[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:
[email protected].
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
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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.
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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) * * *
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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.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
059130 IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503
* * * * *
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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