[Federal Register: November 2, 2005 (Volume 70, Number 211)]
[Rules and Regulations]
[Page 66257-66258]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no05-6]
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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:
john.harshman@fda.gov.
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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