SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) | PAR 23 220

Opportunity Information: Apply for PAR 23 220

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development opportunity (PAR 23-220) is an NIH discretionary grant designed to help small business concerns push promising SBIR/STTR-funded technologies over the final hurdles that often stand between a successful Phase II/Phase IIB project and real-world commercialization. The core idea is to provide targeted, practical support for late-stage development work and specialized technical assistance that is usually difficult to fit within (or fund through) traditional Phase II or Phase IIB mechanisms, especially when a product is moving into regulated milestones like IND-enabling packages, manufacturing scale-up, or clinical validation. This program is explicitly focused on getting technologies "market ready" by addressing the kinds of translational gaps that can stall otherwise strong innovations right before they reach patients, customers, or investors.

A defining feature of this specific NOFO is that it requires at least one clinical trial to be proposed. In other words, the application cannot be purely preclinical or limited to planning activities; it must include clinical study execution as part of the proposed scope. This aligns with the "Late Stage Development" positioning of the CRP program, signaling that applicants should already be beyond early feasibility and moving into human testing intended to generate meaningful evidence for regulatory, reimbursement, clinical adoption, or commercial partnering. Because clinical trials are complex and resource-intensive, the program is structured to allow significant portions of the work to be subcontracted to outside organizations, such as clinical research organizations, academic medical centers, specialized laboratories, GMP manufacturers, or regulatory consultants. Even so, NIH makes it clear that the small business must remain in charge: the SBC is expected to maintain active oversight and project management responsibility for the research and development across the entire award, rather than handing the project off to subcontractors.

The kinds of activities the CRP award is meant to support are the practical "last mile" items that de-risk a product for commercialization. Examples highlighted in the opportunity include independent replication of key studies (which can strengthen confidence in foundational findings and support due diligence), IND-enabling studies (such as GLP toxicology, pharmacology, biodistribution, or other studies needed for an FDA submission), clinical studies (including the required clinical trial), manufacturing costs (often including process development, scale-up, validation, and GMP production of clinical material), and regulatory assistance (which may include strategy, interactions with FDA, preparation of regulatory documents, and alignment with applicable standards). The NOFO also allows for combinations of these services, which is important because late-stage readiness usually requires coordinated progress across evidence generation, manufacturing, and regulatory planning rather than a single isolated task.

Eligibility is limited to small businesses, consistent with SBIR/STTR goals and the CRP program's purpose of accelerating commercialization within the small business ecosystem. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply either. However, the NOFO notes that "foreign components," as defined under NIH Grants Policy, may be allowed in some circumstances, which typically means discrete elements of the project could potentially be carried out abroad if they meet NIH policy requirements and are well-justified, even though the applicant organization itself must be U.S.-based and eligible as a small business.

Programmatically, proposed projects must align with the scientific missions and interests of one or more participating NIH Institutes and Centers. Practically speaking, that means the technology area, disease or condition focus, and intended clinical application need to map to an NIH IC that participates in the NOFO and sees the work as within its portfolio priorities. Since this is a commercialization-readiness mechanism, applications are generally expected to show not only scientific and technical merit, but also a credible pathway to market, including clarity on the target product profile, regulatory path, clinical development plan, manufacturing readiness, and how the proposed work will position the company for partnering, investment, procurement, or revenue generation.

From the opportunity metadata, the agency is the National Institutes of Health, the instrument type is a grant, and the activity category is health-related. The listed CFDA numbers (including 93.173, 93.233, 93.242, 93.273, 93.837, 93.838, 93.839, 93.840, 93.867) indicate that multiple NIH components and health research domains may be relevant depending on the specific product area. The original closing date is shown as 2025-04-05, which signals that interested small businesses should plan well ahead, especially because clinical trial proposals typically require substantial lead time for protocol development, site planning, regulatory and ethics considerations, contracting, budgeting, and operational readiness.

Overall, this CRP NOFO is best understood as a bridge between SBIR/STTR development success and commercial launch readiness. It is meant for small businesses that already have a strong foundation from prior or current Phase II or Phase IIB support and now need focused funding to complete the high-cost, high-impact steps that unlock regulatory progress and market adoption, with the clear expectation that at least one clinical trial will be conducted and that the small business will remain accountable for the project's direction, quality, and execution.

• The National Institutes of Health in the 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 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, 93.867.
• 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.

Apply for PAR 23 220

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