SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) is forecasting the release of the SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Not Allowed), opportunity number FOR-OD-26-006. This opportunity is managed by the NIH, including multiple participating Institutes and Centers such as the Office of the Director (OD), National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Human Genome Research Institute (NHGRI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), and others. NIH is the primary federal agency conducting and supporting medical research, with a mission to improve health, lengthen life, and reduce illness and disability through funding and supporting high-quality research. The purpose of this grant opportunity is to support small business concerns (SBCs) that have previously or currently received SBIR or STTR Phase II or Phase IIB awards, to help them progress their projects toward commercialization. The CRP program is designed to bridge the gap between research and market readiness by providing support for activities that are not typically funded under standard Phase II or Phase IIB grants or contracts. This includes technical assistance and later-stage research and development (R&D) activities, which may encompass independent replication of key studies, IND-enabling studies, certain clinical studies, manufacturing costs, and regulatory assistance, among other commercialization-related tasks. The opportunity specifically excludes clinical trials under this announcement. Eligible applicants are strictly limited to United States small business concerns as defined by the Small Business Administration (SBA). Applicants must either currently hold or have previously held an active Phase II or IIB SBIR/STTR award within the last 36 months that falls within the mission areas of the participating NIH awarding components. The small business must maintain oversight and management of the R&D, although subcontracting for a significant portion of the work is permitted. The funding opportunity is currently in the forecast stage, with an estimated funding announcement release date of October 1, 2025. The anticipated application due date is January 5, 2026, and the estimated award date is June 1, 2026, with project start dates beginning as early as July 1, 2026. The program does not require cost sharing or matching funds from applicants. The estimated number of awards, total program funding, award ceiling, and award floor are not specified in the forecast notice and must be verified once the full Notice of Funding Opportunity (NOFO) is published. Interested applicants are advised that publication of the official solicitation is contingent upon reauthorization and extension of the SBIR program. As such, applications are not being accepted at this time; the forecast is intended to allow potential applicants time to prepare responsive projects and establish necessary collaborations. Applicants should monitor Grants.gov and the NIH SEED (Small business Education and Entrepreneurial Development) office for updates and further instructions. For questions or further information, applicants may contact NIH SEED at the Office of Extramural Research (OER) via phone at 301-827-8595 or by email at SEEDinfo@nih.gov. No previous recipients or example awardees are listed in the forecast announcement.