Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6327 

been declared a designated new animal 

drug by FDA under section 573(a) of the 

FD&C Act. 

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 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 parts 510 and 516 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 ‘‘AB Science’’; and in the table 

in paragraph (c)(2), numerically add an 

entry for ‘‘052913’’ 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 

* * * * * 

AB Science, 3 Avenue 

George V, 75008 Paris, 

France ............................... 052913 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

052913 ........ AB Science, 3 Avenue George 

V, 75008 Paris, France. 

* * * * * 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 3. The authority citation for 21 CFR 

part 516 continues to read as follows: 

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

371. 

■ 4. Add § 516.1318 to subpart E to read 

as follows: 

§ 516.1318 Masitinib. 

(a) Specifications. Each tablet 

contains 50 or 150 milligrams (mg) 

masitinib mesylate. 

(b) Sponsor. See No. 052913 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. 12.5 mg/kilograms (5.7 mg/lb) 

of body weight daily. 

(2) Indications for use. For the 

treatment of recurrent (post-surgery) or 

nonresectable Grade II or III cutaneous 

mast cell tumors in dogs that have not 

previously received radiotherapy and/or 

chemotherapy except corticosteroids. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. It is a violation 

of Federal law to use this product other 

than as directed in the labeling. 

Dated: January 28, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–2519 Filed 2–3–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Department of the Army, Corps of 

Engineers 

33 CFR Part 334 

Restricted Area, Potomac River, 

Marine Corps Base Quantico, 

Quantico, VA 

AGENCY: U.S. Army Corps of Engineers, 

DoD. 

ACTION: Final rule. 

SUMMARY: The U.S. Army Corps of 

Engineers (Corps) is amending its 

regulations to establish a restricted area 

in the waters of the Potomac River 

extending offshore from the Marine 

Corps Air Facility (MCAF) at Marine 

Corps Base Quantico (MCB Quantico), 

located in Quantico, Virginia. The 

restricted area will address current 

security needs at MCB Quantico, 

including the protection of military 

assets at MCAF which includes the 

Presidential Helicopter Squadron 

(HMX–1). The restricted area will also 

protect public health by preventing 

vessels from disturbing a planned 

environmental remediation area that is 

located to the northeast of MCAF. 

DATES: Effective date: March 7, 2011. 

ADDRESSES: Headquarters, U.S. Army 

Corps of Engineers, Operations and 

Regulatory Community of Practice, 441 

G Street, NW., Washington, DC 20314– 

1000. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Olson, Headquarters, Operations 

and Regulatory Community of Practice, 

Washington, DC at 202–761–4922 or by 

e-mail at david.b.olson@usace.army.mil 

or Mr. Steve Elinsky, U.S. Army Corps 

of Engineers, Baltimore District, 

Regulatory Branch, at 410–962–4503 or 

by e-mail at 

steve.elinsky@usace.army.mil. 

SUPPLEMENTARY INFORMATION: Pursuant 

to its authorities in Section 7 of the 

Rivers and Harbors Act of 1917 (40 Stat. 

266; 33 U.S.C. 1) and Chapter XIX of the 

Army Appropriations Act of 1919 (40 

Stat. 892; 33 U.S.C. 3), the Corps is 

amending its regulations to establish a 

restricted area in the waters of the 

Potomac River extending offshore from 

the MCAF at MCB Quantico, located in 

Quantico, Virginia. The restricted area 

will address current security needs at 

MCB Quantico, including the protection 

of military assets at MCAF which 

includes the Presidential Helicopter 

Squadron (HMX–1). The restricted area 

will also protect public health by 

preventing vessels from disturbing a 

planned environmental remediation 

area that is located to the northeast of 

MCAF. 

The proposed rule was published in 

the August 31, 2010, edition of the 

Federal Register (75 FR 53264) and the 

docket number was COE–2010–0032. In 

September 2010, the Corps Baltimore 

and Norfolk districts issued public 

notices soliciting comments on the 

proposal from all known interested 

parties. The districts received three 

comments. 

One commenter indicated that this 

action does not require essential fish 

habitat (EFH) conservation measures to 

protect EFH. Another commenter said 

that the proposed undertaking would 

have no effect on historic resources in 

Maryland. One commenter stated that 

the establishment of the restricted area 

would not impact recreation nor would 

it adversely affect any documented 

state-listed plant or animal species in 

Virginia. 

None of these comments warrant 

changes to the rule text. However, to 

provide clarity in the final rule, the 

following changes were made to the rule 

text: 

1. The provisions concerning the 

timing of the restrictions stated in 


jdjones on DSK8KYBLC1PROD with RULES
6328 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

paragraph (b)(2) of the proposed rule 

were moved to paragraph (b)(1). 

2. The last two sentences of paragraph 

(a) of the proposed rule were moved to 

paragraph (b)(2). 

3. To clearly indicate that limited 

access to the restricted area by 

commercial fishermen may be granted 

by the Marine Corps, the first sentence 

of paragraph (b)(3) of the proposed rule 

was moved to create a new paragraph 

(d). 

4. The following sentence from 

paragraph (c) of the proposed rule was 

not included in the final rule to simplify 

the enforcement provision of this 

section: ‘‘USMC boats with law 

enforcement personnel will randomly 

patrol the restricted area and provide a 

response capability. All persons, 

vessels, or other craft are prohibited 

from entering, transiting, drifting, 

dredging, or anchoring within the 

restricted area without the permission of 

the Commander, MCB Quantico or his/ 

her designated representative.’’ 

Administrative Requirements 

a. Review Under Executive Order 

12866. This rule is issued with respect 

to a military function of the Department 

of Defense, and the provisions of 

Executive Order 12866 do not apply. 

b. Regulatory Flexibility Act, as 

Amended by the Small Business 

Regulatory Enforcement Fairness Act of 

1996, 5 U.S.C. 601 et seq. This rule has 

been reviewed under the Regulatory 

Flexibility Act (Pub. L. 96–354), which 

requires the preparation of a regulatory 

flexibility analysis for any regulation 

that will have a significant economic 

impact on a substantial number of small 

entities (i.e., small businesses and small 

governments). The Corps determined 

that the establishment of the new 

restricted area zone would not have a 

significant economic impact on a 

substantial number of small entities. For 

more detailed analysis of potential 

economic impacts of this rule, please 

see the regulatory analysis in the 

environmental assessment. 

c. Review Under the National 

Environmental Policy Act. An 

environmental assessment (EA) has 

been prepared. After considering the 

comments received in response to the 

proposed rule, we have concluded that 

the establishment of a restricted area at 

MCB Quantico will not have a 

significant impact to the quality of the 

human environment and, therefore, 

preparation of an environmental impact 

statement is not required. The final EA 

and Finding of No Significant Impact 

may be reviewed at the Baltimore 

District Office. Please contact Mr. Steve 

Elinsky at the phone number specified 

above for further information. 

d. Unfunded Mandates Reform Act. 

This rule does not impose an 

enforceable duty among the private 

sector and, therefore, is not a Federal 

private sector mandate and is not 

subject to the requirements of Section 

202 or 205 of the Unfunded Mandates 

Reform Act (Pub. L. 104–4, 109 Stat. 48, 

2 U.S.C. 1501 et seq.). We have also 

found, under Section 203 of the Act, 

that small governments will not be 

significantly or uniquely affected by this 

rule. 

List of Subjects in 33 CFR Part 334 

Danger zones, Navigation (water), 

Transportation, Waterways. 

For the reasons stated in the 

preamble, the Corps amends 33 CFR 

part 334 as follows: 

PART 334—DANGER ZONE AND 

RESTRICTED AREA REGULATIONS 

■ 1. The authority citation for 33 CFR 

part 334 continues to read as follows: 

Authority: 40 Stat. 266 (33 U.S.C. 1) and 

40 Stat. 892 (33 U.S.C. 3). 

■ 2. Add § 334.235 to read as follows: 

§ 334.235 Potomac River, Marine Corps 

Base Quantico (MCB Quantico) in vicinity of 

Marine Corps Air Facility (MCAF), restricted 

area. 

(a) The area. All of the navigable 

waters of the Potomac River extending 

approximately 500 meters from the 

high-water mark on the Eastern 

shoreline of the MCAF, bounded by 

these coordinates (including the 

Chopawamsic Creek channel, but 

excluding Chopawamsic Island): 

Beginning at latitude 38°29′34.04′′ N, 

longitude 077°18′22.4′′ W (Point A); 

thence to latitude 38°29′43.01′′ N, 

longitude 077°18′4.1′′ (Point B); thence 

to latitude 38°29′55.1′′ N, longitude 

077°17′51.3′′ W (Point C); thence to 

latitude 38°30′10.1′′ N, longitude 

077°17′40.3′′ W (Point D); thence to 

latitude 38°30′23.43′′ N, longitude 

077°17′50.30′′ W (Point E); then along 

the western shoreline of Chopawamsic 

Island to latitude 38°30′35.13′′ N, 

longitude 077°17′47.45′′ W (Point F); 

thence to latitude 38°30′42.1′′ N, 

longitude 077°17′37.1′′ W (Point G); 

thence to latitude 38°30′50.71′′ N, 

longitude 077°17′54.12′′ W (Point H); 

then along the shoreline to latitude 

38°30′0.058′′ N, longitude 077°18′39.26′′ 

W (Point I); then across the 

Chopawamsic Channel to latitude 

38°29′58.45′′ N, longitude 077°18′39.97′′ 

W (Point J); thence to latitude 

38°29′38.2′′ N, longitude 077°18′38.14′′ 

W (Point K); and thence to the 

beginning point of origin. 

(b) The regulations. (1) All persons, 

vessels, or other craft are prohibited 

from entering, transiting, drifting, 

dredging, or anchoring within the 

restricted area without the permission of 

the Commander, MCB Quantico or his/ 

her designated representatives. The 

restriction will be in place 24 hours a 

day, seven days a week. 

(2) The boundary of the restricted area 

will be demarcated with marker buoys 

and warning signs set at 500 foot 

intervals. In addition, lighted, floating, 

small craft intrusion barriers will be 

placed across the Chopawamsic Creek 

channel at the entrance to the channel 

from the Potomac River and 

immediately west of the CSX railroad 

bridge. 

(c) Enforcement. The regulations in 

this section shall be enforced by the 

Commander, MCB Quantico or any such 

agencies he/she designates. The areas 

identified in paragraph (a) of this 

section will be monitored 24 hours a 

day, 7 days a week. Any person or 

vessel encroaching within the areas 

identified in paragraph (a) of this 

section will be directed to immediately 

leave the restricted area. Failure to do so 

could result in forceful removal and/or 

criminal charges. 

(d) Exceptions. Commercial fisherman 

will be authorized controlled access to 

the restricted area (with the exception of 

Chopawamisc Creek channel) after 

registering with MCB Quantico officials 

and following specific access 

notification procedures. 

Dated: January 31, 2011. 

Michael G. Ensch, 

Chief, Operations and Regulatory, Directorate 

of Civil Works. 

[FR Doc. 2011–2478 Filed 2–3–11; 8:45 am] 

BILLING CODE 3720–58–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 51 and 93 

[FRL–9261–6] 

Official Release of the January 2011 

AP–42 Method for Estimating ReEntrained Road Dust From Paved 

Roads 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Announcement of Availability. 

SUMMARY: On January 13, 2011, EPA 

posted the latest version of the method 

for estimating re-entrained road dust 

emissions from cars, trucks, buses, and 


jdjones on DSK8KYBLC1PROD with RULES