2010-9057. 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 Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor's mailing address will be changed.

DATES:

This rule is effective April 20, 2010.

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:

Parnell Laboratories (Aust) Pty. Ltd., Century Estate, unit 6, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia, has informed FDA that it has changed its name and address to Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) 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 “Parnell Laboratories (Aust) Pty. Ltd.”; and in the table in paragraph (c)(2), revise the entry for “068504” 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
*    *    *    *    *
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia	068504
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
068504	Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia
*    *    *    *    *

Dated: April 15, 2010.

Elizabeth Rettie,

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