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

The *Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01)*, funded by the Food and Drug Administration (FDA), is a discretionary grant intended to advance research in pain management, anesthesia, and addiction medicine. This program encourages projects that will develop, implement, and evaluate studies focused on several research needs within these fields, including clinical trial endpoints for chronic pain, stimulant use disorder outcomes, opioid trial assessments, neurodevelopmental outcomes for pediatric patients exposed to anesthesia or opioids, and systematic reviews of anesthetic neurotoxicity in pre-clinical studies. The cooperative agreement structure allows the FDA to actively participate in the planning and execution of awarded projects, supporting collaborative research aligned with public health needs in analgesics, anesthetics, and addiction. The program is expected to provide up to five awards, each with a fixed award amount of $2 million, as both the award ceiling and floor are set at $2 million. No cost-sharing or matching funds are required, enabling eligible organizations to fully utilize federal funding for their proposed research activities. This grant opportunity is categorized under multiple fields, including agriculture, consumer protection, food, and nutrition, reflecting the FDA’s comprehensive mandate to safeguard public health. Eligible applicants encompass a wide range of entities, including state, local, and tribal governments; public and private institutions of higher education; non-profits (with and without 501(c)(3) status); independent school districts; small businesses; and for-profit organizations other than small businesses. This broad eligibility aims to attract applicants with diverse capabilities in clinical and public health research, particularly those with the capacity to contribute valuable insights into the safe and effective use of analgesics and anesthetics and evidence-based strategies for addiction treatment. The official posting and application details will be released at a future date. Applicants are encouraged to prepare by outlining evidence-based research plans that address FDA's priorities for this cooperative agreement, including the safe prescribing of analgesics, management strategies for addiction, and assessments of anesthesia impacts on vulnerable populations. For additional information, applicants may contact Terrin Brown at the FDA via email at terrin.brown@fda.hhs.gov or by phone at (240) 402-7610. Further guidance and submission instructions will be available on Grants.gov once the opportunity is officially posted, providing applicants with specific requirements for proposal development and submission.