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Rule

New Animal Drugs; Change of Sponsor's Name

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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.

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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.

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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.

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List of Subjects in 21 CFR Part 510

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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,

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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2. In § 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:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503059130
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
059130Teva 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.

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[FR Doc. E9-10262 Filed 5-4-09; 8:45 am]

BILLING CODE 4160-01-S