This Solicitation opportunity from Department Of Health And Human Services was posted on September 19, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Electronic Nicotine Delivery System Toxicological Studies
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The FDA intends to award a two-year, sole source, firm-fixed-price contract to Lovelace Biomedical Research Institute to complete ongoing toxicological studies on electronic cigarette aerosols. The contract, under NAICS code 541380 for Testing Laboratories, includes a 12-month base period with an option for an additional year. The studies involve comprehensive in vivo toxicological assessments, including dose-range finding, and 28-day, 90-day, and 180-day exposure experiments, aimed at understanding the long-term health effects of e-cigarette constituents. These studies are critical for supporting FDA’s regulatory review process, particularly for pre-market tobacco product applications, by providing scientific data on potential toxicological risks, biomarkers of harm, and pathology related to repeated e-cigarette use. Lovelace Biomedical Research Institute has already conducted the experiments, and the contract's previous period has expired. The agency seeks to sole source this follow-up work to avoid delays, ensure scientific integrity, and prevent the need for costly and time-consuming repetition of experiments. The contractor’s familiarity with the data and ongoing analysis makes them uniquely qualified to finalize the reports efficiently. Any interested party must submit a capability statement by August 1, 2025, for consideration, but the decision to award the contract solely to Lovelace is at the FDA’s discretion to ensure continuity, accuracy, and timely completion of the scientific evaluation.
General Info
Place of Performance
MD, USASet-Aside
Documents
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Timeline
Submission Closed
Organization & Contact Information
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