SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, Clinical Trial Not Allowed) | PAR 20 128

Opportunity Information: Apply for PAR 20 128

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance opportunity (PAR-20-128) is a National Institutes of Health (NIH) discretionary grant program designed to help small business concerns move an already-funded SBIR or STTR project from late-stage R and D into practical commercialization. The central idea is to provide targeted, commercialization-focused support that is often difficult to fund under a standard Phase II or Phase IIB award. Instead of paying for more core research in the typical sense, this FOA emphasizes the kinds of specialized technical assistance that can remove real-world barriers between a promising technical result and a product that can be introduced to the market, adopted by users, or advanced toward regulatory and investment milestones.

A key feature of this CRP FOA is that it is intended for companies that have previously received NIH SBIR/STTR Phase II or Phase IIB funding and now need additional resources to become "commercialization ready." The activities supported are meant to accelerate the transition into commercialization by funding work products, planning, and expert services that are commonly required at this stage. Examples specifically highlighted include preparing documentation for a Food and Drug Administration (FDA) submission, developing a more mature intellectual property strategy (such as patent landscaping, freedom-to-operate analyses, or broader IP positioning), and building a plan for a future clinical trial. Even though clinical trial planning can be supported, actual clinical trials are not allowed under this announcement, and applications proposing clinical trial activities would not fit the FOA.

The scope also makes clear that substantial portions of the work may be subcontracted to outside organizations, which is typical for commercialization readiness tasks that require regulatory consultants, specialized legal expertise, quality systems support, reimbursement strategists, manufacturing or scale-up advisors, or other domain specialists. At the same time, the small business applicant is expected to remain in charge of the project, maintaining active oversight and management of the R and D-related elements throughout the CRP award. In other words, outsourcing is permitted and often practical, but the small business must stay accountable for coordination, execution, and decision-making rather than acting as a pass-through.

Eligibility is limited to U.S. small businesses that meet SBIR/STTR requirements. Non-U.S. entities (foreign institutions) are not eligible to 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 NIH policy, may be allowable in some circumstances, which typically means certain discrete project elements can occur abroad if they are well-justified and meet NIH policy requirements, even though the applicant organization itself must be domestic and eligible.

Administratively, this is an NIH grant opportunity categorized under broad activity areas that include health and related fields, and it spans many CFDA program numbers across NIH, reflecting that it can align with multiple NIH institutes and centers depending on the technology area. The opportunity was created on 2020-07-10, with an original closing date listed as 2023-04-05. The listing provided does not specify an award ceiling or expected number of awards, so applicants would need to consult the full FOA and any institute-specific guidance to understand typical budget ranges, project periods, and competitiveness expectations.

In practical terms, the program is aimed at reducing late-stage translation risk by paying for the kinds of readiness steps that investors, strategic partners, and regulators often expect to see before a product can move forward. A strong application under this FOA would generally emphasize: the prior SBIR/STTR Phase II or IIB achievements that position the project for commercialization; the specific commercialization or regulatory bottlenecks that remain; the concrete technical assistance activities proposed to address those bottlenecks; clear deliverables (for example, a defined FDA package or a regulatory plan, IP deliverables, manufacturing readiness outputs, or a clinical trial plan without running the trial itself); and a management approach showing the small business is actively directing the work, even when using subcontractors.

• 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, 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, 93.213, 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, 93.859, 93.866, 93.867, 93.879.
• 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 20 128

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