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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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Food and Drug Administration, HHS.


Final rule; technical amendment.


The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Bertek Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.


This rule is effective November 29, 2006.

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David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Start Printed Page 69011Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:

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Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its name to Mylan Bertek Pharmaceuticals, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600 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.

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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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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 “Bertek Pharmaceuticals, Inc.” and alphabetically add a new entry for “Mylan Bertek Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2) revise the entry for “062794” 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
*    *    *    *    *
Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478062794
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
062794Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478
*    *    *    *    *
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Dated: November 16, 2006.

Bernadette Dunham,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. E6-20250 Filed 11-28-06; 8:45 am]