[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Rules and Regulations]
[Page 67520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28154]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 from Fort Dodge 
Animal Health, Division of American Home Products Corp. to Fort Dodge 
Animal Health, Division of Wyeth and to correct the sponsor's street 
address.

DATES: This rule is effective November 6, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products Corp., 500 Fifth St. NW., Fort Dodge, IA 50501, 
has informed FDA of a change of name to Fort Dodge Animal Health, 
Division of Wyeth. Accordingly, the agency is amending the regulations 
in 21 CFR 510.600(c) to reflect the change. In addition, when this 
sponsor's address was first codifed (61 FR 5505, February 13, 1996), an 
incorrect street number was included. At this time, it is being 
corrected.
    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.

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) in the entry for ``Fort Dodge Animal Health, Division of 
American Home Products Corp.'' by removing ``American Home Products 
Corp.'' and ``800'' and by adding in their places, respectively, 
``Wyeth'' and ``500''; and in the table in paragraph (c)(2) in the 
entry for ``000856'' by removing ``American Home Products Corp.'' and 
``800'' and by adding in their places, respectively, ``Wyeth'' and 
``500''.

    Dated: October 28, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-28154 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S