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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 510

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs; Change of Sponsor's Address

DATES: This rule is effective December 27, 2001.

DOCUMENT 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.

SUMMARY: Sponsor name and address changes—; Phibro Animal Health,


SUPPLEMENTAL 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. 801808.

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 510NEW 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) * * *
Firm name and address Drug labeler code * * * * * * *
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]]
* * * * * * *

Dated: November 30, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0131715 Filed 122601; 8:45 am] BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Lonnie W. Luther, Center for Veterinary Medicine (HFV102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270209.


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