35836 Federal Register / Vol. 77, No. 116 / Friday, June 15, 2012 / Rules and Regulations 

For the Nuclear Regulatory Commission. 

J.E. Dyer, 

Chief Financial Officer. 

[FR Doc. 2012–14589 Filed 6–14–12; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2012–0287; Airspace 

Docket No. 11–AWP–21] 

RIN 2120–AA66 

Amendment of Air Traffic Service 

Routes; Southwestern United States 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action modifies Jet Route 

J–2, and VOR Federal airways V–16, V– 

66 and V–202 in southern Arizona and 

New Mexico due to the scheduled 

decommissioning of the Cochise, AZ, 

VHF Omnidirectional Range Tactical 

Air Navigation (VORTAC) which 

currently is used to define segments of 

the routes. 

DATES: Effective date 0901 UTC, July 26, 

2012. 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: Paul 

Gallant, Airspace, Regulations and ATC 

Procedures Group, Office of Airspace 

Services, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

On April 23, 2012, the FAA published 

in the Federal Register a notice of 

proposed rulemaking (NPRM) to 

establish two new RNAV routes in the 

southwestern United States (78 FR 

24156). An NPRM correction published 

in the Federal Register of May 23, 2012 

(77 FR 30437) corrected the description 

of VOR Federal airway V–16. 

Interested parties were invited to 

participate in this rulemaking effort by 

submitting written comments on the 

proposal. One comment was received 

which expressed support for the 

proposal. 

The Rule 

The FAA is amending Title 14, Code 

of Federal Regulations (14 CFR) part 71 

to modify the descriptions of Jet Route 

J–2, and VOR Federal airways V–16, V– 

66 and V–202 in southern Arizona and 

New Mexico. The FAA is taking this 

action due to the scheduled 

decommissioning of the Cochise, AZ, 

VORTAC, which is used in the 

descriptions of the routes. Specifically, 

the portion of J–2 that extends from Gila 

Bend, AZ; to Cochise, AZ; to El Paso, 

TX is realigned to proceed from Gila 

Bend to Tucson, AZ, and then to El 

Paso, TX (with the remainder of the 

route is unchanged). The portion of V– 

16 that currently extends from Tucson, 

AZ; to Cochise, AZ; to Columbus, NM, 

is realigned to proceed from Tucson, 

AZ; to San Simon, AZ; then to 

Columbus, NM (remainder of route 

unchanged). V–66 is modified by 

removing language that excludes 

altitudes above 13,000 feet MSL in one 

segment of the route no longer required 

by air traffic control. V–202 currently 

extends from Tucson, AZ; to Cochise, 

AZ; to San Simon, AZ; to Silver City, 

NM; to Truth or Consequences, NM. The 

western portion of V–202 that extends 

between Tucson-Cochise-San Simon is 

deleted. The modified V–202 begins at 

San Simon, AZ; to Silver City, NM; to 

Truth or Consequences, NM. 

Jet Routes are published in paragraph 

2004, and Domestic VOR Federal 

airways are published in paragraph 

6010, of FAA Order 7400.9V dated 

August 9, 2011, and effective September 

15, 2011, which is incorporated by 

reference in 14 CFR 71.1. The Jet Routes 

and VOR Federal airways listed in this 

document will be published 

subsequently in the Order. 

The FAA has determined that 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 Department of 

Transportation (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 that 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 United States Code. 

Subtitle I, Section 106 describes 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 the 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 Air Traffic Service routes to 

maintain the continuity of navigation 

guidance in the southwestern United 

States. 

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 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 71.1 of FAA Order 7400.9V, 

Airspace Designations and Reporting 

Points, dated August 9, 2011, and 

effective September 15, 2011, is 

amended as follows: 

Paragraph 2004 Jet routes. 

J–2 [Amended] 

From Mission Bay, CA, via Imperial, CA; 

Bard, AZ; INT of the Bard 089° and Gila 

Bend, AZ, 261° radials; Gila Bend; Tucson, 

AZ; El Paso, TX; Fort Stockton, TX; Junction, 

TX; San Antonio, TX; Humble, TX; Lake 

Charles, LA; Baton Rouge, LA; Semmes, AL; 

Crestview, FL; INT of the Crestview 091° and 

the Seminole, FL, 290° radials; Seminole to 

Taylor, FL. 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 116 / Friday, June 15, 2012 / Rules and Regulations 35837 

Paragraph 6010 Domestic VOR federal 

airways. 

V–16 [Amended] 

From Los Angeles, CA; Paradise, CA; Palm 

Springs, CA; Blythe, CA; Buckeye, AZ; 

Phoenix, AZ; INT Phoenix 155° and 

Stanfield, AZ, 105° radials; Tucson, AZ; San 

Simon, AZ; INT San Simon 119° and 

Columbus, NM, 277° radials; Columbus; El 

Paso, TX; Salt Flat, TX; Wink, TX; INT Wink 

066° and Big Spring, TX, 260° radials; Big 

Spring; Abilene, TX; Bowie, TX; Bonham, 

TX; Paris, TX; Texarkana, AR; Pine Bluff, AR; 

Marvell, AR; Holly Springs, MS; Jacks Creek, 

TN; Shelbyville, TN; Hinch Mountain, TN; 

Volunteer, TN; Holston Mountain, TN; 

Pulaski, VA; Roanoke, VA; Lynchburg, VA; 

Flat Rock, VA; Richmond, VA; INT 

Richmond 039° and Patuxent, MD, 228° 

radials; Patuxent; Smyrna, DE; Cedar Lake, 

NJ; Coyle, NJ; INT Coyle 036° and Kennedy, 

NY, 209° radials; Kennedy; INT Kennedy 

040° and Calverton, NY 261° radials; 

Calverton; Norwich, CT; Boston, MA. The 

airspace within Mexico and the airspace 

below 2,000 feet MSL outside the United 

States is excluded. The airspace within 

Restricted Areas R–5002A, R–5002C, and R– 

5002D is excluded during their times of use. 

The airspace within Restricted Areas R–4005 

and R–4006 is excluded. 

V–66 [Amended] 

From Mission Bay, CA; Imperial, CA; 13 

miles, 24 miles, 25 MSL; Bard, AZ; 12 miles, 

35 MSL; INT Bard 089° and Gila Bend, AZ, 

261ß radials; 46 miles, 35 MSL; Gila Bend; 

Tucson, AZ, 7 miles wide (3 miles south and 

4 miles north of centerline); Douglas, AZ; 

INT Douglas 064° and Columbus, NM, 277° 

radials; Columbus; El Paso, TX; 6 miles wide; 

INT El Paso 109° and Hudspeth, TX, 287° 

radials; 6 miles wide; Hudspeth; Pecos, TX; 

Midland, TX; INT Midland 083° and Abilene, 

TX, 252° radials; Abilene; to Millsap, TX. 

From Crimson, AL, Brookwood, AL; 

LaGrange, GA; INT LaGrange 120° and 

Columbus, GA, 068° radials; INT Columbus 

068° and Athens, GA, 195° radials; Athens; 

Greenwood, SC; Sandhills, NC; RaleighDurham, NC; Franklin, VA. 

V–202 [Amended] 

From San Simon, AZ; Silver City, NM; to 

Truth or Consequences, NM. 

Issued in Washington, DC, on June 7, 2012. 

Colby Abbott, 

Acting Manager, Airspace, Regulations and 

ATC Procedures Group. 

[FR Doc. 2012–14412 Filed 6–14–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2012–N–0002] 

Conditionally Approved New Animal 

Drugs for Minor Use and Minor 

Species; Masitinib 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

conditionally approved supplemental 

application for conditional approval of 

a new animal drug (CNADA) intended 

for a minor use filed by AB Science. The 

supplemental CNADA provides for a 

revised indication for masitinib 

mesylate tablets in dogs. 

DATES: This rule is effective June 15, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Steven Fleischer, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8234, 

email: steven.fleischer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: AB 

Science, 3 Avenue George V, 75008 

Paris, France, filed a supplemental 

CNADA 141–308 for KINAVET–CA1 

(masitinib mesylate) Tablets for a 

revised indication for the treatment of 

nonresectable Grade II or III cutaneous 

mast cell tumors in dogs that have not 

previously received radiotherapy and/or 

chemotherapy except corticosteroids. In 

accordance with the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), as 

amended by the Minor Use and Minor 

Species Animal Health Act of 2004 

(MUMS Act), this supplemental 

application is conditionally approved as 

of January 30, 2012, and the regulations 

in 21 CFR part 516 are amended to 

reflect this action. 

A summary of safety and effectiveness 

data and information submitted to 

support conditional approval of this 

application 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. 

KINAVET–CA1 (masitinib mesylate) 

Tablets for the intended uses 

conditionally approved by FDA under 

application number 141–308 qualifies 

for 7 years of exclusive marketing rights 

beginning on December 15, 2010, the 

date of the original conditional 

approval. This new animal drug 

qualifies for exclusive marketing rights 

under section 573(c) of the FD&C Act 

(21 U.S.C. 360ccc–2(c)) because it has 

been declared a designated new animal 

drug by FDA under section 573(a) of the 

FD&C Act. 

FDA has determined under 21 CFR 

25.33 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 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 in 21 CFR Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 516 is amended as follows: 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 1. The authority citation for 21 CFR 

part 516 continues to read as follows: 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. 

■ 2. In § 516.1318, revise paragraph 

(c)(2) to read as follows: 

§ 516.1318 Masitinib. 

* * * * * 

(c) * * * 

(2) Indications for use. For the 

treatment of nonresectable Grade II or III 

cutaneous mast cell tumors in dogs that 

have not previously received 

radiotherapy and/or chemotherapy 

except corticosteroids. 

* * * * * 

Dated: June 8, 2012. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2012–14635 Filed 6–14–12; 8:45 am] 

BILLING CODE 4160–01–P 


srobinson on DSK4SPTVN1PROD with RULES