SBIR Phase II — NIH (PHS Omnibus)
National Institutes of Health
Up to $2.15M (Phase II)
NIH Phase II: full R&D scale-up
NIH Phase II provides up to $2,153,927 total costs for 2 years of full R&D development following a successful Phase I feasibility study. Phase II is a formal competitive re-application — not an automatic continuation — submitted to the same NIH institute that funded Phase I. Peer-reviewed by a study section, scored, and subject to the same percentile-rank funding threshold as Phase I. Non-dilutive federal grant, paid via NIH Payment Management System.
- Funding type
- Grant
- Level
- Federal
- Amount range
- $2,153,927
- Realistic amount
- Most NIH Phase II awards range from $1.5M–$2.15M over 2 years. Direct costs are the budget component controlled by the c…
- Deadline
- Between intakes — NIH SBIR Phase II receipt dates align with Phase I cycles: September 5, January 5, April 5. Next standard receipt: September 5, 2026. New omnibus NOFO expected before that date following April 2026 reauthorization.
- Status
- between-intakes
- States
- Nationwide
- Payment model
- advance
Who qualifies
- Must have completed an NIH SBIR Phase I award (R43) — Phase II (R44) is a competitive follow-on, not an open competition for first-timers
- 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
- Principal Investigator must be primarily employed (>50% of working time) at the applicant firm at time of award
- Active SAM.gov registration with a valid UEI required
- Active eRA Commons registration for the organization and all key personnel
- Registered in the SBA SBIR Company Registry at sbir.gov
- Phase II application must be submitted to the same NIH institute that funded Phase I, unless prior approval is obtained for a different institute
- No cost-sharing required
Hard requirements
- Must be incorporated
- 51%+ US ownership required
- Requires a prior Phase I award
What it covers
Eligible expenses
- Salaries, wages, and fringe benefits for all personnel working on Phase II (PI, co-investigators, research staff)
- Supplies and reagents for prototype development and preclinical/clinical testing
- Equipment necessary for Phase II work (items over $5,000 require prior budget justification)
- Subcontract costs (CROs, testing labs, manufacturing services) — must not exceed two-thirds of total Phase II costs for the applicant's subcontracting (two-thirds rule: majority of work must be performed by the small business)
- Patient care costs if human subjects research requires clinical services
- Consultant fees for technical, regulatory, or commercialization expertise
- Travel for research activities (domestic at GSA rates; foreign with prior approval)
- IP-related costs: patent applications, freedom-to-operate opinions, trademark registration
- Indirect (F&A) costs at the applicant's negotiated rate or 26% de minimis rate
- SBIR fee (7% of direct + indirect costs, allowable as a profit/fee at the prime awardee level)
Ineligible expenses
- Capital equipment over $5,000 per item not justified in the approved budget
- Construction or renovation of facilities
- Fundraising or investor relations activities
- Lobbying or political activities
- Entertainment, alcohol, or personal expenses
- Salaries exceeding the NIH Executive Level II cap ($221,900 as of January 2025)
- Costs incurred before the Notice of Award date (pre-award costs require specific NIH prior approval)
- Subcontract work exceeding two-thirds of the total Phase II award value
- Foreign organization subcontracts beyond program limits without NIH prior approval
How to apply
-
1
Complete Phase I and prepare Phase I results summary
Submit all required Phase I progress and final reports via Research Performance Progress Reports (RPPRs) in eRA Commons. Phase II cannot be submitted while Phase I is still active at most institutes — check with your program officer. Prepare a concise 6-page Phase I results summary for inclusion in the Phase II Research Strategy.
~40 hrs
-
2
Consult your NIH program officer about Phase II timing and scope
Before writing, email the program officer (PO) at your NIH institute to confirm Phase II eligibility, discuss whether your Phase I results support a competitive Phase II application, and get guidance on scope and any institute-specific requirements. POs are explicitly available and this conversation often takes fewer than 2 weeks to complete. It is the highest-ROI 30 minutes of Phase II prep.
~3 hrs
-
3
Develop the Phase II Research Strategy
Phase II Research Strategy is a maximum 12-page document (compared to 6 pages for Phase I). Sections: Background and Significance, Innovation, Approach, and Phase I Results. The Approach must include a detailed milestone chart for all Phase II aims. Phase II requires substantially more rigor than Phase I — reviewers expect prototype-level data from Phase I, not just feasibility signals. Avoid overselling Phase I results; study sections are experienced at evaluating the actual scientific merit of feasibility data.
~120 hrs
-
4
Write the expanded Commercialization Plan
NIH Phase II requires a formal Commercialization Plan as an attachment (not part of the 12-page Research Strategy). Include: target markets, competitive landscape, regulatory strategy (FDA pathway if applicable), IP protection status and strategy, manufacturing plan, and letters of support from potential partners or customers. NIH provides a template; following it closely is strongly recommended.
~25 hrs
-
5
Assemble and submit via Grants.gov to eRA Commons
Complete the SF-424 package in Grants.gov Workspace, including all required attachments. After submission, eRA Commons will display the application for review assignment. Allow 2 full business days before the receipt deadline for submission processing. NIH will send a confirmation with the assigned study section and review date within 4–6 weeks of submission.
~10 hrs
SBIR / STTR details
SBIR phase amounts
| Phase | Max award | Duration |
|---|---|---|
| Phase1 | $323,090 | 6 months typical (up to 12 months) |
| Phase2 | $2,153,927 | 2 years typical (up to 3 years) |
NAICS codes: 541714, 541715, 621999, 334510, 541711, 541712
Phase II is peer-reviewed from scratch — your Phase I score does not carry over. The Commercialization Plan is weighted more heavily: study sections expect FDA pathway clarity, identified manufacturing partners, and letters of interest from customers. The Fast Track mechanism (combined Phase I + Phase II application) cuts 6–12 months off the timeline — ask your program officer whether your technology qualifies.
Deadline & timing
NIH Phase II receipt dates are the same as Phase I: September 5, January 5, April 5. Phase II is a competitive re-application — you apply to the same NIH institute using the R44 mechanism (Phase II) rather than R43 (Phase I). The Phase II application requires a detailed summary of Phase I results in the Research Strategy. Phase I awardees may also apply for the Fast Track mechanism (Phase I + Phase II combined application) or for a Phase I → Phase II direct conversion at some institutes. Allow 8–10 months from submission to award start for a standard Phase II application.
Programs that stack well
- Research & Development Tax Credit (Section 41)
- SBIR Phase I — NIH (PHS Omnibus)
- STTR Phase I — NIH (PHS Omnibus)
- Sbir Phase 3 Commercialization
- State Sbir Matching Programs
Related programs
Last reviewed 2026. GrantCompass is an independent funding-discovery tool and is not affiliated with any government agency. Always confirm details on the official program page.