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

The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): OD, NEI, NHLBI, NIAAA, NICHD, NIDCD, NIMH, and 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.