[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Proposed Rules]
[Pages 35711-35712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14562]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]
RIN 0910-AG38


Deeming Tobacco Products To Be Subject to the Federal Food, Drug, 
and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Regulations on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for a proposed rule that appeared in the Federal 
Register of April 25, 2014. In the proposed rule, FDA requested 
comments, including comments on FDA's proposed options for regulation 
of cigars, regulatory approach to electronic cigarettes and other non-
combustible tobacco products, pathways to market for proposed deemed 
tobacco products, and compliance dates for certain provisions, among 
other issues. 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 proposed rule that 
appeared in the Federal Register of April 25, 2014 (79 FR 23141). 
Submit either electronic or written comments by August 8, 2014.

ADDRESSES: You may submit comments, identified by Agency name, Docket 
No. FDA-2014-N-0189, and/or Regulatory Information Number (RIN) 0910-
AG38, 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 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, Docket No. FDA-2014-N-0189, and RIN 0910-AG38 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: Gerie Voss, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
877-287-1373, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 25, 2014 (79 FR 23141), FDA 
published a proposed rule with a 75-day comment period (ending July 9, 
2014) to request comments, including comments on FDA's proposed options 
for regulation of cigars, regulatory approach to electronic cigarettes 
and other non-combustible tobacco products, pathways to market for 
proposed deemed tobacco products, and compliance dates for certain 
provisions, among other issues.
    The Agency has received multiple requests to extend the comment 
period for the proposed rule including over 2,000 form letters as part 
of a write-in campaign to request additional time to comment. The 
requests conveyed concern that the current 75-day comment period does 
not allow sufficient time to develop a meaningful or thoughtful 
response to questions raised in the proposed rule. 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 proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for an additional 30 days, until August 8, 2014. 
The Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
rulemaking on these important issues.

II. Request for Comments

A. General Information About Submitting 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 Agency name, 
Docket No. FDA-2014-N-0189, and RIN 0910-AG38.

B. Public Availability of Comments

    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. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an

[[Page 35712]]

individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field titled ``Category (Required),'' 
on the ``Your Information'' page on http://www.regulations.gov. For 
this proposed rule, however, FDA will not be following this general 
practice. Instead, FDA will post on http://www.regulations.gov comments 
to this docket that have been submitted by individuals in their 
individual capacity. If you wish to submit any information under a 
claim of confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

    Dated: June 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14562 Filed 6-20-14; 4:15 pm]
BILLING CODE 4160-01-P