[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27068]


[[Page Unknown]]

[Federal Register: November 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
 

Animal Drugs, Feeds, and Related Products; Change of Sponsor

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 a change of sponsor for a new animal drug 
application (NADA) from Triple ``F'', Inc., to A. L. Laboratories, Inc.

EFFECTIVE DATE: November 1, 1994.

FOR FURTHER INFORMATION CONTACT:  Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: Triple ``F'', Inc., 10104 Douglas Ave., Des 
Moines, IA 50322, has informed FDA that it has transferred ownership 
of, and all rights and interests in, approved NADA 133-334 
(Virginiamycin) to A. L. Laboratories, Inc., One Executive Dr., P.O. 
Box 1399, Fort Lee, NJ 07024. Accordingly, the agency is amending the 
regulations in 21 CFR 558.635(b)(2) to reflect the change of sponsor.

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.  558.635  [Amended]

    2. Section 558.635 Virginiamycin is amended in paragraph (b)(2) by 
removing ``011490'' and adding in its place ``046573''.

    Dated: October 24, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-27068 Filed 10-31-94; 8:45 am]
BILLING CODE 4160-01-F