Opportunity Information: Apply for RFA HL 22 013
The NIH HEAL Initiative funding opportunity RFA-HL-22-013 supports pre-clinical research aimed at creating new medicines that can reverse opioid overdose induced respiratory depression (OIRD) while avoiding two major drawbacks of current reversal approaches: stripping away opioid pain relief and triggering rapid, severe opioid withdrawal. The central scientific goal is to identify and advance pharmacotherapy candidates that restore breathing after opioid exposure in a more selective way than standard opioid receptor antagonists, so a patient could potentially regain adequate respiration without immediately losing analgesia or experiencing acute withdrawal. The program is explicitly focused on target validation and candidate therapeutic development in the pre-clinical space, meaning the work should move beyond general concepts and toward well-supported targets, optimized leads, and evidence packages that justify further development. Clinical trials are not allowed under this announcement.
The award mechanism is a UG3/UH3 cooperative agreement, which is designed as a phased, milestone-driven program where early activities de-risk the science and set up a transition into a later stage focused on more advanced development. In practice, applicants are expected to propose a coherent development path that starts with solidifying the biological target and mechanism relevant to OIRD, then progresses through key pre-clinical steps that would make a candidate credible for later translational advancement. Because it is a cooperative agreement, NIH program staff typically have substantial involvement compared with standard grants, and projects are usually managed against clear go/no-go milestones that govern transition between phases and continued support.
The opportunity sits within NIH health and education mission areas and is tied to multiple CFDA numbers (93.233, 93.273, 93.279, 93.838), reflecting the multi-institute nature of HEAL-related efforts and the cross-cutting public health importance of addressing opioid overdose mortality. The funding instrument type indicates NIH intends active stewardship of the portfolio and alignment with HEAL Initiative priorities, emphasizing deliverables and rigor in pre-clinical evidence generation rather than exploratory or purely descriptive research.
Eligibility is broad across U.S.-based organizations and includes state, county, city, township, and special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; independent school districts; public and private institutions of higher education; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses. The FOA also highlights additional eligible applicant types such as 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; eligible federal agencies; and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply directly, but non-domestic components of U.S. organizations are allowed, and foreign components are allowed as defined by the NIH Grants Policy Statement, which can enable specific portions of the work to be conducted abroad when scientifically justified and compliant with NIH policy.
The application window reflected in the source information shows an original closing date of 2021-12-03, with the FOA created on 2021-09-30. While award ceiling and expected awards are not specified in the provided listing, the key takeaway is that this is a targeted, milestone-oriented HEAL Initiative development program meant to generate pre-clinical evidence for therapies that can counter opioid-related respiratory suppression without producing central opioid withdrawal or negating analgesia, thereby addressing a major unmet need in overdose rescue and safer opioid pharmacology.Apply for RFA HL 22 013
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression Without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development) (UG3/UH3 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): 93.233, 93.273, 93.279, 93.838.
- This funding opportunity was created on 2021-09-30.
- Applicants must submit their applications by 2021-12-03. (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.
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Frequently Asked Questions (FAQs)
What is the goal of NIH HEAL Initiative opportunity RFA-HL-22-013?
The goal is to support pre-clinical research to create new medicines that can reverse opioid overdose induced respiratory depression (OIRD). A key requirement is that proposed approaches aim to restore breathing while avoiding two common drawbacks of current reversal methods: (1) stripping away opioid pain relief (analgesia) and (2) triggering rapid, severe opioid withdrawal.
What problem is this funding opportunity trying to solve?
This opportunity targets a major unmet need in overdose rescue: restoring adequate respiration after opioid exposure in a more selective way than standard opioid receptor antagonists, so a patient could potentially resume breathing without immediately losing analgesia or experiencing acute withdrawal.
What types of research does this FOA support?
It supports pre-clinical, milestone-driven research focused on target validation and candidate therapeutic development. Projects are expected to move beyond general ideas and toward well-supported targets, optimized leads, and evidence packages that justify further development.
What does "pre-clinical" mean in the context of this announcement?
In this FOA, pre-clinical means the work is intended to generate rigorous evidence before any clinical testing, emphasizing target/mechanism validation and development of therapeutic candidates rather than conducting studies in humans.
Are clinical trials allowed under this funding opportunity?
No. Clinical trials are not allowed under this announcement.
What is the central scientific objective applicants are expected to pursue?
The central scientific objective is to identify and advance pharmacotherapy candidates that restore breathing after opioid exposure more selectively than standard opioid receptor antagonists, with the aim of avoiding immediate loss of analgesia and avoiding rapid, severe withdrawal.
What kinds of outcomes or deliverables is NIH looking for?
Based on the description provided, NIH is looking for deliverables typical of a development-focused pre-clinical program: validated biological targets and mechanisms relevant to OIRD, optimized lead candidates, and a strong pre-clinical evidence package sufficient to justify later translational advancement.
What award mechanism is used for this program?
The award mechanism is a UG3/UH3 cooperative agreement.
What does the UG3/UH3 phased structure mean for applicants?
UG3/UH3 is designed as a phased, milestone-driven program. Early activities are expected to de-risk the science and prepare for a transition into a later stage focused on more advanced development. Applicants are expected to propose a coherent development path spanning both phases.
How does a cooperative agreement differ from a standard NIH grant in this FOA?
Because this is a cooperative agreement, NIH program staff typically have substantial involvement compared with standard grants. Projects are usually managed against clear go/no-go milestones that influence phase transition and continued support.
What are "go/no-go" milestones in this context?
They are predefined, decision-driving milestones used to evaluate whether a project is making sufficient progress to continue and/or transition from the earlier phase to the later phase of the UG3/UH3 structure.
Is this opportunity intended for exploratory or purely descriptive research?
No. The description emphasizes deliverables and rigor in pre-clinical evidence generation rather than exploratory or purely descriptive research.
Which NIH mission areas does this opportunity fall under?
The opportunity sits within NIH health and education mission areas and aligns with HEAL Initiative priorities related to addressing opioid overdose mortality.
What CFDA numbers are associated with this opportunity?
The listing references multiple CFDA numbers: 93.233, 93.273, 93.279, and 93.838. This reflects the multi-institute nature of HEAL-related efforts and the cross-cutting public health importance of the topic.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations. Eligible applicants include: state, county, city, township, and special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; independent school districts; public and private institutions of higher education; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses.
Are any additional organization types specifically highlighted as eligible?
Yes. The FOA highlights additional eligible applicant types such as 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; eligible federal agencies; and U.S. territories or possessions.
Can foreign institutions apply directly?
No. Foreign institutions (non-U.S. entities) are not eligible to apply directly.
Are any foreign or non-U.S. components allowed at all?
Yes. Non-domestic components of U.S. organizations are allowed, and foreign components are allowed as defined by the NIH Grants Policy Statement. This can allow specific portions of the work to be conducted abroad when scientifically justified and compliant with NIH policy.
What is the focus of the science: opioid antagonists or something else?
The program seeks approaches that are more selective than standard opioid receptor antagonists, specifically aiming to restore breathing after opioid exposure without immediately negating analgesia or triggering acute withdrawal.
Is the funding amount, award ceiling, or number of expected awards provided?
No. The provided listing does not specify the award ceiling or the expected number of awards.
When was this FOA created and what is the closing date shown in the provided information?
The FOA is shown as created on 2021-09-30, and the application window reflected in the source information shows an original closing date of 2021-12-03.
What is the overall "fit" for a strong application, based on the description provided?
A strong fit would be a milestone-based, pre-clinical development plan that starts with solidifying the biological target and mechanism relevant to OIRD and then progresses through key pre-clinical steps toward an optimized candidate and an evidence package that supports later translational advancement, while aligning with HEAL Initiative priorities and the cooperative agreement expectations.
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