Unknown. Final rule

3,268 words·~15 min read·/register/2012/08/09/2012-19498

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--- schema: federal-register doc_type: fedreg source_file: FR-2012-08-09.xml --- 77 154 Thursday, August 9, 2012 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service Air Force Air Force Department NOTICES Performance Review Board; Change of Name, 47617 2012-19426 Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Horse Protection Regulations, 47589 2012-19501 Plant Protection and Quarantine Stakeholder/Customer Satisfaction Survey, 47591-47592 2012-19535 Qualitative Feedback on Agency Service Delivery, 47590-47591 2012-19536 Coast Guard Coast Guard RULES Annual Marine Events:

Eighth Coast Guard District, Sabine River, Orange, TX, 47519-47520 2012-19485 Approval of Classification Societies, 47544-47552 2012-19376 Drawbridge Operations: Cheesequake Creek, Morgan, South Amboy, NJ, 47524-47525 2012-19481 Cheesequake Creek, South Amboy, NJ, 47525 2012-19486 Safety Zones: Mississippi River, Mile Marker 291 to 295, 47525-47528 2012-19482 Special Local Regulations for Marine Events: Wrightsville Channel; Wrightsville Beach, NC, 47520-47522 2012-19483 Special Local Regulations:

Port Huron Offshore Gran Prix, St. Clair River; Port Huron, MI, 47522-47524 2012-19484 PROPOSED RULES Great Lakes Pilotage Rates: 2013 Annual Review and Adjustments; Correction, 47582 2012-19348 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Defense Department Defense Department See Air Force Department Drug Drug Enforcement Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine, 47667 2012-19550 Import/Export Declaration for List I and List II Chemicals, 47666-47667 2012-19529 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Strategies for Preparing At-Risk Youth for Postsecondary Success, 47617-47618 2012-19480 Employment and Training Employment and Training Administration NOTICES Amended Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance:

Wellpoint, Inc., et al.; North Haven, CT, Manchester, NH, and South Portland, ME, 47669-47670 2012-19467 Amended Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance: Honeywell, Skaneateles Falls, NY, and Blackwood, NJ, 47670-47671 2012-19463 Navistar Truck Development and Technology Center and Navistar Truck Reliability Center, Fort Wayne, IN, 47670 2012-19462 RG Steel Sparrows Point LLC, Sparrows Point, MD, 47670 2012-19461 T-Mobile USA, Inc.; Allentown, PA, and Bellevue, WA, 47671 2012-19466 Determinations Regarding Eligibility to Apply for Worker Adjustment Assistance, 47671-47674 2012-19465 Investigations Regarding Eligibility To Apply For Worker Adjustment Assistance, 47674-47675 2012-19464 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Approvals and Promulgations of State Implementation Plans:

Hawaii; Infrastructure Requirements for the 1997 8-Hour Ozone and the 1997 and 2006 Fine Particulate Matter NAAQS, 47530-47533 2012-19301 Determinations of Failure to Attain One-Hour Ozone Standard by 2007, etc.: 1997 Eight-Hour Ozone Standards for New York-Northern New Jersey-Long Island Nonattainment Area; Correction, 47533-47534 2012-19570 Pesticide Tolerances: Paraquat Dichloride, 47539-47544 2012-19320 Revisions to California State Implementation Plan: Mojave Desert, Northern Sierra, Sacramento Metropolitan and San Diego Air Pollution Agencies, 47536-47539 2012-19318 Sacramento Metropolitan Air Quality Management District, 47535-47536 2012-19315 PROPOSED RULES Approvals and Promulgations of Implementation Plans:

Mississippi; Infrastructure Requirements for Fine Particulate Matter National Ambient Air Quality Standards, 47573-47580 2012-19565 Revisions to California State Implementation Plan: Mojave Desert, Northern Sierra, Sacramento Metropolitan and San Diego Air Pollution Agencies, 47581-47582 2012-19316 Sacramento Metropolitan Air Quality Management District, 47581 2012-19314 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47631-47641 2012-19422 2012-19569 Executive Office of the President See Presidential Documents Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:

Hawker Beechcraft Corporation Airplanes, 47568-47570 2012-19541 The Boeing Company Airplanes, 47563-47568 2012-19532 Airworthiness Directives; Hawker Beechcraft Corporation Airplanes, 47570-47572 2012-19495 Federal Emergency Federal Emergency Management Agency NOTICES Major Disaster Declarations: Virginia, 47655-47656 2012-19552 West Virginia; Amendment No. 1, 47655 2012-19551 Federal Energy Federal Energy Regulatory Commission NOTICES Applications for Amendment of Licenses: Algonquin Power Co., 47618-47619 2012-19515 Applications for Transfer of Licenses:

Alcoa Power Generating Inc. to Brookfield Smoky Mountain Hydropower LLC, 47619 2012-19514 Applications: East Tennessee Natural Gas, LLC, 47619-47620 2012-19525 Commission Staff Attendances, 47620-47621 2012-19527 Complaints: Hudson Transmission Partners, LLC v. New York Independent System Operator, Inc., 47621 2012-19516 Draft General Conformity Determinations: Appalachian Gateway Project, 47621-47622 2012-19506 Environmental Site Reviews: TransCanada Hydro Northeast Inc., FirstLight Power Resources, 47622-47623 2012-19513 Filings:

Entergy Gulf States Louisiana, LLC, 47623 2012-19504 Sierra Pacific Power Co., 47623-47624 2012-19505 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorization: Bartram Lane LLC, 47626 2012-19518 Beebe Renewable Energy, LLC, 47625-47626 2012-19520 BFES Inc., 47627-47628 2012-19511 2012-19512 Escanaba Green Energy, LLC , 47624 2012-19517 Laurel Hill Wind Energy, LLC, 47625 2012-19522 MP2 Energy NE LLC, 47624 2012-19510 Perigee Energy, LLC, 47626-47627 2012-19521 Spinning Spur Wind LLC, 47626 2012-19523 Tall Bear Group, LLC, 47624-47625 2012-19524 Zephyr Wind, LLC, 47627 2012-19519 Meetings:

Eagle Crest Energy Eagle Mountain Pumped Storage Hydroelectric Project; Postponement, 47628 2012-19507 Preliminary Permit Applications: Archon Energy 1, Inc., 47628-47629 2012-19508 Records Governing Off-the-Record Communications, 47629 2012-19509 Requests under Blanket Authorizations: Dominion Transmission, Inc., 47629-47630 2012-19526 Staff Attendances: Entergy Regional State Committee Working Group and Stakeholder Meeting, 47630-47631 2012-19528 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Privacy Act of 1974;

System of Records, 47641-47652 2012-19572 Use of Eminent Domain to Restructure Performing Loans, 47652 2012-19566 Federal Motor Federal Motor Carrier Safety Administration NOTICES Pilot Program on NAFTA Trucking Provisions, 47693-47697 2012-19564 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: Endangered Listings on Molokai, Lanai, and Maui; Critical Habitat Designations on Molokai, Lanai, Maui, and Kahoolawe, 47587-47588 2012-19487 Petition to List Desert Massasauga and to Designate Critical Habitat, 47583-47587 2012-19476 NOTICES Environmental Assessments;

Availability, etc.: Comprehensive Conservation Plan, Wichita Mountains Wildlife Refuge, Comanche County, OK, 47657-47660 2012-19497 Environmental Impact Statements; Availability, etc.: Attwater Prairie Chicken National Wildlife Refuge, Austin and Colorado Counties, TX, 47660-47662 2012-19538 Food and Drug Food and Drug Administration RULES New Animal Drugs: Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel, 47511-47512 2012-19498 NOTICES Second Annual Health Professional Organizations Conference, 47652-47653 2012-19549 Forest Forest Service NOTICES Meetings:

Ketchikan Resource Advisory Committee, 47592 2012-19203 Shoshone Resource Advisory Committee, 47593 2012-19496 Umatilla National Forest, Columbia County Resource Advisory Committee, 47592-47593 2012-19494 Umatilla National Forest, Southeast Washington Resource Advisory Committee, 47593 2012-19492 Health and Human Health and Human Services Department See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.

Customs and Border Protection See U.S. Immigration and Customs Enforcement PROPOSED RULES Extension of Border Zone in New Mexico, 47558-47563 2012-19458 Housing Housing and Urban Development Department NOTICES Public Housing Assessment System: Physical Condition Scoring Notice and Revised Dictionary of Deficiency Definitions, 47708-47759 2012-19335 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Indian Gaming Commission Internal Revenue Internal Revenue Service PROPOSED RULES Fees on Health Insurance Policies and Self-Insured Plans for the Patient-Centered Outcomes Research Trust Fund;

Hearing Cancellation, 47573 2012-19585 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47704-47705 2012-19469 Meetings: Taxpayer Advocacy Panel Return Processing Delays Project Committee, 47705 2012-19468 International Trade Adm International Trade Administration NOTICES Antidumping Duty Administrative Reviews; Results, Extensions, Amendments, etc.: Certain Cut-to-Length Carbon Steel Plate from People's Republic of China, 47593-47595 2012-19577 Antidumping Duty Orders:

Small Diameter Graphite Electrodes from People's Republic of China, 47596-47602 2012-19578 Stainless Steel Bar from Brazil, India, Japan, and Spain, 47595-47596 2012-19574 International Trade Com International Trade Commission PROPOSED RULES Retrospective Analysis of Existing Rules, 47572-47573 2012-19296 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Approval as a Nonprofit Budget and Credit Counseling Agency, 47665-47666 2012-19530 Labor Department Labor Department See Employment and Training Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Acquisition and Sale of Trust Real Estate Investment Trust Shares by Individual Account Plans Sponsored by Trust Real Estate Investment Trusts, 47668-47669 2012-19474 Underground Retorts, 47668 2012-19567 Land Land Management Bureau NOTICES Proposed Supplementary Rules for Public Lands within the Lower Lake Creek Special Recreation Management Area, Eugene District, OR, 47662-47665 2012-19533 Public Land Orders: Utah, 47665 2012-19503 National Highway National Highway Traffic Safety Administration RULES Event Data Recorders, 47552-47557 2012-19580 NOTICES Petitions for Decisions of Inconsequential Noncompliance:

General Motors, LLC, 47697-47699 2012-19575 Utilimaster Corp., 47699-47702 2012-19581 National Indian National Indian Gaming Commission RULES Definition of Enforcement Action, 47513-47514 2012-19169 Enforcement Actions, 47517-47519 2012-19163 Issuance of Investigation Completion Letters, 47516-47517 2012-19166 Management Contracts: Background Investigations, 47514-47516 2012-19153 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 47653 2012-19431 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 47653 2012-19546 National Institute of Diabetes and Digestive and Kidney Diseases, 47653-47654 2012-19547 National Institute on Alcohol Abuse and Alcoholism, 47654 2012-19542 National Institute on Drug Abuse, 47654-47655 2012-19539 2012-19545 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings:

Caribbean Fishery Management Council; Correction, 47603 2012-19472 Takes of Marine Mammals Incidental to Specified Activities: Construction and Race Event Activities for the 34th America's Cup in San Francisco Bay, CA, 47603-47617 2012-19554 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47675-47676 2012-19534 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Program to Stimulate Competitive Research Jurisdictional Survey, 47676-47677 2012-19531 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Consideration of Issuance of Amendment to Facility Operating Licenses:

Duke Energy Carolinas, LLC; McGuire Nuclear Station, Units 1 and 2, 47677-47680 2012-19540 Meetings: Advisory Committee on Reactor Safeguards; Revisions, 47680 2012-19548 Requests for Actoin: Entergy Nuclear Operations, Inc., Pilgrim Nuclear Power Station, 47680-47681 2012-19537 Patent Patent and Trademark Office RULES International Trademark Classification Changes, 47528-47530 2012-19568 Postal Service Postal Service NOTICES Meetings; Sunshine Act, 47681 2012-19721 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances:

Honoring the Victims of the Tragedy in Oak Creek, Wisconsin (Proc. 8846), 47761-47763 2012-19746 National Health Center Week (Proc. 8847), 47765-47766 2012-19749 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 47681 2012-19604 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange LLC, 47681-47688 2012-19489 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47688-47690 2012-19493 State Department State Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Civilian Response Corps Database In-Processing Electronic Form, 47690-47691 2012-19562 Designations as Specially Designated Global Terrorists: Azzam Abdullah Zureik Al-Maulid Al-Subhi, also known as Azzam al-Subhi, et al., 47691 2012-19563 Surface Transportation Surface Transportation Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Statutory Authority to Preserve Rail Service, 47702-47704 2012-19555 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration See National Highway Traffic Safety Administration See Surface Transportation Board NOTICES Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits, 47691-47692 2012-19586 Transportation Services Transition from Paper to Electronic Fare Media, 47692-47693 2012-19584 Treasury Treasury Department See Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 47704 2012-19560 Customs U.S. Customs and Border Protection NOTICES Accreditations and Approvals as a Commercial Gauger: AMSPEC Services LLC, 47656 2012-19499 Immigration U.S. Immigration and Customs Enforcement NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notice to Student or Exchange Visitor, 47656 2012-19432 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Rehabilitation Needs Inventory, 47705-47706 2012-19490 Meetings: Advisory Committee on Disability Compensation, 47706 2012-19488 Separate Parts In This Issue Part II Housing and Urban Development Department, 47708-47759 2012-19335 Part III Presidential Documents, 47761-47763, 47765-47766 2012-19746 2012-19749 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. 77 154 Thursday, August 9, 2012 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 524 [Docket No. FDA-2012-N-0002] New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel AGENCY:

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

(FDA)is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. DATES: This rule is effective August 9, 2012. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, email: *george.haibel@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine is adopting use of a monthly **Federal Register** document to codify approval actions for new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs). CVM will no longer publish a separate rule for each action. This approach will allow a more efficient use of available resources. In this document, FDA is amending the animal drug regulations to reflect the original and supplemental approval actions during June 2012, 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.* Table 1—Original and Supplemental NADAs and ANADAs Approved During June 2012 NADA/ANADA Sponsor New animal drug product name Action 21 CFR section FOIA summary NEPA review 141-326 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 RILEXINE (cephalexin) Chewable Tablets for Dogs Original approval for the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of *Staphylococcus pseudintermedius* New 520.376 yes CE 1 141-337 Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave., Madison, WI 53703 RECUVYRA (fentanyl) Transdermal Solution Original approval for control of postoperative pain associated with surgical procedures in dogs New 524.916 yes CE 1 141-338 Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408 INTERCEPTOR SPECTRUM (milbemycin oxime/praziquantel) Chewable Tablets Original approval for prevention of heartworm disease caused by *Dirofilaria immitis* and for the treatment and control of adult roundworm ( *Toxocara canis, Toxascaris leonina* ), adult hookworm ( *Ancylostoma caninum* ), adult whipworm ( *Trichuris vulpis* ), and adult tapeworm ( *Taenia pisiformis, Echinococcus multilocularis,* and *E. granulosus* ) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older New 520.1445 yes CE 1 1 The agency has determined under 21 CFR 25.33 that this action is categorically excluded

(CE)from the requirement to submit an environmental assessment

(EA)or an environmental impact statement

(EIS)because it is of a type that does not individually or cumulatively have a significant effect on the human environment. 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 524 Animal drugs. 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, 21 CFR parts 510, 520, and 524 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “Nexcyon Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2), numerically add an entry for “050929” to 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 * * * * * Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave., Madison, WI 53703 050929 * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * 050929 Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave., Madison, WI 53703 * * * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 4. Section 520.376 is added to read as follows: § 520.376 Cephalexin.

(a)*Specifications.* Each chewable tablet contains 75, 150, 300, or 600 milligrams

(mg)cephalexin.

(b)*Sponsor.* See No. 051311 in § 510.600(c) of this chapter.

(c)*Conditions of use* —(1) *Dogs* —(i) *Amount.* Administer 22 mg per kilogram of body weight twice daily for 28 days.

(ii)*Indications for use.* For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of *Staphylococcus pseudintermedius.*

(iii)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2)[Reserved] § 520.1445 [Redesignated as § 520.1441] § 520.1446 [Redesignated as § 520.1443] 5. Redesignate §§ 520.1445 and 520.1446 as §§ 520.1441 and 520.1443, respectively. 6. Revise the section heading of newly redesignated § 520.1445 to read as follows: § 520.1441 Milbemycin oxime. 7. Revise the section heading of newly redesignated § 520.1446 to read as follows: § 520.1443 Milbemycin oxime and lufenuron. 8. Add new § 520.1445 to read as follows: § 520.1445 Milbemycin oxime and praziquantel.

(a)*Specifications.* Each chewable tablet contains:

(1)2.3 milligrams

(mg)milbemycin oxime and 22.8 mg praziquantel;

(2)5.75 mg milbemycin oxime and 57 mg praziquantel;

(3)11.5 mg milbemycin oxime and 114 mg praziquantel; or

(4)23 mg milbemycin oxime and 228 mg praziquantel.

(b)*Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c)*Conditions of use* —(1) *Dogs* —(i) *Amount.* Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.

(ii)*Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis* and for the treatment and control of adult roundworm ( *Toxocara canis, Toxascaris leonina* ), adult hookworm ( *Ancylostoma caninum* ), adult whipworm ( *Trichuris vulpis* ), and adult tapeworm ( *Taenia pisiformis, Echinococcus multilocularis,* and *E. granulosus* ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.

(iii)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2)[Reserved] PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 9. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 10. Add § 524.916 to read as follows: § 524.916 Fentanyl.

(a)*Specifications.* Each milliliter of solution contains 50 milligrams

(mg)fentanyl.

(b)*Sponsor.* See No. 050929 in § 510.600(c) of this chapter.

(c)*Conditions of use* —(1) *Dogs* —(i) *Amount.* 1.2 mg/lb (2.7 mg/kg) applied topically to the dorsal scapular area 2 to 4 hours prior to surgery.

(ii)*Indications for use.* For the control of postoperative pain associated with surgical procedures in dogs.

(iii)*Limitations.* Fentanyl is a Class II controlled substance. Observe all “black-box warnings” on product labeling. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2)[Reserved] Dated: August 3, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2012-19498 Filed 8-8-12; 8:45 am]

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