In Vivo Toxicology of Tobacco 2015-2020

The FDA's Center for Tobacco Products awarded this Master IDIQ on June 30, 2015, with ordering closed as of September 30, 2020; this vehicle is no longer active. The contract covered in vivo toxicology of tobacco and related products, including nonclinical genetic toxicology studies via inhalation and pharmacokinetic analyses by varying routes, with a shared ceiling of $9 million.

All 16 task orders have been fully obligated against the $18.7 million combined potential value, indicating that actual awards exceeded the vehicle's original ceiling. The FDA Center for Tobacco Products was the sole funding customer. Ordering activity concentrated in 2016–2017, with 14 of 16 orders awarded within a 13-month window (July 2016 through September 2017). The most recent task order was issued on September 14, 2017.

Lovelace Biomedical and Environmental Research Institute, Inc. dominated the vehicle, holding 10 of 16 orders and $11.5 million in combined potential value—roughly 62 percent of total awards. Lovelace Biomedical Research Institute (a distinct legal entity) held an additional 1 order for $2.5 million. IIT Research Institute, Battelle Memorial Institute, and Integrated Laboratory Systems, LLC split the remainder with 2, 1, and 2 orders respectively. All task orders were unrestricted competitive procurements with no set-aside designations.

Task orders ranged from $88,156 to $2.47 million in value, with typical durations between 12 and 24 months. Representative orders addressed e-cigarette aerosol evaluation, genotoxicity assessment of flavoring ingredients, inhalation toxicity of essential oils, pharmacokinetics of nicotine and tobacco-specific nitrosamines, and comparative toxicity profiles of conventional and electronic cigarettes. One order (September 12, 2016) was awarded with zero obligated dollars against a zero ceiling.

The vehicle is expired and closed to new ordering. Pursuit is not viable unless the FDA issues a successor vehicle for tobacco toxicology services.

The U.S. Food and Drug Administration's (FDA), Center for Tobacco Products (CTP) has a need for in vivo toxicology of tobacco and related products. Activities under the proposed contract shall include, but are not limited to, assessing tobacco products in in vivo genetic toxicology nonclinical studies utilizing the inhalation route, which shall include pharmacokinetic analyses (PK) by varying routes, in addition to inhalation.