Amendment 1_7242025.pdf

This is a Notice of Intent to Award a Sole Source contract from the U.S. Food and Drug Administration (FDA) to Lovelace Biomedical Research Institute for toxicological studies on electronic cigarettes (e-cigarettes). The two-year, firm-fixed-price contract aims to complete data analysis, interim reports, and final reports from previous research on e-cigarette aerosol exposures in rodents, with the goal of understanding potential long-term health risks associated with e-cigarette use.

The contract stems from the FDA's need to evaluate the toxicological effects of e-cigarettes, as current in vivo data is limited. The original research, conducted under a previous contract, involved comprehensive chronic exposure studies of electronic nicotine delivery system (ENDS) aerosols, including dose-range finding and pharmacokinetic studies with 28-day, 90-day, and 180-day exposure periods. The sole source award to Lovelace Biomedical Research Institute is justified by the contractor's familiarity with the existing research, the impracticality of transferring samples to a new contractor, and the potential cost and time inefficiencies of repeating the experiments. Responses to this notice are due by 4:00 p.m. ET on August 1, 2025, and must be emailed to Kimberly Pennix with a CC to Ian Weiss.