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

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program is administered by the National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services. NIH is the primary federal agency responsible for biomedical and public health research in the United States. Through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, NIH supports small business concerns (SBCs) in developing innovative technologies that improve human health. The CRP program is specifically designed to address the gap between late-stage research and full commercialization, helping previously funded SBIR/STTR projects advance toward market readiness. The purpose of the CRP program is to provide targeted funding and support for small businesses that have already completed earlier SBIR or STTR phases, particularly Phase II or Phase IIB awards. The program focuses on activities that are not typically supported in those earlier phases but are essential for commercialization. These include independent replication of key studies, regulatory preparation such as IND- or IDE-enabling studies, clinical research, manufacturing scale-up, quality assurance processes, and specialized technical or regulatory consulting. By supporting these activities, the CRP program aims to accelerate the transition of promising biomedical innovations into viable commercial products. Funding under this opportunity is structured as a grant, with flexibility for awardees to subcontract a significant portion of the work to third-party vendors or collaborators. This reflects the program’s emphasis on commercialization readiness, where specialized expertise in manufacturing, regulatory compliance, or clinical validation may be required. The funding scope is broad within the context of late-stage development, but it is limited to activities directly tied to advancing an existing SBIR/STTR-funded project toward commercialization. There is no cost sharing or matching requirement, which reduces the financial burden on small businesses and encourages participation from a wider pool of eligible applicants. Eligibility for the CRP program is restricted to United States-based small business concerns as defined by the Small Business Administration. While the general eligibility listing includes a wide range of entity types, the controlling eligibility language specifies that only qualifying SBCs may apply. Foreign organizations and non-U.S. components of U.S. organizations are not eligible to receive funding, although unfunded collaborations with international partners may be permitted under certain conditions. This ensures that federal funds are directed toward domestic innovation while still allowing for global scientific collaboration where appropriate. The application process follows NIH standard submission procedures through Grants.gov and associated NIH systems. Applicants must prepare a full proposal that builds on prior SBIR/STTR work and clearly demonstrates the need for additional commercialization-focused activities. Required components typically include a detailed research and commercialization plan, budget justification, and supporting documentation related to prior project outcomes. Evaluation criteria emphasize the likelihood of successful commercialization, the technical merit of the proposed activities, and the capability of the small business and its partners to execute the project. The program operates on a recurring basis with multiple receipt dates over several years. The current funding opportunity was posted in late May 2026, with an original application deadline of April 5, 2027, and a final closing date extending to April 5, 2029. This extended window indicates that the program is intended to accept applications across multiple cycles. Applicants should plan their submissions according to NIH standard due dates and allow sufficient time for review and potential resubmission. Contact for the program is provided through the NIH SEED office, which supports small business applicants with guidance and technical assistance. Overall, the CRP program plays a critical role in bridging the gap between research innovation and commercial viability. By focusing on late-stage development and providing flexible funding for specialized activities, it enables small businesses to overcome common barriers to market entry. The program’s structure, eligibility criteria, and emphasis on commercialization outcomes make it a strategic funding opportunity for SBCs seeking to bring biomedical technologies to market.

Focus on demonstrating clear commercialization pathway, regulatory readiness, and strong prior SBIR/STTR outcomes