Small Business Transition Grant for New Entrepreneurs (Parent R41/R42 Clinical Trial Optional)

The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, is a leading federal agency responsible for biomedical and public health research. Through its Small Business Transition Grant for New Entrepreneurs, NIH aims to strengthen the pipeline of early-career scientists entering the entrepreneurial ecosystem. This opportunity is designed as a Small Business Technology Transfer (STTR) mechanism under the R41/R42 activity codes, which emphasizes collaboration between small business concerns and research institutions. The program reflects NIH’s broader mission to advance scientific discovery while translating innovations into practical applications that improve health outcomes. The primary purpose of this funding opportunity is to support early-stage research and development activities within U.S.-based small businesses led by first-time principal investigators. In addition to funding technical research, the program places strong emphasis on entrepreneurial training, mentorship, and career development. Applicants are expected to build both scientific and business capacity, integrating research goals with commercialization strategies. A required component of the project team is a mentor who contributes measurable effort, reinforcing the program’s dual focus on innovation and workforce development. Funding under this opportunity is intended to support Phase I STTR projects and may include Fast-Track applications that combine Phase I and Phase II activities. While specific award amounts and total funding levels are not disclosed in the forecast, the program supports research aligned with a wide array of NIH mission areas, including cardiovascular health, genomics, mental health, substance use, aging, and more. Funds are expected to be used for research and development activities within the small business, as well as for structured entrepreneurial training and mentoring. There is no cost-sharing or matching requirement associated with this opportunity. Eligibility is limited to United States small business concerns as defined by the Small Business Administration. Additionally, the principal investigator must be an early-career individual who has never served as an independent PD/PI on a qualifying research grant and must be a U.S. citizen or lawful permanent resident. The program explicitly targets new entrepreneurs transitioning from academic or research environments into small business leadership roles. Applications must also include a qualified mentor with a defined role in supporting the applicant’s development. At the time of this forecast notice, applications are not yet being accepted. The notice is intended to provide advance awareness so prospective applicants can prepare competitive proposals, identify mentors, and establish necessary partnerships. The estimated application due date is January 5, 2027, with an anticipated posting date of November 5, 2026. Awards are expected to be made by June 1, 2027, with project start dates beginning July 1, 2027. No pre-application requirements such as letters of intent are specified in the forecast. The application process will follow NIH’s standard submission procedures once the official Notice of Funding Opportunity is released. Applicants will likely be required to submit detailed research plans, commercialization strategies, budgets, and supporting documentation through federal grant systems. Evaluation criteria will align with NIH review standards, focusing on scientific merit, innovation, feasibility, and the potential for commercialization. Programmatic considerations may also include the strength of the mentorship plan and the applicant’s readiness to transition into entrepreneurship. For additional information, applicants may contact the NIH SEED Office of Extramural Research via email or phone. As a forecasted opportunity, this program is expected to recur or be part of NIH’s ongoing small business support initiatives, though recurrence is not explicitly stated. Prospective applicants are encouraged to monitor official NIH and Grants.gov postings for updates and the full solicitation release.

Emphasize strong mentorship structure and clear transition to entrepreneurship; align research with NIH mission areas