Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) | PAR 19 327

Opportunity Information: Apply for PAR 19 327

The Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional), PAR 19 327, is a National Institutes of Health funding opportunity designed to speed up the development of new medications for Substance Use Disorders (SUDs). The central idea is to fund studies that can produce clear, decision-ready results in a short time frame, so promising medication candidates can move closer to U.S. Food and Drug Administration (FDA) approval. The announcement is intentionally broad about the kinds of scientific work it will support, welcoming a diverse set of projects that may be preclinical, clinical, or a combination, as long as the proposed work meaningfully advances a medication development pathway rather than simply generating incremental basic knowledge.

This FOA uses the U01 mechanism, meaning awards are cooperative agreements rather than standard investigator-initiated grants. In practice, that signals a hands-on partnership between the funded research team and the National Institute on Drug Abuse (NIDA), with substantial scientific involvement by NIDA staff. Projects funded under this mechanism are expected to be closely monitored, with active programmatic input and milestone-oriented management. The reason for using a U01 instead of a more common R01 is to enable larger, faster, more tightly managed medication development efforts that might be difficult to execute under a traditional grant structure, especially when the work requires coordinated timelines, specialized resources, or rapid go/no-go decision points.

The scope emphasizes high-impact medication studies that can quickly yield the key evidence needed to justify the next development step. Depending on the project, this could include tasks like demonstrating robust preclinical efficacy with translational relevance, refining dosing or formulation, establishing safety signals, identifying biomarkers, or generating early clinical evidence of effectiveness. The FOA explicitly notes that clinical trials are optional, meaning applicants can propose clinical trial work if it is appropriate for their development stage, but they are not required to do so. The unifying requirement is that the research should materially accelerate progress toward an approvable medication for SUDs, rather than stopping at exploratory findings.

Funding size and timing are set up to encourage ambitious, time-limited pushes. Awards are expected to be short-term, with support for up to three years, and budgets can be large, up to 5 million dollars per year as an award ceiling. This scale is meant to support projects that need concentrated resources to deliver definitive outputs within a tight period, consistent with medication development timelines where delays can stall an entire candidate program. Although the listing does not specify a number of expected awards, the emphasis is clearly on substantive, well-justified projects that can produce actionable deliverables quickly.

Eligibility is broad and includes many types of U.S. and non-U.S. institutions and organizations. Standard eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 (non-U.S.) entities, and U.S. territories or possessions. This wide eligibility aligns with the public health urgency of SUD treatment development and the practical reality that medication development capacity exists across academia, government, healthcare systems, community settings, and industry partners.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument type. It sits within an education and health activity category and is associated with CFDA number 93.279. The opportunity was created on 2019-08-01, and the source data shows an original closing date of 2022-09-01, which matters for anyone considering whether the announcement is still active or whether it has been replaced by a newer version. Overall, the program is best understood as a targeted, high-resource, milestone-driven NIH mechanism intended to push SUD medication candidates through critical development steps faster than a traditional research grant would typically allow, with NIDA closely involved to keep progress aligned with regulatory and translational 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 2019-08-01.
• Applicants must submit their applications by 2022-09-01. (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 $500,000.00 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 19 327

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