SAM #75F40126R00031

FDA Solicitation for Clinical Study on ENDS Abuse Liability and Switching Behavior

This opportunity is a clinical research procurement from the FDA Center for Tobacco Products: - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Acquisition and Grants Services (OAGS), Division of Acquisition and Procurement (DAP) - No specific Original Equipment Manufacturers (OEMs) or commercial vendors are named in the solicitation - Services Requested: - Clinical study to investigate associations between acute abuse liability outcomes and switching behavior among adult cigarette smokers - Study focuses on evaluating electronic nicotine delivery systems (ENDS) with high and low nicotine concentrations and their impact on cigarette use reduction - Key deliverables include: - Protocol development (draft, peer review, final) - Clinical study execution (recruitment, screening, data collection, specimen analysis) - Data analysis and reporting (draft and final study reports) - Regular meetings and progress reports (kick-off, biweekly, monthly, recruitment updates) - Obtaining FDA-authorized ENDS products for the study - Securing necessary human subjects clearances (IRB, OMB) - Unique/Notable Requirements: - Contractor must recommend and obtain FDA-authorized ENDS products with specified nicotine concentrations - Study protocol and reports must undergo peer and FDA review - Strict human subjects research compliance (IRB, OMB clearances) - Frequent and structured communication with FDA (biweekly meetings, monthly and weekly reports) - No products, part numbers, or OEM-specific equipment are specified; the focus is on research services and clinical study management

Description

Request for Investigating associations between acute abuse liability outcomes and switching behavior.  See attached soliciation for full details.

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