[Federal Register: December 27, 2001 (Volume 66, Number 248)]
[Rules and Regulations]
[Page 66742-66743]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de01-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's 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 address for Phibro
Animal Health.
DATES: This rule is effective December 27, 2001.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Phibro Animal Health, One Parker Plaza, Fort
Lee, NJ 07024, has informed FDA of a change of sponsor's address to 710
Rt. 46 East, suite 401, Fairfield, NJ 07004. Accordingly, the agency is
amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect
the 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.
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
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. Section 510.600 is amended in the table in paragraph (c)(1) by
revising the entry for ``Phibro Animal Health'' and in the table in
paragraph (c)(2) by revising the entry for ``066104'' 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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* * * * * *
*
Phibro Animal Health, 710 Rt. 46 East, 066104
suite 401, Fairfield, NJ 07004.
* * * * * *
*
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * *
*
066104.................................... Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield, NJ
07004
[[Page 66743]]
* * * * * *
*
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Dated: November 30, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 01-31715 Filed 12-26-01; 8:45 am]
BILLING CODE 4160-01-S