Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) | PAR 18 219

Opportunity Information: Apply for PAR 18 219

The Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional), funding opportunity number PAR 18 219, is a National Institutes of Health program designed to move promising medications for substance-use disorders (SUDs) forward faster than a typical research grant would allow. The central aim is acceleration: the program is looking for preclinical and/or clinical studies that can quickly generate the key evidence needed to de-risk a candidate medication and push it closer to eventual FDA approval. In practice, that means the opportunity is geared toward projects that are highly focused, milestone-driven, and positioned to deliver actionable results on a relatively short timeline, rather than open-ended exploratory work.

A defining feature of this FOA is the use of the U01 cooperative agreement mechanism. Unlike a standard research project grant (such as an R01), a U01 is structured for substantial scientific involvement from the funding institute. Here, that institute is NIDA (the National Institute on Drug Abuse, part of NIH). Applicants should expect close monitoring, active collaboration, and meaningful NIDA staff participation in shaping and overseeing the work as it progresses. This structure is intended to support medications development activities that might be too complex, time-sensitive, or resource-intensive to fit comfortably within a traditional investigator-initiated grant framework. The announcement explicitly frames these awards as a way to enable critical studies that would not be feasible under the R01 activity code.

The scope is intentionally broad in terms of the types of projects that can be proposed, emphasizing a diverse array of preclinical and clinical research studies. The "Clinical Trial Optional" label signals that applications may include clinical trials but are not required to; strong non-clinical development packages (for example, translational preclinical studies that directly inform clinical readiness or regulatory steps) can also fit, as long as they support the overall mission of advancing a medication candidate toward approval. The key evaluation lens is impact and speed: proposed studies should be positioned to yield decisive results that materially advance the medication development pathway for SUD treatment.

In terms of size and duration, the opportunity is built for large, short-term efforts. Awards are expected to run up to 3 years, with an award ceiling of up to $5,000,000 per year. That scale reflects the reality that medications development can require expensive, integrated work, such as manufacturing and formulation planning, rigorous preclinical safety or efficacy packages, or well-powered clinical studies. The FOA also characterizes these as "short-term" U01s, reinforcing that the program is looking for tightly scoped efforts with clear deliverables rather than long, incremental research programs.

Eligibility is expansive, reflecting a desire to attract capable teams across sectors and institution types. Eligible applicants include a wide range of government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized. Both nonprofit organizations (with and without 501(c)(3) status) and for-profit organizations (other than small businesses) may apply, as can small businesses and other types of organizations. The FOA also calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, non-U.S. (foreign) entities, and U.S. territories or possessions. This broad eligibility aligns with the applied, translational nature of medications development, where expertise and infrastructure may reside in academia, industry, community settings, government, or international partners.

Administratively, this is a discretionary funding opportunity using the cooperative agreement funding instrument type, categorized under education and health, with CFDA number 93.279. The opportunity was created on 2017-11-21, and the original closing date listed is 2019-07-25. While the date indicates the specific posting window for that cycle, the program description clearly communicates the intent and structure: fund high-impact, near-term medications development studies for SUDs, at a scale large enough to make real progress quickly, and with hands-on engagement from NIDA to keep projects aligned with milestones and development goals.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 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 2017-11-21.
• Applicants must submit their applications by 2019-07-25. (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 $5,000,000.00 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 PAR 18 219

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