New Animal Drugs; Change of Sponsor's Address, 8289 [05-3177]
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Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Rules and Regulations
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[FR Doc. 05–3035 Filed 2–17–05; 8:45 am]
BILLING CODE 6717–01–P
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.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s address for Phibro
Animal Health.
DATES: This rule is effective February
18, 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: Phibro
Animal Health, 710 Rte. 46 East, suite
401, Fairfield, NJ 07004, has informed
FDA of a change of address to 65
Challenger Rd., 3d floor, Ridgefield
Park, NJ 07660. Accordingly, the agency
is amending the regulations in 21 CFR
510.600(c) to reflect the change.
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.
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–3177 Filed 2–17–05; 8:45 am]
List of Subjects in 21 CFR Part 510
21 CFR Part 520
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Oral Dosage Form New Animal Drugs;
Sulfamethazine Sustained-Release
Boluses; Change of Sponsor
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:
n
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2 Representative Ralph Samuels, Chairman of the
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15:38 Feb 17, 2005
Jkt 205001
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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 for a new animal drug
application (NADA) from Boehringer
PART 510—NEW ANIMAL DRUGS
Ingelheim Vetmedica, Inc. to Phoenix
Scientific, Inc.
n 1. The authority citation for 21 CFR
DATES: This rule is effective February
part 510 continues to read as follows:
18, 2005.
Authority: 21 U.S.C. 321, 331, 351, 352,
FOR FURTHER INFORMATION CONTACT:
353, 360b, 371, 379e.
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
n 2. Section 510.600 is amended in the
Administration, 7500 Standish Pl.,
table in paragraph (c)(1) by revising the
entry for ‘‘Phibro Animal Health’’ and in Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.
the table in paragraph (c)(2) by revising
the entry for ‘‘066104’’ to read as follows. SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc.,
§ 510.600 Names, addresses, and drug
2621 North Belt Hwy., St. Joseph, MO
labeler codes of sponsors of approved
64506–2002, has informed FDA that it
applications.
has transferred ownership of, and all
rights and interest in, NADA 140–270
*
*
*
*
*
for Sulfamethazine Sustained Release
(c) * * *
Bolus to Phoenix Scientific, Inc., 3915
(1) * * *
South 48th St. Terr., St. Joseph, MO
64503.
This rule does not meet the definition
Firm name and address Drug labeler
code
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
Phibro Animal Health, 65
066104
congressional review requirements in 5
Challenger Rd., 3d
U.S.C. 801–808.
floor, Ridgefield Park,
1 New
VerDate jul<14>2003
8289
PO 00000
*
NJ 07660
*
*
*
*
(2) * * *
Firm name and address
*
066104
*
*
*
Phibro Animal Health, 65
Challenger Rd., 3d
floor, Ridgefield Park,
NJ 07660
*
*
*
Frm 00061
Animal drugs.
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 520 is amended as follows:
n
Drug labeler
code
*
List of Subjects in 21 CFR Part 520
*
*
Fmt 4700
Sfmt 4700
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
n
E:\FR\FM\18FER1.SGM
18FER1
]]>Agencies
[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Rules and Regulations]
[Page 8289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3177]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's address for Phibro
Animal Health.
DATES: This rule is effective February 18, 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: Phibro Animal Health, 710 Rte. 46 East,
suite 401, Fairfield, NJ 07004, has informed FDA of a change of address
to 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660. Accordingly,
the agency is amending the regulations in 21 CFR 510.600(c) to reflect
the change.
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
revising the entry for ``Phibro Animal Health'' and in the table in
paragraph (c)(2) by revising the entry for ``066104'' 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
------------------------------------------------------------------------
* * * * *
Phibro Animal Health, 65 Challenger Rd., 3d 066104
floor, Ridgefield Park, NJ 07660
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
066104 Phibro Animal Health, 65 Challenger Rd.,
3d floor, Ridgefield Park, NJ 07660
* * * * *
------------------------------------------------------------------------
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-3177 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S
