[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Rules and Regulations]
[Page 48272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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: 
[email protected].

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.

0
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

0
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.

0
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:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                 Drug labeler  code
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                                * * * * *
Peptech Animal Health Pty, Ltd., 19-25        064288
 Khartoum Rd., Macquarie Park, New South
 Wales 2113, Australia.
                                * * * * *
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    (2) * * *

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         Drug labeler  code                 Firm name and address
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                                * * * * *
064288.............................  Peptech Animal Health Pty, Ltd., 19-
                                      25 Khartoum Rd., Macquarie Park,
                                      New South Wales 2113, Australia
                                * * * * *
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    July 28, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-16280 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S