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

The National Institutes of Health (NIH), within the U.S. Department of Health and Human Services, is preparing to release a Notice of Funding Opportunity (NOFO) for the SBIR/STTR Commercialization Readiness Pilot (CRP) Program. This initiative is part of the broader Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) ecosystem, which is designed to stimulate technological innovation, strengthen the role of small businesses in federal research and development, and increase private sector commercialization of federally funded innovations. The CRP program specifically addresses a critical gap between early-stage research and market readiness by supporting later-stage activities that are not typically funded through Phase II or Phase IIB awards. The primary objective of the CRP program is to accelerate the commercialization of biomedical and health-related technologies that have already received SBIR or STTR Phase II or Phase IIB funding. The program focuses on advancing these projects toward regulatory approval, manufacturing readiness, and market entry. Funding may support a range of activities including independent replication of key studies, Investigational New Drug enabling studies, clinical trials, regulatory compliance efforts, and scaling of manufacturing processes. These activities are essential for translating promising research into viable commercial products that can improve public health outcomes. Funding under this opportunity is expected to support technical assistance and late-stage research and development efforts. While the small business applicant must maintain overall oversight and management responsibility for the project, a significant portion of the work may be subcontracted to partner institutions such as universities, contract research organizations, or other specialized entities. This flexibility allows applicants to leverage external expertise while retaining accountability for project execution and commercialization strategy. There is no cost-sharing or matching requirement specified for this program. Eligibility is limited to United States small business concerns as defined by the Small Business Administration. Applicants must have previously received SBIR or STTR Phase II or Phase IIB funding within the past 36 months or have an active award at the proposed project start date. The program encourages these eligible entities to begin preparing for the upcoming solicitation by forming strategic partnerships and refining their commercialization plans. The intent is to ensure that applicants are well-positioned to submit competitive proposals once the NOFO is officially released. The application process will follow standard NIH submission procedures once the NOFO is published. Although applications are not currently being accepted, the forecast provides estimated key dates to guide preparation. The estimated application due date is September 5, 2026, with an anticipated award date of March 1, 2027, and a projected project start date of April 1, 2027. The publication of the NOFO is contingent upon the reauthorization and extension of the SBIR program, and potential applicants should monitor updates closely. Evaluation criteria are expected to align with NIH standards, including scientific and technical merit, commercialization potential, feasibility of the proposed approach, and the capability of the project team. Applicants should also anticipate requirements for detailed project plans, commercialization strategies, and regulatory pathways. For additional information and guidance, applicants may contact NIH SEED (Small Business Education and Entrepreneurial Development) at 301-827-8595. This forecasted opportunity allows prospective applicants time to develop robust proposals and partnerships in advance of the official solicitation.

Focus on demonstrating strong commercialization pathways and partnerships; ensure prior Phase II/IIB outcomes are clearly validated