E8-9328. 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 Halocarbon Laboratories, Division of Halocarbon Products Corp., to Halocarbon Products Corp.

DATES:

This rule is effective April 29, 2008.

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:

Halocarbon Laboratories, Division of Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ 07661, has informed FDA that it has changed its name to Halocarbon Products Corp. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. FDA is also correcting the sponsor's address in the regulation.

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 “Halocarbon Laboratories”; and in the table in paragraph (c)(2), revise the entry for “012164” 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
*    *    *    *    *
Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661	012164
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
012164	Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661.
*    *    *    *    *

Dated: April 16, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.