Opportunity Information: Apply for RFA EB 18 003
The HEAL Initiative: Translational Development of Devices to Treat Pain (RFA-EB-18-003) is a National Institutes of Health (NIH) funding opportunity that supports preclinical work aimed at moving promising pain-treatment devices closer to first-in-human readiness. The central focus is on device-based technologies and approaches that can treat pain in ways that are safe, effective, and non-addictive, aligning with the broader HEAL (Helping to End Addiction Long-term) Initiative emphasis on reducing reliance on opioid-based pain management. This FOA is explicitly preclinical and does not allow clinical trials, meaning the funded work should not involve testing in humans, but should instead generate the evidence and development progress needed to justify and prepare for a future first-in-human clinical study.
A key theme of this program is the expectation that applicants build on modern mechanistic understanding of pain pathways and select credible neural targets for intervention and/or diagnostics. In practice, this means proposed devices should be grounded in what is known about the anatomy and physiology of pain signaling across the central nervous system, spinal pathways, and peripheral nerves. Projects are intended to demonstrate that a device can engage or measure a biologically plausible target relevant to pain, and that this engagement translates into meaningful preclinical evidence of analgesic potential, improved function, or other relevant outcomes, while avoiding addictive mechanisms.
The scope covers the kinds of translational tasks that commonly block promising device concepts from reaching human testing. Supported activities can include technology development and optimization (for example, iterating device design, improving performance, robustness, usability, or manufacturability) and conducting preclinical studies that establish safety and demonstrate effectiveness in appropriate experimental models. The program also supports studies and documentation needed to prepare for approvals for human use, which generally implies building the technical and evidence base that would later underpin regulatory interactions and submissions. The emphasis is on overcoming the specific challenges that tend to emerge after initial proof-of-concept, such as inconsistent target engagement, insufficient durability or reliability, unclear dose-response relationships for stimulation or sensing, biocompatibility questions, or gaps in safety testing.
This opportunity uses a U18 cooperative agreement mechanism, which is distinct from a typical research grant because it is milestone-driven and involves substantial NIH program staff participation. Applicants are expected to propose a clear, structured project plan with measurable milestones, and NIH staff will work with awardees during project planning and will actively monitor progress over time. The cooperative agreement structure is designed to keep projects tightly aligned with translational goals, support active project oversight, and ensure that funded work stays focused on advancing a device toward first-in-human readiness rather than remaining purely exploratory.
The eligible applicant pool is broad and includes many types of U.S. organizations and governments, such as state, county, city, township, and 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA also highlights additional 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 non-U.S. (foreign) entities.
From the source details provided, the sponsoring agency is NIH, the opportunity category is discretionary, and the funding instrument is a cooperative agreement. The activity category spans areas including health (and other related public service domains), and multiple CFDA program numbers are associated with it (93.121, 93.213, 93.273, 93.279, 93.286, 93.350, 93.393, 93.847, 93.853, 93.865, 93.867). The posting was created on 2018-12-10, and the original closing date listed is 2020-04-15. The award ceiling shown is $500,000. The practical takeaway is that NIH is looking to invest in device projects that have already cleared early proof-of-concept hurdles and now need focused, milestone-based preclinical development to become credible candidates for first-in-human trials, without conducting those clinical trials under this particular FOA.Apply for RFA EB 18 003
- 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 Development of Devices to Treat Pain (U18 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, 93.286, 93.350, 93.393, 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.)
- Each selected applicant is eligible to receive up to $500,000.00 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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Previous opportunity: 2019 U.S. Embassy Lisbon Annual Program Statement
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| Funding Opportunity |
|---|
| 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 |
| 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 |
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