Opportunity Information: Apply for PAR 23 069
The HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (PAR-23-069) is an NIH grant opportunity designed to help certain NIH-funded pain management technologies move from the later stages of R&D into real-world commercialization. It focuses on small businesses that have already made substantial progress under prior NIH SBIR or STTR awards, specifically projects that were previously funded at the Phase II or Phase IIB level in pain management. The central idea is to provide targeted, practical support that makes a company more investable and more partner-ready, rather than funding additional basic research.
A key feature of this FOA is the emphasis on bringing experienced entrepreneurial talent directly into the small business team. The program supports the “embedded entrepreneur” model, where a person with commercialization and business development expertise is added to the leadership effort to strengthen go-to-market planning, sharpen the product story, validate market assumptions, and guide business strategy. Alongside this talent infusion, the award also supports commercialization-focused partnering activities aimed at securing private third-party funding or forming strategic partnerships with industry. In other words, the government funding is meant to de-risk and accelerate the steps that typically unlock follow-on private investment, licensing, co-development, distribution partnerships, or other industry-aligned commercialization pathways.
This is a discretionary grant program under the NIH, tied to the broader HEAL (Helping to End Addiction Long-term) initiative, and it sits in NIH’s health-related funding activity space. The opportunity is limited to eligible small businesses, and it is not open to non-U.S. (foreign) institutions. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, the FOA notes that “foreign components,” as defined under the NIH Grants Policy Statement, may be allowed in some circumstances, which generally means a project might include certain foreign elements if they meet NIH policy definitions and are justified, but the applicant organization itself must remain eligible and U.S.-based under the FOA’s rules. Because those distinctions can be nuanced, applicants typically need to check the full FOA and NIH policy language to confirm whether any international subcontracting, collaboration, or other foreign involvement is permissible.
The funding instrument is a grant, and the award ceiling is listed as $400,000, indicating the maximum amount NIH expects to provide per award under this announcement. The listing does not specify the expected number of awards in the provided source data. The original closing date shown is 2025-09-05, which is the deadline applicants should work against unless NIH posts updates or changes. The opportunity is associated with multiple CFDA (Assistance Listing) numbers: 93.213, 93.350, 93.846, 93.853, and 93.867, reflecting the NIH programs and institutes/centers that may be involved in funding or administering awards under this solicitation.
Finally, the title includes “SB1 Clinical Trial Not Allowed,” which signals that the project activities proposed under this specific funding opportunity should not include clinical trials as defined by NIH. The intent is commercialization readiness and partnering support for pain management innovations that have already progressed through prior SBIR/STTR development stages, rather than initiating or conducting clinical trial work within this award. For applicants, that typically means framing the proposal around activities like partner outreach, investor materials, commercialization planning, product-market fit refinement, regulatory or reimbursement strategy planning (when allowed), and other business development steps that position the technology for private-sector financing or industry partnership.Apply for PAR 23 069
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (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): 93.213, 93.350, 93.846, 93.853, 93.867.
- This funding opportunity was created on 2023-01-03.
- Applicants must submit their applications by 2025-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (PAR-23-069)?
This is an NIH discretionary grant opportunity under the broader HEAL (Helping to End Addiction Long-term) initiative. It is designed to help certain NIH-funded pain management technologies move from later-stage R&D toward real-world commercialization. The program focuses on commercialization readiness and partnering support, rather than funding additional basic research.
What is the main purpose of this funding opportunity?
The main purpose is to make eligible small businesses more investable and more partner-ready. The FOA emphasizes practical commercialization steps that can de-risk the path to market and help unlock follow-on private investment, licensing, co-development, distribution partnerships, or other industry-aligned commercialization pathways.
Who is this program intended for?
The opportunity is limited to eligible small businesses working on pain management technologies that have already made substantial progress under prior NIH SBIR or STTR awards. Specifically, it targets projects previously funded at the Phase II or Phase IIB level in pain management.
Does this program fund early-stage research and development?
Not as described in the provided information. The program is aimed at moving technologies that are already in later stages of R&D into commercialization. The emphasis is on commercialization readiness activities, not additional basic research.
What does "embedded entrepreneur" mean in this FOA?
The embedded entrepreneur model means adding an experienced person with commercialization and business development expertise directly into the small business team. The goal is to strengthen leadership around go-to-market planning, sharpen the product story, validate market assumptions, and guide business strategy.
What kinds of activities does the award support?
Based on the provided description, the award supports commercialization-focused activities and partnering efforts aimed at securing private third-party funding or forming strategic partnerships with industry. Examples mentioned include partner outreach, investor materials, commercialization planning, product-market fit refinement, and regulatory or reimbursement strategy planning (when allowed), along with other business development steps that position the technology for private-sector financing or industry partnership.
What is the program trying to achieve for participating companies?
The program is intended to accelerate and de-risk the steps that typically lead to follow-on private investment or industry partnerships. In practical terms, it aims to help companies become more credible to investors and more prepared to engage potential commercial partners.
Is this a grant or a contract?
This opportunity uses a grant funding instrument.
What is the maximum award amount (award ceiling)?
The award ceiling listed for this FOA is $400,000, meaning this is the maximum amount NIH expects to provide per award under this announcement.
How many awards will NIH make?
The provided source information does not specify the expected number of awards.
What is the application deadline?
The original closing date shown is 2025-09-05. Applicants should plan around that deadline unless NIH posts official updates or changes.
What does "SB1 Clinical Trial Not Allowed" mean for applicants?
It indicates that projects proposed under this funding opportunity should not include clinical trials as defined by NIH. The intent is to fund commercialization readiness and partnering support for pain management innovations, not to initiate or conduct clinical trial work within this award.
If clinical trials are not allowed, what should proposals focus on instead?
Proposals should be framed around commercialization readiness and business development activities described in the FOA information provided, such as refining go-to-market plans, validating market assumptions, strengthening the product narrative for investors and partners, and conducting partnering activities aimed at private funding or strategic collaborations.
Are non-U.S. (foreign) institutions eligible to apply?
No. The opportunity is not open to non-U.S. (foreign) institutions.
Can a U.S. organization apply if it has non-domestic components?
No. Non-domestic components of U.S. organizations are not eligible to apply, based on the provided information.
Are any international elements allowed at all?
The FOA notes that "foreign components," as defined under the NIH Grants Policy Statement, may be allowed in some circumstances. This generally means certain foreign elements might be permissible if they meet NIH policy definitions and are justified, while the applicant organization itself must remain eligible and U.S.-based under the FOA rules.
What should applicants do if they are unsure whether international subcontracting or collaboration is allowed?
Because the distinctions around foreign components can be nuanced, applicants typically need to consult the full FOA and the relevant NIH Grants Policy Statement language to confirm whether any specific international involvement is permissible for their project.
What technology area does this program focus on?
This program focuses on pain management technologies that have progressed through prior NIH SBIR or STTR development stages (specifically Phase II or Phase IIB projects, as described in the provided information).
What are the CFDA (Assistance Listing) numbers associated with this opportunity?
The opportunity is associated with multiple Assistance Listing numbers: 93.213, 93.350, 93.846, 93.853, and 93.867. These reflect NIH programs and institutes/centers that may be involved in funding or administering awards under this solicitation.
How does this FOA relate to the HEAL initiative?
The FOA is tied to HEAL (Helping to End Addiction Long-term) and sits within NIH's health-related funding activity space. The HEAL connection signals alignment with NIH efforts that support solutions in areas related to pain management and broader public health priorities described under the HEAL umbrella.
What makes this opportunity different from a typical R&D-focused SBIR/STTR award?
Based on the provided description, the focus is not on extending core R&D work, but on commercialization readiness. A defining feature is support for embedding experienced entrepreneurial talent into the company team and supporting partnering activities that help attract private capital or strategic industry partners.
What is meant by "partner-ready" and "investable" in the context of this program?
As described, these terms point to practical preparation for private-sector engagement: clearer go-to-market plans, stronger business strategy, validated market assumptions, and a more compelling product story, plus active partnering efforts that can lead to funding or strategic deals.
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