Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed) | PAR 22 058

Opportunity Information: Apply for PAR 22 058

The Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed) funding opportunity (PAR-22-058) is a National Institutes of Health (NIH) grant run through the National Center for Advancing Translational Sciences (NCATS). It was issued specifically in response to the nationwide public health emergency declaration related to the opioid crisis by the U.S. Department of Health and Human Services (HHS), including subsequent renewals tied to the continued consequences of that crisis. In practical terms, the program is positioned as part of the broader HEAL (Helping to End Addiction Long-term) effort and is intended to rapidly strengthen the biomedical and translational workforce capacity needed to accelerate solutions relevant to opioid misuse, addiction, pain, and related health impacts.

This FOA is designed as a career enhancement mechanism for early and mid-career investigators who want to expand or redirect their research trajectory by gaining new, practical translational science capabilities. The target applicant pool includes researchers roughly spanning postdoctoral fellows/associates through the associate professor level, emphasizing people who are already established in research but need structured time and support to acquire new skills. The emphasis is not on running a large independent research program under this award, but on enabling investigators to build competency in therapeutic development activities that will make their future research more translational and impact-oriented.

The scientific focus is on building knowledge and skills in therapeutic drug, biologic, or device development. That framing signals that NCATS is looking for investigators to strengthen their ability to move discoveries along the development pipeline, which can include areas such as target validation, lead optimization concepts, preclinical development considerations, formulation and delivery issues, biomarker strategy, translational pharmacology, regulatory science exposure, manufacturing and quality considerations, and other practical elements that typically sit between basic discovery and real-world interventions. While the FOA is connected to the opioid public health emergency and the HEAL initiative context, the core goal described in the synopsis is workforce development in translational therapeutic development, so proposals are expected to be aligned with that skill-building purpose.

A key restriction is embedded in the title: clinical trials are not allowed under this opportunity. Applicants therefore need to design their proposed activities so that they do not include conducting a clinical trial as defined by NIH. The award is meant to support career development and training experiences rather than clinical testing of interventions. Applicants generally need to think in terms of mentored or structured learning, hands-on experiences, and career enhancement activities that build translational capacity without initiating or running a clinical trial.

Eligibility is broad at the organizational level, consistent with many NIH opportunities. Eligible applicants include various levels of government (state, county, city/township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (excluding higher education institutions when specified), for-profit organizations (other than small businesses), small businesses, and other categories. The FOA also explicitly calls out a range of institution types that are often emphasized in federal programs to broaden participation and strengthen capacity, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, as well as eligible federal agencies.

There are also important limits related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply as components. However, foreign components are allowed as defined in the NIH Grants Policy Statement. This typically means a U.S.-based applicant can include certain foreign collaborations or elements when they are well-justified and meet NIH policy requirements, but the main applicant organization must be domestic and structured accordingly.

From the administrative details provided, this is a discretionary grant program using the grant funding instrument type, and it falls under education and health activity categories. Multiple CFDA (now often referred to as Assistance Listing) numbers are associated with it, reflecting NIH program accounting across institutes or funding streams: 93.121, 93.213, 93.273, 93.279, 93.313, 93.350, 93.398, 93.846, 93.853, and 93.866. The source information lists an original closing date of 2023-04-19, and the record creation date is 2022-01-21. Award ceiling and expected awards are not specified in the excerpt, which usually means applicants need to consult the full FOA text for budget limits, project period, allowable costs, and the anticipated number of awards.

Overall, the opportunity can be read as an emergency-response, workforce-acceleration career enhancement award meant to quickly equip early and mid-career investigators with applied translational science expertise in therapeutic development areas, in service of the national response to the opioid crisis. Applicants who fit the career stage and can make a strong case that the award will materially expand their translational skill set, while staying within the non-clinical-trial boundary and meeting domestic eligibility rules, are the intended audience for this program.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials 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, 93.313, 93.350, 93.398, 93.846, 93.853, 93.866.
• This funding opportunity was created on 2022-01-21.
• Applicants must submit their applications by 2023-04-19. (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 PAR 22 058

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