Unknown. Final rule; technical amendment

2,055 words·~9 min read·/register/2013/04/02/2013-07578·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2013-04-02.xml --- 78 63 Tuesday, April 2, 2013 Contents Agricultural Marketing Agricultural Marketing Service NOTICES National Organic Program: Draft Guidance on Classification of Materials and Materials for Organic Crop Production, 19637-19638 2013-07613 Agriculture Agriculture Department See Agricultural Marketing Service Centers Disease Centers for Disease Control and Prevention NOTICES Statement of Organization, Functions, and Delegations of Authority, 2013-07545 19711 2013-07582 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicaid Program:

Increased Federal Medical Assistance Percentage Changes under the Affordable Care Act of 2010, 19918-19947 2013-07599 Coast Guard Coast Guard RULES Drawbridge Operations: China Basin, San Francisco, CA, 19585-19586 2013-07572 PROPOSED RULES Special Regulations: St. Thomas Carnival Watersport Activities, Charlotte Amalie Harbor, St Thomas, USVI, 19632-19636 2013-07573 NOTICES Merchant Mariner Medical Evaluation Program, 19725-19726 2013-07574 Commerce Commerce Department See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Futures Commodity Futures Trading Commission NOTICES Exemption of Specified Transactions Authorized by a Tariff or Protocol, 19880-19915 2013-07634 Orders of Exemption, 19670-19689 2013-07633 Defense Department Defense Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19689 2013-07508 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prompt Payment, 19690 2013-07589 Meetings: Defense Business Board Federal Advisory Committee, 19691 2013-07537 Education Department Education Department NOTICES Applications for New Awards: Advanced Placement Test Fee Program, 19691-19695 2013-07635 Meetings: National Advisory Committee on Institutional Quality and Integrity, 19695 2013-07627 Employment and Training Employment and Training Administration PROPOSED RULES Administrative Claims under the Federal Tort Claims Act and Related Statutes, 19632 2013-07525 NOTICES Change in Eligibility for Unemployment Insurance, etc.:

Alaska, Georgia, Louisiana, Maryland, Mississippi, Missouri, Montana, Ohio, South Carolina and Texas, 19735-19736 2013-07631 Reallotment of Workforce Investment Act Title I Formula Allotted Funds: Dislocated Worker Activities for Program Year 2012, 19736-19742 2013-07570 Energy Department Energy Department See Federal Energy Regulatory Commission See Western Area Power Administration PROPOSED RULES Energy Conservation Program for Consumer Products: Test Procedures for Residential Furnace Fans, 19606-19628 2013-07327 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19695-19696 2013-07629 Authority to Import and Export Natural Gas, etc.: Diamond Capital International, LLC, et al., 19696-19698 2013-07626 Environmental Protection Environmental Protection Agency RULES Air Quality Implementation Plans; Approvals and Promulgations: Arkansas; Prevention of Significant Deterioration; Greenhouse Gas Tailoring Rule Revisions, 19596-19599 2013-07391 Greenhouse Gas Reporting: Best Available Monitoring Method Request Submission Deadline for Petroleum and Natural Gas Systems;

Withdrawal, 19605 2013-07536 Implementation Plans and Operating Permits Program; Approvals and Promulgations: Missouri, 19602-19605 2013-07405 Implementation Plans; Approvals and Promulgations: Texas; Reasonably Available Control Technology for 1997 8-Hour Ozone National Ambient Air Quality Standard, 19599-19602 2013-07388 PROPOSED RULES Greenhouse Gas Reporting Rule: 2013 Revisions and Proposed Confidentiality Determinations for New or Substantially Revised Data Elements, 19802-19877 2013-06093 Implementation Plans and Operating Permits Program;

Approvals and Promulgations: Missouri, 19636 2013-07403 NOTICES Meetings: FIFRA Scientific Advisory Panel, 19705-19708 2013-07641 Farm Credit Farm Credit Administration NOTICES Meetings; Sunshine Act, 19708 2013-07750 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: General Electric Company Turbofan Engines, 19628-19630 2013-07546 Interpretation of the Rest Requirements of Nonstop International Supplemental Operations, 19630-19632 2013-07375 Federal Energy Federal Energy Regulatory Commission NOTICES Applications:

Lucid Energy, Inc.; Portland Water Bureau, 19698 2013-07543 Combined Filings, 19699-19700 2013-07587 Requests under Blanket Authorizations: Columbia Gas Transmission, LLC, 19700 2013-07544 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Diabetes Mellitus, 19798-19799 2013-07459 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 19708-19709 2013-07519 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 19709 2013-07518 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Alaska Migratory Bird Subsistence Harvest Household Survey, 19728-19729 2013-07612 Applications: Wild Bird Conservation Act, 19729-19730 2013-07598 Endangered and Threatened Wildlife and Plants: Recovery Permit Applications, 19730 2013-07604 Permits: Endangered Species, 19731-19732 2013-07600 Endangered Species; Marine Mammals, 19730-19731 2013-07597 Food and Drug Food and Drug Administration RULES Biologics License Applications: Technical Amendment;

Change of Address, 19585 2013-07578 NOTICES Center for Devices and Radiological Health: Request for Participants, Experiential Learning Program, 19711-19713 2013-07593 Establishment of a Public Docket: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research, 19713-19714 2013-07576 Guidance for Industry and Staff; Availability: User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications, 19714-19715 2013-07577 Improvement of Tracking and Tracing of Food;

Establishment of Pilot Projects and Congressional Report, 19715-19716 2013-07580 International Consortium of Cardiovascular Registries, 19716-19717 2013-07579 Meetings: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee, 19717-19718 2013-07568 Modifications to Labeling: Nicotine Replacement Therapy Products for Over-the-Counter Human Use, 19718-19721 2013-07528 General Services General Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Prompt Payment, 19690 2013-07589 Health and Human Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Indian Health Service See National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19709-19710 2013-07541 Meetings: Presidential Advisory Council on HIV/AIDS, 19710 2013-07614 Requests for Collaborating Partners for National Women's Health Week, 19710-19711 2013-07617 Homeland Homeland Security Department See Coast Guard See U.S.

Customs and Border Protection Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Affirmative Fair Housing Marketing Plan, 19727-19728 2013-07646 Indian Health Indian Health Service See Indian Health Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Health Service Medical Staff Credentials And Privileges Files, 19721-19723 2013-07596 Industry Industry and Security Bureau NOTICES Meetings:

Sensors and Instrumentation Technical Advisory Committee, 19638-19639 2013-07638 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Surface Mining Reclamation and Enforcement Office Internal Revenue Internal Revenue Service PROPOSED RULES 500,000 Dollar Deduction Limitation for Remuneration Provided by Certain Health Insurance Providers, 19950-19977 2013-07533 International Trade Adm International Trade Administration NOTICES Antidumping Duty Administrative Reviews;

Results, Extensions, Amendments, etc.: Certain Frozen Warmwater Shrimp from India and Thailand, 19639-19645 2013-07648 Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation: Opportunity to Request Administrative Review, 19645-19647 2013-07547 Five-Year Sunset Reviews, 19647-19648 2013-07550 International Trade Com International Trade Commission NOTICES Antidumping Duty Investigations: Diffusion-Annealed, Nickel-Plated Steel Flat-Rolled Products from Japan, 19734-19735 2013-07584 Labor Department Labor Department See Employment and Training Administration PROPOSED RULES Administrative Claims under the Federal Tort Claims Act and Related Statutes, 19632 2013-07525 Land Land Management Bureau NOTICES Meetings:

Twin Falls District Resource Advisory Council, Idaho, 19732 2013-07603 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prompt Payment, 19690 2013-07589 Centennial Challenges: 2014 Night Rover Challenge, 19742-19743 2013-07552 Government-Owned Inventions, Available for Licensing, 19743-19744 2013-07607 2013-07608 2013-07609 2013-07610 2013-07611 Grants of Exclusive Licenses, 19744 2013-07615 Privacy Act;

Systems of Records, 19744-19746 2013-07581 2013-07590 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evaluation of the Brain Disorders in the Developing World, 19723-19724 2013-07555 Meetings: Center for Scientific Review, 19724-19725 2013-07565 2013-07566 National Heart, Lung, and Blood Institute, 19725 2013-07567 National Institute on Drug Abuse, 19724 2013-07564 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Northeast Region Dealer Purchase Reports, 19648-19649 2013-07624 Southwest Region Permit Family of Forms, 19649 2013-07575 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of the Gulf of Mexico; Exempted Fishing Permit, 19649-19651 2013-07630 Meetings: New England Fishery Management Council; Correction, 19651-19652 2013-07623 Takes of Marine Mammals Incidental to Specified Activities: Office of Naval Research Acoustic Technology Experiments in the Western North Pacific Ocean, 19652-19670 2013-07606 National Park National Park Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Backcountry Use Permit, 19732-19733 2013-07594 Environmental Impact Statements; Availability, etc.: Fort Raleigh National Historic Site, NC, 19733-19734 2013-07601 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating and Combined Licenses: Applications and Amendments Involving No Significant Hazards Considerations, 19746-19757 2013-07467 Meetings; Sunshine Act, 19757-19758 2013-07700 Securities Securities and Exchange Commission NOTICES Applications:

Stetson Capital Fund LP and Davis Polk and Wardwell LLP, 19758-19763 2013-07588 Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Credit LLC, 19790-19791 2013-07583 NASDAQ OMX BX, Inc., 19763-19766 2013-07591 NASDAQ Stock Market LLC, 19772-19777, 19791-19794 2013-07548 2013-07586 NYSE Arca, Inc., 19766-19772, 19784-19790 2013-07585 2013-07619 NYSE MKT LLC, 19777-19784 2013-07620 Social Social Security Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19794-19797 2013-07616 State Department State Department NOTICES Designations and Determinations Pursuant to the Foreign Missions Act, 19797-19798 2013-07628 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19734 2013-07554 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration Treasury Treasury Department See Internal Revenue Service See United States Mint Customs U.S.

Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Visa Waiver Program Carrier Agreement, 19726-19727 2013-07639 U.S. Mint United States Mint NOTICES National Baseball Hall of Fame Commemorative Coin Program Design Competition, 19799 2013-07622 United States Mint Kids' Baseball Coin Design Challenge, April 11, 2013, 19799-19800 2013-07625 Veteran Affairs Veterans Affairs Department RULES Grants for Transportation of Veterans in Highly Rural Areas, 19586-19596 2013-07636 Western Western Area Power Administration NOTICES Pacific Northwest-Pacific Southwest Intertie Project:

Rate Order No. WAPA-157, 19700-19705 2013-07618 Separate Parts In This Issue Part II Environmental Protection Agency, 19802-19877 2013-06093 Part III Commodity Futures Trading Commission, 19880-19915 2013-07634 Part IV Health and Human Services Department, Centers for Medicare & Medicaid Services, 19918-19947 2013-07599 Part V Treasury Department, Internal Revenue Service, 19950-19977 2013-07533 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. 78 63 Tuesday, April 2, 2013 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 [Docket No. FDA-2013-N-0011] Change of Address; Biologics License Applications; Technical Amendment AGENCY:

Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration

(FDA)is amending its regulations to update the address for applicants to submit biologics license applications

(BLAs)and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations. DATES: This rule is effective April 2, 2013. FOR FURTHER INFORMATION CONTACT: Scott E. Zeiss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1120, Silver Spring, MD 20993-0002, 301-796-0639. SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 600.2(b) to update the address for applicants to submit BLAs and BLA amendments and supplements regulated by CDER. The new address for all these submissions is CDER Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901B Ammendale Rd., Beltsville, MD 20705. This action is being taken to ensure accuracy and clarity in the Agency's regulations. Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to update an address for the submission of BLAs and BLA amendments and supplements. List of Subjects for 21 CFR Part 600 Biologics, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 600 is amended as follows: PART 600—BIOLOGICAL PRODUCTS: GENERAL 1. The authority citation for 21 CFR part 600 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25. § 600.2 [Amended] 2. Section 600.2 is amended in the first sentence of paragraph

(b)by removing “CDER Therapeutic Biological Products Document Room” and adding in its place “CDER Central Document Room”, and by removing “12229 Wilkins Ave., Rockville, MD 20852” and adding in its place “5901B Ammendale Rd., Beltsville, MD 20705”. Dated: March 27, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013-07578 Filed 4-1-13; 8:45 am]

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