2010-22044. 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 Alpharma, Inc., to Alpharma LLC. The sponsor's mailing address will also be changed.

DATES:

This rule is effective September 3, 2010.

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, email: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 08807 has informed FDA that it has changed its name and address to Alpharma LLC, 400 Crossing Blvd., Bridgewater, NJ 08807. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) 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

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), revise the entry for “Alpharma Inc.”; and in the table in paragraph (c)(2), revise the entry for “046573” 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
*    *    *    *    *
Alpharma LLC, 400 Crossing Blvd., Bridgewater, NJ 08807.	046573
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
046573	Alpharma LLC, 400 Crossing Blvd., Bridgewater, NJ 08807.
*    *    *    *    *

Dated: August 31, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.