[Federal Register Volume 68, Number 53 (Wednesday, March 19, 2003)]
[Rules and Regulations]
[Pages 13225-13226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6492]


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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 Vetrepharm 
Research, Inc., to Bioniche Animal Health USA, Inc.

DATES: This rule is effective March 19, 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: Vetrepharm Research, Inc., 119 Rowe Rd., 
Athens, GA 30601, has informed FDA of a change of name to Bioniche 
Animal Health USA, Inc. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c) to reflect this 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.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 13226]]

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 
removing the entry for ``Vetrepharm Research, Inc.'' and by 
alphabetically adding an entry for ``Bioniche Animal Health USA, 
Inc.''; and in the table in paragraph (c)(2) by revising the entry for 
``064847'' 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
------------------------------------------------------------------------
                                * * * * *
Bioniche Animal Health USA, Inc., 119 Rowe    064847
 Rd., Athens, GA 30601.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
064847                       Bioniche Animal Health USA, Inc., 119 Rowe
                              Rd., Athens, GA 30601
                                * * * * *
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    Dated: February 10, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-6492 Filed 3-18-03; 8:45 am]
BILLING CODE 4160-01-S