Document ID: FDA-2009-N-0665-0016
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor
Posted Date: 2009-05-05T04:00Z

[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Page 20582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10262]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2009-N-0665]

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 IVX Animal 
Health, Inc., to Teva Animal Health, Inc.

DATES: This rule is effective May 5, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has changed 
its name to Teva Animal Health, 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.

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

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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.

0
2. In Sec.  510.600 in the table in paragraph (c)(1), remove the entry 
for ``IVX Animal Health, Inc.'' and alphabetically add a new entry for 
``Teva Animal Health, Inc.''; and in the table in paragraph (c)(2), 
revise the entry for ``059130'' 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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                                * * * * *
Teva Animal Health, Inc., 3915 South 48th     059130
 Street Ter., St. Joseph, MO 64503
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
059130                       Teva Animal Health, Inc., 3915 South 48th
                              Street Ter., St. Joseph, MO 64503
                                * * * * *
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    Dated: April 29, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-10262 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S