Rules and Regulations. Final rule

Agency: Food and Drug Administration, HHS
Action: Final rule
Citation: FR Doc. 2012-13409 · Docket No. FDA-2012-N-0002 · 21 CFR 510

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.

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 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. 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: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. (c) * * * (1) * * * Firm name and address Drug labeler code * * * * * Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, Canada M1B 2K9 043806 * * * * * (2) * * * Drug labeler code Firm name and address * * * * * 043806 Teva 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]