SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required | PAR 19 335

Opportunity Information: Apply for PAR 19 335

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required opportunity (NIH FOA PAR-19-335) is a discretionary grant program designed to help small business concerns move promising NIH-funded SBIR/STTR projects from the later stages of research into real-world commercialization. It specifically targets projects that have already been supported under SBIR or STTR Phase II or Phase IIB and now need additional, practical support to cross the gap between a successful development program and a market-ready product. The central idea is to provide funding for activities that are often necessary for commercialization but can fall outside what typical Phase II/IIB awards comfortably cover, especially when the next steps involve major validation work, regulatory preparation, or clinical progress.

A major focus of this FOA is late-stage development and technical assistance that de-risks the product for investors, strategic partners, regulators, and eventual customers. Examples of supported work include independent replication of key studies (important for credibility and to confirm performance claims), IND-enabling studies for therapeutics (such as toxicology, pharmacology, or other preclinical packages needed to support an Investigational New Drug application), clinical studies, manufacturing and scale-up costs, and regulatory assistance. In practice, that means the program is meant for companies that are past early proof-of-concept and are now dealing with the expensive, operationally complex steps needed to enter or advance through clinical trials, demonstrate robust and reproducible results, and prepare a product for approval and launch.

The funding mechanism is an SBIR grant using the R44 activity code, and the FOA is explicitly marked "Clinical Trial Required," signaling that the work proposed is expected to include a clinical trial component rather than being purely preclinical or non-human validation. This makes the opportunity particularly relevant to small businesses developing drugs, biologics, devices, diagnostics, or digital health tools where clinical evidence is a gating factor for regulatory clearance, adoption, reimbursement, or partnership. Even when certain tasks are contracted out, the small business remains responsible for overall project leadership. NIH notes that a substantial portion of the CRP-supported work may be subcontracted to external organizations (for instance, CROs, manufacturing partners, specialized testing labs, or regulatory consultants), but the awardee is expected to maintain strong oversight, project management, and accountability for the full R and D effort.

Eligibility is limited to U.S. small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some cases, which generally means limited, well-justified foreign involvement could be permitted when it is necessary for the project and compliant with NIH policy, but the applicant and primary organizational footing must remain domestic. The sponsoring agency is the National Institutes of Health, and the funding activity category is Health. The FOA is associated with multiple CFDA numbers (including 93.173, 93.233, 93.242, 93.273, and several others), reflecting that multiple NIH institutes or centers may participate or that the program spans several health and biomedical domains.

Key administrative details included in the source information are that the FOA was created on 2019-08-05 and listed an original closing date of 2020-07-10. The dataset excerpt does not specify an award ceiling or expected number of awards, which typically means applicants would need to rely on the full FOA text and NIH budget guidance for allowable costs, project periods, and any institute-specific constraints. Overall, this opportunity is best understood as a bridge-to-commercialization program for SBIR/STTR awardees who have a technology with demonstrated promise and now need resources to complete the high-stakes, late-stage work (including required clinical trial activities) that turns a strong R and D result into a viable commercial product.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.233, 93.242, 93.273, 93.837, 93.838, 93.839, 93.840, 93.853, 93.866, 93.867.
• This funding opportunity was created on 2019-08-05.
• Applicants must submit their applications by 2020-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 19 335

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