Regulatory Science Consulting for Abuse Potential Assessment

The contract seeks expert regulatory science consulting to provide strategic input on abuse potential assessments in alignment with FDA guidance, supporting the preparation of documentation for regulatory submissions related to drug products with potential for misuse. The scope centers on delivering scientifically sound and FDA-compliant advice to ensure regulatory pathways are met, particularly for substances requiring rigorous abuse liability evaluation as part of approval processes. This is a sole-source subcontract under the 8(a) program, designated for small disadvantaged businesses, and is assigned the NAICS code 541690 for other scientific and technical consulting services. The contracting activity is the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, with the opportunity posted on July 28, 2026, and responses due by August 4, 2026. The place of performance and point of contact details are not specified, but work is expected to be performed remotely or as mutually agreed upon, supporting federal regulatory objectives without geographic restriction.