NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)
Grant Opportunity Analysis
The National Institutes of Health, within the Department of Health and Human Services, is offering the NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award to bridge the gap between SBIR/STTR Phase II and commercialization for biomedical projects. The program provides additional support for later-stage research and development to previously funded NIH SBIR or STTR Phase II recipients, and clinical trials are optional. Eligible applicants are U.S. small business concerns that have previously received an NIH SBIR or STTR Phase II award, and applicants must secure 100% third-party matching funds while demonstrating strong commercial potential and alignment with NIH’s health mission. Applications are due by 5:00 PM local time on specified dates, with the earliest submission date of August 5, 2026 and a close date of April 5, 2029; the contact listed is SEEDinfo@nih.gov.
Eligible Applicants
Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project. This NOFO supports Renewal/Resubmission "Type 2" Applications from recipients with NIH Phase II SBIR/STTR awards that are submitted within the first six due dates following the expiration of their budget period. Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.