Oral Dosage Form New Animal Drugs; Sulfamethazine Sustained-Release Boluses; Change of Sponsor, 8289-8290 [05-3178]
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Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Rules and Regulations
Alliance Pipeline, LP (Alliance)
American Gas Association (AGA)
Anadarko Petroleum Corporation (Anadarko)
Nels Anderson, Jr. (individual)
Arctic Slope Regional Corporation (Arctic
Slope)
Ken Baker 1
Alaska Representative Ethan Berkowitz
BP Exploration (Alaska) Inc., ConocoPhillips
Company, and Exxon Mobil Corporation
(North Slope Producers)
Calpine Corporation (Calpine)
ChevronTexaco Natural Gas, a Division of
Chevron U.S.A. Inc. (ChevronTexaco)
Doyon Limited
Enbridge, Inc. (Enbridge)
Legislative Budget and Audit Committee and
Indicated State Legislators (Alaska
Legislators) 2
MidAmerican Energy Holdings Company and
Alaska Gas Transmission Company
(MidAmerican/AGTA)
Northwest Industrial Gas Users (Northwest
Industrials)
Pacific Star Energy LLC (Pacific Star)
B. Sachau, aka Jean Public (individual)
Shell USA (Shell)
State of Alaska (Alaska)
TransCanada Pipeline Limited (TransCanada)
U.S. Department of the Interior (DOI)
U.S. Geological Survey 3
[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
River Community and Technical College,
Greenbrier Valley Campus.
2 Representative Ralph Samuels, Chairman of the
Alaska Legislative Budget & Audit Committee
(separately).
3 Brenda Johnson, Office of Environmental Affairs
Program.
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
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18FER1
8290
Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Rules and Regulations
Authority: 21 U.S.C. 360b.
§ 520.2260b
[Amended]
2. Section 520.2260b is amended in
paragraph (f)(1) by removing ‘‘000010’’
and by adding in its place ‘‘059130’’.
n
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–3178 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Trenbolone
and Estradiol
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 abbreviated
new animal drug application (ANADA)
filed by Ivy Laboratories, Division of Ivy
Animal Health, Inc. The supplemental
ANADA provides for an additional dose
of trenbolone acetate and estradiol
implant for use in feedlot heifers for
increased rate of weight gain and
improved feed efficiency.
DATES: This rule is effective February
18, 2005.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond Street, Overland
Park, KS 66214, filed a supplement to
ANADA 200–346. The supplemental
ANADA provides for the use of
COMPONENT TE–200 (trenbolone
acetate and estradiol), a subcutaneous
implant containing 200 milligrams (mg)
trenbolone acetate and 20 mg estradiol
in heifers fed in confinement for
slaughter for increased rate of weight
gain and improved feed efficiency. Ivy
Laboratories’ COMPONENT TE–200 is
approved as a generic copy of Intervet,
Inc.’s REVALOR–200, approved under
NADA 140–992. The application is
approved as of January 14, 2005, and the
regulations are amended in 21 CFR
522.2477 to reflect the approval. The
VerDate jul<14>2003
15:38 Feb 17, 2005
Jkt 205001
basis of approval is discussed in the
freedom of information summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate,
Clotrimazole Ointment; Technical
Amendment
AGENCY: Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Phoenix Scientific, Inc. The
supplemental ANADA provides for a
new container size, a 20-gram dropper
bottle, from which gentamicin sulfate,
betamethasone valerate, clotrimazole
ointment may be administered for the
treatment of acute and chronic canine
otitis externa. The regulations are also
being amended to correct the
List of Subjects in 21 CFR Part 522
indications for use to agree with
Animal drugs.
approved product labeling. This action
is being taken to improve the accuracy
n Therefore, under the Federal Food,
of the regulations.
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner DATES: This rule is effective February
of Food and Drugs and redelegated to the 18, 2005.
FOR FURTHER INFORMATION CONTACT:
Center for Veterinary Medicine, 21 CFR
Lonnie W. Luther, Center for Veterinary
part 522 is amended as follows:
Medicine (HFV 104), Food and Drug
Administration, 7519 Standish Pl.,
PART 522—IMPLANTATION OR
Rockville, MD 20855, 301–827–8549, eINJECTABLE DOSAGE FORM NEW
mail: lonnie.luther@fda.gov.
ANIMAL DRUGS
SUPPLEMENTARY INFORMATION: Phoenix
Scientific, Inc., 3915 South 48th St. Ter.,
n 1. The authority citation for 21 CFR
St. Joseph, MO 64503, filed a
part 522 continues to read as follows:
supplement to ANADA 200–287 for use
Authority: 21 U.S.C. 360b.
of TRIPLEMAX (gentamicin sulfate,
U.S.P.; betamethasone valerate, U.S.P.;
n 2. Section 522.2477 is amended by
and clotrimazole, U.S.P. ointment) for
revising paragraph (b)(1) to read as
the treatment of acute and chronic
follows:
canine otitis externa. The supplement
§ 522.2477 Trenbolone acetate and
provides for a new container size, a 20estradiol.
gram dropper bottle. The supplemental
*
*
*
*
*
ANADA is approved as of January 21,
2005, and the regulations are amended
(b) * * *
in 21 CFR 524.1044g to reflect the
(1) No. 021641 for products and uses
approval. The basis of approval is
described in paragraph (d) of this
discussed in the freedom of information
section.
summary.
*
*
*
*
*
The regulations are also being
amended to correct the indications for
Dated: February 8, 2005.
use to agree with approved product
Steven D. Vaughn,
labeling. This action is being taken to
Director, Office of New Animal Drug
improve the accuracy of the regulations.
Evaluation, Center for Veterinary Medicine.
In accordance with the freedom of
[FR Doc. 05–3107 Filed 2–17–05; 8:45 am]
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
BILLING CODE 4160–01–S
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
E:\FR\FM\18FER1.SGM
18FER1
]]>Agencies
[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Rules and Regulations]
[Pages 8289-8290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Sulfamethazine Sustained-
Release Boluses; Change of Sponsor
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 Ingelheim Vetmedica, Inc. to Phoenix
Scientific, Inc.
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: Boehringer Ingelheim Vetmedica, Inc., 2621
North Belt Hwy., St. Joseph, MO 64506-2002, has informed FDA that it
has transferred ownership of, and all rights and interest in, NADA 140-
270 for Sulfamethazine Sustained Release Bolus to Phoenix Scientific,
Inc., 3915 South 48th St. Terr., St. Joseph, MO 64503.
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 520
Animal drugs.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
[[Page 8290]]
Authority: 21 U.S.C. 360b.
Sec. 520.2260b [Amended]
0
2. Section 520.2260b is amended in paragraph (f)(1) by removing
``000010'' and by adding in its place ``059130''.
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-3178 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S
