[Food and Drug Administration](https://www.fda.gov/)

Forecasted (Estimated FY25; official due date not yet posted)

Up to $2,000,000 per award; multiple awards anticipated

Supports clinical trials and research to advance pain management, addiction treatment, anesthesia safety, and evidence-based drug prescribing.

Clinical trials are allowed; opportunity is currently forecasted, not yet open.

--- ## Description This cooperative agreement from the Food and Drug Administration (FDA) aims to support research and clinical trials in the fields of analgesics, anesthetics, and addiction medicine. The program seeks to develop, disseminate, implement, and evaluate research that advances the safe and effective use of drug products for pain management, anesthesia, and substance use disorders. Priority research areas include: - Development and validation of clinical trial endpoints and functional measures for patients with chronic pain. - Outcome measures for clinical trials in stimulant use disorders. - Assessment of opioid clinical trials using both active control and placebo. - Neurodevelopmental outcome assessment in vulnerable pediatric patients exposed to anesthesia and opioids. - Living systematic reviews of pre-clinical studies on anesthetic neurotoxicity. Applicants must propose a comprehensive, evidence-based plan that advances appropriate prescribing practices for analgesia, anesthesia, and substance use disorder treatments. --- ## Due Dates - This is a **forecasted opportunity** for Fiscal Year 2025. - The official application due date has not yet been posted. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/356049) for updates. --- ## Funding Amount - **Award Ceiling:** $2,000,000 per award - **Award Floor:** $2,000,000 per award - **Expected Number of Awards:** Up to 5 - **Funding Instrument:** Cooperative Agreement - **Cost Sharing/Matching:** Not required --- ## Eligibility Eligible applicants include: - State, county, city, or township governments - Special district governments - Independent school districts - Public and state-controlled institutions of higher education - Private institutions of higher education - Native American tribal governments (federally recognized and other tribal organizations) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (excluding higher education institutions) - For-profit organizations (including small businesses) - Unrestricted (open to any type of entity listed above) --- ## Application Process - As this is a forecasted opportunity, the application package and official instructions are not yet available. - Interested applicants should regularly check the [Grants.gov opportunity page](https://www.grants.gov/search-results-detail/356049) for updates, including the official posting and application instructions. - Prepare to submit a comprehensive, evidence-based research plan addressing one or more of the priority areas. --- ## Additional Information - Clinical trials are explicitly allowed under this opportunity. - The program is intended to support research that directly informs regulatory science and public health policy related to pain, anesthesia, and addiction. - Multiple awards may be made, and applicants are encouraged to propose projects with broad impact. --- ## External Links - [FDA Home Page](https://www.fda.gov/) - [Official Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/356049) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|-----------------------------------------|---------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | 240-402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888)-463-6332 |

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

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