2352 Federal Register / Vol. 70, No.
9 / Thursday, January 13, 2005 / Rules and Regulations
regulated organizations will not be
compromised.
After considering these factors, the
Commission has determined to amend
Part 171, as set forth below.
List of Subjects in 17 CFR Part 171
Administrative practice and
procedure, Commodity exchanges,
Commodity futures.
■ In consideration of the following, the
Commission hereby amends chapter I of
title 17 of the Code of Federal
Regulations as follows:
PART 171—RULES RELATING TO
REVIEW OF NATIONAL FUTURES
ASSOCIATION DECISIONS IN
DISCIPLINARY, MEMBERSHIP DENIAL, 2005.
REGISTRATION AND MEMBER
RESPONSIBILITY ACTIONS
■ 1. The authority citation for part 171
continues to read as follows:
Authority: 7 U.S.C. 4a, 12a, and 21.
■ 2. Section 171.1(b) is amended in
paragraph (b)(4) by adding ‘‘, Hearing
Committee’’ between ‘‘Business Conduct 37–39 Burton St., Melton Mowbray,
Committees’’ and ‘‘or arbitration
panels’’; and replacing ‘‘.’’ with ‘‘;’’ at the informed FDA of a change of address to
end of (b)(4); and by adding new
paragraph (b)(5):
§ 171.1 Scope of rules.
* * * * * 21 CFR 510.600(c) to reflect the change.
(b) * * *
(5) Suspension of a member or a
person associated with a member based
solely on that person’s failure to pay an
arbitration award or a settlement
agreement resulting from an arbitration
action brought pursuant to section
17(b)(10) of the Act or rules and
regulations of the National Futures
Association, or a settlement agreement
resulting from a mediation proceeding
sponsored by the National Futures
Association, unless there are
extraordinary circumstances that
involve something more than the
ministerial application of a
predetermined sanction, or raise a
colorable claim that the National
Futures Assocaition has acted
arbitrarily.
* * * * * part 510 continues to read as follows:
Issued in Washington, DC on the 10th day
of January 2005, by the Commission.
Jean A. Webb,
Secretary of the Commission.
[FR Doc. 05–709 Filed 1–12–05; 8:45 am]
BILLING CODE 6351–01–M
VerDate jul<14>2003 14:42 Jan 12, 2005 Jkt 205001
DEPARTMENT OF HEALTH AND § 510.600 Names, addresses, and drug
HUMAN SERVICES labeler codes of sponsors of approved
applications.
Food and Drug Administration * * * * *
(c) * * *
21 CFR Part 510 (1) * * *
New Animal Drugs; Change of Drug label-
Sponsor’s Address Firm name and address
er code
AGENCY: Food and Drug Administration, * * * * *
HHS.
Alstoe, Ltd., Animal Health, 062408
ACTION: Final rule. Pera Innovation Park,
Nottingham Rd., Melton
SUMMARY: The Food and Drug Mowbray, Leicestershire,
Administration (FDA) is amending the England LE13 0PB
animal drug regulations to reflect a
change of sponsor’s address for Alstoe, * * * * *
Ltd.
(2) * * *
DATES: This rule is effective January 13,
Drug labeler Firm name and address
FOR FURTHER INFORMATION CONTACT: code
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug * * * * *
Administration, 7500 Standish Pl.,
062408 Alstoe, Ltd., Animal Health,
Rockville, MD 20855, 301–827–6967, e- Pera Innovation Park,
mail: david.newkirk@fda.gov. Nottingham Rd., Melton
SUPPLEMENTARY INFORMATION: Alstoe, Mowbray, Leicestershire,
Ltd., Animal Health, Granary Chambers, England LE13 0PB
* * * * *
Leicestershire LE13 1AF, England has
Pera Innovation Park, Nottingham Rd., Dated: January 3, 2005.
Melton Mowbray, Leicestershire, Steven D. Vaughn,
England LE13 0PB. Accordingly, the Director, Office of New Animal Drug
agency is amending the regulations in Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–697 Filed 1–12–05; 8:45 am]
This rule does not meet the definition BILLING CODE 4160–01–S
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 DEPARTMENT OF HEALTH AND
congressional review requirements in 5 HUMAN SERVICES
U.S.C. 801–808.
Food and Drug Administration
List of Subjects in 21 CFR Part 510
Administrative practice and 21 CFR Part 520
procedure, Animal drugs, Labeling, Oral Dosage Form New Animal Drugs;
Reporting and recordkeeping Levamisole Powder for Oral Solution
requirements.
■ Therefore, under the Federal Food, AGENCY: Food and Drug Administration,
Drug, and Cosmetic Act and under HHS.
authority delegated to the Commissioner ACTION: Final rule.
of Food and Drugs and redelegated to the
Center for Veterinary Medicine, 21 CFR SUMMARY: The Food and Drug
part 510 is amended as follows: Administration (FDA) is amending the
animal drug regulations to reflect
PART 510—NEW ANIMAL DRUGS approval of an abbreviated new animal
drug application (ANADA) filed by
■ 1. The authority citation for 21 CFR Phoenix Scientific, Inc. The ANADA
provides for use of levamisole
Authority: 21 U.S.C. 321, 331, 351, 352, hydrochloride soluble powder to make
353, 360b, 371, 379e. a drench solution for oral
■ 2. Section 510.600 is amended in the administration to cattle and sheep
table in paragraph (c)(1) by revising the which is effective against various
entry for ‘‘Alstoe, Ltd.’’; and in the table internal parasites.
in paragraph (c)(2) by revising the entry DATES: This rule is effective January 13,
for ‘‘062408’’ to read as follows. 2005.
PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\13JAR1.SGM 13JAR1
 Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Rules and Regulations 2353

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.
Terrace, St. Joseph, MO 64503, filed
ANADA 200–386 for Levamisole
Hydrochloride Soluble Drench Powder
used to make a drench solution for oral
administration to cattle and sheep
which is effective against various
internal parasites. Phoenix Scientific’s
Levamisole Hydrochloride Soluble
Drench Powder is approved as a generic
copy of Schering-Plough Animal Health
Corp.’s, LEVASOL (levamisole
hydrochloride) Soluble Drench Powder,
approved under NADA 112–051. The
ANADA is approved as of December 17,
2004, and the regulations are amended
in 21 CFR 520.1242a to reflect the
approval. The 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.
FDA 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 onestablishes anchorage regulations for
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definitionIsland, MA. This action is intended to
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) becauseincrease the safety of life and property
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 Subject in 21 CFR Part 520
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner the anchorage to a new location within
of Food and Drugs and redelegated to the Buzzards Bay.
Center for Veterinary Medicine, 21 CFR
part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■ 1. The authority citation for 21 CFR
part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
■ 2. Section 520.1242a is amended by
revising paragraphs (a) and (b)(4) to read
as follows:
§ 520.1242a Levamisole powder for oral
solution.
(a) Specifications. Each package of
powder contains 9.075, 11.7, 18.15,
46.8, 362.7, or 544.5 grams (g)
levamisole hydrochloride.
(b) * * *
(4) No. 059130 for use of 46.8-, 362.7-
, and 544.5-g packages as in paragraphs
(e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i),
(e)(2)(ii)(B), and (e)(2)(iii) of this section;
and for use of an 18.15-g package as in
paragraph (e)(3) of this section.
* * * * * 20568). We received one comment on
Dated: January 6, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–675 Filed 1–12–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 110
[CGD01–04–004]
1625–AA01
Anchorage Grounds; Buzzards Bay,
MA
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
SUMMARY: The Coast Guard hereby
Buzzards Bay, Nantucket Sound, and
adjacent waters of Massachusetts by
relocating anchorage ground ‘‘L’’ in
Buzzards Bay to an area near Naushon
on Buzzards Bay, improve the safety of
anchored vessels in anchorage ‘‘L’’, and
provide for the overall safe and efficient
flow of vessel traffic and commerce
along the newly established
Recommended Traffic Route for Deep
Draft Vessels. This regulation will
maintain the original shape and
dimension of anchorage ‘‘L’’ but move
DATES: This rule is effective February
14, 2005.
ADDRESSES: Comments and material
received from the public, as well as
documents indicated in this preamble as
being available in the docket, are part of
docket [CGD01–02–027] and are
available for inspection or copying at
First Coast Guard District, 408 Atlantic
Ave., Boston, Massachusetts 02110
between 8 a.m. and 3 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Mr.
John J. Mauro, Commander (oan), First
Coast Guard District, 408 Atlantic Ave.,
Boston, MA 02110, Telephone (617)
223–8355, e-mail: jmauro@d1.uscg.mil.
SUPPLEMENTARY INFORMATION:
Regulatory Information
On April 16, 2004, we published a
notice of proposed rulemaking (NPRM)
entitled Anchorage Grounds; Buzzards
Bay, MA in the Federal Register (69 FR
the proposed rule. No public hearing
was requested and none was held.
Background and Purpose
In light of significant oil spills in
Rhode Island Sound in 1996 and
Buzzards Bay in 2003, the Coast Guard
investigated methods of improving
navigational safety in Buzzards Bay. The
Coast Guard conducted a Port and
Waterways Safety Assessment (PAWSA)
to collect input on potential
navigational safety improvements in
Buzzards Bay from the local maritime
community. After studying the issue
and collecting mariner input, the Coast
Guard concluded that a Recommended
Traffic Route for Deep Draft vessels in
Buzzards Bay should be implemented to
improve navigation safety in this area.
Presently, there are two designated
anchorage grounds in Buzzards Bay;
anchorage ‘‘L’’ and anchorage ‘‘M’’,
whose locations are described in 33 CFR
110.140(b)(3) and 33 CFR 110.140(b)(4),
respectively. The present location of
anchorage ‘‘L’’ puts it directly in the
path of the Recommended Route for
Deep Draft vessels entering or leaving
the Cape Cod Canal via Cleveland Ledge
Channel depicted on current versions of
NOAA nautical charts in the area. Thus,
this rule is needed to move anchorage
‘‘L’’ to a new and safer location.
Although the location of anchorage ‘‘L’’
will change, its size and shape will
remain the same.
The Coast Guard has defined the
anchorage areas contained herein with
the advice and consent of the Army
Corps of Engineers, New England
District, located at 696 Virginia Rd.,
Concord, MA 01742.
This regulation will not exclude
fishing activity or the transit of vessels
in the anchorage grounds. The Coast
Guard expects no increase in the
amount of vessels utilizing anchorage
‘‘L’’ as a result of this change in its
location.

VerDate jul<14>2003 14:42 Jan 12, 2005 Jkt 205001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\13JAR1.SGM 13JAR1