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

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Grant

Contract Overview

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

AI Contract Overview

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The National Institutes of Health (NIH) plans to issue a Notice of Funding Opportunity (NOFO) for the Commercialization Readiness Pilot (CRP) program aimed at small business concerns (SBCs). This program supports the progression of SBIR and STTR Phase II and Phase IIB projects toward commercialization by providing funding for additional technical assistance and late-stage research and development activities that are not typically covered in earlier grant phases. Eligible activities may include independent validation studies, Investigational New Drug (IND)-enabling studies, clinical trials, manufacturing expenses, and regulatory support. While subcontracting is permitted, the SBC must retain overall management and oversight of the project. The NOFO is contingent on the continued authorization of the SBIR program and is intended to give potential applicants ample time to develop partnerships and prepare proposals. This funding opportunity applies to recipients of recent or ongoing Phase II or IIB SBIR/STTR awards active within the past 36 months and relevant to the missions of the participating NIH Institutes and Centers. The NOFO will be released under the SB1 activity code. Although applications are not currently being solicited, interested small businesses are encouraged to begin planning to apply once the solicitation is published. Support and inquiries can be directed to the NIH SEED office, which offers assistance and guidance for small businesses navigating this process.

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) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
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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