Opportunity Information: Apply for RFA DA 19 002

The National Institutes of Health, through the National Institute on Drug Abuse (NIDA), issued this discretionary funding opportunity (RFA-DA-19-002; CFDA 93.279) to speed the discovery and development of medications that can prevent and treat opioid use disorder (OUD) and opioid overdose. The program is built to move promising therapeutics forward in a practical, milestone-driven way, with the explicit goal of generating the kinds of results that help advance candidates toward FDA approval. Projects may be preclinical, clinical, or a combination of both, and clinical trials are optional under this announcement.

The award uses a UG3/UH3 cooperative agreement structure, meaning the work is supported in two linked phases and NIH/NIDA expects substantial involvement consistent with a cooperative mechanism. The first phase (UG3) is a 2-year "innovation" or planning/early execution period designed around clear, objective milestones that must be met by the end of the phase. Those milestones are not just general aims; they are intended to be concrete go/no-go decision points that demonstrate the candidate and development plan are ready to advance. Projects that successfully meet the UG3 milestones are then considered for transition to the second phase (UH3), which can provide up to 3 additional years of support to carry out the next stage of development. Transition from UG3 to UH3 is not automatic; NIDA administratively reviews whether milestones were achieved and prioritizes projects accordingly, so applicants must write a unified plan that covers both phases from the start.

On the science side, the announcement is broad in the types of therapeutic candidates and study approaches it will consider, as long as the work is positioned to have high impact and produce results quickly enough to meaningfully advance the medication toward the FDA drug development pipeline. Candidates can include small molecules or biologics, and they can be evaluated in preclinical models and/or in studies addressing key clinical manifestations of OUD and overdose. Examples of target outcomes mentioned include withdrawal, craving, relapse, and overdose, reflecting NIDA's interest in medications that can improve real-world clinical endpoints rather than only laboratory measures.

The FOA also makes clear that applications can propose multiple development strategies, including entirely new chemical entities, new formulations of existing marketed medications that are currently approved for other indications (repurposing or reformulation), and combinations of medications that show promise for treating OUD or preventing overdose. In practice, that means an application could focus on optimizing and testing a novel compound, improving delivery or duration of action for an existing drug, or evaluating a rational combination approach, as long as the plan is rigorous, milestone-based, and geared toward development decisions that reduce risk and accelerate progress toward approval.

Eligibility is expansive and includes a wide range of domestic applicants such as state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, eligible federal agencies, regional organizations, and non-U.S. entities (foreign organizations), indicating NIDA's interest in broad participation where the science and development capability are strong.

Key administrative details included in the source data are that the NIH is the issuing agency, the original closing date listed was 2020-01-01, the funding instrument is a cooperative agreement, and an award ceiling of $3,000,000 is indicated. Overall, the opportunity is aimed at teams that can propose a credible end-to-end development path, define measurable early milestones for the UG3 phase, and then execute the more advanced development activities in the UH3 phase to move an OUD/overdose medication candidate closer to FDA review and eventual clinical use.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials 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 2017-12-14.
  • Applicants must submit their applications by 2020-01-01. (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 $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.
Apply for RFA DA 19 002

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Frequently Asked Questions (FAQs)

What is this funding opportunity trying to accomplish?

This NIH/NIDA funding opportunity (RFA-DA-19-002; CFDA 93.279) is designed to speed the discovery and development of medications that can prevent and treat opioid use disorder (OUD) and opioid overdose. The emphasis is on practical, milestone-driven projects that generate results useful for moving a candidate closer to the FDA drug development pipeline and, ultimately, FDA approval.

Which NIH institute is sponsoring the program?

The program is issued by the National Institutes of Health (NIH) through the National Institute on Drug Abuse (NIDA).

What is the funding mechanism for this opportunity?

The funding instrument is a cooperative agreement using a UG3/UH3 structure, which supports work in two linked phases and includes substantial NIH/NIDA involvement consistent with a cooperative mechanism.

What does the UG3/UH3 structure mean in practice?

The project is organized into two connected phases:

  • UG3 phase: Up to 2 years focused on innovation, planning, and early execution, built around clear, objective milestones.
  • UH3 phase: Up to 3 additional years to conduct the next stage of development for projects that successfully meet UG3 milestones and are selected for transition.

How long is the UG3 phase?

The UG3 phase is a 2-year period intended for planning and early execution, with concrete go/no-go milestones that must be met by the end of the phase.

How long is the UH3 phase?

The UH3 phase can provide up to 3 additional years of support to carry out the next stage of development after successful completion of UG3 milestones.

Is transition from UG3 to UH3 automatic?

No. Transition is not automatic. NIDA conducts an administrative review to determine whether UG3 milestones were achieved and prioritizes projects accordingly before approving transition to the UH3 phase.

Do applicants need to submit separate applications for UG3 and UH3?

No. Applicants are expected to write a unified plan that covers both phases from the start, including milestones for the UG3 phase and the proposed development activities for the UH3 phase.

What kind of milestones are expected for the UG3 phase?

Milestones are intended to be concrete, objective go/no-go decision points rather than broad or general aims. They should demonstrate that the therapeutic candidate and the development plan are ready to advance to the next stage.

What types of projects are allowed (preclinical vs. clinical)?

Projects may be preclinical, clinical, or a combination of both under this announcement.

Are clinical trials required?

No. Clinical trials are optional under this announcement.

What types of therapeutic candidates are in scope?

The announcement is broad and can support development of small molecules or biologics, as long as the work is positioned to have high impact and can produce results quickly enough to meaningfully advance the candidate toward the FDA drug development pipeline.

What outcomes or clinical problems does NIDA emphasize?

Examples of target outcomes mentioned include withdrawal, craving, relapse, and overdose. This reflects an interest in medications that can improve real-world clinical endpoints rather than only laboratory measures.

Can the application propose more than one development strategy?

Yes. Applications can propose multiple development strategies as long as the plan is rigorous, milestone-based, and aimed at development decisions that reduce risk and accelerate progress toward approval.

Are new chemical entities allowed?

Yes. The opportunity allows entirely new chemical entities as one possible strategy.

Can existing marketed medications be repurposed or reformulated?

Yes. The FOA explicitly allows new formulations of existing marketed medications that are approved for other indications (repurposing or reformulation).

Are combination medication approaches allowed?

Yes. The FOA allows combinations of medications that show promise for treating OUD or preventing overdose.

What is the overall expectation for project impact and pace?

The work should be positioned to have high impact and produce results quickly enough to meaningfully advance the medication candidate toward the FDA drug development pipeline.

What does it mean that this is a cooperative agreement?

It means NIH/NIDA expects substantial involvement consistent with a cooperative mechanism, alongside the awardee, throughout the project.

Who is eligible to apply?

Eligibility is expansive and includes many domestic applicant types, including state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are institutions serving specific communities called out as eligible?

Yes. The announcement highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, and faith-based or community-based organizations.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among the eligible categories.

Can federal agencies apply?

Yes. Eligible federal agencies are included in the listed eligible categories.

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

Yes. The eligibility list includes non-U.S. entities (foreign organizations).

What is the award ceiling mentioned for this opportunity?

The source data indicates an award ceiling of $3,000,000.

What is the original closing date listed in the opportunity details?

The original closing date listed was 2020-01-01.

How does this program relate to FDA approval?

The program is explicitly focused on generating results that help advance therapeutic candidates toward FDA approval by supporting a credible end-to-end development path, using measurable milestones to guide go/no-go decisions and reduce development risk.

What kinds of activities might be supported in a practical development path?

Based on the description, an application could focus on optimizing and testing a novel compound, improving delivery or duration of action for an existing drug, or evaluating a rational combination approach, with work conducted in preclinical models and/or clinical studies depending on the proposed plan.

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