Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required)

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Description

This NIH funding opportunity is designed to facilitate the career transition of early-career scientists, engineers, clinicians, and health professionals into entrepreneurial roles within U.S. small businesses. The program supports both the professional development of new entrepreneurial Program Directors/Principal Investigators (PDs/PIs) and the conduct of research and development (R&D) projects that require a clinical trial. The grant aims to build entrepreneurial capacity in the biomedical and public health technology sectors, with a strong focus on mentorship, structured entrepreneurial training, and career development.

The program is part of the Small Business Innovation Research (SBIR) mechanism (R43/R44), and all applications must propose a clinical trial. The opportunity is not intended for established entrepreneurs or those with significant prior independent research leadership experience.

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Due Dates

• Next deadlines:

  • September 5, 2025 (New, Renewal, Resubmission, Revision)
  • January 5, 2026
  • April 5, 2026
  • September 5, 2026
  • January 5, 2027
  • April 5, 2027

• Letter of Intent: 30 days prior to the application due date (optional but encouraged)

• Expiration: April 6, 2027

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Phase I: Up to $306,872 total costs (direct, indirect, fee) for up to 6 months
• Phase II: Up to $2,045,816 total costs for up to 2 years
• Fast-Track: Both phases submitted together; budgets as above
• Higher budgets: May be allowed for specific topics with NIH pre-approval (see waiver topics)
• Project duration: Phase I (up to 6 months), Phase II (up to 2 years)
• No cost sharing required
• A reasonable fee (up to 7% of total costs) may be requested

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Eligibility

• Applicant: U.S. small business concern (SBC) as defined by SBA regulations (for-profit, ≤500 employees, U.S.-owned and operated)
• PD/PI:
  • Early-career scientist, engineer, clinician, or health professional
  • U.S. citizen or permanent resident
  • Has not previously served as an independent PD/PI on a major NIH/CDC research grant (>$100,000 direct costs/year) or equivalent
  • Must be new to entrepreneurship and independent research leadership
  • Must be employed by the small business at the time of award and during the project
• Mentor: At least one mentor with entrepreneurial experience is required (minimum 5% effort)
• Foreign organizations: Not eligible; foreign components may be allowed with strong justification
• Multiple applications: Allowed if scientifically distinct

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Application Process

1. Read the full funding announcement and SBIR/STTR application guide.
2. Register your organization with SAM.gov, SBA Company Registry, Grants.gov, and eRA Commons.
3. Prepare your application using the SF424 (R&R) forms and SBIR/STTR-specific instructions.
4. Key required components:
   • Research plan for a clinical trial
   • Career development plan for the PD/PI (max 3 pages, with milestones)
   • Mentor letter of support (max 2 pages)
   • Budget and justification (including mentor and training costs)
   • Data Management and Sharing Plan
   • Facilities and business resources description
   • SBIR Application Certification (if majority-owned by multiple VCs, hedge funds, or private equity)
5. Submit via ASSIST, Grants.gov Workspace, or institutional S2S system.
6. Optional: Submit a letter of intent 30 days before the due date.
7. Review process: Peer review based on scientific merit, commercialization potential, and strength of the entrepreneurial development plan.

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Additional Information

• Clinical trial is required for all applications.
• Mentorship: At least one mentor with entrepreneurial experience must be included as key personnel (minimum 5% effort).
• Entrepreneurial training: A tailored plan is required, which may include NIH or external programs (e.g., I-Corps, C3i, business courses).
• Career development: The PD/PI must have a clear plan for gaining entrepreneurial skills and leadership experience.
• Participating NIH Institutes/Centers: Multiple NIH ICs and CDC participate; applicants are encouraged to contact program staff for fit.
• Pre-application webinar: NIH will hold a technical assistance webinar (see webinar info).
• Data rights: SBIR/STTR recipients may retain data rights for up to 20 years.

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External Links

• Full Funding Announcement (PAR-24-132)
• NIH SBIR/STTR Program Overview
• SBIR/STTR Application Guide (PDF)
• NIH SBIR/STTR Funding Opportunities
• NIH Data Management and Sharing Policy
• NIH Grants Policy Statement
• NIH SEED (Small business Education and Entrepreneurial Development)
• Grants.gov Opportunity Listing

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Contact Information

For additional contacts by institute, see the full announcement, Section VII.

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