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, e-
mail: david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Phibro
Animal Health, 710 Rte. 46 East, suite
1 New 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.
VerDate jul<14>2003 15:38 Feb 17, 2005 Jkt 205001
8289
401, Fairfield, NJ 07004, has informed Dated: February 8, 2005.
FDA of a change of address to 65 Steven D. Vaughn,
Challenger Rd., 3d floor, Ridgefield Director, Office of New Animal Drug
Park, NJ 07660. Accordingly, the agency Evaluation, Center for Veterinary Medicine.
is amending the regulations in 21 CFR [FR Doc. 05–3177 Filed 2–17–05; 8:45 am]
510.600(c) to reflect the change. BILLING CODE 4160–01–S
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
DEPARTMENT OF HEALTH AND
it is a rule of ‘‘particular applicability.’’ HUMAN SERVICES
Therefore, it is not subject to the
congressional review requirements in 5 Food and Drug Administration
U.S.C. 801–808.
21 CFR Part 520
List of Subjects in 21 CFR Part 510
Oral Dosage Form New Animal Drugs;
Administrative practice and
procedure, Animal drugs, Labeling, Sulfamethazine Sustained-Release
Boluses; Change of Sponsor
Reporting and recordkeeping
requirements. AGENCY: Food and Drug Administration,
■ Therefore, under the Federal Food, HHS.
Drug, and Cosmetic Act and under ACTION: Final rule.
authority delegated to the Commissioner
SUMMARY: The Food and Drug
of Food and Drugs and redelegated to the Administration (FDA) is amending the
Center for Veterinary Medicine, 21 CFR animal drug regulations to reflect a
part 510 is amended as follows: change of sponsor for a new animal drug
application (NADA) from Boehringer
PART 510—NEW ANIMAL DRUGS Ingelheim Vetmedica, Inc. to Phoenix
Scientific, Inc.
■ 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
■ 2. Section 510.600 is amended in the Medicine (HFV–100), Food and Drug
table in paragraph (c)(1) by revising the Administration, 7500 Standish Pl.,
entry for ‘‘Phibro Animal Health’’ and in Rockville, MD 20855, 301–827–6967, e-
the table in paragraph (c)(2) by revising mail: david.newkirk@fda.gov.
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
(c) * * * for Sulfamethazine Sustained Release
Bolus to Phoenix Scientific, Inc., 3915
(1) * * * South 48th St. Terr., St. Joseph, MO
64503.
Firm name and address Drug
labeler This rule does not meet the definition
code
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
* * * * * it is a rule of ‘‘particular applicability.’’
Phibro Animal Health, 65 066104 Therefore, it is not subject to the
Challenger Rd., 3d congressional review requirements in 5
floor, Ridgefield Park, U.S.C. 801–808.
NJ 07660
List of Subjects in 21 CFR Part 520
* * * * *
Animal drugs.
(2) * * * ■ Therefore, under the Federal Food,
Drug and Cosmetic Act and under
Drug labeler authority delegated to the Commissioner
Firm name and address
code of Food and Drugs and redelegated to the
Center for Veterinary Medicine, 21 CFR
* * * * * part 520 is amended as follows:
066104 Phibro Animal Health, 65
Challenger Rd., 3d PART 520—ORAL DOSAGE FORM
floor, Ridgefield Park, NEW ANIMAL DRUGS
NJ 07660
* * * * * ■ 1. The authority citation for 21 CFR
part 520 continues to read as follows:
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 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’’.
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, e-
mail: 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.
List of Subjects in 21 CFR Part 522
Animal drugs.
■ Therefore, under the Federal Food,
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.
Center for Veterinary Medicine, 21 CFR
part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■ 1. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
■ 2. Section 522.2477 is amended by
revising paragraph (b)(1) to read as
follows:
§ 522.2477 Trenbolone acetate and
estradiol.
* * * * * ANADA is approved as of January 21,
(b) * * *
(1) No. 021641 for products and uses
described in paragraph (d) of this
section.
* * * * * The regulations are also being
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–3107 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
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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.
Final rule; technical
ACTION:
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
indications for use to agree with
approved product labeling. This action
is being taken to improve the accuracy
of the regulations.
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, e-
mail: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix
Scientific, Inc., 3915 South 48th St. Ter.,
St. Joseph, MO 64503, filed a
supplement to ANADA 200–287 for use
of TRIPLEMAX (gentamicin sulfate,
U.S.P.; betamethasone valerate, U.S.P.;
and clotrimazole, U.S.P. ointment) for
the treatment of acute and chronic
canine otitis externa. The supplement
provides for a new container size, a 20-
gram dropper bottle. The supplemental
2005, and the regulations are amended
in 21 CFR 524.1044g to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
amended to correct the indications for
use to agree with approved product
labeling. This action is being taken to
improve the accuracy of the regulations.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
18FER1