[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Page 29479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14649]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


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 the change of sponsor for an approved new 
animal drug application (NADA) from Syntex Animal Health, Division of 
Syntex Agri-business, Inc., to Fort Dodge Laboratories, Division of 
American Home Products.

EFFECTIVE DATE: June 11, 1996.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Syntex Animal Health, Division of Syntex 
Agri-business, Inc., 3401 Hillview Ave., Palo Alto, CA 94303, has 
informed FDA that it has transferred the ownership of, and all rights 
and interests in, the approved NADA 141-043 (Synovex Plus) to Fort 
Dodge Laboratories, Division of American Home Products Corp., 800 5th 
St. NW., Fort Dodge, IA 50501. -Accordingly, FDA is amending the 
regulations in 21 CFR part 522.2478 to reflect the change of sponsor.

List of Subjects in 21 CFR Part 522

    Animal drugs.
    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec. 522.2478  [Amended]

    2. Section 522.2478 Trenbolone acetate and estradiol benzoate is 
amended in paragraph (a) by removing ``000033'' and adding in its place 
``000856''.

    Dated: May 22, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-14649 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F