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, 35711-35712 [2014-14562]

Download as PDF Federal Register / Vol. 79, No. 121 / Tuesday, June 24, 2014 / Proposed Rules 35711 T–781 Flint, MI (FNT) to AXOBU, Canada (New) Flint, MI (FNT) VORTAC (Lat. 42°58′00.40″ N., long. 083°44′49.10″ W.) KATTY, MI WP (Lat. 42°57′50.59″ N., long. 083°30′50.76″ W.) HANKY, MI FIX (Lat. 42°57′43.51″ N., long. 083°21′59.93″ W.) ADRIE, MI FIX (Lat. 42°57′29.80″ N., long. 083°06′49.84″ W.) MARGN, MI FIX (Lat. 42°56′59.18″ N., long. 082°38′49.14″ W.) BLUEZ, MI FIX (Lat. 42°56′49.98″ N., long. 082°31′36.44″ W.) AXOBU, Canada FIX (Lat. 42°56′39.50″ N., long. 082°23′42.30″ W.) Excluding the airspace within Canada Issued in Washington, DC, on June 17, 2014. Gary A. Norek, Manager, Airspace Policy & Regulations Group. ADDRESSES: [FR Doc. 2014–14759 Filed 6–23–14; 8:45 am] Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. 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: BILLING CODE 4910–13–P 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. Proposed rule; extension of comment period. ACTION: 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. mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 15:58 Jun 23, 2014 Jkt 232001 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 https://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 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 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 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 of cigars, regulatory approach to electronic cigarettes and other noncombustible 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 https://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 https:// www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on https://www.regulations.gov. This is determined by information indicating that the submission is written by an E:\FR\FM\24JNP1.SGM 24JNP1 35712 Federal Register / Vol. 79, No. 121 / Tuesday, June 24, 2014 / Proposed Rules individual, for example, the comment is identified with the category ‘‘Individual Consumer’’ under the field titled ‘‘Category (Required),’’ on the ‘‘Your Information’’ page on https:// www.regulations.gov. For this proposed rule, however, FDA will not be following this general practice. Instead, FDA will post on https:// 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 https://www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to https:// www.regulations.gov, FDA will post the body of your comment on https:// 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 https://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 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 mstockstill on DSK4VPTVN1PROD with PROPOSALS [EPA–R01–OAR–2012–0733, EPA–R01– OAR–2012–0935; A–1–FRL–9911–50– Region–1] Approval and Promulgation of Air Quality Implementation Plans; Maine and New Hampshire; Ambient Air Quality Standards Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the States of SUMMARY: VerDate Mar<15>2010 15:58 Jun 23, 2014 Jkt 232001 Maine and New Hampshire. The revisions primarily update state regulations containing ambient air quality standards (AAQS) consistent with EPA’s national ambient air quality standards (NAAQS). The intended effect of this action is to approve these requirements into the Maine and New Hampshire SIPs. This action is being taken in accordance with the Clean Air Act (CAA). DATES: Written comments must be received on or before July 24, 2014. ADDRESSES: Submit your comments identified by Docket ID Number EPA– R01–OAR–2012–0733 for comments pertaining to our action for Maine, or EPA–R01–OAR–2012–0935 for comments pertaining to our action for New Hampshire, by one of the following methods: 1. www.regulations.gov: Follow the on-line instructions for submitting comments. 2. Email: arnold.anne@epa.gov. 3. Fax: (617) 918–0047 4. Mail: ‘‘Docket Identification Number EPA–R01–OAR–2012–0733 or EPA–R01–OAR–2012–0935,’’ Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05–2), Boston, MA 02109– 3912. 5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold, Manager, Air Quality Planning Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05–2), Boston, MA 02109–3912. Such deliveries are only accepted during the Regional Office’s normal hours of operation. The Regional Office’s official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays. Please see the direct final rule which is located in the Rules Section of this Federal Register for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: David Mackintosh, Air Quality Planning Unit, U.S. Environmental Protection Agency, New England Regional Office, 5 Post Office Square—Suite 100, (Mail Code OEP05–02), Boston, MA 02109– 3912, telephone 617–918–1584, facsimile 617–918–0584, email mackintosh.david@epa.gov. SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal Register, EPA is approving the State’s SIP submittal as a direct final rule PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules Section of this Federal Register. Dated: June 16, 2014. H. Curtis Spalding, Regional Administrator, EPA New England. [FR Doc. 2014–14532 Filed 6–23–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers 33 CFR Part 328 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 110, 112 116, 117, 122, 230, 232, 300, 302, and 401 [EPA–HQ–OW–2011–0880; FRL–9912–78– OW] RIN 2040–AF30 Definition of ‘‘Waters of the United States’’ Under the Clean Water Act; Extension of Comment Period U.S. Army Corps of Engineers (Corps), Department of the Army, Department of Defense; and Environmental Protection Agency (EPA). ACTION: Proposed rule; Extension of Comment Period. AGENCIES: The U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) are extending the comment period for the proposed rule ‘‘Definition of ‘Waters of the United States’ Under the Clean SUMMARY: E:\FR\FM\24JNP1.SGM 24JNP1

Agencies

[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: https://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 
https://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 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 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 https://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 https://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on https://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 https://www.regulations.gov. For 
this proposed rule, however, FDA will not be following this general 
practice. Instead, FDA will post on https://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 https://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to https://www.regulations.gov, FDA will post the body of your comment on https://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 https://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

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