SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)
Can you apply?
This grant is for small business concerns (SBCs) that hold active or recently active Phase II or Phase IIB SBIR/STTR awards from NIH. Applicants must have received their Phase II or IIB award within the last 36 months or have one active at the project start date. The award must align with the mission of one of the participating NIH Institutes and Centers listed (including OD, NEI, NHLBI, NHGRI, and others). Projects must demonstrate readiness to transition from research to commercialization. The program supports technical assistance, later-stage R&D, clinical studies, manufacturing, and regulatory support not typically covered by Phase II/IIB funding.
The SBC must maintain primary oversight and management of R&D activities, though significant work may be subcontracted. This program is designed to bridge the gap between research completion and market entry for biomedical innovations.
Note: Applications are not currently being solicited. Program availability depends on SBIR program reauthorization.
Key dates
- May 28, 2026 Applications open
- Mar 1, 2027 Award announced
- Apr 1, 2027 Project start
- Apr 5, 2029 Application deadline in 1036 days
This grant is for small business concerns (SBCs) that hold active or recently active Phase II or Phase IIB SBIR/STTR awards from NIH. Applicants must have received their Phase II or IIB award within the last 36 months or have one active at the project start date. The award must align with the mission of one of the participating NIH Institutes and Centers listed (including OD, NEI, NHLBI, NHGRI, and others). Projects must demonstrate readiness to transition from research to commercialization. The program supports technical assistance, later-stage R&D, clinical studies, manufacturing, and regulatory support not typically covered by Phase II/IIB funding.
The SBC must maintain primary oversight and management of R&D activities, though significant work may be subcontracted. This program is designed to bridge the gap between research completion and market entry for biomedical innovations.
Note: Applications are not currently being solicited. Program availability depends on SBIR program reauthorization.
Program description
The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): OD, NEI, NHLBI, NHGRI, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NCATS, NCI, NIA, intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications from small business concerns (SBCs) to the Commercialization Readiness Pilot (CRP) program. The NOFO aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R&D throughout the award. Applications are not being solicited at this time. Publication of this solicitation is contingent upon reauthorization and extension of the SBIR program. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the SB1 activity code. Recipients with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months, including those that will be active at the requested start date, within the missions of the NIH awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO.
Who can apply
Eligible applicants
Details
This grant is for small business concerns (SBCs) that hold active or recently active Phase II or Phase IIB SBIR/STTR awards from NIH. Applicants must have received their Phase II or IIB award within the last 36 months or have one active at the project start date. The award must align with the mission of one of the participating NIH Institutes and Centers listed (including OD, NEI, NHLBI, NHGRI, and others). Projects must demonstrate readiness to transition from research to commercialization. The program supports technical assistance, later-stage R&D, clinical studies, manufacturing, and regulatory support not typically covered by Phase II/IIB funding.
The SBC must maintain primary oversight and management of R&D activities, though significant work may be subcontracted. This program is designed to bridge the gap between research completion and market entry for biomedical innovations.
Note: Applications are not currently being solicited. Program availability depends on SBIR program reauthorization.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) Application Form
- Project Narrative
- Budget Narrative and Budget Forms
- Prior Phase II/IIB Award Documentation
- Letters of Support (for subcontractors or collaborators)
- Commercialization Plan or Go-to-Market Strategy
Program contact
- 👤 NIH SEED (Small business Education and Entrepreneurial Development)
- 📧 SEEDinfo@nih.gov
- 📞 301-827-8595
Funding track record
Recent awards under CFDA 93.307 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$57,145,935
-
$48,558,256
-
$43,100,665
-
$41,925,783
-
$41,194,375
-
$38,870,836
-
$37,142,240
-
$35,966,257
-
$35,161,090
-
$34,649,979
Top States by Funding
- CA 9 awards $245.6M
- NC 4 awards $112.1M
- TX 5 awards $81.8M
- NY 5 awards $80.8M
- GA 3 awards $75.2M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.307). How funding has trended year over year.
| 2018 | $262,996,990 | |
| 2019 | $273,841,218 | |
| 2020 | $334,014,214 | |
| 2021 | $899,466,003 | |
| 2022 | $421,276,230 | |
| 2023 | $540,394,878 | |
| 2024 est. | $489,444,934 | |
| 2025 est. | $489,444,934 |
FAQ
Who can apply for the CRP program?
Small business concerns with active or recently completed Phase II/IIB SBIR/STTR awards from participating NIH institutes within the last 36 months. Your prior award must align with an eligible IC's mission.
What types of activities can be funded?
Independent study replication, IND-enabling studies, clinical trials, manufacturing development, regulatory assistance, and technical support. All work advances your innovation toward commercialization.
What is the role of the small business in the project?
The SBC must maintain oversight and management of all R&D. Subcontracting to institutions is allowed, but the SBC leads the overall effort.
When will applications be accepted?
Applications are not currently being solicited. The NOFO publication depends on SBIR program reauthorization. Watch for official announcement.
Is there cost sharing required?
No cost sharing is required for this program.
💡 Tips for applicants
- Start building collaborations now. Identify clinical partners, manufacturers, or regulatory consultants before the application opens.
- Document your Phase II/IIB progress clearly. Show specific gaps between current research and market readiness.
- Frame R&D as commercialization-focused. Emphasize how each activity directly supports product launch or regulatory approval.
- Plan realistic budgets for downstream activities. Include manufacturing scale-up, clinical validation, or regulatory submissions.
- Align your project with the IC's mission. Review the participating institutes and ensure your innovation matches their research priorities.
⚠️ Common mistakes
Applying without a Phase II/IIB award in the required timeframe. Proposing R&D that is primarily basic research rather than commercialization-focused. Failing to clarify the SBC's management role and responsibility in the project.
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