SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) | PAR 23 219

FAQs: NIH SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (PAR-23-219)

What is this funding opportunity?

This is an NIH grant funding announcement for the SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development opportunity (PAR-23-219). It is designed to help small businesses advance promising SBIR or STTR projects beyond the typical end of Phase II or Phase IIB and move closer to real-world commercialization.

What is the main goal of the CRP award?

The main goal is to reduce commercialization risk by funding practical, late-stage development activities that help transform NIH-supported R&D results into something that is manufacturable, regulatory-ready, and more attractive to partners, customers, and follow-on investors.

Who is this program intended for?

This NOFO targets U.S. small business concerns that already have a foundation of NIH-supported SBIR/STTR work, especially projects that were previously funded or are currently funded at the Phase II or Phase IIB level.

Is this opportunity meant for early-stage research or discovery?

No. This CRP opportunity is framed as a bridge to commercialization rather than a program for early discovery. The work proposed should be tied to a defined product development pathway and focused on closing remaining gaps that block market entry or major private-sector uptake.

What kinds of activities can CRP funding support?

The supported activities are intentionally practical and may include late-stage steps such as independent replication of key studies, IND-enabling studies (when applicable), certain clinical study-related efforts that do not meet NIH's clinical trial definition under this solicitation, manufacturing and scale-up work, and regulatory support activities.

Can the award be used for independent replication of key studies?

Yes. Independent replication of key studies is specifically mentioned as an example of supported work, since confirming robustness and reproducibility can be a critical commercialization-readiness step.

Does this opportunity support IND-enabling studies?

Yes. IND-enabling studies are identified as an allowable category of work for products that will ultimately require an FDA Investigational New Drug (IND) application.

Are clinical trials allowed under this NOFO?

No. A key restriction is that clinical trials are not accepted under this specific funding announcement. Applicants need to ensure that any proposed human-subjects activities do not fall under NIH's clinical trial definition for the purposes of this opportunity.

Can the project include any clinical study-related work at all?

Potentially yes, but only if the activities do not meet NIH's definition of a clinical trial under this solicitation. The intent is to support enabling, preparatory, validation, and regulatory work, but not a formal clinical trial as defined for this opportunity.

Does the program support manufacturing and scale-up?

Yes. Manufacturing and scale-up costs are listed as examples of the practical, late-stage development activities that may be supported to help a technology move toward commercialization.

What types of regulatory support are in scope?

Regulatory support examples include regulatory strategy development, documentation preparation, quality systems planning, and other interactions or work that help align the company with applicable regulatory expectations.

Can applicants combine multiple types of supported services in one project?

Yes. The announcement notes that awards can support a combination of services, reflecting that commercialization readiness often requires multiple interlocking tasks rather than a single deliverable.

Can work be subcontracted to outside organizations like universities or CROs?

Yes. Much of the work may be subcontracted to universities, contract research organizations (CROs), manufacturers, or other specialized providers, which can help small businesses access capabilities that are too expensive or specialized to build internally.

If most work is subcontracted, who is expected to remain in charge?

The small business concern (SBC) is expected to remain in charge. NIH emphasizes that the SBC must maintain oversight and management of the research and development across the entire project, including managing vendors and collaborators and keeping work aligned with the commercialization plan.

What does NIH mean by "bridge to commercialization" in this context?

It means the proposed work should be clearly connected to a product development pathway and should target the remaining technical, regulatory, manufacturing, or validation gaps that stand between a successful Phase II/Phase IIB effort and a commercialization-ready product.

Who is eligible to apply?

Eligibility is limited to U.S. small businesses.

Are foreign institutions eligible to apply?

No. Foreign institutions are not eligible to apply for this opportunity.

Are non-U.S. components of U.S. organizations eligible to apply?

No. Non-U.S. components of U.S. organizations are not eligible to apply.

Are any foreign activities allowed at all?

Foreign components (as defined by NIH in the NIH Grants Policy Statement) may be allowed in certain circumstances. This generally means discrete, justified elements of work may occur outside the U.S. if they are essential and cannot be reasonably performed domestically, subject to NIH approval and compliance with NIH policy.

What is the funding mechanism for this opportunity?

The funding instrument is a discretionary NIH grant.

Is this opportunity tied to only one NIH program area?

No. It is associated with multiple CFDA program areas across NIH, reflecting that SBIR/STTR commercialization readiness can apply to a wide range of health-related technologies.

What are the key dates provided for this opportunity?

The notice was created on 2023-07-12, and the original closing date listed is 2025-04-05.

Is the award ceiling or the expected number of awards specified in the provided information?

No. The award ceiling and expected award count are not specified in the provided source details described here. In situations like this, applicants typically need to consult the full NOFO text and any institute-specific guidance for budget expectations, scope fit, and review priorities.

What types of commercialization gaps is this program trying to address?

The program is aimed at closing last-mile gaps that commonly determine commercialization success, such as reproducibility/robustness confirmation, IND-enabling work (when relevant), manufacturing readiness and scale-up, and regulatory preparation (including strategy, documentation, and quality planning).

How should applicants think about aligning the proposed work with commercialization?

The work should be presented as a practical plan to de-risk and accelerate the transition from NIH-funded Phase II/Phase IIB R&D into a commercialization-ready product. The small business should be positioned as accountable for execution, milestone management, and decision-making, with the proposed activities clearly tied to market entry readiness.