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SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

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Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The National Institutes of Health, under the Department of Health and Human Services, is implementing the SBIR/STTR Commercialization Readiness Pilot (CRP) Program through notice PAR-27-098. This initiative is designed to help small business concerns transition previously or currently funded SBIR and STTR Phase II and Phase IIB projects from late-stage research and development into the commercialization stage. The program provides critical support for activities not typically covered in earlier phases, including independent replication of key studies, IND or IDE-enabling studies, clinical trials, manufacturing scale-up, and regulatory assistance. Eligible applicants must be small business concerns with Phase II or IIB awards that have been active within the last 36 months and fall within the missions of the participating NIH institutes and centers. While a significant portion of the work may be subcontracted to other institutions, the small business concern must maintain overall oversight and management of the research and development. This program utilizes the SB1 activity code, with applications being accepted starting August 5, 2026, and multiple submission deadlines scheduled through 2028.

General Info

NIH's CRP program funds late-stage commercial development for recent SBIR/STTR Phase II/IIB small businesses.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
Contacts
NIH SEED (Small business Education and Entrepreneurial Development
contact@example.gov
+1 (555) 000-0000

Full Description

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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.

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