
[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Proposed Rules]
[Page 55671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2013-N-0521]


Menthol in Cigarettes, Tobacco Products; Request for Comments; 
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) is extending the 
comment period for the advance notice of proposed rulemaking (ANPRM) 
that appeared in the Federal Register of July 24, 2013 (78 FR 44484). 
In the ANPRM, FDA requested comments, including comments on FDA's 
preliminary evaluation, and data, research, or other information that 
may inform regulatory actions that FDA might take with respect to 
menthol in cigarettes. 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. Submit either 
electronic or written comments by November 22, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0521, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0521 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren Berkowitz or Annette L. 
Marthaler, Center for Tobacco Products, Food and Drug Administration, 
9200 Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, 
CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 24, 2013 (78 FR 44484), FDA 
published an ANPRM with a 60-day comment period to request comments on 
FDA's preliminary evaluation, and data, research, or other information 
that may inform regulatory actions FDA might take with respect to 
menthol in cigarettes.
    The Agency has received comments requesting a 60-day extension of 
the comment period for the ANPRM. These comments convey concern that 
the current 60-day comment period does not allow sufficient time to 
develop meaningful or thoughtful responses to questions raised in the 
ANPRM. FDA has also received comments opposing an extension of the 
current comment period on the grounds that ample time has been given to 
comment on the issues raised in the ANPRM.
    FDA has considered the requests and is extending the comment period 
for the ANPRM for 60 days, until November 22, 2013. The Agency believes 
that a 60-day extension allows adequate time for interested persons to 
submit comments without significantly delaying any potential regulatory 
action on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22015 Filed 9-10-13; 8:45 am]
BILLING CODE 4160-01-P


