[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Rules and Regulations]
[Page 6892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


New Animal Drugs; 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 an approved new 
animal drug application (NADA) from Bayer Corp., Agriculture Division, 
Animal Health to Schering-Plough Animal Health Corp.

DATES: This rule is effective February 11, 2000.

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: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201 has informed FDA that 
it has transferred ownership of, and all rights and interests in NADA 
113-645 (cloprostenol sodium) to Schering-Plough Animal Health Corp., 
1095 Morris Ave., Union, NJ 07083. Accordingly, the agency is amending 
the regulations in 21 CFR 522.460 to reflect the transfer of ownership.

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

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

    Authority: 21 U.S.C. 360b.


Sec. 522.460  [Amended]

    4. Section 522.460 Cloprostenol sodium is amended in paragraphs 
(a)(2) and (b)(2) by removing ``000859'' and adding in its place 
``000061''.

    Dated: January 24, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-3194 Filed 2-10-00; 8:45 am]
BILLING CODE 4160-01-F