[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71957-71958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5364]


Submission of Plans for Cigarette Packages and Cigarette 
Advertisements; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Submission of 
Plans for Cigarette Packages and Cigarette Advertisements.'' This 
guidance, when finalized, would assist those required to submit 
cigarette plans for cigarette packages and cigarette advertisements by 
providing recommendations related to those submissions, including 
information on what should be in a cigarette plan, who should submit a 
cigarette plan, and when to submit a cigarette plan.

DATES: Submit either electronic or written comments on the draft 
guidance by January 29, 2020.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-5364 for ``Submission of Plans for Cigarette Packages and 
Cigarette Advertisements.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff office between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the

[[Page 71958]]

information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this draft guidance to 
the Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Lauren Belcher or Annette Marthaler, 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Submission of Plans for Cigarette Packages and Cigarette 
Advertisements.'' The Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act) (Pub. L. 111-31) was enacted on June 22, 2009, 
and granted FDA important new authority to regulate the manufacture, 
marketing, and distribution of tobacco products. The Tobacco Control 
Act also amended section 4 of the Federal Cigarette Labeling and 
Advertising Act (FCLAA) to direct FDA to issue regulations requiring 
each cigarette package and advertisement to bear a new textual warning 
label statement accompanied by color graphics depicting the negative 
health consequences of smoking (section 201 of the Tobacco Control 
Act). In enacting this legislation, Congress also provided that FDA may 
adjust the required warnings if FDA found that such a change would 
promote greater public understanding of the risks associated with the 
use of tobacco products (section 202 of the Tobacco Control Act). The 
Tobacco Control Act also modified the requirements of the FCLAA 
regarding the submission of cigarette plans for the random and equal 
display and distribution of required warnings on cigarette packaging 
and quarterly rotation of required warnings in cigarette advertising. 
It also requires that such cigarette plans be submitted to FDA for 
review and approval, rather than to the Federal Trade Commission.
    FDA issued a proposed rule entitled ``Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements'' on August 16, 2019 
(84 FR 42754). The proposed rule, once finalized, would specify the 
color graphics that must accompany the new textual warning statements 
and establish marketing requirements for cigarette packages and 
advertisements. The marketing requirements would require, among other 
things, submission of a cigarette plan that provides for the random and 
equal display and distribution of the required warnings on cigarette 
packaging and quarterly rotation of the required warnings in cigarette 
advertising, as described under section 4 of FCLAA. This draft guidance 
provides recommendations related to preparing and submitting those 
cigarette plans.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA regarding the 
submission of cigarette plans for cigarette packages and 
advertisements. It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information 
described in FDA's August 16, 2019, proposed rule on ``Tobacco 
Products; Required Warnings for Cigarette Packages and 
Advertisements'', which this draft guidance is intended to interpret. 
The proposed collections of information in the proposed rule are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). As 
required by the PRA, FDA has published an analysis of the information 
collection provisions of the proposed rule (84 FR 42754 at 42787) and 
has submitted them for OMB approval.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft guidance at either https://www.regulations.gov or 
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: December 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27991 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P