[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Rules and Regulations]
[Page 72679]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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.
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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 ``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