Document ID: FDA-2010-N-0002-0009
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Bacitracin Zinc; Nicarbazin
Posted Date: 2010-02-22T05:00Z

[Federal Register: February 22, 2010 (Volume 75, Number 34)]
[Rules and Regulations]               
[Page 7555]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe10-7]                         

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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.

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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 
two-way 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.

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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

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.366   [Amended]

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2. In Sec.  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]
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