Tobacco Product Manufacturing Practice; Establishment of a Public Docket, 16824-16825 [2013-06288]

Download as PDF srobinson on DSK4SPTVN1PROD with PROPOSALS 16824 Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Proposed Rules upward from 1,200 feet above the surface at the Tuba City VORTAC, Tuba City, AZ. This action would contain aircraft while in IFR conditions under control of Denver, Albuquerque and Salt Lake City ARTCCs by vectoring aircraft from en route airspace to terminal areas. Class E airspace designations are published in paragraph 6006, of FAA Order 7400.9W, dated August 8, 2012, and effective September 15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order. The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Tuba City VORTAC, Tuba City, AZ. This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). VerDate Mar<15>2010 16:20 Mar 18, 2013 Jkt 229001 The Proposed Amendment Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 71—DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS [Docket No. FDA–2013–N–0227] 1. The authority citation for 14 CFR part 71 continues to read as follows: ■ Food and Drug Administration 21 CFR Chapter I Tobacco Product Manufacturing Practice; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. ACTION: § 71.1 SUMMARY: [Amended] 2. The incorporation by reference in 14 CFR 71.1 of the Federal Aviation Administration Order 7400.9W, Airspace Designations and Reporting Points, dated August 8, 2012, and effective September 15, 2012 is amended as follows: ■ Paragraph 6006 areas. En route domestic airspace * * * * * ANM AZ E6 Tuba City, AZ [New] Tuba City VORTAC, AZ (Lat. 36°07′17″ N., long. 111°16′11″ W.) That airspace extending upward from 1,200 feet above the surface within an area bounded by lat. 39°37′44″ N., long. 111°07′28″ W.; to lat. 39°26′10″ N., long. 110°01′33″ W.; to lat. 38°36′14″ N., long. 109°28′14″ W.; to lat. 38°35′57″ N., long. 109°02′31″ W.; to lat. 38°28′30″ N., long. 109°03′18″ W.; to lat. 38°04′06″ N., long. 108°53′29″ W.; to lat. 37°48′47″ N., long. 108°54′40″ W.; to lat. 37°37′12″ N., long. 109°18′38″ W.; to lat. 37°36′54″ N., long. 109°35′55″ W.; to lat. 37°04′41″ N., long. 109°38′16″ W.; to lat. 36°57′10″ N., long. 108°55′03″ W.; to lat. 36°36′32″ N., long. 108°55′03″ W.; to lat. 36°20′35″ N., long. 108°47′12″ W.; to lat. 36°05′15″ N., long. 108°22′51″ W.; to lat. 36°14′38″ N., long. 107°40′25″ W.; to lat. 35°39′30″ N., long. 107°25′27″ W.; to lat. 35°11′08″ N., long. 110°03′48″ W.; to lat. 35°16′08″ N., long. 111°55′46″ W.; to lat. 35°24′00″ N., long. 112°00′00″ W.; to lat. 35°46′00″ N., long. 111°50′30″ W.; to lat. 36°25′15″ N., long. 111°30′15″ W.; to lat. 36°44′00″ N., long. 111°36′30″ W.; to lat. 37°24′45″ N., long. 111°52′45″ W.; to lat. 37°30′00″ N., long. 112°03′30″ W.; to lat. 37°50′39″ N., long. 112°24′51″ W.; to lat. 38°10′56″ N., long. 111°24′19″ W.; to lat. 38°28′51″ N., long. 110°38′05″ W.; to lat. 39°03′55″ N., long. 110°37′49″ W.; thence to the point of beginning. Issued in Seattle, Washington, on March 7, 2013. Clark Desing, Manager, Operations Support Group, Western Service Center [FR Doc. 2013–06303 Filed 3–18–13; 8:45 am] BILLING CODE 4910–13–P PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 Establishment of a public docket; request for comments. The Food and Drug Administration (FDA) is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies’ recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies’ recommendations and to share information that will improve FDA’s understanding of the tobacco industry and its manufacturing operations. Submit electronic or written comments on the tobacco companies’ recommendations by May 20, 2013. ADDRESSES: Submit electronic comments to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Andrea Bautista, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 877–287–1373, email: andrea.bautista@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31; 123 Stat. 1776) was signed into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. The new provisions include, among other things, the authority to issue regulations related to tobacco product manufacturing practice in order to protect the public health and to assure that tobacco products are in compliance with the FD&C Act. Specifically, section 906(e) of the FD&C E:\FR\FM\19MRP1.SGM 19MRP1 Federal Register / Vol. 78, No. 53 / Tuesday, March 19, 2013 / Proposed Rules Act (21 U.S.C. 387f(e)) provides that ‘‘in applying manufacturing restrictions to tobacco, the Secretary shall * * * prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology.’’ On January 10, 2012, a group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice regulations, (2) a preamble to the recommended regulations, and (3) a cover letter with a meeting request (Ref. 1). The preamble, as noted in the cover letter, provides the participating tobacco companies’ common perspective and interpretation of the recommended regulations. On May 2, 2012, representatives of the tobacco companies met with FDA to present an overview of their recommendations and their approach to developing them. FDA is establishing a docket to provide an opportunity for all interested parties to comment on the tobacco companies’ recommendations and to share information that will improve FDA’s understanding of the tobacco industry and its manufacturing operations. srobinson on DSK4SPTVN1PROD with PROPOSALS II. Comments Interested persons may submit either electronic comments regarding the tobacco companies’ recommendations 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. III. Reference The following reference has been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http:// www.regulations.gov. 1. Recommendations for Tobacco Product Good Manufacturing Practices VerDate Mar<15>2010 16:20 Mar 18, 2013 Jkt 229001 Regulation and Request for Meeting, submitted to FDA, January 10, 2012. Dated: March 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06288 Filed 3–15–13; 11:15 am] BILLING CODE 4160–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 49 [EPA–R09–OAR–2013–0009; FRL–9791–8] Approval of Air Quality Implementation Plans; Navajo Nation; Regional Haze Requirements for Navajo Generating Station; Extension of Comment Period Environmental Protection Agency (EPA). ACTION: Proposed rule; extension of comment period. AGENCY: On February 5, 2013, the Environmental Protection Agency (EPA) proposed a source-specific federal implementation plan (FIP) requiring the Navajo Generating Station (NGS), located on the Navajo Nation, to reduce emissions of oxides of nitrogen (NOX) under the Best Available Retrofit Technology (BART) provision of the Clean Air Act (CAA or Act) in order to reduce visibility impairment resulting from NGS at 11 National Parks and Wilderness Areas. EPA provided a 90day public comment period for the proposed rule that is scheduled to close on May 6, 2013. The Navajo Nation and other stakeholders have submitted requests to extend the comment period an additional 90 days to allow time for interested parties to explore alternatives to BART that provide additional flexibility and also ensure greater reasonable progress than would be achieved under BART. In today’s action, EPA is extending the comment period an additional 90 days. DATES: Comments on the proposed rulemaking published on February 5, 2013 (78 FR 8274) must be submitted no later than August 5, 2013. ADDRESSES: Submit comments identified by docket number EPA–R09– OAR–2013–0009, by one of the following methods: Federal eRulemaking Portal: www.regulations.gov. Follow the on-line instructions. Email: r9ngsbart@epa.gov. Mail or deliver: Anita Lee (Air–2), U.S. Environmental Protection Agency Region 9, 75 Hawthorne Street, San Francisco, CA 94105–3901. SUMMARY: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 16825 Instructions: All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or email. www.regulations.gov is an ‘‘anonymous access’’ system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email directly to EPA, your email address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Hearings: EPA intends to hold public hearings, at least 30 days prior to the close of the comment period, to accept oral and written comments on the proposed rulemaking. EPA will provide notice and additional details related to the hearings in the Federal Register, on our Web site, and in the docket for this proposed rulemaking. Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region 9, 75 Hawthorne Street, San Francisco, California. While documents in the docket are listed in the index, some information may be publicly available only at EPA Region 9 (e.g., maps, voluminous reports, copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Anita Lee, EPA Region 9, (415) 972– 3958, r9ngsbart@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document, ‘‘we’’, ‘‘us’’, and ‘‘our’’ refer to EPA. Table of Contents I. Background II. Today’s Action I. Background NGS is a coal-fired power plant located on the Navajo Nation Indian Reservation, just east of Page, Arizona, approximately 135 miles north of Flagstaff, Arizona. Emissions of NOX from NGS affect visibility at 11 National Parks and Wilderness Areas that are E:\FR\FM\19MRP1.SGM 19MRP1

Agencies

[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Proposed Rules]
[Pages 16824-16825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0227]


Tobacco Product Manufacturing Practice; Establishment of a Public 
Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to obtain input on recommendations for regulations on 
good manufacturing practice for tobacco products that were submitted to 
FDA by a group of 13 tobacco companies (tobacco companies' 
recommendations). FDA is establishing this docket to provide an 
opportunity for all interested parties to comment on the tobacco 
companies' recommendations and to share information that will improve 
FDA's understanding of the tobacco industry and its manufacturing 
operations.

DATES: Submit electronic or written comments on the tobacco companies' 
recommendations by May 20, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Andrea Bautista, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 877-287-1373, email: andrea.bautista@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31; 123 Stat. 1776) was signed into law, amending the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA 
authority to regulate tobacco product manufacturing, distribution, and 
marketing. The new provisions include, among other things, the 
authority to issue regulations related to tobacco product manufacturing 
practice in order to protect the public health and to assure that 
tobacco products are in compliance with the FD&C Act. Specifically, 
section 906(e) of the FD&C

[[Page 16825]]

Act (21 U.S.C. 387f(e)) provides that ``in applying manufacturing 
restrictions to tobacco, the Secretary shall * * * prescribe 
regulations (which may differ based on the type of tobacco product 
involved) requiring that the methods used in, and the facilities and 
controls used for, the manufacture, preproduction design validation 
(including a process to assess the performance of a tobacco product), 
packing, and storage of a tobacco product conform to current good 
manufacturing practice, or hazard analysis and critical control point 
methodology.''
    On January 10, 2012, a group of 13 tobacco companies submitted to 
FDA: (1) Recommendations for good manufacturing practice regulations, 
(2) a preamble to the recommended regulations, and (3) a cover letter 
with a meeting request (Ref. 1). The preamble, as noted in the cover 
letter, provides the participating tobacco companies' common 
perspective and interpretation of the recommended regulations. On May 
2, 2012, representatives of the tobacco companies met with FDA to 
present an overview of their recommendations and their approach to 
developing them.
    FDA is establishing a docket to provide an opportunity for all 
interested parties to comment on the tobacco companies' recommendations 
and to share information that will improve FDA's understanding of the 
tobacco industry and its manufacturing operations.

II. Comments

    Interested persons may submit either electronic comments regarding 
the tobacco companies' recommendations 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.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov.
    1. Recommendations for Tobacco Product Good Manufacturing Practices 
Regulation and Request for Meeting, submitted to FDA, January 10, 2012.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06288 Filed 3-15-13; 11:15 am]
BILLING CODE 4160-01-P