Inactive

The primary objective of this IDIQ contract is to evaluate the impact of tobacco products on human behavior, toxicology, physiology, and pharmacology, including clinical pharmacokinetics and pharmacod... The primary objective of this IDIQ contract is to evaluate the impact of tobacco products on human behavior, toxicology, physiology, and pharmacology, including clinical pharmacokinetics and pharmacodynamics. To fulfill these objectives the Government seeks a Contractor to perform a series of studies (including chemical analyses) with a wide range of tasks Studies may assess the impacts of tobacco products on a variety of outcomes in humans, including dependence, craving, withdrawal, choice behavior, switching behavior and topography, harm perception, subjective and sensory effects, pharmacokinetic and pharmacodynamic effects, toxicology, physiology, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs). Laboratory studies may be required to follow Good Laboratory Practices. For all clinical pharmacology studies, use of a Clinical Pharmacology Unit and Good Clinical Practices are required. Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco product use and may guide tobacco product policies and regulations.