[Federal Register Volume 60, Number 246 (Friday, December 22, 1995)]
[Rules and Regulations]
[Pages 66495-66496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31199]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Zoalene

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 a supplemental new animal drug 
application (NADA) filed by A. L. Pharma, Inc. The supplemental NADA 
provides for wider assay limits for zoalene Type A medicated articles. 
FDA is amending the regulation concerning medicated feed applications 
to reflect the approval.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2701.

SUPPLEMENTARY INFORMATION: A. L. Pharma, Inc., One Executive Dr., P.O. 
Box 1399, Fort Lee, NJ 07024, filed supplemental NADA 11-116, which 
provides for widening the current assay limits for zoalene Type A 
medicated articles. FDA reviewed the data and information submitted and 
is amending 21 CFR 558.4 to provide for an assay range of 92 to 104 
percent for zoalene Type A medicated articles.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    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-

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.4  [Amended]

    2. Section 558.4 Medicated feed applications is amended in 
paragraph (d) in the ``Category I'' table in the entry for ``Zoalene'' 
in the second column by removing ``98-104'' and adding in its place 
``92-104''.


[[Page 66496]]

    Dated: December 14. 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-31199 Filed 12-21-95; 8:45 am]
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