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Rule

New Animal Drugs; Change of Sponsor's Address

Document Details

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 address for Alstoe, Ltd.

DATES:

This rule is effective January 13, 2005.

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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.gov.

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SUPPLEMENTARY INFORMATION:

Alstoe, Ltd., Animal Health, Granary Chambers, 37-39 Burton St., Melton Mowbray, Leicestershire LE13 1AF, England has informed FDA of a change of address to Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) 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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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 revising the entry for “Alstoe, Ltd.”; and in the table in paragraph (c)(2) by revising the entry for “062408” 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
*    *    *    *    *
Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB062408
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
062408Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB
*    *    *    *    *
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Dated: January 3, 2005.

Steven D. Vaughn,

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

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[FR Doc. 05-697 Filed 1-12-05; 8:45 am]

BILLING CODE 4160-01-S