[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Rules and Regulations]
[Page 20533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3820]


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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 and 
Monensin

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 single-ingredient Type A 
medicated articles containing melengestrol and monensin to make two-way 
combination drug Type C medicated feeds for heifers fed in confinement 
for slaughter.

DATES: This rule is effective April 21, 2006.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
422 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and 
RUMENSIN (monensin sodium) single-ingredient Type A medicated articles 
to make, two-way combination drug Type C medicated feeds for heifers 
fed in confinement for slaughter. Ivy Laboratories' ANADA 200-422 is 
approved as a generic copy of Pharmacia and Upjohn's NADA 125-476 for 
combination use of MGA 500 (melengestrol acetate) Liquid Premix and 
RUMENSIN in cattle feed. The application is approved as of March 22, 
2006, and the regulations are amended in 21 CFR 558.342 to reflect the 
approval. The basis of approval is discussed in 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)(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.


Sec.  558.342  [Amended]

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2. In Sec.  558.342, amend the table in paragraphs (e)(1)(v) and 
(e)(1)(vi) in the ``Sponsor'' column by adding in numerical sequence 
``021641''.

    Dated: April 7, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3820 Filed 4-20-06; 8:45 am]
BILLING CODE 4160-01-S