Opportunity Information: Apply for RFA NS 21 010
Apply for RFA NS 21 010
- 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: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)" 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, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2020-09-16.
- Applicants must submit their applications by 2023-11-02. (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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Opportunity Summary:
The HEAL Initiative funding opportunity titled "Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)" (RFA-NS-21-010) is a National Institutes of Health (NIH) cooperative agreement designed to push promising non-opioid pain treatment candidates closer to the clinic. It is a reissue of an earlier announcement (RFA-NS-20-010) and sits within the broader HEAL (Helping to End Addiction Long-term) Initiative, which prioritizes the development of effective pain therapies that do not carry the addiction risks associated with opioids. In practical terms, the program is meant for teams that already have a credible therapeutic starting point and now need resources and structured support to turn that starting point into an IND-ready drug development package.
The scientific focus is on preclinical optimization and early development of both small molecule drugs and biologic therapeutics intended to treat pain, with a clear emphasis on safety, efficacy, and non-addictive potential. The FOA is not meant for very early discovery where a target is still speculative or where there is no tangible therapeutic candidate. Instead, applicants are expected to come in with a promising hit or lead, a robust biological rationale explaining why their mechanism should meaningfully address pain, and assays that can be used to optimize the agent (for example, screening and functional assays that allow structure-activity relationship work for small molecules or potency and binding assays for biologics). The overall goal is acceleration: taking something that looks real and scientifically grounded and moving it efficiently toward clinical testing readiness.
The development work supported under this announcement spans key translational steps that often stall academic or early-stage industry programs. This includes optimization and early development activities (such as improving potency, selectivity, stability, formulation feasibility, and other drug-like properties), IND-enabling studies (typically the regulated or regulation-aligned preclinical studies required before a first-in-human trial, such as certain toxicology, safety pharmacology, and pharmacokinetic work), and the assembly of an Investigational New Drug (IND) application package. While the FOA notes "clinical trial optional," the core intent is to reach the threshold where a clinical trial can be initiated, meaning the funded work is heavily oriented around what is needed to persuade regulators and sponsors that a candidate is sufficiently characterized and safe to enter human testing.
The award mechanism is UG3/UH3, which is a milestone-driven, phased cooperative agreement. In general, this structure is used when NIH wants projects to move through a defined set of go/no-go decision points. The UG3 phase typically supports earlier, preparatory, or optimization work, while the UH3 phase supports the later-stage activities contingent on meeting pre-specified milestones. A defining feature here is that it is a cooperative agreement rather than a standard grant, meaning NIH program staff are expected to be actively involved. That involvement includes participating in the development of the overall project plan, shaping and agreeing upon milestones, and monitoring progress as the project advances. This is intended to keep projects aligned with a practical product development pathway and to ensure that funded work remains tied to deliverables that matter for translation rather than open-ended experimentation.
Eligibility is broad and intentionally inclusive, covering many types of U.S. and non-U.S. entities. The announcement lists typical eligible applicants such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. In addition, the FOA explicitly highlights other eligible applicants, 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations. This breadth signals NIH interest in drawing from a wide innovation base, including academic labs, biotech, public-private partnerships, and organizations serving historically under-resourced communities.
From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument type. The agency is NIH, and the opportunity number is RFA-NS-21-010. The source data lists multiple CFDA numbers (93.121, 93.213, 93.273, 93.279, 93.313, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867), reflecting that the initiative can involve multiple NIH institutes/centers or program lines. The original closing date shown is 2023-11-02, and the record creation date is 2020-09-16. The award ceiling and expected number of awards are not specified in the provided listing, which is common in some NIH FOAs where budgets depend on project scope, negotiated milestones, and available appropriations.
Overall, this FOA is best understood as a structured translational bridge between having an early therapeutic candidate and being ready to file an IND, with NIH acting as an engaged partner through a milestone-based cooperative model. It is aimed at accelerating credible non-addictive analgesic candidates, de-risking the path to first-in-human studies, and strengthening the national pipeline for safer pain treatments under the HEAL Initiative.
Frequently Asked Questions (FAQs)
1) What is the title and opportunity number of this funding opportunity?
The funding opportunity is titled "Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)" and the opportunity number is RFA-NS-21-010.
2) Which federal agency is offering this opportunity?
The agency is the National Institutes of Health (NIH).
3) What larger program or initiative is this opportunity part of?
This opportunity is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative, which prioritizes development of effective pain therapies that do not carry the addiction risks associated with opioids.
4) What is the main purpose of this FOA?
The main purpose is to accelerate promising non-opioid pain treatment candidates toward the clinic by supporting preclinical optimization, IND-enabling studies, and assembly of an IND application package so a program can reach clinical testing readiness.
5) What types of therapeutics are supported under this FOA?
The FOA supports development of both small molecule drugs and biologic therapeutics intended to treat pain, with an emphasis on safety, efficacy, and non-addictive potential.
6) Is this FOA intended for early discovery projects (for example, speculative targets)?
No. This FOA is not intended for very early discovery where a target is still speculative or where there is no tangible therapeutic candidate. Applicants are expected to already have a credible therapeutic starting point (such as a promising hit or lead) and a robust biological rationale.
7) What kinds of starting data or capabilities are applicants expected to have?
Applicants are expected to have a promising hit or lead, a strong biological rationale for why the mechanism should meaningfully address pain, and assays suitable for optimization. Examples mentioned include screening and functional assays that allow structure-activity relationship work for small molecules, or potency and binding assays for biologics.
8) What development activities does the FOA support?
The FOA supports key translational steps including optimization and early development activities (such as improving potency, selectivity, stability, formulation feasibility, and other drug-like properties), IND-enabling studies (such as certain toxicology, safety pharmacology, and pharmacokinetic work), and preparing an Investigational New Drug (IND) application package.
9) What does "IND-enabling" mean in the context of this FOA?
In this context, "IND-enabling" refers to regulated or regulation-aligned preclinical studies typically required before a first-in-human trial, including certain toxicology, safety pharmacology, and pharmacokinetic work.
10) What does "Clinical Trial Optional" mean here?
The FOA states "clinical trial optional," but the core intent is to reach the threshold where a clinical trial can be initiated. The funded work is heavily oriented around the development package needed to support clinical testing readiness.
11) What award mechanism is used (UG3/UH3), and what does it imply?
The award mechanism is UG3/UH3, a milestone-driven, phased cooperative agreement. The UG3 phase typically supports earlier preparatory or optimization work, and the UH3 phase supports later-stage activities that proceed only if pre-specified milestones are met.
12) What does it mean that this is a cooperative agreement rather than a standard grant?
As a cooperative agreement, NIH program staff are expected to be actively involved. Their involvement includes participating in development of the overall project plan, shaping and agreeing upon milestones, and monitoring progress to keep the project aligned with practical product development deliverables.
13) Are there go/no-go decision points?
Yes. The UG3/UH3 structure is designed around defined milestones that function as go/no-go decision points for moving from the UG3 phase into the UH3 phase.
14) Who is eligible to apply?
Eligibility is broad and includes many U.S. and non-U.S. entities. Examples listed include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses.
15) Are foreign (non-U.S.) organizations eligible?
Yes. The FOA explicitly includes foreign (non-U.S.) organizations among eligible applicants.
16) Does the FOA encourage participation by specific types of institutions and organizations?
Yes. The FOA highlights additional eligible applicants including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
17) What is the funding instrument type and funding category?
The opportunity is categorized as discretionary funding and uses the cooperative agreement instrument type.
18) Is this FOA a new opportunity or related to an earlier one?
It is described as a reissue of an earlier announcement, RFA-NS-20-010.
19) Are the award ceiling and expected number of awards provided?
No. The award ceiling and expected number of awards are not specified in the provided listing.
20) What is the closing date shown in the provided record?
The original closing date shown is 2023-11-02.
21) What is the record creation date shown in the provided record?
The record creation date is 2020-09-16.
22) What CFDA numbers are associated with this opportunity?
The source data lists multiple CFDA numbers: 93.121, 93.213, 93.273, 93.279, 93.313, 93.846, 93.847, 93.853, 93.865, 93.866, and 93.867.
23) Why are multiple CFDA numbers listed?
The listing notes that multiple CFDA numbers can reflect that the initiative may involve multiple NIH institutes/centers or program lines.
24) What kind of projects fit best with this FOA?
Projects that fit best are those with a credible non-addictive analgesic candidate and a realistic, deliverable-driven plan to optimize the agent, complete IND-enabling work, and assemble an IND-ready package under a milestone-based cooperative model with NIH involvement.
25) What is the overall impact this FOA is trying to achieve?
The FOA aims to strengthen the national pipeline for safer pain treatments by accelerating credible non-opioid analgesic candidates, de-risking the path to first-in-human studies, and moving programs efficiently toward clinical testing readiness under the HEAL Initiative.
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