Opportunity Information: Apply for RFA NS 19 016
The HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional), Funding Opportunity Number RFA-NS-19-016, is an NIH cooperative agreement designed to push promising pain-related medical devices across the gap between early development and initial human testing. The central goal is to support innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that can improve pain outcomes while reducing, replacing, or eliminating the need for opioid prescribing. In practical terms, NIH is looking for projects that are far enough along to move into serious translational work and, when appropriate, into a small, carefully scoped clinical study that helps finalize device function and design decisions.
The work supported by this program is explicitly translational and is meant to cover key steps that typically stand between a lab-stage concept and a first meaningful clinical evaluation. Funded activities can include building or implementing a clinical prototype, running non-clinical safety and efficacy testing, and completing design verification and validation work that is needed to show the device performs as intended. The FOA also supports the regulatory and ethics groundwork required to initiate human research, including obtaining an Investigational Device Exemption (IDE) from FDA for Significant Risk (SR) studies or obtaining Institutional Review Board (IRB) approval for Non-Significant Risk (NSR) studies. After those steps, the program can support a subsequent small clinical trial, such as an Early Feasibility Study, intended to generate data that cannot reasonably be obtained through additional bench testing or animal studies because the device or intended use is too novel or the relevant questions require human interaction and real-world use conditions.
A defining feature of this funding mechanism is that it is milestone-driven and uses a cooperative agreement structure (UG3/UH3), meaning NIH program staff are expected to be actively involved rather than operating purely in a hands-off grantmaking role. Applicants should expect NIH to participate in shaping the project plan, setting or refining milestones, and monitoring progress against those milestones over time. This structure is meant to keep projects tightly focused on deliverables that enable clinical translation, regulatory readiness, and credible early clinical evidence, rather than open-ended exploratory research.
The FOA also emphasizes that applicants may be able to leverage existing public-private partnership resources tied to NIH initiatives, including partnerships that originated under the NIH BRAIN Initiative, the Common Fund SPARC program (Stimulating Peripheral Activity to Relieve Conditions), and the broader HEAL Initiative. A practical advantage highlighted in the announcement is that some device manufacturers have Memoranda of Understanding (MOUs) with NIH programs, potentially allowing investigators to access devices, components, or specialized capabilities that may not yet be market approved but are appropriate for clinical research. The expectation is that, for many of these devices, existing safety and utility data may already be sufficient to support an IRB NSR determination or an FDA IDE submission without requiring extensive new non-clinical testing, helping shorten the path to first-in-human or early feasibility work.
Eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and certain tribal governments that are not federally recognized. At the same time, it draws a firm boundary around foreign participation: non-U.S. (non-domestic) entities and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components are allowed as defined by the NIH Grants Policy Statement.
Administratively, the opportunity is issued by the National Institutes of Health and classified as a discretionary funding opportunity using the cooperative agreement instrument. It is associated with multiple CFDA numbers (including 93.121, 93.213, 93.242, 93.273, 93.279, 93.286, 93.313, 93.350, 93.361, 93.393, 93.846, 93.847, 93.853, 93.865, 93.867). The original posting date in the provided source data is 2018-12-10, and the original closing date listed is 2020-04-15. Overall, the program is best understood as a structured, NIH-partnered push to move non-opioid pain device solutions through prototype finalization, safety/regulatory readiness, and an initial human study that answers design-defining questions that non-clinical testing cannot.Apply for RFA NS 19 016
- 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: Translational Devices 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, 93.242, 93.273, 93.279, 93.286, 93.313, 93.350, 93.361, 93.393, 93.846, 93.847, 93.853, 93.865, 93.867.
- This funding opportunity was created on 2018-12-10.
- Applicants must submit their applications by 2020-04-15. (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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Previous opportunity: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
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| Funding Opportunity |
|---|
| 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 |
| Small Grants to Enhance the Use of the All of Us Research Programs Data (R03 Clinical Trial Not Allowed) Apply for RFA PM 23 002 Funding Number: RFA PM 23 002 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH Science Education Partnership Award (SEPA) (R25 - Clinical Trial Not Allowed) Apply for PAR 23 137 Funding Number: PAR 23 137 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $250,000 |
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