[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Proposed Rules]
[Pages 26618-26619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2017-N-6565]
RIN 0910-AH60


Regulation of Flavors in Tobacco Products; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the advance notice of proposed rulemaking 
(ANPRM) that appeared in the Federal Register of March 21, 2018. In the 
ANPRM, FDA requested information related to the role that flavors play 
in tobacco products. The Agency is taking this action in response to 
requests for an extension to allow interested persons additional time 
to submit comments.

DATES: FDA is extending the comment period on the ANPRM published on 
March 21, 2018 (83 FR 12294). Submit either electronic or written 
comments by July 19, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 19, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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

[[Page 26619]]

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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2017-N-6565 for ``Regulation of Flavors in Tobacco Products.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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 between 9 a.m. 
and 4 p.m., Monday through Friday.
    <bullet> 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.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.

FOR FURTHER INFORMATION CONTACT: Laura Rich or Katherine Collins, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993, 1-877-287-1373, <a href="/cdn-cgi/l/email-protection#cf8ebca48c9b9f8fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="08497b634b5c58486e6c692660607b266f677e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 21, 2018, 
FDA published an ANPRM with a 90-day comment period to obtain 
information related to the role that flavors play in tobacco products. 
Specifically, the ANPRM is seeking comments, data, research results, or 
other information about, among other things, how flavors attract youth 
to initiate tobacco product use and about whether and how certain 
flavors may help adult cigarette smokers reduce cigarette use and 
switch to potentially less harmful products. FDA is seeking this 
information to inform regulatory actions FDA might take with respect to 
tobacco products with flavors, under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco 
Control Act. Potential regulatory actions include, but are not limited 
to, tobacco product standards and restrictions on sale and distribution 
of tobacco products with flavors.
    The Agency has received a number of requests for a 90-day extension 
of the comment period for the ANPRM and one request for a 105-day 
extension. FDA has considered these requests and is extending the 
comment period for the ANPRM for 30 days, until July 19, 2018.
    The Agency believes that a 30-day extension allows adequate time 
for interested persons to submit comments without significantly 
delaying any potential regulatory action on these important issues.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12369 Filed 6-7-18; 8:45 am]
 BILLING CODE 4164-01-P


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