[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Rules and Regulations]
[Page 40612]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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) * * *
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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.............
* * * * *
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(2) * * *
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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