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New Animal Drugs; Change of Sponsor's Name and Address

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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 American Pharmaceutical Partners, Inc., to Abraxis Pharmaceuticals Products and to change the sponsor's mailing address.

DATES:

This rule is effective May 9, 2007.Start Printed Page 26289

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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: david.newkirk@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

American Pharmaceuticals Partners, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160, has informed FDA of a change of name and mailing address to Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, Il 60018. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.

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. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “American Pharmaceuticals Partners, Inc.” and alphabetically adding a new entry for “Abraxis Pharmaceutical Products”; and in the table in paragraph (c)(2) by revising the entry for “063323” 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
*    *    *    *    *
Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018063323
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
063323Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018
*    *    *    *    *
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Dated: May 1, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-8870 Filed 5-8-07; 8:45 am]

BILLING CODE 4160-01-S