Opportunity Information: Apply for PAR 25 446
Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional), funding opportunity number PAR 25 446, is a National Institutes of Health (NIH) cooperative agreement program designed to push promising substance use disorder (SUD) and overdose interventions closer to real-world use. The core aim is to support research that discovers, refines, and develops interventions that can prevent and/or treat SUDs and overdose, with explicit interest in both medications and medical devices, including approaches that address co-morbid SUDs (for example, individuals with more than one substance use disorder). The emphasis is on studies that are likely to be high impact and that can generate decisive results quickly, so that strong candidates can move toward regulatory approval pathways or faster clinical adoption.
A key feature of this opportunity is the UG3/UH3 phased structure. In practical terms, applicants propose a two-stage project where the first phase (UG3) supports milestone-driven planning, feasibility work, or early development needed to de-risk the intervention and prepare it for more definitive testing. If the project meets clearly defined milestones, it can transition to the second phase (UH3), which supports expanded development or more advanced testing intended to produce the kind of evidence that meaningfully advances an intervention toward approval or implementation. Because this is a cooperative agreement, NIH is expected to have substantial scientific and programmatic involvement during the award, which often means closer collaboration, milestone tracking, and frequent communication than a standard research grant. The "clinical trial optional" designation signals that proposed projects may include clinical trials, but they are not required; strong preclinical or translational development projects may also be a fit as long as the work is clearly positioned to move a candidate intervention forward.
The scope is broad across the intervention pipeline and can include preclinical and clinical research, as long as the work is focused on intervention development rather than purely descriptive or observational science. The opportunity is framed to favor projects that can deliver actionable development outcomes, such as validating a candidate mechanism, establishing proof of concept, optimizing an intervention or device, generating safety and performance data, or producing evidence that supports next-step regulatory interactions or adoption in clinical settings. Interventions can target prevention of SUDs, treatment of SUDs, and prevention or treatment of overdose, including efforts tailored to complex clinical realities like polysubstance use or co-occurring disorders.
Eligibility is intentionally expansive. Applicants can include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions where applicable); for-profit organizations (other than small businesses) as well as small businesses; and additional categories listed as "others." The notice also explicitly highlights other eligible applicants such as eligible federal agencies, faith-based or community-based organizations, non-domestic (non-U.S.) entities (foreign organizations), regional organizations, and U.S. territories or possessions, signaling an openness to a wide range of organizational types and partnership models.
Administratively, this is a discretionary funding opportunity under the Education and Health activity category, tied to CFDA number 93.279, and uses the cooperative agreement funding instrument. The listed award ceiling is $3,000,000, indicating the maximum level of support anticipated per award under the program structure. The opportunity was created on 2025-09-10, and the original closing date is 2028-08-21, suggesting a multi-year window during which applications may be accepted according to the NOFO schedule and NIH receipt dates. Overall, the program is positioned for teams that have a credible, development-ready intervention concept and can propose a milestone-driven plan that moves efficiently from early development into more definitive testing, with a clear line of sight to regulatory approval considerations or practical clinical uptake.Apply for PAR 25 446
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2025-09-10.
- Applicants must submit their applications by 2028-08-21.
- Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional) is an NIH cooperative agreement program intended to move promising substance use disorder (SUD) and overdose interventions closer to real-world use. The funding opportunity number is PAR 25 446.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main goal of the program?
The core aim is to support research that discovers, refines, and develops interventions that can prevent and/or treat SUDs and overdose, with an emphasis on projects that are likely to be high impact and generate decisive results quickly so strong candidates can move toward regulatory approval pathways or faster clinical adoption.
What kinds of interventions are of interest?
The opportunity explicitly expresses interest in both medications and medical devices, including approaches that address co-morbid SUDs (for example, individuals with more than one substance use disorder).
Does the program focus on prevention, treatment, or both?
Both. Interventions may target prevention of SUDs, treatment of SUDs, and prevention or treatment of overdose.
Are overdose-focused interventions eligible?
Yes. The scope includes prevention or treatment of overdose as an explicit target area.
Can projects address polysubstance use or complex clinical realities?
Yes. The opportunity notes interest in interventions tailored to complex clinical realities like polysubstance use or co-occurring disorders.
What does UG3/UH3 mean?
UG3/UH3 is a two-phase, milestone-driven structure. The UG3 phase supports planning, feasibility work, or early development needed to de-risk an intervention and prepare it for more definitive testing. If defined milestones are met, the project can transition to the UH3 phase, which supports expanded development or more advanced testing aimed at producing evidence that meaningfully advances the intervention toward approval or implementation.
What is the purpose of the UG3 phase?
The UG3 phase is intended for milestone-driven planning, feasibility, or early development activities that reduce risk and position the intervention for more definitive work.
What is the purpose of the UH3 phase?
The UH3 phase supports expanded development or more advanced testing to generate stronger evidence and move the intervention toward regulatory approval considerations or practical clinical adoption.
Is transition from UG3 to UH3 automatic?
No. Transition is contingent on meeting clearly defined milestones proposed for the UG3 phase.
What does "clinical trial optional" mean here?
Projects may include clinical trials, but clinical trials are not required. Strong preclinical or translational development projects may also be appropriate, as long as they are clearly positioned to move a candidate intervention forward.
Are preclinical studies allowed?
Yes. The scope is broad across the intervention pipeline and can include preclinical research, provided the work is focused on intervention development.
Are clinical studies allowed?
Yes. The scope can include clinical research, and clinical trials may be included even though they are optional.
What type of research is emphasized?
The program emphasizes intervention development rather than purely descriptive or observational science, favoring projects that can deliver actionable development outcomes.
What are examples of "actionable development outcomes" mentioned?
Examples include validating a candidate mechanism, establishing proof of concept, optimizing an intervention or device, generating safety and performance data, or producing evidence that supports next-step regulatory interactions or adoption in clinical settings.
Is this a standard NIH research grant?
No. This opportunity uses a cooperative agreement, which indicates NIH is expected to have substantial scientific and programmatic involvement during the award.
What does it mean that this is a cooperative agreement?
It typically means closer collaboration with NIH, milestone tracking, and more frequent communication than would be expected with a standard research grant.
What is the funding instrument?
The funding instrument is a cooperative agreement.
What is the maximum award amount?
The listed award ceiling is $3,000,000, indicating the maximum level of support anticipated per award under the program structure.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.279.
How is this opportunity categorized?
It is described as a discretionary funding opportunity under the Education and Health activity category.
When was the opportunity created?
The opportunity was created on 2025-09-10.
What is the closing date?
The original closing date is 2028-08-21, indicating a multi-year window during which applications may be accepted according to the NOFO schedule and NIH receipt dates.
Who is eligible to apply?
Eligibility is intentionally expansive and includes a wide range of entity types across government, education, nonprofit, and private sectors, including U.S. and non-U.S. entities as described in the notice.
Are government entities eligible?
Yes. Eligible applicants include state, county, and city or township governments, as well as special district governments.
Are public or independent school districts eligible?
Yes. Independent school districts are included among eligible applicants.
Are universities and colleges eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments are eligible, as are tribal organizations that are not federally recognized.
Are housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.
Are nonprofit organizations eligible?
Yes. Nonprofits including 501(c)(3) and non-501(c)(3) organizations (excluding higher education institutions where applicable) are eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.
Are faith-based or community-based organizations eligible?
Yes. The notice explicitly highlights faith-based or community-based organizations as eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The notice explicitly highlights non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.
Are U.S. territories eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible.
Are federal agencies eligible?
Yes. The notice explicitly highlights eligible federal agencies as eligible applicants.
What kinds of project teams are a good fit for this program?
The program is positioned for teams with a credible, development-ready intervention concept who can propose a milestone-driven plan that moves efficiently from early development into more definitive testing, with a clear line of sight to regulatory approval considerations or practical clinical uptake.
Does the program encourage faster paths to implementation or adoption?
Yes. The emphasis is on generating decisive results quickly and producing evidence that supports next-step regulatory interactions or adoption in clinical settings.
Does the program support work aimed at regulatory approval pathways?
Yes. The opportunity highlights advancing candidates toward regulatory approval considerations and generating evidence that supports next-step regulatory interactions.
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