[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Rules and Regulations]
[Pages 32487-32488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11030]


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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.

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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 Steris 
Laboratories, Inc., to Watson Laboratories, Inc.

DATES: This rule is effective June 3, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary

[[Page 32488]]

Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6967, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Steris Laboratories, Inc., 620 North 51st 
Ave., Phoenix, AZ 85043-4705, has informed FDA of a change of sponsor's 
name to Watson Laboratories, Inc. 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 
removing the entry for ``Steris Laboratories, Inc.'' and by 
alphabetically adding an entry for ``Watson Laboratories, Inc.''; and 
in the table in paragraph (c)(2) by revising the entry for ``000402'' 
to read as follows:


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

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

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
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                                * * * * *
Watson Laboratories, Inc., 620 North 51st     000402
 Ave., Phoenix, AZ 85043-4705
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
000402                       Watson Laboratories, Inc., 620 North 51st
                              Ave., Phoenix, AZ 85043-4705
                                * * * * *
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    Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-11030 Filed 6-2-05; 8:45 am]
BILLING CODE 4160-01-S