2010-28307. New Animal Drugs; Change of Sponsor's Name

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 North American Nutrition Companies, Inc., to Provimi North America, Inc.

DATES:

This rule is effective November 10, 2010.

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, E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

North American Nutrition Companies, Inc., 6531 State Rte. 503, Lewisburg, OH 45338, has informed FDA that it has changed its name to Provimi North America, Inc. Accordingly, the Agency is amending the regulations in 21 CFR 510.600 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), remove the entry for “North American Nutrition Companies, Inc.”; and alphabetically add a new entry for “Provimi North America, Inc.”; and in the table in paragraph (c)(2), revise the entry for “017790” 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
	*    *    *    *    *
Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338	017790
	*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
	*    *    *    *    *
017790	Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338.
	*    *    *    *    *

Dated: October 28, 2010.

Steven D. Vaughn,

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