[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54016-54017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22044]
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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:
[email protected].
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.
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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, 21 CFR part 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
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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.
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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