Document ID: FDA-2010-N-0002-0028
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2010-04-20T04:00Z

[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Rules and Regulations]               
[Page 20523]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap10-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Change of Sponsor's Name and 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 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: 
david.newkirk@fda.hhs.gov.

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.

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. In Sec.  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:

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

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

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            Firm name and address                  Drug labeler code
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                                * * * * *
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Parnell Technologies Pty. Ltd., unit 4, 476   068504
 Gardeners Rd., Alexandria, New South Wales
 2015, Australia
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                                * * * * *
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    (2) * * *

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     Drug labeler code                  Firm name and address
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                                * * * * *
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068504                       Parnell Technologies Pty. Ltd., unit 4, 476
                              Gardeners Rd., Alexandria, New South Wales
                              2015, Australia
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                                * * * * *
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    Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-9057 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S