Required Warnings for Cigarette Packages and Advertisements

OMB 0910-0877

This ICR collects information from manufacturers, distributors, and certain retailers of cigarettes who will be required to submit plans to FDA relating to the random and equal display and distribution of required warning statements on cigarette packaging and quarterly rotation of required warning statements in alternating sequence in cigarette product advertising ("plan" or "plans"). A record of the FDA-approved plan must also be established and maintained.

The latest form for Required Warnings for Cigarette Packages and Advertisements expires 2023-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0877_Supporting Statement_2023.docx Supporting Statement A
Recordkeeping Burden Other-Guidance
Supplements Other-Guidance
Initial plans Other-Guidance

All Historical Document Collections

202208-0910-010 Approved without change	Extension without change of a currently approved collection	2023-04-21
202107-0910-012 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-07-13
202102-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-02-17
202005-0910-009 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-05-29
202003-0910-007 Approved without change	New collection (Request for a new OMB Control Number)	2020-03-18
201908-0910-005 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2019-08-16

OMB Details

Initial plans

Federal Enterprise Architecture: Health - Consumer Health and Safety