The SBIR/STTR Commercialization Readiness Pilot (CRP) Program, issued under Notice of Funding Opportunity (NOFO) PAR-23-219, is reissued by the National Institutes of Health (NIH) to support the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects into the commercialization stage. This grant opportunity is designed specifically for U.S.-based small business concerns (SBCs) that have had an active NIH SBIR or STTR Phase II or Phase IIB award within the last 36 months. The purpose is to bridge the gap between research and market application by providing targeted support for technical assistance and late-stage research and development (R&D) activities that are not typically funded through earlier phases.

This funding opportunity explicitly excludes clinical trials and is geared toward enabling a wide array of commercialization-supportive activities. These activities include regulatory strategy development, manufacturing process optimization, intellectual property strategy, and specific types of preclinical and analytical studies essential for regulatory compliance and market readiness. Projects may involve outsourcing a significant portion of the work to specialized providers such as Contract Research Organizations (CROs), as long as the SBC maintains direct oversight and control over the project.

Award support can vary significantly depending on the participating NIH Institute or Center (IC), with maximum annual or total award limits ranging from $250,000 to $2,000,000. The general funding cap across most applications is up to $4,091,634 total costs over a maximum three-year period. However, budget caps are specifically tailored by IC; for instance, NIAID limits funding to $1 million per year for three years, while NINDS supports up to $300,000 across all years. Applications must conform strictly to submission requirements and are subject to rigorous review based on commercialization readiness, technical merit, innovation, and alignment with public health priorities.

Eligible applicants are required to follow detailed submission instructions using the NIH ASSIST system, Grants.gov Workspace, or an institutional S2S solution. Applications are due on standard NIH due dates: January 5, April 5, and September 5, annually, through September 6, 2025. Applicants must submit a letter of intent 30 days before the application due date and comply with all NIH and SBIR-specific performance benchmarks and registration requirements.

Reviewers assess applications based on five scored review criteria—Significance, Investigator(s), Innovation, Approach, and Environment—along with commercialization potential, progress to date, and regulatory and fundraising plans. The application must include a commercialization plan that outlines realistic market-based milestones, expected revenue generation, regulatory strategy, and evidence of third-party investor interest or support.

The CRP Program supports new applications and resubmissions but does not allow renewals. Only U.S. small businesses meeting specific ownership and employment criteria, and having previously completed eligible SBIR/STTR projects with NIH, may apply. Applicants must be compliant with all disclosure and registration requirements, including the System for Award Management (SAM), eRA Commons, Grants.gov, and SBA Company Registry.