SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) | PAR 20 130

Opportunity Information: Apply for PAR 20 130

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development opportunity (PAR-20-130) is an NIH grant funding announcement designed to help small business concerns move promising, previously NIH-supported SBIR/STTR projects from the later Phase II or Phase IIB stage into real-world commercialization. The core idea is to close common gaps that often appear right before a product can attract partners, investors, or buyers, especially when the remaining work is too applied, too expensive, or too operationally complex to fit neatly within a typical Phase II or Phase IIB scope.

This program is specifically aimed at small businesses that already have a relevant SBIR or STTR Phase II or Phase IIB project either currently funded or funded in the past, and that now need additional support to reach commercial readiness. NIH is signaling that it wants to see projects mature into marketable products by funding the types of late-stage activities that tend to determine whether a technology becomes a viable medical product or stalls after early validation. The announcement is not just about adding more laboratory experiments; it is about de-risking the path to market with practical, product-focused work.

A defining requirement of this FOA is that the application must propose at least one clinical trial. In other words, this is not a preclinical-only bridge award. The expectation is that the project has progressed far enough that clinical testing is appropriate and necessary for the next major commercialization milestone. Because NIH uses specific definitions and oversight expectations for clinical trials, applicants should be prepared to structure the proposed trial with clear objectives, endpoints, enrollment plans, safety monitoring, and compliance with applicable NIH and regulatory requirements.

The types of activities NIH indicates it may support through this CRP mechanism reflect the reality of late-stage translation. Examples called out include independent replication of key studies (to strengthen credibility and investor or partner confidence), IND-enabling studies (such as toxicology, pharmacology, or other work needed to support an Investigational New Drug application), clinical studies, manufacturing-related costs (often including scale-up, process development, quality systems, or production runs needed for clinical supply), and regulatory assistance (which can include strategy development and preparation for interactions with regulators). The announcement also leaves room for a combination of these services, which is important because late-stage readiness usually requires coordinated progress across clinical, CMC/manufacturing, and regulatory tracks rather than a single isolated task.

While substantial subcontracting is allowed and even expected in many cases (for example, contracting with a CRO for clinical execution, a CDMO for manufacturing, or specialized labs for GLP studies), NIH makes it clear that the small business must remain in charge. The SBC is expected to maintain oversight and active management of the research and development throughout the award. Practically, that means reviewers will look for evidence that the company has the project management capability, vendor oversight plan, and decision-making authority needed to keep the program on track even if many tasks are performed by outside organizations.

Program fit also matters. The proposed work must align with the scientific missions and programmatic interests of one or more participating NIH Institutes and Centers. That means applicants need to map the product and clinical indication to the most relevant NIH IC and clearly explain how the project advances that ICs priorities. Because NIH is a multi-institute agency, alignment is often a make-or-break factor for competitiveness, even when the technology itself is strong.

Eligibility is limited to small businesses. Non-U.S. (non-domestic) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply under this announcement. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some situations, which typically means a U.S. applicant might justify a discrete foreign element if it is essential and well-supported, but the applicant organization itself must be eligible and domestic under NIH SBIR/STTR rules.

Administratively, this is a discretionary NIH grant opportunity in the health and social services funding category, listed under multiple CFDA numbers associated with NIH programs. The original closing date shown for the opportunity was 2023-04-05, and the public summary does not specify an award ceiling or expected number of awards in the provided fields. The opportunity was created on 2020-07-10, reflecting the re-authorization and re-launch of the CRP concept as a targeted push toward commercialization outcomes for SBIR/STTR-funded innovations.

Overall, this CRP FOA is best understood as an NIH-supported commercialization accelerator for SBIR/STTR companies that are already beyond basic feasibility and now need to complete the expensive, high-stakes steps that unlock market entry: credible replication, regulatory-ready preclinical packages, clinical trial execution, manufacturability, and regulatory strategy. The required clinical trial component makes it especially relevant for companies developing therapeutics, biologics, devices, diagnostics, or digital health interventions that have reached a point where human clinical evaluation is the next logical and necessary milestone on the commercialization path.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 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, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2020-07-10.
• Applicants must submit their applications by 2023-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 20 130

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: