FDA Tobacco Assessment Study 2013-2016

The Food and Drug Administration established this Master IDIQ on August 11, 2013, to evaluate the impact of tobacco product constituents on pharmacology and behavior using nonclinical models, with a shared ceiling of $3 million. Ordering closed on September 29, 2018, making this vehicle inactive for pursuit.

The vehicle is no longer available for new task orders. All ordering authority expired over seven years ago, and the most recent delivery order was awarded in July 2016. The three task orders placed against the vehicle exhausted the combined potential value of $3 million, with $3 million obligated across all three awards.

Scope centered on nonclinical animal studies of tobacco constituent effects. Task orders addressed determination of behaviorally effective tobacco constituent doses in rodents, assessment of addictive potential of specific alkaloids (cotinine, anatabine, and mysomine) in rodents, and assessment of abuse liability of aqueous whole tobacco extract from various tobacco products. All work encompassed protocol development, animal care and use committee documentation and approvals, test administration, and data collection and analysis across behavioral, pharmacological, toxicological, histopathology, clinical chemistry, hematology, and safety pharmacology endpoints.

Research Triangle Institute held the single prime contractor position on this vehicle, receiving all three task orders and the full $3 million in combined potential value. The FDA served as the sole customer agency. All task orders were issued under unrestricted (no set-aside) procurement. Delivery order values ranged from $127,454.53 to $1.6 million, with firm fixed price and time-and-materials pricing structures applied across the three awards.

The primary objective of this Master IDIQ is to evaluate the impact of tobacco product constituents on pharmacology and behavior using nonclinical models. To fulfill these objectives, the Government seeks a contractor to perform a series of nonclinical studies with a wide range of tasks. These 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).