Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Rules and Regulations 7555 

combat zone (as defined in 

§ 416.1160(d)). 

* * * * * 

[FR Doc. 2010–3383 Filed 2–19–10; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feeds; Bacitracin Zinc; Nicarbazin 

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 an original abbreviated new 

animal drug application (ANADA) filed 

by Alpharma, Inc. The ANADA 

provides for use of single-ingredient 

Type A medicated articles containing 

bacitracin zinc and nicarbazin to make 

two-way combination drug Type C 

medicated feeds for broiler chickens. 

DATES: This rule is effective February 

22, 2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Alpharma, 

Inc., 440 Rte. 22, Bridgewater, NJ 08807, 

filed ANADA 200–478 for use of 

ALBAC 50 (bacitracin zinc) and 

NICARB (nicarbazin) single-ingredient 

Type A medicated articles to make twoway combination drug Type C 

medicated feeds for broiler chickens. 

Alpharma, Inc.’s, ANADA 200–478 is 

approved as a generic copy of NADA 

141–146, sponsored by Phibro Animal 

Health, for combination use of 

BACIFERM (bacitracin zinc) and 

NICARB. The application is approved as 

of January 21, 2010, and the regulations 

are amended in 21 CFR 558.366 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. 

The agency 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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.366 [Amended] 

■ 2. In § 558.366, in the table in 

paragraph (d), in the ‘‘Nicarbazin in 

grams per ton’’ column, in the entry for 

‘‘113.5 (0.0125 pct.)’’ under the 

‘‘Combination in grams per ton’’ column, 

in the entry for ‘‘Bacitracin zinc 4 to 50,’’ 

add ‘‘046573’’ in numeral sequence 

under the ‘‘Sponsor’’ column. 

Dated: February 17, 2010. 

William T. Flynn, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. 2010–3328 Filed 2–19–10; 8:45 am] 

BILLING CODE 4160–01–S 


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