Opportunity Information: Apply for RFA NS 19 010
The NIH funding opportunity titled "Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)" (RFA-NS-19-010) is designed to move promising, non-addictive pain-treatment candidates through the critical preclinical stages that come before human testing. It focuses specifically on therapeutics that are either small molecules or biologics, with the central aim of producing safer and more effective pain treatments that do not carry the addictive risks associated with many existing analgesics. The program is meant to accelerate the transition from an early "hit" or "lead" into a development-ready candidate positioned to enter clinical trials later, even though this particular award does not allow clinical trials as part of the funded work.
A key requirement is that applicants cannot be starting from scratch. To be competitive, a project needs to already have a credible hit or lead compound or biologic, along with a strong biological rationale explaining why the target or mechanism should affect pain in a meaningful way. In addition, applicants need to have assays in hand that can be used to optimize the agent. In practice, that means the FOA is supporting teams that are ready to do serious medicinal chemistry or biologic engineering and iterate based on data, rather than teams still looking for an initial starting point or trying to validate a vague hypothesis.
The work supported under this FOA spans the main steps of preclinical optimization and early development. That includes improving the therapeutic candidate itself (for example, potency, selectivity, stability, formulation, manufacturability, and overall developability), generating the types of data typically needed before approaching the FDA, and conducting IND-enabling studies. The announcement also explicitly includes assembling the Investigational New Drug (IND) application package, which is a major milestone in translational drug development because it brings together pharmacology, toxicology, manufacturing, and quality information in a form suitable for regulatory review. The overall framing is pragmatic: it is not simply funding basic research about pain pathways, but rather development-oriented work intended to de-risk a candidate and push it toward a clinical entry point.
The award mechanism is a phased, milestone-driven cooperative agreement using the UG3/UH3 structure. The UG3 phase is generally used for early, gated activities where the project must meet predefined milestones to justify moving forward. If those milestones are met, the project can transition into the UH3 phase, which supports the next set of development activities. Because it is a cooperative agreement rather than a standard grant, NIH program staff are expected to be actively involved. That involvement typically includes helping shape the project plan, agreeing on clear go/no-go milestones, and monitoring progress over time. The intent is to keep projects tightly focused on deliverables that matter for translation and to ensure that weak or unproductive development paths are identified early.
Eligibility is broad and includes many types of organizations. Applicants can include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and eligible federal agencies. Tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments) are eligible, as are public housing authorities and Indian housing authorities. The FOA also allows nonprofits (both with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. In addition, the opportunity explicitly highlights eligibility for a range of mission-serving and community-based institution types, including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an interest in drawing strong translational proposals from diverse institutional settings, as long as the project is development-ready and aligned with the non-addictive pain therapy goal.
Administratively, the opportunity is offered by the National Institutes of Health as a discretionary cooperative agreement program. The original posting date in the source data is November 5, 2018, with an original closing date of June 4, 2019. Multiple CFDA numbers are associated with the announcement (93.121, 93.213, 93.273, 93.279, 93.313, 93.393, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867), reflecting NIH’s involvement across several institutes or funding components tied to pain research and translational development. While the listing includes an "Award Ceiling" field, it does not provide a specific ceiling amount in the provided source text, and the number of expected awards is not specified there either.
Overall, this FOA is best understood as a translational bridge for non-addictive pain therapeutics: it supports the disciplined optimization and preclinical development work needed to turn a plausible lead into an IND-ready package, using a structured, milestone-based approach with active NIH engagement, and it stops short of funding actual clinical trials.Apply for RFA NS 19 010
- 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 "Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 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, 93.279, 93.313, 93.393, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2018-11-05.
- Applicants must submit their applications by 2019-06-04. (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 NIH funding opportunity RFA-NS-19-010 about?
RFA-NS-19-010, titled "Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)," supports development-oriented preclinical work to move a promising non-addictive pain therapeutic from an early hit/lead stage toward a development-ready candidate. The goal is to produce safer, effective pain treatments that avoid the addictive risks linked to many existing analgesics.
What kinds of therapeutics does this opportunity support?
The opportunity focuses specifically on therapeutics that are either small molecules or biologics intended to treat pain, with an emphasis on non-addictive approaches.
Are clinical trials allowed under this award?
No. Clinical trials are not allowed as part of the funded work under this FOA. The program is positioned to support the preclinical stages that come before human testing, with the intention of preparing a candidate to enter clinical trials later (outside the scope of this award).
What stage should a project be at to be competitive?
Projects should not be starting from scratch. To be competitive, applicants should already have a credible hit or lead small molecule or biologic and a strong biological rationale for why the target or mechanism meaningfully impacts pain. Applicants are also expected to already have assays that can be used to optimize the agent.
Does the FOA support basic pain pathway research?
The FOA is framed as pragmatic, development-oriented work rather than basic research. It is intended to de-risk a therapeutic candidate and advance it toward a clinical entry point, not simply to study pain biology without a clear translational plan.
What types of preclinical work are supported?
Supported activities span major steps of preclinical optimization and early development, including improving the candidate (for example potency, selectivity, stability, formulation, manufacturability, and overall developability), generating data typically needed before approaching the FDA, and conducting IND-enabling studies.
Does this FOA include support for assembling an IND application?
Yes. The announcement explicitly includes assembling the Investigational New Drug (IND) application package, which integrates pharmacology, toxicology, manufacturing, and quality information suitable for regulatory review.
What does "UG3/UH3" mean in this program?
This opportunity uses a phased, milestone-driven UG3/UH3 cooperative agreement structure. The UG3 phase supports early, gated activities and requires meeting predefined milestones. If those milestones are achieved, the project can transition to the UH3 phase for the next set of development activities.
What does "milestone-driven" mean here?
Milestone-driven means the project is expected to operate against clear, predefined deliverables and go/no-go decision points. Progress toward those milestones is used to determine whether the project should continue and, where applicable, whether it can move from the UG3 phase into the UH3 phase.
What is a cooperative agreement, and how is it different from a standard grant?
This FOA uses a cooperative agreement mechanism, which typically involves active participation by NIH program staff. In this context, NIH staff are expected to help shape the project plan, agree on milestones, and monitor progress to keep the work focused on translational deliverables and to identify weak development paths early.
Is NIH program staff involvement expected during the project?
Yes. Because this is a cooperative agreement, NIH program staff are expected to be actively involved in planning, milestone setting, and ongoing monitoring.
What is the central goal of the program?
The central goal is to accelerate the transition of a promising non-addictive pain therapeutic from a hit/lead into a development-ready candidate positioned to enter clinical trials later, by funding optimization, preclinical development, and IND-enabling work (without conducting clinical trials under this award).
Who is eligible to apply?
Eligibility is broad. Eligible applicants include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; eligible federal agencies; tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofits (with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are mission-serving and community-based institutions eligible?
Yes. The FOA explicitly highlights eligibility for HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. The opportunity explicitly includes non-U.S. entities (foreign organizations) as eligible applicants.
Which agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH) as a discretionary cooperative agreement program.
What are the original posting and closing dates listed for this opportunity?
The original posting date shown in the provided information is November 5, 2018, and the original closing date is June 4, 2019.
Is an award ceiling provided in the information given?
An "Award Ceiling" field is mentioned, but no specific ceiling amount is provided in the source text included here.
Is the number of expected awards specified?
No. The number of expected awards is not specified in the provided information.
What CFDA numbers are associated with this FOA?
The provided information lists multiple CFDA numbers: 93.121, 93.213, 93.273, 93.279, 93.313, 93.393, 93.846, 93.847, 93.853, 93.865, 93.866, and 93.867.
What is meant by "optimization" in the context of this FOA?
"Optimization" refers to iterative improvement of a small molecule or biologic using existing assays to refine properties that matter for development readiness, such as potency, selectivity, stability, formulation, manufacturability, and overall developability.
What does it mean that applicants must not be "starting from scratch"?
It means the application should be built around an existing credible hit or lead therapeutic candidate, supported by a strong biological rationale and accompanied by assays that can guide optimization. The FOA is not intended for projects that still need to find an initial starting point or are only at the stage of exploring a broad hypothesis.
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|---|
| HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed) Apply for RFA EB 18 003 Funding Number: RFA EB 18 003 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $500,000 |
| HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional) Apply for RFA NS 19 016 Funding Number: RFA NS 19 016 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed) Apply for RFA NS 19 020 Funding Number: RFA NS 19 020 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional) Apply for RFA NS 19 017 Funding Number: RFA NS 19 017 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| Administrative Supplement for Research on Bioethical Issues Apply for PA 19 217 Funding Number: PA 19 217 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required) Apply for RFA NS 20 008 Funding Number: RFA NS 20 008 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required) Apply for RFA NS 20 010 Funding Number: RFA NS 20 010 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Developmental Centers for AIDS Research (P30 Clinical Trial Not Allowed) Apply for PAR 20 107 Funding Number: PAR 20 107 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Centers for AIDS Research (P30 Clinical Trial Not Allowed) Apply for PAR 20 106 Funding Number: PAR 20 106 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) Apply for RFA NS 21 010 Funding Number: RFA NS 21 010 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Time-Sensitive Obesity Policy and Program Evaluation (R01 Clinical Trial Not Allowed) Apply for PAR 21 305 Funding Number: PAR 21 305 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed) Apply for RFA NS 22 034 Funding Number: RFA NS 22 034 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed) Apply for RFA TR 22 013 Funding Number: RFA TR 22 013 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes and Cells (U19 Clinical Trial Not Allowed) Apply for RFA NS 22 018 Funding Number: RFA NS 22 018 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 Clinical Trial Optional) Apply for RFA NS 23 003 Funding Number: RFA NS 23 003 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Development and Validation of Non-Rodent Mammalian Models of Pain(R01 Clinical Trial Not Allowed) Apply for RFA NS 22 070 Funding Number: RFA NS 22 070 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $750,000 |
| Catalyst Award for Early-Stage Investigators (ESIs) Pursuing Research on HIV Comorbidities, Coinfections, and Complications (DP1- Clinical Trial Optional) Apply for PAR 23 024 Funding Number: PAR 23 024 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $350,000 |
| Advanced Training in Artificial Intelligence for Precision Nutrition Science Research (AIPrN) Institutional Research Training Programs (T32) Apply for RFA OD 22 027 Funding Number: RFA OD 22 027 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Short Courses on Innovative Methodologies and Approaches in the Behavioral and Social Sciences (R25 Independent Clinical Trial Not Allowed) Apply for RFA OD 23 003 Funding Number: RFA OD 23 003 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $200,000 |
| Enhancing the Use of the All of Us Research Programs Data (R21 Clinical Trial Not Allowed) Apply for RFA PM 23 001 Funding Number: RFA PM 23 001 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
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