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Rule

New Animal Drugs; Change of Sponsor's Name and 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 name from Belcher Pharmaceuticals, Inc., to Belcher Pharmaceuticals, LLC. The sponsor's mailing address will also be changed.

DATES:

This rule is effective November 26, 2010.

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FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240-276-8300, e-mail: steven.vaughn@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 has informed FDA that it has changed its name and address to Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777. Accordingly, the Agency is amending the regulations in 21 CFR 510.600 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), revise the entry for “Belcher Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2), revise the entry for “062250” 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
*    *    *    *    *
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777062250
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
062250Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
*    *    *    *    *
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Dated: November 19, 2010.

Elizabeth Rettie,

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

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[FR Doc. 2010-29693 Filed 11-24-10; 8:45 am]

BILLING CODE 4160-01-P