The Tobacco Regulatory Science (TRS) Knowledge Center

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are pleased to announce the continuation of the Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science. CASEL 2.0 will be administered through a cooperative agreement under award number 2-U54-DA046060-06, co-led by Jeanne Rosenthal (Westat) and Robin Mermelstein (University of Illinois at Chicago). CASEL will facilitate synthesis, coordination, and communication of research and career enhancement within the scientific research programs funded by the FDA Center for Tobacco Products (CTP). Through leadership, coordination, and facilitation of communication and collaborative efforts among tobacco regulatory science investigators, CASEL can accelerate the identification, integration, and advancement of research findings relevant to the Family Smoking Prevention and Tobacco Control Act. New to CASEL 2.0 is an Opportunity Fund (OF) that will support time-sensitive, rapid response projects to which extramural investigators may apply. The OF will be made available each year to support projects that address the high priority, time-sensitive research needs of the FDA CTP. More information.

On September 26, 2023, the FDA’s Center for Tobacco Products (CTP) and National Institutes of Health (NIH) announced funding awards for seven organizations within Tobacco Centers of Regulatory Science (TCORS). These new funding awards are the third round of TCORS, a long-standing component of the Tobacco Regulatory Science Program, or TRSP, a trans-HHS collaborative research effort between NIH and FDA, which fosters regulatory research. The collective expertise in tobacco regulatory science, as well as biomedical, behavioral, and social science research supported by funding from FDA, provides the scientific evidence needed to better inform FDA’s regulatory authorities. Made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addiction, and marketing), they generate critical research that informs the FDA’s regulation of tobacco products. More information.

The third cohort (TCORS 3.0) was awarded to seven institutions:

• The Ohio State University (Columbus, OH)
• The Pennsylvania State University (Hershey, Pennsylvania)
• University of Southern California (Los Angeles, CA)
• University of Kentucky (Lexington, KY)
• University of Michigan (Ann Arbor, MI)
• The University of North Carolina (Chapel Hill, NC)
• Yale University (New Haven, CT)

FDA’s Center for Tobacco Products (CTP) and NIH’s National Institute on Drug Abuse (NIDA) are announcing the availability of the Wave 6 Public-Use File (PUF) from the Population Assessment of Tobacco and Health (PATH) Study. These Wave 6 files contain questionnaire data collected between March 2021 and November 2021. In addition, Wave 5.5 Ever/Never Special Collection Public-Use Files (SCPUF) are now available along with updated Master Linkage Files (MLF).

Members of the research community are encouraged to apply for access to the Restricted-Use Files and Biomarker Restricted-Use Files. Public-Use Files are also available for download. In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013-2014) and urine collected during Wave 2 (2014-2015), Wave 3 (2015-2016), Wave 4 (2016-2018), and Wave 5 (2018-2019).

Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com