SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) | PAR 23 219

Opportunity Information: Apply for PAR 23 219

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development opportunity (PAR-23-219) is an NIH grant funding announcement designed to help small businesses push promising SBIR or STTR projects past the typical end point of Phase II or Phase IIB and closer to real-world commercialization. The central idea is to provide targeted, practical support for the kinds of last-mile development activities that often determine whether a technology, product, or platform can successfully move from a research result into a product that is manufacturable, regulatory-ready, and attractive to partners, customers, or follow-on investors.

This NOFO focuses specifically on small business concerns that already have a foundation of NIH-supported SBIR/STTR work, particularly projects previously or currently funded at the Phase II or Phase IIB level. Rather than funding early discovery, the CRP award is meant to reduce commercialization risk by paying for late-stage development steps that are essential but frequently too expensive, too specialized, or too operationally focused to fit well within standard Phase II/IIB scopes. The program is framed as a bridge to commercialization, meaning the work should be clearly connected to a defined product development pathway and should address remaining technical, regulatory, manufacturing, or validation gaps that stand in the way of market entry or significant private-sector uptake.

The kinds of activities supported are intentionally practical and may include independent replication of key studies (to confirm robustness and reproducibility), IND-enabling studies (for products that will ultimately require an FDA Investigational New Drug application), certain clinical study-related efforts that do not meet NIH's definition of a clinical trial under this specific solicitation, manufacturing and scale-up costs, and regulatory support such as strategy development, documentation preparation, quality systems planning, and interactions that help the company align with applicable regulatory expectations. The announcement also highlights that awards can support a combination of services, which reflects how commercialization readiness is often a package of interlocking tasks rather than a single experiment or deliverable.

Even though much of the work may be subcontracted to universities, contract research organizations, manufacturers, or other specialized providers, the small business is expected to remain in charge. NIH emphasizes that the SBC must maintain oversight and management of the research and development across the entire project. In practice, that means the small business should be the hub that sets milestones, manages vendors and collaborators, controls decision-making, and ensures the work stays aligned with the commercialization plan. The outsourcing flexibility is meant to help small firms access specialized capabilities without losing accountability for progress and outcomes.

A key restriction in this specific NOFO is that clinical trials are not accepted. Applicants therefore need to be careful about how they describe any human-subjects work and should ensure proposed activities do not fall under NIH's clinical trial definition for the purposes of this opportunity. The intent is to fund late-stage development that can include important preparatory, enabling, validation, and regulatory steps, but not a formal clinical trial under the solicitation rules.

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 to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, may be allowed in certain circumstances, which typically means discrete, justified elements of work may occur outside the U.S. if they are essential and cannot be reasonably performed domestically, subject to NIH approval and policy compliance. The funding instrument is a discretionary NIH grant, and the opportunity is associated with multiple CFDA program areas across NIH (reflecting that SBIR/STTR and commercialization readiness can apply to a wide range of health-related technologies). The original closing date listed for the opportunity is 2025-04-05, and the notice was created on 2023-07-12. Award ceiling and expected award count are not specified in the provided source details, which usually means applicants should consult the full NOFO text and any institute-specific guidance for budget expectations, scope fit, and review priorities.

Overall, this CRP solicitation is aimed at de-risking and accelerating the transition from successful NIH-funded Phase II or Phase IIB R and D into a commercialization-ready product by funding the high-impact, late-stage activities that make a technology credible to regulators, manufacturers, investors, and downstream partners, while keeping the small business clearly accountable for execution and outcomes.

• The National Institutes of Health in the education, environment, food and nutrition, health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.233, 93.242, 93.273, 93.286, 93.350, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.867.
• This funding opportunity was created on 2023-07-12.
• Applicants must submit their applications by 2025-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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