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

DATES:

This rule is effective March 19, 2003.

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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, 301-827-6967, e-mail: dnewkirk@cvm.fda.gov.

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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.

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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

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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. 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:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601064847
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
064847Bioniche 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.

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[FR Doc. 03-6492 Filed 3-18-03; 8:45 am]

BILLING CODE 4160-01-S