SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)
NIH funds U.S. small business concerns to carry out late-stage SBIR/STTR commercialization work, including replication, IND/IDE-enabling studies, clinical studies, manufacturing scale-up, and regulatory or specialized technical support.
RESTRICTED TO: SMALL BUSINESS SBIR STTR
⚑ SBIR/STTR small-business applicant only; universities cannot apply directly · Foreign organizations and non-domestic components of U.S. organizations are not eligible · Supports late-stage commercialization activities beyond typical Phase II/Phase IIB scope · Significant subcontracting is allowed
Unit fits — one characterization, each unit's own rules
| Tom Love Innovation Hub | 100 strong | SBIR/STTR — core Hub pipeline (faculty founders + small-business partners); funds commercialization; prototyping/demonstration stage; deep-tech content |
| IPPRA | 15 none | university cannot apply directly (ineligible) |
| Physical Sciences & Engineering (demo) | 15 none | university cannot apply directly (ineligible) |
Description
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.
Eligibility
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <SEEDinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.