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Rule

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

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.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective July 11, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

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 Back to Top

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:

begin regulatory text

PART 510—NEW ANIMAL DRUGS Back to Top

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.

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:

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

* * * * *

(c) * * *

(1) * * *

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

(2) * * *

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

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

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