Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed) | PAR 22 057

Opportunity Information: Apply for PAR 22 057

The NIH funding opportunity PAR 22-057, titled "Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed)," is designed to help early and mid-career researchers broaden their capabilities in translational science, specifically around the development of therapeutics such as drugs, biologics, and medical devices. The program sits within the HEAL (Helping to End Addiction Long-term) Initiative and is motivated by the urgent public health need to accelerate new and better treatments for pain, opioid use disorder, addiction more broadly, and overdose. The central idea is to strengthen the workforce of scientists who can move discoveries from basic research settings into practical interventions that improve individual and population health.

This FOA emphasizes translational science as more than simply applying laboratory findings to humans. It describes translation as the full pathway of turning observations from the lab, clinic, and community into real-world interventions, ranging from diagnostics and therapeutics to procedures and behavioral changes. In that framing, translational science is the discipline that studies how each step of the translational pipeline works, including both scientific and operational principles. The opportunity is aimed at investigators who already have solid domain expertise in a particular field but want to gain a broader, more integrated understanding of what it takes to shepherd an idea through the key stages of therapeutic development.

A major rationale for the award is that traditional academic training often produces deep specialization, which is valuable, but does not always provide practical exposure to the multiple specialized domains involved in therapeutic product development. The FOA specifically highlights the complexity of the expertise needed to assemble regulatory and development packages such as an Investigational New Drug (IND) application for drugs/biologics, an Investigational Device Exemption (IDE) for devices, or a New Drug Application (NDA) for marketing approval. Because these processes require familiarity with a wide range of areas (for example, preclinical development strategy, manufacturing and quality considerations, regulatory science, and other operational steps), the FOA positions this K18 as a way for eligible investigators to obtain targeted, participatory training that would otherwise be difficult to access within a conventional academic career path.

The target applicant pool is described as early and mid-career investigators, with examples spanning postdoctoral fellows/associates through associate professors. While the FOA is a career enhancement mechanism, it is not structured to support independent clinical trials, as indicated by the "Clinical Trials Not Allowed" designation. In practice, that means the supported activities are meant to focus on skill and knowledge acquisition and career development in translational science and therapeutic development rather than running a clinical trial as part of the award.

Eligible applicant organizations are broad and include many types of U.S.-based institutions and entities, such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses) and small businesses, as well as various units of government (state, county, city/township, special districts), independent school districts, and public housing authorities/Indian housing authorities. The FOA also explicitly calls out additional eligible categories that NIH often highlights to encourage wide participation, including Alaska Native and Native Hawaiian 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, U.S. territories or possessions, eligible federal agencies, and Indian/Native American tribal governments and tribal organizations (including those other than federally recognized, as specified).

At the same time, there are clear geographic and organizational restrictions related to foreign involvement. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible. However, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S. applicant organization may include certain foreign elements within the project if they meet NIH policy definitions and requirements. This structure preserves the award as primarily U.S.-anchored while still permitting justified international collaboration components under NIH rules.

From the listing information provided, this is a discretionary grant opportunity under the NIH, with activity and subject areas tied to education and health. The FOA is associated with multiple CFDA numbers (93.121, 93.213, 93.273, 93.279, 93.313, 93.350, 93.398, 93.846, 93.853, 93.866), reflecting its alignment with several NIH institutes, centers, and program authorities connected to translational science and the HEAL Initiative. The original closing date shown is January 22, 2022, and the record creation date is January 6, 2022. The award ceiling and expected number of awards are not specified in the provided source data, suggesting applicants would need to consult the full FOA text and NIH guidance for budget limits, project period details, and any cohort or funding level expectations.

• 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 2022-01-06.
• Applicants must submit their applications by 2022-01-22. (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 PAR 22 057

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