NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)
Grant Opportunity Analysis
NIH, through HHS with CDC and FDA participation, is offering SBIR grants to U.S. small businesses to advance scientific innovations toward commercialization. The program supports feasibility studies and research and development across Phase I, Phase II, Direct to Phase II, and Fast-Track applications, with clinical trials optional for most participating components. Eligible applicants are limited to U.S. small business concerns and must meet ownership, employee, and performance criteria, while certain NIH institutes and all FDA components do not accept clinical trial applications under this opportunity. Applications are due September 5, 2026, January 5, 2027, and April 5, 2027, and must be submitted through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution; NIH SEED can be reached at SEEDinfo@nih.gov.
Eligible Applicants
Only United States small business concerns (SBCs), as defined by the Small Business Administration (SBA)(sbir.gov/apply) are eligible to submit applications for this opportunity.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.