Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Not Allowed)

The Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Not Allowed) is a funding opportunity provided by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). This initiative supports early-career researchers transitioning to entrepreneurial roles within U.S.-based small business concerns. The program leverages the Small Business Innovation Research (SBIR) mechanism to offer both Phase I and Fast-Track funding to small businesses that engage emerging scientists as Principal Investigators (PIs), simultaneously fostering their entrepreneurial development and supporting the technical research they lead. This funding opportunity was designed to address the gap in entrepreneurial experience that many highly skilled scientists face when attempting to move from academia or clinical environments into business-oriented roles. It targets scientists, engineers, clinicians, and health professionals who have a strong technical background but limited independent research leadership or business experience. Alongside the research project, the program mandates a career development plan for the PD/PI that includes structured mentorship, entrepreneurship training, and clear metrics for growth. Eligible applicants must be U.S.-based small businesses that meet the standard SBIR eligibility requirements, including ownership and operational constraints. The PD/PI must be a U.S. citizen or permanent resident and new to research entrepreneurship. The program encourages participation from a wide range of scientific domains, provided the technology aligns with the missions of one or more of the participating NIH or CDC Institutes and Centers. Each application must also propose a strong mentoring plan, featuring at least one mentor with prior entrepreneurial and mentorship experience, dedicated to guiding both the research and the career development of the PD/PI. Funding levels vary based on the phase. For Phase I, the general budget cap is $306,872; for Phase II, it is $2,045,816, although exceptions exist for specific topics listed in NIH waiver guidelines. Projects must not include clinical trials. Fast-Track submissions must include clearly defined milestones for Phase I to II transitions, and each proposal must include measurable outcomes for both research goals and entrepreneurial development. Applications are accepted on a recurring cycle with due dates typically falling on January 5, April 5, and September 5 annually through January 2027. Letters of intent are requested 30 days before each deadline. Though this opportunity is now expired, future rounds are anticipated. Submission is via the NIH ASSIST system or Grants.gov, and strict adherence to SBIR/STTR application instructions is required. Inquiries are encouraged and can be directed to NIH SEED at SEEDinfo@nih.gov or individual contacts for participating NIH institutes. This opportunity provides a unique platform for fostering a new generation of scientific entrepreneurs capable of bringing health innovations to market through federally funded small business research.