Grand Opportunity in Medications Development for Substance Use Disorders (U01) | Apply Online

Opportunity Summary:

The Grand Opportunity in Medications Development for Substance Use Disorders (U01) (Funding Opportunity Number PAR-13-270) is a National Institutes of Health funding opportunity designed to speed up the development of new or improved medications for Substance Use Disorders (SUDs). The core intent is practical and translational: support preclinical and/or clinical studies that can quickly generate the kinds of high-impact results needed to move promising medication candidates closer to U.S. Food and Drug Administration (FDA) approval. In other words, the program is aimed at tackling the critical, expensive, and time-sensitive steps in the medications development pipeline that often slow progress when using more traditional NIH grant mechanisms.

This FOA uses the U01 mechanism, which is a cooperative agreement rather than a standard research grant. That distinction matters because it signals substantial scientific involvement from the funding institute, specifically the National Institute on Drug Abuse (NIDA). Projects funded under this announcement are expected to be closely monitored, with significant participation by NIDA staff in shaping, overseeing, and coordinating the research effort as it moves forward. The program emphasizes that these projects should be the type of studies that are difficult to support through an R01, often because they require larger budgets, more coordination, faster execution, or more programmatic oversight than a typical investigator-initiated grant.

The anticipated awards are intentionally large and short-term to match the goal of rapidly advancing medications: awards can be funded for up to 3 years, with an award ceiling of up to $5,000,000 per year. The estimated total funding listed for the opportunity is $10,000,000. By structuring the program this way, NIH is essentially trying to buy down risk and remove bottlenecks in development by funding well-defined, milestone-oriented studies that can deliver actionable results on a fast timeline.

In scope, the announcement encourages a wide range of medications development research, spanning both preclinical and clinical stages. While the summary language does not list specific substances, targets, or study designs, the emphasis is on projects that directly advance a medication toward clinical utility and eventual regulatory approval. That typically implies activities such as late-stage preclinical development, IND-enabling work, early human safety and pharmacology studies, proof-of-concept trials, efficacy trials, or other key development steps where clear outcomes can be measured and used to justify the next regulatory or clinical milestone.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument. It falls under the Health activity category and is associated with CFDA number 93.279 (Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement, which reduces barriers for applicants and makes the program accessible to a broad range of organizations.

Eligibility is broad and includes many types of U.S. and non-U.S. entities. Eligible applicants include state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits); for-profit organizations (including small businesses and other for-profits); independent school districts; public housing authorities/Indian housing authorities; and a wide range of tribal entities, including federally recognized tribal governments and other tribal organizations. The eligibility section also explicitly includes institutions serving specific populations (such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions), as well as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign participation is allowed: non-U.S. organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted consistent with the NIH Grants Policy Statement.

Key dates associated with the announcement include a posted/creation date of July 11, 2013, with an original and current closing date of September 7, 2016, and an archive date of October 8, 2016. The full announcement was hosted through the NIH Grants Guide and is referenced via the additional information link (http://grants.nih.gov/grants/guide/pa-files/PAR-13-270.html). For technical issues accessing the announcement, the listed contact is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).

Overall, this funding opportunity is best understood as a fast-moving, high-budget NIH program built to push SUD medication candidates through pivotal development steps under close collaboration with NIDA. It is meant for teams that can propose a focused, development-oriented plan capable of producing near-term results with clear implications for the next phase of clinical testing and eventual FDA review.

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