Tobacco Products Pharmacology Study

The FDA Food and Drug Administration awarded this Master IDIQ to conduct clinical studies evaluating the impact of tobacco products on human behavior, pharmacology, and pharmacokinetics, with the last date to place orders against the vehicle September 25, 2018—the vehicle is no longer active and ordering has been closed for seven years and nine months.

The vehicle is exhausted. All $10.1 million of combined potential value has been obligated across eight task orders issued between September 2013 and September 2017. The most recent order was placed in 2017; no ordering activity has occurred since. FDA was the sole customer, placing all eight orders. The vehicle carried no set-aside designations; all orders were unrestricted competitive awards.

Battelle Memorial Institute dominated the vehicle, winning five orders worth $6.1 million combined potential value—roughly 60 percent of the vehicle's total activity. Lovelace Biomedical and Environmental Research Institute, Inc. won two orders for $2.2 million, and Lovelace Biomedical Research Institute (a separate legal entity) won one order for $1.8 million, together accounting for the remaining 40 percent. Task orders ranged from approximately $783,000 to $1.8 million, with typical durations spanning two to four years.

Awarded studies assessed nicotine pharmacokinetics and subjective effects across product types—mentholated smokeless tobacco, large cigars, and variations in menthol content and pH—in current-use populations. All orders used firm fixed price contracting. Place of performance centered on the research institutes' primary laboratory facilities, reflecting the clinical and bioanalytical nature of the work.

This vehicle presents no BD opportunity. The ordering period has closed, the contract ceiling is fully obligated, and no successor IDIQ is cited in the source. Firms seeking similar FDA tobacco-products research work must pursue new solicitations or other contract vehicles.

The primary objective of this Master IDIQ is to evaluate the impact of tobacco products on human behavior, topography, and pharmacology, including clinical pharmacokinetics and pharmacodynamics. To fulfill these objectives, the Government seeks a contractor to perform a series of clinical studies with a wide range of tasks. Studies may assess the impacts of tobacco products on dependence, craving, withdrawal, choice behavior, use behavior and topography, harm perception, physiological and pharmacodynamic effects, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs).