New Animal Drugs; Change of Sponsor's Name, 70997 [05-23297]
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70997
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations
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
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
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:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
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 ‘‘Schering-Plough Animal
Health Corp.’’; and in the table in
paragraph (c)(2) by revising the entry for
‘‘000061’’ to read as follows.
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Schering-Plough Animal
Health Corp., 556 Morris
Ave., Summit, NJ 07901.
*
*
*
Drug labeler
code
*
000061
*
*
*
(2) * * *
Drug labeler
code
*
000061
*
*
*
Food and Drug Administration
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Firm name and address
*
*
*
Schering-Plough Animal
Health Corp., 556 Morris
Ave., Summit, NJ 07901
*
*
*
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–23296 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
Final rule.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I 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:
21 CFR Part 522
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
12:24 Nov 23, 2005
Jkt 208001
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:
I
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, email: david.newkirk@fda.gov.
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 § 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,
§ 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.
SUMMARY:
I
VerDate Aug<31>2005
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
IVX Animal Health, Inc.,
3915 South 48th Street
Ter., St. Joseph, MO
64503.
*
*
*
Drug labeler
code
*
059130
*
*
*
(2) * * *
Drug labeler
code
*
059130
*
*
*
Firm name and address
*
*
*
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Implantation or Injectable Dosage
Form New Animal Drugs; Boldenone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Fort
Dodge Animal Health. The
supplemental NADA provides for
E:\FR\FM\25NOR1.SGM
25NOR1
]]>Agencies
[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Page 70997]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23297]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
david.newkirk@fda.gov.
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
------------------------------------------------------------------------
* * * * *
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
