Simpler Grants.gov #FOR-FD-24-010

FDA Cooperative Agreement for Human Abuse Potential Study of Botanical Kratom

The U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, is soliciting applications for a cooperative agreement to conduct a human abuse potential (HAP) study of botanical Kratom (Mitragyna speciosa). - Government Buyer: - U.S. Food and Drug Administration (FDA) - Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are named, as this is a research grant opportunity - Products/Services Requested: - Development, implementation, and evaluation of a clinical trial to assess the human abuse potential of botanical Kratom - Study must follow FDA guidance for abuse potential assessment, including: - Selection of appropriate comparators - Outcome measures - Statistical analyses - Submission of an Investigational New Drug (IND) application - Institutional Review Board (IRB) clearance - Unique or Notable Requirements: - Strict adherence to FDA guidance for HAP studies - IND submission and IRB approval are mandatory - Open to a wide range of eligible applicants (nonprofits, educational institutions, businesses, government entities) - Funding instrument is a cooperative agreement - Estimated award amount is $2,000,000

Description

The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. The study should follow the guidance for industry on the assessment of abuse potential of drugs, including selection of appropriate comparators and outcome measures. Applicants must complete submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance. The award is a cooperative agreement with an expected funding amount of $2,000,000.

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