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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: HEAL Initiative - Translational Development of Devices to Treat Pain (RFA-EB-18-003)
What is this funding opportunity?
This opportunity is the NIH HEAL (Helping to End Addiction Long-term) Initiative Funding Opportunity Announcement (FOA) titled "Translational Development of Devices to Treat Pain" (RFA-EB-18-003). It supports preclinical work to move promising pain-treatment devices closer to first-in-human readiness.
What is the main goal of the program?
The goal is to advance device-based pain treatment technologies toward first-in-human studies by funding translational, milestone-driven preclinical development. The program emphasizes approaches that are safe, effective, and non-addictive, supporting broader HEAL priorities to reduce reliance on opioid-based pain management.
Is this opportunity for clinical research in humans?
No. The FOA is explicitly preclinical and does not allow clinical trials. Funded work should not involve testing in humans and should instead generate evidence and development progress to justify and prepare for a future first-in-human clinical study.
What kinds of technologies does the FOA focus on?
The central focus is on device-based technologies and approaches for treating pain. Projects should be aimed at producing credible preclinical evidence and completing development steps needed to make a device ready for first-in-human testing later.
How should applicants justify the device approach scientifically?
Applications are expected to build on modern mechanistic understanding of pain pathways and select credible neural targets for intervention and/or diagnostics. Proposed devices should be grounded in established anatomy and physiology of pain signaling across the central nervous system, spinal pathways, and peripheral nerves.
What does "target engagement" mean in the context of this FOA?
Based on the FOA description, projects should demonstrate that the 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.
What outcomes are relevant for preclinical studies under this FOA?
The FOA emphasizes generating meaningful preclinical evidence tied to pain-relevant outcomes, such as analgesic potential and improved function, while avoiding addictive mechanisms.
What types of activities are supported?
Supported activities include translational tasks that commonly block device concepts from reaching human testing, such as:
- Technology development and optimization (e.g., iterating device design, improving performance, robustness, usability, or manufacturability)
- Preclinical studies to establish safety and demonstrate effectiveness in appropriate experimental models
- Studies and documentation that help prepare for approvals for human use (i.e., building a technical and evidence base to support later regulatory interactions and submissions)
What development barriers is this program trying to help overcome?
The FOA highlights common post-proof-of-concept issues that can stall translation, including inconsistent target engagement, insufficient durability or reliability, unclear dose-response relationships for stimulation or sensing, biocompatibility questions, and gaps in safety testing.
Does the FOA support device optimization and manufacturability improvements?
Yes. The scope includes technology development and optimization activities such as improving performance, robustness, usability, and manufacturability as part of translational development.
Does the FOA include regulatory preparation activities?
It supports studies and documentation needed to prepare for approvals for human use. The description suggests this means building the technical and evidence base that would later underpin regulatory interactions and submissions, even though human testing itself is not allowed under this FOA.
What funding mechanism is used?
This opportunity uses a U18 cooperative agreement mechanism.
How is a U18 cooperative agreement different from a typical research grant?
In this FOA, the U18 cooperative agreement is milestone-driven and includes substantial NIH program staff participation. Applicants are expected to propose a clear, structured plan with measurable milestones, and NIH staff will work with awardees during planning and actively monitor progress over time.
What is NIH's role during the project?
NIH program staff are expected to participate substantially by working with awardees during project planning and actively monitoring progress, helping keep the effort aligned with translational goals and first-in-human readiness (without conducting the first-in-human trial under this FOA).
What kind of project plan is expected?
The FOA expects a structured project plan with clear, measurable milestones. This aligns with the cooperative agreement model and the focus on focused translational progress rather than purely exploratory research.
Who can apply?
The eligible applicant pool is broad. Examples of eligible applicants include many U.S. organizations and governments, nonprofits, for-profits, higher education institutions, small businesses, tribal governments and organizations, public housing authorities, and other entities. The FOA also highlights eligibility for a range of additional institution types and organizations.
Are small businesses eligible?
Yes. The eligibility list explicitly includes small businesses.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations (other than small businesses) as well as small businesses.
Are nonprofits eligible even if they do not have 501(c)(3) status?
Yes. The eligibility list includes nonprofits with or without 501(c)(3) status.
Are academic institutions eligible?
Yes. Eligibility includes public and state-controlled institutions of higher education and private institutions of higher education, among other institution types.
Are tribal governments and tribal organizations eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and other tribal organizations, and it also highlights Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories or possessions eligible?
Yes. The FOA highlights eligibility for U.S. territories or possessions.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The FOA highlights non-U.S. (foreign) entities as eligible applicants.
What is the sponsoring agency and opportunity category?
The sponsoring agency is the National Institutes of Health (NIH), and the opportunity category is discretionary.
What is the funding instrument?
The funding instrument is a cooperative agreement (U18).
What is the award ceiling listed for this opportunity?
The award ceiling shown in the provided source details is $500,000.
When was the opportunity posted and what is the closing date shown?
The posting was created on 2018-12-10, and the original closing date listed is 2020-04-15.
What CFDA program numbers are associated with this FOA?
The provided information lists multiple associated CFDA program numbers: 93.121, 93.213, 93.273, 93.279, 93.286, 93.350, 93.393, 93.847, 93.853, 93.865, 93.867.
What stage of development is this program aiming to fund?
The practical takeaway described 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.
Does this FOA prioritize non-addictive approaches to pain treatment?
Yes. A central emphasis is that device-based approaches should treat pain in ways that are safe, effective, and non-addictive, aligning with HEAL goals to reduce dependence on opioid-based pain management.
Does the FOA include diagnostic devices as well as interventional devices?
The description notes credible neural targets for intervention and/or diagnostics, indicating that projects may involve interventions and/or measurements tied to pain-relevant targets, as long as the work stays within preclinical scope.
What kinds of preclinical models are expected?
The FOA references "appropriate experimental models" for establishing safety and demonstrating effectiveness. Specific models are not detailed in the provided information, but the expectation is that they are suitable for supporting translational claims about target engagement and pain-relevant outcomes.
What is the overall emphasis of the cooperative agreement structure?
The cooperative agreement structure is designed to keep projects tightly aligned with translational goals, provide active project oversight, and ensure funded work stays focused on advancing a device toward first-in-human readiness rather than remaining purely exploratory.
Browse more opportunities from the same category: Education, Food and Nutrition, Health, Income Security and Social Services
Next opportunity: HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)
Previous opportunity: 2019 U.S. Embassy Lisbon Annual Program Statement
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA EB 18 003
Applicants also applied for:
Applicants who have applied for this opportunity (RFA EB 18 003) also looked into and applied for these:
| 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 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA EB 18 003", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.