Funder: National Institutes of Health
Due Dates: September 5, 2025 (New, Renewal, Resubmission, Revision)
Funding Amounts: Phase I: up to $306,872 (1 year) | Phase II: up to $2,045,816 (2 years); higher budgets possible for select topics
Summary: Supports U.S. small businesses to conduct R&D and clinical trials aligned with NIH research missions through the STTR program.
Key Information: Clinical trial(s) are required; only U.S. small businesses are eligible; updated program priorities as of March 2025.
Description
This opportunity invites U.S. small businesses to apply for Small Business Technology Transfer (STTR) grants to conduct research and development (R&D) projects that include at least one clinical trial. The program aims to foster technology transfer through collaboration between small businesses and research institutions, supporting the development and commercialization of innovative health-related technologies and products that align with the missions of participating NIH Institutes and Centers.
The STTR program is designed to stimulate technological innovation, strengthen the role of small businesses in meeting federal R&D needs, and increase private sector commercialization of innovations derived from federal funding. Projects must be relevant to the scientific priorities of one or more participating NIH Institutes or Centers.
Due Dates
- Next application deadline: September 5, 2025 (for new, renewal, resubmission, and revision applications)
- Applications are due by 5:00 PM local time of the applicant organization.
- Standard NIH due dates apply; see the NIH due dates page for details.
Funding Amount
- Phase I: Up to $306,872 total costs for up to 1 year.
- Phase II: Up to $2,045,816 total costs for up to 2 years.
- Phase IIB (if applicable): Budget limits set by participating NIH Institutes/Centers.
- Budget waivers: Higher budgets may be allowed for specific topics; see the current list of approved topics for budget waivers.
- Number of awards: Contingent on NIH appropriations and the number of meritorious applications.
Eligibility
- Applicant type: Only U.S. small business concerns (SBCs) are eligible.
- Must be organized for profit, have a place of business in the U.S., and have no more than 500 employees.
- Must be at least 50% owned and controlled by U.S. citizens or permanent resident aliens, or by certain qualifying entities (see full eligibility details).
- Small businesses majority-owned by multiple venture capital, hedge fund, or private equity firms are not eligible for STTR.
- Project requirements: Must propose at least one clinical trial.
- Foreign organizations: Not eligible to apply. Foreign components may be allowed if justified.
- Partnering research institution: Required for STTR; at least 30% of the research effort must be performed by the research institution, and at least 40% by the small business.
Application Process
- Submission systems: Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
- Required registrations:
- Application guide: Follow the SBIR/STTR (B) Instructions in the NIH How to Apply – Application Guide.
- Key application components:
- Research plan
- Data Management and Sharing Plan
- Commercialization plan (for Phase II and Fast-Track)
- Human Subjects and Clinical Trials Information (if applicable)
- Review process: Applications are peer-reviewed for scientific and technical merit, commercialization potential, and alignment with NIH priorities.
Additional Information
- Clinical trial requirement: All applications must propose at least one clinical trial. If your project does not include a clinical trial, consider PA-24-247.
- Updated priorities: The funding opportunity was updated in March 2025; applicants should review the full announcement for changes.
- Performance benchmarks: Applicants with significant prior SBIR/STTR funding must meet transition and commercialization benchmarks.
- Data rights: SBIR/STTR recipients may retain data rights for up to 20 years after the award date.
- Cost sharing: Not required.
- Multiple applications: Allowed if each is scientifically distinct.
External Links
Contact Information