
[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Proposed Rules]
[Pages 76096-76097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2011-N-0467]
RIN 0910-AG43


Non-Face-to-Face Sale and Distribution of Tobacco Products and 
Advertising, Promotion, and Marketing of 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) is extending the 
comment period until January 19, 2012, for an advance notice of 
proposed rulemaking (ANPRM) that was published in the Federal Register 
of September 9, 2011 (76 FR 55835). In that document, FDA requested 
comments, data, research, or other information related to non-face-to-
face sale and distribution of tobacco products; the advertising, 
promotion, and marketing of such products; and the advertising of 
tobacco products via the Internet, email, direct mail, telephone, smart 
phones, and other communication technologies that can be directed to 
specific recipients. The Agency is extending the comment period in 
response to a request to give interested parties additional time to 
comment.

DATES: Submit either electronic or written comments by January 19, 
2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0467 and/or RIN number 0910-AG43, 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:
     FAX: (301) 827-6870.
     Mail/Hand delivery/Courier (for paper, disk, 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-2011-N-0467 and Regulatory Information Number (RIN 
0910-AG43) 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: Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, (877) 287-1373, beth.buckler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 9, 2011 (76 FR 55835), FDA 
issued an ANPRM to obtain information related to the regulation of non-
face-to-face sale and distribution of tobacco products and the 
advertising, promotion, and marketing of tobacco products. FDA took 
this action as part of its implementation of the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31, 123 Stat. 1776). 
FDA requested comments, data, research, or other information related to 
non-face-to-face sale and distribution of tobacco products; the 
advertising, promotion, and marketing of such products; and the 
advertising of tobacco products via the Internet, email, direct mail, 
telephone, smart phones, and other communication technologies that can 
be directed to specific recipients. FDA intends to use the information 
submitted in response to the ANPRM to inform its regulation of the sale 
and distribution of tobacco products through a non-face-to-face 
exchange and the advertising, promotion, and marketing of tobacco 
products. FDA provided a 90-day comment period (i.e., until December 8, 
2011) for the ANPRM.

[[Page 76097]]

    FDA has received a request to extend the comment period. The 
request stated that additional time is needed to coordinate factual 
information and policy positions with a large number of States on 
several of the questions in the ANPRM. The request noted that their 
comments will be more thorough and of more assistance to FDA if more 
time is available to develop them.
    FDA has considered the request and is extending the comment period 
an additional 6 weeks, until January 19, 2012. We believe that the 
additional time will provide interested parties sufficient time to 
submit comments on the ANPRM.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
ANPRM. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

    Dated: December 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31225 Filed 12-5-11; 8:45 am]
BILLING CODE 4160-01-P


