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

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program is an initiative led by the National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services. This program is designed to support small business concerns that have previously received SBIR or STTR Phase II or Phase IIB funding and are transitioning their technologies toward commercialization. Multiple NIH Institutes and Centers participate in this effort, including those focused on mental health, aging, cardiovascular diseases, and communication disorders, reflecting the broad biomedical and public health scope of the program. The primary purpose of the CRP program is to address the funding gap that often exists between early-stage research and market-ready products. While Phase II and IIB awards typically support research and development, they may not fully cover later-stage activities required for commercialization. This program aims to provide additional funding to facilitate activities such as independent replication studies, regulatory preparation, manufacturing scale-up, and clinical validation. By supporting these activities, the program seeks to accelerate the transition of promising biomedical innovations into products that can benefit public health. Funding under this opportunity is expected to support a wide range of allowable activities tied directly to commercialization readiness. These include Investigational New Drug enabling studies, clinical trials, regulatory assistance, and manufacturing-related expenses. A significant portion of the work may be subcontracted to specialized organizations; however, the applying small business must retain primary oversight and management responsibility for the project. The funding opportunity does not require cost sharing or matching contributions, reducing financial barriers for eligible applicants. Eligibility is limited to United States-based small business concerns as defined by the Small Business Administration. Applicants must have an active or recently active SBIR or STTR Phase II or Phase IIB award within the past 36 months and must align with the mission areas of participating NIH Institutes and Centers. This ensures that applicants have demonstrated prior success and are positioned to advance their technologies toward commercialization with additional targeted support. The application process for this opportunity is not yet open, as this is a forecasted notice. NIH has provided this advance notice to allow potential applicants time to prepare collaborations, refine commercialization strategies, and develop competitive proposals. Once officially released, applications will be submitted through standard NIH mechanisms, likely requiring detailed research plans, commercialization strategies, budgets, and supporting documentation consistent with SBIR/STTR application requirements. The estimated timeline indicates that the formal funding opportunity announcement will be posted around October 1, 2025, with applications due by January 5, 2026. Awards are expected to be made by June 1, 2026, with project start dates beginning around July 1, 2026. As this program is contingent upon reauthorization of the SBIR program, final availability may depend on legislative actions. Interested applicants are encouraged to monitor updates and prepare in advance for submission once the opportunity is formally released.

Focus on demonstrating commercialization readiness and strong prior SBIR/STTR Phase II or IIB performance with clear path to market