[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Page 70997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23297]


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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

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 Phoenix 
Scientific, Inc., to IVX Animal Health, Inc. In order to improve the 
accuracy of the regulations, erroneous entries for Phoenix 
Pharmaceutical, Inc., are also being removed at this time.

DATES: This rule is effective November 25, 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: 
<a href="/cdn-cgi/l/email-protection#bfdbdec9d6db91d1dac8d4d6cdd4ffd9dbde91d8d0c9"><span class="__cf_email__" data-cfemail="9efaffe8f7fab0f0fbe9f5f7ecf5def8faffb0f9f1e8">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has changed 
its name to IVX Animal Health, Inc. Accordingly, the agency is amending 
the regulations in Sec.  510.600 (21 CFR 510.600) to reflect the 
change.
    In addition, FDA has noticed that Phoenix Pharmaceutical, Inc., is 
no longer a sponsor of an approved new animal drug application. At this 
time, Sec.  510.600 is amended to remove entries for this sponsor. This 
action is being taken to improve the accuracy of the regulations.
    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 
removing the entries for ``Phoenix Pharmaceutical, Inc.'' and ``Phoenix 
Scientific, Inc.'', and by alphabetically adding a new entry for ``IVX 
Animal Health, Inc.''; and in the table in paragraph (c)(2) by removing 
the entry for ``057319'' and by revising the entry for ``059130'' 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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                                * * * * *
IVX Animal Health, Inc., 3915 South 48th      059130
 Street Ter., St. Joseph, MO 64503.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
059130                       IVX Animal Health, Inc., 3915 South 48th
                              Street Ter., St. Joseph, MO 64503
                                * * * * *
------------------------------------------------------------------------


    Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-23297 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S


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