Document ID: FDA-2010-N-0002-0016
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Zilpaterol
Posted Date: 2010-03-11T05:00Z

[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Rules and Regulations]               
[Page 11451-11452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr10-8]                         

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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; Zilpaterol

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 three abbreviated new animal 
drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy 
Animal Health, Inc. The ANADAs provides for use of single-ingredient 
Type A medicated articles containing zilpaterol, melengestrol, 
monensin, and tylosin to make two-way, three-way, and four-way 
combination drug Type B and Type C medicated feeds for heifers fed in 
confinement for slaughter.

DATES:  This rule is effective March 11, 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: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-483 for 
use of ZILMAX (zilpaterol hydrochloride) and HEIFERMAX 500 
(melengestrol acetate) Liquid Premix single-ingredient Type A medicated 
articles to make dry and liquid, two way combination drug Type B and 
Type C medicated feeds for heifers fed in confinement for slaughter. 
Ivy Laboratories' ANADA 200-483 is approved as a generic copy of 
Intervet, Inc.'s combination medicated feed use of ZILMAX and MGA 500 
(melengestrol acetate), approved under NADA 141-284.
    Ivy Laboratories also filed ANADA 200-479 for use of ZILMAX, 
HEIFERMAX 500 Liquid Premix, and RUMENSIN (monensin USP) single-
ingredient Type A medicated articles to make dry and liquid, three-way 
combination drug Type B and Type C medicated feeds for heifers fed in 
confinement for slaughter. Ivy Laboratories' ANADA 200-479 is approved 
as a generic copy of Intervet, Inc.'s combination medicated feed use of 
ZILMAX, MGA 500, and RUMENSIN, approved under NADA 141-282.
    Ivy Laboratories also filed ANADA 200-480 for use of ZILMAX, 
HEIFERMAX 500 Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate) 
single-ingredient Type A medicated articles to make dry and liquid, 
four-way combination drug Type C medicated feeds for heifers fed in 
confinement for slaughter. Ivy Laboratories' ANADA 200-480 is approved 
as a generic copy of Intervet, Inc.'s combination medicated feed use of 
ZILMAX, MGA 500, RUMENSIN, and TYLAN, approved under NADA 141-280.
    The abbreviated applications are approved as of December 30, 2009, 
and the regulations are amended in 21 CFR 558.665 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 
each 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 these actions are 
of a type that do 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 Subject 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.  558.665   [Amended]

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2. In Sec.  558.665, in the table in paragraphs (e)(2), (e)(4), and 
(e)(6), in the ``Limitations'' column remove ``No. 000009'' and add in 
its place ``Nos. 000009 or 021641'' and in the ``Sponsor''

[[Page 11452]]

column add in numerical sequence ``021641''.

    Dated: March 8, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-5224 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S