Change Request December 2021

U.S. Food and Drug Administration

Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications

OMB Control Number 0910-0810

“Monthly Monitoring Study”

Change Request

December 2021

The Food and Drug Administration is submitting this non-substantive change request to add a second year of data collection to the individual generic approval “Monthly Monitoring Study” (ICR Reference 201907-0910-006). The purpose of the Monthly Monitoring Study is to assess changes in vape use and perceptions. Given the evolving tobacco product landscape resulting from changes in product regulations, e-cigarette brand and flavor availability, and the COVID-19 pandemic which has impacted youth vaping, we would like to extend our data collection for another year to continue to track how these factors impact youth’s use and perceptions around vaping in order to inform future communication and educational initiatives. We estimate the burden to be identical for the second year to the first year. Therefore, we are doubling the previous estimate to cover the second-year burden. The new estimated total is 13,650 hours, an increase by 6,824 hours. There are no other changes to the collection.

Tracked Supporting Statements

Clean Supporting Statements