[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Rules and Regulations]
[Pages 25641-25642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's Name and Address

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's name and address for 
Global Pharmaceutical Corp.

DATES: This rule is effective May 3, 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: Global Pharmaceutical Corp., Castor and 
Kensington Aves., Philadelphia, PA 19124, has informed FDA of a change 
of sponsor's name and address to IMPAX Laboratories, Inc., 30831 
Huntwood Ave., Hayward, CA 94544. Accordingly, the agency is amending 
the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the 
change of sponsor's name and address.
    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.

[[Page 25642]]

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

    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 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Global Pharmaceutical Corp.'' and by 
alphabetically adding an entry for ``IMPAX Laboratories, Inc., 30831 
Huntwood Ave., Hayward, CA 94544''; and in the table in paragraph 
(c)(2) in the entry for ``000115'' by removing the sponsor name and 
address and by adding their place ``IMPAX Laboratories, Inc., 30831 
Huntwood Ave., Hayward, CA 94544.

    Dated: April 24, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-10932 Filed 5-2-00; 8:45 am]
BILLING CODE 4160-01-F