2010-29693. 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 Belcher Pharmaceuticals, Inc., to Belcher Pharmaceuticals, LLC. The sponsor's mailing address will also be changed.

DATES:

This rule is effective November 26, 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:

Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773 has informed FDA that it has changed its name and address to Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777. 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), revise the entry for “Belcher Pharmaceuticals, Inc.”; and in the table in paragraph (c)(2), revise the entry for “062250” 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
*    *    *    *    *
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777	062250
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
062250	Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
*    *    *    *    *

Dated: November 19, 2010.

Elizabeth Rettie,

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