[Federal Register Volume 66, Number 248 (Thursday, December 27, 2001)]
[Rules and Regulations]
[Pages 66742-66743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31715]


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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.
 
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------

    (2) * * * 

----------------------------------------------------------------------------------------------------------------
             Drug labeler code                                      Firm name and address
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *                  *                  *
                                                        *
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