NCATS STTR Phase I

NCATS STTR Phase I

Funds U.S. small businesses and their nonprofit research partners to conduct feasibility studies on translational science innovations toward commercialization.

NCATS STTR Phase I is a six-month feasibility grant for U.S. small businesses working in partnership with a nonprofit research institution (university, hospital, or federal lab). It runs under the NIH SBIR/STTR Omnibus Solicitation — the same grant vehicle used by all NIH institutes — but NCATS selects applicants whose work fits its specific translational science priorities. Awards are normally $314,995 in total costs for the six-month project period. Applications may exceed $314,995 only with prior approval from the NCATS Grants Management Officer.

STTR is designed for technology transfer: moving research from nonprofit institutions into the commercial sector. The key structural requirement is a formal collaboration agreement between the small business (which serves as the prime recipient) and a nonprofit research institution. The institution must contribute at least 30% of the total research effort; the small business must contribute at least 40%. The PI may be employed by either organization, but must devote effort to the project.

Eligible businesses must be U.S.-based for-profit small businesses with 500 or fewer employees (including affiliates). The nonprofit partner must be a U.S.-based university, nonprofit research organization, or federally funded research and development center (FFRDC). Foreign organizations may participate as subcontractors, but only with prior NIH approval.

Applications are submitted through the NIH SBIR/STTR Omnibus Solicitation, which accepts applications three times per year: January 5, April 5, and September 5. The typical award arrives six to nine months after submission. Applications are reviewed by an NIH Scientific Review Group and then by the NCATS Advisory Council before funding decisions are made.

A successful STTR Phase I is expected to produce sufficient data to justify a Phase II application. Phase I results are not required before applying to Phase II, but Phase II applications without Phase I outcomes are rare and require special justification.