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NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should visit the respective agency SBIR sites to read the official version of the solicitations and download the appropriate forms and rules.


If no search results for your keyword(s) were found, you are encouraged to review Agency omnibus solicitations for additional funding opportunities. Omnibus solicitations are structured to be broad, extensive Programmatic issuances with research areas related to the petitioning Agency and are not limited to predetermined Topics/Subtopics. If upon reviewing you have additional questions, you may consider reaching out to the respective Agency for clarification regarding acceptable proposals (https://www.sbir.gov/agency-contacts).

  1. RFA-TR-22-032: Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) (U43/U44- Clinical Trail Not Allowed)

    Release Date: 09-19-2022Open Date: 10-21-2022 Due Dates: Multiple Close Date: 08-22-2023

    Section I. Funding Opportunity Description 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 small business concerns (SBCs) to propose a ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  2. RFA-NS-23-006: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)

    Release Date: 09-15-2022Open Date: 12-05-2022 Due Dates: Multiple Close Date: 04-05-2025

    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 ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  3. RFA-DE-23-008: Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (Fast-Track- R44- Clinical Trial Not Allowed)

    Release Date: 08-02-2022Open Date: 10-10-2022Due Date: 11-09-2022Close Date: 11-10-2022

    Purpose This FOA seeks to accelerate the clinical translation of novel biomaterials for DOC applications through implementation of advanced data-driven tools specifically designed to overcome critical bottlenecks in R&D cycles that lead to delays in regulatory evaluations and translation to human use. This initiative leverages the FDA-CDRH’s Medical Device Development Tools (MDDT) program frame ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  4. RFA-TR-22-029: Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

    Release Date: 07-13-2022Open Date: 07-18-2022 Due Dates: Multiple Close Date: 07-13-2023

    A. Overview While there are thousands of rare diseases, the number of underlying etiologies is much smaller. Moreover, many disease etiologies underlie multiple traditional diseases. This is most readily seen for rare monogenic diseases, where the most common etiologies include premature termination codons, protein misfolding, and abnormal RNA splicing. Other examples of rare disease shared molec ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  5. RFA-AG-23-029: NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award (R43/R44 Clinical Trial Optional)

    Release Date: 07-06-2022Open Date: 01-17-2023Due Date: 02-17-2023Close Date: 02-18-2023

    The number of available tenure-track faculty positions has not kept pace with the growing number of Ph.D. graduates in recent years. This imbalance has created a highly competitive job environment, making it increasingly difficult for Ph.D. graduates to transition to academic appointments. Doctoral and post-doctoral training programs have heavily revolved around developing skill sets that are dire ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  6. RFA-ES-22-006: New Approaches for Incorporating Genetic Diversity into Toxicity Testing (R43/R44 Clinical Trial Not Allowed)

    Release Date: 06-30-2022Open Date: 10-08-2022Due Date: 11-08-2022Close Date: 11-09-2022

    This FOA solicits Phase I (R43), Phase II, Direct to Phase II (R44) and Fast-track (R44) SBIR grant applications from SBCs to develop resources and approaches that reflect the variability in responses to chemical exposures based on genetic diversity in the human population. These can include panels of human cells or cell lines, rodent panels, including cell lines generated from rodent diversity pa ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  7. RFA-DA-23-018: Enabling SUD Digital Therapeutics Research to Improve Payor Adoption (R44- Clinical Trial Only)

    Release Date: 06-29-2022Open Date: 10-15-2022Due Date: 11-15-2022Close Date: 11-16-2022

    Purpose and Research Objectives Substance use disorders (SUDs) profoundly affect nearly every aspect of society. Drug and alcohol use in the United States costs $1.4 trillion in economic loss and societal harm annually. This includes $578 billion in economic loss and $874 billion in societal harm through quality-of-life adjustment and premature loss of life. There are safe and effective FDA-appro ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  8. RFA-DA-23-017: Therapeutic Development of Psychoplastogenic Compounds for Substance Use Disorders (R43/R44- Clinical Trials Not Allowed)

    Release Date: 06-23-2022Open Date: 10-18-2022Due Date: 11-18-2022Close Date: 11-19-2022

    Substance Use Disorders (SUD) are defined as a collection of chronic disorders initiated by the misuse of legal and illicit drugs, then potentially leading to an uncontrollable drug-seeking behavior. The neuroimaging studies of SUD patients have demonstrated abnormal prefrontal cortex (PFC) function. The PFC can regulate the ability of the limbic reward circuitry, modulate attention, and can apply ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  9. PAS-22-196: Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)

    Release Date: 06-21-2022Open Date: 12-05-2022 Due Dates: Multiple Close Date: 09-08-2025

    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 t ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  10. RFA-DA-23-020: Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expedite Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)

    Release Date: 06-10-2022Open Date: 10-14-2022Due Date: 11-14-2022Close Date: 11-15-2022

    The scope and complexity of the current drug crisis is staggering, and there is an urgent need for a comprehensive effort to offer new medical products to affected individuals, families, and communities. Scientific advances and product development based on those advances can provide solutions to help overcome the crisis. Medical products regulated by the U.S. Food and Drug Administration (FDA), in ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
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