[Federal Register Volume 85, Number 55 (Friday, March 20, 2020)]
[Notices]
[Pages 16103-16104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05936]


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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; 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 final guidance for industry entitled ``Submission of 
Plans for Cigarette Packages and Cigarette Advertisements.'' This 
guidance is intended to assist those required to submit cigarette plans 
for cigarette packages and cigarette advertisements by providing 
content, timing, and other recommendations related to those 
submissions.

DATES: The announcement of the guidance is published in the Federal 
Register on March 20, 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 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.govinfo.gov/content/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

[[Page 16104]]

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 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 guidance may be sent. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the 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 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 packages and 
quarterly rotation of required warnings in cigarette advertisements. 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 rule entitled ``Tobacco Products; Required Warnings 
for Cigarette Packages and Advertisements'' on March 18, 2020. The rule 
specifies the color graphics that must accompany the new textual 
warning label statements and establishes marketing requirements for 
cigarette packages and advertisements. The marketing requirements 
include, among other things, submission of a cigarette plan that 
provides for the random and equal display and distribution of the 
required warnings on cigarette packages and quarterly rotation of the 
required warnings in cigarette advertisements, as described under 
section 4 of FCLAA.
    This guidance provides recommendations related to preparing and 
submitting those cigarette plans. It discusses the regulatory 
requirements to submit cigarette plans as well as:
     Who submits a cigarette plan;
     the scope of a cigarette plan;
     when to submit a cigarette plan;
     what information should be submitted as part of a 
cigarette plan;
     where to submit a cigarette plan; and
     what approval of a cigarette plan means.
    FDA previously published a draft version of the guidance and sought 
public comment (84 FR 71957, December 30, 2019) (announcing the 
availability of the draft guidance). Among other things, comments 
express some concerns, such as about printing processes, as well as the 
difficulty of achieving random and equal display and distribution of 
required warnings. FDA has considered the comments it received, and 
included revisions in the final guidance that: (1) Discuss, per the 
final rule, that manufacturers may print different required warnings on 
front and rear panels of a cigarette package; (2) recognize that some 
level of deviation is appropriate given the language of the FCLAA; and 
(3) provide updated examples in an appendix to the guidance that 
demonstrate how random and equal display and distribution may be 
achieved with various printing methods, including those used by small 
manufacturers.

II. Significance of Guidance

    FDA is issuing this guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance refers to collections of information described in 
FDA's rule on ``Tobacco Products; Required Warnings for Cigarette 
Packages and Advertisements,'' which this guidance is intended to 
interpret. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The information collection 
provisions in the final rule have been submitted to OMB for review as 
required by section 3507(d) of the Paperwork Reduction Act of 1995.

IV. Electronic Access

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

    Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05936 Filed 3-19-20; 8:45 am]
 BILLING CODE 4164-01-P