Drawbridge Operation Regulation; High Street Drawbridge, Alameda, CA, 20585-20586 [E9-10241]
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Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $130
million, using the most current (2007)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
List of Subjects in 21 CFR Part 601
Administrative practice and
procedure, Biologics, Confidential
business information.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR part 601 is amended
as follows:
B. Environmental Impact
■
The agency has determined under 21
CFR 25.31(h) that this action is of a type
that does not individually or
cumulatively have a significant adverse
effect on the human environment.
Therefore, neither an environmental
assessment nor an environmental
impact statement is required.
C. Federalism
FDA has analyzed this direct final
rule in accordance with the principles
set forth in Executive Order 13132. FDA
has determined that the direct final rule
does not contain policies that have
substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
PART 601—LICENSING
1. The authority citation for 21 CFR
part 601 continues to read as follows:
Authority: 15 U.S.C. 1451–1561; 21 U.S.C.
321, 351, 352, 353, 355, 356b, 360, 360c–
360f, 360h–360j, 371, 374, 379e, 381; 42
U.S.C. 216, 241, 262, 263, 264; sec 122, Pub.
L. 105–115, 111 Stat. 2322 (21 U.S.C. 355
note).
■
2. Revise § 601.8 to read as follows:
§ 601.8
Publication of revocation.
The Commissioner, following
revocation of a biologics license under
21 CFR 601.5(b), will publish a notice
in the Federal Register with a statement
of the specific grounds for the
revocation.
Dated: March 25, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10244 Filed 5–4–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
VI. Paperwork Reduction Act of 1995
33 CFR Part 117
This direct final rule contains no
collections of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520) is not required.
[Docket No. USCG–2009–0024]
VII. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VerDate Nov<24>2008
22:59 May 04, 2009
Jkt 217001
Drawbridge Operation Regulation;
High Street Drawbridge, Alameda, CA
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Eleventh
Coast Guard District, has issued a
temporary deviation from the regulation
governing the operation of the High
Street drawbridge across the Oakland
Inner Harbor, mile 6.0, at Alameda, CA.
The deviation is necessary to allow
seismic retrofitting of the bridge. This
deviation allows single leaf operation of
the double leaf, bascule style
drawbridge, during the deviation
period.
DATES: This deviation is effective from
12:01 a.m. on May 1, 2009 until 11:59
p.m. on August 31, 2009.
PO 00000
Frm 00027
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Sfmt 4700
20585
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of the docket USCG–
2009–0024 and are available online by
going to https://www.regulations.gov,
selecting the Advanced Docket Search
option on the right side of the screen,
inserting USCG–2009–0024 in the
Docket ID box, pressing Enter, and then
clicking on the item in the Docket ID
column. This material is also available
for inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule call
David H. Sulouff, Chief, Bridge Section,
Eleventh Coast Guard District,
telephone (510) 437–3516. If you have
questions on viewing the docket, call
Renee Wright, Program Manager, Docket
Operations, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION: The
County of Alameda requested a
temporary change to the operation of the
High Street drawbridge across the
Oakland Inner Harbor, mile 6.0, at
Alameda, CA. The High Street
drawbridge navigation span provides a
horizontal clearance of 244 feet between
pier fenders. During single leaf
operation, horizontal clearance is
reduced to approximately 100 feet. The
drawbridge provides a vertical clearance
of 16 feet above Mean High Water in the
closed-to-navigation position and
unlimited vertical clearance in the
open-to-navigation position. As required
by 33 CFR 117.181, the draw shall open
on signal; except that, from 8 a.m. to 9
a.m. and 4:30 p.m. to 6:30 p.m. Monday
through Friday except Federal holidays,
the draw need not be opened for the
passage of vessels. However, the draw
shall open during the above closed
periods for vessels which must, for
reasons of safety, move on a tide or
slack water, if at least two hours notice
is given. The waterway is navigated by
commercial, recreational, emergency
and law enforcement vessels.
Between the hours of 7 a.m. and 9
p.m. Monday through Thursday, and
between the hours of 7 a.m. and 3:30
p.m. on Friday, the drawspan may be
operated, one leaf at a time, while the
opposite leaf is seismically retrofitted.
The drawbridge will be operated in the
normal double leaf operation mode at
night and on weekends, when work is
not actually being performed on the
bridge. The starting and ending dates for
the project are from 12:01 a.m. on May
E:\FR\FM\05MYR1.SGM
05MYR1
20586
Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations
1, 2009 until 11:59 p.m. on August 31,
2009. This temporary deviation has
been coordinated with the waterway
users. The largest tug and barge
combination on the waterway will be
able to continue navigating safely
through the bridge. Recreational and
other waterway traffic will not be
negatively impacted by the project.
Vessels that can transit the bridge,
while in the closed-to-navigation
position, may continue to do so at any
time.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
Dated: April 16, 2009.
P.F. Zukunft,
Rear Admiral, U.S. Coast Guard, Commander,
Eleventh Coast Guard District.
[FR Doc. E9–10241 Filed 5–4–09; 8:45 am]
BILLING CODE 4910–15–P
Regulatory Information
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Publishing an NPRM and
delaying its effective date would be
contrary to public interest because
immediate action is needed to protect
participant and spectator craft from the
hazards associated with the Pittsburgh
Pirates Fireworks Display.
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2009–0016]
RIN 1625–AA00
Safety Zone; Allegheny River Mile
Marker 0.4 to Mile Marker 0.6,
Pittsburgh, PA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a temporary safety zone for
the waters of the Allegheny River from
mile marker 0.4 to mile marker 0.6,
extending the entire width of the river.
This safety zone is needed to protect
spectators and vessels from the hazards
associated with the Pittsburgh Pirates
Fireworks Display. Entry into this zone
is prohibited, unless specifically
authorized by the Captain of the Port
Pittsburgh or a designated
representative.
DATES: This rule is effective from 8:30
p.m. on May 2, 2009 until 11:30 p.m. on
September 26, 2009.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2009–
0016 and are available online by going
to https://www.regulations.gov, selecting
the Advanced Docket Search option on
the right side of the screen, inserting
USCG–2009–0016 in the Docket ID box,
VerDate Nov<24>2008
22:59 May 04, 2009
Jkt 217001
pressing Enter, and then clicking on the
item in the Docket ID column. They are
also available for inspection or copying
two locations: the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays,
and the U.S. Coast Guard Marine Safety
Unit Pittsburgh, Suite 1150 Town Place,
100 Forbes Avenue, Pittsburgh, PA
15222, between 8 a.m. and 4 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call Lieutenant Junior Grade
Douglas Kang Marine Safety Unit
Pittsburgh, telephone 412–644–5808. If
you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION:
Background and Purpose
The Captain of the Port Pittsburgh is
establishing a safety zone for the waters
of the Allegheny River from mile marker
0.4 to mile marker 0.6, extending the
entire width of the river at the
conclusion of each Pittsburgh Pirates
baseball game involving a fireworks
display. A safety zone is needed to
protect participant and spectator craft
from the hazards associated with the
Pittsburgh Pirates Fireworks Display.
Discussion of Rule
The Captain of the Port Pittsburgh is
establishing a safety zone for the waters
of the Allegheny River from mile marker
0.4 to mile marker 0.6, extending the
entire width of the river. Vessels shall
not enter into, depart from, or move
within this safety zone without
permission from the Captain of the Port
Pittsburgh or his authorized
representative. Persons or vessels
requiring entry into or passage through
a safety zone must request permission
from the Captain of the Port Pittsburgh,
or a designated representative. They
may be contacted on VHF–FM Channel
PO 00000
Frm 00028
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13 or 16, or through Coast Guard Sector
Ohio Valley at 1–800–253–7465. This
rule is effective from 8:30 p.m. on May
2, 2009 until 11:30 p.m. on September
26, 2009. However, this rule will only
be enforced from 8:30 p.m. until 11:30
p.m. on days in which fireworks are
scheduled to follow a Pittsburgh Pirates
baseball game. These dates are: May 2,
May 30, June 27, July 18, August 8,
September 5, and September 26, 2009.
The times of enforcement and
scheduled game dates are based upon a
prearranged schedule and may change.
The Captain of the Port Pittsburgh will
inform the public through broadcast
notices to mariners of the enforcement
period for the safety zone as well as any
changes in the planned schedule.
Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on 13 of these statutes or
executive orders.
Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order.
This rule will be in effect for a short
period of time and notifications to the
marine community will be made
through broadcast notices to mariners.
The impacts on routine navigation are
expected to be minimal.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have
a significant economic impact on a
substantial number of small entities.
This rule will affect the following
entities, some of which may be small
entities: the owners or operators of
vessels intending to transit that portion
of the Allegheny River from mile marker
0.4 to mile marker 0.6, from 8:30 p.m.
on May 2, 2009 until 11:30 p.m. on
E:\FR\FM\05MYR1.SGM
05MYR1
Agencies
[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Pages 20585-20586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10241]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2009-0024]
Drawbridge Operation Regulation; High Street Drawbridge, Alameda,
CA
AGENCY: Coast Guard, DHS.
ACTION: Notice of temporary deviation from regulations.
-----------------------------------------------------------------------
SUMMARY: The Commander, Eleventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
High Street drawbridge across the Oakland Inner Harbor, mile 6.0, at
Alameda, CA. The deviation is necessary to allow seismic retrofitting
of the bridge. This deviation allows single leaf operation of the
double leaf, bascule style drawbridge, during the deviation period.
DATES: This deviation is effective from 12:01 a.m. on May 1, 2009 until
11:59 p.m. on August 31, 2009.
ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of the docket USCG-2009-0024 and are available
online by going to https://www.regulations.gov, selecting the Advanced
Docket Search option on the right side of the screen, inserting USCG-
2009-0024 in the Docket ID box, pressing Enter, and then clicking on
the item in the Docket ID column. This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If you have questions on this rule
call David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard
District, telephone (510) 437-3516. If you have questions on viewing
the docket, call Renee Wright, Program Manager, Docket Operations,
telephone (202) 366-9826.
SUPPLEMENTARY INFORMATION: The County of Alameda requested a temporary
change to the operation of the High Street drawbridge across the
Oakland Inner Harbor, mile 6.0, at Alameda, CA. The High Street
drawbridge navigation span provides a horizontal clearance of 244 feet
between pier fenders. During single leaf operation, horizontal
clearance is reduced to approximately 100 feet. The drawbridge provides
a vertical clearance of 16 feet above Mean High Water in the closed-to-
navigation position and unlimited vertical clearance in the open-to-
navigation position. As required by 33 CFR 117.181, the draw shall open
on signal; except that, from 8 a.m. to 9 a.m. and 4:30 p.m. to 6:30
p.m. Monday through Friday except Federal holidays, the draw need not
be opened for the passage of vessels. However, the draw shall open
during the above closed periods for vessels which must, for reasons of
safety, move on a tide or slack water, if at least two hours notice is
given. The waterway is navigated by commercial, recreational, emergency
and law enforcement vessels.
Between the hours of 7 a.m. and 9 p.m. Monday through Thursday, and
between the hours of 7 a.m. and 3:30 p.m. on Friday, the drawspan may
be operated, one leaf at a time, while the opposite leaf is seismically
retrofitted. The drawbridge will be operated in the normal double leaf
operation mode at night and on weekends, when work is not actually
being performed on the bridge. The starting and ending dates for the
project are from 12:01 a.m. on May
[[Page 20586]]
1, 2009 until 11:59 p.m. on August 31, 2009. This temporary deviation
has been coordinated with the waterway users. The largest tug and barge
combination on the waterway will be able to continue navigating safely
through the bridge. Recreational and other waterway traffic will not be
negatively impacted by the project.
Vessels that can transit the bridge, while in the closed-to-
navigation position, may continue to do so at any time.
In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.
Dated: April 16, 2009.
P.F. Zukunft,
Rear Admiral, U.S. Coast Guard, Commander, Eleventh Coast Guard
District.
[FR Doc. E9-10241 Filed 5-4-09; 8:45 am]
BILLING CODE 4910-15-P