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

The Commercialization Readiness Pilot (CRP) program helps small business concerns (SBCs) move NIH-funded SBIR or STTR projects from late-stage development to commercialization. The CRP supports later-stage research and development (R&D) and/or technical assistance that Phase II and Phase IIB Strategic Breakthrough awards do not typically support. This includes:Independent replication or confirmation of key studiesIND- or IDE-enabling studiesClinical studiesManufacturing scale-up and related quality activitiesRegulatory and other specialized technical supportSBCs may subcontract (outsource) a significant amount of the work in a CRP to meet the project goals.

Only United States small business concerns (SBCs), as defined by the Small Business Administration (SBA)(sbir.gov/apply) are eligible to submit applications for this opportunity.Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.