Change Request Memo

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

(OMB Control Number 0910-0810)

Change Request

February 13, 2018

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to add 2,302 burden hours and 61,463 annual responses. OMB originally approved 7,128 hours and 21,600 annual responses. The new total would be 9,430 hours and 83,063 responses. FDA will use these hours to seek OMB approval for two studies prior to seeking an extension of the umbrella information collection. No other changes are occurring.

Tracked supporting statement