STTR Phase I — NIH (PHS Omnibus)

Who qualifies

• For-profit US small business concern with 500 or fewer employees (including all affiliates)
• More than 50% owned and controlled by US citizens or permanent resident aliens
• Must formally partner with a US-based research institution — eligible partners include accredited universities and colleges, domestic nonprofit research organizations, and federally funded R&D centers (FFRDCs)
• The research institution must perform at least 30% of the Phase I work (measured in direct costs) — this is a hard requirement, not a target
• The small business must perform at least 40% of the Phase I work directly (the remaining ≤30% may go to other subcontractors)
• PI (Principal Investigator at the small business) and the Co-PI at the research institution must both be committed to the project — NIH STTR explicitly requires two key personnel from two organizations
• The small business's PI does NOT need to be primarily employed at the small business (unlike SBIR) — this is the key STTR flexibility for academic founders
• A formal IP agreement (IP Rights Agreement) between the small business and the research institution is required and must be submitted with the application
• Active SAM.gov registration and SBA SBIR Company Registry membership required
• eRA Commons accounts required for the small business and the research institution

Hard requirements

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

What it covers

How to apply

1. 1

   Identify a research institution partner and establish the collaboration

   The research institution partnership is the defining feature of STTR. Identify a university lab, nonprofit research org, or FFRDC whose technology or expertise complements your commercialization goals. A co-PI at the partner institution is required. Allow 4–8 weeks to negotiate the collaboration — universities have technology transfer offices (TTOs) and subcontract offices that must process the STTR agreement.

   ~20 hrs

2. 2

   Negotiate the IP Rights Agreement between the two organizations

   NIH requires a written IP Rights Agreement before submission — the document must specify who owns any IP generated, the terms of commercialization rights, and how the 30%/40%/30% work allocation will be executed. This is typically negotiated between your company and the university's TTO. University TTOs are often slow — start 8–10 weeks before the receipt date. A standard template IP agreement is available from some NIH institutes.

   ~15 hrs

3. 3

   Register in SAM.gov, SBIR Company Registry, and eRA Commons

   Complete SAM.gov registration (UEI) for your small business — allow 2–3 weeks for new registrations. Register in the SBA SBIR Company Registry at sbir.gov. Both the small business and the research institution need active eRA Commons accounts. If your university partner is new to NIH grants, their registration in eRA Commons may take 2–4 weeks — check early.

   ~6 hrs

4. 4

   Develop Specific Aims and identify the target NIH institute

   Write a 1-page Specific Aims document describing the problem, your approach, and Phase I feasibility objectives. Identify the 1–2 NIH institutes whose mission matches your science. Email the program officer at each candidate institute to confirm fit — STTR program officers are the same as SBIR POs and are explicitly accessible. Confirm that both the small business's and the institution's science qualify before writing the full application.

   ~25 hrs

5. 5

   Write the full Phase I application

   Phase I Research Strategy is 6 pages maximum (same as SBIR Phase I). In addition to standard SBIR sections, STTR requires: (a) explicit justification of the 30%/40% work allocation in the budget narrative, (b) letters of support from the research institution leadership (typically Provost or department chair), (c) the signed IP Rights Agreement as an attachment, and (d) biosketches for both the small business PI and the research institution co-PI. Commercialization Plan is required.

   ~100 hrs

6. 6

   Submit via Grants.gov Workspace to eRA Commons

   Assemble the full package in Grants.gov Workspace. The research institution's signing official must also be registered in eRA Commons and authorize the subcontract budget. Allow 3 full business days before the receipt deadline — STTR applications have more moving parts than SBIR and eRA Commons routing between two institutions adds complexity.

   ~10 hrs

SBIR / STTR details

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

Deadline & timing

NIH STTR receipt dates are identical to SBIR: September 5, January 5, April 5. The STTR mechanism uses the R41 (Phase I) and R42 (Phase II) grant mechanisms rather than SBIR's R43/R44. Following the April 13, 2026 reauthorization, NIH has no active STTR NOFO as of May 2026; the next PHS omnibus is expected to open several weeks before the September 5, 2026 receipt date. The research institution subcontract must be formalized before submission — allow 4–6 weeks for institutional subcontract negotiation.

Programs that stack well

• Research & Development Tax Credit (Section 41)
• SBIR Phase I — NIH (PHS Omnibus)
• SBIR Phase II — NIH (PHS Omnibus)
• State Sbir Matching Programs
• Nsf Sbir Phase 1

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