Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) titled "Small Business Transition Grant for New Entrepreneurs" to support early-career scientists transitioning into entrepreneurial roles through the Small Business Technology Transfer (STTR) mechanism. The program is designed to foster innovation and commercialization of biomedical technologies by simultaneously supporting the technical development and entrepreneurial training of newly appointed Principal Investigators (PDs/PIs). Targeted participants are researchers with experience in scientific discovery or healthcare delivery but minimal prior experience in leading independent research or entrepreneurial ventures. The goal is to empower these individuals to develop their skills in business development while advancing technologies aligned with NIH’s mission to improve health. Applicants must be United States-based Small Business Concerns (SBCs) eligible under STTR regulations, including specific ownership and operation criteria. The proposed projects must be non-clinical and align with the missions of participating NIH Institutes and Centers. SBCs must dedicate at least 40% of research activities internally and partner with a nonprofit research institution to conduct at least 30% of the work. Phase I and Fast-Track submissions are accepted, with budgets not to exceed $306,872 for Phase I and $2,045,816 for Phase II, though higher budgets may be approved for specific topics. Award periods typically do not exceed 1 year for Phase I and 2 years for Phase II. Recipients must also comply with data sharing requirements and performance benchmarks, including commercialization and transition rates. A major requirement of this funding opportunity is the inclusion of a mentor with entrepreneurial expertise who is not a multiple PD/PI and must commit at least 5% effort to mentoring the transitioning PD/PI. Applicants must submit a detailed career development plan with measurable milestones outlining how the PD/PI will gain entrepreneurial competencies. This may include participation in established NIH entrepreneurial training programs or equivalent alternatives. Additionally, the mentor must provide a tailored letter of support describing their qualifications, mentoring commitment, and plan to guide the PD/PI through technical and commercial challenges. Applications are submitted via ASSIST, Grants.gov Workspace, or institutional system-to-system platforms. Deadlines occur three times annually: January 5, April 5, and September 5. Letters of intent are due 30 days prior to the application deadline. Awards are made based on scientific merit, alignment with NIH priorities, and national security risk assessments. Phase I recipients may progress to Phase II either through standard transition or Fast-Track options. The program is not intended for those with substantial prior entrepreneurial leadership. The NOFO is set to expire on November 17, 2025, but NIH may accept late applications under specific conditions. The opportunity supports applications with national eligibility, and while submission is competitive, potential applicants are encouraged to contact relevant NIH program officials for pre-application guidance. Evaluation criteria emphasize both the scientific feasibility and the potential for the PD/PI’s entrepreneurial growth. NIH anticipates that successful applicants will not only commercialize innovative technologies but also emerge as leaders in the biomedical small business sector.