Opportunity Information: Apply for RFA NS 25 012
The NIH HEAL Initiative: Studies to Enable Analgesic Discovery (R61/R33 - Clinical Trial Not Allowed) funding opportunity (RFA-NS-25-012) is a discretionary NIH grant designed to jump-start early, translational research that can feed directly into a stronger, later-stage pain drug discovery pipeline. It sits within the broader HEAL (Helping to End Addiction Long-term) Initiative, which emphasizes the development of safe, effective, and non-addictive treatments for pain. In practical terms, this opportunity is meant to help research teams do the enabling work that often determines whether a pain therapeutic concept can realistically mature into a bona fide discovery program, with the explicit intent of advancing projects toward the entry criteria for NIH's Pain Therapeutics Development Program.
The core scientific focus is on building the foundation for an organized discovery "testing funnel" rather than running clinical studies. Applicants are expected to concentrate on assay development and optimization, screening approaches to identify promising "hits," and the early characterization of those hits and potential therapeutic agents. The program explicitly allows a range of therapeutic modalities, including small molecules, biologics, and natural products. The kinds of activities that fit this scope typically include creating or refining robust, reproducible assays (for example, target engagement assays, phenotypic screening assays, or other translationally relevant test systems), establishing screening workflows and quality controls, conducting screening campaigns to uncover candidate hits, and performing initial follow-up work to understand whether those hits have properties consistent with a viable analgesic development path (such as early selectivity, basic structure-activity relationships, or preliminary mechanism-relevant validation). As the title notes, clinical trials are not allowed under this announcement, reinforcing that the work should remain in preclinical and discovery-enabling territory.
From a mechanism standpoint, the R61/R33 structure is a phased, milestone-driven approach commonly used by NIH to support early development projects that need to demonstrate concrete progress before transitioning to the next stage. While the notice text provided does not spell out specific milestone language, in general the intent of this type of structure is to support an initial, shorter "startup" or feasibility phase followed by a second phase that is contingent on meeting predefined progress criteria. For applicants, the practical takeaway is that the project should be planned as a stepwise program where the early work clearly de-risks the later work and produces outputs that would make the project competitive for downstream translational programs like the Pain Therapeutics Development Program.
The applicant eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations (other than small businesses); and small businesses. The opportunity also highlights additional eligible applicant categories 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, eligible federal agencies, regional organizations, and U.S. territories or possessions. However, there are important geographic restrictions: non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may be able to include certain internationally performed elements under NIH policy, even though a foreign organization cannot be the applicant.
Administratively, the agency is the National Institutes of Health, and the opportunity is associated with multiple CFDA numbers (93.121, 93.213, 93.273, 93.393, 93.395, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867), reflecting NIH's multi-institute participation in HEAL-related pain and translational science efforts. The opportunity was created on 2024-03-26, and the original closing date listed is 2027-01-15, indicating a multi-year window in which applications may be accepted according to the solicitation's schedule. The award ceiling listed is $350,000, which signals that projects should be designed with a focused, enabling scope: enough to establish validated assays, run targeted screening, and generate initial hit follow-up data, but not so broad as to cover extensive preclinical development or clinical testing.
Overall, this NOFO is best understood as a targeted on-ramp for analgesic discovery: it funds the nuts-and-bolts work of building screening-ready assays and generating early evidence around candidate analgesic agents so that the most promising projects can credibly move into more advanced translational development programs within NIH's pain therapeutics ecosystem, all while staying firmly outside of clinical trial activities.Apply for RFA NS 25 012
- The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Studies to Enable Analgesic Discovery (R61/R33 - 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, 93.393, 93.395, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2024-03-26.
- Applicants must submit their applications by 2027-01-15.
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- 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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FAQs: NIH HEAL Initiative - Studies to Enable Analgesic Discovery (R61/R33 - Clinical Trial Not Allowed) (RFA-NS-25-012)
What is this funding opportunity?
This is a discretionary National Institutes of Health (NIH) grant opportunity under the NIH HEAL (Helping to End Addiction Long-term) Initiative titled "Studies to Enable Analgesic Discovery" using the R61/R33 mechanism (Clinical Trial Not Allowed). The goal is to jump-start early, translational research that strengthens the front end of the pain drug discovery pipeline.
What is the main purpose of this program?
The program is designed to fund enabling, discovery-focused work that helps determine whether an analgesic concept can mature into a credible drug discovery program. It is intended to move projects toward the entry criteria for NIH's Pain Therapeutics Development Program.
How does this relate to the NIH HEAL Initiative?
It sits within the broader HEAL Initiative, which emphasizes development of safe, effective, and non-addictive treatments for pain. This specific opportunity focuses on early steps that support analgesic discovery rather than later-stage development or clinical evaluation.
Are clinical trials allowed under this opportunity?
No. The funding opportunity explicitly states "Clinical Trial Not Allowed," meaning proposed work should remain in preclinical and discovery-enabling territory and should not include clinical studies.
What types of research activities are a good fit for this NOFO?
Activities that build the foundation for an organized discovery "testing funnel" are in scope. Examples include assay development and optimization, screening approaches to identify promising hits, and early characterization of hits and potential therapeutic agents.
What kinds of assays or test systems can be supported?
The opportunity supports creation or refinement of robust, reproducible assays and translationally relevant test systems. Examples mentioned include target engagement assays, phenotypic screening assays, and other relevant test platforms intended to support screening and early validation.
Does this program support screening campaigns?
Yes. Establishing screening workflows and quality controls and conducting screening campaigns to uncover candidate hits are described as activities that typically fit the scope.
What does "hit follow-up" or early characterization mean in this context?
It refers to initial work to understand whether screening hits have properties consistent with a viable analgesic development path. Examples provided include early selectivity assessments, basic structure-activity relationships (SAR), and preliminary mechanism-relevant validation.
What therapeutic modalities are eligible?
A range of modalities is explicitly allowed, including small molecules, biologics, and natural products.
Is this program intended to fund full preclinical development?
The description emphasizes enabling and early discovery work rather than extensive preclinical development. It focuses on assay readiness, screening, and initial hit validation rather than broad or late-stage preclinical packages.
What is the funding mechanism (R61/R33) and what does it imply for project planning?
The R61/R33 is a phased, milestone-driven NIH structure. It generally supports an initial, shorter startup or feasibility phase followed by a second phase that is contingent on meeting predefined progress criteria. Practically, projects should be planned as a stepwise program where early work de-risks later work and produces outputs that position the project for downstream translational programs.
Does the opportunity specify detailed milestones in the provided text?
No. The information provided notes that the notice text does not spell out specific milestone language, but it explains that the general intent of the mechanism is milestone-driven progress with a transition contingent on meeting criteria.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the opportunity number?
The opportunity is identified as RFA-NS-25-012.
What is the overall scientific emphasis of the NOFO?
The emphasis is on building the enabling foundation for analgesic discovery by creating a screening-ready testing funnel: robust assays, screening workflows, discovery screening, and early evidence that candidate hits could support a viable analgesic development path.
What is the award ceiling?
The listed award ceiling is $350,000.
How should applicants think about scope given the award ceiling?
The description suggests designing a focused enabling project sized to establish validated assays, run targeted screening, and generate initial hit follow-up data, rather than proposing expansive development efforts or clinical work.
When was this opportunity created?
The opportunity was created on 2024-03-26.
What is the listed closing date?
The original closing date listed is 2027-01-15, indicating a multi-year window during which applications may be accepted according to the solicitation schedule.
What types of organizations are eligible to apply?
Eligibility is broad for U.S.-based applicants and includes: state, county, and local governments; 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations (other than small businesses); and small businesses.
Are any additional eligible applicant categories highlighted?
Yes. The opportunity highlights 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; eligible federal agencies; regional organizations; and U.S. territories or possessions.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
Can a U.S. applicant include work performed outside the United States?
Potentially, yes. While non-domestic components of U.S. organizations are not eligible to apply, "foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This means a U.S. applicant may be able to include certain internationally performed elements under NIH policy even though a foreign organization cannot be the applicant.
Are non-domestic components of U.S. organizations eligible?
No. The information provided states that non-domestic components of U.S. organizations are not eligible to apply.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with multiple CFDA numbers: 93.121, 93.213, 93.273, 93.393, 93.395, 93.846, 93.847, 93.853, 93.865, 93.866, and 93.867.
Why are there multiple CFDA numbers listed?
The provided description indicates this reflects NIH's multi-institute participation in HEAL-related pain and translational science efforts.
What is the intended downstream path for successful projects?
The explicit intent is to advance projects toward the entry criteria for NIH's Pain Therapeutics Development Program by generating enabling tools, screening outputs, and early evidence around candidate analgesic agents.
What is the simplest way to describe this NOFO?
It is an on-ramp for analgesic discovery that funds the nuts-and-bolts enabling work (assays, screening, early hit validation) needed to build a credible pain therapeutics discovery program, without doing clinical trials.
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