Document ID: FDA-2010-N-0002-0087
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor's Address
Posted Date: 2010-12-21T05:00Z

[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Rules and Regulations]
[Pages 79955-79956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31952]

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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 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 address for Intervet, Inc., a 
sponsor of approved new animal drug applications.

DATES: This rule is effective December 21, 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: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068 has informed FDA that it has changed its address to 
556 Morris Ave., Summit, NJ 07901. 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

0
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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``Intervet, Inc.''; and in the table in paragraph (c)(2), revise 
the entry for ``000061'' 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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                                                  * * * * * * *
Intervet, Inc., 556 Morris Ave., Summit, NJ 07901.....                                                    000061
 
                                                  * * * * * * *
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     (2) * * *

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                   Drug labeler code                                      Firm name and address
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                                                  * * * * * * *
000061................................................        Intervet, Inc., 556 Morris Ave., Summit, NJ 07901.
 
                                                  * * * * * * *
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[[Page 79956]]

    Dated: December 9, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-31952 Filed 12-20-10; 8:45 am]
BILLING CODE 4160-01-P