The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required), administered by the National Institutes of Health (NIH), is designed to support small business concerns (SBCs) transitioning previously or currently funded SBIR and STTR Phase II or IIB projects toward commercialization. This initiative provides funding for activities not typically supported under earlier phases, such as technical assistance and advanced research and development, with a particular emphasis on projects requiring at least one clinical trial. Eligible applicants must have received Phase II or IIB funding within the last 36 months from participating NIH Institutes or Centers (ICs).

The purpose of this funding opportunity is to help SBCs bridge the funding gap, often referred to as the "Valley of Death," that exists between the end of SBIR/STTR Phase II awards and commercialization. The CRP allows companies to outsource significant portions of their project to external entities such as contract research organizations, provided that the applicant maintains substantial oversight. Applicants are required to address specific commercialization risks and outline activities such as clinical studies, regulatory strategy development, IND-enabling studies, GMP manufacturing, and market research.

The funding supports a wide scope of activities, including technical assistance, late-stage R&D, and product development activities such as optimization of device designs, GLP animal studies, manufacturing scale-up, IND/IDE-enabling studies, and clinical trial preparations. Participating NIH ICs include the Office of the Director, NEI, NHLBI, NIAAA, NICHD, NIDCD, NIMH, and NIA. Each IC may set its own budget restrictions and project scopes. For example, the NEI limits total budgets to $750,000 across all years, while NIDCD restricts annual requests to $1,750,000.

Eligible applicants include U.S.-based SBCs that meet ownership and size standards and have received relevant Phase II or IIB awards from NIH. The program excludes foreign entities and components, although limited foreign subcontracts may be permissible. Applicants are required to register in multiple federal systems before submission and follow detailed instructions laid out in the NIH SF424 (R&R) SBIR/STTR Application Guide, with specific deviations for this NOFO.

Applications must include a commercialization plan, project management and regulatory plans, and a detailed fundraising strategy if third-party investment is required. Additional required elements include a progress report on commercialization efforts, letters of support, and human subjects protection documentation where applicable. Evaluation will be based on criteria such as significance, investigator expertise, innovation, approach, environment, and the strength of commercialization and regulatory strategies.

Applications are accepted on multiple NIH standard due dates throughout the year (January, April, and September), and the next submission deadline is April 5, 2025. The opportunity is not offered on a rolling basis but is recurring, with the current cycle closing on September 6, 2025. Contact information is provided for scientific, administrative, and grants management questions across participating ICs.