[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]
-----------------------------------------------------------------------
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Advertisements; Draft Guidance for Industry; Availability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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Submission of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DATES: Submit either electronic or written comments on the draft
guidance by January 29, 2020.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