The Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required), issued under PAR-24-132 by the U.S. Department of Health and Human Services, through the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), aims to foster the entrepreneurial development of early-career scientists transitioning into small business environments. This initiative specifically supports small business concerns (SBCs) that employ researchers serving as Program Directors/Principal Investigators (PDs/PIs) for proposed clinical trials. The grant emphasizes both the scientific research and the entrepreneurial growth of the PD/PI, with a dual focus on technological development and commercial readiness.
The grant is administered under the Small Business Innovation Research (SBIR) Phase I and Fast-Track mechanisms, requiring that all applications propose clinical trials. Fast-Track applications are accepted, but Direct to Phase II applications are not. The funding structure allows up to $306,872 for Phase I and $2,045,816 for Phase II in total costs, though budget exceptions may be granted for specific topic areas. Project periods may not exceed 6 months for Phase I and 2 years for Phase II. Applicants are encouraged to consult with program officials early in the planning process if budgets exceed the standard limits.
Eligible applicants are limited to United States-based SBCs that meet specific ownership, size, and operational criteria. The PD/PI must be a U.S. citizen or lawful permanent resident with minimal prior experience as a PD/PI of large-scale research projects. The intent is to recruit or elevate researchers into genuine leadership roles, allowing them to direct their proposed project while receiving structured mentorship and entrepreneurial training. Mentors must commit at least 5% effort and must not be listed as multiple PDs/PIs. The training must include tailored career development plans that combine technical oversight with business and commercialization skills, leveraging programs such as NIH I-Corps, C3i, and external entrepreneurship resources.
Applications must include a detailed career development plan, mentor letters of support, and a clear delineation of research and training milestones. Each SBC is expected to provide a supportive environment that includes access to scientific, business, and commercialization resources. All proposals must align with the mission areas of one of the participating NIH or CDC Institutes or Centers, with several agencies including NHLBI, NIA, NEI, NHGRI, NIAAA, NICHD, and others providing specific thematic priorities.
Key application dates include multiple NIH standard due dates through April 2027. The next available cycle opens August 5, 2024, with an initial application deadline of September 5, 2024. Letters of Intent are due 30 days prior to the application deadline. Applications are submitted via the NIH ASSIST platform or Grants.gov. Participation in a pre-application webinar is encouraged but not required. The funding opportunity remains active until its expiration on April 6, 2027.
Scientific and administrative contacts for each participating institute are provided, with applicants encouraged to consult with the appropriate institute staff before submitting proposals to ensure alignment with mission areas. The NIH SEED Office is also available to field inquiries regarding the application process. All applications will be subject to NIH’s rigorous peer review criteria and must comply with all stated instructions and policy guidelines.
