The National Institutes of Health (NIH) is set to announce the SBIR/STTR Commercialization Readiness Pilot (CRP) Program, aimed at providing technical assistance and support for late-stage development of small business concerns (SBCs) that have previously received NIH SBIR or STTR Phase II or Phase IIB funding. This program is designed to facilitate the transition of these projects to commercialization by offering resources for activities such as independent study replication, IND-enabling studies, and regulatory assistance, which are typically not covered by standard Phase II or Phase IIB grants. Eligible applicants must be U.S.-based small businesses that meet specific ownership and operational criteria, with applications expected to be solicited following the reauthorization of the SBIR program. Interested parties can reach out to the NIH SEED Office at SEEDinfo@nih.gov or call 301-827-8595 for further information, with the estimated synopsis posting date set for October 1, 2025, and the application deadline anticipated for January 5, 2026.

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&amp;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&amp;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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