Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required)

The Small Business Transition Grant for New Entrepreneurs is administered by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to support early-career scientists transitioning into entrepreneurial roles. This grant leverages the SBIR Phase I and Fast-Track mechanisms to promote both research development and entrepreneurial skill-building among new principal investigators (PDs/PIs) within eligible small businesses. Participating NIH institutes include NEI, NHLBI, NHGRI, NIA, NIAAA, NICHD, NIDCD, NIDA, NINR, NLM, NCCIH, and NIOSH. Each institute outlines specific priority areas aligned with its health-focused mission. The grant supports early-stage biomedical and public health technology development where the proposed PD/PI is expected to lead the R&D project while simultaneously receiving structured mentorship and participating in entrepreneurial training. The PD/PI must be a U.S. citizen or permanent resident who has not previously led major independent research grants. Key components include a robust mentorship plan and a structured career development plan that includes training activities, such as participation in recognized NIH or external entrepreneurship programs. The award ceiling is $306,872 for Phase I and $2,045,816 for Phase II, with durations of up to 6 months and 2 years respectively. Fast-Track applications must combine both phases and include measurable development and commercialization milestones. A mentor is required, and their time commitment must be documented. The mentor cannot be a co-PI and must have entrepreneurial and prior mentorship experience. Eligible applicants are U.S.-based small businesses meeting SBA requirements. Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional S2S system. Applications must conform to NIH guidelines, and noncompliance may result in rejection. Required documents include a detailed career development plan and a mentor letter of support. Applications proposing clinical trials are required under this specific funding opportunity (PAR-24-132). The initial deadline is September 5, 2024, followed by additional standard NIH due dates through April 2027. Letters of Intent are due 30 days prior to each submission deadline. The current opportunity expires on November 17, 2025, and is expected to recur annually. A technical assistance webinar is held periodically to support applicants.