Grand Opportunity in Medications Development for Substance-Use Disorders (U01) | PAR 16 431

Opportunity Information: Apply for PAR 16 431

The Grand Opportunity in Medications Development for Substance-Use Disorders (U01) (Funding Opportunity Number PAR 16 431) is a National Institutes of Health (NIH) funding announcement designed to speed up the development of medications to treat substance-use disorders (SUDs). The central focus is on moving promising medication candidates forward through the kinds of studies that generate clear, decision-ready evidence, with the explicit aim of advancing treatments closer to eventual U.S. Food and Drug Administration (FDA) approval. Unlike smaller, longer-horizon investigator-initiated grants, this opportunity is set up to support projects that can produce high-impact results on an accelerated timeline and directly address critical gaps in the medications development pipeline.

The mechanism is a U01 cooperative agreement, which means awardees should expect substantial scientific involvement from the funding institute rather than a hands-off relationship. In this case, the National Institute on Drug Abuse (NIDA) plays an active role through close monitoring and significant participation in the scientific direction and oversight of the funded work. This structure is intended to keep projects tightly focused, milestone-driven, and aligned with regulatory and translational requirements, particularly when the work needs coordinated guidance to move efficiently from experimental findings toward clinical utility.

Projects may be preclinical, clinical, or include both, as long as they meaningfully contribute to medications development for SUDs. The FOA emphasizes studies that are likely to yield the kinds of results needed to justify and design later-stage development steps, including work that may be difficult to fund under a traditional R01 because it can be too expensive, too time-sensitive, or too operationally complex. In practice, the opportunity is meant to cover pivotal enabling studies that can quickly clarify whether a candidate medication is ready to advance, how it should be tested, or what key risks and uncertainties must be resolved first.

The awards are expected to be short-term and large. Funding can last up to 3 years, with an award ceiling of up to $5,000,000 per year, reflecting the expectation that these projects may involve significant coordination, specialized infrastructure, intensive data collection, or other resource-heavy components typical of advanced translational work. The goal is not incremental progress over many years, but rather concentrated investment to generate decisive outcomes that move a medication development program forward.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations, reflecting an intent to draw from a wide range of scientific, clinical, and community-based expertise. Eligible applicants include 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 Native American tribal governments; Native American tribal organizations (other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicants 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (foreign) entities, tribal governments that are not federally recognized, and U.S. territories or possessions.

Administratively, this is a discretionary funding opportunity in the education and health activity category, associated with CFDA number 93.279. The listing notes an original closing date of January 24, 2018, and a creation date of September 8, 2016. Overall, the opportunity is best understood as a high-dollar, high-intensity, milestone-oriented pathway for medications development in SUDs, deliberately structured to support projects that need strong institute partnership and resources to reach outcomes that can meaningfully accelerate progress toward FDA-regulated approval pathways.

• 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)" 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 2016-09-08.
• Applicants must submit their applications by 2018-01-24. (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 16 431

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