SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) | PAR 20 129

Opportunity Information: Apply for PAR 20 129

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development funding opportunity (PAR-20-129) is an NIH grant mechanism designed to help small business concerns move an existing SBIR or STTR project from the later Phase II or Phase IIB stage into real-world commercialization. Instead of supporting early discovery or basic feasibility work, this program is meant to close the practical gaps that often prevent promising, previously funded technologies from reaching the market. In other words, it is tailored for companies that already have significant NIH-backed progress and now need targeted resources to finish the last major technical, regulatory, manufacturing, or validation steps that typical Phase II-style funding does not fully cover.

A key feature of this FOA is that it supports two broad categories of “commercialization readiness” activities: specialized technical assistance and later stage research and development. The intent is to fund work that directly increases the likelihood that the product, platform, or service can successfully transition into a commercial offering. Examples of allowable activities include independent replication of key findings (which can be critical for de-risking a technology in the eyes of investors, strategic partners, or regulators), IND-enabling studies for therapeutics, certain clinical-related studies that do not meet the NIH definition of a clinical trial, manufacturing and scale-up costs, and regulatory support. The overall theme is practical readiness: generating the data packages, quality systems, documentation, prototypes, or process improvements needed to move from “it works in a controlled setting” to “it is credible, reproducible, manufacturable, and ready for a regulatory and market pathway.”

Even though the program allows substantial subcontracting, the small business applicant is expected to remain in charge. This means the SBC must actively oversee and manage the research and development activities throughout the award period, even if a large portion of the hands-on work is performed by outside partners such as CROs, academic labs, manufacturing contractors, or regulatory consultants. NIH is signaling that the award is not meant to be “handed off” entirely to third parties; the company must function as the driver of the project plan, timelines, deliverables, and quality of execution.

This FOA explicitly does not accept clinical trials. That limitation matters because it narrows what human-related work can be proposed. Applicants need to be careful to distinguish between activities that NIH would consider a clinical trial (which would make the application nonresponsive) versus other late-stage activities such as IND-enabling nonclinical studies, validation testing, usability or human factors work that is not a clinical trial under NIH definitions, or preparatory steps that support a future clinical trial funded elsewhere. The practical takeaway is that applicants should shape the scope around late-stage preclinical, engineering, manufacturing, regulatory, and verification/validation activities rather than interventional studies intended to evaluate health-related outcomes in human participants.

Eligibility is limited to U.S. small business concerns, consistent with SBIR/STTR requirements. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the FOA notes that “foreign components,” as defined by the NIH Grants Policy Statement, may be allowed in some cases, which generally means certain discrete elements of work may be performed outside the U.S. if they are strongly justified and meet NIH policy requirements. Applicants should treat that as an exception requiring clear rationale rather than the default approach.

Administratively, this is a discretionary NIH grant opportunity within the SBIR/STTR ecosystem, tied to multiple CFDA numbers that correspond to various NIH institutes and centers (reflecting that many health-related topic areas could potentially fit). The funding opportunity was created on July 10, 2020, and the listed closing date in the provided record is April 5, 2023. While the source data does not specify an award ceiling or the expected number of awards, the program’s stated purpose makes it clear that the emphasis is on enabling commercialization outcomes by funding the specific late-stage steps that most directly reduce risk and position a technology for partnering, investment, regulatory submission readiness, manufacturing readiness, or market entry.

Overall, PAR-20-129 is best understood as a bridge program for NIH-backed SBIR/STTR projects that have already demonstrated technical promise and now need focused, execution-oriented support to clear the final hurdles to commercialization, with the important constraint that the work cannot include NIH-defined clinical trials and must remain under the active direction and management of the small business awardee.

• The National Institutes of Health in the food and nutrition, 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 Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.233, 93.242, 93.273, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 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 20 129

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