[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Rules and Regulations]
[Pages 2566-2567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-761]


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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 
liquid Type A medicated article to make Type C medicated feeds for 
heifers fed in confinement for slaughter and for heifers intended for 
breeding.

DATES: This rule is effective January 14, 2005.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
343 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix, a 
liquid Type A medicated article used to make dry and liquid Type C 
medicated feeds for heifers fed in confinement for slaughter and for 
heifers intended for breeding. Ivy Laboratories' HEIFERMAX 500 Liquid 
Premix is approved as a generic copy of Pharmacia and Upjohn Co.'s MGA 
500 (melengestrol acetate) Liquid Premix, approved under NADA 39-402. 
The application is approved as of December 3, 2004, and the regulations 
are amended in 21 CFR 558.342 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.
    The agency 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 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.

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2. Section 558.342 is amended by revising paragraph (b) and in the 
table in

[[Page 2567]]

paragraphs (e)(1)(i) and (e)(1)(ii) in the ``Sponsor'' column by adding 
in numerical sequence ``021641'' to read as follows:


Sec.  558.342  Melengestrol.

* * * * *
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 000009 for use of products described in paragraph (a) of 
this section.
    (2) No. 021641 for use of product described in paragraph (a)(2) of 
this section.
* * * * *

    Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-761 Filed 1-13-05; 8:45 am]
BILLING CODE 4160-01-S