STTR Phase II — NIH (PHS Omnibus)

Who qualifies

• Must have successfully completed NIH STTR Phase I (R41 mechanism) — Phase II requires demonstrated Phase I feasibility via a scored and funded Phase I application at NIH
• Research institution partner from Phase I must continue as Phase II partner, OR a new qualified US research institution must be approved; partner institution must perform at least 30% of Phase II work
• Small business must perform at least 40% of Phase II work directly
• For-profit US small business with 500 or fewer employees including affiliates
• More than 50% owned and controlled by US citizens or permanent resident aliens
• Mandatory foreign national screening: the April 2026 reauthorization requires all applicants to disclose foreign ownership, foreign control, or foreign influence (FOCI) — new compliance requirement effective for all awards issued after April 13, 2026
• Principal Investigator may be primarily employed at either the small business OR the research institution (STTR flexibility vs. SBIR's strict >50% SBC requirement)
• Active SAM.gov registration with valid UEI required
• eRA Commons accounts active for PI, signing officials, and the research institution
• Updated subcontract or consortium agreement with the research institution required before submission
• No cost-sharing required

Hard requirements

• Must be incorporated
• 51%+ US ownership required
• Requires a prior Phase I award
• Requires a research-institution partner

What it covers

How to apply

1. 1

   Complete Phase I and incorporate results into Phase II Research Strategy

   NIH STTR Phase II is a competitive reapplication — Phase I final results must be incorporated into the Phase II Research Strategy. The Phase I results section is not optional; peer reviewers rely heavily on documented Phase I feasibility data to score Phase II scientific merit. A weak or incomplete Phase I results summary significantly reduces Phase II review scores. Target completion and submission of the Phase II R42 within 1–2 receipt cycles after Phase I ends.

   ~30 hrs

2. 2

   Update or renew the Research Institution subcontract agreement

   NIH requires an updated subcontract or consortium agreement between the small business and the research institution covering Phase II scope, IP rights, 30%/40% work allocations, publication rights, and regulatory requirements (human subjects, vertebrate animals if applicable). University TTOs require institutional sign-off — budget 4–6 weeks for the agreement process. Ensure the Phase II subcontract budget represents at least 30% of the proposed Phase II total costs.

   ~15 hrs

3. 3

   Prepare the full R42 Phase II application package

   Phase II R42 applications include: (1) Research Strategy (12 pages maximum) covering Phase I Summary, Background and Significance, Innovation, Approach for Phase II; (2) Specific Aims (1 page) clearly stating Phase II objectives; (3) Commercialization Plan (12 pages); (4) Budget and Budget Justification for both the small business and the research institution subcontract; (5) required forms including Biosketches, Facilities & Resources, and Institutional Certifications. The 12-page Phase II Research Strategy is shorter per-page than academic R01s, so prioritize Phase I results evidence and Phase II hypothesis-driven approach.

   ~120 hrs

4. 4

   Submit via Grants.gov Workspace to eRA Commons

   Assemble the R42 application package in Grants.gov Workspace and submit before the receipt date (5pm local time for the applicant institution). Allow 2 full business days before the deadline for Workspace processing and error resolution. eRA Commons will issue a confirmation tracking number. Confirm that the research institution subcontract budget and key personnel bios have been properly attached.

   ~8 hrs

5. 5

   Study section peer review, scoring, and award

   Phase II R42 applications undergo the same formal NIH peer review process as Phase I (R41): assigned to a study section, scored by a panel of scientific reviewers, and presented to the NIH Institute Advisory Council for funding recommendation. Phase II review typically weights Phase I feasibility results heavily — a strong summary statement with Phase I data dramatically improves Phase II funding odds. Fundable applications need scores in approximately the top 10–20% for the target institute. Award timeline: approximately 9–11 months from submission to project start.

   ~15 hrs

SBIR / STTR details

NAICS codes: 541714, 541715, 621999, 334510, 541711, 541712

Deadline & timing

NIH STTR Phase II (R42) uses the same receipt dates as Phase I (R41) and all NIH SBIR mechanisms: September 5, January 5, April 5. Unlike some SBIR programs where Phase II is invitation-based, NIH STTR Phase II requires a full competitive application using the R42 mechanism submitted to the same NIH institute as Phase I. The Phase II application requires Phase I final report results incorporated into the Research Strategy. Phase I awardees may also apply for STTR Fast Track (Phase I + Phase II combined). Allow 9–11 months from Phase II submission to award start.

Programs that stack well

• Research & Development Tax Credit (Section 41)
• STTR Phase I — NIH (PHS Omnibus)
• SBIR Phase II — NIH (PHS Omnibus)
• STTR Phase II — Department of Energy
• SBIR Phase I — NIH (PHS Omnibus)

Related programs