Series Description

The FDA Grand Rounds highlights cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
The Population Assessment of Tobacco and Health (PATH) Study, a national, longitudinal cohort study of tobacco use and health in the United States, is one of the first large tobacco research efforts undertaken by FDA Center for Tobacco Products (CTP) and National Institute of Health (NIH) after Congress gave FDA authority to regulate tobacco products in 2009. This presentation will share an overview and history of the PATH Study, evolution of the study design made over time in response to important changes in tobacco marketplace and regulatory environment and highlight how its designs and findings can inform tobacco regulatory science and public health.

References

• Hyland, A., Ambrose, B. K., Conway, K. P., Borek, N., Lambert, E., Carusi, C., … Compton, W. M. (2017). Design and methods of the Population Assessment of Tobacco and Health (PATH) Study. Tobacco Control. 26:371-378. https://doi.org/10.1136/tobaccocontrol-2016-052934.
• Piesse, A., Opsomer, J., Dohrmann, S., DiGaetano, R., Morganstein, D., Taylor, K., Carusi, C., & Hyland, A. (2021). Longitudinal Uses of the Population Assessment of Tobacco and Health Study. Tobacco Regulatory Science, 7(1), 3–16. https://doi.org/10.18001/trs.7.1.1
• PATH Study Series page at National Addiction & HIV Data Archive Program (NAHDAP), University of Michigan: https://doi.org/10.3886/Series606

Series Objectives

• Discuss the research conducted at the FDA
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Describe the mission and vision of the Center for Tobacco Products.
• Discuss the design and objectives of the Population Assessment of Tobacco and Health (PATH) Study.
• Describe how scientific data generated from the PATH Study supports tobacco regulatory science and public health.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

• Cheng, Yu-Ching, PhD, Supervisory Epidemiologist, FDA Center for Tobacco Products - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose