Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed

The Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services, is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed." This initiative supports research aligned with FDA’s mission to protect public health by assuring the safety and efficacy of drugs. The program is situated within the FDA's broader efforts to address public health challenges related to pain management, anesthesia safety, and addiction treatment. This grant opportunity seeks to fund research that develops, implements, and evaluates interventions and methodologies in the fields of anesthesiology, addiction medicine, and pain medicine. Specifically, the grant supports activities such as evaluating function as a clinical trial endpoint in chronic pain patients, identifying outcome measures for stimulant use disorder trials, and assessing clinical trial designs using active control and placebo for opioid studies. Additional priorities include studying neurodevelopmental outcomes in pediatric patients exposed to anesthetics and opioids, and conducting a living systematic review of pre-clinical studies on anesthetic neurotoxicity. Eligible applicants include a broad array of public and private entities, including nonprofits (with or without 501(c)(3) status), state and local governments, tribal organizations, educational institutions, and certain for-profit organizations. The funding instrument for this opportunity is a cooperative agreement, indicating substantial federal involvement in the funded projects. Award amounts are fixed at $2 million, with up to five awards anticipated. There are no cost-sharing or matching requirements. Applicants must submit a comprehensive, evidence-based research plan that aligns with the outlined priorities and supports appropriate prescribing practices for analgesics, anesthetics, and treatments for substance use disorders. Although application materials are not yet released, applicants should expect a submission via Grants.gov, following standard federal grant submission protocols. Specific components, evaluation criteria, and deadlines will be announced upon the official posting of the Notice of Funding Opportunity. The forecasted announcement date is August 14, 2024, for Fiscal Year 2025 funding. Award dates and project start timelines are yet to be finalized. Interested applicants may contact Terrin Brown at 240-402-7610 or via email at [email protected] for additional information. Given the high-priority research areas involved, this opportunity is expected to attract institutions with expertise in clinical trials, pain management, addiction studies, and pediatric anesthesiology.