64714 Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations 

phone: (425) 917–6479; fax: (425) 917–6590; 

email: gregg.nesemeier@faa.gov. 

(l) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(3) The following service information was 

approved for IBR on November 27, 2012. 

(i) Boeing Alert Service Bulletin 737– 

22A1211, dated April 13, 2010. 

(ii) Boeing Alert Service Bulletin 737– 

22A1224, dated May 18, 2012. 

(4) The following service information was 

approved for IBR on May 12, 2005 (70 FR 

17603, April 7, 2005). 

(i) Boeing Alert Service Bulletin 737– 

22A1164, dated May 20, 2004. 

(ii) Reserved. 

(5) For The Boeing Company service 

information identified in this AD, contact 

Boeing Commercial Airplanes, Attention: 

Data & Services Management, P.O. Box 3707, 

MC 2H–65, Seattle, WA 98124–2207; 

telephone 206–544–5000, extension 1; fax 

206–766–5680; Internet https:// 

www.myboeingfleet.com. 

(6) You may view this service information 

at FAA, Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, Washington. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

(7) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http:// 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on October 

5, 2012. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–25782 Filed 10–22–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2012–0569; Airspace 

Docket No. 12–ANM–17] 

Modification of Class E Airspace; Wolf 

Point, MT 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action modifies Class E 

airspace at Wolf Point, MT. Controlled 

airspace is necessary to accommodate 

aircraft using Nondirectional Radio 

Beacon (NDB) standard instrument 

approach procedures at L M Clayton 

Airport, Wolf Point, MT. This improves 

the safety and management of 

Instrument Flight Rules (IFR) operations 

at the airport. 

DATES: Effective date, 0901 UTC, 

January 10, 2013. The Director of the 

Federal Register approves this 

incorporation by reference action under 

1 CFR Part 51, subject to the annual 

revision of FAA Order 7400.9 and 

publication of conforming amendments. 

FOR FURTHER INFORMATION CONTACT: 

Eldon Taylor, Federal Aviation 

Administration, Operations Support 

Group, Western Service Center, 1601 

Lind Avenue SW., Renton, WA 98057; 

telephone (425) 203–4537. 

SUPPLEMENTARY INFORMATION: 

History 

On July 24, 2012, the FAA published 

in the Federal Register a notice of 

proposed rulemaking (NPRM) to modify 

controlled airspace at L M Clayton 

Airport, Wolf Point, MT (77 FR 43183). 

Interested parties were invited to 

participate in this rulemaking effort by 

submitting written comments on the 

proposal to the FAA. No comments 

were received. 

Class E airspace designations are 

published in paragraph 6005, of FAA 

Order 7400.9W dated August 8, 2012, 

and effective September 15, 2012, which 

is incorporated by reference in 14 CFR 

Part 71.1. The Class E airspace 

designations listed in this document 

will be published subsequently in that 

Order. 

The Rule 

This action amends Title 14 Code of 

Federal Regulations (14 CFR) part 71 by 

modifying Class E airspace extending 

upward from 700 feet above the surface, 

at L M Clayton Airport, to accommodate 

IFR aircraft executing NDB standard 

instrument approach procedures at the 

airport. This action is necessary for the 

safety and management of IFR 

operations. 

The FAA has determined this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified this rule, when promulgated, 

will not have a significant economic 

impact on a substantial number of small 

entities under the criteria of the 

Regulatory Flexibility Act. The FAA’s 

authority to issue rules regarding 

aviation safety is found in Title 49 of the 

U.S. Code. Subtitle 1, Section 106 

discusses the authority of the FAA 

Administrator. Subtitle VII, Aviation 

Programs, describes in more detail the 

scope of the agency’s authority. This 

rulemaking is promulgated under the 

authority described in Subtitle VII, Part 

A, Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it modifies 

controlled airspace at L M Clayton 

Airport, Wolf Point, MT. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1E, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 311a. This airspace action is 

not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

Part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR Part 71.1 of the Federal Aviation 

Administration Order 7400.9W, 

Airspace Designations and Reporting 

Points, dated August 8, 2012, and 

effective September 15, 2012 is 

amended as follows: 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 205 / Tuesday, October 23, 2012 / Rules and Regulations 64715 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

ANM MT E5 Wolf Point, MT [Modified] 

Wolf Point, L M Clayton Airport, MT 

(Lat. 48°05′40′′ N., long. 105°34′30′′ W.) 

That airspace extending upward from 700 

feet above the surface within an 8-mile radius 

of L M Clayton Airport; that airspace 

extending upward from 1,200 feet above the 

surface bounded by a line beginning at lat. 

48°02′00′′ N., long. 104°13′00′′ W.; to lat. 

47°48′00′′ N., long. 104°33′00′′ W.; to lat. 

47°48′00′′ N., long. 106°00′02′′ W.; to lat. 48° 

20′00′′ N., long. 106°00′02′′ W.; to lat. 

48°20′00′′ N., long. 104°17′00′′ W.; thence to 

the point of beginning. 

Issued in Seattle, Washington, on October 

11, 2012. 

John Warner, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2012–26043 Filed 10–22–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 522, 524, 529, and 

558 

[Docket No. FDA–2012–N–0002] 

New Animal Drugs; Approvals; 

Changes of Sponsor; Change of 

Sponsor’s Name; Change of Sponsor’s 

Address; Alfaxalone; Ivermectin and 

Clorsulon; Narasin; Triptorelin 

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 September 2012. FDA 

is also informing the public of the 

availability of summaries the basis of 

approval and of environmental review 

documents, where applicable. The 

animal drug regulations are also being 

amended to reflect a change of 

sponsorship for four ophthalmic 

ointments, a change of sponsor’s name, 

and a change of sponsor’s address. 

DATES: This rule is effective October 23, 

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 is 

amending the animal drug regulations to 

reflect approval actions during 

September 2012, as listed in table 1. 

With respect to these actions, FDA is 

also 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 

through the Center for Veterinary 

Medicine’s FOIA Electronic Reading 

Room. FOI Summaries may be found 

listed by application number at: http:// 

www.fda.gov/AnimalVeterinary/ 

Products/ 

ApprovedAnimalDrugProducts/ 

FOIADrugSummaries/default.htm. 

Environmental Assessments (EAs) and 

Finding Of No Serious Impacts 

(FONSIs) may be found listed by the 

established name of the active 

pharmaceutical ingredient at: http:// 

www.fda.gov/AnimalVeterinary/ 

DevelopmentApprovalProcess/ 

EnvironmentalAssessments/ 

ucm300656.htm. 

Also, Fougera Pharmaceuticals, Inc., 

P.O. Box 2006, 60 Baylis Rd., Melville, 

NY 11747, has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, NADA 065–015 for 

VETROPOLYCIN HC (bacitracin zinc, 

polymyxin B sulfate, neomycin sulfate, 

and hydrocortisone) Ophthalmic 

Ointment, NADA 065–016 for 

VETROPOLYCIN (bacitracin zinc, 

neomycin sulfate, and polymyxin B 

sulfate) Ophthalmic Ointment, NADA 

065–460 for VETROCLORICIN 

(chloramphenicol) Ophthalmic 

Ointment, and ANADA 200–273 for 

VETRO–GEN (gentamicin sulfate) 

Ophthalmic Ointment to Dechra Ltd., 

Dechra House, Jamage Industrial Estate, 

Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom. Accordingly, the Agency is 

amending the regulations in 21 CFR part 

524 to reflect these changes. 

In addition, UDL Laboratories, Inc., 

12720 Dairy Ashford Rd., Sugar Land, 

TX 77478, has informed FDA that it has 

changed its name to Mylan Institutional, 

Inc., and ECO LLC, 8209 Hollister Ave., 

Las Vegas, NV 89131 has informed FDA 

of a change of address to 344 Nassau St., 

Princeton, NJ 08540. Accordingly, the 

Agency is amending the regulations in 

21 CFR 510.600(c) to reflect these 

changes. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2012 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR Section 

FOIA 

Summary 

NEPA 

Review 

141–339 ... JBS United Animal Health II LLC, 

322 S. Main St., Sheridan, IN 

46069.

OVUGEL (triptorelin acetate) ......... Original approval for the synchronization of time of insemination in 

weaned sows to facilitate a single fixed-time artificial insemination.

529.2620 yes .......... CE1

141–340 ... Elanco Animal Health, A Division 

of Eli Lilly & Co., Lilly Corporate 

Center, Indianapolis, IN 46285.

SKYCIS 100 (narasin) Type A 

medicated article.

Original approval for use in medicated feed for increased rate of 

weight gain and improved feed 

efficiency in growing-finishing 

swine.

558.363 yes .......... EA/ 

FONSI 2

141–342 ... Jurox Pty. Ltd., 85 Gardiner Rd., 

Rutherford, NSW 2320, Australia.

ALFAXAN (alfaxalone) Intravenous 

Injectable Anesthetic for Cats 

and Dogs.

Original approval for the induction 

and maintenance of anesthesia 

and for induction of anesthesia 

followed by maintenance with an 

inhalant anesthetic, in dogs and 

cats.

522.52 yes .......... CE1


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