This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PDs/PIs to investigate the mechanism of action of pain relief by medical devices with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, U.S. Virgin Islands, Guam, American Samoa, Commonwealth of the Northern Mariana Islands
Type of Grant: Grant
Deadline: 06/09/2025
Details:
More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance in the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative pain treatment options are thus critically needed.
Through targeted research efforts, the NIH HEAL Initiative aims to support the development of safe and effective devices to treat pain with little or no addiction liability. This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PD/PIs to investigate the mechanism of action of pain relief by medical devices with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies. Program teams are expected to accomplish goals that require considerable synergy and collaborative interactions. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider objectives that will produce major advances in the field of pain relief by medical devices.
Program Approach and Scope
To accomplish these goals, applications are being solicited from interdisciplinary teams to utilize multi-faceted approaches to discovering the mechanisms of pain relief by medical devices for FDA-approved or -cleared therapies. Device technologies within scope of this FOA only include medical devices for pain that have already received FDA Premarket Approval (PMA) or FDA Premarket Notification 510(k). Devices that are exempt from Premarket Notification 510(k) are not within scope of this FOA. Projects should also propose/investigate methods for implementing new or optimized therapeutic procedures that have a high likelihood of improving the standard of care.
For applications proposing a clinical trial, note the following definitions and restrictions for this funding announcement:
- Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The following types of clinical trials are considered to be in scope of this funding announcement:
- Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., how an intervention works, but not if it works or is safe).
- Basic Experimental Studies with Humans (BESH). Basic experimental studies involving humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial
- Clinical trials designed primarily to determine the safety, tolerability, and/or clinical efficacy of an intervention will not be supported under this FOA.
- To determine whether your human subjects research study meets the NIH definition of a clinical trial, and for further clarification on how NIH defines the different types of clinical trials, please refer to the following resources:
- NOT-OD-15-015: Notice of Revised NIH Definition of “Clinical Trial”
- NIH’s Definition of a Clinical Trial
- Decision Tree for NIH Clinical Trial Definition
- NIH Definition of Clinical Trial Case Studies.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
