Document ID: FDA-2010-N-0002-0056
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name and Address
Posted Date: 2010-09-03T04:00Z

[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Rules and Regulations]               
[Page 54016-54017]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se10-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

 
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, 
Inc., to Alpharma LLC. The sponsor's mailing address will also be 
changed.

DATES:  This rule is effective September 3, 2010.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, email: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 
08807 has informed FDA that it has changed its name and address to 
Alpharma LLC, 400 Crossing Blvd., Bridgewater, NJ 08807. Accordingly, 
the agency is amending the regulations in 21 CFR 510.600(c) 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.

List of Subjects in 21 CFR Part 510

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

0
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 Inc.''; and in the table in paragraph (c)(2), revise the 
entry for ``046573'' to read as follows:

[[Page 54017]]

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

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

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            Firm name and address                  Drug labeler code
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                                * * * * *
Alpharma LLC, 400 Crossing Blvd.,             046573
 Bridgewater, NJ 08807.

                                * * * * *
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    (2) * * *

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     Drug labeler code                  Firm name and address
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                                * * * * *
046573.....................  Alpharma LLC, 400 Crossing Blvd.,
                              Bridgewater, NJ 08807.

                                * * * * *
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    Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-22044 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S