[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Rules and Regulations]
[Pages 66257-66258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Melengestrol

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 abbreviated new animal drug 
application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal 
Health, Inc. The ANADA provides for use of a melengestrol acetate Type 
A medicated article with monensin and tylosin Type A medicated articles 
to make three-way combination Type C medicated feeds for heifers fed in 
confinement for slaughter.

DATES: This rule is effective November 2, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
375 that provides for use of HEIFERMAX 500 Liquid Premix (melengestrol 
acetate), RUMENSIN (monensin sodium), and TYLAN (tylosin tartrate) Type 
A medicated articles to make dry and liquid three-way combination Type 
C medicated feeds used for increased rate of weight gain and improved 
feed efficiency, prevention and control of coccidiosis due to Eimeria 
bovis and E. zuernii, for suppression of estrus (heat), and reduction 
of incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement 
for slaughter. Ivy Laboratories' ANADA 200-375 is approved as a generic 
copy of Pharmacia & Upjohn's NADA 138-870. The ANADA is approved as of 
September 19, 2005, and the regulation in 21 CFR 558.342 is amended to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    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)(2) 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.

[[Page 66258]]

Sec.  558.342  [Amended]

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2. Section 558.342 is amended in paragraph (e)(1)(vii) in the table in 
the ``Sponsor'' column by adding in numerical sequence ``021641''.

    Dated: October 13, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-21808 Filed 11-1-05; 8:45 am]
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