NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)

The National Institute of Neurological Disorders and Stroke (NINDS), a part of the U.S. Department of Health and Human Services' National Institutes of Health (NIH), is offering renewal awards under the Small Business Innovation Research (SBIR) Phase II program through Funding Opportunity Announcement (FOA) PAR-24-222. This initiative, known as SBIR Phase IIB, supports pre-clinical research projects that have previously completed a Phase II SBIR or STTR award. The overarching objective is to help bridge the funding gap—often termed the "Valley of Death"—between early-stage development and commercialization for promising biotechnology products or tools, particularly those requiring Federal regulatory approval. This grant is aimed specifically at projects requiring significant additional investment post-Phase II to continue development. Awardees are encouraged to secure independent third-party funding to support commercialization activities in tandem with the Phase IIB award. Eligible projects typically include medical technologies, therapeutics, diagnostics, or complex research tools that align with NINDS’s mission of reducing the burden of neurological disease. The FOA is focused exclusively on pre-clinical research and does not allow clinical trials under this mechanism. Only small businesses are eligible to apply, and foreign organizations or their components are not permitted to serve as the primary applicant. However, foreign components may be included in U.S.-based applications under specific conditions as defined in NIH policy. Cost sharing or matching is not required for this opportunity. Applications must be submitted electronically through Grants.gov and must follow NIH standard submission procedures. The next due date for submission is November 17, 2025, with future deadlines recurring annually through April 5, 2027. While Letters of Intent are not required, applicants are expected to meet all standard application criteria for NIH SBIR renewals. Each application will undergo rigorous scientific peer review in accordance with NIH procedures. Proposals are assessed based on scientific merit, innovation, potential for commercialization, and the likelihood of transitioning to market. Funding decisions also consider programmatic relevance and the availability of funds. The FOA does not specify the number of awards or total program funding, and there is no explicit range for the amount of funding available. Awards are contingent on the availability of funds and the quality of submissions. For additional information, applicants can contact the NIH Grants Information team at [email protected].

Emphasize strong commercialization strategy; secure third-party funding prior to application; ensure alignment with NINDS mission