HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke, in collaboration with several institutes within the National Institutes of Health, has announced a forthcoming Notice of Funding Opportunity for the HEAL Initiative: Pain Management Effectiveness Research Network. This initiative is part of the U.S. Department of Health and Human Services’ efforts to support clinical trial research addressing acute and chronic pain across a wide spectrum of diseases and conditions. The funding mechanism will use the UG3/UH3 cooperative agreement activity code, emphasizing a phased approach to both planning and implementation of multisite, large-scale clinical trials. The HEAL Initiative’s overarching purpose is to expand the evidence base for effective therapeutics that reduce opioid reliance, alleviate pain, and improve functional outcomes. This program encourages applications that evaluate existing pharmaceutical treatments, repurposed therapeutics, and medical devices, with a particular focus on real-world effectiveness. By generating rigorous clinical evidence, the program aims to improve clinical decision-making for patients and families dealing with a variety of pain conditions. Funding under this initiative is anticipated to support large, multisite studies. While no specific ceiling or floor award amounts have been released at this stage, applicants should expect funding commensurate with the scope of the proposed research. The cooperative agreement structure signals significant programmatic involvement from NIH staff, providing guidance throughout planning and implementation. This framework is intended to ensure that funded projects are both scientifically sound and aligned with the initiative’s goal of reducing the burden of pain while addressing the opioid crisis. Eligibility for this opportunity is broad, including state, county, city, and township governments; special district governments; independent school districts; public and private institutions of higher education; Native American tribal governments and organizations; public housing authorities; nonprofits both with and without IRS 501(c)(3) status; for-profit organizations including small businesses; and other eligible agencies such as faith-based or community-based organizations, U.S. territories, regional organizations, foreign institutions, and certain federal agencies. This extensive eligibility pool underscores NIH’s intention to foster collaboration across multiple sectors and disciplines. The estimated posting date for the full Notice of Funding Opportunity is October 15, 2025. Applications are expected to be due by January 5, 2026, with awards anticipated on August 31, 2026, and project starts beginning September 1, 2026. At present, there are no pre-application deadlines, and applications are not yet being solicited. This forecast has been issued to allow prospective applicants ample time to develop partnerships and responsive projects in advance of the official release. Potential applicants are encouraged to monitor Grants.gov and NIH communications for the official NOFO release and subsequent application materials. Inquiries regarding the program should be directed to Yolanda F. Vallejo, PhD, at the National Center for Advancing Translational Sciences. She may be reached by phone at 301-451-1751. No email address was provided at this time. This opportunity represents a continuation of NIH’s commitment to addressing the national pain and opioid crisis through rigorous, collaborative clinical research.