Opportunity Information: Apply for RFA NS 20 008
The HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required) is an NIH Small Business Technology Transfer (STTR) funding opportunity designed to accelerate practical, science-based solutions that can help reduce the harms associated with the national opioid crisis. The main idea is to push promising pain-management innovations out of the lab and toward real-world use by supporting small businesses working in formal collaboration with research institutions. This program is specifically framed around developing better ways to treat pain while lowering reliance on addictive opioids, and it places a strong emphasis on measurable progress toward products, clinical evidence, and eventual deployment.
The scope of projects NIH is looking for centers on improving pain treatment through both therapies and enabling technologies. A major priority area is the development of new non-addictive medications, meaning drug candidates intended to relieve pain without the addiction risks associated with traditional opioids. Alongside therapeutics, the FOA is also focused on devices and other technology-based approaches that can enhance pain management, which could include neuromodulation tools, wearable or implantable systems, digital therapeutics, or other engineered solutions that meaningfully improve how pain is treated in clinical settings. Another highlighted need is objective pain measurement, reflecting NIH interest in tools that can quantify or characterize pain more reliably than subjective self-report alone. These measurement approaches might involve biomarkers, sensor-derived signals, imaging, algorithmic assessments, or other methods that can support diagnosis, treatment decisions, patient stratification, and evaluation of treatment response.
In addition to end-product therapies and devices, the announcement signals interest in foundational development tools that make pain-therapy innovation faster and more predictive. This includes new screening tools and models designed specifically for pain research and pain-therapy development. In practice, that could mean improved in vitro assays, organoid or microphysiological systems, animal or computational models with better predictive validity, or platforms that can identify and validate targets and candidates more efficiently. The common thread is that NIH wants projects that can accelerate the pipeline for pain therapeutics and technologies, not just generate academic knowledge.
This opportunity uses the STTR phased mechanism, listed as R41/R42. In general STTR programs are structured to support early feasibility work followed by more advanced development, with Phase I (R41) typically supporting proof-of-concept and Phase II (R42) supporting further R&D, refinement, and steps toward commercialization and broader clinical adoption. The title explicitly notes “Clinical Trial Required,” which indicates that the supported project is expected to include a clinical trial component as part of the proposed work, aligning the program with translational goals and human evidence generation rather than purely preclinical development.
Eligibility is aimed at small businesses, consistent with the STTR program’s purpose of moving innovations toward commercialization through a small business working with a research partner. The NIH listing also clarifies foreign eligibility limits: non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. At the same time, “foreign components” as defined by the NIH Grants Policy Statement may be allowable in some circumstances, meaning certain discrete elements of the project might be performed abroad if they meet NIH policy requirements and are explicitly approved, but the applicant organization itself must be eligible and U.S.-based as required.
Administratively, the opportunity is run by the National Institutes of Health and is cataloged under Funding Opportunity Number RFA-NS-20-008. It is a discretionary grant program and spans multiple CFDA (assistance listing) numbers associated with NIH institutes and centers that support neuroscience, pain, and related health research. The original closing date shown is September 8, 2022, and the record does not specify an award ceiling or expected number of awards in the provided fields, which often means applicants need to consult the full FOA text for budget guidance, project period limits, and any institute-specific considerations.
Overall, this FOA is best understood as a targeted HEAL Initiative investment in practical, clinically grounded pain-management solutions: non-addictive therapeutics, enabling devices, objective measurement methods, and better screening/modeling tools, all advanced through a small business plus research institution partnership with a strong emphasis on translation and clinical trial activity.Apply for RFA NS 20 008
- 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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.233, 93.273, 93.286, 93.393, 93.394, 93.395, 93.399, 93.837, 93.838, 93.839, 93.840, 93.847, 93.853, 93.859, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2019-10-04.
- Applicants must submit their applications by 2022-09-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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FAQs: The HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required)
What is this funding opportunity?
This is an NIH Small Business Technology Transfer (STTR) funding opportunity under the HEAL Initiative focused on advancing practical, science-based pain management solutions. It is intended to help reduce harms associated with the national opioid crisis by moving promising innovations from the lab toward real-world use.
What is the official funding opportunity number (FOA number)?
The Funding Opportunity Number listed is RFA-NS-20-008.
Which agency runs this program?
The program is administered by the National Institutes of Health (NIH).
What is the overall goal of the HEAL Initiative program described here?
The goal is to accelerate pain-management therapies and technologies that can reduce reliance on addictive opioids. NIH emphasizes measurable progress toward products, clinical evidence, and eventual deployment in real-world settings.
What funding mechanism does this opportunity use?
This opportunity uses the STTR phased mechanism R41/R42. In general terms, Phase I (R41) supports early feasibility and proof-of-concept work, and Phase II (R42) supports further research and development, refinement, and steps toward commercialization and broader clinical adoption.
Is a clinical trial required under this FOA?
Yes. The title explicitly includes "Clinical Trial Required," indicating the proposed project is expected to include a clinical trial component as part of the supported work rather than being purely preclinical.
Who is the intended applicant type?
The opportunity is aimed at small businesses, consistent with the STTR program purpose of moving innovations toward commercialization through a small business working in formal collaboration with a research institution.
Does the program require collaboration with a research institution?
Yes. The STTR model described emphasizes a small business working in formal collaboration with research institutions to translate innovations toward practical use.
What kinds of projects are within scope?
NIH is looking for projects that improve pain treatment through therapies and enabling technologies, with a strong emphasis on translation, product-oriented development, and generating clinical evidence.
Are non-addictive pain medications a priority area?
Yes. A major priority area is the development of new non-addictive medications intended to relieve pain without the addiction risks associated with traditional opioids.
What types of devices or technologies are encouraged?
The scope includes devices and technology-based approaches that can enhance pain management. Examples mentioned include neuromodulation tools, wearable or implantable systems, digital therapeutics, and other engineered solutions that meaningfully improve how pain is treated in clinical settings.
Does this FOA include objective pain measurement tools?
Yes. NIH highlights a need for objective pain measurement tools that can quantify or characterize pain more reliably than subjective self-report alone. Potential approaches described include biomarkers, sensor-derived signals, imaging, algorithmic assessments, and related methods supporting diagnosis, treatment decisions, patient stratification, and evaluation of treatment response.
Are screening tools and models for pain research considered responsive?
Yes. The announcement signals interest in foundational development tools that make pain-therapy innovation faster and more predictive, including new screening tools and models designed specifically for pain research and pain-therapy development.
What examples of screening tools or models are mentioned?
Examples include improved in vitro assays, organoid or microphysiological systems, animal or computational models with better predictive validity, and platforms that can identify and validate targets and candidates more efficiently.
Is basic academic knowledge generation the main focus?
No. The common thread described is acceleration of the pipeline for pain therapeutics and technologies, not simply generating academic knowledge. NIH emphasizes practical development, measurable progress, and movement toward products and deployment.
Are foreign organizations eligible to apply?
No. The NIH listing notes that non-U.S. entities (foreign institutions) are not eligible to apply.
Can non-U.S. components of U.S. organizations apply?
No. The listing states that non-U.S. components of U.S. organizations are not eligible to apply.
Are any foreign components allowed at all?
Possibly. The information provided notes that "foreign components" (as defined by the NIH Grants Policy Statement) may be allowable in some circumstances. This suggests discrete elements of a project might be performed abroad if they meet NIH policy requirements and are explicitly approved, while the applicant organization itself must remain eligible and U.S.-based as required.
Is this a discretionary grant program?
Yes. The opportunity is described as a discretionary grant program.
Does the listing provide an award ceiling or number of expected awards?
No. The provided record fields do not specify an award ceiling or an expected number of awards.
What does the listing say about the closing date?
The original closing date shown is September 8, 2022.
Does this opportunity relate to multiple NIH assistance listing (CFDA) numbers?
Yes. The listing indicates it spans multiple CFDA (assistance listing) numbers associated with NIH institutes and centers that support neuroscience, pain, and related health research.
What is the practical takeaway for applicants designing a project?
Based on the description, NIH is looking for small business-led, research-institution partnered projects that translate pain-management innovations toward real-world use, prioritize non-addictive pain treatments and enabling technologies, include objective measurement where relevant, and incorporate a clinical trial component aligned with generating human evidence.
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| Funding Opportunity |
|---|
| 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 |
| Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed) Apply for RFA TR 23 011 Funding Number: RFA TR 23 011 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 23 028 Funding Number: RFA NS 23 028 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| HEAL Initiative: HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain: Acute Pain Clinical Trials Program (U01 Clinical Trial Required) Apply for RFA HD 24 011 Funding Number: RFA HD 24 011 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 24 019 Funding Number: RFA NS 24 019 Agency: National Institutes of Health Category: Education, Food and Nutrition, Health, Income Security and Social Services Funding Amount: Case Dependent |
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