NCATS SBIR/STTR Small Business Programs

NCATS SBIR Phase I

Supports small businesses testing translational science tools and technologies through early feasibility and commercialization groundwork.

The National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health, administers SBIR Phase I grants (R43) to fund small US businesses seeking to establish the technical merit and feasibility of translational science innovations. NCATS focuses on four priority topic areas: preclinical drug discovery and development, biomedical and clinical and health research informatics, clinical and dissemination and implementation research, and rare disease and unmet medical needs. These areas reflect NCATS's core mission to develop new approaches, tools, and technologies that enable earlier and more efficient translation of basic discoveries into clinical interventions.

The standard NIH SBIR Phase I budget is approximately $306,000 (R43 mechanism). Applications are submitted via the NIH parent FOA PA-25-303 or NCATS-specific RFAs, and topics are reviewed biannually. Eligibility is limited to US-based small business concerns — domestic, majority US-owned for-profit companies. The STTR Phase I variant (R41) follows the same process but requires a formal partnering agreement with a US research institution that conducts at least a portion of the work. NCATS also offers a Phase IIB/III Bridge mechanism for companies that require extended support beyond standard Phase II to reach commercialization readiness.

Applicants should contact NCATS-SBIRSTTR@mail.nih.gov before preparing a submission to confirm that the proposed work aligns with current biannual review topics and that the relevant FOA is active. Because NCATS underwent organizational restructuring in 2026 and FY2026 OMB appropriations withholding created fund-release uncertainty across NIH, early engagement with NCATS program staff is especially important to verify current funding availability and submission cycle timing before investing in a full application package.