[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45875-45876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration, HHS

21 CFR Part 510


New Animal Drugs; Change of Sponsor Address

AGENCY: Food and Drug Administration.

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 address for Wellmark 
International.

DATES: This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT: Norman Turner, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Wellmark International, 1000 Tower Rd., 
suite 245, Bensenville, IL 60106, has informed FDA of a change of 
sponsor address to 1100 East Woodfield Rd., suite 500, Schaumburg, IL 
60173. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor 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 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.


    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) * * *

[[Page 45876]]



 
------------------------------------------------------------------------
        Firm name and address                 Drug labeler code
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  *                    *                    *                    *
                   *                    *                    *
Wellmark International, 1100 East    011536
 Woodfield Rd., suite 500,
 Schaumburg, IL 60173
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
011536                               Wellmark International, 1100 East
                                      Woodfield Rd., suite 500,
                                      Schaumburg, IL 60173
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------


    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18824 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F