Change Request Memo

U.S. Food and Drug Administration

Change Request for OMB Control No. 0910-0877

Required Warnings for Cigarette Packages and Advertisements

Feb 11, 2021

The Food and Drug Administration is seeking OMB approval of this nonmaterial/non-substantive change request to replace the associated guidance “Submission of Plans for Cigarette Packages and Cigarette Advertisements”. On December 2, 2020, the U.S. District Court for the Eastern District of Texas granted a motion by the plaintiffs in a case to postpone the effective date of the cigarette health warnings final rule by 90 days. The collection includes the above referenced guidance on the submission of cigarette plans and, subsequent to the court’s order, we have updated the dates in the guidance.