E6-20250. New Animal Drugs; Change of Sponsor's Name

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Bertek Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.

DATES:

This rule is effective November 29, 2006.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its name to Mylan Bertek Pharmaceuticals, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600 to reflect the 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 “Bertek Pharmaceuticals, Inc.” and alphabetically add a new entry for “Mylan Bertek Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2) revise the entry for “062794” 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
*    *    *    *    *
Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478	062794
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
062794	Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478
*    *    *    *    *

Dated: November 16, 2006.

Bernadette Dunham,

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