Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional) | RFA DA 19 002

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.

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