SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)
This funding opportunity provides financial support to U.S.-based small businesses that have previously received NIH Phase II or Phase IIB awards, helping them advance their research projects toward commercialization through technical assistance and late-stage development activities.
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.
Award Range
Not specified - $2,000,000
Total Program Funding
Not specified
Number of Awards
Not specified
Matching Requirement
No
Additional Details
Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. National Institute on Aging (NIA) Generally, NIA will not accept annual budget requests exceeding $2,000,000 in total costs per year. Award Budget Budgets up to $4,091,634 total funding support (direct costs, indirect costs, fee) for the entire budget period may be requested except for the budget limitations for CRP applications associated with the Institutes/Centers listed below: National Institute on Deafness and Communication Disorders (NIDCD) NIDCD will not accept annual budget requests exceeding $1,750,000 total costs per year. National Institute of Allergy and Infectious Diseases (NIAID) NIAID will consider awards up to $1,000,000 per year total costs for up to 3 years. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Budgets may not exceed $500,000 total funding support in any year up to $1,500,000 total costs (direct costs, indirect costs, fee) across all years. National Institute of Biomedical Imaging and Bioengineering (NIBIB) Budgets may not exceed $750,000, total funding support (direct costs, indirect costs, fee) for a project period of up to two years, with no more than $500,000 total costs requested in one year. NIBIB will not support project periods of more than two years. National Cancer Institute (NCI) Total funding support may not exceed $250,000 in total costs (direct costs, indirect costs, fee). National Institute for Neurological Disorders and Stroke (NINDS) NINDS supports budget requests up to $300,000 total costs across all years. National Eye Institute (NEI) Budgets may not exceed $750,000 total costs (direct costs, indirect costs, fee) across all years. National Center for Advancing Translational Sciences (NCATS) Budgets up to $300,000, total funding support (direct costs, indirect costs, fee) for the entire budget period may be requested. National Heart, Lung, and Blood Institute (NHLBI) NHLBI will only accept budgets up to $500,000 total costs (direct costs, indirect costs, fee) across all years. National Human Genome Research Institute (NHGRI) Total funding support may not exceed $250,000 in total costs (direct costs, indirect costs, fee). National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Budgets may not exceed $1,000,000 total funding support for the entire project period. The National Institute of Environmental Health Sciences (NIEHS) Budgets up to $300,000, total funding support (direct costs, indirect costs, fee) for the entire budget period may be requested. National Institute of Dental and Craniofacial Research (NIDCR) NIDCR will consider awards up to $1,000,000 per year total costs for up to 3 years. Applicants are strongly encouraged to contact program officials prior to submitting any application and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Eligible Applicants
Additional Requirements
Other Eligible Applicants include the following:Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Geographic Eligibility
All
Next Deadline
August 6, 2025
Letter of Intent
Application Opens
July 12, 2023
Application Closes
September 5, 2025
Grantor
U.S. Department of Health & Human Services (National Institutes of Health)
Phone
301-480-7075Subscribe to view contact details