Funder: National Institutes of Health
Due Dates: August 6, 2025 (Letter of Intent) | September 5, 2025 (Application) | January 5, 2026 | April 5, 2026 | September 5, 2026 | January 5, 2027 | April 5, 2027 (final due date)
Funding Amounts: Up to $306,872 (Phase I, 1 year) and $2,045,816 (Phase II, 2 years); Fast-Track available; budget waivers possible for select topics.
Summary: Supports early-career researchers transitioning to entrepreneurship in small businesses, combining R&D funding with structured entrepreneurial training, mentoring, and career development.
Key Information: Clinical trial(s) are required; only U.S. small businesses are eligible; strong emphasis on mentorship and career development plan for new entrepreneurs.
Description
This NIH funding opportunity is designed to accelerate the transition of early-career scientists and health professionals into entrepreneurial roles within U.S. small businesses. The program provides support for both research and development (R&D) activities and structured entrepreneurial training, mentoring, and career development for the Program Director/Principal Investigator (PD/PI). The goal is to help new entrepreneurs gain industry experience, develop commercializable biomedical technologies, and build the skills needed to lead independent research and business projects aligned with NIH’s mission to improve health.
The grant uses the Small Business Technology Transfer (STTR) R41/R42 mechanism and requires that all applications propose at least one clinical trial. The program is not intended for established entrepreneurs or those with significant prior independent research leadership experience.
Due Dates
- Letter of Intent Deadlines: 30 days prior to each application due date (e.g., August 6, 2025 for September 5, 2025 application)
- Application Deadlines:
- September 5, 2025
- January 5, 2026
- April 5, 2026
- September 5, 2026
- January 5, 2027
- April 5, 2027 (final due date)
- Review and Award Cycles: Standard NIH review cycles apply; earliest start dates are typically 4–6 months after application deadlines.
See the NIH standard due dates for more details.
Funding Amount
- Phase I: Up to $306,872 total costs (direct, indirect, and fee), project period up to 1 year.
- Phase II: Up to $2,045,816 total costs, project period up to 2 years.
- Fast-Track: Both phases can be submitted and reviewed together.
- Budget Waivers: Higher budgets may be allowed for specific topics; see approved topics for budget waivers.
- Fee: Up to 7% of total costs may be requested as a profit/fee.
- Allowable Costs: Includes R&D, entrepreneurial training, mentoring, and career development activities.
Applicants are encouraged to propose a budget and duration appropriate for the project scope and to contact NIH program officials if requesting funds above standard limits.
Eligibility
- Applicant: Only U.S. small business concerns (SBCs) are eligible. Must be for-profit, have a place of business in the U.S., and meet SBA size standards (≤500 employees).
- PD/PI: Must be a U.S. citizen or permanent resident, and new to entrepreneurship (no prior independent NIH R-series or equivalent grants over $100,000/year, or prior leadership of major research projects).
- Mentor: At least one mentor with entrepreneurial experience is required; must commit at least 5% effort.
- Project: Must propose at least one clinical trial.
- Foreign organizations/components: Not eligible to apply; foreign components may be allowed with strong justification.
- Multiple Applications: Allowed if scientifically distinct; an individual may serve as PD/PI on only one application.
See the full eligibility criteria.
Application Process
- Letter of Intent: Strongly encouraged, due 30 days before the application deadline. Email to NIH SEED (SEEDinfo@nih.gov).
- Application Submission: Use NIH ASSIST, Grants.gov Workspace, or institutional S2S system.
- Required Registrations: SAM, SBA Company Registry, eRA Commons, Grants.gov.
- Application Components:
- Project Summary/Abstract (include research and career development objectives)
- Research Plan (including clinical trial details)
- Career Development Plan (max 3 pages, with milestones and success criteria)
- Mentor Letter of Support (max 2 pages)
- Budget and Justification (including training/mentoring costs)
- Data Management and Sharing Plan
- Human Subjects/Clinical Trials forms
- Letters of Support (for collaborators, mentors, etc.)
- Review Criteria: Emphasis on scientific merit, commercialization potential, quality of entrepreneurial training/mentoring, and fit of the PD/PI for career transition.
See the NIH Application Guide and the full NOFO for detailed instructions.
Additional Information
- Mentorship: A strong, experienced mentor (or mentoring team) is required; must be listed as key personnel and provide a tailored letter of support.
- Entrepreneurial Training: The PD/PI must have a structured plan for entrepreneurial skill development, which may include NIH or external programs (e.g., I-Corps, C3i, business courses).
- Career Development: The plan should address gaps in the PD/PI’s entrepreneurial experience and outline how the project will foster independence.
- Participating NIH Institutes: Multiple NIH Institutes participate; applicants should ensure their project aligns with the mission and priorities of at least one participating Institute.
- Webinar: NIH will hold a technical assistance webinar on June 11, 2024. Webinar details and materials.
- Data Rights: SBIR/STTR recipients may retain data rights for up to 20 years after award.
- Foreign Disclosure: Applicants must comply with new requirements for disclosure of foreign relationships and affiliations.
External Links
Contact Information
Institute-specific contacts (for scientific/program questions):
For additional contacts, see the full NOFO contact section.