[Federal Register Volume 68, Number 110 (Monday, June 9, 2003)]
[Rules and Regulations]
[Page 34293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14303]


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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; Technical Amendment

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 Cyanamid Co., to Fort Dodge Animal 
Health, Division of Wyeth Holdings Corp. The regulations are also being 
revised to correct the address for Fort Dodge Animal Health, Division 
of Wyeth.

DATES: This rule is effective June 9, 2003.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855; 301-827-6967; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501, has 
informed FDA of a change of name to Fort Dodge Animal Health, Division 
of Wyeth Holdings Corp. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c) to reflect the change.
    In addition, when the name of Fort Dodge Animal Health, Division of 
American Home Products Corp. was changed to Fort Dodge Animal Health, 
Division of Wyeth (67 FR 67520, November 6, 2002), an inaccurate 
correction to the address was made. At this time, it is being changed 
to the original and correct 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.

List of Subjects in 21 CFR Part 510

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

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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

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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]

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2. Section 510.600 Names, addresses, and drug labeler codes of sponsors 
of approved applications is amended.
    a. In the table in paragraph (c)(1), in the entry for ``Fort Dodge 
Animal Health, Division of Wyeth'' and in the table in paragraph 
(c)(2), in the entry for ``000856'' by removing ``500'' and by adding 
in its place ``800''.
    b. In the table in paragraph (c)(1), in the entry for ``Fort Dodge 
Animal Health, Division of American Cyanamid Co.'' and in the table in 
paragraph (c)(2), in the entry for ``053501'' by removing ``American 
Cyanamid Co.'' and by adding in its place ``Wyeth Holdings Corp.''.

    Dated: May 19, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-14303 Filed 6-6-03; 8:45 am]
BILLING CODE 4160-01-S