Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior

The Food and Drug Administration's Office of Acquisition and Grant Services seeks a contractor to conduct a clinical research study investigating associations between acute abuse liability outcomes and switching behavior in electronic nicotine delivery systems, with proposals due July 6, 2026 and questions due June 22, 2026. This is an unrestricted firm-fixed-price RFP issued under FAR Part 12, not set aside for small business.

Place of performance is the contractor's facility, with administrative oversight at Silver Spring, Maryland. The four-year contract requires a two-phase clinical study: an acute laboratory phase with two experimental sessions measuring plasma nicotine pharmacokinetics, pharmacodynamic effects, subjective effects, use topography, and biomarkers of exposure; and an ambulatory phase lasting approximately three months monitoring product switching and cessation behavior. The contractor must recruit adult cigarette smokers with minimal ENDS experience, select FDA-approved ENDS products, develop and obtain IRB and OMB clearances for the clinical protocol, conduct data analyses, and submit comprehensive study reports. The NAICS code is 541380, Testing Laboratories and Services; PSC is Q301, Reference Laboratory Testing.

Key personnel requirements include a Clinical Data Manager with a master's degree and three clinical studies experience, a Pharmacokineticist holding a Ph.D. and two clinical studies experience, a Project Director/Manager with a bachelor's degree and extensive clinical research management experience, and a Senior Scientist holding a Ph.D. and three clinical research projects as lead scientist. The technical section is limited to 15 pages. Evaluation weighs technical understanding and approach most heavily, followed by relevant past performance, staffing plan, key personnel qualifications, and pricing. The anticipated award date is on or about September 2026. All peer-reviewed publications must be submitted to NIH PubMed Central. The contract is a rated order under the Defense Priorities and Allocations System.