In Vivo Toxicology of Tobacco 2015-2020

The U.S. Food and Drug Administration's (FDA) Center for Tobacco Products established this Indefinite Delivery/Indefinite Quantity (IDIQ) contract to support comprehensive in vivo toxicology research focused on tobacco and related products. The primary objective of this contract vehicle is to enable scientific assessment of tobacco product constituents through advanced research methodologies, with a particular emphasis on genetic toxicology, pharmacokinetic analyses, and inhalation-based studies. Contractors under this vehicle are tasked with conducting sophisticated scientific investigations that help the FDA understand the potential health impacts of various tobacco and electronic nicotine delivery system (ENDS) products.

Task orders under this IDIQ demonstrate a robust range of toxicological research, with contract values typically spanning $88,156 to $2,472,244 and durations averaging 12-24 months. Key contractors include Lovelace Biomedical and Environmental Research Institute, IIT Research Institute, and Integrated Laboratory Systems, LLC, who have consistently won delivery orders to perform specialized research. The task orders cover diverse research areas such as genotoxicity assessments of flavoring ingredients, cytotoxicity studies of nicotine solvents, evaluation of e-cigarette aerosols, and comparative pharmacokinetic analyses of tobacco-specific compounds. All task orders were firm fixed-price contracts issued without specific set-aside designations, indicating open competition among qualified research organizations. The research primarily supports the FDA's regulatory oversight of tobacco products by generating scientific data on their potential health effects.