HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed) | RFA DA 24 063

Opportunity Information: Apply for RFA DA 24 063

The HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed) funding opportunity, listed as RFA-DA-24-063, is a National Institutes of Health (NIH) research grant aimed at pushing medication development for opioid-related harms earlier in the pipeline. The core focus is on finding new, druggable biological targets and generating optimizable research probes that can serve as starting points for safe and effective therapeutics. In practical terms, the NOFO is designed to help investigators move beyond already well-studied mechanisms by uncovering fresh molecular or cellular targets tied to opioid use disorders (OUD), overdose risk, and the increasingly common reality of opioid use occurring alongside other substances (opioid-polysubstance comorbidities). Because it is an R01 and explicitly states "Clinical Trial Not Allowed," the work is intended to be preclinical or otherwise non-clinical-trial human research, emphasizing target identification, validation, and early discovery steps rather than testing interventions in clinical trial settings.

This NOFO sits under the broader NIH Helping to End Addictions Long-term (HEAL) Initiative, which is a major federal effort to speed up solutions across the full opioid addiction cycle. The funding purpose is framed around supporting science that can ultimately lead to medications addressing multiple phases and drivers of opioid addiction and harm, including the progression from initial exposure to chronic use, the biology of withdrawal, mechanisms of craving, the vulnerability to relapse, and the acute and long-term factors that contribute to overdose. By emphasizing "novel targets" and "optimizable probes," the opportunity is signaling interest in rigorous target discovery and target validation work, along with early-stage medicinal chemistry or probe development approaches that can generate tool compounds suitable for follow-on optimization and, eventually, translational development. The overall intent is to expand the set of credible therapeutic options by creating a stronger foundation of validated targets and tractable chemical starting points.

From an eligibility standpoint, the program is broadly open and includes a wide range of applicant types across government, academia, nonprofit, and private sectors. Eligible applicants include state, county, city or township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities. Institutions of higher education are eligible across public/state-controlled and private categories. The NOFO also allows participation from federally recognized Native American tribal governments as well as Native American tribal organizations that are not federally recognized tribal governments. Both nonprofit organizations (with or without 501(c)(3) status) and for-profit organizations (other than small businesses) can apply, and small businesses are also explicitly eligible. In addition to these standard categories, the NOFO highlights other 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, and eligible agencies of the federal government. It also allows non-domestic (non-U.S.) entities (foreign organizations), regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions, reflecting an intent to attract a diverse pool of scientific approaches and research environments.

Administratively, this is a discretionary grant opportunity with NIH as the issuing agency. It is categorized under funding activity areas that include education and health (and related social service domains as listed in the source data). The CFDA/assistance listing numbers associated with the opportunity include 93.213, 93.279, 93.855, 93.865, 93.866. The original closing date provided is February 1, 2024, and the opportunity was created on July 19, 2023. The listed award ceiling is $400,000, which indicates the maximum amount expected per award under the terms summarized in the provided data. The number of expected awards is not specified in the excerpted source information.

Taken together, the program is essentially a targeted invitation for research teams to deliver the early, high-value building blocks needed for new OUD and overdose therapeutics: credible, druggable targets and practical probe compounds that can be optimized. It is positioned as a catalyst within HEAL for diversifying and strengthening the medication development pipeline, with the long-term objective of producing safer and more effective treatments that can address not only OUD itself but also relapse dynamics, overdose risk, and co-use with other substances.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.279, 93.855, 93.865, 93.866.
• This funding opportunity was created on 2023-07-19.
• Applicants must submit their applications by 2024-02-01. (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 $400,000.00 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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