10484 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

Street Ter., St. Joseph, MO 64503, filed 

ANADA 200–463 that provides for the 

use of Amprolium 9.6% Oral Solution 

to make medicated drinking water for 

chickens and turkeys for the treatment 

of coccidiosis. IVX Animal Health, Inc.’s 

Amprolium 9.6% Oral Solution is 

approved as a generic copy of 

Huvepharma, AD’s AMPROVINE 9.6% 

Solution, approved under NADA 13– 

149. The ANADA is approved as of 

February 12, 2009, and the regulations 

are amended in 21 CFR 520.100 to 

reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support 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. 

FDA has determined under 21 CFR 

25.33(a)(1) 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 520 

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 part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 520.100, revise paragraph (b)(3) 

to read as follows: 

§ 520.100 Amprolium. 

* * * * * 

(b) * * * 

(3) No. 059130 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (d) of this 

section. 

* * * * * 

Dated: February 27, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–5131 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

[Docket No. FDA–2009–N–0665] 

Other Dosage Form New Animal 

Drugs; Sevoflurane 

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 of a supplemental new animal 

drug application (NADA) filed by 

Abbott Laboratories, Inc. The 

supplemental NADA provides for a 

revised induction dose of sevoflurane 

inhalant anesthetic in dogs. 

DATES: This rule is effective March 11, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Abbott 

Laboratories, North Chicago, IL 60064, 

has filed a supplement to NADA 141– 

103 for SEVOFLO (sevoflurane) used for 

induction and maintenance of general 

anesthesia in dogs. The supplemental 

NADA provides for a revised induction 

dose of sevoflurane. The supplemental 

NADA is approved as of July 27, 2006, 

and the regulations are amended in 21 

CFR 529.2150 to reflect the approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(d)(1) 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 529 

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 part 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 529.2150 [Amended] 

■ 2. In § 529.2150, in the first sentence 

in paragraph (c)(1), remove ‘‘5 to 7 

percent sevoflurane’’ and in its place 

add ‘‘Up to 7 percent sevoflurane’’. 

Dated: March 3, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–4879 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 110 

[Docket No. USCG–2008–0155] 

RIN 1625–AA01 

Anchorage Regulations; Port of New 

York 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

size of Romer Shoal Anchorage Ground 

in Lower New York Bay. This action is 

necessary to facilitate safe navigation in 

the area and to provide safe and secure 

anchorages for vessels transiting this 

area. This change to the anchorage is 

intended to increase the safety of life 

and property within this area of the Port 

of New York by providing for greater 

safety of anchored vessels and to 

enhance the safe and efficient flow of 

commercial vessels and commerce. 

DATES: This rule is effective April 10, 

2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2008–0155 and are 

available online by going to http:// 

www.regulations.gov, selecting the 


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