05-16280. New Animal Drugs; Change of Sponsor's 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 address for Peptech Animal Health Pty, Ltd.

DATES:

This rule is effective August 17, 2005.

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:

Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd., North Ryde, New South Wales 2113, Australia has informed FDA of a change of address to 19-25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) 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. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for “Peptech Animal Health Pty, Ltd.”; and in the table in paragraph (c)(2) by revising the entry for “064288” 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
*    *    *    *    *
Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia	064288
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
064288	Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia
*    *    *    *    *

July 28, 2005.

Bernadette A. Dunham,

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