NCATS STTR Phase I

NCATS STTR Phase II

Funds U.S. small businesses and their nonprofit research partners to continue and expand translational R&D begun in STTR Phase I toward a commercial product.

NCATS STTR Phase II is the continuation grant that follows a successful STTR Phase I award. It funds the expansion of the R&D work initiated in Phase I, with the goal of producing a commercial product, process, or service. Awards are normally $2,095,748 in total costs over a two-year project period. Applications may exceed this amount with prior approval from the NCATS Grants Management Officer.

Like Phase I, STTR Phase II requires a formal collaboration agreement with a U.S. nonprofit research institution (university, hospital, or federally funded research and development center). The institution must perform at least 30% of the total research effort; the small business must perform at least 40%. The requirement for a nonprofit partner distinguishes STTR from the SBIR program, where no such partner is needed.

Eligible businesses must be U.S.-based for-profit small businesses with 500 or fewer employees including affiliates. A prior STTR Phase I award is required before applying for Phase II — applicants without a Phase I award from the same funding agency (NIH) must provide written justification in what is called a Competing Renewal (Phase IIA). In practice, most applicants hold an active or recently completed Phase I from NCATS or another NIH institute.

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 receive scientific merit review followed by NCATS Advisory Council review before funding decisions are made.

Successful Phase II awardees producing highly promising data may be eligible for a Phase IIB (Competing Renewal) to bridge toward commercialization, but this requires a separate application. NCATS also offers Technical and Business Assistance (TABA) services to Phase II awardees to support commercialization.