Assessment of Nicotine Dose Discrimination in Marketed Cigarettes

The Food and Drug Administration seeks proposals to assess nicotine dose discrimination in marketed cigarettes through a double-blind clinical study involving current smokers. Offerors must demonstrate expertise in recruiting and screening participants, administering cigarettes and intravenous nicotine using controlled methods, collecting behavioral, subjective, physiological, pharmacological, and biological data, and analyzing results. Proposals will be evaluated based on technical approach, past experience, key personnel qualifications, and price, with technical weighing most heavily. Proposals are due by March 6, 2020.

This is not a small business set-aside. The NAICS code is 541720 for research and development in the physical, engineering, and life sciences with a size standard of $22 million. The solicitation does not designate any incumbent or current contractors. The three-year contract will involve screening and testing a minimum of 100 participants across sites in the United States and potentially Canada, with fixed pricing for protocol development, study implementation, and reporting deliverables. Performance will occur at contractor and FDA facilities.