Document ID: FDA-2012-N-0002-0013
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name
Posted Date: 2012-06-04T04:00Z

[Federal Register Volume 77, Number 107 (Monday, June 4, 2012)]
[Rules and Regulations]
[Pages 32897-32898]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13409]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor's Name

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 Novopharm 
Ltd. to Teva Canada Ltd.

DATES: This rule is effective June 4, 2012.

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, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novopharm Ltd., 30 Novopharm Ct., Toronto, 
Ontario, Canada M1B 2K9 has informed FDA of a change of name to Teva 
Canada Ltd. Accordingly, the Agency is amending the regulations in 21 
CFR 510.600(c) to reflect these changes.
    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

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

[[Page 32898]]

    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), remove the entry 
for ``Novopharm Ltd.'' and alphabetically add a new entry for ``Teva 
Canada Ltd.''; and in the table in paragraph (c)(2), revise the entry 
for ``043806'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
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                                * * * * *
Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada      043806
 M1B 2K9.....................................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
             Drug labeler code                 Firm name and  address
------------------------------------------------------------------------
 
                                * * * * *
043806....................................  Teva Canada Ltd., 30
                                             Novopharm Ct., Toronto,
                                             Ontario, Canada M1B 2K9.
 
                                * * * * *
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    Dated: May 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13409 Filed 6-1-12; 8:45 am]
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