Clinical Study Protocol Development

The contract involves the development of a comprehensive clinical study protocol to assess the acute abuse liability of electronic nicotine delivery systems (ENDS). This protocol must include detailed elements such as study design, criteria for subject selection, dosing regimens, and safety monitoring procedures. The completed protocol will be subject to review and approval by the FDA. This subcontract opportunity, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, was posted on June 8, 2026, with a response deadline of July 6, 2026. The work is to be performed in Silver Spring, Maryland, and falls under the NAICS code 541611, which relates to administrative management and general management consulting services. The contract emphasizes adherence to regulatory standards and aims to ensure a robust evaluation framework for potential abuse risks associated with ENDS products.