Unknown. Final rule; technical amendment

4,295 words·~20 min read·/register/2016/06/08/2016-13517

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-2016-06-08.xml --- 81 110 Wednesday, June 8, 2016 Contents Agricultural Marketing Agricultural Marketing Service PROPOSED RULES National Organic Program: Livestock and Poultry Practices, 36810 2016-13537 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Commodity Credit Corporation See Farm Service Agency See Forest Service See Rural Utilities Service Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Interstate Firearms Shipment Report of Theft/Loss, 36957 2016-13520 Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Mangoes from India into the Continental United States, 36860-36861 2016-13567 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36918-36923 2016-13570 2016-13571 2016-13572 2016-13573 Centers Medicare Centers for Medicare & Medicaid Services NOTICES A Bill You Can Understand Design and Innovation Challenge:

Help Patients Understand Their Medical Bills and the Financial Aspect of Health; Requirements and Registration; Correction, 36923 2016-13548 Civil Rights Civil Rights Commission NOTICES Meetings: Missouri Advisory Committee, 36867 2016-13506 New Mexico Advisory Committee, 36866-36867 2016-13508 Requests for Nominations: North Carolina, Missouri, Arizona, and Oklahoma Advisory Committees, 36865-36866 2016-13507 Coast Guard Coast Guard RULES Drawbridge Operations: Indian Creek, Miami Beach, FL, 36798-36800 2016-13458 Safety Zones:

Cincinnati Reds Season Fireworks, 36800-36801 2016-13584 PROPOSED RULES Safety Zones: Ohio River Mile 42.5 to 43.0, Chester, WV, 36831-36833 2016-13586 NOTICES Meetings: Towing Safety Advisory Committee; Correction, 36940 2016-13515 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Commodity Credit Commodity Credit Corporation NOTICES Availability of Funds: Cotton Ginning Cost-Share Program Payments to Cotton Producers, 36861-36863 2016-13672 Defense Department Defense Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 36894-36895 2016-13561 2016-13566 Meetings: Defense Advisory Committee on Military Personnel Testing, 36895 2016-13524 Education Department Education Department PROPOSED RULES Supplemental Priority for Discretionary Grant Programs, 36833-36836 2016-13456 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Race to the Top: Early Learning Challenge Annual Performance Report, 36902-36903 2016-13460 Applications for New Awards:

Comprehensive Centers Program: National Comprehensive Center on Improving Literacy for Students with Disabilities, 36895-36902 2016-13587 Energy Department Energy Department See Federal Energy Regulatory Commission RULES Energy Conservation Program: Test Procedures for Central Air Conditioners and Heat Pumps, 36992-37120 2016-12592 NOTICES Applications to Export Liquefied Natural Gas: Venture Global Plaquemines LNG, LLC, 36903-36904 2016-13550 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;

Approvals and Promulgations: California; El Dorado County Air Quality Management District and Yolo-Solano Air Quality Management District; Fine Particulate Matter (PM2.5) NAAQS; Completeness Findings, 36803-36805 2016-13491 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Mississippi: Infrastructure Requirements for the 2012 PM2.5 National Ambient Air Quality Standard, 36848-36858 2016-13601 South Carolina; Prong 4—2008 Ozone, 2010 NO2, SO2, and 2012 PM2.5, 36842-36848 2016-13606 NOTICES Access by EPA Contractors to Information Claimed as Confidential Business Information, 36912-36913 2016-13580 Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations to Terminate Certain Uses, 36913-36915 2016-13581 Settlements:

Cannon Drive Drum Superfund Site, Social Circle, Walton County, GA, 36911 2016-13585 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36863-36864 2016-13538 Federal Accounting Federal Accounting Standards Advisory Board NOTICES Tax Expenditures: Management's Discussion and Analysis and Disclosure Requirements, 36915-36916 2016-13559 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Bombardier, Inc. Airplanes, 36813-36815 2016-12887 PILATUS AIRCRAFT LTD. Airplanes, 36810-36813 2016-13249 Proposed Establishment of Class E Airspace: Lakota, ND, 36815-36816 2016-13304 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Automatic Dependent Surveillance—Broadcast (ADS-B) Rebate System, 36985-36986 2016-13307 Intents to Release Airport Properties: St. Petersburg-Clearwater International, St. Petersburg, FL, 36984-36985 2016-13554 Federal Communications Federal Communications Commission RULES Updating Competitive Bidding Rules, 36805-36806 2016-13088 PROPOSED RULES Petitions for Reconsiderations of Actions in Rulemaking Proceedings, 36858 2016-13485 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 36916-36917 2016-13486 Federal Emergency Federal Emergency Management Agency NOTICES Public Assistance Program Minimum Standards; Reopening of Comment Period, 36940-36941 2016-13546 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 36904-36911 2016-13444 2016-13445 2016-13446 2016-13447 2016-13448 2016-13512 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Sempra Gas and Power Marketing, LLC, 36909 2016-13513 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 36917-36918 2016-13532 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea, 36858-36859 2016-13564 Federal Railroad Federal Railroad Administration PROPOSED RULES Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea, 36858-36859 2016-13564 NOTICES Compliance Waivers;

Petitions: South Central Florida Express, 36986-36987 2016-13487 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Funds Transfer Market Research Study, 36987-36988 2016-13539 Fish Fish and Wildlife Service PROPOSED RULES Subsistence Management Regulations: Public Lands in Alaska: Tongass National Forest Submerged Lands, 36836-36842 2016-13374 Food and Drug Food and Drug Administration RULES New Animal Drugs:

Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship, 36787-36790 2016-13517 Withdrawal of Approval of a New Animal Drug Application, 36790-36791 2016-13518 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mammography Quality Standards Act Requirements, 36924-36928 2016-13522 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: ALPROLIX, 36928-36929 2016-13526 ELOCTATE, 36929-36931 2016-13521 Meetings:

Cellular, Tissue and Gene Therapies Advisory Committee, 36923-36924 2016-13457 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 36988 2016-13459 2016-13525 Forest Forest Service PROPOSED RULES Subsistence Management Regulations: Public Lands in Alaska: Tongass National Forest Submerged Lands, 36836-36842 2016-13374 NOTICES Meetings: Deschutes-Ochoco Resource Advisory Committee, 36864 2016-13560 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 Health Resources and Services Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Findings of Research Misconduct, 36932-36933 2016-13541 Meetings:

Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 36933 2016-13558 President's Advisory Council on Faith-based and Neighborhood Partnerships, 36932 2016-13540 Health Resources Health Resources and Services Administration NOTICES Meetings: Advisory Committee on Training in Primary Care Medicine and Dentistry, 36931 2016-13523 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service See Office of Natural Resources Revenue Internal Revenue Internal Revenue Service RULES Certain Transfers of Property to Regulated Investment Companies and Real Estate Investment Trusts, 36793-36798 2016-13443 PROPOSED RULES Certain Transfers of Property to Regulated Investment Companies and Real Estate Investment Trusts, 36816-36818 2016-13425 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Furfuryl Alcohol from the People's Republic of China, 36873-36874 2016-13576 Magnesium Metal from the People's Republic of China, 36874-36875 2016-13574 Polyethylene Retail Carrier Bags from Thailand, 36891-36892 2016-13468 Porcelain-on-Steel Cooking Ware from the People's Republic of China, 36870-36871 2016-13578 Determinations of Sales at Less Than Fair Value: Certain Iron Mechanical Transfer Drive Components from Canada, 36887-36890 2016-13535 Certain Iron Mechanical Transfer Drive Components from the People's Republic of China, 36876-36881 2016-13533 Certain Oil Country Tubular Goods from the Republic of Turkey, 36876 2016-13536 Circular Welded Carbon-Quality Steel Pipe from Pakistan, 36867-36870 2016-13481 Circular Welded Carbon-Quality Steel Pipe from the Socialist Republic of Vietnam, 36884-36887 2016-13484 Circular Welded Carbon-Quality Steel Pipe from the Sultanate of Oman, 36871-36873 2016-13480 Circular Welded Carbon-Quality Steel Pipe from the United Arab Emirates, 36881-36884 2016-13528 International Trade Com International Trade Commission NOTICES Investigations;

Determinations, Modifications, and Rulings, etc.: Aquarium Fittings and Parts Thereof, 36956-36957 2016-13495 Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same, 36955-36956 2016-13467 Justice Department Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau Labor Department Labor Department See Mine Safety and Health Administration Land Land Management Bureau NOTICES Environmental Assessments; Availability, etc.: Amendment of Land Use Plans for BLM-Administered Public Lands in Wisconsin and Minnesota, 36941-36942 2016-13557 Plats of Surveys:

Oregon/Washington, 36942-36943 2016-13565 Realty Actions: Proposed Non-Competitive (Direct) Sale of Public Land in Fresno and Monterey Counties, CA, 36943-36944 2016-13555 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 36957-36958 2016-13644 Mine Mine Safety and Health Administration PROPOSED RULES Examinations of Working Places in Metal and Nonmetal Mines, 36818-36826 2016-13218 Exposure of Underground Miners to Diesel Exhaust, 36826-36831 2016-13219 NASA National Aeronautics and Space Administration NOTICES Meetings:

NASA Advisory Council; Ad Hoc Task Force on STEM Education, 36958 2016-13562 National Archives National Archives and Records Administration RULES Privacy Act; Exemptions, 36801-36803 2016-13599 NOTICES Privacy Act; Systems of Records, 36959-36962 2016-13600 National Institute National Institutes of Health NOTICES Exclusive Licenses; Proposed Approvals: Development of Anti-GPC3 Chimeric Antigen Receptor based on HN3 for the Treatment of Human Cancers, 36933-36934 2016-13530 Government-Owned Inventions;

Availability for Licensing, 36936-36937 2016-13499 Meetings: Center for Scientific Review, 36935-36936, 36938-36939 2016-13496 2016-13497 2016-13498 National Center for Advancing Translational Sciences, 36935, 36939 2016-13494 2016-13531 National Heart, Lung, and Blood Institute, 36934-36935 2016-13500 2016-13501 National Institute of Diabetes and Digestive and Kidney Diseases, 36937-36938 2016-13502 National Institute of Environmental Health Sciences, 36937 2016-13529 National Institute on Minority Health and Health Disparities, 36937 2016-13503 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska:

Other Hook-and-Line Fishery by Catcher Vessels in the Gulf of Alaska, 36808-36809 2016-13454 Fisheries Off West Coast States: Tribal Usual and Accustomed Fishing Areas, 36806-36808 2016-13469 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Monitoring Systems and Vessel Monitoring Systems for Atlantic Highly Migratory Species, 36893-36894 2016-13519 National Coastal Mapping Strategy 1.0; Coastal Lidar Elevation for a 3D Nation, 36892-36893 2016-13568 National Park National Park Service NOTICES Inventory Completions:

Department of Anthropology, Indiana University, Bloomington, IN, 36950 2016-13593 Evanston History Center, Evanston, IL, 36946-36947 2016-13590 Lake County Discovery Museum, Wauconda, IL, 36947-36949 2016-13591 Los Angeles County Museum of Natural History, Los Angeles, CA, 36950-36951 2016-13594 Office of the State Archaeologist, University of Iowa, Iowa City, IA, 36944-36945, 36952 2016-13592 2016-13595 2016-13596 University of Pennsylvania Museum of Archaeology and Anthropology, Philadelphia, PA, 36952-36954 2016-13597 Repatriation of Cultural Items:

Catalina Island Museum, Avalon, CA, 36945-36946, 36949 2016-13588 2016-13589 Lakeshore Museum Center, Muskegon, MI, 36954 2016-13598 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36962-36963 2016-13449 National Transportation National Transportation Safety Board NOTICES Meetings: PIREPs: Pay it Forward . . . Because Weather for One, is Weather for None; Forum, 36963 2016-13509 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Interim Staff Guidances:

Fuel Retrievability in Spent Fuel Storage Applications, 36963-36964 2016-13569 Meetings: Advisory Committee on the Medical Uses of Isotopes, 36964-36965 2016-13552 Natural Resources Office of Natural Resources Revenue NOTICES Major Portion Prices and Due Date for Additional Royalty Payments on Indian Gas Production in Designated Areas Not Associated with an Index Zone, 36954-36955 2016-13461 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 36864-36865 2016-13543 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36977-36979, 36984 2016-13463 2016-13464 2016-13465 2016-13466 Applications: Carey Credit Income Fund, et al., 36967-36973 2016-13514 Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Credit, LLC, 36979-36981 2016-13477 Miami International Securities Exchange, LLC, 36965-36966 2016-13483 New York Stock Exchange, LLC, 36973-36975, 36981 2016-13473 2016-13474 NYSE Arca, Inc., 36967, 36981-36984 2016-13472 2016-13475 NYSE MKT, LLC, 36966-36967, 36975-36977 2016-13471 2016-13476 State Department State Department RULES Civil Monetary Penalties Inflationary Adjustment, 36791-36793 2016-13455 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 36939-36940 2016-13511 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration Treasury Treasury Department See Fiscal Service See Foreign Assets Control Office See Internal Revenue Service Veteran Affairs Veterans Affairs Department NOTICES Meetings: Rehabilitation Research and Development Service Scientific Merit Review Board, 36989 2016-13527 Separate Parts In This Issue Part II Energy Department, 36992-37120 2016-12592 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, 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. 81 110 Wednesday, June 8, 2016 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 556, and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Approval of New Animal Drug Applications;

Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February. DATES: This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 2016. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, *george.haibel@fda.hhs.gov.* SUPPLEMENTARY INFORMATION:

I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during March and April 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act

(NEPA)and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: *http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.* Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book), at: *http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.* Table 1—Original and Supplemental NADAs and ANADAs Approved During March and April 2016 File No. Sponsor Product name Action 21 CFR section FOIA summary NEPA review 141-392 Elanco Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 IMRESTOR (pegbovigrastim injection) Original approval for the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers 522.1684 yes EA/FONSI 1 141-455 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 GALLIPRANT (grapiprant tablets) Original approval for the control of pain and inflammation associated with osteoarthritis in dogs 510.600 520.1084 yes CE 2 3 141-460 ECO LLC, 344 Nassau St., Princeton, NJ 08540 AIVLOSIN 17% (tylvalosin tartrate) Type A Medicated Article Original approval for control of porcine proliferative enteropathy

(PPE)associated with *Lawsonia intracellularis* infection in groups of swine in buildings experiencing an outbreak of PPE 558.633 yes CE 2 4 1 The Agency has carefully considered an environmental assessment

(EA)of the potential environmental impact of this action and has made a finding of no significant impact (FONSI). 2 The Agency has determined that this action is categorically excluded

(CE)from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 3 CE granted under 21 CFR 25.33(d)(1). 4 CE granted under 21 CFR 25.33(d)(5). II. Changes of Sponsorship Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 (Bayer) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland: File No. Product name 21 CFR section 099-169 Oxytocin Injection 522.1680 124-241 PVL Oxytocin Injectable Solution 522.1680 200-069 OvaCyst (gonadorelin diacetate tetrahydrate) Injection 522.1077 200-253 ProstaMate (dinoprost tromethamine) Injectable Solution 522.690 Bayer has also transferred sponsorship of NADA 141-070 for RAPINOVET (propofol) Injectable Emulsion to iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. III. Withdrawals of Approval In addition, during March and April 2016, the following two sponsors have requested that FDA withdraw approval of the NADAs and ANADAs listed in the following table because the products are no longer manufactured or marketed: File No. Sponsor Product name 21 CFR section 007-076 1 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland SULFA-NO X Liquid (sulfaquinoxaline) 3.44% Solution 520.2325a 008-244 1 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland SULFA-NO X Concentrate (sulfaquinoxaline) 12.85% Solution 520.2325a 041-955 1 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland Erythromycin Medicated Premix 558.248 049-729 1 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland PURINA Sulfa (sulfamethazine) 12.5% Solution 520.2261a 100-128 1 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland Supersweet Medipak TYLAN 10 558.625 200-307 1 Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada J5T 3S5 Penicillin G Potassium Soluble Powder 520.1696b 1 These NADAs were identified as being affected by guidance for industry #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” December 2013. Elsewhere in this issue of the **Federal Register** , FDA gave notice that approval of NADAs 007-076, 008-244, 041-955, 049-729, 100-128, and ANADA 200-307, and all supplements and amendments thereto, is withdrawn, effective June 20, 2016. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval. IV. Technical Amendments FDA has noticed that the section heading for 21 CFR 520.1430 does not accurately reflect the new animal drug for which approved conditions of use are codified. At this time, we are amending the section heading to read “Mibolerone” rather than “Megestrol acetate tablets.” This action is being taken to improve the accuracy of the regulations. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520 and 522 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, parts 510, 520, 522, 556, and 558 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] 2. In § 510.600: a. In the table in paragraph (c)(1), alphabetically add entries for “Aratana Therapeutics, Inc.” and “iVaoes Animal Health” and revise entry for “Huvepharma AD;” and b. In the table in paragraph (c)(2), revise the entry for “016592” and numerically add entries for “086026” and “086064.” The additions and revisions read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(c)* * *

(1)* * * Firm name and address Drug labeler code * * * * * * * Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 086026 * * * * * * * Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria 016592 * * * * * * * iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155 086064 * * * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * * * 016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria * * * * * * * 086026 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 * * * * * * * 086064 iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155 * * * * * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 4. Add § 520.1084 to read as follows: § 520.1084 Grapiprant.

(a)*Specifications.* Each tablet contains 20, 60, or 100 milligrams

(mg)grapiprant.

(b)*Sponsor.* See No. 086026 in § 510.600(c) of this chapter.

(c)*Conditions of use in dogs* —(1) *Amount.* Administer 0.9 mg/lb (2 mg/kg) once daily by mouth.

(2)*Indications for use.* For the control of pain and inflammation associated with osteoarthritis in dogs.

(3)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. 5. Revise the heading of § 520.1430 to read as follows: § 520.1430 Mibolerone. § 520.1696b [Amended] 6. Effective June 20, 2016, in § 520.1696b, in paragraph (b), remove “059320,”. § 520.2261a [Amended] 7. Effective June 20, 2016, in § 520.2261a, in paragraph (b), remove “Nos. 016592 and 061623” and in its place add “No. 016592”. § 520.2325a [Amended] 8. Effective June 20, 2016, in § 520.2325a, remove paragraph (a)(2) and redesignate paragraphs (a)(3) and

(4)as paragraphs (a)(2) and (3). PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 9. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.690 [Amended] 10. In § 522.690, in paragraph (b)(3), remove “000859” and in its place add “061623”. § 522.1077 [Amended] 11. In § 522.1077, in paragraph (b)(3), remove “000859 and 050604” and in its place add “050604 and 061623”. § 522.1680 [Amended] 12. In § 522.1680, in paragraph (b), remove “000859”. 13. Add § 522.1684 to read as follows: § 522.1684 Pegbovigrastim.

(a)*Specifications.* Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim.

(b)*Sponsor.* See No. 000986 in § 510.600(c) of this chapter.

(c)*Conditions of use in cattle* —(1) *Amount.* Administer the first dose (syringe) by subcutaneous injection 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) by subcutaneous injection within 24 hours after calving.

(2)*Indications for use.* For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers.

(3)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 522.2005 [Amended] 14. In § 522.2005, in paragraph (b)(1), remove “000859” and in its place add “086064”. PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 15. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 16. In § 556.748, revise paragraph

(c)to read as follows: § 556.748 Tylvalosin.

(c)*Related conditions of use.* See §§ 520.2645 and 558.633 of this chapter. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 17. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 18. In § 558.4, in paragraph (d), in the “Category I” table, add an entry in alphabetical order for “Tylvalosin” to read as follows: § 558.4 Requirement of a medicated feed mill license.

(d)* * * Category I Drug Assay limits percent Type A Type B maximum

(200x)Assay limits percent Type B/C * * * * * * * Tylvalosin 90-110 3.86 g/lb 85-115 * * * * * * * § 558.248 [Amended] 19. Effective June 20, 2016, in § 558.248, revise paragraphs

(a)and

(b)and remove and reserve paragraph (d)(1)(iii). The revisions read as follows: § 558.248 Erythromycin.

(a)*Specifications.* Type A medicated articles containing 5 or 10 percent erythromycin thiocyanate.

(b)*Sponsor.* See No. 061623 in § 510.600(c) of this chapter. § 558.625 [Amended] 20. Effective June 20, 2016, in § 558.625, remove paragraph (b)(3) and redesignate paragraphs (b)(4) and

(5)as paragraphs (b)(3) and (4). 21. Add § 558.633 to read as follows: § 558.633 Tylvalosin.

(a)*Specifications.* Type A medicated articles containing 77.12 grams tylvalosin per pound as tylvalosin tartrate.

(b)*Sponsor.* See No. 066916 in § 510.600(c) of this chapter.

(c)*Related tolerances.* See § 556.748 of this chapter.

(d)*Special considerations* —(1) Federal law restricts tylvalosin medicated feeds to use under a veterinary feed directive

(VFD)and the professional supervision of a licensed veterinarian. See § 558.6 of this chapter for additional requirements.

(2)VFDs for tylvalosin shall not be refilled.

(3)An expiration date of 1 week is required for tylvalosin Type C medicated swine feeds in pelleted or crumbled form.

(e)*Conditions of use in swine* —(1) *Amount.* Administer 38.6 grams tylvalosin per ton of Type C medicated feed (42.5 ppm) as the sole ration for 14 consecutive days.

(2)*Indications for use.* For the control of porcine proliferative enteropathy

(PPE)associated with *Lawsonia intracellularis* infection in groups of swine in buildings experiencing an outbreak of PPE. Dated: May 31, 2016. Tracey Forfa, Acting Director, Center for Veterinary Medicine. [FR Doc. 2016-13517 Filed 6-7-16; 8:45 am]

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