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.
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SBIR/STTR Commercialization Readiness Pilot (CRP) Technical Assistance (PAR-20-128): FAQs

What is the SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance opportunity (PAR-20-128)?

It is a discretionary NIH grant opportunity designed to help eligible U.S. small businesses move an already-funded NIH SBIR or STTR project from late-stage R&D into practical commercialization. The focus is on targeted, commercialization-oriented technical assistance rather than additional core research.

What is the main purpose of this FOA?

The purpose is to provide commercialization-focused support that is often difficult to fund under a standard SBIR/STTR Phase II or Phase IIB award, and to remove real-world barriers between a promising technical result and a product that can reach the market, be adopted by users, or advance toward regulatory and investment milestones.

Who is this program intended for?

This program 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."

Do applicants need to have prior NIH SBIR/STTR funding to apply?

Yes. The opportunity is specifically aimed at small businesses with an already-funded NIH SBIR/STTR project at the Phase II or Phase IIB stage that is transitioning toward commercialization.

What kinds of activities does the CRP award support?

The CRP award supports specialized technical assistance activities that accelerate readiness for commercialization. Examples highlighted include FDA submission documentation preparation, development of a more mature IP strategy (such as patent landscaping and freedom-to-operate analyses), and building a plan for a future clinical trial (planning only).

Does this funding pay for more core research and development?

Not in the typical sense. This FOA emphasizes targeted technical assistance and commercialization readiness tasks rather than funding additional core research that would typically be supported under a standard Phase II or Phase IIB award.

Are clinical trials allowed under this announcement?

No. While clinical trial planning can be supported, actual clinical trials are not allowed under this announcement. Applications proposing clinical trial activities would not fit the FOA.

Is clinical trial planning allowed?

Yes. The FOA explicitly notes that planning for a future clinical trial can be supported, as long as the application does not propose conducting the clinical trial itself.

Can CRP funds be used for FDA-related work?

Yes. One example specifically highlighted is preparing documentation for a Food and Drug Administration (FDA) submission.

Can CRP funds be used for intellectual property (IP) strategy work?

Yes. The FOA highlights developing a more mature IP strategy, including activities like patent landscaping, freedom-to-operate analyses, and broader IP positioning.

Can a company subcontract work to outside organizations?

Yes. The scope makes clear that substantial portions of the work may be subcontracted, which is common for commercialization readiness tasks that require specialized expertise.

What types of subcontractors or specialists are commonly relevant for CRP activities?

Examples mentioned include regulatory consultants, specialized legal expertise, quality systems support, reimbursement strategists, manufacturing or scale-up advisors, and other domain specialists.

If subcontracting is allowed, what is the small business applicant responsible for?

The small business is expected to remain in charge of the project and to maintain active oversight and management of the R&D-related elements throughout the CRP award. Outsourcing is permitted, but the applicant cannot act merely as a pass-through entity.

Can the applicant simply pass funds through to contractors?

No. The FOA indicates the small business must stay accountable for coordination, execution, and decision-making, even when substantial work is subcontracted.

Who is eligible to apply?

Eligibility is limited to U.S. small businesses that meet SBIR/STTR requirements.

Are non-U.S. (foreign) institutions eligible to apply?

No. Non-U.S. entities (foreign institutions) are not eligible to apply under 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 components allowed in the project?

Possibly. The FOA notes that foreign components, as defined by NIH policy, may be allowable in some circumstances. This generally means discrete project elements could occur abroad if they are well-justified and meet NIH policy requirements, while the applicant organization must still be domestic and eligible.

What NIH areas does this opportunity cover?

It is categorized under broad activity areas that include health and related fields, and it spans many CFDA program numbers across NIH. This reflects that it can align with multiple NIH institutes and centers depending on the technology area.

When was this opportunity created, and what is the closing date listed in the provided information?

The opportunity was created on 2020-07-10. The listing provided includes an original closing date of 2023-04-05.

Does the provided listing specify an award ceiling or the expected number of awards?

No. The information provided states that the listing does not specify an award ceiling or the expected number of awards, and that applicants would need to consult the full FOA and any institute-specific guidance for typical budget ranges, project periods, and competitiveness expectations.

What is the program trying to accomplish in practical commercialization terms?

The program is aimed at reducing late-stage translation risk by paying for readiness steps that investors, strategic partners, and regulators often expect before a product can move forward.

What would a strong application generally emphasize under this FOA?

Based on the description provided, a strong application would generally emphasize prior Phase II or Phase IIB achievements, the specific commercialization or regulatory bottlenecks that remain, the concrete technical assistance activities proposed to address those bottlenecks, clear deliverables (such as a defined FDA package or regulatory plan, IP deliverables, manufacturing readiness outputs, or a clinical trial plan without running the trial), and a management approach demonstrating active direction by the small business even when using subcontractors.

What are examples of deliverables that fit this FOA?

Examples described include a defined FDA package or regulatory plan, IP-related deliverables (such as patent landscaping or freedom-to-operate outputs), manufacturing readiness outputs, and a clinical trial plan (without conducting the trial).

How does this FOA differ from a typical Phase II or Phase IIB award?

The FOA is designed to fund targeted commercialization readiness technical assistance that is often difficult to support under standard Phase II or Phase IIB mechanisms, rather than funding more core research.

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