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Informing the Regulatory Process Through a Large-Scale Longitudinal Study of Smokers: Collaboration of the FDA Center for Tobacco Products and the National Institute on Drug Abuse

July 28, 2011: Cessation: Emerging Interventions and Innovations

Wilson Compton, M.D., M.P.E., Director, Division of Epidemiology, Services and Prevention Research, National Institute on Drug Abuse, National Institute of Health

Following the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) the National Institute on Drug Abuse and FDA's Center for Tobacco Products are implementing a large national longitudinal cohort study (N=20,000+) tobacco product users to monitor the tobacco-related behavioral and health impacts of this legislation. The "HAVE" framework—host, agent, vector and environment—will be employed and tested. Dr. Compton briefly reviewed the nationally representative tobacco measurement systems that are currently available and concluded his remarks with a timeline for the study. The RFP was published in April 2011, applications were submitted in May, reviews were completed in June and the anticipated award is in September 2011. The estimated award costs are $120–130 million over the first five years.

Following Dr. Compton's presentation, Dr. McAfee invited comments or questions. Dr. Compton was asked whether the study design included a rolling panel of subjects and the response was that it does. A second question was asked about whether the sample will include only smokers or non-smokers as well. Dr. Compton responded that it will be a household survey with some former smokers, a small sample of non-smokers and an oversampling of current tobacco users.

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