Drawbridge Operation Regulation; Buffalo Bayou, Mile 4.3, Houston, Harris County, TX, 16294-16296 [2011-6876]
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16294
Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations
proposing to require the application of
the black box warning to labeling and
advertising through notice and comment
rulemaking. For the purposes of this
analysis, we assume that this final rule
will establish special controls with a
reference to a black box warning
regarding off-label use, but the analysis
of the impact of the addition of the
warning to the product label will be
included in a separate rulemaking.
erowe on DSK5CLS3C1PROD with RULES
B. Costs of the Final Rule
This final rule is deregulatory. Device
manufacturers currently subject to class
III requirements will be subject to the
less burdensome requirements for
makers of class II devices. Through this
classification, manufacturers of ovarian
adnexal mass assessment test system
devices will be relieved of the obligation
to submit a PMA prior to marketing. The
cost of submitting a PMA can reach
$1,000,000, plus user fees of an
additional $217,787 in FY 2010,
increasing to $256,384 in 2012. This
device classification will substantially
reduce an existing burden on
manufacturers of ovarian adnexal mass
assessment test system devices.
Considering the cost of submitting a
PMA plus the relevant user fees, the
reduction could be $1,000,000 per
device.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Classification of the affected
device into class II after it had
automatically been placed in class III
will relieve manufacturers of the cost of
complying with the premarket approval
requirements of section 515 of the FD&C
Act. Because of the reduced burden, the
Agency does not believe that this final
rule will have a significant economic
impact on a substantial number of small
entities.
VII. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of the Executive Order requires
Agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
Federal law includes an express
preemption provision that preempts
certain state requirements ‘‘different or
in addition to’’ certain federal
requirements applicable to devices. 21
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U.S.C. 360k; See Medtronic v. Lohr, 518
U.S. 470 (1996); Riegel v. Medtronic,
Inc., 552 U.S. 312 (2008). The special
controls established by this rulemaking
create ‘‘requirements’’ to address each
identified risk to health presented by
these specific medical devices under 21
U.S.C. 360k, even though product
sponsors may have flexibility in how
they meet those requirements. Cf.
Papike v. Tambrands, Inc., 107 F.3d
737, 740–42 (9th Cir. 1997).
VIII. Paperwork Reduction Act of 1995
This final rule establishes as special
controls a guidance document that
refers to previously approved
collections of information found in
other FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520).
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of the
guidance document entitled ‘‘Guidance
for Industry and FDA Staff; Class II
Special Controls Guidance Document:
Ovarian Adnexal Mass Assessment
Score Test System.’’ The notice contains
an analysis of the paperwork burden for
the guidance.
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Petition from Vermillion, Inc., for
reclassification of the OVA1TM Test
submitted July 22, 2009.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 866.6050 is added to
subpart G to read as follows:
■
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Fmt 4700
(a) Identification. An ovarian/adnexal
mass assessment test system is a device
that measures one or more proteins in
serum or plasma. It yields a single result
for the likelihood that an adnexal pelvic
mass in a woman, for whom surgery is
planned, is malignant. The test is for
adjunctive use, in the context of a
negative primary clinical and
radiological evaluation, to augment the
identification of patients whose
gynecologic surgery requires oncology
expertise and resources.
(b) Classification. Class II (special
controls). The special control for this
device is FDA’s guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Ovarian Adnexal
Mass Assessment Score Test System.’’
For the availability of this guidance
document, see § 866.1(e).
Dated: March 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6620 Filed 3–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
IX. References
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§ 866.6050 Ovarian adnexal mass
assessment score test system.
Sfmt 4700
33 CFR Part 117
[Docket No. USCG–2011–0100]
RIN 1625–AA09
Drawbridge Operation Regulation;
Buffalo Bayou, Mile 4.3, Houston,
Harris County, TX
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is removing
the existing drawbridge operation
regulation for the drawbridge across
Buffalo Bayou, mile 4.3, Houston, Harris
County, Texas. The bridge was replaced
with a fixed bridge in 1991 and the
operating regulation is no longer
applicable or necessary.
DATES: This rule is effective March 23,
2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket, are part of docket USCG–2011–
0100 and are available by going to
https://www.regulations.gov, inserting
USCG–2011–0100 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ This
material is also available for inspection
or copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
SUMMARY:
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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 or
e-mail Mr. Jim Wetherington, Bridge
Specialist, Coast Guard; telephone 504–
671–2128, e-mail
james.r.wetherington@uscg.mil. If you
have questions on viewing the docket,
call Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
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Regulatory Information
The Coast Guard is issuing this final
rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b), the Coast Guard finds that good
cause exists for not publishing a notice
of proposed rulemaking (NPRM) with
respect to this rule because the
drawbridge requiring draw operations in
33 CFR 117.955(b), was removed and
replaced with a fixed span bridge in
1991. The bridge operator and those
transiting in the vicinity of this bridge
have not been governed by the draw
operations since the bridge was
removed and replaced. Therefore, the
regulation is no longer applicable and
should be removed from publication.
Under 5 U.S.C. 553(d)(1), a rule that
relieves a restriction is not required to
provide the 30 day notice period before
its effective date. This rule removes the
draw operations requirements under 33
CFR 117.955(b), thus removing a
regulatory restriction on the public.
Additionally, under 5 U.S.C. 553(d)(3),
the Coast Guard finds that good cause
exists for making this rule effective in
less than 30 days after publication in the
Federal Register. The bridge has been a
fixed bridge for 20 years and this rule
only requires an administrative change
to the Federal Register, omitting a
regulatory requirement that is no longer
applicable or necessary.
Basis and Purpose
The drawbridge across Buffalo Bayou,
mile 4.3, was removed and replaced
with a fixed bridge in 1991. The
elimination of this drawbridge
necessitates the removal of the
drawbridge operation regulation
pertaining to this drawbridge.
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The regulation governing the
operation of the bridge is found in 33
CFR 117.955(b). The purpose of this rule
is to remove the section of 33 CFR
117.955 (b) that refers to the bridge at
mile 4.3, from the Code of Federal
Regulations since it governs a bridge
that is no longer able to be opened.
Discussion of Rule
The Coast Guard is changing the
regulation in 33 CFR 117 by removing
restrictions and the regulatory burden
related to the draw operations for this
bridge that is no longer in existence
without publishing an NPRM. The
change removes the section of the
regulation governing the bridge since
the bridge has been replaced with a
fixed bridge. This change does not affect
vessel operators using the waterway.
Thus, it is not necessary to publish an
NPRM.
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.
The Coast Guard does not consider
this rule to be ‘‘significant’’ under that
Order because it is an administrative
change and does not affect the way
vessels operate on the waterway.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.), the Coast Guard
considers whether this final rule will
have a significant economic impact on
a substantial number of small entities.
‘‘Small entities’’ include (1) small
businesses, not-for-profit organizations
that are independently owned and
operated and are not dominant in their
fields, and (2) governmental
jurisdictions with populations of less
than 50,000.
Since the drawbridge across the
Buffalo Bayou, mile 4.3 at Houston,
Texas, has been removed and replaced
with a fixed bridge, the regulation
governing draw operations for this
bridge is no longer needed. There is no
new restriction or regulation being
imposed by this rule; therefore, the
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16295
Coast Guard certifies under 5 U.S.C.
605(b) that this final rule will not have
a significant economic impact on a
substantial number of small entities.
Collection of Information
This rule calls for no new collection
of information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520).
Federalism
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on State or local governments and
would either preempt State law or
impose a substantial direct cost of
compliance on them. We have analyzed
this rule under that Order and have
determined that it does not have
implications for federalism.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
Taking of Private Property
This rule will not cause a taking of
private property or otherwise have
taking implications under Executive
Order 12630, Governmental Actions and
Interference with Constitutionally
Protected Property Rights.
Civil Justice Reform
This rule meets applicable standards
in sections 3(a) and 3(b)(2) of Executive
Order 12988, Civil Justice Reform, to
minimize litigation, eliminate
ambiguity, and reduce burden.
Protection of Children
We have analyzed this rule under
Executive Order 13045, Protection of
Children from Environmental Health
Risks and Safety Risks. This rule is not
an economically significant rule and
would not create an environmental risk
to health or risk to safety that might
disproportionately affect children.
Indian Tribal Governments
This rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes.
Energy Effects
We have analyzed this rule under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
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Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA)
(15 U.S.C. 272 note) directs agencies to
use voluntary consensus standards in
their regulatory activities unless the
agency provides Congress, through the
Office of Management and Budget, with
an explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedures; and related management
systems practices) that are developed or
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guides the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA) (42 U.S.C. 4321–4370f), and
have concluded that this action is one
of a category of actions which do not
individually or cumulatively have a
significant effect on the human
environment. This rule is categorically
excluded, under figure 2–1, paragraph
(32)(e), of the Instruction.
Under figure 2–1, paragraph (32)(e), of
the Instruction, an environmental
analysis checklist and a categorical
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exclusion determination are not
required for this rule.
List of Subjects in 33 CFR Part 117
Bridges.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 117 as follows:
PART 117—DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:
■
Authority: 33 U.S.C. 499; 33 CFR 1.05–1;
Department of Homeland Security Delegation
No. 0170.1.
2. Revise § 117.955 (b) to read as
follows:
■
§ 117.955
Buffalo Bayou.
*
*
*
*
*
(b) The draw of the Union Pacific Rail
Road Bridge, mile 3.1, need not be
opened to the passage of vessels.
Dated: March 10, 2011.
Mary E. Landry,
Rear Admiral, U.S. Coast Guard, Commander,
Eighth Coast Guard District.
[FR Doc. 2011–6876 Filed 3–22–11; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2011–0113]
Drawbridge Operation Regulation;
Pocomoke River, Snow Hill, MD
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
The Commander, Fifth Coast
Guard District, has issued a temporary
deviation from the regulations
governing the operation of the S12
Bridge across Pocomoke River, mile
29.9, at Snow Hill, MD. The deviation
restricts the operation of the draw span
to facilitate the cleaning and painting of
the bridge.
DATES: This deviation is effective from
7 a.m. on March 15, 2011 through 11:59
p.m. on May 30, 2011.
ADDRESSES: Documents mentioned in
this preamble as being available in the
docket are part of docket USCG–2011–
0113 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–0113 in the ‘‘Keyword’’ box
and then clicking ‘‘Search’’. They are
also available for inspection or copying
SUMMARY:
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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 or
e-mail Mr. Waverly W. Gregory, Jr.,
Bridge Administrator, Fifth Coast Guard
District; telephone 757–398–6222, email Waverly.W.Gregory@uscg.mil. If
you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION: The
Maryland State Highway
Administration (SHA), who owns and
operates this single leaf bascule
drawbridge, has requested a temporary
deviation from the current operating
schedule to facilitate the cleaning and
painting of the structure. Under the
regular operating schedule, the bridge
opens on signal as required by 33 CFR
117.569(c) if at least five hours advance
notice is given.
The S12 Bridge across Pocomoke
River, mile 29.9 at Snow Hill MD, has
a vertical clearance in the closed
position of two feet above mean high
water and five feet above mean low
water. Under this temporary deviation,
the contractor has requested to maintain
the bridge in the closed position to
vessels from 7 a.m. on March 15, 2011
through 11:59 p.m. on May 30, 2011, to
allow for the potential delays caused by
anticipated seasonal weather patterns
that will interfere with environmental
conditions required for sandblasting and
painting of the bridge.
Bridge opening data supplied by SHA
and reviewed by the Coast Guard
revealed vessel openings of the draw
span from March 2010 through May
2010. Specifically, the drawbridge
opened for vessels a total of 23, 13, and
25 times during the months of March
2010 through May 2010, respectively.
We also contacted a nearby canoe shop
owner who indicated that he can work
around the restrictions.
The Coast Guard has coordinated the
restrictions with the local users of the
waterway and will inform other users
through our Local and Broadcast
Notices to Mariners of the closure
periods for the bridge so that vessels can
arrange their transits to minimize any
impact caused by the temporary
deviation. There are no alternate routes
for vessels transiting this section of the
Pocomoke River and the drawbridge
will be able to open in the event of an
emergency.
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]]>Agencies
[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16294-16296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6876]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2011-0100]
RIN 1625-AA09
Drawbridge Operation Regulation; Buffalo Bayou, Mile 4.3,
Houston, Harris County, TX
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is removing the existing drawbridge operation
regulation for the drawbridge across Buffalo Bayou, mile 4.3, Houston,
Harris County, Texas. The bridge was replaced with a fixed bridge in
1991 and the operating regulation is no longer applicable or necessary.
DATES: This rule is effective March 23, 2011.
ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2011-0100 and are available by
going to https://www.regulations.gov, inserting USCG-2011-0100 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground
[[Page 16295]]
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 or e-mail Mr. Jim Wetherington, Bridge Specialist, Coast Guard;
telephone 504-671-2128, e-mail james.r.wetherington@uscg.mil. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone 202-366-9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the drawbridge requiring draw
operations in 33 CFR 117.955(b), was removed and replaced with a fixed
span bridge in 1991. The bridge operator and those transiting in the
vicinity of this bridge have not been governed by the draw operations
since the bridge was removed and replaced. Therefore, the regulation is
no longer applicable and should be removed from publication.
Under 5 U.S.C. 553(d)(1), a rule that relieves a restriction is not
required to provide the 30 day notice period before its effective date.
This rule removes the draw operations requirements under 33 CFR
117.955(b), thus removing a regulatory restriction on the public.
Additionally, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good
cause exists for making this rule effective in less than 30 days after
publication in the Federal Register. The bridge has been a fixed bridge
for 20 years and this rule only requires an administrative change to
the Federal Register, omitting a regulatory requirement that is no
longer applicable or necessary.
Basis and Purpose
The drawbridge across Buffalo Bayou, mile 4.3, was removed and
replaced with a fixed bridge in 1991. The elimination of this
drawbridge necessitates the removal of the drawbridge operation
regulation pertaining to this drawbridge.
The regulation governing the operation of the bridge is found in 33
CFR 117.955(b). The purpose of this rule is to remove the section of 33
CFR 117.955 (b) that refers to the bridge at mile 4.3, from the Code of
Federal Regulations since it governs a bridge that is no longer able to
be opened.
Discussion of Rule
The Coast Guard is changing the regulation in 33 CFR 117 by
removing restrictions and the regulatory burden related to the draw
operations for this bridge that is no longer in existence without
publishing an NPRM. The change removes the section of the regulation
governing the bridge since the bridge has been replaced with a fixed
bridge. This change does not affect vessel operators using the
waterway. Thus, it is not necessary to publish an NPRM.
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.
The Coast Guard does not consider this rule to be ``significant''
under that Order because it is an administrative change and does not
affect the way vessels operate on the waterway.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard considers whether this final rule will have a significant
economic impact on a substantial number of small entities. ``Small
entities'' include (1) small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and (2) governmental jurisdictions with populations of less
than 50,000.
Since the drawbridge across the Buffalo Bayou, mile 4.3 at Houston,
Texas, has been removed and replaced with a fixed bridge, the
regulation governing draw operations for this bridge is no longer
needed. There is no new restriction or regulation being imposed by this
rule; therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that
this final rule will not have a significant economic impact on a
substantial number of small entities.
Collection of Information
This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Federalism
A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.
Taking of Private Property
This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.
Civil Justice Reform
This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.
Protection of Children
We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.
Indian Tribal Governments
This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial
[[Page 16296]]
direct effect on one or more Indian tribes, on the relationship between
the Federal Government and Indian tribes, or on the distribution of
power and responsibilities between the Federal Government and Indian
tribes.
Energy Effects
We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.
Technical Standards
The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.
Environment
We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.
List of Subjects in 33 CFR Part 117
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:
PART 117--DRAWBRIDGE OPERATION REGULATIONS
0
1. The authority citation for part 117 continues to read as follows:
Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.
0
2. Revise Sec. 117.955 (b) to read as follows:
Sec. 117.955 Buffalo Bayou.
* * * * *
(b) The draw of the Union Pacific Rail Road Bridge, mile 3.1, need
not be opened to the passage of vessels.
Dated: March 10, 2011.
Mary E. Landry,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2011-6876 Filed 3-22-11; 8:45 am]
BILLING CODE 9110-04-P
