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

The National Institutes of Health (NIH), a division of the U.S. Department of Health and Human Services, is forecasting a funding opportunity titled the SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Required), under opportunity number FOR-OD-26-007. This opportunity is administered through several NIH Institutes and Centers, including OD, NEI, NHLBI, NIAAA, NICHD, NIDCD, NIMH, and NIA. The program is designed specifically for U.S. small business concerns and focuses on accelerating the commercialization of innovations developed under SBIR and STTR Phase II or Phase IIB awards. This forecasted Notice of Funding Opportunity (NOFO) aims to support small businesses by providing financial and technical resources to transition NIH-funded research projects toward market readiness. The scope includes support for activities such as independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, regulatory assistance, and manufacturing costs. These efforts are not typically covered under the standard SBIR or STTR Phase II or Phase IIB funding mechanisms. Importantly, although subcontracting is permitted for many of the project activities, the award recipient must retain primary oversight and management responsibilities for the research and development. To be eligible, applicants must be classified as United States small business concerns (SBCs), as defined by the Small Business Administration (SBA). This criterion applies exclusively, and no other categories of applicant institutions or individuals are eligible. Eligible applicants are also required to have a qualifying SBIR or STTR Phase II or IIB award that has been active within the last 36 months, including awards that are still active at the proposed project start date. This opportunity is currently in forecast status and applications are not yet being accepted. The anticipated publication date for the official NOFO is October 1, 2025. Following publication, the estimated application due date is January 5, 2026. Award announcements are expected by June 1, 2026, with the anticipated project start date being July 1, 2026. This timeline offers potential applicants adequate lead time to develop collaborative relationships and prepare competitive proposals. This grant will be issued under the SB1 activity code and is contingent upon reauthorization and extension of the SBIR program. It falls within several assistance listings including research fields such as deafness and communication disorders, sleep disorders, mental health, alcohol and cardiovascular research, lung and blood disease research, aging, and vision. The opportunity does not require cost sharing or matching funds from applicants. Inquiries about this opportunity can be directed to NIH SEED (Small business Education and Entrepreneurial Development), Office of Extramural Research (OER), via phone at 301-827-8595 or email at SEEDinfo@nih.gov. As a forecasted opportunity, this listing serves to inform and prepare the eligible small business community ahead of formal solicitation and application acceptance.