Change Request Memo

U.S. Food and Drug Administration

Change Request for OMB Control No. 0910-0877

Required Warnings for Cigarette Packages and Advertisements

May 28, 2020

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 May 8, 2020, the U.S. District Court for the Eastern District of Texas granted a joint motion to govern the proceedings in a case and postpone the effective date of the cigarette health warnings final rule by 120 days. The collection includes the above referenced guidance on the submission of cigarette plans and subsequent to the courts order we have updated the dates in the guidance.