SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed | PAR 19 334

Opportunity Information: Apply for PAR 19 334

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance opportunity (PAR-19-334) is a National Institutes of Health (NIH) discretionary grant program designed specifically for small business concerns that have already received SBIR or STTR Phase II or Phase IIB support and are now trying to move that work across the difficult gap between late-stage R and D and real-world commercialization. The central idea is to provide targeted, commercialization-focused technical assistance that is often hard to fund under a typical Phase II or Phase IIB budget, even though it can be critical for getting a product, platform, or technology to market.

This FOA is not meant to restart or broadly expand core laboratory or product-development R and D that belongs in a standard SBIR/STTR research grant. Instead, it is meant to help a company get "commercialization readiness" items done: the specialized planning, documentation, and strategy work that reduces regulatory, business, and execution risk right before commercialization. Examples highlighted in the announcement include preparing documents needed for a Food and Drug Administration (FDA) submission (such as materials that support regulatory interactions), developing and refining an intellectual property strategy (which can involve patent landscaping, freedom-to-operate analysis, and portfolio planning), and planning for a future clinical trial. In other words, the program is aimed at sharpening the commercialization pathway and de-risking next steps so the prior SBIR/STTR-funded technology can move faster toward investors, strategic partners, regulatory milestones, manufacturing readiness, and market entry.

A key boundary in this announcement is that clinical trials are not allowed. Even if the funded project relates to a medical product, diagnostic, therapeutic, or digital health tool, the CRP award under this FOA cannot support the conduct of a clinical trial. What it can support, based on the description, is clinical trial planning and preparatory work as technical assistance, but not enrolling participants or running the trial itself. That distinction matters for applicants because it shapes what activities, timelines, and deliverables can be proposed and budgeted.

From a project management standpoint, NIH makes clear that subcontracting is permissible and, in practice, expected for many of these technical assistance functions. A company might bring in regulatory consultants, IP counsel, reimbursement advisors, quality system specialists, or other expert vendors to complete discrete commercialization-readiness tasks. Even so, the small business applicant must remain in control: the SBC is expected to provide oversight and maintain management of the R and D and overall project execution throughout the award. The program is structured to help a small business accelerate toward commercialization while still ensuring the company, not outside contractors, is driving decisions, integrating the work, and owning the outcomes.

Eligibility is limited to small businesses (the standard SBIR/STTR-eligible small business concerns). Foreign institutions and other non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the FOA notes that "foreign components" may be allowed as defined under the NIH Grants Policy Statement, meaning certain discrete elements of work could potentially be performed abroad if they meet NIH policy requirements and are appropriately justified, even though the applicant organization itself must be U.S.-based and eligible.

Administratively, this is an NIH grant (Funding Instrument: Grant) under the SBIR mechanism (SB1, R44) and is associated with multiple CFDA program areas spanning health-related research and development (the FOA lists a broad set of CFDA numbers). The opportunity was originally created on August 5, 2019, with an original closing date of July 9, 2020. The listing does not specify an award ceiling or the expected number of awards in the provided source data, so applicants would typically need to consult the full FOA text and any linked NIH Institute or Center guidance to understand budget expectations, durations, review criteria, and institute-specific priorities.

In practical terms, a strong CRP application under this announcement would usually read like a focused commercialization work plan tied directly to a previously funded Phase II or Phase IIB project. It would explain what remains between the current state of the technology and a credible commercialization inflection point, then propose well-scoped technical assistance activities to close those gaps, with clear deliverables (for example, a completed FDA submission package or pre-submission briefing materials, an IP strategy and prioritized patent filing plan, a detailed clinical trial protocol and operational plan without actually conducting the trial, or other similar commercialization-enabling outputs). The overall purpose is to push mature SBIR/STTR-funded innovations out of the lab stage and toward market readiness by paying for the specialized work that makes commercialization feasible and investable, while staying within NIH rules and explicitly excluding clinical trial execution.

• 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 (SB1, R44) 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, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.855, 93.859, 93.866, 93.867.
• This funding opportunity was created on 2019-08-05.
• Applicants must submit their applications by 2020-07-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 19 334

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