[Federal Register Volume 70, Number 44 (Tuesday, March 8, 2005)]
[Rules and Regulations]
[Pages 11120-11121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4480]


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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 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 address for Wellmark 
International.

DATES: This rule is effective March 8, 2005.

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: Wellmark International, 1100 East Woodfield 
Rd., suite 500, Schaumburg, IL 60173 has informed FDA of a change of 
address to 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 
60173. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c) to reflect the change.
    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.

0
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

0
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.
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
revising the entry for ``Wellmark International''; and in the table in 
paragraph (c)(2) by revising the entry for ``011536'' to read as 
follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

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             Firm name and address                  Drug labeler code
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                                * * * * *
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Wellmark International, 1501 East Woodfield      011536
 Rd., suite 200 West, Schaumburg, IL 60173
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                                * * * * *
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    (2) * * *

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    Drug labeler code                 Firm name and address
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                                * * * * *
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011536                   Wellmark International, 1501 East Woodfield
                          Rd., suite 200 West, Schaumburg, IL 60173
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                                * * * * *
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[[Page 11121]]

    Dated: February 16, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-4480 Filed 3-7-05; 8:45 am]
BILLING CODE 4160-01-S