05-697. New Animal Drugs; Change of Sponsor's Address  

  • Start Preamble

    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 Alstoe, Ltd.

    DATES:

    This rule is effective January 13, 2005.

    Start Further Info

    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: david.newkirk@fda.gov.

    End Further Info End Preamble Start Supplemental Information

    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.

    Start List of Subjects

    List of Subjects in 21 CFR Part 510

    • Administrative practice and procedure
    • Animal drugs
    • Labeling
    • Reporting and recordkeeping requirements
    End List of Subjects Start Amendment Part

    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:

    End Amendment Part Start Part

    PART 510—NEW ANIMAL DRUGS

    End Part Start Amendment Part

    1. The authority citation for 21 CFR part 510 continues to read as follows:

    End Amendment Part Start Authority

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    End Authority Start Amendment Part

    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.

    End Amendment Part
    Names, addresses, and drug labeler codes of sponsors of approved applications.
    * * * * *

    (c) * * *

    (1) * * *

    Firm name and addressDrug labeler code
    *    *    *    *    *
    Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB062408
    *    *    *    *    *

    (2) * * *

    Drug labeler codeFirm name and address
    *    *    *    *    *
    062408Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB
    *    *    *    *    *
    Start Signature

    Dated: January 3, 2005.

    Steven D. Vaughn,

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

    End Signature End Supplemental Information

    [FR Doc. 05-697 Filed 1-12-05; 8:45 am]

    BILLING CODE 4160-01-S

Document Information

Effective Date:
1/13/2005
Published:
01/13/2005
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
05-697
Dates:
This rule is effective January 13, 2005.
Pages:
2352-2352 (1 pages)
PDF File:
05-697.pdf
CFR: (1)
21 CFR 510.600