SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, Clinical Trial Not Allowed)

Section I. Funding Opportunity Description Purpose 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 are limited in the amount of outsourcing allowed and some projects require technical assistance that is typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance). 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 2022 under Public Law 114-328, Section 1834 and Public Law 115-232, including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This funding opportunity announcement (FOA) aims to re-implement the CRP Program at NIH. The goal of this FOA is to facilitate the transition of previously funded SBIR/STTR Phase II projects to the commercialization stage by providing additional support for later stage technical assistance activities not typically supported through Phase II or Phase IIB grants or contracts. This FOA supports: Phase II or IIB SBIR/STTR awards that have ended or will close out by the requested start date ("Type 2" Renewal applications). Phase II or IIB SBIR/STTR awards that will be active at the requested Project Start date ("Type 1" New applications). 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. Scientific/Technical Scope NIH ICs participating in this FOA 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 FOA include, but are not limited to the following: Development of regulatory strategy, including assembling the documentation needed for the Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission to the Federal Drug Administration (FDA). Development of reimbursement strategy. Design and planning for a clinical trial including: Preparation of documents required to support a clinical trial (e.g., case report forms, pharmacy manual, study coordinator manual, monitoring plan), preparation of clinical trial protocol, and preparation of investigator's brochure. 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 offered through a third-party technical assistance provider, including market research. Unlike 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. Studies outside of the scope of this FOA: Research and development activities outside of technical assistance, such as clinical and vertebrate animal research, are not permitted through this FOA. This FOA does not accept clinical trial(s). If your proposed work includes an NIH-defined clinical trial that would be assigned to one of these NIH Institutes/Centers, you must contact relevant program staff to discuss alternatives for support of those studies under SBIR/STTR FOAs for clinical trials. For SBIR/STTR applications proposing clinical trials, please use a FOA that accepts clinical trial applicants: https://sbir.nih.gov/funding. Applicants should consider some NIH Institutes/Centers participate in the following: The Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late Stage Development (SB1, Clinical Trial Required) FOA (PAR-20-130) supports both technical assistance and late stage research and development activities for Phase II and Phase IIB awardees that involve clinical trials. The Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) FOA (PAR-20-129) supports both technical assistance and late stage research and development activities for Phase II and Phase IIB awardees that do not involve clinical trials. The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. (See https://sbir.nih.gov/sites/default/files/2019-2_SBIR-STTR-topics.pdf for more information) Applicants cannot submit a Phase IIB and CRP concurrently; see Section III. 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 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) FOAs (PAR-20-129 or PAR-20-130). For SBIR/STTR Phase II awardees 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-19-047.html), which is published as a Request for Applications once per year, typically in the Spring. 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 awardees. Applications for research involving human subjects can be submitted in response to this FOA, but NEI may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects are strongly encouraged to contact Scientific/Research staff. National Heart Lung and Blood Institute 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 Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late-Stage Development (SB1) FOAs (PAR-20-129 or PAR-20-130) so applicants interested in only requesting technical assistance should apply through this funding opportunity. 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 on Aging NIA’s Office of Small Business Research invites NIA Phase II and Phase IIB awardees to apply to the Late-Stage Commercialization Readiness Pilot Program (CRP), provided that the proposed R & D falls within NIA’s mission. Applications addressing Alzheimer’s disease (AD) and AD-related dementias (ADRD) are of particular interest. NIA also participates in the SBIR/STTR Commercialization Readiness Pilot Program Technical Assistance and Late-Stage Development (SB1) (PAR-20-129 or PAR-20-130) FOAs. National Institute on Alcohol Abuse and Alcoholism (NIAAA) The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in CRP applications from NIAAA Phase II or Phase IIB funded applicants in the General Topic Areas listed above, except that NIAAA will not provide support for clinical trial-related activities under this CRP FOA. NIAAA will support only proposed CRP projects on the development of novel therapies that are within the NIAAA mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. Applicants considering projects involving any type of human subjects research are strongly encouraged to contact program staff for consultation before submission. NIAAA also participates in the Commercialization Readiness Pilot (CRP) Program Late Stage Development (SB1) Clinical Trial Not Allowed (PAR-20-129) and applicants interested in requesting only technical assistance should apply through that funding opportunity. 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 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 awardees 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. 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-18-547 (see: https://grants.nih.gov/grants/guide/pa-files/PAR-18-547.html). Applicants considering projects involving any type of human subjects research are strongly encouraged to contact Scientific/Research staff for consultation before submission. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) The NIDDK invites NIDDK Phase II and Phase IIB awardees to apply to the Technical Assistance Commercialization Readiness Pilot (CRP) Program, provided that the proposed R & D falls within NIDDK’s mission. For Phase II awardees, 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 SBIR/STTR funding page: https://sbir.nih.gov/funding. The NIDDK also participates in the Technical Assistance and Late Stage Development Commercialization Readiness Pilot (CRP) Program (SB1) (PAR-20-129). Potential applicants are strongly encouraged to contact program staff noted in 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 Institute of General Medical Sciences (NIGMS) NIGMS will consider CRP applications from previous NIGMS Phase II awardees in the General Topic Areas listed above. NIGMS will only support proposed CRP projects that are within the NIGMS mission. For information about NIGMS’s Small Business Program, please visit https://www.nigms.nih.gov/about/overview/BBCB/biomedicaltechnology/Pages/smallbusinessgrants.aspx. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award. 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 Library of Medicine (NLM) The National Library of Medicine welcomes CRP applications from recent NLM Phase II/IIB awardees that are consistent with the topic areas described above, provided they are within the NLM mission. NLM will not provide support for implementation of clinical trials under this FOA. Applicants with currently active Phase II/IIB awards are strongly encouraged to contact NLM Scientific/Research Staff. For information about NLM's Small Business Program, please visit: https://www.nlm.nih.gov/ep/grantsbir.html. 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.