HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed) | RFA DA 22 031

Opportunity Information: Apply for RFA DA 22 031

The National Institutes of Health (NIH), through the HEAL (Helping to End Addictions Long-term) Initiative, released this discretionary grant opportunity titled "HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-DA-22-031. It is an R01 research grant aimed at accelerating the early stages of medication development for opioid-related conditions by backing projects that identify new, druggable biological targets and generate optimizable research probes. The core idea is to expand the pipeline of potential medications that could ultimately help prevent and treat opioid use disorders (OUD), reduce opioid overdose risk, and address the increasingly common reality of opioid-polysubstance use comorbidities.

The scientific focus is on discovery and preclinical-enabling work rather than testing interventions in people. The "clinical trial not allowed" designation signals that the supported studies should not include clinical trials as defined by NIH, meaning applicants should propose research that advances target identification, validation, and probe/lead discovery or optimization without moving into prospective human intervention studies. Within that boundary, the FOA is positioned to support research that could inform safe and effective therapeutics across the entire opioid addiction cycle. That cycle is described broadly in the announcement, spanning progression to chronic use, withdrawal symptoms, craving, relapse, and overdose. In practice, that framing encourages applicants to think beyond any single symptom or stage and instead propose targets and molecular approaches that could meaningfully change outcomes at one or more points along that trajectory.

Programmatically, this FOA sits within the HEAL Initiative's medication development priorities, which are oriented toward speeding the creation of new treatment options and reducing the public health burden of opioids. The opportunity explicitly emphasizes two linked deliverables: first, the identification of "druggable" new targets (meaning targets that are realistically amenable to modulation by a therapeutic modality such as small molecules, peptides, biologics, or other approaches), and second, the discovery of "optimizable probes" (chemical or biological tools that can be refined and used to interrogate the target and build a credible path toward a medication). The intent is to move the field from basic observations to actionable starting points that can be optimized, characterized, and potentially advanced toward development programs.

In terms of who can apply, eligibility is broad and includes many organization types across government, academia, nonprofit, and industry. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations). That wide eligibility reflects an interest in pulling in expertise from multiple sectors, including medicinal chemistry, neurobiology, pharmacology, toxicology, and translational research capabilities that may sit outside traditional academic settings.

Administratively, the opportunity is categorized as a grant under the health and education activity areas and is associated with CFDA numbers 93.213, 93.279, and 93.846. The original closing date provided in the source data is 2021-10-19, with a creation date of 2021-07-06. The listing also shows an award ceiling of $400,000, indicating an upper bound on the amount expected per award under the terms presented in the summarized data. The agency is NIH, and the FOA is connected to HEAL's broader medication development portfolio, which NIH summarizes publicly on its HEAL medication options page.

Overall, this grant opportunity is best understood as a translational discovery mechanism: it is meant to fund the kind of target-focused and probe-generating research that can de-risk later-stage development and ultimately feed a pipeline of candidate therapeutics for OUD, overdose prevention, and opioid-related polysubstance challenges. The emphasis is on building credible starting points for medications by identifying tractable targets and producing tool compounds or probes that can be optimized, rather than running human trials at this stage.

• The National Institutes of Health in the education, health 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, 93.846.
• This funding opportunity was created on 2021-07-06.
• Applicants must submit their applications by 2021-10-19. (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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