Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed) | RFA TR 23 010

Opportunity Information: Apply for RFA TR 23 010

The funding opportunity titled "Emergency Awards: HEAL Initiative - Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-TR-23-010) is a National Institutes of Health (NIH) grant program issued by the National Center for Advancing Translational Sciences (NCATS). It was released as part of the federal public health emergency response to the opioid crisis, explicitly tied to the Secretary of Health and Human Services determination that a nationwide public health emergency exists due to the continued consequences of opioid addiction and overdose. In practical terms, this announcement is meant to move quickly and push new scientific ideas forward that could ultimately lead to better medications and interventions, recognizing the urgency and scale of opioid-related harm.

The core purpose of the announcement is to support early-stage research aimed at identifying new "druggable" biological targets related to pain, opioid use disorder (OUD), and/or opioid overdose. The emphasis on "druggable targets" means the projects should focus on proteins or pathways that are realistically actionable for therapeutic development, such as targets that could be modulated by small molecules, biologics, or other pharmacologic approaches. A defining feature is the focus on the "understudied druggable proteome," meaning the program is specifically encouraging researchers to look beyond the usual well-characterized targets and instead explore proteins that have historically received less attention, even though they may be amenable to drug discovery. The broader rationale is that many existing pain and addiction treatments are limited, and progress may require expanding the target landscape to uncover new mechanisms and opportunities.

This opportunity sits within the larger NIH Helping to End Addiction Long-term (HEAL) Initiative. HEAL is a major NIH-wide effort designed to speed the development of new solutions for the opioid crisis, including new medications and therapeutic strategies. Within that context, the work supported under this announcement is intended to help lay the groundwork for future therapeutic development across the full opioid addiction cycle. That includes stages and outcomes such as progression from acute exposure to chronic use, management of withdrawal symptoms, reduction of craving, prevention of relapse, and reduction of overdose risk. While this specific award is focused on early discovery, the long-term goal is to generate evidence and target validation that can later be translated into tangible treatment development.

The funding mechanism is an R21, which is generally designed for exploratory, high-risk/high-reward studies that can open up new directions rather than fully mature programs. The title explicitly states "Clinical Trial Not Allowed," meaning applicants cannot propose a clinical trial under this announcement. The projects should stay in the preclinical or early translational discovery space, such as target identification and validation, generation of mechanistic data, early assay development, or other foundational studies that make a target more credible and actionable for later drug discovery pipelines.

Eligibility is broad and includes a wide range of domestic organizations and government entities. Eligible applicants include state, county, city/township, and 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; and Native American tribal organizations that are not federally recognized tribal governments. The announcement also allows public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses. It further highlights additional eligible applicant types 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, tribal governments other than federally recognized, and U.S. territories or possessions. At the same time, the announcement is clear about foreign participation restrictions: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed.

Administratively, the opportunity is categorized as a discretionary grant program within the broad activity areas of education, health, income security, and social services. It lists multiple CFDA numbers associated with NIH and health research assistance programs (93.121, 93.213, 93.273, 93.279, 93.350, 93.846, 93.853, 93.865, 93.866). The opportunity was created on April 14, 2023, and the original closing date was May 22, 2023. The provided source data does not specify an award ceiling or the expected number of awards, which suggests applicants would need to consult the full FOA text for budget limits, project period expectations, and any special review or programmatic priorities.

Overall, this FOA is best understood as an emergency-response research investment meant to expand the pipeline of potential therapeutic targets for pain and opioid-related conditions. It aims to seed new ideas and validate less-explored proteins and pathways so that future drug development efforts under HEAL and related programs have more, and better, starting points for creating medications that address addiction, relapse, withdrawal, and overdose.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 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): 93.121, 93.213, 93.273, 93.279, 93.350, 93.846, 93.853, 93.865, 93.866.
• This funding opportunity was created on 2023-04-14.
• Applicants must submit their applications by 2023-05-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 RFA TR 23 010

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