Document ID: FDA-2011-N-0003-0022
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name and Address
Posted Date: 2011-07-11T04:00Z

[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Rules and Regulations]
[Page 40612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2011-N-0003]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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.

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.

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.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

    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:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

0
2. In Sec.  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:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

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

     (2) * * *

------------------------------------------------------------------------
             Drug labeler code                  Firm name and address
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                                * * * * *
046573....................................  Alpharma, LLC, a wholly
                                             owned subsidiary of Pfizer,
                                             Inc., 235 East 42d St., New
                                             York, NY 10017
 
                                * * * * *
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    Dated: July 1, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-17292 Filed 7-8-11; 8:45 am]
BILLING CODE 4160-01-P