[Federal Register Volume 65, Number 225 (Tuesday, November 21, 2000)]
[Rules and Regulations]
[Page 69865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29764]


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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 Novartis 
Animal Health US, Inc.

DATES: This rule is effective November 21, 2000.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., P.O. Box 
18300, Greensboro, NC 27419-8300, has informed FDA of a change of 
sponsor's address to 3200 Northline Ave., suite 300, Greensboro, NC 
27408. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor's address.
    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. Section 510.600 is amended in the table in paragraph (c)(1) by 
revising the entry for ``Novartis Animal Health US, Inc.'' and in the 
table in paragraph (c)(2) by revising the entry for ``058198'' 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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*                  *                  *                  *
                  *                  *                  *
Novartis Animal Health US, Inc.,     058198
 3200 Northline Ave., suite 300,
 Greensboro, NC 27408
*                  *                  *                  *
                  *                  *                  *
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    (2) * * *

 
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                   Drug labeler code                                      Firm name and address
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*                  *                  *                  *                  *                  *
                                                        *
058198                                                   Novartis Animal Health US, Inc., 3200 Northline Ave.,
                                                          suite 300, Greensboro, NC 27408
*                  *                  *                  *                  *                  *
                                                        *
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    Dated: November 6, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-29764 Filed 11-20-00; 8:45 am]
BILLING CODE 4160-01-F