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Rule

New Animal Drugs; Change of Sponsor's Name

Document Details

Information about this document as published in the Federal Register.

Published Document

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ACTION:

Final rule.

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

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

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 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:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada M1B 2K9043806
*    *    *    *    *

(2) * * *

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

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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