SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Not Allowed | PAR 19 333

Opportunity Information: Apply for PAR 19 333

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development opportunity (Funding Opportunity Number PAR 19-333) is a National Institutes of Health (NIH) discretionary grant designed to help small business concerns push promising SBIR or STTR projects across the gap between Phase II/Phase IIB research and real-world commercialization. It is specifically positioned as a “commercialization readiness” award, meaning the focus is not on early discovery, but on the practical work and support needed to make a previously funded innovation investor-ready, regulator-ready, partner-ready, and ultimately market-ready. The FOA is categorized as “Clinical Trial Not Allowed,” which signals that applicants should not propose NIH-defined clinical trials under this funding mechanism, even though the announcement language notes that clinical studies may be part of late-stage work in some contexts. In practice, applicants should treat this as a late-stage pre-commercial or translational R and D and technical assistance award that must remain outside the clinical trial definition for this particular FOA.

At its core, the program is meant for companies that have already received SBIR/STTR Phase II or Phase IIB support (either currently funded or previously funded) and now need an additional push to reduce technical, regulatory, manufacturing, or validation risks that commonly stall commercialization. Traditional Phase II funding often does not fully cover expensive, time-consuming activities like scaling manufacturing processes, producing compliant lots, paying for specialized regulatory consulting, or running independent replication studies to confirm key performance claims. The CRP program is built to cover exactly those types of “last-mile” needs, allowing a small business to assemble the evidence, documentation, and operational capabilities that customers, strategic partners, and regulators typically require before adoption or clearance.

The FOA highlights several example uses of funds that are aligned with commercialization readiness. These include independent replication of key studies to validate earlier results, IND-enabling work (for product candidates that would eventually require FDA submission), manufacturing costs tied to late-stage development, and regulatory support such as strategy development or preparation activities. The program also allows for technical assistance, which can include specialized expertise that strengthens the commercialization pathway, such as quality systems planning, design controls, product verification/validation planning, market research that directly informs product positioning, reimbursement planning, or partnership support, as long as the work remains consistent with the award’s scope and NIH rules.

A notable feature of this CRP mechanism is that a significant portion of the work may be subcontracted. That flexibility reflects the reality that late-stage development often depends on outside partners like contract research organizations, GMP manufacturers, specialized testing labs, regulatory consultants, or engineering firms. Even with substantial subcontracting, the small business is expected to remain in charge. NIH’s intent is that the company retains active oversight and management of the R and D, integrates vendor outputs into a coherent development plan, and remains accountable for milestones, quality, and decision-making. In other words, the award is not meant to be “handed off” to an academic lab or contractor while the company takes a passive role.

Eligibility is limited to U.S. small business concerns. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some circumstances. This usually means that while the applicant organization must be U.S.-based and eligible, certain discrete elements of work can potentially occur outside the U.S. if they are strongly justified (for example, unique expertise, resources, or populations), are permissible under NIH policy, and are clearly documented and approved through the application and award process.

Administratively, this is an NIH grant (Funding Instrument Type: Grant) and is associated with a broad set of NIH CFDA numbers spanning multiple institutes and mission areas, reflecting that the CRP concept can apply across many health-related technologies (drugs, diagnostics, devices, digital health tools, platform technologies, and other biomedical or behavioral health innovations). The opportunity’s original closing date listed in the provided data is July 10, 2020, and the FOA was created on August 5, 2019. The excerpt does not provide an award ceiling or expected number of awards, which typically means applicants would need to consult the full FOA and any institute-specific guidance for budget expectations, project period limits, and review considerations.

In practical terms, the CRP program is aimed at companies that can clearly show (1) prior SBIR/STTR Phase II or Phase IIB support tied to the technology, (2) a credible commercialization plan, (3) specific remaining barriers that prevent market entry or partnering, and (4) a well-structured, milestone-driven late-stage development package to overcome those barriers. Strong applications tend to connect the technical work directly to commercialization outcomes, such as readiness for a regulatory submission, readiness for a manufacturing scale-up decision, completion of verification/validation needed for customers, or generation of independent data that derisks adoption and investment.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (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): 93.121, 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, 93.866, 93.867.
• This funding opportunity was created on 2019-08-05.
• Applicants must submit their applications by 2020-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 19 333

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