Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2012-11-28.xml --- 77 229 Wednesday, November 28, 2012 Contents Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 70991-70992 2012-28833 2012-28834 Census Bureau Census Bureau NOTICES Meetings: Federal Economic Statistics Advisory Committee, 70992 2012-28816 Centers Disease Centers for Disease Control and Prevention NOTICES Delegations of Authority:

Patents and Inventions, 71004-71005 2012-28733 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Child Support Enforcement Program Expenditure Report and Child Support Enforcement Program Collection Report, 71005 2012-28795 Coast Guard Coast Guard RULES Reconsideration of Letters of Recommendation for Waterfront Facilities Handling LNG and LHG, 70886-70891 2012-28794 Safety Zones: Bay Bridge Construction, San Francisco Bay, San Francisco, CA, 70891-70893 2012-28792 PROPOSED RULES Security Zones:

Potomac and Anacostia Rivers; Washington, DC, 70964-70967 2012-28790 Commerce Commerce Department See Census Bureau See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Coordinating Coordinating Council on Juvenile Justice and Delinquency Prevention NOTICES Meetings, 70994-70995 2012-28787 Department of Transportation See Pipeline and Hazardous Materials Safety Administration Education Department Education Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Student Assistance General Provisions - Financial Assistance for Students with Intellectual Disabilities, 70995 2012-28780 Energy Department Energy Department See Energy Information Administration See Federal Energy Regulatory Commission Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 70995-70996 2012-28814 Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances:

Dinotefuran, 70908-70914 2012-28472 Fenpropathrin, 70902-70908 2012-28721 NOTICES Product Cancellation Orders and Amendments to Terminate Uses: Azinphos-methyl; Amendment to Existing Stocks Provision, 70998 2012-28725 Requests to Voluntarily Cancel Certain Pesticide Registrations, 70998-71001 2012-28726 Federal Aviation Federal Aviation Administration PROPOSED RULES Special Conditions: Embraer S.A., Model EMB-550 Airplane; Interaction of Systems and Structures, 70941-70945 2012-28768 NOTICES Meetings:

RTCA Special Committee 223, Airport Surface Wireless Communications, 71028 2012-28854 Federal Communications Federal Communications Commission PROPOSED RULES Accessible Emergency Information, and Apparatus Requirements for Emergency Information and Video Description: Implementation of Twenty-First Century Communications and Video Accessibility Act of 2010, 70970-70987 2012-28716 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings: Advisory Committee on Economic Inclusion, 71001 2012-28804 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Assistance to Firefighters Grant Program—Grant Application Supplemental Information, 71010-71011 2012-28841 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 70996-70997 2012-28842 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 71001-71002 2012-28779 Ocean Transportation Intermediary License Applicants, 71002 2012-28836 Ocean Transportation Intermediary License Revocations, 71002-71003 2012-28775 Federal Motor Federal Motor Carrier Safety Administration NOTICES Exemptions:

Transecurity LLC; Parts and Accessories Necessary for Safe Operation, 71028-71030 2012-28823 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Funds Transfer Market Research Study, 71035-71036 2012-28710 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Designation of Critical Habitat for the Southern Selkirk Mountains Population of Woodland Caribou, 71042-71082 2012-28512 PROPOSED RULES Endangered and Threatened Wildlife and Plants:

Status Review for Petition to List Ashy Storm-petrel, 70987-70988 2012-28811 NOTICES Environmental Assessments and Comprehensive Conservation Plans: Dungeness National Wildlife Refuge, Clallam County, WA, 71011-71012 2012-28753 Meetings: Conference of Parties to Convention on International Trade in Endangered Species of Wild Fauna and Flora, 71012-71013 2012-28897 Proposed Low-Effect Habitat Conservation Plans; Availability: Spring Mountain Raceway Expansion Project, Pahrump, Nye County, NV, 71013-71015 2012-28843 Food and Drug Food and Drug Administration RULES Uniform Compliance Date for Food Labeling Regulations, 70885-70886 2012-28817 PROPOSED RULES Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products:

Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing, 70955-70958 2012-28835 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments, etc., 71005-71006 2012-28774 Enforcement Action Dates: Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for Treatment of Cyanide Poisoning, 71006-71008 2012-28773 Guidances for Industry:

Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal, 71008-71009 2012-28809 Meetings: Framework for Pharmacy Compounding; State and Federal Roles, 71009-71010 2012-28786 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Production Activities: ZF Transmissions Gray Court, LLC, Foreign-Trade Zone 38, Spartanburg County, SC, 70992-70993 2012-28847 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71015-71016 2012-28812 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration NOTICES Meetings:

President's Council on Fitness, Sports, and Nutrition, 71003 2012-28781 WHO Consultative Expert Working Group on Research and Development Financing and Coordination, 71003 2012-28782 Statements of Organization, Functions, and Delegations of Authority, 71004 2012-28783 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Indian Affairs Indian Affairs Bureau PROPOSED RULES Osage Negotiated Rulemaking Committee; Public Meeting Cancellation, 70964 2012-28806 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Tribal Self-Governance Program, 71016 2012-28805 Industry Industry and Security Bureau PROPOSED RULES Revisions to Export Administration Regulations: Control of Military Electronic Equipment and Related Items President Determines No Longer Warrant Control under United States Munitions List, 70945-70955 2012-28396 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Indian Affairs Bureau Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 71036-71040 2012-28788 2012-28789 2012-28791 2012-28793 2012-28800 2012-28801 2012-28802 International Trade Adm International Trade Administration NOTICES Initiations of Antidumping Duty New Shipper Reviews: Steel Wire Garment Hangers from People's Republic of China, 70993-70994 2012-28849 International Trade Com International Trade Commission NOTICES Investigations: Hardwood Plywood from China, 71017 2012-28818 Justice Department Justice Department See Juvenile Justice and Delinquency Prevention Office NOTICES Lodgings of Proposed Consent Decrees under CERCLA, 71017 2012-28777 Juvenile Juvenile Justice and Delinquency Prevention Office NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: National Youth Gang Survey, 71018 2012-28183 Marine Marine Mammal Commission NOTICES Meetings; Sunshine Act, 71018-71019 2012-28901 2012-28905 National Archives National Archives and Records Administration NOTICES Meetings: Advisory Committee on Records of Congress, 71019 2012-28853 National Highway National Highway Traffic Safety Administration RULES Federal Motor Vehicle Safety Standards: Side Impact Protection; Correction, 70914-70915 2012-28810 NOTICES Petitions to Modify Exemptions:

Mitsubishi Motors R and D of America; Previously Approved Antitheft Device, 71030-71031 2012-28813 National Oceanic National Oceanic and Atmospheric Administration RULES Endangered and Threatened Wildlife and Plants: Endangered Status for Main Hawaiian Islands Insular False Killer Whale Distinct Population Segment, 70915-70939 2012-28766 Fisheries of the Northeastern United States: Targeted Acadian Redfish Fishery for Sector Vessels, 70939-70940 2012-28820 PROPOSED RULES Small-Mesh Multispecies Fishery:

Control Date to Limit Excessive Accumulation of Control, Qualifying Landings History, and Referendum Eligibility, 70988-70990 2012-28838 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Gulf of Mexico Fishery Management Council Stakeholder Communication Survey, 70994 2012-28803 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Interim Staff Guidances: Japan Lessons-Learned Project Directorate; Performing Seismic Margin Assessment, etc., 71019-71020 2012-28755 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Actions on Special Permit Applications, 71031-71033 2012-28583 Applications for Modifications of Special Permits, 71033-71034 2012-28588 Applications for Special Permits, 71034-71035 2012-28590 Delays in Processing of Special Permits Applications, 71035 2012-28585 Postal Service Postal Service RULES New Marking Standards for Parcels Containing Hazardous Materials, 70895-70902 2012-28673 Public Debt Public Debt Bureau See Fiscal Service Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations;

Proposed Rule Changes: National Stock Exchange, Inc., 71022-71023 2012-28797 New York Stock Exchange LLC, 71023-71028 2012-28798 2012-28799 NYSE Arca, Inc., 71020-71022 2012-28796 State Department State Department PROPOSED RULES Amendment to the International Traffic in Arms Regulations: Revision of U.S. Munitions List Category XI and Definition for Equipment, 70958-70964 2012-28477 NOTICES Meetings: Advisory Committee on International Law, 71028 2012-28851 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration Treasury Treasury Department See Fiscal Service See Internal Revenue Service Veteran Affairs Veterans Affairs Department RULES Authorization for Non-VA Medical Services, 70893-70895 2012-28778 PROPOSED RULES Authorization for Non-VA Medical Services, 70967-70969 2012-28776 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 71042-71082 2012-28512 Reader Aids Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 77 229 Wednesday, November 28, 2012 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2000-N-0011] Uniform Compliance Date for Food Labeling Regulations AGENCY:

Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA or we) is establishing January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between January 1, 2013, and December 31, 2014. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 15, 2010, we established January 1, 2014, as the uniform compliance date for food labeling regulations issued between January 1, 2011, and December 31, 2012.

DATES: This rule is effective November 28, 2012. Submit electronic or written comments by January 28, 2013. ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-N-0011, 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 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-2000-N-0011 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: Paul L. Ferrari, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1722. SUPPLEMENTARY INFORMATION: I. Background FDA periodically issues regulations requiring changes in the labeling of food. If the effective dates of these labeling changes were not coordinated, the cumulative economic impact on the food industry of having to respond separately to each change would be substantial.

Therefore, we periodically have announced uniform compliance dates for new food labeling requirements (see, e.g., the **Federal Register** of October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710); December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015); November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851); December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); and December 15, 2010 (75 FR 78155). Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for the use of existing label inventories and the development of new labeling materials.

This policy serves consumers' interests as well because the cost of multiple short-term label revisions that would otherwise occur would likely be passed on to consumers in the form of higher prices. We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This final rule contains no collections of information.

Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).

We believe that this final rule is not a significant regulatory action under Executive Order 12866. The establishment of a uniform compliance date does not in itself lead to costs or benefits. We will assess the costs and benefits of the uniform compliance date in the regulatory impact analyses of the labeling rules that take effect at that date. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities.

Because the final rule does not impose compliance costs on small entities, FDA certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.

” The current threshold after adjustment for inflation is $139 million, using the most current

(2011)Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required. This action is not intended to change existing requirements for compliance dates contained in final rules published before January 1, 2013. Therefore, all final rules published by FDA in the **Federal Register** before January 1, 2013, will still go into effect on the date stated in the respective final rule. We generally encourage industry to comply with new labeling regulations as quickly as feasible, however. Thus, when industry members voluntarily change their labels, it is appropriate that they incorporate any new requirements that have been published as final regulations up to that time. In rulemaking that began with publication of a proposed rule on April 15, 1996 (61 FR 16422), and ended with a final rule on December 24, 1996, we provided notice and an opportunity for comment on the practice of establishing uniform compliance dates by issuance of a final rule announcing the date. Receiving no comments objecting to this practice, we find any further rulemaking unnecessary for establishment of the uniform compliance date. Nonetheless, under 21 CFR 10.40(e)(1), we are providing an opportunity for comment on whether this uniform compliance date should be modified or revoked. The new uniform compliance date will apply only to final FDA food labeling regulations that require changes in the labeling of food products and that publish after January 1, 2013, and before December 31, 2014. Those regulations will specifically identify January 1, 2016, as their compliance date. All food products subject to the January 1, 2016, compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2016. If any food labeling regulation involves special circumstances that justify a compliance date other than January 1, 2016, we will determine for that regulation an appropriate compliance date, which will be specified when the final regulation is published. II. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to *http://www.regulations.gov.* 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: November 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012-28817 Filed 11-27-12; 8:45 am]

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