[Federal Register Volume 66, Number 162 (Tuesday, August 21, 2001)]
[Rules and Regulations]
[Page 43773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20982]


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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 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 and address for 
Orion Corp. ORION-FARMOS.

DATES: This rule is effective August 21, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Orion Corp. ORION-FARMOS, P.O. Box 425, SF-
20101 Turku, Finland, has informed FDA of a change of sponsor's name 
and address to Orion Corp., Orionintie 1, 02200 Espoo, Finland. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor's name and 
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 ``Orion Corp. ORION-FARMOS'' and in the table in 
paragraph (c)(2) by revising the entry for ``052483'' 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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*                  *                  *                  *
                  *                  *                  *
Orion Corp., Orionintie 1, 02200     052483
 Espoo, Finland
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
052483                               Orion Corp., Orionintie 1, 02200
                                      Espoo, Finland
 
*                  *                  *                  *
                  *                  *                  *
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    Dated: July 31, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-20982 Filed 8-20-01; 8:45 am]
BILLING CODE 4160-01-S