Assessment of Tobacco Pharmacology and Behavior in Nonclinical Models

The primary objective of this vehicle is to evaluate the impact of tobacco product constituents on pharmacology and behavior using nonclinical models. Tasks shall include: providing input on scientific protocols and methodologies, providing animal subjects
protection including Animal Care and Use Committee (ACUC) documentation and approval, providing documentation for FDA ACUC, administering the test constituent(s), collecting behavioral, pharmacological and toxicological data, performing data analyses, and creating scientific reports. Studies will assess the impacts of tobacco product constituents on pharmacological, toxicological and behavioral outputs, including histopathology and gross pathology, clinical chemistry and hematology, safety pharmacology endpoints for cardiovascular and respiratory systems, midbrain neurotransmitter release, reinforcement/reward, dependence, withdrawal, choice behavior, and physiological effects (e.g., peak plasma levels). Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco products and tobacco product constituents, and may guide tobacco product policies and regulations.