[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Proposed Rules]
[Pages 26619-26620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1130

[Docket No. FDA-2017-N-6189]
RIN 0910-AH86


Tobacco Product Standard for Nicotine Level of Combusted 
Cigarettes; 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 the Agency) is 
extending the comment period for the advance notice of proposed 
rulemaking (ANPRM) that appeared in the Federal Register of March 16, 
2018. In the ANPRM, FDA requested information for consideration in 
developing a tobacco product standard to set a maximum nicotine level 
in combusted cigarettes so that they are minimally addictive or 
nonaddictive. 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 16, 2018 (83 FR 11818). Submit either electronic or written 
comments by July 16, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 16, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service

[[Page 26620]]

acceptance receipt is on or before that date.

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-2017-N-6189 for ``Tobacco Product Standard for Nicotine Level of 
Combusted Cigarettes.'' 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.
     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: Gerie Voss, 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-
CTP-1373, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2018, 
FDA published an ANPRM with a 90-day comment period to obtain 
information for consideration in developing a tobacco product standard 
to set a maximum nicotine level in combusted cigarettes so that they 
are minimally addictive or nonaddictive. Comments on the scope of 
products to be covered, maximum nicotine level for a potential nicotine 
tobacco product standard, implementation methods, analytical testing 
methods, technical achievability, possible countervailing effects, and 
other topics will aid FDA in its consideration regarding development of 
a tobacco product standard to set a maximum nicotine level in combusted 
cigarettes.
    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 120-day 
extension. FDA has considered the requests and is extending the comment 
period for the ANPRM for an additional 30 days, until July 16, 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. 2018-12368 Filed 6-7-18; 8:45 am]
 BILLING CODE 4164-01-P


