[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Rules and Regulations]
[Page 2352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-697]


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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 Alstoe, 
Ltd.

DATES: This rule is effective January 13, 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: Alstoe, Ltd., Animal Health, Granary 
Chambers, 37-39 Burton St., Melton Mowbray, Leicestershire LE13 1AF, 
England has informed FDA of a change of address to Pera Innovation 
Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB. 
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 ``Alstoe, Ltd.''; and in the table in paragraph 
(c)(2) by revising the entry for ``062408'' 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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Alstoe, Ltd., Animal Health, Pera Innovation   062408
 Park, Nottingham Rd., Melton Mowbray,
 Leicestershire, England LE13 0PB
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                                * * * * *
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    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
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                                * * * * *
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062408                      Alstoe, Ltd., Animal Health, Pera Innovation
                             Park, Nottingham Rd., Melton Mowbray,
                             Leicestershire, England LE13 0PB
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                                * * * * *
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    Dated: January 3, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-697 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S