Document ID: FDA-2010-N-0002-0080
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name and Address
Posted Date: 2010-11-26T05:00Z

[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Rules and Regulations]
[Page 72679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29693]

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

DATES: This rule is effective November 26, 2010.

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: Belcher Pharmaceuticals, Inc., 12393 Belcher 
Rd., suite 420, Largo, FL 33773 has informed FDA that it has changed 
its name and address to Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy 
Rd., Largo, FL 33777. Accordingly, the Agency is amending the 
regulations in 21 CFR 510.600 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

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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 ``Belcher Pharmaceuticals, Inc.''; and in the table in paragraph 
(c)(2), revise the entry for ``062250'' to read as follows:

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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                                * * * * *
Belcher Pharmaceuticals, LLC, 6911 Bryan     062250
 Dairy Rd., Largo, FL 33777.
 
                                * * * * *
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     (2) * * *

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         Drug labeler code                  Firm name and address
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                                * * * * *
062250............................  Belcher Pharmaceuticals, LLC, 6911
                                     Bryan Dairy Rd., Largo, FL 33777.
 
                                * * * * *
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    Dated: November 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-29693 Filed 11-24-10; 8:45 am]
BILLING CODE 4160-01-P