HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 Clinical Trial Optional) | RFA NS 23 003

Opportunity Information: Apply for RFA NS 23 003

The HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity (RFA-NS-23-003) created under the NIH HEAL (Helping to End Addiction Long-term) Initiative. It targets a major public health problem: more than 25 million Americans experience daily chronic pain, and for years the healthcare system leaned too heavily on opioids despite limited long-term functional benefit and a high risk of misuse and addiction. That pattern helped fuel the opioid overdose and addiction crisis, and the FOA is positioned as part of NIH's broader strategy to accelerate non-opioid, low-addiction-risk approaches to pain management.

The core purpose of the FOA is to support interdisciplinary, team-based research aimed at uncovering how pain-relieving medical devices actually work, with an emphasis on optimizing outcomes for technologies that are already FDA-approved or FDA-cleared. In other words, the program is not simply asking whether a device reduces pain; it is pushing applicants to dig into the underlying mechanisms of action, using rigorous experimental and analytical approaches that can explain why, how, for whom, and under what conditions a device produces pain relief. The expectation is that a better mechanistic understanding will translate into more effective device use in real-world settings, improved therapeutic protocols, and clearer pathways for refinement or next-generation improvements, all while reducing reliance on opioid therapies.

This opportunity uses the RM1 mechanism, which is designed to support high-impact, integrated team science. Applications are expected to be led by multiple program directors/principal investigators (PDs/PIs), reflecting the program's emphasis on collaborative synergy rather than loosely connected projects. NIH signals that funded teams should be able to accomplish goals that genuinely require close coordination across disciplines, including shared conceptual frameworks, joint experimental designs, and integrated interpretation of results. The FOA also encourages teams to develop new principles and methods for experimentation, analysis, and interpretation, suggesting a preference for projects that do more than apply standard tools and instead move the field forward in how device-based pain relief is studied and understood.

While the FOA is focused on mechanisms, it is labeled "Clinical Trial Optional," meaning applicants may propose clinical trials if they are justified by the research aims, but a clinical trial is not required. This flexibility allows teams to build a mechanistic narrative using preclinical models, human studies, computational approaches, or hybrid translational pipelines, depending on what best answers the central questions about device-mediated analgesia. The overall tone of the announcement favors ambitious objectives that can drive major advances in the science of pain relief by medical devices, rather than incremental or narrowly scoped efforts.

Eligibility is broad and includes many types of domestic organizations and governmental units. Eligible applicants include 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) status (as long as they are not institutions of higher education in those specific categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights several categories of organizations as eligible, such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly limits non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions cannot apply as the primary applicant, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means certain discrete parts of a project can be conducted abroad when well-justified and compliant with NIH policy.

Administratively, the announcement is categorized as a discretionary grant opportunity from NIH, with an original closing date of April 27, 2023, and a creation date of August 1, 2022. It is associated with multiple CFDA listings (93.121, 93.213, 93.273, 93.279, 93.393, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867), reflecting that HEAL-related pain research spans several NIH institutes and program areas. The public description does not specify an award ceiling or the expected number of awards in the provided source data, but the RM1 mechanism and the emphasis on integrated team science generally imply substantial, multi-component projects designed to produce field-shaping outputs.

In practical terms, the FOA is a call for multi-PI teams that can combine expertise such as pain neurobiology, bioengineering, neuromodulation, clinical pain medicine, computational modeling, imaging, biomarker discovery, data science, and advanced statistics to explain device-driven pain relief at a mechanistic level. The end goal is to strengthen the scientific foundations behind FDA-cleared or approved pain devices so they can be used more precisely and effectively, ultimately expanding credible non-opioid pain treatment options and helping reduce addiction-related harms tied to opioid exposure.

• 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: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices (RM1 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, 93.273, 93.279, 93.393, 93.846, 93.847, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2022-08-01.
• Applicants must submit their applications by 2023-04-27. (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.

Apply for RFA NS 23 003

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