E9-29627. New Animal Drugs; Change of Sponsor's Name and Address

AGENCY:

Food and Drug Administration, HHS.

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 Schering-Plough Animal Health Corp. to Intervet, Inc., and to change the sponsor's mailing address.

DATES:

This rule is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, has informed FDA of a change of name and mailing address to Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068. 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 “Schering-Plough Animal Health Corp.” and alphabetically add a new entry for “Intervet, Inc.”; and in the table in paragraph (c)(2), revise the entry for “000061” 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
*    *    *    *    *
Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068	000061
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
000061	Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068
*    *    *    *    *

Dated: December 8, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.