to counter weapons of mass destruction (WMDs), DTRA leads a broad range of R&D programs that support Army, SOCOM, and DoD stakeholders. DTRA research includes technologies fielded to support missions conducted in underground facilities (UGFs) and subterranean (SubT) environments, such as E2MAPS.   The E2MAPS program is seeking a capability to perform real-time conversion of dense 3D point clouds to lightweight Building Information Models (Scan-to-BIM, collectively). Such a capability would benefit Army operators by enabling quicker identification of critical facility infrastructure, supporting mission planning, reducing cognitive load, and reducing network bandwidth. Existing capabilities to perform Scan-to-BIM in post-processing exist but cannot be applied to maps generated during fast-paced tactical operations. For this reason, DTRA is actively seeking the means to fund and integrate the proposed work.   PHASE I: This is a Direct to Phase II. The technologies to enable DEEP-BIM currently exist but have not yet been collectively applied to enable real-time Scan-to-BIM capabilities at the edge. Building information models of large facilities are currently able to be generated with commercial software using reasonable computer resources and little human correction. Object recognition using imaging and LiDAR exists to support these capabilities as well as a host of other applications. Edge computing capabilities are widely available and applied in multiple forms with the E2MAPS program. The proposed DEEP-BIM project will integrate these technologies and enable them to be directly applied to subterranean counter-WMD operations performed by the Army, SOCOM, and other mission stakeholders   PHASE II: This topic is a Direct-to-Phase-II. Expected Deliverables include, but are not limited to a ROS-based Scan-to-BIM software module, Phase III transition plan, and Technology roadmap outline: Stage 0: Requirements definition. Coordinate with E2MAPS Soldier end users to prioritize features of interest, including objects, extended infrastructure, and environment. Milestone 0: Delivery of prioritized requirements. Stage 1: Development of modular, ROS-based Scan-to-BIM framework. Integration into E2MAPS. Stage 2: Integration of basic WMD object models into Scan-to-BIM framework using existing DTRA datasets for laboratory object identification. Milestone 1: DEEP-BIM Minimum Viable Product integrated into to E2MAPS. Stage 3: Integration of Scan-to-BIM models for extended infrastructure in UGFs. Milestone 2: Assessment of Scan-to-BIM ROS module at Army end user SubT realistic training event. Stage 4: Refinement of Scan-to-BIM ROS module. Binary, licensing, and documentation delivery. Milestone 3: Delivery of stable binary, licensing, and documentation.   PHASE III DUAL USE APPLICATIONS: There is high dual-use potential for building information modeling. Investments in new construction are constantly being made in both the private and public sector.  There are many opportunities for government programs and private firms to use this technology in their planning.    KEYWORDS:  information model; mapping; computation; BIM; point cloud; edge computing   REFERENCES: 1. https://www.united-bim.com/ultimate-guide-of-scan-to-bim/ 2. https://www.truepointscanning.com/using-3d-laser-scanning-for-facility-design-modifications 3. Wang, et al., Vision-assisted BIM reconstruction from 3D LiDAR point clouds for MEP scenes, Automation in Construction, October 2021. https://doi.org/10.1016/j.autcon.2021.103997 4. Wallbaum, et al., Towards Real-Time Scan-Versus-BIM: Methods, Applications, and Challenges, European Conference on Computing in Construction, July 2021. http://dx.doi.org/10.35490/EC3.2021.17 sbir_topic_link: https://www.sbir.gov/node/2464823 subtopics: [ ] - topic_title: 'Machine Translation for Indo-Pacific Low Resource Languages ' branch: Army topic_number: A234-021 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy; Advanced Computing and Software   OBJECTIVE: US Army Pacific executes Operation Pathways within the INDOPACOM AOR and the multitude of languages, populations, and cultures within the INDOPACOM AOR. In order to provide effects that instantiate and reinforce the INDOPACOM Desired Perceptions (available at the SECRET//NOFORN Level), the Theater Army requires a range of Natural Language Processing (NLP) capabilities from Machine Translation to stance detection and summarization technologies to both produce effects and assess the information environment for the range of Low Resource Languages resident within this AOR.   DESCRIPTION: Recent relevant research on this topic focuses on languages within Western, educated, industrialized, rich, and democratic demographic populations. But due to the emergence of Large Language Models such as GPT-3 and 4 and BLOOM, generational improvements in Low Resource Language NLP capabilities are technically viable. USARPAC seeks to leverage those advances for languages resident in this AOR.    Most commercial access translation technologies through API and do not perform bespoke model training. Further, most commercial services perform higher level analysis (stance detection) on already translated media where best practices would necessitate development in the source language.   Computing resources are inexpensive and scalable and available training data is likely acquirable through crowd-sourced manual labeling. Some zero-shot approaches may be effective for lower-fidelity requirements. Further, this technology leverages LLMs available through open-source repositories and emerging techniques such as Dictionary-based Phrase-level Prompting of Large Language Models for Machine Translation.   By translating and assessing media in source languages, these technologies would enable reach into previously inaccessible populations and enable at-scale assessment tools rather than endure knowledge losses due to default to-English approaches.   PHASE I: A successful Phase I will have a justifiable and solidified proof of concept for low resource language.   PHASE II: Expected deliverables of this phase include a Deployed Machine Translation model. Testing and Evaluation would be executed in accordance with standard-practice metrics based on widely accepted and emerging evaluation benchmarks (FLORES) via GEMBA, Word Error Rate, Bilingual Evaluation Understudy, and other academic-grade metrics.   PHASE III DUAL USE APPLICATIONS: Initial model development will transition to continuous training and development for use-cases specific to the transition partner, US Army Pacific. There is high dual-use potential for machine translation. The technology can be used by many industries as globalization occurs and multi-lingual communications become a priority.   KEYWORDS:  large language model; natual language processing; machine translation; Low resource languages   REFERENCES: Costa-jussà, Marta R., et al. "No language left behind: Scaling human-centered machine translation." ArXivpreprint arXiv:2207.04672 (2022).   Hendy, Amr, et al. "How good are gpt models at machine translation? a comprehensive evaluation." arXivpreprint arXiv:2302.09210 (2023).   Ghazvininejad, Marjan, Hila Gonen, and Luke Zettlemoyer. "Dictionary-based Phrase-level Prompting of Large Language Models for Machine Translation." arXiv preprint arXiv:2302.07856 (2023).   sbir_topic_link: https://www.sbir.gov/node/2464825 subtopics: [ ] - topic_title: Heavy Lift Vertical Take-off and Landing; Heavy VTOL branch: Army topic_number: A234-022 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI/Autonomy; Sustainment & Logistics OBJECTIVE: Design, Develop and Demonstrate Heavy-lift Vertical Takeoff and Landing (HVTOL) Systems to enhance the U.S. Army’s resupply capability.   DESCRIPTION: Heavy Vertical Takeoff and Landing (HVTOL) Systems will provide unique capabilities over currently planned VTOL systems in that they will provide upward of 10X the lift capability. This ability is vital for future Army combat operations. Successful advancement of Heavy-Lift Vertical Takeoff and Landing (HVTOL) Systems would enhance U.S. Army modernization priorities by increasing the amount of equipment that can be carried by a single platform at one time. This will reduce the number of flights it takes to resupply a forward unit, allow for heavier modular mission payloads to be carried and ultimately take Soldiers out of harm’s way by utilizing an uncrewed platform.    Currently there are no uncrewed systems being fielded to US Army units. The Joint Tactical Autonomous Aerial Resupply System (JTAARS) is only requiring a lift capability of 125 lbs payload capability while other efforts are crewed cargo lift platforms at or above 3000lbs, on autonomous conversions utilizing full-sized helicopter platforms. Primary obstacles to overcome for successful operation of Heavy-Lift Vertical Takeoff and Landing (HVTOL) Systems is the balance of lift capability versus the distance a platform can fly to resupply units while displaying to Army units the time and effort saved by utilizing these platforms.    The goals of this effort are the design, development, and demonstration of Heavy Vertical Takeoff and Landing (HVTOL) Systems that can lift a threshold or minimum of 800lbs and goal of 1400lbs while having the ability to fly 100 miles threshold/minimum and a goal of greater than 100 miles.     These designs should be able to be loaded and unloaded in the field either by soldiers or autonomously, be able to fly autonomously or with human takeover, assist and fly routes while avoiding obstacles, select multiple routes, have an override system that allows soldiers to divert or modify resupply locations, autonomously select safe landing zones, have an override for human landing zone selection.  Systems should be able to utilize or integrate modular mission payloads moving forward and common attachment systems are of benefit.    PHASE I: This topic is accepting Direct to Phase II proposals only. Feasibility documentation should describe a design for a new or improved existing VTOL craft to achieve threshold or minimum of 800lbs and goal of 1400lbs payload capacity, while having the ability to fly 100 miles threshold/minimum and a goal of greater than 100 miles. The resulting design should include any relevant features or modifications to include air frame, propulsion, fuel/power systems, control, autonomy, navigation, hazardous cargo handling, and safety/loss of signal.    PHASE II: In this Direct to Phase II solicitation, companies should be able to clearly indicate progress beyond the goals outlined in phase I in their proposals. For Direct to Phase II, companies will Develop and Demonstrate Heavy-Lift Vertical Takeoff and Landing (HVTOL) Systems. The system should include navigation controls, obstacle avoidance, override systems, loading and unloading controls, instructions, and training and safety instructions. Required Phase 2 deliverables include all necessary components (hardware and software) to control the platform, attach payload to the platform (TBD), ability to select navigation route, route override, landing or delivery zone selection, zone selection override, lost link control, system safety, remote payload controls, ammo safe capability, soldier safety capable, a final report, and monthly progress reports. The system will be demonstrated in future Army experimentation or test events to evaluate performance.    Phase II evaluation goals will include:  Demonstrated lift capability at test ranges, with a stage-gate lift of 500lbs at an Army experimentation or test event in early-mid 2024, prior to completion of the period of performance (PoP). Success is required to become eligible for a sequential phase II.  Full systems, plans, designs, or other documentation that clearly shows how this technology will progress to a demonstrated lift in the 800-1400lb range during a potential phase II sequential award. Companies that do not include these detailed plans will not be eligible for full technical consideration.   Phase II duration is not to exceed 12 months and a cost of $3 million.   This topic is planning for an immediate sequential phase II award to demonstrate lift/transport progress from the 500lb milestone to a demonstrated lift of 800 – 1400 lbs following the conclusion of the original PoP. Further requirements to be addressed in the sequential award will include ability to integrate with DoD’s Modular Open Systems Architecture (MOSA), control systems, spectrum management, hardening/security, etc.    Preferred integration with an externally supplied autonomous payload (selected vendors will be informed following contracting)  Final performance demonstration of minimum 800lb lift at an Army experimentation or test event in spring 2025, with external autonomous payload integration.   Test reports detailing solution performance.  Product documentation detailing operation of prototype.  Monthly progress reports describing all technical challenges, technical risk, and progress against the schedule.  Final technical report, to specifically include system cost.    Sequential Phase II duration is not to exceed 12 months and a cost of $3 million.   In accordance with the Small Business Act (15 U.S.C. §638, subsection (aa)(1)), no Federal agency may issue an award under the SBIR program or the STTR program if the size of the award exceeds the award guidelines established under this section by more than 50 percent without a waiver from the SBA. SBA shall adjust the maximum dollar amount every year for inflation. As of October 2022, agencies may issue a Phase I award (including modifications) up to $295,924 and a Phase II award (including modifications) up to $1,972,828 without seeking SBA approval. Any award above those levels will require a waiver.  Any award resulting from this solicitation that exceeds these amounts is subject to the SBA’s prior approval of such waiver as a pre-requisite to funds availability; this solicitation does not guarantee any award. Army Applications Laboratory has secured a waiver to exceed the maximum phase II award amount for this solicitation as well as the follow-on sequential award.   PHASE III: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives through the effort. Companies may develop a manufacturing-ready product design, capable of integration with the existing or future system, and demonstrate technology integration. Low-rate production will occur as required. Companies will engage in laboratory or operational testing as required. Phase III deliverables include system-level integration technical data package, installation documentation, and system-level prototype for demonstration and government-sponsored testing.   Additionally, Phase III goals will include:  Additional capability developments  Performance measurement in a variety of different operational test environments  Test reports detailing solution performance.  Operationally relevant demonstration of lift system integration with payload system  Working toward further technology improvements, additional testing/modifications, and integration with Army stakeholders toward large scale adoption and commercialization.   KEYWORDS: VTOL; Heavy UAS; Cargo UAS; Contested Logistics; Resupply; Autonomous UAS;   REFERENCES: https://www.army.mil/article/219887/jtaars_concept_presented_to_industry  https://www.army.mil/article/265428/army_focuses_on_contested_logistics_a_threat_to_enemy  https://www.forbes.com/sites/davidhambling/2021/03/16/us-army-pushes-ahead-with-battlefield-resupply-drones/?sh=b67f5796b94f  https://www.sciencedirect.com/science/article/abs/pii/S1570870522000178 (The introduction section gives good information on potential mission types and needs; the inclusion of this reference is not intended to endorse any of the article’s methods or conclusions)  https://warontherocks.com/2022/05/flying-dirty-unmanned-casualty-evacuation-on-the-contaminated-battlefield/  sbir_topic_link: https://www.sbir.gov/node/2464827 subtopics: [ ] - topic_title: > Knowledge-Level Distributed Active Data Platforms for Ops-Log Synchronization branch: Army topic_number: A234-023 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Artificial Intelligence/ Machine Learning (AI/ML) OBJECTIVE: The purpose of this topic is to significantly extend the Army’s current effort to establish a tactical-level data platform for collecting and disseminating relevant battlefield data by improving its representation and information value to the human decision-making process and provide a foundation for autonomy and automated analytic reasoning (AI/ML) through the data mesh construct. Tactical operational forces and sustainment forces prosecuting missions in contested environments, need the ability to improve understanding, synchronization, and situational awareness. This effort will expand and improve the ongoing efforts of the data-level tactical data platform which have established a number of use cases, benefits, and process flows. The topic team intends to leverage existing partnerships and experimentation to test, evaluate, and refine the concepts and usage over this effort as well. DESCRIPTION: This capability should fold into the ongoing PEO C3T Tactical Data Platform effort, adding technology for hybrid knowledge graph technology, richer knowledge-based representations, and facilitating more advanced decision support and reasoning capabilities utilizing AI/ML. This would be fielded as part of the C3T Tactical Data Platform across the full spectrum of tactical level operational and sustainment units, leveraging the computing infrastructure and communications channels already defined for the current Tactical Data Platform capabilities. The expectation is that companies can solve several problems with one solution; therefore, the request has identified five (5) areas of improvement: Automated Transformation of Data to Knowledge, Knowledge-Level Representation of the Tactical Situational Awareness with embedded meaning, Representing and Continuously Reasoning over Plans, Space, Time, and Entity State, Situational pattern recognition and model projection for automated detection of potentially impacting Patterns/events, and bridging Knowledge between Operations and Logistics to ensure synchronized and orchestrated awareness and unity of effort. PHASE I: This is a Direct to Phase II topic (DP2). The commercial market for these knowledge-level automation and reasoning enhancements are at a high enough Technology Readiness Level (TRL) for this to be a Phase II topic. As part of the submission package, the proposing company will be required to include specific tangible examples of existing capabilities within each of the sub-areas they are proposing. The existing capabilities should be described with details of demonstrated capability, screenshots and references where available, and details of the companies, organizations, or events in which they were demonstrated. The company will be asked to demonstrate each of these capabilities in an Army tactical scenario or event that will occur 9 months into the Direct-to-Phase II award. The company submissions package will also need to provide specific evidence or demonstration of the technologies ability to operate in the constraints of a tactical environment, including intermittent communications, low-bandwidth, noisy data, and limited computational power. (DIRECT TO) PHASE II: As a Direct to Phase II proposal, proposal submission should include a roadmap of the expected deliverables: 3MAC: Design and Model Review 6MAC: Phase I validation of Key Technologies 9MAC: Build 1 Demonstration of Base Knowledge-level capabilities 12MAC: Build 2 Integration with current Tactical Data Platform 15MAC: Build 3 Experimentation/First Evaluation Release 18MAC: Build 4 Exp Revision / Ops-Log Sync 22MAC: Build 5 Final Release / Second Evaluation Release 24MAC: Final Report PHASE III DUAL USE APPLICATIONS: There is high dual-use potential for automated data platforms. They can help companies make better decisions and improve efficiency. As businesses grow, they will need the ability to manage and analyze large sets of data. These platforms will allow them to make informed decisions from the results of these analyses. Complete the maturation of the company’s technology developed in Phase II and produce prototypes to support further development and commercialization. KEYWORDS:  AI/ML; Autonomy; Data-driven; Decision-making; Data Platforms; Knowledge; Pattern Recognition REFERENCES: https://access.redhat.com/documentation/en-us/reference_architectures/2017/html/microservice_architecture/microservice_architecture https://www.ibm.com/cloud/architecture/architectures/aiAnalyticsArchitecture/reference-architecture/ sbir_topic_link: https://www.sbir.gov/node/2464837 subtopics: [ ] - topic_title: Low Cost SWIR Laser Sensor branch: Army topic_number: A234-024 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber; Microelectronics OBJECTIVE: Develop a Short-Wave Infrared (SWIR) detector capable of asynchronously locating short laser pulses for target marking with the potential of an order of magnitude lower cost than current sensors. Utilize new detector technology to lower manufacturing cost for SWIR sensors. A lower cost laser sensor would enable integration into platforms that support Soldier Lethality and Next Generation Combat Vehicles (NGCV). DESCRIPTION: Short Wave InfraRed (SWIR) cameras with Asynchronous Laser Pulse Detection (ALPD) are an emerging technology. This has the potential to be used as a multi-function solution for various marking and detection tasks. The major barrier to the proliferation of current SWIR ALPD cameras is cost. At high price points, these SWIR ALPD cameras are unlikely to proliferate across the armed forces. A low-cost, next-generation laser detection sensor is needed. Current detectors use Indium Gallium Arsenide (InGaAs) focal plane arrays (FPA) that are meticulously bump bonded onto a Read Out Integrated Circuit (ROIC). This process requires both expensive materials and intensive labor, thus lowering yield and driving costs up. Previous efforts to lower the cost of this technology have proven unsuccessful. This SBIR effort aims to pair a low-cost detector material, such as quantum dots or other innovations, to a ROIC with laser detection capability. A novel approach to laser detection could have significant cost implications in production. This moderate-risk, high-payoff approach to a low-cost SWIR laser detector should produce a device that can detect laser pulses at operationally relevant ranges for marking tasks. PHASE I: This is a Direct to Phase II (DP2) topic. A DP2 award is requested because of the demonstrations we have observed during lab and field evaluations of the candidate technology. The Colloidal Quantum Dots (CQD) material and process has been successfully applied to a standard ROIC and does have sensitivity in the SWIR spectrum to detect the laser spots. Awarding a phase II SBIR would allow for the development of the CQD process on a Read Out Integrated Circuit (ROIC) designed for laser pulse detection, as well as optimizing the quantum dot sensitivity at the laser wavelength. Much of the potential in this technology has been identified and we wish to expand its application to better fit our customers’ needs. (DIRECT TO) PHASE II: Develop and demonstrate a 2D SWIR detector with asynchronous laser pulse detection. This device should use a detector material and process that has the potential to be significantly lower cost than existing solutions in production quantities. An imaging function is desired but not a requirement for this effort. PHASE III DUAL USE APPLICATIONS: This system could be used in a broad range of military applications where laser detection is necessary. Optimize system design for size, weight and power, to include ruggedization to survive in a military environment. Recent advances in methods for synthesis and surface functionalization of CQDs have driven the commercialization of display and lighting applications and provide promising developments in the related fields of lasing and IR sensors. Current market applications, including start-up usage, for quantum dot technology embedded into semiconductors include: Multimedia technology provides more immersive and realistic experiences. Smartphone sensing recognition and augmented facial ID recognition.  Augment solar panels energy collection capabilities, which can be leveraged for renewable energy as well as agriculture production.  Medical usage, namely bio-imaging and modeling of protein structures as well as infrared sensing. Quantum computing research in the nascent and pivotal future sector.  KEYWORDS: Sensors; Short Wave InfraRed (SWIR); Lasers; Detection; Cameras; Colloidal Quantum Dots (CQD); Low Cost; Read Out Integrated Circuit (ROIC) REFERENCES: ST’s Quantum Dot Sensor set for volume Swir Imaging. ST’s quantum dot sensor set for volume SWIR imaging | Imaging and Machine Vision Europe. (2021, December 15). https://www.imveurope.com/news/sts-quantum-dot-sensor-set-volume-swir-imaging Palomaki, P., & Keuleyan, S. (2022a, November 22). Move over, CMOS: Here come snapshots by Quantum Dots. IEEE Spectrum. https://spectrum.ieee.org/move-over-cmos-here-come-snapshots-by-quantum-dots SWIR Vision Systems. (2022). SWIR Vision Systems Acuros® vs Sony® IMX990: A Closer Look at Key Metrics and Performance [White paper]. https://www.swirvisionsystems.com/wp-content/uploads/WhitePaper_SWIR-Vision-Systems-Acuros-vs-Sony.pdf sbir_topic_link: https://www.sbir.gov/node/2464841 subtopics: [ ] - topic_title: Medium-Format Displays for Mixed Reality (MR) Systems branch: Air Force topic_number: A234-025 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Microelectronics; Integrated Sensing and Cyber; Advanced Computing and Software OBJECTIVE: Recent advances in head-mounted displays have identified an opportunity for low-cost and high-performance systems based on medium format size display panels, where the diagonal is on the order of 2.0"" - 3.5"" as opposed to the older techniques using small ""microdisplays"" with diagonal screen sizes of 1.0"" or less. Likewise, the pixel pitch of the larger medium format displays is on the order of 15-80 microns, as opposed to 9-12 microns for the micro-displays.  The larger scale of the medium format relieves the requirement for magnification by the eyepiece optics, and hence a lower cost system can result. The problem is in obtaining military-grade medium format display panels with sufficient pixel resolution, since the commercial market for medium formats is more focused on low-pixel resolutions devices such as the iWatch. Also, daylight readability is a requirement not currently met by commercial units. This topic involves the development of daylight readable, medium format (1.6” – 3.0” diag.) display panels for use in mixed reality (MR) head mounted display systems. DESCRIPTION: Perform research & fabrication for a medium format (1.6" - 3.5" diag) display with at least 1280 x 720 color pixels, frame rate 60 Hz, adjustable brightness from 1 to 800 fL for daylight readability, contrast ratio of 1000:1, and AA-battery powered drive electronics to receive external video input.  The display's physical size & weight shall be minimized to support packaging into a head-mounted display system. Deliverables shall include as appropriate design review materials, electrical schematics, trade study results, and functioning hardware samples & test data. This device will help solve many problems encountered by the Integrated Visual Augmentation System (IVAS). This new display component would enable the use of low-cost visor optics to complete a display system with performance compatibility. PHASE I: This is a Direct to Phase II topic. A Direct to Phase II (DP2) is recommended because the Government has received a proof of concept monochrome version of the medium format display as well as research regarding the path to achieve full color operation using similar principles. The level of maturity that the new display device offers indicates that a Phase I can justifiably be foregone and prototyping can begin to complete the desired development timeline. DIRECT TO PHASE II: Upon acknowledging and (potentially) utilizing the research provided in Phase 1 description as premises for technical approach within proposal submission, awardees will then begin Prototype Kickoff, Design Review, Fabrication, Test, Delivery/Demonstration. PHASE III DUAL USE APPLICATIONS: The high-resolution display market has received attention and capital from large tech companies.  Google and LG completed a joint venture to create a high-resolution OLED VR headset, which leverages identical technology to OLED displays.  Current market applications, including start-up usage, for OLED high-resolution display panels include: VR/AR augmentation, especially the ability to create a more vibrant and realistic environment.  This especially benefits the video game industry.  Video games, TV, mobile phones, and computer monitors will have brighter portable displays, thereby creating a better user experience. Healthcare and surgery capabilities can leverage OLED displays that are less harmful because they are cooler to the touch. KEYWORDS:  Display systems; Micro-displays; Integrated Visual Augmentation System (IVAS); Visor optics; panels REFERENCES:   Hamer, et. al., ""High-performance OLED microdisplays made with multi-stack OLED formulations on CMOS backplanes"", SPIE Proceedings Volume 11473, Organic and Hybrid Light Emitting Materials and Devices XXIV; 114730F (2020), https://doi.org/10.1117/12.2569848 Vogel, et. al., ""OLED microdisplays in near-to-eye applications: challenges and solutions"", SPIE Proceedings Volume 10335, Digital Optical Technologies 2017; 1033503 (2017) https://doi.org/10.1117/12.2270224 sbir_topic_link: https://www.sbir.gov/node/2464847 subtopics: [ ] - topic_title: Porting RTK to High Assurance Kernel branch: Army topic_number: A234-026 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy; Advanced Computing and Software OBJECTIVE: Develop innovative techniques and tools to run the Robotic Technology Kernel (RTK) software library securely and efficiently on a high-assurance separation kernel. Demonstrate feasibility via proof-of-concept and practical prototype. Validate the new capabilities using a high-assurance separation kernel, Robot Operating System (ROS) test suite, RTK applications and a representative hardware platform under realistic concept of operations. DESCRIPTION: This topic seeks innovative technology and demonstration that showcases the feasibility, security and performance of running the RTK and ROS software library on a high-assurance separation kernel. Supported by the DARPA High-Assurance Cyber Military Systems (HACMS) program, both seL4 and CertiKOS have made great leaps in terms of software capabilities and maturity. However, significant challenges exist to bridge the gap between research prototypes and adoption. It is critical to leverage such innovative techniques and tools and build assured systems based on appropriate techniques and tools applying sound security design and engineering principles. The ported RTK/ROS over a separation kernel should function and perform with added security and it should maintain the features of (1) cross-platform: new RTK capabilities can be leveraged by all RTK-enabled platforms; (2) cross-controller: any RTK-enabled platforms can be controlled by any RTK compatible controller; and (3) cross-effort: an effort delivers new capabilities to the RTK, which in turn is leveraged for new efforts. In addition to memory isolation, the ported RTK/ROS should be amenable to other security checks such as the concept of Monitor and Policy Enforcement, as applicable and needed in DoD use cases including Autonomy and Swarm. PHASE I: Develop the technical approach, analyze trade-off options, and justify design choices. All design choices, including a representative hardware platform, should be made in agreement with the Government counterpart. Finalize the overall design that can securely and efficiently run RTK (and ROS) on a high-assurance separation kernel. Analyze the costs and benefits, accounting for practical implementation constraints in Army platforms and use cases. Prepare the path for a proof-of-concept demonstration. Document all lessons learned for way forward. PHASE II: Fully develop the technology and a practical prototype. Test and evaluate the security and performance of the ported RTK (and ROS) running on a high-assurance separation kernel, under various ROS/RTK test cases as well as relevant mission scenarios. Demonstrate the capabilities using a representative hardware platform under realistic concept of operations, such as those adopted in previous Army efforts [5]. Enhance and mature the technology and prototype for transition. PHASE III DUAL USE APPLICATIONS: High Assurance Kernel Technology and Robotic Technology Kernel (RTK) have medium adoption across a range of industries including autonomous vehicles, aerospace and defense, and Internet of Things (IoT). The use of this technology helps to enable security, reliability, and trustworthiness of critical systems. The IoT and software segment registers in highest share of revenue as well as innovation. The growing use of digital manufacturing and IoT integration in production of smart and autonomous vehicles will likely drive continued growth. The integration of high assurance kernel security solutions will enable companies to improve their cybersecurity stature as well as offer more security in a myriad of arenas, including the continued growth of autonomous offerings, signaling sustained demand for this technology in future years as technology evolves and new economies accelerate digitalization and industrialization in manufacturing processes.  KEYWORDS:  Robotics; Robot Operating System; Robot Technology Kernel; Cybersecurity; Software; Performance REFERENCES: M. Vai, D. Whelihan, K. Denny, R. lychev, J. Hughes, D. Kava, A. Lee, N. Evancich, R. Chark, D. Lide, K. Kwak, J. Li, D. Schafer, M. Lych, K. Tilloton, and W. Tirenin, “Agile and Resilient Embedded Systems”, IEEE Conference on Military Communications, 2021. D. Whelihan, M. Vai, N. Evanich, K.J. Kwak, J. H. Li, M. Britton, B. Frantz, D. Hadcock, M. Lynch, D. Schafer, J. DeMatteis, and D. Russo, “Designing Agility and Resilience into Embedded Systems,” IEEE Conference on Military Communications, 2017. Cynthia Irvine, “Combining ROS with seL4 for Trustworthy Autonomous Systems,” Second Annual Trusted Computing Center of Excellence Summit, 2019. Robot Operating System (ROS) - https://www.ros.org/ US Army – TARDEC Ground Vehicle Robotics, “Introduction to Robotic Technology Kernel (RTK),” Distribution Statement A. Gerwin Klein, June Andronick, Kevin Elphinstone, Toby Murray, Thomas Sewell, Rafal Kolanski, and Gernot Heiser, “Comprehensive formal verification of an OS microkernel,” ACM Trans. Comput. Syst. 32, 1, Article 2, February 2014. Certified Kit Operating System (CertiKOS), https://flint.cs.yale.edu/certikos/ Trusted Computing Center of Excellence - https://trustedcomputingcoe.org/ TCCOE Summits - https://trustedcomputingcoe.org/summits/  https://sel4.systems/Foundation/Services/home.pml  Daniel Limbrick, “Performance Evaluation of ROS on an seL4-based Raspberry Pi / Jetson TK1,” Second Annual Trusted Computing Center of Excellence Summit, 2019. Gernot Heiser, “The seL4 Microkernel - An Introduction.” White Paper. The seL4 Foundation, Revision 1.2 of 2020-06-10. sbir_topic_link: https://www.sbir.gov/node/2464851 subtopics: [ ] - topic_title: Energy Demand Reduction and Clean Energy Tech Open Topic branch: Army topic_number: A234-P027 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; OBJECTIVE: The purpose of the Energy Demand Reduction and Clean Energy Tech Open Topic is to bring potentially valuable small business innovations to the Army and create an opportunity to expand the relevance of the Army SBIR program to firms who do not normally compete for SBIR awards.  DESCRIPTION: While the Energy Demand Reduction and Clean Energy Tech Open Topic will accept proposals on any technical challenge requiring the application of Energy Demand Reduction and clean energy technologies, submissions addressing the following core technical areas will be prioritized for award: Energy Storage (man-portable, ground vehicle and support equipment applications, and airborne vehicle solutions) Clean Energy Generation (primary but not exclusive range of 1kW-200kW and 20-1,000 energy consumption endpoints) Micro-grid components compatible with the DoD’s Tactical Microgrid Standard Electric and Hybrid Electric Transportation (ground vehicles, ground support equipment, UAV, helicopter, and small-fixed wing aircraft solutions) Charging of electrified transportation in austere environments PHASE I: The purpose of Phase I is to demonstrate or determine the scientific, technical, and commercial merit and feasibility of the concept. The Phase I period of performance will be 6 months. Small businesses shall deliver a proof of technical feasibility at the end of the Period of Performance.    Phase I Submission Materials: 5-page technical volume for down-select. 8-slide commercialization plan; template provided in announcement. Post-Phase I Deliverables: Small Business: A feasibility study to demonstrate the technical and commercial practicality of the concept to include an assessment of its technical readiness and potential applicability to military and commercial markets. Technical POC and Transition Partner: Commitment secured from TPOC and Transition Partner to associate with potential Phase II work. (Transition Partner is defined as an Army organization planning to integrate and fund the technology after SBIR funding has expired).   (DIRECT TO) PHASE II: Proposers interested in submitting a Direct to Phase II (DP2) proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above has been met and describes the potential military and/or commercial applications. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results.   DP2 Submission Materials: 10-page technical volume for down-select. 5 pages showing how technical feasibility has already been achieved. 8-slide commercialization plan; template provided in announcement. PHASE II: Produce prototype solutions that will be practical and feasible to operate in edge and austere environments. Companies will provide a technology transition and commercialization plan for DOD and commercial markets. The Army will evaluate each product in a realistic field environment and provide solutions to stakeholders for further evaluation. Based on Soldier field evaluations, companies will be requested to update the previously delivered prototypes to meet final design configuration. PHASE III DUAL USE APPLICATIONS: The renewable energy sector can use energy storage technologies to store excess energy that is generated during periods of low demand or high production.   The transportation industry can utilize energy storage technologies in electric vehicles. Batteries with new storage capabilities can enable longer driving ranges and shorter charging times for the vehicles.   By integrating clean energy into their grids, electric utilities can reduce their reliance on fossil fuels and lower their greenhouse gas emissions.   The manufacturing industry consumes significant amounts of energy. By adopting alternative methods of energy generation, manufacturers can reduce their carbon footprint and the operational costs that they currently have.  The are countless opportunities to apply the use of the technologies that come out of this effort into a wide variety of industries.  KEYWORDS: Energy Storage; Clean Energy Generation; Clean Micro-Grid; Electric Transportation; Clean Industry Technology REFERENCES: https://www.armysbir.army.mil/topics/; https://www.army.mil/e2/downloads/rv7/about/2022_army_climate_strategy.pdf; https://www.army.mil/e2/downloads/rv7/about/2022_Army_Climate_Strategy_Implementation_Plan_FY23-FY27.pdf; https://www.army.mil/article/259086/u_s_army_awards_prizes_for_clean_tech_solutions_aligned_to_its_climate_strategy sbir_topic_link: https://www.sbir.gov/node/2464861 subtopics: [ ] - topic_title: 'Remote Breaching of Obstacles ' branch: Army topic_number: A234-028 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Human-Machine Interfaces, Directed Energy, Integrated Sensing and Cyber, Trusted AI and Autonomy   The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws.   OBJECTIVE: Develop and demonstrate solutions or components of solutions for remote breaching of obstacles to decrease risk by removing Soldiers from the point of breach.   DESCRIPTION: Breaching is a key task performed by Army forces in order to move through enemy-emplaced obstacles intended to block, disrupt, turn, or fix friendly forces. Mined wire obstacles consist of anti-vehicle and/or anti-personnel mines or other explosive hazards that may be surface-laid or buried, with trigger mechanisms to include pressure plate, magnetic, vibration, radar, and others. Mines and explosive hazards can be manually emplaced or scattered by quick-delivery mechanisms such as aircraft or artillery. Mined obstacles are often accompanied by concertina wire, anti-tank ditches, berms, and physical barriers such as “tetrahedrons” to slow vehicle and personnel movement. Obstacles are usually overwatched by enemy forces to engage friendly forces attempting to breach the obstacle.   The Army’s current breaching methods require Soldiers at the point of breach, introducing the possibility of catastrophic loss of personnel and equipment and creating a risk to mission accomplishment. To conduct a breaching operation, Soldiers must locate the obstacle and decide where to breach a lane through the obstacle. Then they use an explosive device such as a Mine Clearing Line Charge (MICLIC) or mechanical means such as a plow or flail to detonate mines or move them out of the breach lane. Soldiers then “proof” the lane to verify that the obstacle has been neutralized, often using a mine roller to detonate any remaining mines. Finally, they mark the breach lane to guide passage of friendly forces through the lane.   The Army is seeking solutions for remote breaching to decrease risk by removing Soldiers from the point of breach. We are particularly seeking technologies that contribute to one or more tasks associated with breaching mine and wire obstacles, to include but not limited to:   Detecting mines and other surface or subsurface explosive hazards and communicating or marking their locations Detecting physical obstacles such as wire, anti-tank ditches, berms, tetrahedrons, or other types of barriers Neutralizing mines, explosive hazards, and physical barriers through explosive, mechanical, kinetic, electromagnetic, directed energy, or other means Verifying (proofing) the breach lane to ensure the obstacle has been neutralized Marking the breach lane to guide safe passage of vehicular or personnel traffic Command and control of the breaching operation   Solutions should allow Soldiers to conduct breaching from a safe distance of approximately 1000 meters or more from the point of breach. This may include technologies that can be employed by air or ground uncrewed systems or launched from a safe distance.   Solutions should be capable of integrating as part of a larger breaching concept and may be employed alongside other systems either fielded or in development, such as a remotely controlled Assault Breacher Vehicle or other technologies resulting from this solicitation. The Army is open to solutions in the form of modular mission payloads that integrate with existing or planned robotic platforms such as the Robotic Combat Vehicle (RCV) or other ground or air platforms.   The Army desires speed and flexibility in remote breaching methods. Solutions should be employable quickly in response to a hastily-employed enemy obstacle, such as air-delivered scatterable mines, or as part of a deliberate breaching operation against a larger, more complex obstacle. Ideally, solutions should be scalable for use against obstacles with greater depth.   There is likely to be significant technology overlap with solutions that can be used for non-combat operations such as locating and clearing legacy minefields. However, the focus of this solicitation is on technologies for creating a breach lane in an enemy-emplaced obstacle in the context of a fast-paced, contested combat environment.   PHASE I: Design a proof-of-concept solution or component(s) of a solution for remote breaching of obstacles to remove Soldiers from the point of breach. Solutions may include technologies for detecting or neutralizing mines, explosive hazards, or barriers, verifying that the obstacle has been neutralized, marking the breach lane, controlling the breaching operation, or other components that contribute to a successful breaching operation. Proposals will be evaluated based on the contributions they can provide to the overall breaching effort and the likelihood of the technology providing an effective solution. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed effort, and to determine the quality of performance of the awarded companies prior to providing further support in Phase II. Final deliverable will be a concept design presentation, optional proof of technology demonstration, and plans for follow-on Phase II work.   Companies selected for a Phase I award may voluntarily participate in the Army Applications Laboratory (AAL) 12-week cohort program. The AAL cohort program is designed to solve specific Army modernization challenges on a compressed timeline. The cohort program matches qualified companies with Army problem owners to speed capability development, accelerate transition, and de-risk or inform requirements. This program is designed for businesses that have unique, applicable technology and are interested in growing a new line of business through the DoD.   The cohort program will enhance technology development through rapid exposure to Army stakeholders and the Army maneuver support community. Planned activities include a problem topic deep dive, in-person exposure to current breaching techniques, and stakeholder engagement with requirements writers, acquisitions managers, and end users. An example cohort program for this topic is:   Week 1 (15 Jan 2024)                    Orientation and problem deep-dive (in-person: Ft. Stewart, GA) Week 2 (22 Jan 2024)                    Concept research and planning Week 3 (29 Jan 2024)                    Concept confirmation brief (virtual) Week 4-6 5 Feb 2024)                   Concept research and planning Week 7 (26 Feb 2024)                   Mid-point concept refinement brief (in-person: Ft. Leonard Wood, MO) Week 8-11 (4 Mar 2024)              Concept design refinement Week 12 (1 Apr 2024)                   Final concept design brief (in-person: Austin, TX)   Cohort programming will be provided free of charge. Proposers who plan to participate in the cohort (if awarded a Phase I) are encouraged to include travel costs for three cohort trips, within the continental US, for five days each (including travel days) for in-person programming. Details will be provided to awardees under this topic at Phase I award.   PHASE II: Develop, build, and demonstrate a prototype of the concept advanced during Phase I. Prototypes should be capable of integration with existing Army systems and/or newly developed systems from other awardees. They should also showcase modularity and prove effective during simulated or operational demonstrations. Phase II deliverables include a demonstration and delivery of a Technology Readiness Level (TRL) 6 prototype for further Army evaluation, as well as quarterly and final reports detailing design and performance analysis of the prototype. Phase II proposals will be evaluated, in part, on cost reasonableness and speed to delivery of a TRL 6 prototype.   Awardees may also be eligible for Phase IIb award after completion of Phase II period of performance. Phase IIb can extend the period of performance with additional funding and additional matching opportunities to finish building out solutions with the stakeholders’ discretion.   PHASE III: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives through the effort. Companies may develop a manufacturing-ready product design, capable of integration with the existing or future system, and demonstrate technology integration. Low-rate production will occur as required. Companies will engage in laboratory or operational testing as required. Phase III deliverables include system-level integration technical data package, installation documentation, and system-level prototype for demonstration and government-sponsored testing.   WEBINAR DATE: A Webinar will be conducted for this solicitation on Wednesday, October 11, at 10:00am CST. Please register at: https://remotebreachingwebinar.eventbrite.com.   KEYWORDS: Obstacle, Barrier, Mine, Wire, Ditch, Breach, Reduce, Clear, Remote, Robotic, Autonomous, Unmanned, Uncrewed   REFERENCES: Combined Arms Breach. TRADOC G2 G&V. https://www.youtube.com/watch?v=ZZ-sCT_maAQ US Army digs deep to develop robot minefield ‘breachers’. C4ISRNET. https://www.c4isrnet.com/newsletters/unmanned-systems/2022/11/03/us-army-digs-deep-to-develop-robot-minefield-breachers/ sbir_topic_link: https://www.sbir.gov/node/2464863 subtopics: [ ] - topic_title: MCSC Open Topic for Logistics in a Contested Environment branch: Navy topic_number: N234-P01 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Sustainment; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - DON is seeking proposals for enhancing existing prototypes or concepts to improve operations in contested environments for extended periods of time through heightened tensions and conflict by significantly reducing or eliminating the need for replenishment or sustainment.   DESCRIPTION: A contested logistics environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets logistics operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths. Resilient logistics connects the foundry to the Fleet, is enabled by secure communications and information technology, and includes all activities and technologies needed to refuel, rearm, resupply, repair, and revive distributed naval forces down to the last tactical mile.   The Department of the Navy requests proposals for existing technology demonstration platforms, prototypes, and commercial products to assess their relevance to Naval missions through operational experimentation. Proposers should have an existing solution, either hardware and/or software, which can be evaluated through military utility assessments with end users.   The areas of interest for the Marine Corps are improved fuel efficiency and/or methods to utilize fossil fuel alternatives, such as hydrogen, for: Marine Corps Tactical Vehicles, Mobile Power Systems, Batteries, and energy storage systems for human portable devices such as radios. Examples of current Marine Corps systems are provided in the references.   Proposal for this topic shall address one or more of the following: generation storage distribution   PHASE I: Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I Base will be detailed in a final technical report (Final Report). The Results of Phase I Option (if exercised) will further refine the final technical report.   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award Report of Inventions and subcontractors, due 120 days from start of Base award   Phase I Option (if exercised) deliverables include: Kick-Off Briefing, due 15 days from start of Option award Final Report, due 180 days from start of Option award Updated Report of Inventions and subcontractors, due 180 days from start of Option   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   Develop and deliver a functional prototype(s) which can be tested, evaluated through a military utility assessments with end users, and/or certified (as appropriate), develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   PHASE III DUAL USE APPLICATIONS: Improve the technology per the Phase II guidance and transition to a fielding activity. Dual-Use applications may include commercially available trucks, generators, batteries, and energy storage systems.   REFERENCES: Marine Corps Portfolios, Logistics Combat Element Systems, Light Tactical Vehicles: https://www.marcorsyscom.marines.mil/Portfolios/Logistics-Combat-Element-Systems/Light-Tactical-Vehicles/ Marine Corps Portfolios, Logistics Combat Element Systems, Medium and Heavy Tactical Vehicles: https://www.marcorsyscom.marines.mil/LCES/Medium-Heavy-Tactical-Vehicles/ Marine Corps Portfolios, Logistics Combat Element Systems, Mobile Power: https://www.marcorsyscom.marines.mil/Portfolios/Logistics-Combat-Element-Systems/Engineer-Systems/Power-Team/Mobile-Power/ Marine Corps Portfolios, Logistics Combat Element Systems, Advanced Power Systems: https://www.marcorsyscom.marines.mil/Portfolios/Logistics-Combat-Element-Systems/Engineer-Systems/Power-Team/Advanced-Power-Systems/   KEYWORDS: Contested Logistics Environment; Marine Corps Tactical Vehicles; Mobile Power Systems; Batteries; Energy Storage Systems; Fuel Efficiency; Fossil Fuel Alternatives sbir_topic_link: https://www.sbir.gov/node/2464993 subtopics: [ ] - topic_title: NAVAIR Open Topic for Logistics in a Contested Environment branch: Navy topic_number: N234-P02 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S) - Advanced Computing and Software; Integrated Sensing and Cyber; Trusted AI and Autonomy   The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws.   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC: DON is seeking proposals for enhancing existing prototypes or concepts to improve operations in contested environments for extended periods of time through heightened tensions and conflict by significantly enhancing or reducing or eliminating the need for replenishment or sustainment.   DESCRIPTION: A contested logistics environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets logistics operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths. Resilient logistics connects the foundry to the Fleet, is enabled by secure communications and information technology, and includes all activities and technologies needed to refuel, rearm, resupply, repair, and revive distributed naval forces down to the last tactical mile. Please indicate the technology area of interest within the Abstract section of the Cover Sheet, Volume 1. The technology areas of interest are: NEXT-GENERATION LOGISTICS AIRCRAFT. Design refinement/experimentation of tactical unmanned resupply aircraft that are attritable and/or offer reduced detectability (last-tactical mile delivery); large capacity, intra-theater, cargo and medevac aircraft which are not reliant upon large airfields. Short takeoff and landing (STOL), vertical takeoff and landing (VTOL), novel shipboard launch and recovery and automated cargo handling systems. Air to Air refueling capability. AIRCRAFT BATTLE-DAMAGE REPAIR. Non-destructive inspection methods; expedient battle-damage analysis and safe flight envelope modification; composite and low-observable materiel repairs; fiber-optic repairs; damage tolerant/resistant structures and systems; access to maintenance data with limited or no reachback to home station. REDUCED FUEL/SUPPLY DEMAND. Increased energy efficiency and/or methods to generate energy or fuel substitutes for aircraft and support equipment. Electric or Hybrid-Electronic STOL/ VTOL systems. Reliable engines for UAVs that utilize common, existing aviation fuels. Reduced consumable usage and/or ability to manufacture consumables and limited-life parts in austere locations. LOGISTICS C3 IMPROVEMENTS. Sense and avoid systems for UAS. Increased autonomy for unmanned resupply aircraft. Alternative PNT systems, including optical ship-relative navigation. Reduced data-exchange requirements. Low Probability of Intercept/Detection (LPI/D) communications methods. Innovative air traffic control and/ or space de-confliction systems.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue no awards. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000. Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to harden, ruggedize, and/or marinize the technology for integration into an operational environment. The outcome to be a working prototype that can be tested and/or certified, including a fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD), if appropriate.   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support.   REFERENCES: Chief of Naval Operations (CNO) Navigation Plan. Released January 2021, Updated 2022. https://media.defense.gov/2022/Jul/26/2003042389/-1/-1/1/NAVIGATION%20PLAN%202022_SIGNED.PDF Force Design 2030. Strategic guidance for surviving and thriving inside contested spaces. Integrated planning teams study and analyze the concepts for validation and refinement. https://www.marines.mil/Force-Design-2030/ O’Rourke, Brian. "Prepare for Contested Logistics." US Naval Institute. Vol. 148/4/1,430. April 2022 https://www.usni.org/magazines/proceedings/2022/april/prepare-contested-logistics   KEYWORDS: contested logistics; next-generation logistics aircraft; battle-damage repair; reduced fuel/supply demand; logistics C3 improvement sbir_topic_link: https://www.sbir.gov/node/2464995 subtopics: [ ] - topic_title: "NAVSEA Open Topic for Operations and Logistics in a Contested Environment: Improve/Manage Energy Efficiency for the DON's Non-nuclear Deployable Power Generators" branch: Navy topic_number: N234-P03 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Sustainment; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - NAVSEA is seeking proposals for commercial technology to ensure resilient logistics and technology in a contested environment.   DESCRIPTION: NAVSEA requests proposals for existing technology demonstration platforms, prototypes, and commercial products in a contested environment to assess their relevance to Naval missions through operational experimentation. For Phase I awardees, NAVSEA will provide an operational context which technologies will be assessed against and provide feedback and guidance on enhancements to align with the Fleet’s warfighting objectives. The proposing small business concern should have an existing solution, either hardware and/or software, which can be evaluated through operational experimentation with end users.   A contested environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths.   As stated in the instruction, only one proposal from a single small business concern will be accepted for this topic. The proposed capability will address: Commercial technology (Technology Readiness Level TRL 8/9) to improve/manage energy efficiency for the Department of the Navy’s non-nuclear deployable power generators (ground vehicle engines, aircraft engines, ship main and auxiliary engine, free standing portable generators, batteries). These may include alternate fuel sources such as hydrogen. Increased fuel efficiency and/or methods to generate fuel or fuel substitutes. Deployable power generator that utilize alternate fuel sources such as hydrogen. Improved batteries and energy storage systems for human transportable devices such as radios.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e. transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   The Phase I Option, if exercised, will include the initial design specifications and capabilities description to build a prototype solution in Phase II.   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to develop a functional prototype to demonstrate the capability, develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support. Since the Navy is seeking commercial technologies, these technologies already have commercial applications.   REFERENCES: GAO Report GAO-23-105608; “CONTESTED INFORMATION ENVIRONMENT: Actions Needed to Strengthen Education and Training for DOD Leaders”; https://www.gao.gov/assets/gao-23-105608.pdf Marine Corp Association; “Littoral Operations in a Contested Environment”; https://www.marines.mil/News/News-Display/Article/2708135/littoral-operations-in-a-contested-environment-loce/#:~:text=Littoral%20Operations%20in%20a%20Contested%20Environment%20(LOCE)%20is%20a%20concept,depth%2C%20complexity%2C%20and%20lethality.   KEYWORDS: Contested Logistics; Contested Environment; UUV and USV; Energy efficiency; Launch and recovery; Maritime mining and MCM sbir_topic_link: https://www.sbir.gov/node/2464997 subtopics: [ ] - topic_title: 'NAVSEA Open Topic for Operations and Logistics in a Contested Environment: Improve Launch and Recovery of Air, Sea Surface, and UUV from Naval Vessels' branch: Navy topic_number: N234-P04 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Sustainment; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - NAVSEA is seeking proposals for commercial technology to ensure resilient logistics and technology in a contested environment.   DESCRIPTION: NAVSEA requests proposals for existing technology demonstration platforms, prototypes, and commercial products in a contested environment to assess their relevance to Naval missions through operational experimentation. For Phase I awardees, NAVSEA will provide an operational context which technologies will be assessed against and provide feedback and guidance on enhancements to align with the Fleet’s warfighting objectives. The proposing small business concern should have an existing solution, either hardware and/or software, which can be evaluated through operational experimentation with end users.   A contested environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths.   As stated in the instruction, only one proposal from a single small business concern will be accepted for this topic. The proposed capability will address: Commercial technology (TRL 8/9) to improve launch and recovery of air, sea surface, and undersea unmanned vehicles from Naval Vessels (architecture, artificial Intelligence applications, automated guidance).   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   The Phase I Option, if exercised, will include the initial design specifications and capabilities description to build a prototype solution in Phase II.   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to develop a functional prototype to demonstrate the capability, develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support. Since the Navy is seeking commercial technologies, these technologies already have commercial applications.   REFERENCES: GAO Report GAO-23-105608; “CONTESTED INFORMATION ENVIRONMENT: Actions Needed to Strengthen Education and Training for DOD Leaders”; https://www.gao.gov/assets/gao-23-105608.pdf Marine Corp Association; “Littoral Operations in a Contested Environment”; https://www.marines.mil/News/News-Display/Article/2708135/littoral-operations-in-a-contested-environment-loce/#:~:text=Littoral%20Operations%20in%20a%20Contested%20Environment%20(LOCE)%20is%20a%20concept,depth%2C%20complexity%2C%20and%20lethality.   KEYWORDS: Contested Logistics; Contested Environment; UUV and USV; Energy efficiency; Launch and recovery; Maritime mining and MCM sbir_topic_link: https://www.sbir.gov/node/2464999 subtopics: [ ] - topic_title: 'NAVSEA Open Topic for Operations and Logistics in a Contested Environment: Enhance Mission Capabilities of USV/UUV and Systems' branch: Navy topic_number: N234-P05 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Sustainment; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - NAVSEA is seeking proposals for commercial technology to ensure resilient logistics and technology in a contested environment.   DESCRIPTION: NAVSEA requests proposals for existing technology demonstration platforms, prototypes, and commercial products in a contested environment to assess their relevance to Naval missions through operational experimentation. For Phase I awardees, NAVSEA will provide an operational context which technologies will be assessed against and provide feedback and guidance on enhancements to align with the Fleet’s warfighting objectives. The proposing small business concern should have an existing solution, either hardware and/or software, which can be evaluated through operational experimentation with end users.   A contested environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths.   As stated in the instruction, only one proposal from a single small business concern will be accepted for this topic. The proposed capability will address: Commercial technology (TRL 8/9) to enhance mission capabilities of unmanned surface and subsurface vessels (USV/UUV) and systems. Global Positioning System (GPS) denied navigation, small unmanned underwater vehicles and bottom crawlers, improved C3 (Command, Control and Communications), resilient communications paths, high throughput data exfiltration/infiltration paths, replenishment, and monitoring, sustainment, repair and maintenance of unmanned systems. Sense and avoid systems for small UUVs. Increased autonomy for unmanned resupply USV. Alternative Position Navigation and Timing (PNT) systems, including optical ship-relative navigation. Reduced data-exchange requirements. Low Probability of Intercept/Detection (LPI/D) communications methods.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   The Phase I Option, if exercised, will include the initial design specifications and capabilities description to build a prototype solution in Phase II.   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to develop a functional prototype to demonstrate the capability, develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support. Since the Navy is seeking commercial technologies, these technologies already have commercial applications.   REFERENCES: GAO Report GAO-23-105608; “CONTESTED INFORMATION ENVIRONMENT: Actions Needed to Strengthen Education and Training for DOD Leaders”; https://www.gao.gov/assets/gao-23-105608.pdf Marine Corp Association; “Littoral Operations in a Contested Environment”; https://www.marines.mil/News/News-Display/Article/2708135/littoral-operations-in-a-contested-environment-loce/#:~:text=Littoral%20Operations%20in%20a%20Contested%20Environment%20(LOCE)%20is%20a%20concept,depth%2C%20complexity%2C%20and%20lethality.   KEYWORDS: Contested Logistics; Contested Environment; UUV and USV; Energy efficiency; Launch and recovery; Maritime mining and MCM sbir_topic_link: https://www.sbir.gov/node/2465001 subtopics: [ ] - topic_title: 'NAVSEA Open Topic for Operations and Logistics in a Contested Environment: Expand Lethality of Technologies of Maritime Mining and Mine Countermeasures' branch: Navy topic_number: N234-P06 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Renewable Energy Generation and Storage; Sustainment; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - NAVSEA is seeking proposals for commercial technology to ensure resilient logistics and technology in a contested environment.   DESCRIPTION: NAVSEA requests proposals for existing technology demonstration platforms, prototypes, and commercial products in a contested environment to assess their relevance to Naval missions through operational experimentation. For Phase I awardees, NAVSEA will provide an operational context which technologies will be assessed against and provide feedback and guidance on enhancements to align with the Fleet’s warfighting objectives. Proposing small business concern’s should have an existing solution, either hardware and/or software, which can be evaluated through operational experimentation with end users.   A contested environment means an environment in which armed forces engage in conflict with an adversary that presents challenges in all domains and directly targets operations, facilities, and activities in the United States, abroad, or in transit from one location to the other. State and non-state actors employ space, cyberspace, and electromagnetic spectrum (EMS) capabilities, as well as information operations, against friendly naval forces. Adversaries may use these capabilities in attempts to deny, degrade, and exploit our use of our historic command, control, communications, computer, intelligence, surveillance, and reconnaissance (C4ISR) strengths.   As stated in the instruction, only one proposal from a single small business concern will be accepted for this topic. The proposed capability will address: Commercial technology (TRL 8/9) to expand the lethality of technologies that enhance ability of both maritime mining and mine countermeasures (MCM) systems to detect, classify, identify, neutralize, and assess battle damage. Additional interest in technologies supporting maritime mining operations, minefield management, and associated enabling technologies such as, but not limited to, data exfiltration from expeditionary assets.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   The Phase I Option, if exercised, will include the initial design specifications and capabilities description to build a prototype solution in Phase II.   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to develop a functional prototype to demonstrate the capability, develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support. Since the Navy is seeking commercial technologies, these technologies already have commercial applications.   REFERENCES: GAO Report GAO-23-105608; “CONTESTED INFORMATION ENVIRONMENT: Actions Needed to Strengthen Education and Training for DOD Leaders”; https://www.gao.gov/assets/gao-23-105608.pdf Marine Corp Association; “Littoral Operations in a Contested Environment”; https://www.marines.mil/News/News-Display/Article/2708135/littoral-operations-in-a-contested-environment-loce/#:~:text=Littoral%20Operations%20in%20a%20Contested%20Environment%20(LOCE)%20is%20a%20concept,depth%2C%20complexity%2C%20and%20lethality.   KEYWORDS: Contested Logistics; Contested Environment; UUV and USV; Energy efficiency; Launch and recovery; Maritime mining and MCM sbir_topic_link: https://www.sbir.gov/node/2465003 subtopics: [ ] - topic_title: ' NAVWAR Open Topic for Holistic Common Operational Picture (COP): PMW 170' branch: Navy topic_number: N234-P07 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - The resultant capability will provide a DEVSECOPS environment to mature efforts that feed the Maritime Tactical Command and Control production. It will also provide an AI tool that will sift data and identify potential Global Positioning System (GPS) threats in near real-time.   DESCRIPTION: The Department of Navy is seeking proposals to improve the quality and speed of decision making for operational and tactical commanders through advanced technology. These technologies may include, but not limited to, solutions that support force maneuver, effects and data synchronization, and course of action (COA) decision making.  Specifically, PEO C4I (PMW 170) requires a software (SW)-based Navigation Warfare Situational Awareness (SA) tool that uses Artificial Intelligence (AI) to sift data and identify potential GPS threats in near real-time. The solution should go beyond training neural networks or other machine learning (ML) methodologies.   The  benefit to the warfighter will be a solution to provide real-time GPS threats and can integrate into the Navigation Warfare COP, which can be used by operational commanders at the Combatant Command (COCOM) level down to individual platform/units to make informed decisions with a better understanding of warfighting capability.   Work produced in Phase II may become classified. The prospective contractor(s) must be U.S. owned and operated with no foreign influence as defined by DoD 5220.22-M, National Industrial Security Program Operating Manual, unless acceptable mitigating procedures have been implemented and approved by the Defense Counterintelligence Security Agency (DCSA). The selected contractor must be able to acquire and maintain an appropriate security-level facility and Personnel Security Clearances to perform on advanced phases of this project as set forth by DCSA and NAVWAR to gain access to classified information about the national defense of the United States and its allies. This will be an inherent requirement. The selected company will be required to safeguard classified material IAW DoD 5220.22-M during the advanced phases of this contract.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue no awards. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   Deliverables specific to this topic and in addition to those listed above: A study describing research and results of potential algorithms, taking into account the GPS-Based Positioning, Navigation and Timing Services (GPNTS) architecture and interfaces. Phase I should also include Modeling & Simulation (M&S) to support outcome/recommendations.   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   Develop software that will be integrated into GPNTS and performance validation in a fleet experimentation/demonstration, or relevant environment.  Develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD). It is highly likely that the work, prototyping, test, simulation, and validation may become classified in Phase II (see Description for details). However, the proposal for Phase II will be UNCLASSIFIED.   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support.   REFERENCES: P. Bethi, S. Pathipati and A. P, "Stealthy GPS Spoofing: Spoofer Systems, Spoofing Techniques and Strategies," 2020 IEEE 17th India Council International Conference (INDICON), New Delhi, India, 2020, pp. 1-7, doi:10.1109/INDICON49873.2020.9342317. Keller, John, “The growing problem of jamming and spoofing of GPS satellite navigation signals just keeps getting worse.” Military Aerospace Electronics, July 20, 2021 https://www.militaryaerospace.com/rf-analog/article/14207023/gps-signals-jamming   KEYWORDS: Maritime; Tactical; Command; Control; Positioning; Navigation; Timing sbir_topic_link: https://www.sbir.gov/node/2465005 subtopics: [ ] - topic_title: 'NAVWAR Open Topic for Holistic Common Operational Picture (COP): PMW 150' branch: Navy topic_number: N234-P08 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software; Trusted AI and Autonomy   OBJECTIVE: DEPARTMENT OF THE NAVY OPEN TOPIC - The resultant capability will provide a DEVSECOPS environment to mature efforts that feed the Maritime Tactical Command and Control production. It will also provide an AI tool that will sift data and identify potential Global Positioning System (GPS) threats in near real-time.   DESCRIPTION: The Department of Navy is seeking proposals to improve the quality and speed of decision making for operational and tactical commanders through advanced technology. These technologies may include, but not limited to, solutions that support force maneuver, effects and data synchronization, and course of action (COA) decision making.  Specifically, PEO C4I (PMW 150) requires a resultant capability that will provide a DEVSECOPS environment to mature efforts that feed the Maritime Tactical Command and Control (MTC2) production process.   The benefit to the warfighter is to enable rapid COA response options to continuously assess and hold at risk dynamic maritime threats.   Work produced in Phase II may become classified. The prospective contractor(s) must be U.S. owned and operated with no foreign influence as defined by DoD 5220.22-M, National Industrial Security Program Operating Manual, unless acceptable mitigating procedures have been implemented and approved by the Defense Counterintelligence Security Agency (DCSA). The selected contractor must be able to acquire and maintain an appropriate security-level facility and Personnel Security Clearances to perform on advanced phases of this project as set forth by DCSA and NAVWAR to gain access to classified information about the national defense of the United States and its allies. This will be an inherent requirement. The selected company will be required to safeguard classified material IAW DoD 5220.22-M during the advanced phases of this contract.   PHASE I: The DON is planning to issue multiple Phase I awards for this topic but reserves the right to issue no awards. Each Phase I proposal must include a Base and Option period of performance. The Phase I Base must have a period of performance of four (4) months at a cost not to exceed $75,000. The Phase I Option must have a period of performance of six (6) months at a cost not to exceed $100,000.   Phase I feasibility will describe the existing proposed technology, existing DON system(s) to improve, modifications required, anticipated improvements to existing capabilities, impacts to current logistics if any (i.e., transportation, storage, maintenance, safety, etc.) and transition approach to the DON system. Results of Phase I will be detailed in a final technical report (Final Report).   Phase I deliverables include: Kick-Off Briefing, due 15 days from start of Base award Final Report, due 120 days from start of Base award Initial Phase II Proposal, due 120 days from start of Base award   PHASE II: All Phase I awardees may submit an Initial Phase II proposal for evaluation and selection. The evaluation criteria for Phase II is the same as Phase I (as stated in this BAA). The Phase I Final Report and Initial Phase II Proposal will be used to evaluate the small business concern’s potential to adapt commercial products to fill a capability gap, improve performance, or modernize an existing capability for DON and transition the technology to Phase III. Details on the due date, content, and submission requirements of the Initial Phase II Proposal will be provided by the awarding SYSCOM either in the Phase I contract or by subsequent notification.   The scope of the Phase II effort will be specific to each project but is generally expected to develop a functional prototype to demonstrate the capability, develop transition plan including production and fielding approach (including updated logistics and safety consideration) and further commercialization (non-DoD).   Deliverables include all software, scripts, architecture models, system/software design artifacts, user and transition assessment documentation, and fleet experimentation (FLEX) reports.   It is highly likely that the work, prototyping, test, simulation, and validation may become classified in Phase II (see Description for details). However, the proposal for Phase II will be UNCLASSIFIED.   PHASE III DUAL USE APPLICATIONS: Field capability and logistics support.   REFERENCES: SBIR@Connect Spotlight: Meet NAVWAR’s Program Offices. Information on PEO C4I and Space Systems. Better understand the needs of the government, specifically NAVWAR https://vimeo.com/569585983 Official U.S. Navy Web site for Naval Information Warfare Systems Command (NAVWAR) https://www.navwar.navy.mil/   KEYWORDS: Maritime; Tactical; Command; Control; Positioning; Navigation; Timing sbir_topic_link: https://www.sbir.gov/node/2465007 subtopics: [ ] - topic_title: 'Decontamination of Open Wounds - Open Topic' branch: Office for Chemical and Biological Defense topic_number: CBD234-P001 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Biotechnology   OBJECTIVE: The purpose of developing an effective man-portable capability that will rapidly remove chemical warfare agents (CWAs) and other toxic industrial chemicals (TICs) of interest to the U.S. Department of Defense from both intact and wounded human skin, under austere conditions is to bring potentially valuable small business innovations to the Chemical and Biological Defense Program portfolio to discover and develop chemical medical countermeasures (cMCMs) capable of neutralizing CWAs in wounds and on the skin for the treatment of the Warfighter.   DESCRIPTION:  Although decontamination issues have been studied since the onset of chemical warfare, decontamination of chemical warfare agents (CWAs) from the skin remains a thorny problem for a variety of reasons.   These include, first and foremost, the ability to rapidly and effectively remove a diversity of toxic chemicals that currently are, or could be, CWAs, without harming or damaging the contaminated skin or wound. Prompt and rapid post-exposure decontamination is critical to reduce the post-exposure effects of CWAs.   In addition, a practical decontamination product needs to satisfy a plethora of secondary requirements, which include but are not limited to: Being simple to use in the field under harsh and likely confusing situations. Be light weight, compact, and easily stowed in a soldier’s pack. Be fast acting and effective under a wide range of environmental conditions. Meet and satisfy Federal Drug Agency (FDA) requirements. Meet and satisfy major DoD logistical requirements, i.e., long shelf-life, ease of transportation, manufacturability, and cost-effectiveness. Last, but not least, in addition to removing the toxic agents from skin, the product should be able to detoxify these chemical agents, both while it is being applied on the skin and after its removal. Rapid agent detoxification and decontamination effectiveness are intricately linked because in-situ detoxification is an effective method of reducing agent concentration on the skin before the agent has time to diffuse into the sub-dermal region. Detoxification of the agent also attenuates or prevents secondary contamination of medical or other personnel, and of the environment.   Chemical warfare agents (CWAs) are among the most lethal and sinister substances manufactured by man (1). They are designed to kill, maim, immobilize, or psychologically threaten enemy troops. CWAs can attack the skin which is not only the body’s interface with the outside environment, but also the largest organ of the body, with a surface area of roughly 1.6 m² for women and 1.8 m² for men (6).  Skin exposure to warfare agents is also a major problem during non- conventional war (5), or terrorist attack. Over the eons, a wide variety of materials in gas, liquid or solid form have been mobilized for this purpose. At present, CWAs of greatest concern in military operations are relatively low volatility organic liquids that attack the skin (vesicants) or attack the nervous system (nerve agents) (2-4).   Human skin, the largest human organ, developed as a physical barrier to the environment (to keep things out) but also maintains the aqueous nature of the human body (to keep things in). Mammalian skin consists of three major layers: stratum corneum, epidermis, and dermis. The stratum corneum, the thin outer layer of keratin-filled dead cells (corneocytes) bounded by densely crosslinked protein and embedded in crystalline lamellar lipids, represents the major barrier protecting the body from loss of internal components and entry of undesirable external materials. The stratum corneum, composed of keratinized dead cells that are continually being replaced, is the first major barrier to chemical agents. The layer underneath the stratum corneum, the epidermis, contains cells that differentiate from viable keratinocytes to corneocytes during their migration from the dermis to the stratum corneum. It also contains a large number of specialized cells. The dermis is the main component of living skin.   The purpose of decontamination is to reduce an initial amount of harmful material deposited on the surface of a person or object from the environment to a level that is low enough allow it to continue to safely function. It should be noted that permeability of the contaminant through the surface of the person or object is a complicating issue for any surface decontamination process. Contaminant permeability renders decontamination more difficult to perform, places time limitations on the window of opportunity for its performance.   The alternative to decontamination is discarding the object, which in the case of living beings, is not an option.   Current skin decontamination methods rely heavily on “wet” decontamination practices, which include washing the body with water, or soap and water (Roul et al., 2017). Alternatively, rapid decontamination makes extensive use of “dry” decontamination, which is based on adsorptive properties of powders, such as activated carbon or Fuller’s Earth (FE) (Roul et al., 2017).   Improved personal decontamination methods/products should consider: The effects on both intact skin and open wounds. Impacts on the subsequent wound healing process. Agent variable decontamination efficiency. Post-decontamination CWA detoxification capability. Rapid agent detoxification and decontamination effectiveness are intricately linked because in-situ detoxification is an effective method of reducing agent concentration on the skin before the agent has time to diffuse into the sub-dermal region. Post-decontamination detoxification of the contaminant(s)will also attenuate or prevent secondary contamination of medical or other personnel, and of the environment.   There is a clear need to develop an effective man-portable capability that will rapidly remove chemical warfare agents (CWAs) and other toxic industrial chemicals (TICs) of interest to the U.S. Department of Defense from human skin, both intact and wounded, under austere conditions.   PHASE I: A feasibility study to demonstrate the technical and commercial practicality of the concept to include an assessment of its technical readiness and potential applicability to military and commercial markets. PHASE II: Businesses will produce practical and feasible prototype solutions that can operate in edge and austere environments. Companies will provide a technology transition and commercialization plan for Department of Defense and commercial markets. The DoD will evaluate each product in a realistic field environment and provide solutions to stakeholders for further evaluation. Based on Soldier field assessment, the DoD will request companies to update the previously delivered prototypes to meet final design configuration.   REFERENCES: R.K. Gordon and E.D. Clarkson,(2009), “Rapid Decontamination of Chemical Warfare Agents”, Chapter 71, p. 1069 - 1081, Handbook of Toxicology of Chemical Warfare Agents”,  CHAPTER 71 - Rapid Decontamination of Chemical Warfare Agents (prevor.com.cn) K.J. Smith, K.J., et al. (1995). Sulfur mustard: its continuing threat as a chemical warfare agent, the cutaneous lesions induced, progress in understanding its mechanism of action, its long-term health effects, and new developments for protection and therapy. J. Am. Acad. Dermatol. 32: 765–76 C. Bismuth, C., et al. (2004). Chemical weapons: documented use and compounds on the horizon. Toxicol. Lett. 149: 11–18 M. Ghanei and A.A. Harandi (2007). Long term consequences from exposure to sulfur mustard: a review. Inhal. Toxicol. 19: 451–6 S. Reutter, (1999). Hazards of chemical weapons release during war: new perspectives. Environ. Health Perspect. 107: 985–90. Surface Area of Human Skin - The Physics Factbook (hypertextbook.com). G.K. Menon, (2002). New insights into skin structure: scratching the surface. Adv. Drug Deliv. Rev. 54: S3–17. J. Hadgraft, and M.E. Lane (2005). Skin permeation: the years of enlightenment. Int. J. Pharmacol. 305: 2–12. B.  Godin, and E., Touitou, E. (2012). Dermal and Transdermal Delivery. In: Bhushan, B. (eds) Encyclopedia of Nanotechnology. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-9751-4_81  H.I, Maibach, and R.C. Wester, “Percutaneous Absorption: In Vivo Methods in Humans and Animals”, Journal of the American College of Toxicology. 1989;8(5):803-813. doi:10.3109/10915818909018039 Handbook of Toxicology of Chemical Warfare Agents, 2009    Handbook of Toxicology of Chemical Warfare Agents | ScienceDirect).  H.Z. Zhu, et al, “Effect of Soap-Water Wash on Human Epidermal Penetration”, pp. 87-99, Chapter 6, “Skin Decontamination”, H. Zhu and H.I. Mailbach, Ed., G. Springer Nature Switzerland, 2020 https://oi.org/10.1007/978-3-030-24009-7_6  A. Roul et al., “Fuller’s Earth Efficiency in Skin Decontamination”, pp. 121-139, Chapter 8 “Skin Decontamination”, H. Zhu and H.I. Mailbach, Ed., G. Springer Nature Switzerland, 2020 https://oi.org/10.1007/978-3-030-24009-7_8 Fuller's Earth - Medical Countermeasures Database - CHEMM (hhs.gov)  (11) (PDF) ADSORPTION STUDIES OF FULLERS EARTH NANOCOMPOSITES FOR THE REMOVAL OF COPPER AND REACTIVE YELLOW 18 (researchgate.net) A. Roul et al., “Fuller’s Earth Efficiency in Skin Decontamination”, pp. 121-139, Chapter 8 “Skin Decontamination”, H. Zhu and H.I. Mailbach, Ed., G. Springer Nature Switzerland, 2020 https://oi.org/10.1007/978-3-030-24009-7_8 S. Dachir, et al, « Fuller’s Earth: Old and Faithful Skin Decontamination Against Toxic Agents”, p. 101 -117, Chapter 7, “Skin Decontamination”, H. Zhu and H.I. Mailbach, Ed., G. Springer Nature Switzerland, 2020 https://oi.org/10.1007/978-3-030-24009-7_7 M291 Skin Decontamination Kit | CCDC-CBC | MRIGlobal CBRNE Tech Index  U.S. DHS, CHEMM, “Reactive Skin Decontamination Lotion (RSDL) – Medical Counter Measures Data Base ( 2017) Reactive Skin Decontamination Lotion (RSDL) - Medical Countermeasures Database - CHEMM (hhs.gov) E.H. Braue, Jr., et al, «Evaluation of RSDL, M291 SDK, 0.5% Bleach, 1% Soapy Water and SERWACWA”, Part 1: Challenge with VX, USAMRICD-TR-09-01, U.S. Army Medical Research Institute of Chemical Research, Aberdeen Proving Ground, MD 21010-5400, June 2009. E.H. Braue, Jr., et al, «Evaluation of RSDL, M291 SDK, 0.5% Bleach, 1% Soapy Water and SERWACWA”, Part2: Challenge with Soman, USAMRICD-TR-09-01, U.S. Army Medical Research Institute of Chemical Research, Aberdeen Proving Ground, MD 21010-5400, July 2010. I. Koplovitz, « Comparison of Four Skin Decontamination Procedures Using Reactive Skin Decontamination Lotion (RSDL) Following Cutaneous VX Exposure in Guinea Pigs, USAMRICD-TR-17-01, U.S. Army Medical Research Institute of Chemical Research, Aberdeen Proving Ground, MD 21010-5400, January 2016. Emergent Biosolutions Inc., Resources – RSDL Emergent Biosolutions Inc.,  RSDL – Reactive Skin Decontamination Lotion Kit L. Taysse et al., 2007, Cutaneous challenge with chemical warfare agents in the SKH-1 hairless mouse (II): effects of some currently used skin decontaminants (RSDL and Fuller's earth) against liquid sulphur mustard and VX exposure - PubMed (nih.gov)  S. Tang et al, 2019, Hydrophilic scaffolds of oxime as the potent catalytic inactivator of reactive organophosphate - ScienceDirect  T.J. Walters, et al.,” Effect of reactive skin decontamination lotion on skin wound healing in laboratory rats”. Mil. Med. 172: 318–21 2007.  B.A. Mantooth et al, “Transport and Reactivity of Decontaminants to Provide Hazard Mitigation of Chemical Warfare Agents from Materials”, ECBC-TR-1383, p. 2, June 2016  O. Koper, “The Development of FAST-ACT® by Nanoscale Corporation”, Chapter 14, pp 235-248, ACS Symposium Series, Vol. 1045, “Nanoscale Materials in Chemistry: Environmental Applications”, edited by L.E. Erickson et al, 2010. 30. Battelle Memorial Institute, “Determination of Surface Removal and Reactivity of Three Powder Formulations with Selected Chemical Warfare Agents”, Final Report (Battelle Study No. 337-G004762), June 2002. P.W. Bartram and J.T. Lynn, Evaluation of FAST-ACTTM Formulations (Phase III, Test Service Agreement No. 0219T), ECBC-TR-378, Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD 21010-5424, April 2004 A. Pinhal et al, 2021, (a_Andreia-Pinhal-EPA-2021.pdf (herts.ac.uk)). H. H. Hill, Jr.  and S.J. Martin, “Conventional analytical methods for chemical warfare agents”, Pure Appl. Chem., Vol. 74, No. 12, pp. 2281–2291, 2002. Ch. E. Kientz. “Chromatography and mass spectrometry of chemical warfare agents, toxins and related compounds: state of the art and future prospects”, J. Chromatogr. A814, 1–23 (1998). J. R. Smith, M. L. Shih, E. O. Price, G. E. Platoff, J. J. Schlager. “Army medical laboratory telemedicine: Role of mass spectrometry in telediagnosis for chemical and biological defense”, J. Appl. Toxicol.21, S35–S41 (2001). “A Literature Review of Wipe sampling Methods for Chemical Warfare Agents and Toxic Industrial Chemicals”, EPA/600/R-11/079 January 2007). Document Display | NEPIS | US EPA S.A. Willison and et al, (2019) The imp(act of wipe sampling variables on method performance associated with indoor pesticide misuse and highly contaminated areas (nih.gov) NIOSH Manual of Analytical Methods (NMAM), 5th Edition (2022) NMAM 5th Edition Web Book | NIOSH | CDC ASTM D6661-17, Standard Practice for Field Collection of Organic Compounds from Surfaces Using Wipe Sampling, 2017 Karen Rossington, 2012 (The attraction of presat wipes (manufacturingchemist.com), Karen Rossington, 2017 ( Methods for testing presaturated wipes (cleanroomtechnology.com), Y. Liu et al, “Skin Exposure to Aliphatic Polyisocyanates in the Auto Body Repair and Refinishing Industry: III. A personal Exposure Algorithm”, Ann. Occup. Hyg., 53 (1), 33-40, 2009 (Skin_Exposure_to_Aliphatic_Polyisocyanates_in_the_auto_body_industry, Y Liu et al 2008.pdf). M. N. Richards, et al, “An approximate analytical approach to estimate the diffusivity of toxic chemicals in polymer barrier materials from the time evolution of sessile drop profiles”, Polymer Bulletin, 76, 339–364, 2019, An approximate analytical approach to estimate the diffusivity of toxic chemicals in polymer barrier materials from the time evolution of sessile drop profiles | SpringerLink   KEYWORDS: Decontamination; Chemical Warfare Agents; Personnel Decontamination; Casualty Decontamination; Skin Decontamination; Open Wound Decontamination; Chemical Agent Detoxification sbir_topic_link: https://www.sbir.gov/node/2464981 subtopics: [ ] - topic_title: 'Vibe: Innovation in Commodity Coherence' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-01 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Network Systems-of-Systems The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws. OBJECTIVE: Beamforming is utilized in numerous applications from wireless communications, acoustics, radar, and sonar as a means to direct a specific signal towards a particular receiver. Such applications typically require computing power to perform the signal processing and a sensor array to send or receive signals. These requirements are tailored to the specific application and may cause significant impact to the overall resources available for operations. Given the ubiquity of Commercial Off-the-Shelf (COTS) compute, sensors, and sensor platforms, there are multiple applications that could benefit from utilizing commodity hardware in lieu of requiring application-specific technologies. Beamforming requires relative time synchronization between nodes within an array and the ability to establish range metrics between senders prior to being able to beamform to a specific receiver. Typically, arrays are custom built where such information is already known or can easily be calculated. However, the creation of an array from heterogeneous commodity hardware requires such calculations to be performed on-the-fly and repeatedly as there could be modifications to the array during signal emissions. This Defense Advanced Research Projects Agency (DARPA) topic is seeking technologies for achieving time synchronization and coherence from a cooperating set of commodity devices. Vibe performers will explore novel approaches and develop prototypes for establishing distributed frequency coherence between a set of commodity devices to be able to achieve beamforming to a known receiver. Vibe is interested in any hardware/software methods that can achieve beamforming while also minimizing customized hardware solutions, maintaining a small form factor, and leaving the hardware inconspicuous. DESCRIPTION: Performers will develop novel approaches for utilizing commodity hardware for achieving distributed coherence and beamforming. Vibe prototypes should be able to demonstrate the ability to establish and maintain time synchronization necessary for coherent beamforming of a given frequency and waveform to a receiver. This can range from audible acoustic, ultrasonic, GSM, LTE, Bluetooth, WiFi, or other frequencies and waveforms of commercial/military interest and value. This receiver will also be controlled by the performer, but must also utilize COTS technologies to validate the transmitted signal. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Therefore, Phase I proposals will not be accepted or reviewed. Phase I feasibility will be demonstrated through evidence of: a completed feasibility study or a basic prototype system; definition and characterization of properties desirable for both Department of Defense (DoD) and civilian use; and comparisons with alternative state-of-the-art methodologies (competing approaches). This includes determining, insofar as possible, the scientific and technical merit and feasibility of ideas appearing to have application to the core objective of achieving coherence between a cooperating set of commodity devices. Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above have been met and describe the potential military or commercial applications. DP2 documentation should include: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, and risks/mitigations, assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and ability in computer science, mathematics, physics, electrical engineering, and software engineering. For detailed information on DP2 requirements and eligibility, please refer to the DoD BAA and the DARPA Instructions for this topic. PHASE II: The goal of Vibe is to design and evaluate an array to achieve coherent signal transmission and beamforming utilizing commodity hardware. Proposals should include development, installation, integration, demonstration and/or test and evaluation of the proposed prototype system. These activities should focus specifically on: 1. Evaluating the adapted solution against the proposed objectives. 2. Describing in detail how the installed solution differs from the non-defense commercial offering to solve DoD need(s) as well as how it can be scaled for wide adoption, i.e., modified for scale and broader signals. 3. Identifying the proposed solution's clear transition path considering input from affected stakeholders, including but not limited to, end users, engineering, sustainment, contracting, finance, legal, and cyber. Specifying the solution's integration with other current and potential future solutions. 4. Describing the solution's sustainability, i.e., supportability. Identifying other specific DoD or Governmental customers for the solution. Phase II will culminate in a system demonstration using one or more compelling use case(s) consistent with commercial opportunities, DoD opportunities, and/or insertion into a DARPA program. The below schedule of milestones and deliverables is provided to establish expectations and desired results for the Phase II effort. Schedule/Milestones/Deliverables: Proposers will execute Research and Development (R&D) plan as described in their proposal. Proposers will also complete a commercialization plan that addresses relevant material costs and potential material/equipment suppliers. • Month 1: Phase II Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) (in person or virtual, as needed) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 3, 5, 7: Technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (while this will normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 9: Interim technical progress briefing (live system demo with annotated slides) to the DARPA PM (in-person or virtual as needed) detailing progress made (include quantitative assessment of capability developed to date), tasks accomplished, major risks/mitigations, planned activities, and technical plan for the remainder of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12, 15, 18: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 3, 5, and 7), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 21/Final Phase II Deliverables: Final architecture demonstration with documented details, demonstrating the establishment of an array using commodity hardware with sufficient timing and ranging capabilities; demonstrating beamforming to a designated receiver, documented application programming interfaces; any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the end of phase commercialization plan). Proposers must demonstrate in their proposal the ability to apply for and obtain a Facility Clearance Letter (FCL) with secret safeguarding, or already possess an FCL with secret safeguarding by Phase III. Proposals must outline the proposer’s security plan for conducting prototyping, software development and testing of DoD applications at the collateral secret level by Phase III. All proposals must be unclassified, but proposers may submit classified annexes with prior approval of the DARPA Information Innovation Office Program Security Officer (I2O PSO); for instructions on classified annex submittals, contact I2Osecurity@DARPA.mil. Security Classification Guides governing potential classified Vibe applications may be provided to authorized U.S. contractor proposers upon request. PHASE III DUAL USE APPLICATIONS: Phase III work will be oriented towards transition and commercialization of the developed Vibe technologies. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Primary Vibe support will be to national efforts in both commercial and military applications for novel signal delivery and resilient communications. Such technology can be used for protecting transmitters, localizing specific receivers, and providing signal in non-traditional environments. REFERENCES: 1. K. Alemdar, D. Varshey, S. Mohanti, U. Muncuk, K. Chowdhury, "RFClock: Timing, Phase and Frequency Synchronization for Distributed Wireless Networks,” ACM International Conference on Mobile Computing and Networking (MobiCom 2021), New Orleans, LA, USA, 2021. 2. F. Quitin, M. M. U. Rahman, R. Mudumbai and U. Madhow, "A Scalable Architecture for Distributed Transmit Beamforming with Commodity Radios: Design and Proof of Concept," in IEEE Transactions on Wireless Communications, vol. 12, no. 3, pp. 1418-1428, March 2013, doi: 10.1109/TWC.2013.012513.121029. KEYWORDS: coherence, ranging, distributed coordination, beamforming sbir_topic_link: https://www.sbir.gov/node/2414699 subtopics: [ ] - topic_title: Synthetic User Personas (SUP) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-02 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber OBJECTIVE: The objective of Synthetic User Personas (SUP) is to generate labeled, synthetic cyber data suitable for enabling machine learning algorithms that support holistic cyber defenses. DESCRIPTION: Currently there is little to no labeled unified host and network data available to the cyber research community to facilitate the development and testing of machine learning algorithms for cyber defenses. Both network data, that captures network connections and packet flows, and host or endpoint data, that captures the use of applications and other activities on a machine, are necessary to build comprehensive cyber defenses. There are two categories of existing datasets. The first is anonymized data from networks with human users such as that provided by the Los Alamos National Laboratory [1]. The second is synthetic data generated and collected from a cyber exercise [2]. The data generated using each approach has significant problems that prevent its use in developing and testing machine learning algorithms. One strength of anonymized data is that none of the events are synthetic. The data represents the actual activity on the network from which it was collected. What anonymized data typically lacks, however, is any sense of ground truth. Anonymized data usually contains limited events, preventing more realistic enrichments and limiting the scope of detection algorithms that can be trained. Using anonymized data from a real network also raises the question of whether there was a malicious actor active when collecting the data, and as a result, there is malicious activity represented in the dataset. If there was a malicious actor, there is no reliable or practical way to identify the specific events that were produced by the actor’s activity. As a result, such datasets are not suitable for training machine learning algorithms. Further, elements of anonymized datasets may not be consistent amongst each other since there may be correlations in the actual collected data that are not recognized and preserved by the anonymization process. Alternatively, synthetic data can be easily and automatically annotated with ground truth (e.g., accurately identify and label benign and malicious events). However, to date, synthetic datasets lack the realism required to fully support development, training, and testing of machine learning algorithms. Synthetic datasets also typically contain unwanted artifacts that reduce or eliminate their value (e.g., artificial artifacts introduce biases when training machine learning algorithms). The existence of unified endpoint and network data is rare because of several issues. First, the anonymization of endpoint data and network data both present unique challenges. Notably, the limitless variations of potential endpoint data makes anonymizing it impossible for arbitrary use cases. Preserving correlations among data elements in both types of data is also incredibly challenging, and again impossible for generalized cases. Second, the collection of endpoint data for research purposes typically requires Institutional Review Board approval. Third, the configuration management of and policies governing the endpoints may prohibit the deployment of a collection agent. Finally, most commercial agents do not make collected endpoint telemetry available for local analysis, instead sending it for centralized (e.g., cloud) processing. SUP will implement synthetic agents designed to generate user activity without creating spurious network or host artifacts. SUP will not create a self-hosted agent that generates activity and filters out its own events from the event stream. Rather, SUP will passively and remotely interpret data (e.g., from a computer screen) to understand the machine state, and then interact with the machine using external input sources (e.g., keyboard and mouse), thus emulating human users. All of the generation activity is “off box” so that no generational artifacts contaminate the collected data. This is a key factor in ensuring that the collected data is free of any spurious artifacts that may incorrectly bias machine learning algorithms generated from the synthetic data. The “off box” synthetic agents implemented by SUP will be capable of scaling to at least five hundred (500) hosts within an enterprise test network. Additionally, SUP will provide for the ability to generate and record user activity and associated data without the addition of software on the subject hosts and without relying on remote logins to the subject hosts. Ideally, the lightweight “off box” synthetic agents will be built with a language that natively supports concurrency, enabling straightforward scaling well beyond the 500-host requirement. SUP will be able to respond correctly and continue proper operation after unexpected pop-ups and other operating system notifications occur. This will be implemented without reliance on timeouts or waiting periods to avoid unknown dialogs; and SUP will not make any assumptions as to when dialogs may or may not appear. SUP will continue to operate properly when the screen resolution changes unexpectedly (i.e., dependencies on image matching should work at any resolution without the need for code changes or a collection of images at every possible resolution). Within an enterprise environment, typically there are many different types of employees and departments that need to be protected, each of which may represent different types of user behavior, with communications closely matching organizational groups and software use differing as well. SUP will enable the emulation of multiple user profiles to provide a variety of realistic user behaviors across the environment. User modeling efforts may span multiple levels of complexity. For example, activities may be performed at random, quickly changing from web browsing tasks to e-mail. Alternatively, a specific workflow may be defined, providing scripts or playbooks from which to draw on actions. Finally, complex emergent behaviors may be built on models of real human behavior. Previous work has explored many approaches to user behavior modeling. Amirkhanyan et al. [3] looked at modeling user behavior using graphical methods called user behavior state graphs. Drawing on human factors research, Garg et al. [4] included features such as nervousness, typing speed, and mouse movement behaviors into user behavior patterns that could then be replicated in a testbed environment. Blythe et. al [5] explored using the Belief-Desire-Intention model for creating intelligent agents that were capable of using planning and reaction to achieve preset goals. These methods were demonstrated as part of the Deter Agents Simulating Human-Behavior module that is a part of DeterLab [6]. Additionally, the GHOSTS-SPECTRE project has also demonstrated use of machine learning methods to drive web browsing behavior in support of data generation while modeling changing user preferences [7]. Traditionally, user data generation has used an agent “on box.” The agent creates artifacts as a result of its activity and those artifacts must be filtered out if possible; otherwise, they may introduce biases into any learned algorithm. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Phase I feasibility will be demonstrated through evidence of: a completed feasibility study or a basic prototype system; definition and characterization of properties desirable for both Department of Defense (DoD) and civilian use; and comparisons with alternative state-of-the-art methodologies (competing approaches). Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above have been met and describe the potential commercial applications. DP2 documentation should include: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, and risks/mitigations, and assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed SUP solution can enable more realistic cyber training. This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and ability in networking, computer science, mathematics, and software engineering. For detailed information on DP2 requirements and eligibility, please refer to the DoD BAA and the DARPA Instructions for this topic. PHASE II: The goal of SUP is to generate realistic synthetic data that is void of artifacts and capable of scaling. An average cyber operator should not be able to determine that the data is synthetic by looking at the generated data, even when the operator has knowledge of typical human activity that was modeled when generating the synthetic data. The operator’s view of user behavior is limited to the event activity of the user; the operator will not have visibility of the actual content created by the user. The SUP prototype should easily scale as a result of its architecture and implementation language. DP2 proposals should present systems that: • generate realistic synthetic data without artifacts such that an average operator cannot determine that the event data is synthetic; and • scale to at least five hundred (500) end user machines. • Phase II will culminate in a system demonstration using one or more compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II effort. Deliverables must include: • a software implementation of SUP for a virtualized test environment; and • an example dataset generated by SUP suitable for machine learning research. The Phase II Option period will further mature the technology for insertion into a larger DARPA Program, DoD/Intelligence Community (IC) Acquisition Program, another Federal agency; or commercialization into the private sector. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal. • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (while this will normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (include quantitative assessment of capabilities developed to date), tasks accomplished, major risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24 (Final Phase II Deliverables): Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to generate artifact-free data at scale; documented application programming interfaces; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the end-of-phase commercialization plan). Month 30 (Phase II Option period): Interim Option period technical progress briefing (with annotated slides) to the DARPA PM. Interim report of prototype performance against existing state-of-the-art technologies documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Option period technical progress briefing (with annotated slides) to the DARPA PM. Final Phase II Option period report of prototype performance against existing state-of-the-art technologies, including quantitative metrics for scalability, assessments of realism, and costs, risks, and schedule for implementation of the full prototype capability into a government-chosen test facility. PHASE III DUAL USE APPLICATIONS: SUP has potential applicability across DoD, IC, U.S. Government (USG), and commercial entities. For DoD/IC/USG, SUP is extremely well-suited for large-scale cyber exercises, smaller-scale operator training, weapon system software testing, and automation of rote tasks. SUP has the same applicability as DoD/IC/USG for the commercial sector. The Phase III work will be oriented towards transition and commercialization of the developed SUP technologies. The proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in military or private sector markets. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Primary SUP support will be to national efforts to explore application of artificial intelligence (AI) to improve generation of realistic user events captured during cyber-security testing on synthetic ranges. AI technologies will provide the foundation for developing sophisticated user behavior models that can be used in cyber range exercises. In particular, it is important that these models are realistic and do not bias machine learning approaches because of predictable artifacts. Results of SUP are intended to improve the quality of cyber ranges used across academia, industry, and government REFERENCES: 1. Los Alamos National Laboratory. “Advanced Research in Cyber Systems Data Sets.” Triad National Security, LLC for the U.S. Department of Energy's National Nuclear Security Administration, https://csr.lanl.gov/data/. July 5, 2022. 2. DARPA (2020) Operationally Transparent Cyber Data Release [Data Set]. Available at: https://github.com/FiveDirections/OpTC-data 3. Amirkhanyan, A., Sapegin, A., Gawron, M., Cheng, F., & Meinel, C. (2015, September). Simulation user behavior on a security testbed using user behavior states graph. In Proceedings of the 8th International Conference on Security of Information and Networks (pp. 217-223). Available at: https://www.researchgate.net/publication/279535149_Simulation_User_Behavior_on_A_Security_Testbed_Using_User_Behavior_States_Graph 4. Garg, A., Vidyaraman, S., Upadhyaya, S., & Kwiat, K. (2006, April). USim: a user behavior simulation framework for training and testing IDSes in GUI based systems. In 39th Annual Simulation Symposium (ANSS'06) (pp. 8-pp). IEEE. Available at: https://cse.buffalo.edu/~shambhu/documents/pdf/USim.pdf 5. Blythe, J., Botello, A., Sutton, J., Mazzocco, D., Lin, J., Spraragen, M., & Zyda, M. (2011, August). Testing cyber security with simulated humans. In Twenty-Third IAAI Conference. Available at: https://www.researchgate.net/publication/221016543_Testing_Cyber_Security_with_Simulated_Humans 6. University of Southern California Information Sciences Institute (USC-ISI). “The cyber DEfense Technology Experimental Research (DETER) Lab Capabilities.” The DETER Project, USC-ISI, https://deter-project.org/deterlab_capabilities#dash. July 5, 2022. 7. Carnegie Mellon University Software Engineering Institute (2020) GHOSTS-SPECTRE [Source Code] Available at: https://github.com/cmu-sei/GHOSTS-SPECTRE KEYWORDS: Machine Learning, Cyber, Artificial Intelligence, Automation, Data, Analytics sbir_topic_link: https://www.sbir.gov/node/2414703 subtopics: [ ] - topic_title: Space Metamaterial Electronically Scanned Array (Space-MESA) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-03 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Space Technology The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws. OBJECTIVE: Develop a proof of concept metamaterial antenna specifically designed to provide space-based detection, tracking, and imaging of moving targets. The prototype should include fabrication of a metasurface aperture (sub tile) that can support wide angle, high-speed beamsteering, as well as any testing capabilities needed for capturing full antenna patterns from the prototype. DESCRIPTION: Providing persistent, global, space-based detection, tracking, and imaging requires high-capacity and low-cost sensors. This cost is most acutely felt in the new low-cost “proliferated” space domain where space vehicle costs have been plummeting. The most suitable type of sensor for performance is a synthetic aperture radar (SAR) due to its ability to provide fast, wide field of regard to detect, track, and image multiple moving objects of interest regardless of weather. However, SARs are not cost effective to deploy aboard spacecraft in the numbers necessary to provide a persistent, global capability. Another option could be lower-cost fixed mesh-reflectors or planar arrays as they are capable of generating adequate antenna gain, but they lack the ability to electronically steer a beam, and can only image one or two targets per pass. Due to the lack of capability offered by fixed-beam systems and the prohibitive cost of using traditional SAR-equipped satellites for global coverage, DARPA is looking for cost-effective, fully-steerable track-while-scan radars that can be deployed in low earth orbit (LEO). To provide the cost-effective capability DARPA is looking for, metamaterial electronically scanned array (MESA) radars are of particular interest due to their ability to offer similar performance to traditional Active Electronically Scanned Arrays (AESAs), but at an order of magnitude less cost due to their simpler design. While MESAs technology has been developed for both ground and air applications, it has not yet been developed for deployment to and usage in space environments. To detect and track objects over large areas (100s of square kilometers), the MESA would need to be constructed of coherent, digital tiles. A super-array of digital tiles though would require new means to solve coherence and calibration challenges, while also burdened with the extreme temperature variations and high orbital velocities experienced in a space environment. In this effort, proposers will design and develop an operational electronically-steerable metamaterial antenna sub tile prototype, as well as: • Design and develop a near-field probe antenna test system to capture full antenna patters out of the antenna prototype • Document manufacturing development steps necessary for the metamaterial antenna • Develop all hardware and software to control drive electronics of active components of sub-tile to electronically steer a beam. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Previous Phase 1 qualified efforts should have demonstrated that they can design and produce an electronically steerable antenna capable of achieving the metrics listed below. Results should be supported by prior demonstration or laboratory testing. • Steerable to ± 60° in azimuth and elevation with sub 1° steps • Ability to survive high peak radiofrequency powers from 800W to 1200W for apertures 1m2 and greater Efficiency data of 40% or greater at broadside • Peak sidelobe levels of 15dB or greater at broadside • Ability to steer large apertures (150?? Lambda or greater) in 10us or less PHASE II: The Phase II effort consists of a Phase II base of 12 months and a Phase II option of 12 months. Phase II fixed payable milestones for this program should include: • Month 2: Initial report on architecture and program plan • Month 6: Interim report on system trade study and architecture, antenna design, and system requirements • Month 12: Phase II report documenting status of X-band antenna design and development, antenna test platform, antenna manufacturing process development, and hardware/software to control drive electronics progress • Month 18: Interim report documenting X-band antenna design and fabrication, antenna test platform design, antenna manufacturing results, and hardware/software to control drive electronics progress • Month 24: Final Phase II report documenting X-band antenna design and test results, antenna test platform design and specifications, antenna manufacturing process, and verification results of hardware and software to control drive electronics PHASE III DUAL USE APPLICATIONS: Metasurface Electronically Scanned Array (MESA) radars are currently high technology readiness level and in full-rate production, providing high-performance at low cost for both air and ground usage, for military and commercial applications. Further developing this metamaterial antenna technology to be operable in space while providing the performance needed for wide-area moving target indication would attract significant interest from space-focused agencies within the Department of Defense, and potentially commercial partners as well. REFERENCES: 1. https://en.wikipedia.org/wiki/Active_electronically_scanned_array 2. https://en.wikipedia.org/wiki/Metamaterial_antenna 3. https://www.microwavejournal.com/articles/27373-metamaterial-advances-for-radar-and-communications KEYWORDS: Metamaterials, Synthetic Aperture Radar, Electronical Scanned Arrays sbir_topic_link: https://www.sbir.gov/node/2414705 subtopics: [ ] - topic_title: > Super-resolution Thermal Metrology for High Power Density Devices branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-04 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Microelectronics OBJECTIVE: This topic seeks to develop a super-resolution thermal metrology tool to enable accurate characterization of semiconductor materials and devices, and wide bandgap and ultra-wide bandgap materials and devices, in particular, at nanometer length scale. DESCRIPTION: Radar and communication systems are ubiquitous in both military and commercial applications. In these platforms, system performance can be improved by increasing the radio frequency (RF) output power of the transmitter power amplifier (PA), which is directly proportional to the output power density of the PA transistor. However, the operating output power densities achieved in today’s wide bandgap transistors are thermally limited to values substantially below theoretical electronic limits. The government has an interest in developing technologies to overcome these thermal limitations and realize robust, high-power density transistors that operate near their fundamental electronic limit of RF output power, with a focus on achieving high power density through reduction in transistor thermal resistance [1]. Success requires metrology that can accurately measure thermal resistance and interfacial thermal resistance of a variety of material and device structures. Furthermore, these measurements are required to verify that performer high-power transistors meet program metrics. Existing thermal metrology tools often use pump-probe laser-based techniques, such as time-domain thermoreflectance (TDTR), frequency-domain thermoreflectance (FDTR), and recent variants such as steady state thermoreflectance (SSTR)[2] . While these techniques are useful for the measurement of thermal resistance in thin films and interfaces, they are are limited in spatial resolution [2,3], and cannot measure thermal resistance and thermal resistance gradients in submicron devices. The ability to measure thermal resistance beyond the surface film (i.e., in the buried channel layer of a heterojunction device) and also characterize at both nanoscale and microscale dimensions, is critical to the development of high power density devices. The purpose of this direct to Phase II (DP2) SBIR topic is to develop a super-resolution thermal metrology tool that enables accurate characterization of the thermal resistance of semiconductor materials, heterostructures and devices, particularly wide bandgap and ultra-wide bandgap materials and devices at nanometer length scale. The tool must be capable of measuring both epilayers and operating devices with a thermal resolution less than 0.25 oC, thermal precision of 1 oC, spatial resolution below 50 nm, accuracy above 90%, and reproducibility and repeatability less than 2%. Specific measurement capabilities include thermal resistance, thermal boundary resistance of interfaces, and temperature of an operating device and, in particular, buried channel layers. The device-scale measurements must characterize both the surface and cross-section of a multi-finger, submicron GaN high-electron-mobility transistor (HEMT) and an ultra-wide bandgap AlGaN HEMT. In addition, a comprehensive validation plan should be provided. For example, the plan should include device-relevant material structures, such as GaN transistor layers, that are compared to other thermal measurement techniques for verification of results. The plan may also incorporate National Institute of Standards and Technology (NIST) standards. The final Phase II base deliverable will be a laboratory demonstration of the thermal metrology tool, along with a plan for construction of tool and delivery to a U.S. government organization. The Phase II option of this topic will address the development of this thermal metrology tool into an automated, turnkey system that will be delivered to a U.S. government laboratory. The deliverables of the Phase II option will include both the tool, calibration standards, and any necessary software for demonstrating material and device thermal characterization. Finally, on-site support will be required to ensure proper installation and operation at the U.S. government organization. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. This DP2 SBIR requires documentation of existing thermal metrology capabilities and a proposed plan with supporting analysis showing that achieving 50 nm spatial resolution with high precision and accuracy is feasible. The documentation must include measured data, including thermal resistance, from existing thermal metrology techniques demonstrating less than 2 µm spatial resolution and the ability to resolve interfaces beyond the surface film. In addition, validation data from the existing thermal metrology tool should be provided. PHASE II: The proposed plan must describe the path towards a successful final DP2 SBIR deliverable which meets the requirements listed below. This DP2 SBIR will have an 18-month duration in which the super-resolution thermal metrology tool will be designed, developed, validated, and tested for performance goals. The requirements of the thermal metrology tool are: 1. Capable of measuring thermal resistance, thermal boundary resistance, and temperature of operating multi-finger, submicron GaN HEMT and ultra-wide bandgap AlGaN HEMT with the following specifications: a. Spatial resolution < 50 nm b. Thermal resolution < 0.25 oC c. Thermal precision: 1 oC d. Accuracy > 90% e. Reproducibility and repeatability < 2% 2. Tool validation using a comparison of measured results of device relevant structures to other thermal metrology techniques. In addition, validation may use available NIST standards. Phase II (base) fixed milestones include: • Month 1: Detailed report on super-resolution thermal metrology tool design, including documentation of path towards achieving in-situ device testing and meeting DP2 SBIR goals. • Month 3: Report on progress towards final design and demonstration of thermal metrology tool. • Month 6: Report on progress towards final design and demonstration of thermal metrology tool. • Month 9: Report on progress towards final design and demonstration of thermal metrology tool. • Month 12: Initial prototype demonstration of super-resolution thermal metrology tool. Detailed report should include validation data as well as thermal resistance, temperature, and thermal resolution of the surface and cross-section of GaN and AlGaN transistors with less than 100 nm spatial resolution. Documentation should also describe the path towards the final DF2 SBIR deliverable. • Month 15: Detailed report on progress towards final design and demonstration of the thermal metrology tool, including validation data and transistor thermal characterization. • Month 18: Final demonstration of a prototype thermal metrology tool that meets requirements listed above. Detailed data report containing final validation measurements and thermal characterization of surface and cross-section of GaN and AlGaN transistors with less than 50 nm spatial resolution. Plan for construction of tool and delivery to a U.S. government organization. Phase II (option) This DP2 SBIR will have a 6-month option in which the super-resolution thermal metrology tool demonstrated in Phase II will be developed into a turn-key, push-button, automated system. A Phase II option final report will detail the successful demonstration of a fully-automated measurement of the thermal resistance, thermal boundary resistance, temperature, and thermal resolution of an operating multi-finger, submicron GaN HEMT and ultra-wide bandgap AlGaN HEMT. The DP2 option will also include: 1. Delivery of prototype automated, turnkey thermal metrology tool to a designated U.S. government organization. 2. Support for installation and operation at the U.S. government laboratory. 3. Demonstration of thermal characterization of GaN HEMT and ultra-wide bandgap AlGaN HEMT on-site at the U.S. government organization. Phase II (option) fixed milestones include: • Month 1: Detailed report on automated, push-button thermal metrology tool design and path toward achieving DP2 Option goals. Coordinate with the designated U.S. government organization to provide a preliminary plan for delivery and installation. • Month 3: Report on thermal metrology tool development progress. • Month 6: Delivery of final prototype thermal metrology tool, including calibration standards and any necessary software for demonstrating material and device thermal characterization. Detailed report containing final validation measurements and thermal characterization of surface and cross-section of GaN and AlGaN transistors with less than 50 nm spatial resolution. PHASE III DUAL USE APPLICATIONS: This SBIR will enable a commercially available, automated thermal metrology tool for use by academia, semiconductor foundries (commercial and defense), and material vendors. Specifically, this technology will provide high resolution thermal metrology so that transistor developers can accurately characterize the thermal resistance and temperature of a wide variety of films, material structures, devices, and packages. This thermal characterization data can be incorporated into device modeling and design, enabling devices with higher power density and improved robustness for a wide range of defense and commercial radar and communication applications. REFERENCES: [1] DARPA Broad Agency Announcement, Technologies for Heat Removal in Electronics at the Device Scale (THREADS), Microsystems Technology Office, HR001123S0013, November 18, 2022. [2] Olson, David, et al., "Spatially resolved thermoreflectance techniques for thermal conductivity measurements from the nanoscale to the mesoscale", Journal of Applied Physics 126, 2019. [3] Yuan, Chao, et al., “A review of thermoreflectance techniques for characterizing wide bandgap semiconductors’ thermal properties and devices’ temperatures,” Journal of Applied Physics 132, 2022. KEYWORDS: Microelectronics, thermal metrology, thermoreflectance, thermal resistance, temperature, transistor, wide bandgap, ultra-wide bandgap sbir_topic_link: https://www.sbir.gov/node/2414707 subtopics: [ ] - topic_title: Wearables at the Edge to Augment Readiness (WEAR) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-05 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials, Microelectronics OBJECTIVE: The objective of the Wearables at the Edge to Augment Readiness (WEAR) SBIR topic is to develop a secure and lightweight framework for real-time analysis of sensory data from wearables to monitor warfighter health and readiness at the edge. DESCRIPTION: Wearable technology is now fundamental to all areas of the human ecosystem. The term wearable technology refers to small electronic and mobile devices, or computers with wireless communications capability that are incorporated into gadgets, accessories, or clothes, which can be worn on the human body [1]; for the purposes of this SBIR topic, it does not apply to invasive versions such as micro-chips or smart tattoos. Wearable technology can provide invaluable physiological and environmental data that can potentially be used to assess a warfighters’ physical/mental wellness and readiness. Modern edge devices, like smartphones and smart watches, are equipped with an ever-increasing set of sensors, such as accelerometers, magnetometers, gyroscopes, etc., that can continuously record users’ movements and motion [2]. The observed patterns can be an effective tool for seamless Human Activity Recognition which is the process of identifying and labeling human activities by applying Artificial Intelligence (AI)/Machine Learning (ML) to sensor data generated by smart devices both in isolation and in combination [3, 4]. However, smartphone and wearable sensor signals are typically noisy and can lack context/causality due to inaccurate timestamps when the device sleeps, goes into low-power mode, or experiences high resource utilization. Thus, it can be challenging to fuse any of the various raw sensor data to achieve positive or negative assessment in wellness areas such as personal healthcare, injuries, fall detection, as well as monitoring functional/behavioral health. For instance, sensor data can be processed into feature data related to sleep or different physical activities that potentially correlate to effects on an individual’s health [5, 6]. The objective of WEAR is to develop a secure and lightweight framework for real-time analysis of sensory data from wearables to monitor warfighter health and readiness at the edge. Importantly, WEAR will achieve this goal while consuming less than 5% of the wearable battery over 10 days, assuming an initial full battery charge. The battery consumption metric is of particular interest to WEAR as warfighters at the edge (e.g., expeditionary forces deployed to remote locations or Special Operations Forces units) may not be able to recharge wearable batteries due to mission constraints limiting access to power sources for re-charging. Equally important is the need for all processing to occur at the edge because of security concerns [8]. Existing commercial efforts require cloud and off-premises server resources to analyze sensor data. PHASE I: This topic is soliciting Direct to Phase 2 (DP2) proposals only. Phase I feasibility will be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of framework properties/technology capabilities desirable for both Department of Defense (DoD)/government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed WEAR solution can enable accurate and reliable analysis of sensory data at the edge. This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in AI/ML, data analytics, edge technologies, software development/engineering, and mobile security/privacy. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The Personal Health Determinations (WEAR) SBIR topic seeks to develop a secure and lightweight framework that can perform real-time analysis of sensory data from wearables to monitor warfighter operational health and readiness at the edge, while consuming less than 5% of the wearable battery over 10 days, assuming an initial full battery charge (i.e., WEAR component overhead can be no more than 5% of the wearable battery over 10 days). One potential direction to achieve this goal is to leverage advances in low-power sensing at the chipset level present in modern mobile and wearable devices, including but not limited to “always-on sensing.” The primary interest is in commercial-off-the-shelf hardware paired with novel sensor drivers and algorithms developed to operate at low power. A secondary objective is to offer modular application programming interfaces (APIs) to access sensor data and edge ML models/algorithms that can fit into the resource-constrained environments of commercial wearables. The end goal is the capability to monitor and accurately assess warfighter operational health and readiness by using the sensory information on the edge devices without transporting information outside of the wearable or smartphone devices. Any custom hardware or sensors are out of scope for this solicitation. DP2 proposals should: • describe a proposed framework design/architecture to achieve the above stated goals; • present a plan for maturation of the framework to a demonstrable prototype system; and • detail a test plan, complete with proposed metrics and scope, for verification and validation of the prototype system performance. Phase II will culminate in a prototype system demonstration using one or more compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program (e.g., Warfighter Analytics using Smartphones for Health (WASH [7]), which seeks to use data collected from cellphone sensors to enable novel algorithms that conduct passive, continuous, real-time assessment of the warfighter). The Phase II Option period will further mature the technology for insertion into a DoD/Intelligence Community (IC) Acquisition Program, another Federal agency; or commercialization into the private sector. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II and Phase II Option period efforts. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to perform real-time analysis of sensory data at the edge while consuming less than 5% of the wearable battery over 10 days; documented APIs; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan). • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Phase II Option period technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics for battery consumption and assessment of monitoring/assessment capabilities to support determinations of warfighter health status. PHASE III DUAL USE APPLICATIONS: Phase III Dual use applications (Commercial DoD/Military): WEAR has potential applicability across DoD and commercial entities. For DoD, WEAR is extremely well-suited for continuous, low-cost, opportunistic monitoring of warfighter health in the field, where specialized equipment and medical experts are not necessarily available. WEAR has the same applicability for the commercial sector and has the potential to provide doctors and physicians with invaluable historical patient health data that can be correlated to their activities, environment, and physiological responses. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed WEAR technologies. The proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in military or private sector markets. Primary WEAR support will be to national efforts to explore the ability to collect and fuse sensor data and apply ML algorithms at the edge to that data in a manner that does not drain device battery. Results of WEAR are intended to improve healthcare monitoring and assessment at the edge, across government and industry. REFERENCES: [1] Aleksandr Ometov, Viktoriia Shubina, Lucie Klus, Justyna Skibinska, Salwa Saafi, Pavel Pascacio, Laura Flueratoru, Darwin Quezada Gaibor, Nadezhda Chukhno, Olga Chukhno, Asad Ali, Asma Channa, Ekaterina Svertoka, Waleed Bin Qaim, Raúl Casanova-Marqués, Sylvia Holcer, Joaquín Torres-Sospedra, Sven Casteleyn, Giuseppe Ruggeri, Giuseppe Araniti, Radim Burget, Jiri Hosek, Elena Simona Lohan, A Survey on Wearable Technology: History, State-of-the-Art and Current Challenges, Computer Networks, Volume 193, 2021, 108074, ISSN 1389-1286, https://doi.org/10.1016/j.comnet.2021.108074. (Available at https://www.sciencedirect.com/science/article/pii/S1389128621001651) [2] Paula Delgado-Santos, Giuseppe Stragapede, Ruben Tolosana, Richard Guest, Farzin Deravi, and Ruben Vera-Rodriguez. 2022. A Survey of Privacy Vulnerabilities of Mobile Device Sensors. ACM Comput. Surv. 54, 11s, Article 224 (January 2022), 30 pages. https://doi.org/10.1145/3510579. (Available at https://dl.acm.org/doi/pdf/10.1145/3510579) [3] Straczkiewicz, M., James, P. & Onnela, JP. A systematic review of smartphone-based human activity recognition methods for health research. npj Digit. Med. 4, 148 (2021). https://doi.org/10.1038/s41746-021-00514-4. (Available at https://www.nature.com/articles/s41746-021-00514-4) [4] E. Ramanujam, T. Perumal and S. Padmavathi, "Human Activity Recognition With Smartphone and Wearable Sensors Using Deep Learning Techniques: A Review," in IEEE Sensors Journal, vol. 21, no. 12, pp. 13029-13040, 15 June15, 2021, doi: 10.1109/JSEN.2021.3069927. (Available at https://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=9389739) [5] Jun-Ki Min, Afsaneh Doryab, Jason Wiese, Shahriyar Amini, John Zimmerman, and Jason I. Hong. 2014. Toss 'n' turn: smartphone as sleep and sleep quality detector. In Proceedings of the SIGCHI Conference on Human Factors in Computing Systems (CHI '14). Association for Computing Machinery, New York, NY, USA, 477–486. https://doi.org/10.1145/2556288.2557220 (Available at https://dl.acm.org/doi/pdf/10.1145/2556288.2557220) [6] Sardar, A. W., Ullah, F., Bacha, J., Khan, J., Ali, F., & Lee, S. (2022). Mobile sensors based platform of Human Physical Activities Recognition for COVID-19 spread minimization. Computers in biology and medicine, 146, 105662. https://doi.org/10.1016/j.compbiomed.2022.105662. (Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9137241/pdf/main.pdf) [7] Defense Advanced Research Projects Agency. (2017, May 8). Warfighter Analytics using Smartphones for Health (WASH) Broad Agency Announcement HR001117S0032. (Available at https://cpb-us-w2.wpmucdn.com/wp.wpi.edu/dist/d/274/files/2017/05/DODBAA-SMARTPHONES.pdf) [8] Fitness tracking app Strava gives away location of secret US army bases. https://www.theguardian.com/world/2018/jan/28/fitness-tracking-app-gives-away-location-of-secret-us-army-bases KEYWORDS: Wearable Technology, Health Monitoring, Health Assessment, Data Analytics, Edge Technology, Activity Recognition, Machine Learning sbir_topic_link: https://www.sbir.gov/node/2414709 subtopics: [ ] - topic_title: Exploiting Sparsity in Python (ESPy) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-06 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software OBJECTIVE: Extend the scientific Python programming ecosystem to incorporate a rich set of matrix and tensor operations supported by a compilation system capable of automatic efficient code generation for execution on a range of run-time hardware architectures, including hardware with features that optimize or accelerate operations on sparse data. DESCRIPTION: Of the nearly 44 zettabytes of data humans have gathered to date, most of it is collected, processed and stored as multi-dimensional arrays or tensors. From the earliest computer and the first FORTRAN compiler, we have perfected how to store and compute dense tensor data. However, a large portion of the data, either obtained from nature or generated by humans, is sparse. The Python programming environment is increasingly the tool of choice for scientific processing, but it has poor support for sparsity; current practice is to ignore the sparsity and treat the data as dense, incurring unnecessary overhead, or to transform the data into unnatural dense formats, making the programs much more complicated. Capitalizing on sparsity can greatly increase the efficiency of scientific computations, but the challenge is that there are a large number of sparse data formats, each of which takes advantage of particular features of the data; the algorithms that operate on these different data formats are then specialized to exploit the advantages of the specific data formats. An additional challenge is that there are a variety of hardware accelerators for matrix and tensor computations, ranging from features in conventional CPUs and GPUs to new hardware capabilities that have been developed to accelerate computations on sparse data. Dealing with this complexity is a challenge that is not within the reach of most programmers. The objective of this effort is to make the processing of sparse data as accessible and efficient as working with dense data. Specifically, to make the Python APIs for array processing (in NumPy, SciPy, PyTorch, and scikit-learn used by 10s of millions of people) work seamlessly with sparse data. ESPy will build on the current Python scientific library approach (e.g. NumPy and SciPy), to minimize source code changes and encourage community take-up, and add sparsity awareness and the ability to target multiple hardware architectures, including at least one architecture with features aimed at accelerating computation on sparse data. A framework or domain-specific language approach can be used to encapsulate the Python application, or the Python environment can be extended with an array/tensor algebra compiler; the selected approach should require minimal source-code changes. A compilation intermediate representation should be devised or adapted that incorporates sparse semantics, such as degree of sparsity and data formatting, and that can be efficiently targeted at multiple run-time hardware architectures. Data formatting transformations should be minimized. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Selected performers will have an established and documented background and experience with most or all of the following: the design and implementation of Python-based libraries, frameworks, domain-specific-languages, compilers, compilation intermediate representations, code generation and optimization, and a range of target computer architectures including CPUs, GPUs, and hardware accelerators. Performers should also be able to document familiarity with sparse and dense tensor algebra, including comprehensive coverage of the many sparse and dense data structures and formats. PHASE II: The goal of ESPy is to establish an efficient and easy-to-use sparse tensor algebra capability in the Python scientific ecosystem. The facility can be based on a library approach, or use a domain-specific language or a framework to facilitate the capability, as long as there are minimal code changes for the Python programmer. There are a multitude of sparse object data structures and formats, and ESPy should support as many of these as possible, and be capable of extension to additional sparse data formats as needed or required. ESPy should also support multiple target architectures including at least one architecture implementation with features that can be exploited to accelerate sparse vector or matrix processing. ESPy’s support of tensor algebra shall be more than just addition and multiplication by providing a rich set of operators and functions, such as convolutions and semi-rings. Expected Phase II metrics: • At least 100X faster performance on a sparse array- and tensor-processing benchmark vs generic Python processing using scientific libraries with sbir_topic_link: https://www.sbir.gov/node/2414711 subtopics: [ ] - topic_title: 'Safe Food for Everyone (SaFE) - SBIR XL' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234XL-01 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Weapons, Information Systems OBJECTIVE: The goal of SaFE is to develop practical; low-cost; small size, weight, and power; non-isotopic sources for food irradiation and other applications requiring pathogen sterilization, supporting ubiquitous treatment at points of production and points of distribution, particularly in austere or compromised environments (e.g., expeditionary operations, humanitarian relief, or disaster response). DESCRIPTION: This SBIR XL topic will focus on the development of compact, low-cost, high efficiency, and economically viable electron accelerator systems. The topic is composed of two linked subtopics: Subtopic 1 will develop accelerator technology, and Subtopic 2 will focus on distributed system designs and pilot demonstrations. Accelerators developed as part of the first subtopic will be capable of generating continuous, high current electron beams at 2 to 10 MeV energies using 10 kW electric sources. 10 kW generators are commonly used in deployed support operations such as those found in containerized kitchens. Specifically, this subtopic will explore recent innovations resulting in accelerator designs that can be produced for tens of thousands of dollars compared to millions of dollars for traditional high power accelerators such as Rhodotrons and S-band LINACs, while being suitable for new distributed system architectures. High-gradient direct current (DC) accelerator structures, novel voltage multiplier designs, and new innovations in dielectric materials may provide viable technical approaches. Further, new solid state amplifiers could provide a potential path for radiofrequency (RF) approaches. Such configurations could present the highest potential for compact, low-cost, high wall-plug efficiency accelerator designs. The second subtopic, system studies, will initially focus on two use cases: (1) a single 10 kW system for deployed or austere environments and (2) multiple distributed 10 kW systems for point of packaging applications. Subtopic 2 performers will conduct detailed economic analysis including capital costs and operations and maintenance costs. The analysis will define minimum viable product and systems characteristics that can be economically produced and address the maximum number of applications for wide-spread use while still achieving treatment and throughput requirements. Further, practical issues such as radiation shielding, automation, and regulatory concerns will be addressed. These analyses will be informed by strong food industry, U.S. Army Natick Soldier Center, Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) engagements. Systems work will culminate in a proof-of-concept pilot demonstration of the specific subtopic accelerator technology. Such a demonstration aims to establish broader adoption of food irradiation and enhance food safety and security for both deployed and domestic applications. In addition, secondary applications such as sterilization and remediation will be examined. It is envisioned that between the two subtopics, technical, economic, and regulatory hurdles currently hindering food irradiation adoption will be fully addressed. This, in turn, will jumpstart commercial activity in this sector leading to viable products, new industrial development, and overall greater food safety and security. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. There is no Phase I; however, proposers must provide evidence of approach feasibility with results at a level commensurate with the conclusion of a Phase I effort. Examples of such evidence are included below for each subtopic. Proposers to Subtopic 1 are required to provide documentation outlining success in high efficiency accelerator component technologies. Achievements must be substantial. For example, a key component for a DC accelerator could be a Cockroft-Walton voltage ladder. Such a ladder showing 1 MV and an efficiency of >70% into a representative load would be considered sufficient. Proposers to Subtopic 2 are required to provide documentation outlining success in prior end-to-end system design, demonstration of hands-on work with analogous technologies (including core competencies with accelerator technologies), and experience working with regulatory agencies – specifically the FDA and state regulatory bodies for machine-produced radiation sources. PHASE II: SaFE is composed of two linked subtopics over an anticipated 3-year period of performance. The period of performance is divided into a 12-month base and two 12-month option periods. Proposers may apply to one or both subtopics. Subtopic 1: Accelerator technology development. The overall goal of Subtopic 1 is to produce and demonstrate a turn-key high efficiency, low cost, reasonably compact, irradiation accelerator prototype at technology readiness level 6 with the following characteristics: Parameter Threshold Objective Tunable electron energy range (MeV) 2-5 2-10 Max x-ray energy (MeV) 5 7.5 Wall plug efficiency (Pbeam/Pwall) > 0.3 > 0.7 Unit cost ($) < $100,000 < $50,000 The accelerator must make use of 10 kW electric generator output such as 120V@100A or 208V@50A. The complete, turn-key system including controls, accelerator, RF generation (if appropriate), shielding, beam steering, and target must be compatible with a single 463L pallet. Additional suitability metrics include a removable x-ray converter (such as tantalum) to support x-ray production, continuous or near continuous operation, and targets compatible with conveyer-based operations. The 12-month base period will focus on accelerator design, modeling, and component development. The design will progress through typical processes including a system requirements review, preliminary design review, and a critical design review. Components will be developed and tested supporting the overall accelerator design. Base period (12 month) milestones: • Month 1: Kickoff materials. Slide deck summarizing technical approach to meet overall goals, risks, and risk mitigations and quantified milestone schedule • Month 3: System Requirements Review • Month 6: Preliminary Design Review • Month 12: Critical Design Review During the 12-month Option 1 period, components will be refined and integrated into a prototype system. This system will be tested to verify performance and ultimately used in Subtopic 2’s pilot system demonstration. Option 1 period (12 month) milestones: • Month 6: Complete Accelerator Prototype • Month 9: Test and Eval of Prototype • Month 10: X-ray Target Assessment • Month 12: Integrated T&E of Prototype During the 12-month Option 2 period, support will be provided to Subtopic 2’s pilot system demonstration and the accelerator will be further refined to a minimum viable product using feedback from Subtopic 2. Option 2 period (12 month) milestones: • Month 6: Accelerator Integration Report • Month 12: Final Accelerator and System Design Monthly written technical progress reports will supplement the above milestones (see template under SBIR/STTR BAA DOCUMENTS at https://www.darpa.mil/work-with-us/for-small-businesses/participate-sbir-sttr-program). Subtopic 1 performers are expected to collaborate with subtopic 2 performers in this program. Subtopic 2: Irradiation system design and proof-of-concept pilot demonstration Subtopic 2 will complete system studies for two use cases using the accelerator technology of Subtopic 1. As mentioned above, the first use case will examine operation in deployed or austere environments. Food-based logistical support aims to feed 300 troops from mobilized trailers or 800 troops from containerized kitchens. About 32 lbs. of food supplies (including packaging) are needed per troop per week. This is about 2 kg/day at an average density of ~0.5 g/cc. Detailed modeling and analysis will be carried out on various objects and package configurations, and optimization studies will be conducted to provide effective treatment per object at maximum throughput. In addition, Monte Carlo analysis will be used to study radiation shielding. Such shielding could make use of supplied or indigenous materials or combinations of both to minimize size and weight. Handling systems will also be developed and included in the design studies. Metrics for this use case are described in the table below. Parameter Threshold Objective Size and weight (463L pallets) < 2 < 1 Throughput (kg/hr) > 50 > 180 Dose/item (kGy) > 0.4 > 1 Dose uniformity ratio < 2.5 < 1.4 Size and weight metrics include the full accelerator of Subtopic 1. Object and packaging details as well as feedback on aspects of practical system suitability are anticipated through discussions with performer(s) and DoD stakeholders during the base period. The second system study will examine using the accelerator of Subtopic 1 in a distributed architecture at the point of packaging. Perishable food such as lettuce or ground beef and associated packaging will be analyzed. Detailed technical analysis, economic analysis, and commercialization plans for the system will be completed with the goal of minimizing overall system costs. The specific use case will be proposed by the performer. Metrics for this use case are described in the table below. Parameter Threshold Objective Throughput (kg/hr) > 1,000 > 3,600 Dose (kGy) > 0.4 > 1 Dose uniformity ratio < 2.5 < 1.4 In addition to system studies, Subtopic 2 will develop and demonstrate a proof of concept pilot for both of the use cases described above. This includes addressing all regulatory requirements and potentially crafting petitions to regulatory bodies describing the specific needs of distributed systems. The 12-month base period will focus on separate design studies for the use cases described above and progress through typical design review elements, including a system requirements review and preliminary design review. In addition, all relevant regulations will be identified. Base period (12 month) milestones: • Month 1: Kickoff materials. Slide deck summarizing approaches to meet overall goals, risks, and risk mitigations and quantified milestone schedule • Month 3: System Requirements Review • Month 9: Preliminary Design Review • Month 12: Final base period report and design update During the 12-month Option 1 period, systems will be refined through a critical design review. A minimum viable product will be defined for the accelerator system of Subtopic 1. Pilot plans will be progressed and address all regulations. Option 1 period (12 month) milestones: • Month 3: 1) Critical Design Review, including summary of minimum viable product findings for accelerator technology, and 2) Preliminary pilot plan • Month 6: Interim pilot plan • Month 12: Final pilot plan During the 12-month Option 2 period, the accelerator from Subtopic 1 will be used to complete a concept pilot demonstration. Option 2 period (12 month) milestones: Month 3: Initial pilot operation report Month 6: Interim pilot operation report Month 12: Final pilot operation report Monthly written technical progress reports will supplement the above milestones (see template under SBIR/STTR BAA DOCUMENTS at https://www.darpa.mil/work-with-us/for-small-businesses/participate-sbir-sttr-program). Subtopic 1 and 2 are linked. Monthly coordination meetings between the teams are anticipated to facilitate communication and successful completion of overall program goals. PHASE III DUAL USE APPLICATIONS: While the U.S. food supply is among the safest in the world, the FDA estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. More significantly, the USDA estimates that food waste is between 30 and 40 percent of the U.S. food supply, with spoilage being a significant contributor. Based on estimates from USDA’s Economic Research Service of 31 percent food loss at the retail and consumer levels, this corresponded to approximately 133 billion pounds and $161 billion worth of food in 2010. Globally, about 1.4 billion tons of food is wasted every year. From a food security perspective, the U.S. imports 94% of its seafood, 55% of fruit, and 32% of vegetables, while the FDA is only able to inspect 1-2% of these foodstuffs. Lastly, there is a need to treat food for improved safety and stability during expeditionary operations or in environments where food quality may be compromised, such as in disaster response or humanitarian relief operations. Development of “in-house,” port-of-entry, or expeditionary irradiation capabilities would provide a new means to avoid or significantly improve these food safety and waste issues. For food safety applications, the availability of in-house technologies will help reduce and control costs, provide greater flexibility in managing inventory, facilitate new product formulations, protect against supply chain disruption, and decrease the impact of waste management. Being able to cold pasteurize food at points of production, import, or distribution and in austere environments could present a transformational ability to improve food safety and security and reduce the threat from natural, accidental, or intentional food contamination. Further, these sources could also be used for a range of other applications. For example, low-cost e-beam technology can be employed to remediate urgently needed capabilities to degrade per– and polyfluoroalkyl substances (PFAS) in groundwater and soils. In-situ sterilization of medical devices is a further need for such sources. Overall, advancement in improving food safety, availability, and security could have global impacts and significantly advance U.S. national security agendas. By enabling safe and secure food supplies in underdeveloped countries, there are new opportunities for the U.S. to provide additional stability in these regimes. Successful proposals for this SBIR offering must make significant arguments supporting the commercial viability of their approach. Hence, proposals to Subtopic 1 must provide initial evidence that their technical approach will allow accelerator structures that are much lower cost to produce (>10-100x) and operate (>10x) than traditional accelerator systems such as S-band LINACs and rhodotrons, while still achieving required beam powers for high throughput food treatment. Proposals for Subtopic 2 must make arguments that, should the above accelerator technology be available, it would enable highly economic treatment of foodstuffs at points of production/packaging and ports of entry. Transition and commercialization (T-C) milestones have been added as part of the option phases to aid in assuring commercial viability. REFERENCES: 1. https://www.aiche.org/resources/publications/cep/2016/november/introduction-electron-beam-food-irradiation 2. https://www.armytimes.com/news/your-army/2019/10/07/the-plan-to-give-soldiers-a-days-worth-of-mres-in-one-ration-seven-days-of-food-weighing-less-than-10-pounds/ 3. https://www.fda.gov/food/consumers/what-you-need-know-about-foodborne-illnesses# 4. https://www.usda.gov/foodwaste/faqs# 5. https://www.rts.com/resources/guides/food-waste-america/ 6. https://www.ers.usda.gov/amber-waves/2022/february/india-and-mexico-top-sources-of-pathogen-based-u-s-food-import-refusals/ 7. https://doi.org/10.1016/j.radphyschem.2021.109705 8. https://www.osti.gov/servlets/purl/1774110 KEYWORDS: Food irradiation, cold pasteurization, medical sterilization, x-rays, linear accelerators, radiation dose sbir_topic_link: https://www.sbir.gov/node/2414713 subtopics: [ ] - topic_title: Deuce Coupe branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-07 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing & Cyber, Trusted AI & Autonomy OBJECTIVE: To address supply chain shortages by providing a fast, reliable, and widely-available capability to identify, appraise, and extract valuable mechanical and electronic components from scrapped or damaged systems, for reuse in functioning systems [1-3]. DESCRIPTION: Mechanical parts recycling, and electronic waste (e-waste) reuse falls into two broad categories. The first is the recovery of valuable materials such as aluminum, steel, gold, rare earths, and lithium. This is a high-volume bulk process where the high-value manufactured components are systematically reduced to raw material [4]. The second broad category is ad-hoc recovery through junkyards and scrap-picking. In this case, experts look through the scrap and select the parts needed—a labor-intensive process that does not scale. The experts have (1) the skills to understand which parts are needed [5], (2) an encyclopedic knowledge of which systems have the needed part and where it is in the system, (3) the ability to assess whether the scrapped part appears to be functional, and (4) the expertise to safely extract the needed part [6]. Today, each of these steps requires substantial knowledge of potential donor systems. Given the plethora of donor systems (cars, trucks, phones, computers, printers) now available, and the broad understanding of available components and means of extraction, the potential utility of harvesting this vast pool of high-value resources is far above what can be done today by human experts [7]. Note: please see DARPA SBIR 23.4 - Release 4 under the DoD STTR 23.4 Annual BAA at https://www.defensesbirsttr.mil/SBIR-STTR/Opportunities/ for DARPA proposal instructions, to include duration and funding information for this topic. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. In a Deuce Coupe environment, operators equipped with high-end cell phones would be given search lists and then cued to look for the sources of needed components. Based on information from service manuals, shop manuals, disassembly information, and related sources [8], Deuce Coupe-developed software would use image-feature extraction, natural language processing, and knowledge of physical dynamics to identify systems containing the necessary components [9]. When a candidate donor system is identified, the operator is then cued as to where to find the material within the system [10, 11]. Feasibility requirements firms must meet to be considered for a Phase II award: • Ability to create the models and structures needed to identify embedded material • Capability to capture information from sensors to feed the inventory of material Success criteria for Phase I: Identification of the components needed. In Phase I, the identification will not require a pass/fail for the component [12]. PHASE II: During Phase II, Deuce Coupe will use the sensors on the phone to evaluate the state of the identified components or sub-assemblies [3, 13]. A highly-skilled mechanic or technician can examine the appearance, color, and shape of parts and subsystems and then rapidly assess the part’s condition and suitability for reuse [2, 14]. Phase II Milestones (Base): • Month 4: Demonstration of an automated, functioning workflow to take an operator from parts ingestion though populating a s design system component library • Month 7: Capability to ingest and identify junked systems (e.g. car, truck) and provide sufficient metadata to be able to access the parts database systems • Month 10: Capability to provide information on the available parts from the junked systems based on sensor input and synthesis of the metadata on the system (e.g. shop manual) Phase II Milestones (Option): • Month 5: Ability to assess the utility of a part based on sensor data and evaluate its capacity for reuse • Month 6: Capability to advise on preferential reuse of parts based on assessed utility of the part and information in available metadata Success criteria for Phase II: the components are to be identified with a reliability indicator that is accurate 80% of the time for P(working) and 90% of the time for P(failure). PHASE III DUAL USE APPLICATIONS: Scale up to provide efficient and local resupply, measuring the ability to keep a greater quantity of systems in the field for longer periods of time, while simultaneously increasing confidence levels for systems’ operational capabilities. Expand the range of sourcing possibilities for parts and subsystems, thus allowing otherwise-incapacitated systems to be made available for operation. REFERENCES: 1. J. Aitken and A. Murray, "Crash repair in the UK: reusing salvaged parts in car repair centres," International Journal of Logistics: Research and Applications, vol. 13, no. 5, pp. 359-372, 2010. 2. O. Akinade et al., "Design for deconstruction using a circular economy approach: Barriers and strategies for improvement," Production Planning & Control, vol. 31, no. 10, pp. 829-840, 2020. 3. A. A. Dubey and J. Adhikari, "Design and development of smart junkyard system based on machine learning," International Research Journal of Modernization in Engineering Technology and Science, vol. 4, no. 6, 2022. 4. S. S. Sawyer-Beaulieu, J. A. Stagner, and E. K. Tam, "Sustainability issues affecting the successful management and recycling of end-of-life vehicles in Canada and the United States," in Environmental issues in automotive industry: Springer, 2014, pp. 223-245. 5. A. K. Parlikad and D. McFarlane, "Quantifying the impact of AIDC technologies for vehicle component recovery," Computers & Industrial Engineering, vol. 59, no. 2, pp. 296-307, 2010. 6. P. Thongkaow, T. Prueksasit, and W. Siriwong, "Quantification and characterization of recovered materials in the cycle of the informal household electronic waste dismantling in Buriram province, Thailand: A challenge towards sustainable management and circular economy," Waste Management & Research, vol. 40, no. 12, pp. 1766-1776, 2022. 7. T. A. Kurniawan et al., "Transformation of solid waste management in China: moving towards sustainability through digitalization-based circular economy," Sustainability, vol. 14, no. 4, p. 2374, 2022. 8. D. Page, A. Koschan, and M. Abidi, "Methodologies and techniques for reverse engineering–the potential for automation with 3-d laser scanners," in Reverse Engineering: Springer, 2008, pp. 11-32. 9. M. Ghoreishi and A. Happonen, "Key enablers for deploying artificial intelligence for circular economy embracing sustainable product design: Three case studies," in AIP conference proceedings, 2020, vol. 2233, no. 1: AIP Publishing LLC, p. 050008. 10. P. Haribabu, S. R. Kassa, J. Nagaraju, R. Karthik, N. Shirisha, and M. Anila, "Implementation of an smart waste management system using IoT," in 2017 International Conference on Intelligent Sustainable Systems (ICISS), 2017: IEEE, pp. 1155-1156. 11. S. Keivanpour, D. Ait Kadi, and C. Mascle, "End-of-life aircraft treatment in the context of sustainable development, lean management, and global business," International Journal of Sustainable Transportation, vol. 11, no. 5, pp. 357-380, 2017. 12. C. A. Zimring, "The complex environmental legacy of the automobile shredder," Technology and culture, vol. 52, no. 3, pp. 523-547, 2011. 13. E. Williams et al., "Towards the development of junkyard hacks: networked robotics applications," in 31st Florida Conference on Recent Advances in Robotics, 2018. 14. F. Elghaish, S. T. Matarneh, D. J. Edwards, F. P. Rahimian, H. El-Gohary, and O. Ejohwomu, "Applications of Industry 4.0 digital technologies towards a construction circular economy: gap analysis and conceptual framework," Construction Innovation, no. ahead-of-print, 2022. KEYWORDS: Supply Chain, Sustainability, Resilience, Machine Reasoning, Automatic decomposition of system-of-systems, Automatic assessment of system wear, Part reuse, Machine vision, Mobile applications sbir_topic_link: https://www.sbir.gov/node/2414715 subtopics: [ ] - topic_title: > Empirical Proving Ground for Cryptographic Engineering Challenges in Large-scale Deployments (EPiC EagLe) – SBIR XL branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234XL-02 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software, Integrated Network Systems-of-Systems, Quantum Science The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws. OBJECTIVE: The Empirical Proving Ground for Cryptographic Engineering Challenges in Large-scale Deployments (EPiC EagLe) effort will develop sound state-of-the-art experimental methodologies and operational benchmarks for evaluating distributed trust solutions such as: 1) modifications of existing Public Key Infrastructures (PKIs) and Key Management Infrastructures (KMIs) to recover from loss-of-trust events at Internet scale, 2) hybrid PKIs that add novel delegation and transient trust protocols, and 3) novel designs of PKIs and KMIs for networks with special link, bandwidth, and latency requirements and constraints, such as connected battlespaces. This effort will demonstrate the capability to evaluate such solutions, at scale, exceeding traditional methodologies’ ability to assess the Internet’s commercial PKI’s and Internet-of-Things (IoT) scales. DESCRIPTION: This effort will develop sound state-of-the-art experimental methodologies and operational benchmarks for evaluating distributed trust solutions and demonstrate the capability of evaluating such solutions, at scale, exceeding traditional methodologies’ ability to assess the Internet’s commercial PKI’s and IoT’s scales. Innovative approaches should address the experimental methodology for evaluating implementations of distributed trust schemes—or modifications of existing schemes, such as those focused on recovery—at large scales, under realistic connectivity (or intermittent connectivity) constraints, along with the required simulation framework, metrics of success, assessment methods, and integration of solutions into robust, real-time cyber defense capabilities of interest to the DoD. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. The Phase I feasibility study shall include the documentation of a basic distributed trust evaluation prototype consisting of the software code and hardware capabilities that are capable of experimenting with Research & Development (R&D) concepts of Tactical Certificate Authorities (CAs) that employ flexible policies, extensions, and protocols for battlefield use. Proposers interested in submitting a Direct to Phase II (DP2) proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above has been met and supports relevant military and/or commercial applications. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. For detailed information on DP2 requirements and eligibility, please refer to Appendix B of the DARPA Instructions for DoD BAA 2023.4. PHASE II: Phase II shall produce system design, implementation, and maintenance capabilities to significantly advance the state of the art in PKI scaling challenges for IoT and IoT-like battlespace uses. In today’s Internet PKIs, simple loss-of-trust events such as an expiring PKI certificate led to massive outages of national telecom providers, major cloud computing services, and even critical transportation systems, with no effective automated means of timely recovery [1, 4-7]. Such outages, although indirect to the DoD, are likely to create major challenges for DoD operations. There currently are limited scalable capabilities for recovering from loss-of-trust events such as expiration of trusted certificates, expiry of root-of-trust certificates, or compromises of such certificates or PKI subsystems. Despite the “impending doom” of multiple Internet Root-of-Trust certificates approaching their expiry dates [2], the Internet PKI and IoT trust technologies lack well-designed technological fallbacks for recovery. When proposed, such technological fallbacks cannot be comprehensively evaluated without creating major deployments at representative scales, which are cost-prohibitive. Today, the DoD lacks the capability to experimentally test proposed distributed trust solutions at DoD-relevant scales. Although simulation technologies such as OPNET facilitate introductory training in DoD encryption protocols (e.g., [8]) and limited experimentation with proposed replacements of inefficient key management systems (e.g., [9]), these systems are limited in scale, and cannot be extended to simulate the behaviors of millions or hundreds of millions of nodes. This stymies the Government’s abilities to pose cryptographic engineering challenges and to evaluate proposed solutions. Today, our understanding of (rare) successful recovery derives from a few actual loss-of-trust events such as expiration of the trusted intermediate CA certificate of the Mozilla Firefox browser, which lead to worldwide deactivation of Firefox plugins (including critical security plugins). Mozilla recovered from this near-catastrophic event via an ad hoc manipulation of the certificates’ trust paths, made possible by a serendipitous feature of the browser’s trust chain validation implementation and ad hoc manipulation of the browser key store [1]. The two features that serendipitously enabled this recovery effort were used in ways not intended by their original design and not considered before the outage. Today, there exists no rigorous sets of metrics, models, or simulations to discuss scalability requirements of trust management solutions such as hierarchical PKIs or any hybrid schemes. There is strong anecdotal evidence from industry that PKI and key management problems at scale create non-trivial operational surprises. However, lack of a common framework for evaluating research in distributed trust solutions at scale stymies progress. In particular, the challenges of recovering from loss-of-trust events or of migrating authority on a large scale have not been formalized at all, despite their increasing practical importance. Phase II will create an experimental methodology for evaluating implementations of distributed trust schemes - or modifications of existing schemes, such as those focused on recovery - at large scales, under realistic connectivity (or intermittent connectivity) constraints. This methodology shall employ novel lightweight virtualization approaches to create simulation approaches that allow simulating relevant behaviors of up to hundreds of millions of nodes, with realistic link topologies and models. The new architectural approach to simulation shall faithfully emulate small relevant code segments of implementations under test, while aggressively aggregating non-relevant aspects of node and network behaviors. These methodologies and simulation tools will help pose and answer operational questions about distributed trust, including introduction of new features into PKIs and KMIs, and allow creation of meaningful operational benchmarks for trust engineering. For example, they will create the capability to experimentally test in simulation whether a trust scheme is likely to perform a given mix of operations on a given scale, under given connectivity constraints, and to pose challenges for cryptographic engineering in terms of such scale benchmarks. The methodology shall enable the study of principled loss-of-trust recovery methods based on distributed graph algorithms, such as trust path manipulations generalizing the ad hoc Firefox recovery example. Furthermore, the methodology will allow exploration of scenarios that involve migration of the root-of-trust, which become increasingly important with the ageing of IoT roots of trust, and threats of wide-spread compromises of trusted boot chains (cf. [3]). Finally, a principled simulation framework will enable not only stochastic simulation experiments but, with modifications, will support sound reasoning about protocol properties under probabilistic network models. EPiC EagLe will leverage formal reasoning, simulation, and modern cryptographic primitives to develop the first of its kind PKI frameworks that can recover from emergent loss of trust events. Successful offerors in their proposals will demonstrate a strong understanding of the technology area and they will articulate a compelling necessity for S&T funding to support their respective proposed technology approaches over existing capabilities. Schedule/Milestones/Deliverables Phase II fixed payable milestones for this program shall include: • Month 2: New Capabilities Report, that identifies additions and modifications that will be researched, developed, and customized for incorporation in the pilot demonstration. • Month 4: PI meeting presentation material, including demonstration of progress to date, PowerPoint presentations of accomplishments and plans. • Month 6: Demonstration Plan that identifies schedule, location, computing resources, and any other requirements for the pilot demonstration. • Month 9: Initial demonstration of stand-alone pilot application to DARPA; identification of military transition partner(s) and other interested DoD organizations • Month 12: PI meeting presentation material, including demonstration of progress to date, PowerPoint presentations of accomplishments and plans. • Month 15: Demonstration to military transition partners (s) and other DoD organizations. • Month 18: PI meeting presentation material, including demonstration of progress to date, PowerPoint presentations of accomplishments and plans. • Month 21: PI meeting presentation material, including demonstration of progress to date, PowerPoint presentations of accomplishments and plans. • Month 24: Final software and/or hardware delivery, both object and source code, for operation by DARPA or other Government personnel for additional demonstrations, with suitable documentation in a contractor proposed format. Deliver a Final Report, including quantitative metrics on decision making benefits, costs, risks, and schedule for implementation of a full prototype capability based on the pilot demonstration, along with the novel designs of PKIs and KMIs for networks with special link, bandwidth, and latency requirements and constraints. This report shall include an identification of estimated level of effort to integrate the pilot capability into an operational environment, addressing computing infrastructure and environment, decision making processes, real-time and archival data sources, maintenance and updating needs; reliability, sensitivity, and uncertainty quantification; and transferability to other military users and problems. The report shall also document any scientific advances that have been achieved under the program. (A brief statement of claims supplemented by publication material will meet this requirement.) Provide Final PI meeting presentation material. Phase II Option: The option shall address preliminary steps toward the certification, accreditation and/or verification of the resulting base effort's sound experimental methodologies and operational benchmarks for evaluating distributed trust solutions. Proposed solutions shall include a summary of how the methodologies are likely to succeed on DoD and IoT scales and under link, bandwidth, and latency constraints specific to DoD environments and missions. Schedule/Milestones/Deliverables for Phase II Option: Phase II fixed payable milestones for this program option shall include: • Month 2: Plan that identifies the schedule, location, computing resources and/or any other requirements for the experimental methodologies and operational benchmarks and infrastructure for evaluating distributed trust solutions required for transition to the DoD. • Month 4: Presentation on the detailed software and hardware plan for the technical capability. • Month 7: Interim report on progress toward certification, accreditation and/or verification of the technical capability for DoD use. • Month 10: Review and/or demonstration of the prototype capability with the documentation supporting certification, accreditation and/or verification. • Month 12: Final Phase II option report summarizing the certification, accreditation and/or verification approach, architecture and algorithms; data sets; results; performance characterization and quantification of robustness. PHASE III DUAL USE APPLICATIONS: The DoD and the commercial world have similar challenges with respect to maintaining the cyber integrity of their computing and communications infrastructure. The Phase III effort will see the developed methodology and testbed transitioned into a DoD cyber environment capable of testing large-scale software deployments (including distributed trust software) in simulations consisting of virtual machines (VMs), up to tens of thousands of emulated nodes. Government ranges and commercial systems such as national telecom providers, major cloud computing services, and critical transportation systems have similar challenges in their PKI and KMI infrastructures and face severe scaling challenges for IoT and IoT-like battlespace uses. Thus, the resulting methodology and operational benchmarks are directly transitionable to both the DoD and the commercial sectors: military and commercial air, sea, space and ground communication systems; commercial hardening of critical industrial plant (i.e. control systems, manufacturing lines, chemical processes, etc.) through PKI and KMI infrastructures; securing cloud infrastructure associated with optimization of industrial processes and condition-based maintenance of air, sea, space and ground networked communication systems. As part of Phase III, the developed capability should be transitioned into an enterprise level system that can be used to test large-scale software deployments (including distributed trust software) in simulations consisting of virtual machines (VMs), up to tens of thousands of emulated nodes. The resulting capability is directly transitionable to the Army, the Air Force, the Navy, and the National Security Agency for experimenting with Research & Development (R&D) concepts of Tactical Certificate Authorities (CAs) that employ flexible policies, extensions, and protocols for battlefield use. This is a dual-use technology that applies to both military and commercial software environments affected by cyber adversaries. REFERENCES: 1. Eric Rescorla, Technical Details on the Recent Firefox Add-on Outage, https://hacks.mozilla.org/2019/05/technical-details-on-the-recent-firefox-add-on-outage/ 2. Scott Helme, The Impending Doom of Expiring Root CAs and Legacy Clients, https://scotthelme.co.uk/impending-doom-root-ca-expiring-legacy-clients/ 3. Mark Ermolov, Intel x86 Root of Trust: loss of trust, http://blog.ptsecurity.com/2020/03/intelx86-root-of-trust-loss-of-trust.html 4. Corinne Reichert, Ericsson: Expired certificate caused O2 and SoftBank outages, https://www.zdnet.com/article/ericsson-expired-certificate-caused-o2-and-softbank-outages/, 2018 5. John Ribeiro, Microsoft's Azure service hit by expired SSL certificate, https://www.computerworld.com/article/2495453/microsoft-s-azure-service-hit-by-expired-ssl-certificate.html, 2013 6. Dennis Fisher, Final Report on DigiNotar Hack Shows Total Compromise of CA Servers, https://threatpost.com/final-report-diginotar-hack-shows-total-compromise-ca-servers-103112/77170/, 2012 7. Nihal Krishan, Internet goes down for millions, tech companies scramble as key encryption service, expires, https://www.yahoo.com/now/internet-goes-down-millions-tech-021400230.html, 2021 8. Tae H. Oh et al., Teaching High-Assurance Internet Protocol Encryption (HAIPE) Using OPNET Modeler Simulation Tool, SIGITE’09, https://dl.acm.org/doi/pdf/10.1145/1631728.1631771, 2009 9. J. Liu, X. Tong et al., A Centralized Key Management Scheme Based on McEliece PKC for Space Network, IEEE Access, vol. 8, pp. 42708-42719, 2020, doi: 10.1109/ACCESS.2020.2976753. KEYWORDS: Battlespace Environments, Information Systems Technology, Public Key Infrastructures sbir_topic_link: https://www.sbir.gov/node/2414717 subtopics: [ ] - topic_title: 2D Polyglots branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-08 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced computing and software The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws. OBJECTIVE: Develop polyglots (dual embedded formats) for existing 2-dimensional codes (e.g., QR codes) that enable high-bandwidth, secure data transfer. Assess potential security vulnerabilities in polyglot approaches. DESCRIPTION: DoD employees are interacting with physical-cyber data transfers at an ever-increasing rate; simply walking through an airport might require scanning 2-dimensional (2D) codes numerous times to receive basic goods and services, such as food menus and flight boarding passes. One of the most prevalent types of 2D codes is Quick Response (QR) code originating in 1994 from a Japanese automotive company. With the widespread adoption of mobile phones, QR codes have become a standard to store and transfer data in a physical format. The convenience that QR codes provide comes with certain limitations, such as the amount of data it can store and a balance between usability and security. 2D codes (e.g., QR codes, Data Matrix, MaxiCode, PDF417) are designed and optimized for a specific task; for example, data matrix codes used by shipping are fast to scan, however they only store 1.55kb of data as compared to 3kb for QR v4. 2D codes are often represented pictographically as part of printed media, such as a menu in a restaurant. They have low data density as a result of error correction and robustness to environmental effects (e.g., scratches). To increase the data density, preserve the inherent optimizations of each format, and ensure backwards compatibility, this study will investigate combining formats into 2D polyglots. In this context, a polyglot is a format that is valid in multiple computer programs. Polyglots are possible by combining two or more formats, each of which are able to be interpreted by multiple programs as having a valid format, for example, a file which is both a picture and a PowerPoint presentation. This study will investigate the effects that 2D polyglots have in QR codes and their potential to reduce the attack surface and increase data density. A basis of confidence that polyglots can exist in 2D codes is the known, trivial case of a 2D code imbedded in another 2D code [D14]. For more than a decade it has been widely known that current 2D codes have inherent vulnerabilities [D15, F19, K10]. Usability was heavily favored over security in the design of these codes. This imbalance led to a widely adopted standard with pervasive vulnerabilities. Attacks can take advantage of error correction algorithms and data sparsity to exploit 2D formatting assumptions and the inconsistences which software makes when interpreting a 2D code. For example, standard QR codes have orientation markers and data is only parsed in one direction; polyglot QR codes can contain multiple, non-conflicting formats that can be read independently based on approach direction.Finally, to ensure current systems and software can still be used, any enhancements to the SOTA must also be backwards compatible. Introducing new software and standards would inevitably have new and possibly unintended effects on security and efficiency. PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above have been met and describe the potential commercial applications. DP2 documentation should include: • Technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, and risks/mitigations, and assessments; • Presentation materials and/or white papers; • Technical papers; • Test and measurement data; • Prototype designs/models; • Performance projections, goals, or results in different use cases; and, • Documentation of related topics such as how the proposed SUP solution can enable more realistic cyber training. This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and ability in networking, computer science, mathematics, and software engineering. For detailed information on DP2 requirements and eligibility, please refer to the DoD BAA and the DARPA Instructions for this topic. PHASE II: The goal of 2D Polyglots is to develop a QR code that can hold more data while maintaining backwards compatibility and to identify vulnerabilities present in current 2D codes.DP2 proposals should propose a research design to achieve the following goals: • Develop a protype system to demonstrate feasibility for producing 2D polyglots in a platform independent language (e.g., python 3.0, Golang); • Identify vulnerabilities and possible mitigations in 2D and 2D polyglot codes; • Detail a test plan, complete with proposed metrics and scope, for verification and validation of the system performance. Phase II will culminate in a system demonstration using one or more compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II effort. • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) (in person or virtual, as needed) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 3, 4, 5: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (while this will normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 6: Interim technical progress briefing (with annotated slides) to the DARPA PM (in-person or virtual as needed) detailing progress made (include quantitative assessment of capability developed to date), tasks accomplished, major risks/mitigations, planned activities, and technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 7, 8, 9: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 10/Final Phase II Deliverables: Final architecture with documented details, demonstrating diagnosing a malicious activity and unauthorized modification on software/hardware; documented application programming interfaces; any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the end of phase commercialization plan). PHASE III DUAL USE APPLICATIONS: The Phase III work will be oriented towards transition and commercialization of the developed 2-D Polyglots technologies. The proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype software into a viable product or non-R&D service for sale in military or private sector markets. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Outcomes have the potential to significantly benefit the DoD and numerous commercial entities by improving knowledge of 2D codes including capabilities and vulnerabilities. Specifically, in the DoD space, 2D Polyglots technologies will be able to provide new data transfer methods utilizing 2D codes and highlight any potential vulnerabilities in current 2D codes used across the DoD enterprise. The development of polyglot technologies will have security benefits across the defense industrial base (DIB). REFERENCES: 1. Dabrowski, A., Krombholz, K., Ullrich, J. and Weippl, E.R., 2014, November. QR inception: Barcode-in-barcode attacks. In Proceedings of the 4th ACM workshop on security and privacy in smartphones & mobile devices (pp. 3-10). 2. Dabrowski, A., Echizen, I. and Weippl, E.R., 2015, May. Error-correcting codes as source for decoding ambiguity. In 2015 IEEE Security and Privacy Workshops (pp. 99-105). IEEE. 3. Kieseberg, P., Leithner, M., Mulazzani, M., Munroe, L., Schrittwieser, S., Sinha, M. and Weippl, E., 2010, November. QR code security. In Proceedings of the 8th International Conference on Advances in Mobile Computing and Multimedia (pp. 430-435). 4. Focardi, R., Luccio, F.L. and Wahsheh, H.A., 2019. Usable security for QR code. Journal of Information Security and Applications, 48, p.102369. KEYWORDS: Information assurance, computing and software technology, electro-optical sensors, cybersecurity, authentication, confidentiality, QR codes, Data Matrix, PDF417, MaxiCode, and 2D codes. sbir_topic_link: https://www.sbir.gov/node/2414719 subtopics: [ ] - topic_title: > Passive Analytics for Remote Quantification of External Resources (PARQER) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-09 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber, Advanced computing and Software OBJECTIVE: The Passive Analytics for Remote Quantification of External Resources (PARQER) SBIR topic seeks to develop and demonstrate novel techniques to passively assess the security posture of remote networks/subnetworks, without requiring any special network accesses. DESCRIPTION: The near-constant stream of news reports on the compromise of systems and networks across government and commercial sectors reveals the challenges of securing large networks of systems with complicated topologies [1] [2] [3] [4]. The inherent asymmetry of effort required to defend an asset vs. effort to gain illicit access to an asset favors attackers that can spend as much time as necessary to locate vulnerable targets (e.g., a server that administrators neglected to patch [5], or a network configured with overly permissive firewall policies [6]). In such an environment where the attacker is advantaged, network administrators and security officers practice defense in depth [7] [8] by reducing the network attack surface and deploying an array of security mechanisms and technologies such as firewalls and intrusion detection/ prevention systems. The extent of an organization’s efforts to minimize network attack surfaces and deploy defensive mechanisms can be largely unknown (e.g., due to poor documentation), even to the organization itself [9]. Often and unfortunately, details about the deployed security mechanisms (or the lack thereof) are only made available after an organization’s network is compromised, and when forensic analysts conduct a postmortem of the attack [10] [11]. For the Department of Defense (DoD) and Intelligence Community (IC), the same problem exists and is compounded by the distinction between, and respective operational responsibilities of, network owners/operators and defenders such as Cybersecurity Service Provider (CSSPs) and Cyber Protection Teams (CPTs). Within the DoD/IC, CPTs are tasked with defending critical military networks; whereas CSSPs are responsible for the continuous monitoring and vulnerability patching of networks, and conducting threat-oriented missions to defeat cyber adversaries. [12] Similar to commercial organizations, critical details of network topology, configuration [13], and security posture [14] are often poorly documented and not immediately available to external responders (such as CPTs). An additional complicating factor of having network knowledge spread among different organizations and individuals (CPTs and CSSPs) is that it makes it difficult to have an accurate holistic picture of the security posture of lower-tier networks at any given time. It is therefore of critical importance for the DoD/IC and large commercial network owners to be able to quickly and passively assess the defensive posture of a remote network/subnetwork in a way that does not require any special access to the network. PHASE I: The PARQER SBIR topic is soliciting Direct to Phase II (DP2) proposals only, which must include supporting documentation of Phase 1 feasibility. Phase I feasibility must be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of system properties/technology capabilities desirable for DoD/IC/Government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include, at a minimum: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD/IC insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed PARQER solution can enable passive, remote assessment of network/subnetwork security posture. The collection of Phase I feasibility material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in the technical areas of software engineering, data analytics, network security, and cybersecurity. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The PARQER DP2 SBIR topic seeks to develop and demonstrate novel techniques to enable passive assessment of the security posture of remote networks/subnetworks, without requiring any special access to the network. Most current tools and techniques employed by security operations centers are based on active interrogation. The tools and techniques are often too noisy (e.g., high volumes of alerts and high false positive rates), do not generalize across security mechanisms (i.e., the tools are siloed), and have significant blind spots (e.g., false negatives). Ideal PARQER solutions would overcome such limitations of active techniques, as well as be resistant to intentional misdirection and evasion. PARQER solutions must have the ability to provably scale yet provide fine resolution of the analyzed network. Successful PARQER proposals should clearly describe how proposed combinations of data and analytic techniques will provide high accuracy results in a landscape of ever-evolving security products.Phase II will culminate in a prototype system demonstration using one or more compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program (e.g., Signature Management using Operational Knowledge and Environments (SMOKE), which seeks to develop data-driven tools to automate the planning and execution of threat-emulated cyber infrastructure needed for network security assessments). The Phase II Option period will further mature the technology for insertion into a DoD/Intelligence Community (IC) Acquisition Program, another Federal agency; or commercialization into the private sector. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II and Phase II Option period efforts. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation; • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM; • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM; • Months 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM; • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the passive assessment of the security posture of remote networks/subnetworks; documented APIs; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan); • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization; and, • Month 36 (Phase II Option period): Final Phase II Option period demonstration and technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics of system performance. PHASE III DUAL USE APPLICATIONS: Phase III Dual use applications (Commercial DoD/Military): PARQER has potential applicability across DoD/IC/Government and commercial entities. For DoD/IC/Government, PARQER is extremely well-suited to address one of the biggest issues in government information security today by providing the ability to quickly and passively assess the defensive posture of a remote network/subnetwork. PARQER has the same applicability for the commercial sector. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed PARQER technologies. For Phase III, the proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in government or private sector markets. Primary PARQER support will be to national efforts to help secure government and commercial networks. Results of PARQER are intended to improve the ability of network owners across government and industry to quickly find the root causes of network compromise incidents, and rapidly mitigate the situation, ultimately improving the security posture of their networks. REFERENCES: 1. PortSwigger. 2022. The Daily Swig, Cybersecurity News and Views. https://portswigger.net/daily-swig/data-breach 2. SecureLink. 2022. Recent Data Breaches in the News. https://www.securelink.com/resources/data-breach-news/ 3. Cybersecurity Ventures. 2022. Today’s Top Cybersecurity News Stories. https://cybersecurityventures.com/cybercrime-news/ 4. The New York times. “How a Cyberattack Plunged a Long Island County Into the 1990s.” 2022. https://www.nytimes.com/2022/11/28/nyregion/suffolk-county-cyber-attack.html 5. Robb, Drew. “Is Neglect Driving the Surge in Cybersecurity Breaches?” 2022. https://www.shrm.org/resourcesandtools/hr-topics/technology/pages/neglect-driving-surge-cybersecurity-breaches.aspx 6. Fugue. “A Technical Analysis of the Capital One Cloud Misconfiguration Breach.” 2019. https://www.fugue.co/blog/a-technical-analysis-of-the-capital-one-cloud-misconfiguration-breach 7. The Department of Homeland Security’s National Cybersecurity and Communications Integration Center and Industrial Control Systems Cyber Emergency Response Team. Recommended Practice: Improving Industrial Control System Cybersecurity with Defense-in-Depth Strategies. 2016. (Available at https://www.cisa.gov/uscert/sites/default/files/recommended_practices/NCCIC_ICS-CERT_Defense_in_Depth_2016_S508C.pdf) 8. National Security Agency. Defense in Depth: A practical strategy for achieving Information Assurance in today’s highly networked environments. 2010. (Available at https://citadel-information.com/wp-content/uploads/2010/12/nsa-defense-in-depth.pdf) 9. Burton, Dave. “The Dangers of Firewall Misconfigurations and How to Avoid Them.” 2020. https://www.akamai.com/blog/security/the-dangers-of-firewall-misconfigurations-and-how-to-avoid-them 10. Gartner. “Is the Cloud Secure?” 2019. https://www.gartner.com/smarterwithgartner/is-the-cloud-secure 11. Whittaker, Zack. “Equifax breach was ‘entirely preventable’ had it used basic security measures, says House report.” 2018. https://techcrunch.com/2018/12/10/equifax-breach-preventable-house-oversight-report/ 12. Joint Publication 3-12. Cyberspace Operations. 2018. Available at https://www.jcs.mil/Portals/36/Documents/Doctrine/pubs/jp3_12.pdf 13. Marius Musch, Robin Kirchner, Max Boll, and Martin Johns. 2022. Server-Side Browsers: Exploring the Web's Hidden Attack Surface. In Proceedings of the 2022 ACM on Asia Conference on Computer and Communications Security (ASIA CCS '22). Association for Computing Machinery, New York, NY, USA, 1168–1181. https://doi.org/10.1145/3488932.3517414. Available at https://loxo.ias.cs.tu-bs.de/papers/2022_AsiaCCS_SSBrowsers.pdf 14. Bo Lu, Xiaokuan Zhang, Ziman Ling, Yinqian Zhang, and Zhiqiang Lin. 2018. A Measurement Study of Authentication Rate-Limiting Mechanisms of Modern Websites. In Proceedings of the 34th Annual Computer Security Applications Conference (ACSAC '18). Association for Computing Machinery, New York, NY, USA, 89–100. https://doi.org/10.1145/3274694.3274714. Available at https://yinqian.org/papers/acsac18a.pdf KEYWORDS: network security, cybersecurity, defense in depth, passive network analytics sbir_topic_link: https://www.sbir.gov/node/2414723 subtopics: [ ] - topic_title: Assessing Virtual Private Network (VPN) Networthiness (AVN) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-10 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber, Advanced computing and Software OBJECTIVE: The Assessing Virtual Private Network (VPN) Networthiness (AVN) SBIR topic seeks to develop and demonstrate techniques and systems for automatically analyzing third-party commercial VPN solutions to determine the actual operational privacy profile/performance of such services. DESCRIPTION: Following the COVID-19 pandemic, and the concomitant increase in remote work, organizations and teleworkers sought solutions to keep their connections private and their workplace communications confidential. In other scenarios around the world, populations have sought private and secure solutions to circumvent restrictions on internet access placed on them by authoritarian regimes. It is therefore unsurprising that commercial VPN services have experienced substantial increases in demand over recent years [1, 2, 3]. The surge in VPN service demand has caused an increase in supply to the extent that (for example) the Google Play Store houses several hundred different apps that offer free (for examples, see [4]) and paid VPN services advertising increased privacy, high-speed bandwidth, large numbers of egress servers, access to censored websites, etc. [5] Even though users may be able to easily differentiate between fast and slow VPN services by merely using the service, unfortunately there are no outward signs they can use to quantify the privacy provided by VPN services. As such, users who employ such services to increase their privacy, may in fact be revealing their data to remote networks of less trustworthiness than their own local networks [6, 7]. It is therefore important to be able to proactively and continuously evaluate the properties and quality of protection that a commercial VPN solution offers. With rare exception [8], existing reviews of VPN services are typically conducted by technology journalists and are therefore limited to assessments of the VPN performance (e.g., speed), price, user friendliness (e.g., ease-of-use), features and supported protocols (e.g., see [9]).The AVN SBIR topic seeks to address this shortfall by developing and demonstrating techniques and systems for automatically analyzing third-party commercial VPN solutions to determine their networthiness, where networthiness considerations align with those of the Department of Defense (DoD) and Intelligence Community (IC) [10]. PHASE I: The AVN SBIR topic is soliciting Direct to Phase 2 (DP2) proposals only, which must include supporting documentation of Phase I feasibility. Phase I feasibility must be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of system properties/technology capabilities desirable for DoD/IC/government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include, at a minimum: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD/IC insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed AVN solution can enable accurate and reliable analysis of third- party VPN solutions. The collection of Phase 1 feasibility material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in the technical areas of software engineering, network security, privacy, analytics, and machine learning. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The AVN DP2 SBIR topic seeks to develop and demonstrate techniques and systems for automatically analyzing third-party commercial VPN solutions to determine the actual operational privacy profile/performance of such services. AVN solutions will provide an objective quantification of the privacy-related performance of third-party VPN services across platforms (e.g., Android, iPhone, PC, MAC, Ubuntu, etc.). Ideal solutions would require limited manual intervention and not rely on information elicited by the VPN service provider. AVN approaches will need to provably scale with the large number of available and future commercial VPN services. Ideally, AVN solutions would enable a user to tailor analyses to specific requirements as VPNs offer varying privacy protections that are not uniformly valuable to every user. DP2 proposals should: • describe a proposed framework design/architecture to achieve the above stated goals; • present a plan for maturation of the framework to a demonstrable prototype system; and • detail a test plan, complete with proposed quantitative metrics for privacy, and for verification and validation of the prototype system performance. Phase II will culminate in a prototype system demonstration using one or more compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program, for example, the Signature Management using Operational Knowledge and Environments (SMOKE) [11] program, which seeks to develop data-driven tools to automate the planning and execution of threat-emulated cyber infrastructure needed for network security assessments. The Phase II Option period will further mature the technology for insertion into a DoD/ IC Acquisition Program, another Federal agency, or commercialization into the private sector. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II and Phase II Option period efforts. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to automatically analyze third-party commercial VPN solutions; documented application programming interfaces; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan). • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Phase II Option period technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics for assessment of privacy features/capabilities. PHASE III DUAL USE APPLICATIONS: AVN has potential applicability across DoD/IC/government and commercial entities. For DoD/IC/government, AVN is extremely well-suited for proactive and continuous assessment of privacy features/performance of various VPN services. AVN has the same applicability for the commercial sector and has the potential to provide individuals worldwide with reliable private connections and communications. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed AVN technologies. For Phase III, the proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in government or private sector markets. Primary AVN support will be to national efforts to help secure government, commercial, and personal networks and devices against advanced persistent threats that target vulnerable VPN devices. Results of AVN are intended to improve understanding of the risks associated with VPNs, across government and industry. REFERENCES: 1. “The Impact of COVID-19 on VPN Usage and Streaming Habits”, https://www.cartesian.com/the-impact-of-covid-19-on-vpn-usage-and-streaming-habits/ 2. “VPN Demand Surges Around the World”, https://www.top10vpn.com/research/vpn-demand-statistics/ 3. “Four Risks to Consider with Expanded VPN Deployments”, https://www.f5.com/labs/articles/cisotociso/four-risks-to-consider-with-expanded-vpn-deployments 4. “Free VPN Ownership & Security Investigations Update”, https://www.top10vpn.com/research/free-vpn-investigations/ownership-risk-index-update/ 5. Muhammad Ikram, Narseo Vallina-Rodriguez, Suranga Seneviratne, Mohamed Ali Kaafar, and Vern Paxson. 2016. An Analysis of the Privacy and Security Risks of Android VPN Permission-enabled Apps. In Proceedings of the 2016 Internet Measurement Conference (IMC '16). Association for Computing Machinery, New York, NY, USA, 349–364. https://doi.org/10.1145/2987443.2987471. Available at https://www.cs.umd.edu/class/spring2017/cmsc818O/papers/vpn-app-risks.pdf 6. O. Akgul, R. Roberts, M. Namara, D. Levin and M. L. Mazurek, "Investigating Influencer VPN Ads on YouTube," 2022 IEEE Symposium on Security and Privacy (SP), 2022, pp. 876-892, doi: 10.1109/SP46214.2022.9833633. Available at https://www.cs.umd.edu/~akgul/papers/vpn-ads.pdf 7. Free VPNs are bad for your privacy”, https://techcrunch.com/2020/09/24/free-vpn-bad-for-privacy/ 8. Grauer, Yael. “Security and Privacy of VPNs Running on Windows 10.” Consumer Reports Digital Lab. 2021. Available at https://digital-lab-wp.consumerreports.org/wp-content/uploads/2021/12/VPN-White-Paper.pdf 9. https://www.top10vpn.com/reviews/ 10. https://www.nsa.gov/Press-Room/News-Highlights/Article/Article/2791320/nsa-cisa-release-guidance-on-selecting-and-hardening-remote-access-vpns/ 11. Defense Advanced Research Projects Agency, SMOKE Broad Agency Announcement HR001122S0006 (2021) (Available at https://sam.gov/opp/6ab1fdaedfd6411ba966025cd74e467c/view) KEYWORDS: custom analytics, network security, privacy, virtual private network sbir_topic_link: https://www.sbir.gov/node/2414725 subtopics: [ ] - topic_title: > Electronic Control Unit Authentication in Autonomous Vehicles (ECU2A) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-11 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): FutureG, Trusted AI and Autonomy, Advanced Computing and Software, Integrated Sensing and Cyber OBJECTIVE: The objective of the Electronic Control Unit Authentication in Autonomous Vehicles (ECU2A) Direct to Phase 2 (DP2) SBIR topic is to develop prototype systems to authenticate, monitor, and detect malicious activities in Electronic Control Units (ECUs) of modern intelligent military and civilian vehicles. DESCRIPTION: ECUs are one of the most critical embedded systems that control many subsystems in a vehicle [1]. A vehicle’s distributed network of ECUs is responsible for the control/functionality of the engine and transmission system, as well as for the control/functionality of the vehicle’s comfort and entertainment systems. Due to the extensive and growing use of ECUs in modern vehicles, and the associated increased costs and complexities they bring (e.g., due to multiple manufacturers, system integration requirements) [2], many vehicle manufacturers have adapted their manufacturing models and design flows to use the intellectual property of third-party ECU manufacturers, and outsource the fabrication of ECU hardware to offshore foundries to reduce the cost and time-to-market for their vehicles. Unfortunately, outsourcing ECU fabrication raises important security concerns [3, 4] for intelligent vehicles used by the civilian sector as well as US expeditionary forces abroad.The various Internet-of-Things (IoT) networks (e.g., Cellular, Local and Personal Area Networks, Low Power Wide Area Networks, and Mesh networks [5]) and the continuing increases in the scale of networked systems offers unprecedented interconnectivity of electronic devices, to include ECUs. Because of the ubiquitous nature and large attack surfaces of IoT networks, threats such as man-in-the-middle attacks, denial of service attacks, and hijacking of services attacks [6] can be successfully executed through bypassing the authentication process of ECUs. The consequences of such attacks can increase in severity if the ECUs are tampered with during production [7, 8, 9], prior to installation in the vehicle. Therefore, it is critical to have the ability to securely authenticate vehicular ECUs and to continuously monitor them for detection of malicious activity. PHASE I: The ECU2A SBIR topic is soliciting DP2 proposals only, which must include supporting documentation of Phase I feasibility. Phase I feasibility must be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of system properties/technology capabilities desirable for DoD/IC/government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include, at a minimum: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD/IC insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed ECU2A solution can enable secure authentication and continuous monitoring of ECUs in modern intelligent vehicles. The collection of Phase I feasibility material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in the technical areas of software engineering, network security, cyber security, analytics, and machine learning. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The objective of the ECU2A DP2 SBIR topic is to develop prototype systems to authenticate, monitor, and detect malicious activities in ECUs of modern intelligent military and civilian vehicles.ECU2A will develop new hardware/software/component verification methods, algorithms, and machine learning models to improve vehicular ECU security. Strong ECU2A proposals should address several technical challenges, such as: • effective tools and algorithms for one-time ECU authentication and continuous ECU monitoring schemes; • models capable of rapidly identifying compromised ECUs;. • ECU software/hardware validation techniques, prior to and after installment; • zero-overhead, non-intrusive monitoring schemes, that do not require direct ECU access, for easy and secure deployment; • techniques to rapidly minimize the connection/communication between the source of malicious activity and a targeted ECU; • capabilities to detect hardware/software trojans with no reverse-engineering techniques; • monitoring methods for devices operating on a broad range of ECU components, and which have an air-gapped nature. Phase II will culminate in a demonstration of the application and validation of ECU2A-developed technologies for detecting malicious activity against one or more concrete technological use cases of integrated software systems.Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to authenticate, monitor, and detect malicious activities in ECUs; documented application programming interfaces; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan). • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Phase II Option period technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics for assessment of prototype features/capabilities. PHASE III DUAL USE APPLICATIONS: ECU2A has potential applicability across DoD/IC/government and commercial entities. For DoD/IC/government, ECU2A is extremely well-suited for improving the security of intelligent vehicles used by US expeditionary forces abroad. ECU2A has the same applicability for the commercial sector.Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed ECU2A technologies. For Phase III, the proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in government or private sector markets. Primary ECU2A support will be to national efforts to help secure military and commercial intelligent vehicle ECUs against threats that target vulnerabilities. Results of ECU2A are intended to improve understanding of the threats and vulnerabilities associated with the increasing use of intelligent vehicles, across government and industry. REFERENCES: 1. Jaks, L. (2014). Security Evaluation of the Electronic Control Unit Software Update Process. Available at: http://kth.diva-portal.org/smash/get/diva2:934083/FULLTEXT01.pdf 2. Electronics Sourcing. (2022). How Many Chips are in Our Cars?https://electronics-sourcing.com/2022/05/04/how-many-chips-are-in-our-cars 3. R. Kurachi et al., "Evaluation of Security Access Service in Automotive Diagnostic Communication," 2019 IEEE 89th Vehicular Technology Conference (VTC2019-Spring), 2019, pp. 1-7, doi: 10.1109/VTCSpring.2019.8746714. Available at https://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=8746714. 4. Spaan, R.. Secure updates in automotive systems. Nijmegen: Radboud University(2016): 1-71. Available at: https://www.ru.nl/publish/pages/769526/z_remy_spaan.pdf 5. IotaComm. 2020. Four Types Of IoT Wireless Networks. https://www.iotacommunications.com/blog/types-of-iot-networks/ 6. Huq, N. et al. “Cybersecurity for Connected Cars: Exploring Risks in 5G, Cloud, and OtherConnected Technologies.” Trend Micro Research. 2021. Available at: https://documents.trendmicro.com/assets/white_papers/wp-cybersecurity-for-connected-cars-exploring-risks-in-5g-cloud-and-other-connected-technologies.pdf 7. Cho, Kyong-Tak, and Kang G. Shin. "Fingerprinting electronic control units for vehicle intrusiondetection." 25th USENIX Security Symposium (USENIX Security 16). 2016. Available at https://www.usenix.org/system/files/conference/usenixsecurity16/sec16_paper_cho.pdf 8. Kim, Kyounggon, et al. "Cybersecurity for autonomous vehicles: Review of attacks and defense."Computers & Security, Volume 103 (2021): 102150. ISSN 0167-4048, https://doi.org/10.1016/j.cose.2020.102150. 9. Wasicek, A. and Weimerskirch, A. “Recognizing manipulated electronic control units,” . SAE Technical Paper 2015-01-0202, 2015, https://doi.org/10.4271/2015-01-0202.. Available at https://ptolemy.berkeley.edu/projects/chess/pubs/1111/autoids_v2_preprint1.pdf. KEYWORDS: Electronic Control Units, Cyber Security, Intrusion Detection, Intelligent Vehicles sbir_topic_link: https://www.sbir.gov/node/2414727 subtopics: [ ] - topic_title: Network Black Box (NBB) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-12 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber, Advanced computing and Software OBJECTIVE: The Network Black Box Direct to Phase 2 (DP2) SBIR topic seeks to develop and demonstrate a system prototype capable of automatically retaining, retrieving, and analyzing network data to support threat detection and response efforts by cyber security operations teams. DESCRIPTION: Today’s enterprise networks are challenged by a myriad of cyber threats that can jeopardize the confidentiality, integrity, and availability of a network. An organization’s enterprise security controls aim to protect the organization’s networks against threats from hackers, malicious software, and attempts to steal sensitive information [1]. Threat hunting and incident response tactics, techniques, and procedures (TTPs) employed by an organization’s cyber security operations teams help protect the networks by continuously monitoring for threats in progress that evade security controls and breach the network [2]. Despite significant investment in enterprise security controls, and the collection and use of diverse and voluminous datasets for threat hunting and incident response, many organizations lack the infrastructure capacity and resources to store key enterprise network security data in a reliable, efficient, and cost-effective way, for durations comparable to the average dwell time [3] of cyber attackers (i.e., the amount of time an attacker spends on a target network before being detected). Dwell times, which vary based on region and other factors, can average up to two months, giving attackers plenty of time to wreak havoc on the target network [4]. In addition, shortfalls in infrastructure capacity and resources adversely impacts an organization’s ability to efficiently and effectively conduct incident response forensics on the network security data, once intrusion is detected.Organizations across government and industry would benefit from a simple, yet powerful, reliable, efficient, and cost-effective mechanism to support automated retention, retrieval, and analysis of key enterprise network data for security operations teams to conduct incident response forensics, such as root cause analysis [5] and lateral movement [6] detection, ex post facto. PHASE I: The Network Black Box SBIR topic is soliciting Direct to Phase 2 (DP2) proposals only, which must include supporting documentation of Phase 1 feasibility. Phase I feasibility must be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of system properties/technology capabilities desirable for DoD/IC/government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include, at a minimum: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD/IC insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed Network Black Box solution can enable the retention, retrieval, and analysis of network data to support threat detection and response efforts by security operations teams. The collection of Phase 1 feasibility material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in the technical areas of cyber operations, software engineering, network security, data analytics, artificial intelligence, and machine learning. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The Network Black Box DP2 SBIR topic seeks to develop and demonstrate a system prototype capable of automatically retaining, retrieving, and analyzing network data to support threat detection and response efforts by security operations teams. It is envisioned that Network Black Box approaches will take the form of a physical or virtual appliance with an intuitive user interface supporting at least the two use cases stated previously, namely root cause analysis and lateral movement detection. Proposed solutions should enable organizations to retain and analyze enterprise network data for at least one year for a network consisting of at least 10,000 hosts. Strong Network Black Box proposals will provide experimental evidence and a quantitative analysis on the cost, capacity, and scalability of such a capability, and present preliminary evidence on the usefulness of the retained data for root cause analysis, lateral movement detection, and any additional use cases. DP2 proposals should: • describe a proposed framework design/architecture to achieve the above stated goals; • present a plan for maturation of the framework to a demonstrable prototype system; and • detail a test plan, complete with proposed quantitative metrics for verification and validation of the prototype system performance. Phase II will culminate in a prototype system demonstration using compelling use cases consistent with commercial opportunities and/or insertion into a DARPA program (e.g., the Cyber Agents for Security Testing and Learning Environments (CASTLE) [7] program which seeks to generate data-driven, machine-readable descriptions of how attacker tools behave, how attack paths unfold, and how to label observable attack behavior; and the Signature Management using Operational Knowledge and Environments (SMOKE) [8] program which seeks to assist red teams with planning with deploying TTPs to evade network defenders in order to achieve assessment objectives (e.g., lateral movement in networks) and assess how networks perform against malicious cyber actors (MCAs)). The Phase II Option period will further mature the technology for insertion into a DoD/ IC Acquisition Program, another Federal agency, or commercialization into the private sector.The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II and Phase II Option period efforts. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to automatically retain, retrieve, and analyze network data to support threat detection and response efforts by security operations teams; documented application programming interfaces; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan). • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Phase II Option period technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics for assessment of privacy features/capabilities. PHASE III DUAL USE APPLICATIONS: Network Black Box has potential applicability across DoD/IC/government and commercial entities. For DoD/IC/government, Network Black Box is extremely well-suited for forensic analysts tasked with conducting postmortems after an organization’s network is compromised. Network Black Box has the same applicability for the commercial sector. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed Network Black Box technologies. For Phase III, the proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in government or private sector markets. Primary Network Black Box support will be to national efforts to help secure government and commercial networks against MCAs that target critical networks. Results of Network Black Box are intended to improve understanding of MCA threats and improve detection and response actions across government and industry. REFERENCES: 1. NIST SP 800-53 Revision 5. 2020. “Security and Privacy Controls for Information Systems and Organizations.” https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r5.pdf 2. Waqas, Iam. PrivacyAffairs. 2022. .https://www.privacyaffairs.com/threat-hunting-vs-incident-response/ \ 3. Armor Defense. 2021. “Dwell Time as a Critical Security Success Metric.” https://cdn.armor.com/app/uploads/2020/04/Ebook-DwellTime.pdf 4. Nayyar, Saryu. “Why The Dwell Time Of Cyberattacks Has Not Changed.” 2021. https://www.forbes.com/sites/forbestechcouncil/2021/05/03/why-the-dwell-time-of-cyberattacks-has-not-changed/?sh=1ddedc37457d 5. Gross, Natalie. CDW StateTech. 2021. “Incident Response: The Steps to a Root Cause Analysis for State Government.” 6. Cybertalk.org. 2022. https://www.cybertalk.org/what-is-lateral-movement-computing/ 7. DARPA I2O. 2022. Broad Agency Announcement, Cyber Agents for Security Testing and LearningEnvironments (CASTLE) HR001123S0002. Available at https://sam.gov/opp/5fa7645fdf464f70b5c67e24585926f7/view. 8. DARPA I2O. 2021. Broad Agency Announcement, Signature Management using Operational Knowledge and Environments (SMOKE) HR001122S0006. Available at https://sam.gov/opp/8832e2b8d9864169a234834eea89e5f1/view KEYWORDS: Network Security, Cybersecurity, Incident Response, Threat Hunting, Artificial Intelligence, Machine Learning, Automation, Data Analytics sbir_topic_link: https://www.sbir.gov/node/2414731 subtopics: [ ] - topic_title: 5G Test Environment (5GTE) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-13 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Integrated Sensing and Cyber, Advanced computing and Software OBJECTIVE: The objective of the 5GTE Direct to Phase 2 (DP2) SBIR topic is to develop a scalable, open-source Internet of Things (IoT) fifth generation (5G) test environment capability to support research and development of nascent 5G technologies. DESCRIPTION: 5GTE seeks to develop a 5G test environment for IoT devices to enable research, development, and experimentation with a broad range of 5G-capable devices, both static and mobile. The focus of 5GTE is to provide an open-source, realistic 5G radio access network to enable rapid prototyping of wireless protocols and applications including, but not limited to: cyber security, artificial intelligence, and edge-computing. A key requirement of 5GTE is the ability to rapidly and accurately scale as new technologies and devices are introduced/become available. 5GTE must also provide remote access and device update capabilities. To broaden the range of supported devices and to facilitate development, 5GTE should have the ability to support different wireless communication technologies (e.g., fourth generation, wireless fidelity). 5GTE’s network access should support high-fidelity quality of service for experimentation with different 3rd Generation Partnership (3GPP) [1] Project Release 17 [2] use cases. While open-source 5G testbed architectures do exist [3], they do not fully support remote accessibility and management to allow for multiple experiments and tests to co-exist simultaneously. PHASE I: The 5GTE SBIR topic is soliciting DP2 proposals only, which must include supporting documentation of Phase I feasibility. Phase I feasibility must be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of system properties/technology capabilities desirable for DoD/IC/government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches). Entities interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific/technical merit and feasibility described above has been achieved and also describe the potential commercial applications. DP2 Phase I feasibility documentation should include, at a minimum: • technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD/IC insertion opportunity, risks/mitigations, and technology assessments; • presentation materials and/or white papers; • technical papers; • test and measurement data; • prototype designs/models; • performance projections, goals, or results in different use cases; and, • documentation of related topics such as how the proposed 5GTE solution can enable research and development of nascent 5G technologies. The collection of Phase I feasibility material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and abilities in the technical areas of: mobile communications, software engineering, network security, cyber security, programmable networking, and artificial intelligence. For detailed information on DP2 requirements and eligibility, please refer to the DoD Broad Agency Announcement and the DARPA Instructions for this topic. PHASE II: The objective of the 5GTE DP2 SBIR topic is to develop a scalable, open-source IoT 5G test environment capability to support research and development of nascent 5G technologies. 5GTE DP2 proposals should: 1. describe a proposed design/architecture to achieve the 5GTE goals, along with application programming interfaces that allow for an open IoT testbed infrastructure; 2. present a plan for maturation of the architecture to a prototype testbed to demonstrate accurate and scalable experimentation capabilities; and, 3. detail a test plan, complete with proposed metrics and scope (e.g., testbed structure, types/numbers of devices, etc.) for verification and validation of the testbed capabilities. 5GTE should have the ability to support multiple isolated environments to enable testing in parallel with security guarantees. Each isolated environment would support full standards compliant user authentication on the 5G core side, where the end devices can use programmable subscriber identity module cards; and the core would support network slicing capabilities. Strong 5GTE proposals would include: • additional scaling capabilities enabled via emulation of various end devices; • solutions based on components with strong open-source development and community support, such as the technology projects that reside within the Linux Foundation [5]; and, • a commercialization plan for the proposed 5GTE which articulates a clear vision for the potential business opportunities as 5G capabilities and standards evolve. Phase II will culminate in a testbed demonstration using one or more compelling IoT use cases consistent with commercial opportunities and/or insertion into the DARPA/I2O Open, Programmable, Secure 5G (OPS-5G) program [4]. The below schedule of milestones and deliverables is provided to establish expectations and desired results/end product for the DP2 effort. Schedule/Milestones/Deliverables: Proposers will execute the research and development (R&D) plan as described in the proposal, including the below: • Month 1: Phase I Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. • Months 4, 7, 10: Quarterly technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 12: Interim technical progress briefing (with annotated slides) to the DARPA PM detailing progress made (including quantitative assessment of capabilities developed to date), tasks accomplished, risks/mitigations, planned activities, technical plan for the second half of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 15, 18, 21: Quarterly technical progress reports detailing technical progress made, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 4, 7, and 10), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. • Month 24: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details; a demonstration of the ability to authenticate, monitor, and detect malicious activities in ECUs; documented application programming interfaces; and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the commercialization plan). • Month 30 (Phase II Option period): Interim report of matured prototype performance against existing state-of-the-art technologies, documenting key technical gaps towards productization. • Month 36 (Phase II Option period): Final Phase II Option period technical progress briefing (with annotated slides) to the DARPA PM including prototype performance against existing state-of-the-art technologies, including quantitative metrics for assessment of test environment features/capabilities. PHASE III DUAL USE APPLICATIONS: 5GTE has potential applicability across DoD/IC/government and commercial entities. For DoD/IC/government, 5GTE is extremely well-suited for supporting research to investigate 5G capability enhancements and cyber risks. 5GTE has the same applicability for the commercial sector. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed 5GTE technologies. For Phase III, the proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in government or private sector markets. Primary 5GTE support will be to national efforts to advance US 5G capabilities and to promote awareness of 5G risks to national security. Results of 5GTE are intended to enable accurate test and evaluation of nascent 5G technologies at scale, across government and industry. REFERENCES: 1. 3GPP. 3GPP - A Global Initiative. https://www.3gpp.org/ 2. 3GPP. 3GPP – The 5G Standard. https://www.3gpp.org/specifications-technologies/releases/release-17 3. Institute for the Wireless Internet of Things at Northeastern University. Testbeds to develop and experiment with open, programmable, 5G networks. https://open5g.info/testbeds/ 4. DARPA Broad Agency Announcement: Open Programmable Secure 5G (OPS-5G), HR001120S0026, January 30, 2020. Available at https://beta.sam.gov/opp/6ee795ad86a044d1a64f441ef713a476/view 5. The Linux Foundation. The Linux Foundation. https://www.linuxfoundation.org/ KEYWORDS: Fifth Generation (5G), Internet of Things (IoT), Test Environment, Scalability, Open-source, Security, Cyber Security, Artificial Intelligence, and Edge-computing sbir_topic_link: https://www.sbir.gov/node/2414735 subtopics: [ ] - topic_title: 'Autonomous Systems at Scale - Open Topic' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-P01 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software, Human-Machine Interfaces, Microelectronics, Trusted AI and Autonomy   OBJECTIVE: The objective of the Autonomous Systems at Scale Open SBIR topic is to develop autonomous systems that remove service members from dangerous environments and speed manual-labor tasks to enable paradigm-shifting tactics.   DESCRIPTION: The DoD’s ability to maintain a global presence currently requires intensive manpower focused on well-defined and sometimes monotonous tasks. Autonomous solutions can be powerful force multipliers, reallocating the burden of these tasks to machines and decreasing risks to personnel. For example, Explosive Ordnance Disposal (EOD) operations often involve a human technician following written instructions to execute procedures on well-understood ordnance, either by hand or by remotely operating Unmanned Systems (UxS). Removing humans from the blast radius will not only decrease risk but also allow personnel to prioritize novel first-seen threats.    Developing autonomous solutions for well-defined problems comes with a range of challenges that differ by domain. For example, ground-based systems can encounter environmental obstacles while interacting with clutter, aerial vehicle utility is often limited by power capacity, and unmanned underwater vehicles suffer from communications limitations. Additionally, fielded systems often do not have interoperable architectures.   DARPA solicits technologies to address the critical limitations of creating autonomous solutions for well-defined problems. Examples of technologies of interest include but are not limited to systems that: 1. Build or repair damaged infrastructure (e.g., repairing many blast craters in parallel and with minimal human oversight). 2. Decrease the operator-to-robot ratio in UxS response operations (e.g., allowing a single operator to quickly neutralize large numbers of explosive threats in a near-peer conflict). 3. Reduce the manpower requirements of physical burdens (e.g, unloading cargo at an expeditionary base).    Strong proposals will identify a critical limitation to scalable autonomy, then design a system and/or component that overcomes the problem. Proposers should identify metrics that compare the proposed concept with the deployed state of the art. The aim of the solicitation is to create an unclassified prototype that is ready for field testing at the end of Phase II. Submissions solely focused on software or solely focused on hardware without significant autonomy are not of interest, nor are proposed solutions in the areas of kinetic effects or intelligence, surveillance, and reconnaissance. Systems developed should be robust and maximize operational availability.   An initial white paper describing the technical approach is required and will be screened for responsiveness to the topic. The technical white paper should include an overview of the proposed concept with details to support feasibility. The overview should address the bullets below listed in order of importance: Proposed system: Describe the proposed system. Outline the design and operation of the main hardware and software components that are being proposed for development and if applicable, which parts of the system are COTS.  Concept of Employment: Identify how the proposed system could be employed. Provide details on the problem the autonomous system is addressing and the prevalence of this problem. What metric does the proposed solution improve, and by how much? Scalability: Provide a brief analysis of the feasibility of scaling the system across the DoD and industry. Are the production costs low enough to merit widespread adoption? Is the system sufficiently autonomous that large-scale deployment wouldn’t require significant training or human labor? What are the projected maintenance requirements, operational availabilities, and service lifetimes?   PHASE I: Companies will complete a feasibility study that demonstrates the firm’s competitive technical advantage relative to other commercial products (if other products exist) and develop concept plans for how the company’s technology can be applied to more efficiently scale autonomous capability. Studies should clearly detail and identify a firm’s technology at both the individual component and system levels, provide supporting literature for technical feasibility, highlight existing performance data, showcase the technology’s application opportunities to a broad base of customers outside the defense space, a market strategy for the commercial space, how the technology directly increases the prevalence of autonomous capability as well as include a technology development roadmap to demonstrate scientific and engineering viability.  Proposers should recommend quarterly technical milestones that will be used to demonstrate their progress to DARPA throughout Phase I. These milestones will also be accompanied by monthly financial and technical summary reports.   At the end of Phase I, the company will be required to provide a formal proposal in writing, to include quarterly milestones, defining how their technology would be developed and implemented into relevant concepts of operation. A commercialization roadmap will also be required to demonstrate a high probability that continued design and development will result in a Phase II mature product. For example, a proposal that addresses infrastructure repair might describe how the solution(s) would be employed in expeditionary military construction operations, how it nests into a broader commercial need, and specify what performance metrics (threshold and objective) would demonstrate system viability.   PHASE II: Produce prototype solutions that enable mission essential tasks. These products will be provided to select DoD units for further evaluation by personnel. In addition, companies will provide a technology transition and commercialization plan for DOD and commercial markets.   PHASE III DUAL USE APPLICATIONS: Components and/or systems could be applied to scale autonomy in multiple industries, including but not limited to, those within the energy and construction sectors that leverage UxS in survey or infrastructure development tasks.  These same technologies have DOD application in the air, ground, and underwater domains. The business will transition the solution to provide expanded mission capability for a broad range or potential Government and civilian users and alternate mission applications.   REFERENCES: B.N. Diggs et al., “Automated Construction of Expeditionary Structures (ACES)” US Army Corps of Engineers Engineer Research and Development Center/Construction Engineering Research Laboratory (ERDC/CERL TR-21-6). February 2021. K. Song and P.C. Chu. “Conceptual Design of Future Undersea Unmanned Vehicle (UUV) System for Mine Disposal.” IEEE Systems Journal, Vol 6, 2012   KEYWORDS: Unmanned Systems; Autonomy; Robotics; Logistics; Artificial Intelligence, Autonomous Logistics; Autonomous Construction; Infrastructure Survivability sbir_topic_link: https://www.sbir.gov/node/2464935 subtopics: [ ] - topic_title: Canopies for High-speed Ultra-Long Terrain Execution (CHUTE) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-14 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials, Human-Machine Interfaces   OBJECTIVE: Design, develop and demonstrate a proof-of-concept ram-air parachute specifically capable of low-altitude (<1000 feet) and long-distance (>10 km) flight, in a parachute rig weighing <50 kg. Such parachute systems will need to be capable of forcing air into parachute cells to keep them inflated during flight over long distances, with ultimate range being a function of the capabilities of this forced air system. Proposers should include any testing capabilities needed to verify that the modified canopy is in an airworthy (jumpable) configuration, without significant impact to the probability of a successful opening.   DESCRIPTION: Parachute technology has evolved (Figure 1) since the creation of round canopies, which slow the rate of descent by creating drag. Ram-air canopies, developed in the 1970s, have inflatable parallel cells that fill with high-pressure air from vents that face forward on the leading edge of the airfoil. The fabric is shaped, and the parachute lines trimmed under load, such that the ballooning fabric inflates into a cambered airfoil shape. Air must flow faster over the top than the bottom, creating lift in addition to drag, and allowing steerability by controlled deflection of air. The use of airplane terminology is no accident; ram-air canopy designs share many features with airplane wings.   Figure 1. Evolution of parachute technology, demonstrating the steady growth toward rigid wing-like structures. CHUTE aims to redesign the canopy wing for long-distance, low-altitude flight with an airplane philosophy in mind.   In order to create a new paradigm for quiet, long-distance, low-altitude flight using parachutes, DARPA seeks to leverage recent advances in aerodynamics and materials technology to develop cost-effective ram-air parachutes that deliver a revolutionary leap in the distance that can be traversed, without significantly adding to the mass of the overall parachute rig or impacting its airworthiness (defined here as “jumpability”, the probability of a successful parachute opening).    Today’s state of the art is dynamic, maneuverable cross-braced canopies used in the competitive high-speed sport of parachute swooping. Swooping canopies can generate speeds in excess of 70 miles per hour, traverse lengths greater than a football field at one foot above ground level (AGL), change direction abruptly when flying around “gates”, and land on a specific target with accuracy. Zero porosity aerodynamic parachute material, span-wise inflatable ribs, low drag lines, a more rigid wing-like design, and high wing loading allow finer control in close proximity to the ground, sometimes simply by shifting weight in the harness. However, modern parachutes ultimately remain a prisoner to energy conservation. Swoopers generate high kinetic energy by trading for potential energy (altitude over a drop zone). When this kinetic energy is exhausted, they must land, placing physics limits on speed and distance they can traverse.   Powered paragliders are one way that sustained flight may be possible. However, three limitations place constraints on the use of these systems for military operations: noise, weight and speed. Powered paragliders can create in excess of 120 dB of sound, typically weigh >250 lbs, and have large parafoils with dozens of cells, resulting in parasitic drag that limits sustained speed to <30 mph. Powered paragliders are therefore out of scope for this effort. The Joint Precision Aerial Descent System (JPADS) has used winches, wires and pulleys located below the parachute to demonstrate lightweight, adjustable airflow control on round parachutes, but is ultimately constrained by the round canopy’s limited maneuverability. Round canopies are therefore out of scope for this effort. Concepts that rely exclusively on powered cargo and do not add propulsion to the parachute canopy (e.g. LRPADS [2]) are out of scope. For more information on this topic, see https://www.youtube.com/watch?v=7_kqMjz94B8.   PHASE I: Phase I consists of a base period of six months that will result in the development, design, and refinement of a low-mass (<50 kg) parachute system design capable of long-distance (>10 km) flight, to create continuously inflated parachute cells at altitudes of 1000-3000 ft. AGL.   Successful proposals for this SBIR offering must make significant arguments supporting the ability to rapidly iterate and execute to meet the timelines laid out in this solicitation, while addressing three key aspects of the program goals: (1) how the method of powered propulsion or forced air will be integrated into the parachute wing and/or jumper; (2) to what degree such propulsion interacts with, or relies upon, ground effect aerodynamics and canopy wing design; (3) how the parachute and powered propulsion system will be built and tested via real-world jump operations planned for Phase II. Successful proposals will also demonstrate in-depth knowledge of aerodynamic design and parachute fabrication, and should illustrate how their method might be expected to meet the envisioned metrics.   This effort is expected to primarily center around new active airflow control and/or powered motor methods, that are conformally integrated with ram-air parachutes and allow sustained flight for as long as that control or power is provided. Methods such as adjustable inlet control, battery-powered bleed air for directional control, laminar flow injection, boundary layer control to maintain lift across long traverse distances, or other innovative methods, are suitable for investigation. Recent developments have shown that designed geometric openings can create macro-control with new wing shapes, or the opening/closing of slots or voids for air flow (e.g., ram air parachutes with controllable flaps for directional control). Additional efforts to minimize drag may be required to maximize range.    Phase I fixed payable milestones for this program should include:  Phase I Base period (required): 6 months Month 2: Concept Design Review (CoDR) on powered parachute design, in accordance with the metrics below. Month 4: Preliminary Design Review (PDR). Initial report on “do no harm” probability. Month 6: Critical Design Review (CDR). Interim report on “do no harm” probability, scalability, proposed cost and noise estimates. Present initial test and evaluation plan, hardware purchase plan, and safety plan for Phase II testing.    Performers may perform lab or bench-scale testing to increase design fidelity as desired, as long as this does not negatively impact the design review schedule. Performers will work with DARPA to identify potential transition partners for demonstrations in Phase II. Performers will present plans to manufacture prototype parachute(s) and test them in Phase II.    Phase I metrics: Present the design, at a CDR level, of a parachute system that can: Deliver air to canopy cells, or use other innovative methods, to maintain sustained parachute canopy flight at an altitude of >500 ft. AGL and <3000 ft. AGL (<5000 ft. MSL), Do so for a horizontal flight distance greater than 10 km from the point of engagement, Do so in less than 20 seconds from a manual initiation command, Do so while preserving total mass of the parachute rig (to include a reserve parachute) at <50 kg, If weight is added to the body of the jumper, add no more than 50 lbs. to the weight of the jumper, Be capable of being engaged while airborne, and disengaged via manual control in order to land as needed, Maintain a forward speed of at least 20 mph, at an altitude of >500 ft. AGL and <3000 ft. AGL (<5000 ft. MSL), Determine the probability of a successful opening of the prototype, i.e., demonstrate “do no harm” with the added mechanism(s) to existing opening probability when in a rigger-approved, properly packed configuration. Present estimates of the noise generated by the system in flight, in decibels (dB), Present scalability calculations for maximum projected range, with added mass, Present the proposed cost of the parachute system when produced at scale, as demonstrated via techno-economic analysis of the cost of production, in dollars per parachute rig. Systems may use initiation energy from a parachute dive that increases velocity (e.g., a diving swoop that trades potential energy for kinetic energy), but may not use such methods when at the flight altitude.   Proposers must begin their effort with an experienced, licensed parachute rigger team, with significant practical experience in parachute packing, repair, evaluation, and modification. Additionally, by the end of Phase I, proposers should demonstrate the following:  To show available expertise for Phase II fabrication of the proposed design: teaming with an existing commercial parachute manufacturer that has sold at least 5,000 airworthy canopy units;  To conduct jump testing in Phase II: teaming with an existing US Parachute Association (USPA) compliant drop zone [1].   PHASE II: The Phase II effort consists of a base period of 12 months, an Option 1 period of 12 months and an Option 2 period of 12 months. The Option 2 period will follow the Option 1 period. DARPA reserves the right to release a separate Direct to Phase II (DP2) SBIR solicitation in lieu of exercising either Option.   Testing in the base period will center around design, feasibility testing and proof-of-concept. Experimental assessments of ram-air generation, and interaction with parachute cells, may also be necessary to demonstrate a proof of concept. Testing in the option periods will expand the maximum range, reduce noise, and conduct a challenge-based flyoff (Figure 2).   Phase II fixed payable milestones for this program should include:  Base period: 12 months Month 4: Bench Testing Review (BTR). First prototype ready for bench testing at parachute manufacturer facility. Deliver assessments of the degree of maneuverability and speed, and experimentally demonstrate key components that produce parachute cell inflation. Deliver interim report on trade studies, integration of hardware to canopy and canopy to rig, and system design. Present final test and evaluation plan, and safety plan for testing.  Month 9 (optional; dummy real-world jumps may be substituted to achieve the same end goal): Complete wind tunnel testing. Deliver interim report, describing results of wind tunnel testing, design iterations, and manufacturing results.  Month 12: Complete first round of dummy parachute jumps to evaluate airworthiness. Test Readiness Board (TRB) and Safety Review Board (SRB) to determine criteria for human jump testing, to include safety mitigation plans. Present readiness for live test to DARPA.   Option 1 (Initial test jumps): 12 months Month 16: Complete dummy parachute jumps to evaluate airworthiness. Go/no-go for human jump testing, to include updated safety mitigation plans.  Month 22: Complete jump testing at USPA approved drop zone. Demonstrate steadily decreasing altitudes and steadily increasing ranges. Demonstrate at least 5 km. straight-line range at >500 ft. AGL and <2500 ft. AGL, in a parachute rig weighing <50 kg, and document real-world noise level (dB) in excess of the ambient. Month 24: Update Phase II report documenting powered parachute system design and testing results, future specifications, manufacturing process, and evaluation of airworthiness. Evaluate cost of full-rate production using partner parachute manufacturer facilities. Option 2 (Advanced test jumps): 12 months Month 27: Demonstrate ability to perform ±50 feet of in-flight altitude adjustment by manual control. Demonstrate ability to interrupt/disengage the actuation system in order to land immediately. Test modifications to reduce sound level. Prepare expanded version of actuation system for long-range testing. Month 30: Parachuting Challenge flyoff 1 (interim, home drop zone). Long-range (at least 8 km), low-altitude (maximum of 1500 ft. AGL) jump testing at USPA approved drop zone.  Month 33: Parachute Challenge flyoff 2 (final, DARPA-selected drop zone). Maximum feasible range, low-altitude (maximum of 1000 ft. AGL) jump testing. Measure sound addition to the ambient noise level; validate <50 kg. total rig weight. Month 36: Final Phase II report documenting powered parachute system design and testing results, manufacturing process, and verifications of airworthiness. Demonstrate long-distance, low-altitude system for Department of Defense observers and customers. Present future commercialization plans.   Figure 2. A notional Parachute Challenge flyoff course, demonstrating long-distance legs and steadily increasing sharpness of turns / smaller turn radius. The first challenge will occur at the performer’s partner drop zone. The second challenge will occur at a drop zone of DARPA’s choosing (SOA: state of the art).   PHASE III DUAL USE APPLICATIONS: Ram-air parachute technology is currently at high technology readiness level and in full-rate production for both military and civilian uses. Multiple commercial and DoD applications are envisioned after the successful demonstration of a powered parachute prototype. DoD use by Special Operations Command. The ability to use designed systems for silent, low-altitude ingress is expected to have significant ramifications for pararescue jumpers and military special operators. The ability to separate landing zones (LZ) from targets by over 10 km will allow significant freedom to ingress route planning, and place less demand on helicopter aircraft to place themselves in harm’s way to deliver operators to their LZs. Commercial use by US Parachute Association, and other international skydiving entities. Cross-braced canopies has created the sport of parachute swooping, which today boasts national and international championships, and the creation of over 20 distinct parachute designs, each of which has sold over 5,000 units at costs of >$4,000 USD per piece. A safe, powered parachute system is expected to revolutionize modern recreational skydiving and create a significant market for parachutes that can do more than simply land where the wind, and existing kinetic energy, dictate. The products delivered in this effort will create a new sport with significant mass-market attraction, and there is a viable business model from the skydiver audience – for example, the US Parachute Association alone has over 35,000 members.   REFERENCES: [1] USPA Dropzone Locator, United States Parachute Association. https://uspa.org/DZlocator [2] Long Range Precision Aerial Delivery System (LRPADS). https://ombra.us/product/long-range-precision-aerial-delivery-system/   KEYWORDS: Systems Level, Handling, Product Design, System   sbir_topic_link: https://www.sbir.gov/node/2464921 subtopics: [ ] - topic_title: 'Bright ELectron and Light Sources (BELLS) - SBIR XL' branch: Defense Advanced Research Projects Agency topic_number: 'HR0011SB20234XL-03 ' topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Biomedical OBJECTIVE: The goal of BELLS is to demonstrate and commercialize practical sources of intense, tunable electrons and monochromatic hard x-rays. These sources would support transformative capabilities for applications such as non-destructive inspection, medical diagnostics, and treatments. DESCRIPTION: BELLS will develop compact sources of monoenergetic electrons and photons suitable for demonstrating a range of transformative medical and non-destructive inspection applications with the overall goal of defining a minimum viable product (MVP) for commercialization. BELLS contains two subtopics that will be executed in parallel. Subtopic 1 focuses on maturing existing laboratory scale systems to demonstrate application feasibility and further productization. Subtopic 2 seeks to mature specific component technologies to be integrated into Subtopic 1 laboratory-scale systems that provide brightness enhancements enabling additional applications and productization opportunities. Subtopic 1: Demonstration and Productization. High-quality electron and photon sources are of broad interest for a range of security, industrial, and medical applications. Recent advances in photoinjectors[1], linear accelerators[2], high power lasers[3], and a range of ancillary technologies have resulted in several prototype systems that provide novel, compact testbeds for investigating these applications. However, further maturation and demonstration of these technologies is needed to realize systems with commercialization potential. The purpose of this subtopic is to mature testbed system(s) demonstrating one or more applications and to define minimum viable commercial product(s). High-quality electrons produced from photoinjectors and linear accelerators offer utility by themselves as well as the ability to produce bright monoenergetic x-rays through laser-Compton interactions[4]. Controlling the accelerator power allows the energy of electrons and x-rays to be tuned. For x-rays, it is possible to achieve synchrotron-like performance while achieving higher energies (100s of keV to MeV energies) in highly compact form factors. Very high-energy electron beams (100s of MeV) and bright light sources enable a range of applications including, but not limited to: • Medical imaging, including phase contrast • Medical radiotherapy, including FLASH and theranostics • Nondestructive test and evaluation, including high resolution tomography and semiconductor metrology. The effort will not just explore the technical applications of these sources, but also the business cases, economic impacts, and regulatory requirements for such technologies to be broadly employed. These studies will support jump-starting medical and industrial activity in this sector, leading to commercially viable system designs. Subtopic 2: Brightness Enhancements. Application performance can often be improved with increased source brightness, i.e. intensity and purity. This subtopic seeks to enhance the testbed(s)/prototype(s) of Subtopic 1 by advancing and integrating new component technology. Examples of such technology could include improvements in laser systems, electron systems, spot size reduction strategies, Fabry-Perot cavities, pulse stacking, and pulse recirculation. PHASE I: BELLS is a direct to Phase II SBIR XL program only; there is no Phase I. Proposers must provide experimental evidence of their approach concept commensurate to a Phase I effort that achieves significant performance. Specifically, proposers must provide evidence of existing performance in the three technology areas described below: • Photoinjector o C-band or higher frequency o Support microamp or greater average currents o Support micropulse structures at RF frequencies at macro system repetition rates of 100 Hz or greater o > 10 pC of charge produced per incident laser pulse o Support electron energy of 5 MeV or greater o Normalized emittance of 1 µm or better • Electron accelerator o C-band or higher frequency o Acceleration gradients 50 MV/m or greater o Support electron energy of 50 MeV or greater o Support 10 micron or smaller laser-Compton interaction spot sizes • Interaction laser o Support 10 micron or smaller laser-Compton interaction spot sizes o Sufficient energy to support laser-Compton applications generating > 30 keV photons PHASE II: Subtopic 1: Demonstrations and Productization Proposers must apply to Subtopic 1 to be eligible to apply to Subtopic 2. Subtopic 2 will run concurrently with Subtopic 1. The purpose of this subtopic is to mature existing laboratory scale systems into platforms demonstrating one or more applications, and defining a minimum viable commercial product for supporting those applications. Proposers must clearly and quantitatively describe the existing laboratory system that can support laser-Compton x-ray generation. This includes key subsystems such as photoinjector, linear electron accelerator, interaction laser, and precision subsystem synchronization. Proposers must also choose at least one application (preferably more) and describe in detail how the existing laboratory scale system can be used to develop and mature a testbed enabling productization. This must include both a technical description and an economic analysis supporting commercial viability of the approach. This analysis must also include participation by one or more relevant stakeholders able to employ this product for the described application(s). In addition, the system must support the performance metrics in the table below for photon production. Parameter Threshold Objective Intensity Intensity (photons/s) > 10^9 > 10^10 Repetition Rate (Hz) > 100 > 1000 Energy Minimum (keV) > 100 > 300 Purity Bandwidth (dE/E) < 10% < 0.1% Here, “threshold” indicates the minimum acceptable performance levels while “objective” levels are highly desired. The base period will focus on completing a BELLS testbed capable of producing relevant levels of electrons and laser-Compton photons for the chosen application(s). Performers will conduct outreach to customers, stakeholders, industrial partners, and regulators to engage in testbed use. Option period 1 will focus on testbed demonstration and characterization activities, and develop system requirements for a minimum viable product. System characterization supporting the laser-Compton performance metrics above is expected. Option period 2 continues testbed activities while further developing the minimum viable product through a critical design review. Active participation of customers, stakeholders, industrial partners, and regulators (as appropriate) is required throughout both option periods. Base period (6 months) milestones: • Month 1: Kickoff slide deck summarizing technical approach to meet overall goals, risks, and risk mitigations, and quantified milestone schedule • Month 3: Testbed build interim report • Month 6: Testbed build final report Option period 1 (6 months) milestones: • Month 1: Testbed demonstration kickoff materials, with stakeholder participation • Month 3: Testbed characterization report • Month 6: Testbed demonstration interim report, MVP system requirements review report Option period 2 (6 months) milestones: • Month 1: Testbed stakeholder engagement and transition report • Month 3: MVP preliminary design review report • Month 6: Testbed demonstration final report, MVP critical design review report Monthly written technical progress reports will supplement the above milestones (see template under SBIR/STTR BAA DOCUMENTS at https://www.darpa.mil/work-with-us/for-small-businesses/participate-sbir-sttr-program). Subtopic 2: Brightness Enhancements Proposers can propose to Subtopic 2 within their Subtopic 1 proposal. This subtopic seeks to enhance the testbed(s) of subtopic 1 by advancing and integrating component technology – specifically, laser-Compton performance to improve brightness, supporting commercially-relevant applications. Proposers must clearly describe the new component technology and anticipated testbed performance increases. Increases in performance must enable an additional application or improve the commercial prospects of the minimum viable product. Development timelines must align to integration into the testbed by the end of the option period 1. The Base period will focus on developing component technology to enhance brightness. During the option period 1, components will be refined and integrated into the testbed. During the option period 2, the enhanced testbed will be tested to verify performance, assess improvements in testbed capabilities, and enable further minimum viable product definition. Base period (6 months) milestones: • Month 1: Kickoff slide deck summarizing technical approach to meet overall goals, risks, and risk mitigations, and quantified milestone schedule • Month 3: Testbed enhancement preliminary design review report • Month 6: Testbed enhancement critical design review report Option period 1 (6 months) milestones: • Month 1: Testbed enhancement integration readiness report • Month 3: Testbed enhancement interim report • Month 6: Testbed enhancement final report Option period 2 (6 months) milestones: • Month 1: Enhanced testbed stakeholder engagement and transition report • Month 3: Enhanced testbed characterization report • Month 6: Final system performance report Monthly written technical progress reports will supplement the above milestones (see template under SBIR/STTR BAA DOCUMENTS at https://www.darpa.mil/work-with-us/for-small-businesses/participate-sbir-sttr-program). PHASE III DUAL USE APPLICATIONS: The successful development of such electron and x-ray sources supports a range of medical and non-destructive inspection applications. These include microbeam radiation diagnostic procedures, FLASH e-beam/x-ray radiotherapy, and innovations in theranostics. These sources would also be of high interest to the semiconductor industry for nanometrology and in-line inspection at semiconductor foundries, to include fraud detection. Successful proposals for this SBIR offering must make significant arguments supporting the commercial viability of their approach. Hence, proposals must provide initial evidence that their laboratory scale systems have sufficient technical maturity and performance characteristics that would support economically viable applications with development into a minimally viable product. Proposals for Subtopic 2 must make arguments that the proposed enhancement(s) could significantly advance the economics of productization of their system concepts. Transition and commercialization (T-C) milestones have been added as part of the option periods to aid in assuring commercial viability REFERENCES: 1. Performance of a second generation X-band rf photoinjector, Marsh et al., Phys. Rev. Accel. Beams 21, 073401, 2018 2. Design and demonstration of a distributed-coupling linear accelerator structure, Tantawi et al., Phys. Rev. Accel. Beams 23, 092001, 2020 3. 1 kHz repetition rate 1.1 J picosecond laser, Wang et al., Laser Congress AM2A.4, 2021 4. Photon flux and spectrum of ?-rays Compton sources, V. Petrillo et al., Nucl. Instrum. Methods Phys. Res A, 693, 109-116, 2012 KEYWORDS: Monochromatic hard x-rays, tunable electrons. sbir_topic_link: https://www.sbir.gov/node/2414737 subtopics: [ ] - topic_title: 'Fast, Light, Airworthy, Repackable ParachutE (FLARE) - SBIR XL' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234XL-04 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials, Human-Machine Interfaces   OBJECTIVE: Develop and demonstrate a proof-of-concept ram-air parachute specifically designed to provide automated repacking of an unpacked canopy for special operations and other applications. The prototype should include fabricated hardware integrated into a commercially available parachute rig, and should support repacking on a fast timeline (<60 seconds), with the addition of no more than 20% of the mass of the parachute rig. Proposers should include any testing capabilities needed to verify that the modified canopy is in an airworthy (jumpable) configuration, without significant impact to the probability of a successful opening.   DESCRIPTION: Parachutes are used by the Department of Defense in ejection seats (e.g., the F-16 ACES II system), for special operations ingress, and advance airdrop (Figure 1).     If ejecting behind enemy lines becomes necessary, particularly in time-critical scenarios, a large open canopy on the ground can be an indicator to the location of downed aircrew. The ability to trigger an automated repack of this parachute, without impacting its airworthiness and probability of successful opening, is desired. Special operators plan parachute ingress routes to allow sufficient distance from the target to land and manually pack the parachute. The ability to trigger a time-critical repack to minimize ground footprint could significantly change route planning and allow a landing closer to a target for maximum impact. Finally, logistics airdrops from an airborne platform are capable of delivering large amounts of mass to areas of engagement, but leave a large footprint; the ability to minimize this footprint to support special operations is also of interest to the Department of Defense.        Figure 1. Three scenarios that benefit from repackable parachutes: Downed aircrew (left), special operations ingress (center), and advance logistics airdrops (right).   For more information on this topic, see https://www.youtube.com/watch?v=YXBjhBVaxpw.   PHASE I: This is a Direct to Phase II (DP2) topic only. In order to demonstrate that Phase I feasibility has been met, proposers should demonstrate the following:  To show available expertise for immediate fabrication of the proposed design: teaming with an existing commercial parachute manufacturer that has sold at least 5,000 airworthy canopy units;  An initial design with detailed descriptions of physical mechanisms that shows the ability to retract and stow parachute lines into the container;  To conduct jump testing: teaming with an existing US Parachute Association (USPA) compliant drop zone [1];  An experienced, licensed parachute rigger team with significant practical experience in parachute packing, repair, evaluation, and modification   PHASE II: The Phase II effort consists of a DP2 base period of 12 months, an Option 1 (required) period of 6 months and an Option 2 (optional) period of 6 months. The Option 2 period will follow the Option 1 period. Testing in the base and Option 1 periods will be conducted on ram-air canopies, to preserve maximum aerodynamic flexibility. Testing in the Option 2 period will be conducted on round canopies, and evaluate the jumpability (defined here as the probability of a successful parachute opening, with the addition of the repacking mechanism) of repacked ram-air parachutes.     In this effort, proposers will design and develop a jumpable, repackable parachute prototype that will: Repack an opened parachute into its container using electromagnetic, mechanical or other mechanisms, Do so in less than 60 seconds from a manual initiation command, Do so while adding less than 20% mass to an existing commercially available parachute rig, Determine the probability of a successful opening of the prototype before automated repacking, i.e., demonstrate that the added repacking mechanism “does no harm” to existing opening probability when in a rigger-approved, properly packed configuration, Characterize the probability of a successful opening of the prototype after automated repacking, toward potential future commercialization opportunities.   It is expected that designed repackable parachutes will need to be test jumped in order to support the goals of this effort. Proposers should describe their ability to work with parachute test jumpers, at appropriate drop zones, in order to accomplish statistical significance on the probability of a successful parachute opening with added repacking mechanisms. The wide number of commercially available parachuting rigs for recreational skydiving, and the high reliability of belly-mounted and rig-mounted reserve parachutes, allow for a rapid cycle of design-test-fly-redesign that proposers should plan to leverage.   The minimum deliverable will be an airworthy, repackable proof-of-concept parachute prototype in a complete rig (i.e., with a container, main and reserve parachute, and other accompanying hardware).   Phase II fixed payable milestones for this program should include:    Base period (required): 12 months Month 2: Concept Design Review (CoDR) on repackable parachute design, with hardware purchase plan and initial test and evaluation plan; Month 6: Bench Testing Review (BTR). First prototype ready for bench testing at parachute manufacturer facility. Interim report on trade studies, integration of hardware to canopy and canopy to rig, and system design. Present final test and evaluation plan, and safety plan for testing.  Month 9 (optional; dummy real-world jumps may be substituted to achieve the same end goal): Complete wind tunnel testing. Deliver interim report, describing results of wind tunnel testing, design iterations, and manufacturing results.  Month 12: Complete first round of dummy parachute jumps to evaluate airworthiness. Test Readiness Board (TRB) and Safety Review Board (SRB) to determine go/no-go for human jump testing, to include safety mitigation plans. Present readiness for live test to DARPA.     Option 1 (Initial test jumps) (required): 6 months Month 15: Complete initial phase of ram-air canopy jump testing at USPA approved drop zone. Month 17: Complete final phase of ram-air canopy jump testing.  Month 18: Update Phase II report documenting repackable parachute system design and testing results, future specifications, manufacturing process, and verification of airworthiness. Demonstrate repackable system for Department of Defense observers and customers. Present scaling plans to large canopies (airdrop size) and high-impact loading canopy (ejection seats) applications. Evaluate cost of full-rate production using partner parachute manufacturer facilities.     Option 2 (Advanced test jumps) (optional): 6 months Month 20: Present TRB and SRB, with results from bench testing, of large (>500 sq. ft) repackable round canopies. Present re-design for repackable and rejumpable ram-air designs.   Month 23: Update interim report to include results of test jumps. Large round canopy jump testing at USPA approved drop zone. Dummy parachute jump testing to evaluate airworthiness of previously repacked parachutes at USPA approved drop zone. Month 24: Final Phase II report documenting repackable parachute system design and testing results, parachute manufacturing process, and verifications of airworthiness. Demonstrate round and ram-air repackable system for Department of Defense observers and customers. Present future commercialization plans.   Successful proposals for this SBIR offering must make significant arguments supporting the ability to rapidly iterate and execute to meet the timelines laid out in this solicitation.   PHASE III DUAL USE APPLICATIONS: Ram-air and round parachute technology are currently at high technology readiness level and in full-rate production for both military and civilian uses. Adding the capability for rapid, on-command repack while maintaining the reliability and performance of existing parachute systems, and enabling tactics centered around advance logistics airdrops to support special operations, would attract attention from US Special Operations Command (USSOCOM), Air Combat Command (ACC), and similar agencies within the Department of Defense.    It is fully anticipated that this technology would have simultaneous, broad applicability to the members of the US Parachute Association (USPA) and the international Fédération Aéronautique Internationale (World Air Sports Federation) that regulates and encourages the recreational skydiving community around the world. The products delivered in this effort are expected to be directly applicable to an existing sport with significant mass-market attraction, and a viable business model from the skydiver audience – for example, the US Parachute Association alone has over 35,000 members.   REFERENCES: [1] USPA Dropzone Locator, United States Parachute Association. https://uspa.org/DZlocator   KEYWORDS: Systems Level, Handling, Product Design, System sbir_topic_link: https://www.sbir.gov/node/2464925 subtopics: [ ] - topic_title: Additive Components Enhanced for Extreme Environments (ACE3) branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-15 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Materials   The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws.   OBJECTIVE: The Additive Components Enhanced for Extreme Environments (ACE3) effort seeks to dramatically reduce lead times for critical components in turbine systems by enhancing the high temperature mechanical properties of additively manufactured superalloys through novel post-processing techniques. Proposals must focus on difficult to source, long lead time components that control system efficiency and lifetime; in particular, high-performance components used in the hot gas path of power and propulsion turbines. This topic is soliciting Direct to Phase II (DP2) proposals only.   DESCRIPTION: The Department of Defense (DoD) faces technical and procurement challenges with hot-section components in turbines (e.g., blades, vanes, seals, etc.) across various ground and aerospace platforms. These components operate in high temperature oxidizing environments while under extreme mechanical loads, requiring specialized materials and manufacturing techniques. Traditionally, these hot-section components are produced by casting nickel-based superalloys using a directional or single crystal solidification approach. These specialized casting techniques are costly and time-consuming, resulting in part replacement lead times averaging 18 to 36 months due to the highly specialized knowledge and equipment required to produce parts.     The objective of ACE3 is to reduce critical hot-section turbine part lead times by exploiting the supply chain advantages of additive manufacturing (AM).. Melt-based AM of nickel-based superalloys offers advantages in precision, reduced scrappage, enhanced design freedom, shorter lead times, and a potential reduction in manufacturing costs compared to conventional directional or single crystal casting operations. However, AM techniques typically impart a fine grain size (e.g., 10-100 µm), resulting in inferior high-temperature creep properties compared to those of directionally solidified or single crystal materials [1]. Therefore, while additively manufactured blades and vanes are extremely attractive for next-generation engine designs and sustainment of DoD’s existing fleet, implementation is inhibited by poor high-temperature mechanical properties. To address this issue, the ACE3 project seeks to demonstrate new post-processing technologies that dramatically enhance the high-temperature mechanical behavior of hollow core or net-shaped nickel-based superalloys fabricated with laser powder bed fusion (LPBF) by transforming the as-built components from fine (<100 µm) grain structure to coarse (>1 mm) grain structure, resulting in creep performance improvement by at least an order-of-magnitude. Electron beam additive manufacturing is specifically not of interest due to inherent issues with short filament lifetimes and de-powdering of hollow core structures.    Proposals must include: (1) an effective strategy for addressing difficult to source, long lead time components that control efficiency and lifetime in the hot gas path of turbine engines; (2) the proposer’s familiarity with turbine design including the basic functional and design requirements of hot-section components; and (3) alloy(s) of interest to be tested and a relevant component design to evaluate the proposed post-processing strategy. Proposals are not limited to current component designs – novel designs uniquely enabled through additive manufacturing are encouraged.   PHASE I: This topic is soliciting Direct to Phase II (DP2) proposals only. Previous efforts must have demonstrated a post-processing approach capable of achieving the milestones and metrics listed below supported by prior laboratory testing results:  Demonstrated ability to perform post-processing on a commercially relevant nickel-based superalloy additively manufactured via laser powder bed fusion (LPBF), such as Inconel 738LC (IN738LC). Demonstrated at least 10x increase in grain size relative to the as-built material along the build direction following post-processing. Demonstrated the ability to retain at least 20% (area fraction) <100> cube texture in the build direction following post-processing. Demonstrated the ability to control grain structure as a function of position within a test article with cm-scale precision   PHASE II: The ACE3 DP2 project seeks to build on the accomplishments listed in the Phase I section above to: (1) fully characterize the high-temperature mechanical properties of additively manufactured superalloy test specimens with and without the demonstrated post-processing strategy; (2) apply the validated post-processing strategy to an exemplary component design fabricated by LPBF; and (3) confirm the structure and properties match those expected from baseline coupon-level testing while also demonstrating the ability to successfully process components at scale with a scrap rate <5%. Final components must be subject to proof testing in a relevant environment to verify functional performance (TRL 6). Performers must bring their own exemplar design and propose a component-level test strategy sufficient for TRL 6 justification. The Phase II effort will consist of a 12-month base period with a 12-month option period.   Schedule/Milestones/Deliverables: Phase II fixed milestones for this program must include: Month 1: Project kickoff meeting; all supporting positions identified in the proposal are assigned to personnel and names are provided to the Government. Month 3: Preliminary high-temperature mechanical test results on additively manufactured superalloy coupons in as-built and post-processed conditions using the proposed strategy. Quarterly presentation detailing results. Month 6: Complete mechanical test results demonstrating statistically significant improvement in high-temperature material properties. System requirements and preliminary design for processing exemplary components. Month 6 technical report and presentation detailing results. Month 9: Final design, development plan and preliminary results for exemplary component processing. Quarterly presentation detailing results. Month 12: Process demonstrated for the exemplary component, including measurements meeting the target geometry and microstructure. Process automation reduced to practice to produce sufficient parts for system-level testing. Month 12 technical report and presentation detailing results.   Option Milestones/Deliverables: Month 15: Quarterly presentation detailing part manufacturing progress toward system-level testing. Month 18: Components manufactured, post-processed, and delivered to test facility. Technical report and presentation detailing results. Month 21: Results of system-level testing in a relevant environment (TRL 6). Post mortem analysis completed on tested components and assessment of outcome. Quarterly presentation detailing results. Month 24: Final Phase II report and technical presentation summarizing all results, lessons learned, and potential transition path.  Technical reports must be delivered in Microsoft Word or PDF format; presentations must be delivered in Microsoft PowerPoint or PDF format.   PHASE III DUAL USE APPLICATIONS: The novel post-processing technology developed under this effort will have widespread application in both military and commercial gas turbine engines used in power generation and propulsion. Enabling additive manufacturing of hot-section components will achieve more reliable and efficient supply chains, a decrease in overall costs, and the ability to explore novel component designs for improved thermal efficiency and fuel economy.   REFERENCES: V. Kalyanasundaram, A. De Luca, R. Wróbel, J. Tang, S.R. Holdsworth, C. Leinenbach, E. Hosseini, “Tensile and creep-rupture response of additively manufactured nickel-based superalloy CM247LC”, Additive Manufacturing Letters 5 (2023) 100119. https://doi.org/10.1016/j.addlet.2022.100119.   KEYWORDS: gas turbines, power generation, jet engine propulsion, sustainment, advanced materials, additive manufacturing, high temperature mechanical properties sbir_topic_link: https://www.sbir.gov/node/2464947 subtopics: [ ] - topic_title: 'Prospero: Modernizing Secure Facility Design, Construction, and Accreditation' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-16 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Human-Machine Interfaces,Trusted AI and Autonomy   OBJECTIVE: Consolidations and acquisitions in the Defense Industrial Base (DIB) make it imperative for new small businesses to emerge to promote innovation and competition. However, strict requirements for classified program execution inhibits these new small businesses from immediately performing on programs. The major inhibitors are cost (monetary and time) and process (convoluted based on sponsor, location, and accreditor). Significant resources can be sunk into the Secure Area/Sensitive Compartmented Information Facility (SCIF)/Special Access Program Facility (SAPF) construction and accreditation process with no guarantees that the completed area would actually be usable. Several businesses have emerged that specialize in constructing such facilities, but offer their expertise as a significant markup that is cost prohibitive for small businesses. Existing research into Language Models (LMs) has been done to provide a means to both fill in the blanks within sentences based on context clues and automate an interactive knowledge base from a knowledge corpus. Additional research has leveraged Artificial Intelligence (AI) for monitoring construction progress, comparing completed construction to initial designs, and identifying materials from construction images.   This Defense Advanced Research Projects Agency (DARPA) topic is seeking technologies for automating, scaling, updating, and simplifying the process for applying, designing, constructing, and validating Secure Areas/SCIFs/SAPFs. Prospero performers will explore approaches and develop prototypes for automating paperwork, designing secure rooms, and overseeing construction. Prospero is interested in software tools that can be utilized by non-security personnel at all steps of the design and accreditation process that can also be offered at a minimal cost to the end-user.   DESCRIPTION: Performers will develop approaches for utilizing AI, Machine Learning (ML), and LMs to automate, update, and improve secure facility design, paperwork, oversight, and validation. Prospero prototypes should be able to demonstrate the ability to automate the paperwork processes, reduce the barrier to entry for secure facility design, and streamline the process for overseeing facility construction.   The program seeks breakthrough approaches to various technical challenges, including but not limited to: Developing efficient models and techniques for automating accreditation paperwork Developing efficient algorithms and techniques for monitoring secure facility construction to meet auditing requirements Developing tools for non-experts to be able to fulfill accreditation reporting requirements Understanding the accreditation process across multiple sponsors Streamlining disparate sponsor requirements into a single knowledge base   PHASE I: This is a Direct to Phase II (DP2) solicitation. Therefore, Phase I proposals will not be accepted or reviewed. Phase I feasibility will be demonstrated through evidence of: a completed feasibility study or a basic prototype system; definition and characterization of properties desirable for both Department of Defense (DoD) and civilian use; and comparisons with alternative state-of-the-art methodologies (competing approaches). This includes determining, insofar as possible, the scientific and technical merit and feasibility of ideas appearing to have application to the core objective of automating the design, submission, and validation of secure facilities. Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above have been met and describe the potential military or commercial applications. DP2 documentation should include: technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, and risks/mitigations, assessments; presentation materials and/or white papers; technical papers; prototype designs/models;   This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and ability in computer science, physical security, electrical engineering, and software engineering. For detailed information on DP2 requirements and eligibility, please refer to the DoD BAA and the DARPA Instructions for this topic.   PHASE II: The goal of Prospero is to design and evaluate tools and techniques for automating and streamlining secure facility design, construction, and accreditation. Proposals should include development, installation, integration, demonstration and/or test and evaluation of the proposed prototype system. These activities should focus specifically on: Evaluating the adapted solution against the proposed objectives Describing in detail how the installed solution differs from the non-defense commercial offering to solve DOD need(s) as well as how it can be scaled for wide adoption, i.e., modified for scale across additional sponsors. Identifying the proposed solution's clear transition path considering input from affected stakeholders, including but not limited to, end users, engineering, sustainment, security, contracting, finance, legal, and cyber. Specifying the solution's integration with other current and potential future solutions. Describing the solution's sustainability, i.e., supportability. Identifying other specific DoD or Governmental customers for the solution.   Phase II will culminate in a system demonstration using one or more compelling use cases consistent with commercial opportunities, DOD opportunities, and/or insertion into a DARPA program. The below schedule of milestones and deliverables is provided to establish expectations and desired results for the Phase II effort.   Schedule/Milestones/Deliverables: Proposers will execute Research and Development (R&D) plan as described in their proposal. Proposers will also complete a commercialization plan that addresses relevant material costs and potential material/equipment suppliers. Month 1: Phase II Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) (in person or virtual, as needed) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, proposed metrics, and plan for prototype demonstration/validation. Months 2, 4: Technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (while this will normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. Month 6: Interim technical progress briefing (live system demo with annotated slides) to the DARPA PM (in-person or virtual as needed) detailing progress made (include quantitative assessment of capability developed to date), tasks accomplished, major risks/mitigations, planned activities, and technical plan for the remainder of Phase II, the demonstration/verification plan for the end of Phase II, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. Month 9, 12, 15: Quarterly technical progress reports detailing technical progress made, tasks accomplished, major risks/mitigations, a technical plan for the remainder of Phase II (with necessary updates as in the parenthetical remark for Months 2 and 4), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. Month 18/Final Phase II Deliverables: Final demonstration with documented details, demonstrating accreditation paperwork automation; demonstrating automated SCIF/SAPF design for multiple sponsors; demonstrating construction oversight that meets auditing requirements; any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; and the end of phase commercialization plan).   PHASE III DUAL USE APPLICATIONS: Phase III work will be oriented towards transition and commercialization of the developed Prospero technologies. The proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype software into a viable product or non-R&D service for sale in military or private sector markets. Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program.   Primary Prospero support will be to national efforts for growing the DIB and improving secure facility construction processes. Such technology can be used to enable any small business to construct secure facilities while minimizing the risks associated with the current processes.   REFERENCES: Donahue, Chris, Mina Lee, and Percy Liang. "Enabling language models to fill in the blanks." arXiv preprint arXiv:2005.05339 (2020). Gil, Daeyoung, Ghang Lee, and Kahyun Jeon. "Classification of images from construction sites using a deep-learning algorithm." ISARC. Proceedings of the International Symposium on Automation and Robotics in Construction. Vol. 35. IAARC Publications, 2018. Mahami, Hadi, et al. "Material recognition for automated progress monitoring using deep learning methods." arXiv preprint arXiv:2006.16344 (2020). Petroni, Fabio, et al. "Language models as knowledge bases?." arXiv preprint arXiv:1909.01066 (2019).   KEYWORDS: physical security, construction monitoring, language models, knowledge base, accreditation sbir_topic_link: https://www.sbir.gov/node/2464959 subtopics: [ ] - topic_title: ' Artificial Intelligence Cyber Challenge (AIxCC)' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234-17 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software, Integrated Sensing and Cyber, Trusted AI and Autonomy   OBJECTIVE: The objective of the Artificial Intelligence Cyber Challenge (AIxCC) SBIR topic is to develop innovative systems guided by Artificial Intelligence (AI) and Machine Learning (ML) to semi-automatically find and fix software vulnerabilities.   DESCRIPTION: In an increasingly interconnected world, software undergirds everything from modern financial systems to public utilities, and older software is unable to be secured manually at scale [1] [2]. Critical infrastructure is among the worst affected; most vulnerabilities within these systems go unidentified, and a majority of the identified vulnerabilities have no patch or mitigation [3]. This state of affairs presents a serious threat to U.S. national security.     Today, manual vulnerability discovery and remediation requires subject matter experts (SME) who can identify and investigate vulnerabilities within software and develop fixes for them. Beginning with the invention of fuzz testing in 1988 [4], the development of tools and techniques for automatic vulnerability discovery and remediation (AVD&R) has continued to move forward toward systems that implement logical reasoning and program analysis approaches to identify and characterize software vulnerabilities.  Recent advancements in AI and ML, such as Large Language Models (LLMs), have potential to push AVD&R beyond the inherent barriers of today’s logical reasoning systems. By leveraging their symbolic abstractions, neural networks and deep learning techniques can be harnessed to reduce false positives and produce more precise tooling, significantly reducing human intervention. A neuro-symbolic approach could learn novel vulnerability patterns, moving far beyond the capabilities of current tools. Further, by leveraging ML to generate code, patches can be generated automatically at scale. LLMs, have shown enormous potential for reasoning over software, and provide a strong foundation for innovation in AVD&R. Automatic code generation tools, such as CodePilot [5], have been able to write parts of software with little human-intervention. Further, ChatGPT [6] [7] has been shown to be able to accurately find, characterize, and fix certain vulnerabilities. LLMs will also enable new approaches to computer-human teaming for AVD&R, ameliorating the friction found in current tools that prevents their widespread use. [7]   The objective of AIxCC is to facilitate innovation at the intersection of AVD&R and AI to secure widely used code that underpins critical infrastructure.   PHASE I: This is a Direct to Phase II (DP2) solicitation. Therefore, Phase I proposals will not be accepted or reviewed. Phase I feasibility will be demonstrated through evidence of: a completed feasibility study or a basic prototype system; definition and characterization of properties desirable for both Department of Defense (DoD) and civilian use; and comparisons with alternative state-of-the-art methodologies (competing approaches). This includes determining, insofar as possible, the scientific and technical merit and feasibility of ideas appearing to have application to the core objective of developing a framework for scalable and automated discovery of vulnerabilities in arbitrary complex systems. Proposers interested in submitting a DP2 proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above have been met and describe the potential military or commercial applications. DP2 documentation should include: •     technical reports describing results and conclusions of existing work, particularly regarding the commercial opportunity or DoD insertion opportunity, and risks/mitigations, assessments; •     presentation materials and/or white papers; •     technical papers; •     test and measurement data; •     prototype designs/models; •     performance projections, goals, or results in different use cases.   This collection of material will verify mastery of the required content for DP2 consideration. DP2 proposers must also demonstrate knowledge, skills, and ability in computer science, mathematics, physics, electrical engineering, and/or software engineering or related disciplines. For detailed information on DP2 requirements and eligibility, please refer to the DoD BAA and the DARPA Instructions for this topic.   PHASE II: The goal of AIxCC is to leverage advancements in AI and ML, such as LLMs, create open-source solutions for semi-automatically discovering and remediating software vulnerabilities at speed and at scale to secure widely used critical code. These open-source systems should be well documented and tested against a suit of tests to determine efficacy.    DP2 proposals should: describe a proposed system to achieve the aforementioned goals and present a technical plan and approach, with notable risks/mitigations.  provide an proposed plan to open-source the system under an Open Source Inititative (OSI) approved license.   Phase II will include a test and evaluation event where the system must demonstrate its efficacy against a set of AVD&R challenges.   A Phase II Option period will further mature AIxCC systems to expand applications to additional technology transition and prototype activities for the DoD, another Federal agency, or the private sector. The Phase II Option will be contingent on results from a test and evaluation of the final Phase II prototype system. All Phase II Option matured prototypes must be open-sourced with appropriate licensing.   The below schedule of milestones and deliverables is provided to establish expectations and desired results/end products for the Phase II and Phase II Option period efforts.    Schedule/Milestones/Deliverables:   Proposers will execute a Research and Development (R&D) plan as described in their proposal including the following fixed payable milestones for this program: •     Month 1: Phase II Kickoff briefing (with annotated slides) to the DARPA Program Manager (PM) including: any updates to the proposed plan and technical approach, risks/mitigations, schedule (inclusive of dependencies) with planned capability milestones and deliverables, and plan for prototype. •     Month 3: Technical progress report detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of Phase II (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. •     Month 6: Test and evaluation of final prototype via participation in an AIxCC competition event.  •     Month 9: Final technical progress briefing (with annotated slides) to the DARPA PM. Final architecture with documented details and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document; the commercialization plan; and a proposed license and plan for open-sourcing the system).   Phase II Option Period •     Months 12 and 15 (Phase II Option period): Technical progress reports detailing technical progress to date, tasks accomplished, risks/mitigations, a technical plan for the remainder of the Phase II Option period (while this would normally report progress against the plan detailed in the proposal or presented at the Kickoff briefing, it is understood that scientific discoveries, competition, and regulatory changes may all have impacts on the planned work and DARPA must be made aware of any revisions that result), planned activities, trip summaries, and any potential issues or problem areas that require the attention of the DARPA PM. •     Month 18 (Phase II Option period): Test and evaluation of matured prototype via participation in an AIxCC competition event. •     Month 22 (Phase II Option Period): Final Phase II Option period technical progress (with annotated slides) to the DARPA PM. Final architecture with documented details and any other necessary documentation (including, at a minimum, user manuals and a detailed system design document, the commercialization plan; and a link to a open-source licensed source code repository for the matured prototype used in Month 18 test and evaluation).   PHASE III DUAL USE APPLICATIONS: AIxCC has potential applicability across DoD and commercial entities. For USG, AIxCC is well-suited for scaled cybersecurity analysis of real-world systems. AIxCC has the same applicability as the USG for the commercial sector.     Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. The Phase III work will be oriented towards transition and commercialization of the developed AIxCC frameworks. The proposer is required to obtain funding from either the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in military or private sector markets. Primary AIxCC support will be to national efforts to explore the ability develop automated cybersecurity tools applicable to real-world systems. Results from AIxCC are intended to improve cybersecurity posture and assessment across government and industry.   REFERENCES: Carnegie, "Timeline of Cyber Incidents Involving Financial Institutions," 2022. [Online]. Available: https://carnegieendowment.org/specialprojects/protectingfinancialstability/timeline. A. Haines, "DNI HAINES OPENING STATEMENT ON THE 2023 ANNUAL THREAT ASSESSMENT OF THE U.S. INTELLIGENCE COMMUNITY," DNI, 2023. Dragos, "ICS/OT CYBERSECURITY YEAR IN REVIEW 2022," Dragos, 2022. B. Miller, CS 736 Fall 1988, 1988. OpenAI, "Evaluating Large Language Models Trained on Code," 2021. D. Sobania, M. Briesch, C. Hanna and J. Petke, "An Analysis of the Automatic Bug Fixing Performance of ChatGPT," in arXiv:2301.08653, 2023. E. Dreibelbis, "Watch Out, Software Engineers: ChatGPT Is Now Finding, Fixing Bugs in Code," PCMag, 27 January 2023. [Online]. Available: https://www.pcmag.com/news/watch-out-software-engineers-chatgpt-is-now-finding-fixing-bugs-in-code.   KEYWORDS: Cybersecurity, Vulnerability Research, Static Analysis, Symbolic Execution, Dynamic Analysis, Computer Network Security sbir_topic_link: https://www.sbir.gov/node/2464965 subtopics: [ ] - topic_title: 'Project CAPTURE: Capturing Aerial Payloads To Unleash Reliable Exploitation – SBIR XL' branch: Defense Advanced Research Projects Agency topic_number: HR0011SB20234XL-05 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Human-Machine Interfaces   OBJECTIVE: Develop and demonstrate a prototype system to capture and recover exploitable payloads from slow speed high-altitude aerial systems of interest within or approaching U.S. sovereign airspace.   DESCRIPTION: Recent incursions of U.S. airspace demonstrated limitations of the ability to recover sensitive payloads from slow-speed high-altitude objects in a manner that is both effective for follow on exploitation and scalable to employment over diverse geographic areas. The military’s current ability to respond to slow-moving, high-altitude objects is constrained by physics and the capabilities of current weapons systems. For example, the F-22 is one of few aircraft able to operate at an altitude above 50,000 feet. Additionally, these aircraft travel at hundreds of miles per hour while attempting to identify and target slow-moving or stationary objects. Aerial systems of interest are typically downed in areas of lower risk to humans. These constraints, coupled with current technical capabilities, result in limited engagement opportunities and difficult recovery operations.          The DARPA CAPTURE effort seeks to rapidly develop and demonstrate an integrated prototype system to capture and retrieve aerial systems of interest flying slowly at high altitudes under positive control in a manner safe to the surrounding area while maximizing exploitation of the captured system. Solutions should address the following unique challenges: •     Aerial systems of interest may range from 500 pounds (threshold) to 1,500 pounds (objective) •     Aerial systems of interest may constitute varying sizes or shapes •     Aerial systems of interest may operate up to 60,000 feet (threshold) to 75,000 feet (objective) •     Captured systems should include the aerial system’s payloads (threshold) or the entirety of the aerial system of interest (objective) •     Capture of aerial systems of interest should be in a manner allowing for controlled descent for recovery near inhabited or otherwise currently avoided recovery areas •     Captured aerial systems of interest should be in a condition maximizing the ability for technical exploitation upon recoverySolution response time to aerial systems of interest approaching or within any U.S. sovereign airspace should scale to an order of hours after an engagement decision.    Solutions should take advantage of existing military and commercial logistics infrastructure where possible. Solutions should clearly identify what existing technologies or systems would be used as part of the approach. Examples may include, but are not limited to, involvement of specific slow-moving aircraft or use of surface-based systems. Solutions requiring additional government furnished information, dependencies, or equipment to be potentially provided as part of the solution should be clearly and plainly described for consideration of the proposed approach.   PHASE I: This topic is Direct to Phase II only. The desired system may leverage existing technologies and systems to rapidly integrate into a prototype system in order to demonstrate the desired objective capability. The proposal documentation should address the following areas to demonstrate system readiness to proceed straight to Phase II: •     Design, fabrication, and flight test experience of high-altitude systems that operate above 50,000 ft. •     Pedigree of the proposed concept to include any relevant prior test and analysis activities.   PHASE II: The base period should produce a fieldable prototype final design review that satisfies project objectives in no more than six months after contract award. A follow-on option phase should include a final demonstration no more than 9 to 12 months after contract award. This timeline emphasizes the desire for innovative yet simple development of readily available capabilities. The prototype system may use or modify existing technologies and operational systems (military or commercial) to rapidly achieve program objectives.     The performer will be expected to provide a Statement of Work (SOW) listing tasks and associated subtasks required to meet the following deliverables commensurate within the stated timeline for this effort: •     Description and analysis of the concept of employment  •     Description and analysis of the concept of operations  •     System concept and designs to include any modification of existing designs  •     Technical, cost, and schedule risk analysis of the proposed approach •     Anticipated risk reduction testing plan and schedule •     Final prototype system hardware, software, and technical data packages •     Field test demonstration     The performer must identify what government information and assets must be made available as part of the development process and system testing (GFI and GFE). It is anticipated that multiple existing military systems may be required for completing the concept of operations. Engagement of these systems and organization functions is also expected to promote the rapid transition of the prototype system. Follow-on options to the base effort are expected to include the rapid incorporation into the operational systems and organizations.   PHASE III DUAL USE APPLICATIONS: Transition partners will be integral to the execution during the Phase II effort due to the rapid and inherent utilization of operational assets requirements.   REFERENCES: https://www.whitehouse.gov/briefing-room/speeches-remarks/2023/02/16/remarks-by-president-biden-on-the-united-states-response-to-recent-aerial-objects/   https://www.defense.gov/News/News-Stories/Article/Article/3297104/chinese-surveillance-balloons-global-in-scope-says-official/   KEYWORDS: Manned/unmanned air vehicles; missiles; air capture/retrieval systems sbir_topic_link: https://www.sbir.gov/node/2464973 subtopics: [ ] - topic_title: Anti-Shock Drug, Pre-Hospital (ASD-PH) branch: Defense Health Agency topic_number: DHA234-D001 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care OBJECTIVE: Develop a drug that would be useful in a pre-hospital setting for treatment of hemorrhagic shock in humans. DESCRIPTION: Severe blood loss, such as may be experienced in combat or other settings, if left untreated, will result in a deficiency of oxygen that will lead to the death of cells, tissues, and organs, and ultimately death. A pharmaceutical solution is required to address, in a pre-hospital setting, this life-threatening situation. The desired benefits of the drug are that its administration would increase the probability of survival, reduce the need for other treatment products, and reduce the need for prompt medical evacuation. The following characteristics are considered desirable: (1) The drug would most likely be administered promptly after injury, before blood or blood components are administered; however, a drug that would be administered as a pre-treatment, prior to injury, would also be of interest. (2) The drug would be administered in a low volume, perhaps 5 to 20 milliliters, to minimize the burden of transporting it and administering it. (3) The drug would be stable (retain its effectiveness) for at least one year over a broad temperature range such as 2 to 40 degrees Celsius. (4) The drug would be amenable to administration by several routes, such as oral, intravenous, intraosseous, inhalation, and intramuscular. PHASE I: DoD seeks the identification of an active pharmaceutical ingredient (API), administration of which will provide effective treatment of shock in a pre-hospital setting. The performer will determine the scientific, technical, and commercial merit and feasibility of such an API. Upon conclusion of Phase I, the performer will have: • Identified a concept for the mechanism of action for the API. • Ascertained key elements (chemical moieties) of the API. • Produced a candidate formulation, for one or more routes of administration, for the API. • Performed a detailed analysis of predicted performance (safety and efficacy) of the API as formulated for administration. • Defined key technological milestones for development of the API into a drug approvable bythe Food and Drug Administration (FDA) for human use. • Demonstrated the feasibility of analyzing the safety and efficacy of the API when formulatedfor administration and outlined the criteria for success. This topic is accepting Direct to Phase II (DPII) proposals ONLY. Proposers submitting a DPII proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above has been met and describes the potential commercial applications. Documentation should include all relevant information including, but not limited to, technical reports, test data, and performance goals/results. PHASE II: The expectations and required deliverables for Phase II work are: • Using results from Phase I, produce a batch of candidate ASD-PH formulated foradministration to one or more vertebrate species as part of pre-clinical testing. • Test a candidate ASD-PH for efficacy in a suitable animal model. The animal model mustinvolve blood loss that, untreated, would reproducibly lead to death of most test subjectsfrom shock within approximately 60 minutes after blood loss. • Prepare a Product Development Plan and seek comments from the FDA on its acceptability. • Manufacture a batch of candidate ASD-PH suitable for pre-clinical testing of safety under Good Laboratory Practices (GLPs). • Perform Investigational New Drug (IND)-enabling studies. • Update/revise the Product Development Plan to take into account the results of pre-clinicaltesting and FDA advice. • Deliver a Technical Data Package containing submissions to the FDA, communications fromthe FDA, and the Product Development Plan. • Upon request by the Government sponsor, deliver a sample of candidate ASD-PH to the Government for retention and/or analyses at no cost to the performer. The quantity of sample delivered to the Government will not be so great as to interfere with the performer’s plans for development. PHASE III DUAL USE APPLICATIONS: Phase III will culminate in an FDA-approved treatment for shock suitable for use in role 1 of military health care and in similar non-military austere settings such remote areas where paramedics and other personnel provide emergency medical treatment. It will be the logical conclusion of product development conducted in phases I and II. Phase III work will include the engagement of relevant stakeholders within DoD to ensure that product labeling and packaging are accomplished with due consideration of military operational requirements and logistical support. REFERENCES: 1. Campion EM, Pritts TA, Dorlac WC, Nguyen AQ, Fraley SM, Hanseman D, Robinson BR.Implementation of a military-derived damage-control resuscitation strategy in a civiliantrauma center decreases acute hypoxia in massively transfused patients. J Trauma Acute CareSurg. 2013 Aug;75(2 Suppl 2):S221-7. doi: 10.1097/TA.0b013e318299d59b. PMID:23883912; PMCID: PMC4245019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4245019/ 2. Huang Q, Gao S, Yao Y, Wang Y, Li J, Chen J, Guo C, Zhao D, Li X. Innate immunity andimmunotherapy for hemorrhagic shock. Front Immunol. 2022 Aug 25;13:918380. doi:10.3389/fimmu.2022.918380. PMID: 36091025; PMCID: PMC9453212. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9453212/ KEYWORDS: Trauma; energy metabolism; hemorrhagic shock; hypoxia sbir_topic_link: https://www.sbir.gov/node/2414739 subtopics: [ ] - topic_title: > Open Topic for Temporary Stabilization of Corneal and Corneoscleral Injuries branch: Defense Health Agency topic_number: DHA234-P001 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care OBJECTIVE: The objective of this topic is the development of a non-surgical prototype technology capable of obtaining approval/clearance by the Food and Drug Administration (FDA) that is simple enough for medical personnel to administer in a theater of operations (TO) with minimal additional training that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries during transport to a higher echelon of care where surgical intervention is available. This award will seek offerors to engage the FDA, conduct Good Laboratory Practice (GLP) animal studies, and deliver prototype devices to the government. DESCRIPTION: Ocular injuries are common occurrences among warfighters, occurring disproportionately compared to injuries affecting more protected areas of the body. The cornea is the first tissue of the ocular structure and often impacted first in trauma. Combat corneal injuries often have a significant impact on vision and there can be significant delays in receiving specialty care for combat ocular trauma. In recent combat operations corneal puncture injuries resulted in poor visual outcomes often resulting in blindness. This is predominantly due to inadequate battlefield interventions to close the open ocular wounds and restore intraocular pressure. A study published in 2020 describes the cause and type of ocular injuries in modern warfare and analyzed all patients with eye injuries from the Iraq and Afghanistan conflicts who were treated at Military Treatment Facilities (MTF). They reported 67,586 persons were admitted to either a United States or United Kingdom MTF for treatment of injuries. 8-10% of wounded soldiers had ocular injuries. 82% of those injuries occurred in battle and 71% were from explosions, and 56% had open globe injuries. [1] If an open globe (OG) injury is suspected on the battlefield, a rigid eye shield is applied to protect the eye, and the injured warfighter is evacuated to an ophthalmic specialist. Then, OG injuries are closed with sutures to create a watertight seal. This may occur up to 24 hr post-injury currently and is expected to increase up to 72 hr in future combat operations where air evacuation may not be guaranteed. [2-4] However, 53% of OG injured eyes retain intraocular foreign body upon injury and require evacuation to an ophthalmic specialist for surgical intervention. [5] In order to address corneal and corneoscleral injuries earlier and in a way that is relevant to the the austerity encountered in a TO, a product that allows for temporary stabilization of corneal and corneoscleral injuries is needed. The temporary cornea repair (TCR) will serve as a bridge management strategy that will remain in place until more definitive care is available. The TCR capability will be in support of MTFs associated with the Military Healthcare System at Role of Care (RoC) 2 (Forward Resuscitative Surgical Team) and RoC 3 (Combat Support Hospital). For a description of RoC please see the reference section. PHASE I: This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror shall provide detail and documentation which demonstrates the accomplishment of a "Phase I-like" effort, including a feasibility study. This includes, insofar as possible, the scientific and technical merit of a non-surgical prototype that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries. Feasibility documentation of particular interest is prior evidence leading to: • Preliminary data to support the safety and efficacy of the prototype. • Design specifications for the prototype. • GLP-biocompatibility (in vitro and in vivo) safety validation data if available. • Statistically significant performance data if available. PHASE II: This phase will focus on refinement and optimization of a non-surgical prototype that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries and can be tested in a military relevant environment. Offerors should propose technology solutions ranging from initial testing of design concepts and evaluation of candidate(s) where study endpoints are defined, and animal models are proposed. ((Technology Readiness level (TRL) 3)) to component validation in a non-GLP laboratory environment to refine hypothesis and identify relevant statistical data required for further technological assessment (TRL 4). Further information regarding DOD Biomedical TRLs can be found in the reference section. The work may include, but is not necessarily limited to, the following: • Prototype refinement/maturation progressing towards clinical product • Preclinical studies (as needed) to support an Investigational Device Exemption (IDE) (or • other appropriate FDA) submission • Preclinical studies under GLP (as needed) to support IDE (or other appropriate FDA) submission • IDE (or other appropriate FDA) submission • Stability and shelf-life studies if performed • Establishment of Good Manufacturing Practice (GMP) planning for clinical trials and for market release • The performer is expected deliver up to 4 prototypes for military relevant testing. The desired prototype should be simple enough for medical personnel to administer in a TO with minimal additional training, safe enough to use on any suspected corneal or corneoscleral injuries, capable of maintaining a tight seal for an extended period during transport, and effective at stabilizing the eye such that it preserves eyesight. PHASE III DUAL USE APPLICATIONS: The goal for this Phase is to further development and testing of the prototype through commercialization and FDA approval for its intended use as a temporary stabilization of corneal and corneoscleral injuries. The temporary cornea repair would need to serve as a bridge management strategy that will remain in place until more definitive care is available. Military uses of this technology would support RoC 2 and 3, as well as a mass casualty event where casualties greatly overwhelm first responders and patients need to be triaged to preserve life, limb, and sight. REFERENCES: 1. [1] Breeze J, Blanch RJ, Mazzoli R, DuBose J, Bowley DM, Powers DB. Comparing the Management of Eye Injuries by Coalition Military Surgeons during the Iraq and Afghanistan Conflicts. Ophthalmology. 2020 Apr;127(4):458-466. 1. [2] Linde, A. S., Mcginnis, L. J. & Thompson, D. M. Multi-battle domain-perspective in military medical simulation trauma training. J Trauma Treat https:// doi. org/ 10. 4172/ 2167- 1222. 10003 91 (2017). 2. [3] Riesberg, J., Powell, D. & Loos, P. The loss of the golden hour. Special Warfare Mag. 30(1), 49–51 (2017). 3. [4] Army, U. S. The US army in multi-domain operations 2028. TRADOC Pamphlet 525, 3–1 (2018). 4. [5] Vlasov, A. et al. Corneal and Corneoscleral Injury in Combat Ocular Trauma from Operations Iraqi Freedom and Enduring Freedom. Mil. Med. 182, 114–119, https://doi.org/10.7205/MILMED-D-16-00041 (2017). 5. Roles of Care doctrine: https://www.jcs.mil/Portals/36/Documents/Doctrine/pubs/jp4_02ch1.pdf 6. Combat Ocular Trauma: Open-globe wounds in operation Iraqi Freedom and Operation Enduring Freedom: risk factors for poor visual outcomes and enucleation; Harris JP, Justin GA, Brooks DI, Woreta FA, Agrawal RV, Ryan DS, Weichel ED, Colyer MH.; Acta Ophthalmol. 2021 Dec. 7. Military Relevant Testing: Development and Characterization of a Benchtop Corneal Puncture Injury Model; Eric J. Snider, Lauren E. Cornell, Jorge M. Acevedo, Brandon Gross, Peter R. Edsall, Brian J. Lund, and David O. Zamora; Sci Rep. 2020; 10: 4218. KEYWORDS: Cornea injuries, corneoscleral injuries, corneal repair, combat ocular trauma, open globe injuries, roles of care sbir_topic_link: https://www.sbir.gov/node/2414741 subtopics: [ ] - topic_title: High Performance Clock Oscillator branch: Defense Microelectronics Activity topic_number: DMEA234-D01 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Microelectronics; Space Technology   OBJECTIVE: The Department of Defense(DoD) is seeking the development of a high performance, full in-system programmable, industrial  temperature rated (storage -55C to 125 C; operational -40 C to 105 C), US Sources, high G (30kG) operational shock, performance better than 0.001 ppb/g, 100kG survival shock, lower power (<30mW @ 1.8V), supply range 1.8 – 3.3V, microelectromechanical systems (MEMS) oscillator smaller than 9mm in area packaged and He proof, while capable of operations from 1 to 105 MHz with frequency stability of 0.5ppm in operational temperature range, the Allan deviation (ADEV ) better than 1E-11 in 1 to 9 Sec. The device shall be printed circuit board (PCB ) surface mountable with a large central electrically conductive pad for mechanical stability and seek to minimize the overall footprint and volume to the maximum extent possible.   DESCRIPTION: There are many applications for the DoD  which require high precision, low Size, Weight, Area and power (SWAP) clock sources. For example, satellite communications (SATCOM ), global navigation satellite system (GNSS)  receivers require reference clocks that have high frequency stability, low phase noise and low power operations.  Additional applications related to fuzing and other high acceleration applications require the clock generators for microelectronics to be survivable and operational under high G environments. Harshness of military environments and application of microelectromechanical systems (MEMS) oscillators is well documented  [1]. Clock oscillators that can deliver high performance (50-100ppb frequency stability over operating temperatures, 1E-11 ADEV), low power, in system programming capability in the range of 1-105MHz are required. The oscillators should be operable under 30kG and survivable under 100kG shocks. Research on quartz crystals has demonstrated g-sensitivity of 2E-69/g [2] and MEMS oscillators have shown even lower sensitivity [3, 4].   PHASE I: Conduct a feasibility study and design of a MEMS oscillator with high performance and survivability under high-G conditions, 30kG and 100kG respectively. The consideration for the MEMS design shall be described. Architecture, design and methods of fabrication shall be defended regarding the following application-based specifications:   Frequency stability of 100ppb or better in the range of 1-105MHz. ADEV of 1E-11 in 1 to 9 Sec. Full in-system programmable for entire range. The oscillator shall operate over the temperature range (-55 to 105C). Power consumption <30mW@1.8V Operation from 1.8V to 3.3V. Operational under 30kG environment with low G-sensitivity of 0.001ppb/g. Survivable under 100kG shock.   The feasibility study shall detail the process and techniques used along with associated costs. If there are bulk quantity discounts factored in, the report shall disclose quantity price break points and which steps were discounted wherever relevant. It must include:   Proposed manufacturing processes flow and techniques used including dicing and etching methodologies, along with figures and diagrams describing the process. Bulk material and specification (i.e., crystal orientation, dopant species, resistivity, epi thickness, if any, etc.). Cost break down for manufacturing compared to existing (both commercial and research) and comparative theoretical options.  Methodologies and analysis techniques used for characterizing the proposed device.   The delivered report shall fully describe the proposed techniques and characterization methodologies, including a notional list of fabrication tools, facility requirements, and a program plan for follow-on phase development. If any of the above items cannot be fully addressed, the report must include relevant research and rationale that demonstrates their inapplicability to the proposed technique. If adhering to the above items is possible, but not financially feasible, the report must include relevant justification. Finally, the challenges and special considerations for testing of accelerometers under high-g stress environments shall be addressed.   FEASIBILITY DOCUMENTATION: Offerors interested in participating in Direct to Phase II must include in their response to this topic Phase I feasibility documentation that substantiates the scientific and technical merit and Phase I feasibility described in Phase I above has been met (i.e., the small business must have performed Phase I-type research and development related to the topic, but from non-SBIR funding sources) and describes the potential commercialization applications. The documentation provided must validate that the proposer has completed development of technology as stated in Phase I above. Documentation shall include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. Work submitted within the feasibility documentation must have been substantially performed by the offeror and/or the principal investigator (PI).   PHASE II: Build, test and deliver a fully functional MEMS oscillator based on the design developed in Phase I. Demonstrate the capability of performance while adhering to the specifications outlined in Phase I. Production yields should be considered to keep costs with commercialization a viable option. The final report shall address manufacturing yield and reflect that the tested prototypes were selected from across multiple lots to demonstrate repeatability and quality with low variation within wafer, wafer to wafer, and lot to lot. If a non-random selection was required to optimize performance, the final report must detail reasoning for using non-random selection and the selection criteria used.    Deliver a detailed final report that documents the cost breakdown per device, manufacturing processes utilized, fabrication toolset required to perform the proposed techniques, all facility requirements, all electrical characterization, and all device design data (Technology Computer Aided Design (TCAD) files, modeling/simulation results, etc.). If there are bulk quantity discounts factored in any of the cost breakdowns, the final report shall disclose quantity price break points and which steps were discounted wherever relevant. The final report shall contain sufficient technical detail such that an entity skilled in semiconductor fabrication can repeat the presented results.   PHASE III DUAL USE APPLICATIONS: This technology could be utilized for other DoD and commercial applications where high performance and/or repeated shock events may occur, such as precision SATCOM, GNSS microcircuits, fuzing and munition electronics, flight termination systems, or crash test instrumentation.   REFERENCES: T. G. Brown, “Harsh military environments and microelectromechanical (MEMS) device”, Proceedings of IEEE Sensors, vol 2, 2003  M Bloch et al, “Acceleration ‘G’ Compensated Quartz Crystal Oscillators”, 2009 IEEE International Frequency Control Symposium Joint with the 22nd European Frequency and Time forum, 2009 Bongsang Kim et al, “MEMS Resonators with extremely low vibration and shock sensitivity”, IEEE Sensors, 2011 Beheshteh Najafabadi, “Study of Acceleration Sensitivity and Nonlinear Behavior in Silicon-based MEMS Resonators”, Doctoral Dissertation, University of Central Florida, 2019   KEYWORDS: MEMS, Temperature compensated Crystal Oscillator (TCXO ), Oscillators sbir_topic_link: https://www.sbir.gov/node/2465015 subtopics: [ ] - topic_title: > Portable Automated Solution for the Library Preparation for Sequencing branch: Defense Threat Reduction Agency topic_number: DTRA234-001 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Biotechnology   The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws.   OBJECTIVE: DTRA seeks to develop a portable tool capable of preparing DNA and RNA libraries for sequencing utilizing a minION in a tactical environment. Further automatization is envisioned to extract, purify, and isolate the genomic library for use in sequencing using the minION. Successful development of this tool will provide benefits to both government and commercial users of the minION sequencing capability by decreasing both the operator load and potential error in the preparation of biological samples.   DESCRIPTION: Biological Warfare Agent (BWA) detection and identification options for tactical users are limited in both the available technologies and scope of the ID capability. Lab-based theater confirmatory DNA and RNA sequencing are possible, but are not technically or tactically feasible for operators at the current time. Additionally, the methods employed by operators, Hand Held Assay (HHA) and Polymerase Chain Reaction-based (PCR) tools, are definitively limited to known and specifically targeted BWAs. Sequencing, however, is capable of having a BWA library that is only limited by available processing power and available genomic data. The specific need for these users is a tool that can streamline the library preparation of low complexity, high biomass BWA samples for use in a minION in a time-constrained tactical environment. BWA library preparation includes the extraction and purification of the genomic sequence along with the fragmentation of the DNA and attachment of the adaptor protein. When combined with the Oxford Nanopores minION, on-target sequencing results will be viewable in real-time by CONUS/OCONUS laboratories, and decision-makers at the Joint Operations Center (JOC). Applying automated library preparation will prevent potential errors by employed operators, while minimizing the overall time commitment.   Requirements for this development are as follows: •           Tool Capabilities : o          Isolate DNA/RNA from low complexity, high biomass BWA sample o          Isolation of DNA/RNA must work on all types (i.e. bacteria, viruses, etc.) of BWA samples o          All steps must be automated, with the exception of the insertion of the raw sample. o          Production of  DNA/RNA library must be compatible with Oxford Nanopores minION •           Tool Design o          Approximate Run Time (from insertion of raw sample): <= 10 minutes o          Approximate Overall Dimensions: 6” x 6” x 3” o          Weight = <5.0 lbs. o          Capable of running isolated or using a windows laptop with GUI software   PHASE I: Begin with a market research study of potential COTS hardware solutions that meet tool requirements. Demonstrate the feasibility of automated DNA/RNA library preparations and confirm the compatibility of the prepared library with the Nanopore Technologies (NPT) minION. Conduct successful benchtop functionality testing consisting of library preparation for a pre-determined raw sample followed by accurate identification utilizing the minION and related software. Culminate Phase I with a conceptual flow chart and system design to demonstrate that for Phase II an initial development path from start to finish has been given adequate consideration, risk and their mitigation have been investigated, and a development plan that provides confidence in the outcome has been established.   PHASE II: Focus on building, testing, and refining with an integrated initial prototype. After full functionality is achieved with the prototype, conduct successful benchtop functionality testing consisting of library preparation for multiple pre-determined raw samples followed by accurate identification using the minION and related software. Pending a successful functionality test, a minimum of two fully functional units will be fabricated with packaging that meets all of the final tool’s requirements.  Discussion will occur with the DTRA program team about future integration into a fully equipped sequencing kit.  DTRA seeks an end state that results in a single device that can prepare the library from a variety of biological raw samples while being run on the minION.   PHASE III DUAL USE APPLICATIONS: This phase will further develop the capability developed in Phase II by improving robustness and user application.  Although additional funding may be provided through DoD sources, the awardee should look to other public or private sector funding sources for assistance with transition and commercialization.   REFERENCES: Nanopore Technologies, MinION -https://nanoporetech.com/products/minionHandheld Genomic Sequencer Shows Promise in Field Demo https://www.army.mil/article/209780/handheld_genomic_sequencer_shows_promise_in_field_demoSequencer for soldiers: battlefield genomics https://nanoporetech.com/resource-centre/sequencers-soldiers-battlefield-genomics-0Arnhouse Digital Devices Corporation, BioDigital PC12X https://addc.com/product/biodigitalpc-12x/   KEYWORDS: Biosequencing; Portable Genomic Sequencing; Sample Preparation sbir_topic_link: https://www.sbir.gov/node/2465019 subtopics: [ ] - topic_title: > Capability to Determine the Effect of Dust and Debris on the Chemistry Environment post CWMD Weapons Strike branch: Defense Threat Reduction Agency topic_number: DTRA234-002 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software   The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws.   OBJECTIVE: Develop the diagnostics, experimentation processes, and the modeling and simulation (M&S) needed to determine the effects of dust and debris on agents after weapons detonating in structures.   DESCRIPTION: Real world CWMD strike kinetic weapons often encounter responding structures.  Weapon strikes on targets generate significant dust and debris, e.g. fragment striking of walls and floors, building collapse, ground based debris.    Particulates in the environment have been shown to affect the late time chemical combustion of non-ideal explosives such as the metals found in many weapon systems and the late time combustion of biological and chemical agents.  This reduces weapon effectiveness. Currently, we lack the ability to measure and model the effect of dust and debris on agent defeat.   Development of well-characterized experiments and accompanying M&S are needed for this critical effort.  These experiments and M&S can be utilized outside of the DoD to understand the effects on environments from industrial pollution, forest fires, and other particulates in the air that would change natural and industrial occurring chemistry within buildings or in open air.   This SBIR looks at for a well entwined the experimental and M&S effort.   This should include develop diagnostics, experimentation processes, and the M&S needed to determine the effects of dust and debris on agents and in general late-time chemistry.  This effort pairs with other efforts at DTRA and elsewhere aimed at understanding the amount of dust and debris generated from weapons detonating in structures. It also ties into a separate ongoing DTRA effort aimed at generating a well-characterized amount of dust and debris in laboratory and field settings.      This SBIR has as an end goal of taking dust and debris generated as a function of time to determine effects on the chemistry throughout the process (not just end states).  Effects to explore include mixing, pressure, and temperature, size of fireball and late-time combustion of agent, metals and other species.  The work from this effort can incorporated into mission planning software for DoD/DOE programs and be utilized commercially in the modeling of environmental effects from pollutions and forest fires.    PHASE I: Phase I: Initial experimentation and modeling of effect of dust and debris •           Develop M&S, diagnostics, and testing for effects at the laboratory scale •           M&S code should be able to accept outside data on dust generation efforts   PHASE II: Phase 2: Prototype M&S and experimental techniques •           Develop M&S capability to determine effect of dust and debris on chemistry towards use in full scale application •           Perform experiments to examine scale-up effects of dust and late-time chemistry •           Utilize data, obtained through this SBIR, past efforts, and from concurrent DTRA projects to refine theory & models •           Develop experimental hardware/techniques for full scale applications towards model validation   PHASE III DUAL USE APPLICATIONS: Phase 3: Full-weapon and target efforts •           Model and participate in testing of full-scale weapons •           Refine techniques based on full-scale results •           Tie in with Agent Defeat mission planning codes such as IMEA •           Market capabilities to larger DoD/DOE and industrial/environmental community   REFERENCES: "The simulation of dust effects from fragmenting charges" Orlando A. Soto et al.   International Journal of Numerical Methods for Heat & Fluid Flow Vol. 26 No. 3/4, 2016pp. 999-1026 "A multiphase shock tube for shock wave interactions with dense particle fields" Justin L. Wagner et al.  Exp Fluids "On the passage of a shock wave through a dusty-gas layer" Miura H, Glass II Proc R Soc 385:85-105 "Dust Deflagration Extinction" Kris Chatrathi and John Going  Process Safety Progress (Vo1.19, No.3)   KEYWORDS: CWMD; Kinetic; Chemistry; Dust; Debris; Effects; Weapons; Temperature; Pressure; Planning sbir_topic_link: https://www.sbir.gov/node/2465021 subtopics: [ ] - topic_title: > Deep Learning and Extraction of Chemical Synthesis or Biosynthetic Pathways from Scientific Literature branch: Defense Threat Reduction Agency topic_number: DTRA234-003 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software; Biotechnology   OBJECTIVE: Conduct proof-of-concept studies to enable automated knowledge extraction and Natural Language Processing (NLP) approaches in machine learning (ML) for chemical synthesis or biosynthetic pathways of publicly available scientific publications that may pose dual-use research of concern (DURC).  This topic seeks development of (1) computational methods for employing large language models (LLMs) for automated production of knowledge ontologies from scientific literature and (2) a scalable system with automated annotation capability.   DESCRIPTION: Scientific research of dual use concern includes research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, materiel, national security, among other sectors.  Automated, large-scale extraction of procedures for chemical synthesis or biosynthesis will increase the efficiency and effectiveness of analysts seeking to provide timely courses of action (COA) for relevant decision makers concerning biological or chemical synthesis information of interest to the Defense Threat Reduction Agency (DTRA) and end users.  An ideal system shall require minimal human-in-the-loop, enabling a subject matter expert (SME) to supplement the model with ad hoc data.   The development of open-source semantic systems have expanded beyond manually curated, commercial databases such as Reaxys (Reference 1).  One recent effort, SynKB, has applied methods to automatically extract data from organic chemistry reactions described in United States (U.S.) and European commercial patents (Reference 2).  The SynKB system enables chemists to perform structured queries over large corpora of synthesis procedures.  Other research groups have applied language models for molecular design, whereby the model implicitly learns the “vocabulary” and composition of valid molecules and provides the ability to survey optimized molecular properties (Reference 3).  Text-like representations of chemical reactions (SMILES) and Natural Language Processing (NLP) neural network Transformer architectures have been applied to retrosynthesis prediction problems (Reference 4).  Another research team has developed the AiZynthTrain package for training synthesis models on USPTO patent data with the intent to integrate into retrosynthesis software (Reference 5).  This topic seeks to build upon these and similar NLP-based approaches for knowledge extraction that may be broadly applied to chemical or biological scientific domains, improve system scalability, and automate data annotation capabilities. DTRA’s areas of interest include, but are not limited to: (1) understanding viable synthesis routes to a chemical compound from precursor molecules or substrates, and other starting materials, and (2) retrosynthesis prediction, which may be used to identify possible routes of synthesis and determine the most effective route for the synthesis process.   PHASE I: Leverage an LLM-based ontology system that uses textual knowledge of ontologies to extract information about biosynthetic or chemical synthetic procedure details from open source literature.  The proof-of-concept system shall provide information about viable routes to a chemical compound and possible retrosynthesis analysis.  Performers shall utilize visual analytical methods that enable users to browse and search for chemical-related data.  Performers are encouraged to represent findings to a user with chemical-pathway association graphs, knowledge graphs, or by other means.  The architecture shall be scalable, and shall leverage automated annotation capabilities in lieu of human annotation.   The devised solution shall capture relationships between concepts that indicate possible DURC.  The performers will develop quantitative metrics to evaluate the LLM neural network classification performance by way of statistical approaches.   Phase I deliverables will include (1) a final report and (2) demonstration of the preliminary architecture.  The report should provide results on architecture performance using unambiguous statistical methods, describe training and development, and identify advantages, limitations, and weaknesses.  The architecture shall be described, including operating system, other software requirements (if applicable), and data sources.   PHASE II: Phase II efforts will focus on refinement of the approach developed during Phase I and prototype demonstration.  The Phase II deliverables will be a prototype demonstration of the LLM neural network architecture and a report detailing: (1) a description of the approach, optimization techniques, and performance outcomes; (2) training, testing and validation methods; (3) a real world evaluation of the approach with a use case of mutual interest with DTRA; and (4) advantages, disadvantages, and limitations of the approach.  The performer will identify weaknesses of the approach, and identify methods that may improve performance in the classifier and aspects of the overall architecture.  The performer will provide details about user interfaces (if applicable) and any associated executables.   PHASE III DUAL USE APPLICATIONS: The performer will identify and employ features that have the potential for use in commercial applications.   REFERENCES: “Reaxys: An Expert-curated Chemistry Database,”https://www.elsevier.com/solutions/reaxys F. Bai, et al., “SynKB: Semantic Search for Synthetic Procedures” in arXiv, 2022. J. Owoyemi, et al., “SmilesFormer: Language Model for Molecular Design” in ChemRxiv, 2023 (preprint publication) I. V. Tetko, et al. “State-of-the Art Augmented NLP Transformer Models for Direct and Single-Step Retrosynthesis,” in Nature Communications, vol. 11, p. 1-11, 2020. S. Genheden, et al. “AiZynth Train: Robust, Reproducible, and Extensible Pipelines for Training Synthesis Prediction Models” in ACS Journal of Chemical Information and Modeling, vol. 63, p. 1841 – 1846, 2023.   KEYWORDS: Biosynthetic Pathways, Chemical Synthesis, Deep Learning, Extraction sbir_topic_link: https://www.sbir.gov/node/2465023 subtopics: [ ] - topic_title: Remote Through-Container Identification of CBRNE materials branch: Defense Threat Reduction Agency topic_number: DTRA234-004 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Advanced Computing and Software   OBJECTIVE: Conduct a proof of concept study to develop a rapid, remote, handheld, ruggedized, all-weather, self-powered, user-friendly device to be used by first responders to quickly and accurately identify the contents within opaque, sealed containers at a stand-off distance.   DESCRIPTION: The aim of this effort is to conduct a proof of concept study to develop a remote, light-weight handheld, ruggedized, self-powered, device to identify the contents of opaque sealed containers at various stand-off distances The solution should provide a user friendly interface and be accessible while wearing protective clothing for chemical or biological hazards. Additionally, the device should also have the capability to interpret and learn new materials as they are encountered. A similar topic was released was in 2012 under DTRA122-012 which ran through a Phase I effort. However, the emphasis here is placed on designing a handheld solution rather than man-portable, ensuring it can be operated with the latest issue of CBRNE protective clothing, ensuring rapid results, and taking advantage of the latest machine learning algorithms to improve the identification of unknown materials encountered in the field. Currently available sensors fall short of meeting all of these requirements.  The outcome of this effort shall improve upon current methods of identifying and characterizing CWAs in a tactical setting while streamlining and simplifying testing process for end users.   PHASE I: The performer must demonstrate in a laboratory environment the capability of sensing through opaque containers of varying thickness to detect and identify CBRNE contents such as chemical, biological, radiological materials with a high degree of confidence while minimizing physical contact with CWAs inside chemical munitions or improvised devices. The performer shall explore the tradeoff space related to the performance objectives and metrics. Additionally, the performer shall provide a design concept for a prototype related to form factors to include the device being handheld, ruggedized, providing rapid results, accessible while wearing CBRNE protective clothing, and providing a mechanism to discover new previously unknown materials in the field.   PHASE II: Phase II must develop a prototype device to meet the form factor requirements to include being lightweight, handheld, battery operated, and accessible while wearing protective clothing. The prototype must have a field upgradable library to learn new materials as they are encountered.  The Phase II final report should include a development plan for follow-on production and a Phase III roadmap. Phase II demonstrations should be provided for the DoD community and clearly demonstrate successful and accurate detection and identification of unknown substances in sealed containers.   PHASE III DUAL USE APPLICATIONS: Phase III must include identification of support for commercialization of the device to include other government and commercial entities. Although additional funding may be provided through DoD sources, the awardee should look to other public or private sector funding sources for assistance with transition and commercialization.   REFERENCES: https://www.sbir.gov/sbirsearch/detail/372784 Sinha, D.N., Anthony, B.W., and Lizon, D.C.. Swept frequency acoustic interferometry technique for chemical weapons verification and monitoring. United States: N. p., 1995. Web. Phillip G. Wilcox, Phillip G. Wilcox, Jason A. Guicheteau, Jason A. Guicheteau, "Comparison of handheld Raman sensors through opaque containers", Proc. SPIE 10629, Chemical, Biological, Radiological, Nuclear, and Explosives (CBRNE) Sensing XIX, 106290M (16 May 2018); doi: 10.1117/12.2303968 W. E. Parker1, W. M. Buckley1, S. A. Kreek1, A. J. Caffrey2, G. J. Mauger1, A. D. Lavietes1, and A. D. Dougan1, “A portable system for nuclear, chemical agent, and explosives identification.” AIP Conference Proceedings 576, 1073 (2001);https://doi.org/10.1063/1.1395491   KEYWORDS: stand-off, opaque, remote identification sbir_topic_link: https://www.sbir.gov/node/2465025 subtopics: [ ] - topic_title: > Signature Detection and Training via Application of Digital Product-Insertion Technologies branch: Defense Threat Reduction Agency topic_number: DTRA234-005 topic_description: | OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Trusted AI and Autonomy   OBJECTIVE: To investigate and demonstrate a proof-of-concept to explore the applicability of emerging digital product-insertion technologies to the detection of and changes in signatures of interest and to the 3-D rendering of real-world objects and settings in synthetic VR/AR/XR training environments for operators and inspectors.   DESCRIPTION: Advances in commercial technologies and AI have led to the development of unique capabilities that can have direct application to DoD and national security requirements.  For example, digital product insertion and related AI capabilities for seamlessly emplacing 2-D and 3-D products in media have demonstrated significant advancements that have direct application to technologies relevant to national security. These advances in AI can support requirements such as rendering 3-D environments in near-real-time and the development of models and signature identification capabilities that require limited or no training data. Areas of interest for Over-the-Horizon Arms Control and potential applications include: • Identification of novel signatures of interest within the nuclear pathway • Rapid generation of AR/VR/XR-enabled synthetic training environments from images, videos, CAD/CAM drawings • Detecting evidence of alterations, including image and video authentication and DeepFake detection • Enhancing capabilities of DTRA inspection teams and counterproliferation practitioners via VR/AR/XR technologies, including the real-time insertion of threat objects.   PHASE I: Design and execute a technical feasibility study to examine the application of novel artificial intelligence digital product-insertion capabilities in three priority areas:   Priority Area 1: Detection 1. Identification of abnormal seismic signatures in video footage. 2. Identification of other insights from video footage such as power fluctuations, equipment operating status, etc.   Priority Area 2: Training 3-D rendering of objects and settings into synthetic VR/AR/XR training environments.   Priority Area 3: Image/Video Interpretation 1. Detection of indicators of alterations in images and video. 2. Identification of environmental change (e.g., equipment layout) in images and security camera footage. 3. Detection of image or video alteration. 4. Identification, extraction, and 3-D rendering of unfamiliar objects. 5. 2-D to 3-D rendering into CAD or comparable/relevant formats 6. Reduction or elimination for the need of training data to classify images/video or classify