Skip to Content

Rule

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 Alpharma, LLC, to Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc. The sponsor's mailing address will also be changed.

DATES:

This rule is effective July 11, 2011.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Alpharma, LLC, 400 Crossing Blvd., Bridgewater, NJ 08807 has informed FDA of a change of name and mailing address to Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017. 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.

Start List of Subjects

List of Subjects in 21 CFR Part 510

End List of Subjects

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, 21 CFR part 510 is amended as follows:

Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “Alpharma LLC”; and in the table in paragraph (c)(2), revise the entry for “046573” to read as follows:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017046573
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
046573Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017
*    *    *    *    *
Start Signature

Dated: July 1, 2011.

Elizabeth Rettie,

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

End Signature End Supplemental Information

[FR Doc. 2011-17292 Filed 7-8-11; 8:45 am]

BILLING CODE 4160-01-P