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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Frequently Asked Questions (FAQs)

1) What is NIH PAR 22-057?

PAR 22-057 is an NIH funding opportunity titled "Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed)." It supports career enhancement activities that help investigators expand their capabilities in translational science focused on therapeutic development.

2) What is the main goal of this funding opportunity?

The goal is to strengthen the workforce of scientists who can move discoveries from basic research settings into practical interventions that improve individual and population health, with an emphasis on accelerating new and better treatments related to pain, opioid use disorder, addiction, and overdose.

3) How does this FOA define "translational science"?

Translational science is framed as the discipline that studies how the full translational pipeline works, including scientific and operational principles. Translation is described as the full pathway of turning observations from the lab, clinic, and community into real-world interventions, including diagnostics, therapeutics, procedures, and behavioral changes.

4) What types of therapeutics are emphasized?

The opportunity specifically highlights the development of therapeutics such as drugs, biologics, and medical devices.

5) How is this FOA connected to the HEAL Initiative?

This program sits within the NIH HEAL (Helping to End Addiction Long-term) Initiative and is motivated by the urgent public health need to speed up development of treatments related to pain, opioid use disorder, addiction more broadly, and overdose.

6) Who is this award intended for?

It is aimed at early and mid-career investigators. Examples mentioned include individuals ranging from postdoctoral fellows/associates through associate professors.

7) Is this a training grant or a research project grant?

Based on the information provided, it is a career enhancement mechanism (K18) designed for skill and knowledge acquisition and professional development in translational science and therapeutic development, rather than a mechanism primarily intended to support running a research project like an independent clinical trial.

8) Why does NIH describe a need for this type of award?

The FOA notes that traditional academic training often produces deep specialization but may not provide practical exposure to the many specialized domains required for therapeutic product development. This award is positioned to provide targeted, participatory training that can be difficult to access through a conventional academic career path.

9) What kinds of skills or areas of exposure does the FOA highlight?

The FOA highlights the complexity involved in developing regulatory and development packages such as an IND (for drugs/biologics), an IDE (for devices), or an NDA (for marketing approval). It points to the need for familiarity with areas such as preclinical development strategy, manufacturing and quality considerations, regulatory science, and other operational steps.

10) Are clinical trials allowed under this opportunity?

No. The title explicitly states "K18 Clinical Trials Not Allowed," and the description indicates supported activities are meant to focus on skill and knowledge acquisition and career development rather than running a clinical trial as part of the award.

11) Can an applicant include clinical trial-related work at all?

The provided information only states that independent clinical trials are not supported under this FOA. It does not describe any exceptions or allowable clinical trial-related activities beyond that statement.

12) What types of organizations are eligible to apply?

Eligible applicant organizations are broad and include U.S.-based 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, and multiple types of government entities (state, county, city/township, special districts), independent school districts, and public housing authorities/Indian housing authorities.

13) Are minority-serving institutions and community-based organizations included as eligible applicants?

Yes. The FOA explicitly calls out Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based or community-based organizations and regional organizations.

14) Are U.S. territories included?

Yes. The eligibility list includes U.S. territories or possessions.

15) Are tribal governments and tribal organizations eligible?

Yes. The FOA includes Indian/Native American tribal governments and tribal organizations, including categories specified as eligible even if other than federally recognized (as stated in the provided description).

16) Can a non-U.S. (foreign) organization apply as the main applicant?

No. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as applicant organizations.

17) Can a U.S. organization with a non-U.S. component apply?

Non-domestic components of U.S. organizations are not eligible. However, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign elements within the project if they meet NIH policy definitions and requirements.

18) What does it mean that "foreign components" may be allowed?

It means the award is primarily U.S.-anchored, but a U.S. applicant organization may include justified international collaboration elements that meet NIH definitions and requirements for a foreign component under NIH policy.

19) What subject areas does this opportunity fall under?

From the listing information provided, the opportunity is tied to education and health, and it aligns with translational science and the HEAL Initiative.

20) Is this considered a discretionary grant opportunity?

Yes. The listing information indicates it is a discretionary grant opportunity under NIH.

21) Are there CFDA numbers associated with this FOA?

Yes. 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, and 93.866.

22) Are the award ceiling or the expected number of awards provided?

No. The provided source data does not specify an award ceiling or an expected number of awards. The description suggests 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.

23) What is the closing date listed for this opportunity?

The original closing date shown is January 22, 2022.

24) When was this opportunity record created?

The record creation date shown is January 6, 2022.

25) What is the central workforce issue this FOA is trying to address?

The FOA is responding to the gap between deep academic specialization and the cross-domain, practical expertise needed to shepherd a therapeutic idea through development stages, including regulatory and operational milestones. It aims to expand investigators' integrated understanding of therapeutic development.

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