Safety Zone; Wando Terminal Crane Movement; Charleston, SC, 8357-8359 [2018-03915]
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
nor an environmental impact statement
is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in part 814, subparts A
through E, regarding premarket
approval, have been approved under
OMB control number 0910–0231; the
collections of information in part 807,
subpart E, regarding premarket
notification submissions, have been
approved under OMB control number
0910–0120; and the collections of
information in 21 CFR parts 801 and
809, regarding labeling, have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 864
Blood, Medical devices, Packaging
and containers.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 864 is
amended as follows:
PART 864—HEMATOLOGY AND
PATHOLOGY DEVICES
1. The authority citation for part 864
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 864.1866 to subpart B to read
as follows:
■
daltland on DSKBBV9HB2PROD with RULES
§ 864.1866
Lynch syndrome test systems.
(a) Identification. Lynch syndrome
test systems are in vitro diagnostic tests
for use with tumor tissue to identify
previously diagnosed cancer patients at
risk for having Lynch syndrome.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include the following
information, as appropriate:
(i) A detailed description of all test
components, including all provided
reagents, and required but not provided,
ancillary reagents.
VerDate Sep<11>2014
18:04 Feb 26, 2018
Jkt 244001
(ii) A detailed description of
instrumentation and equipment,
including illustrations or photographs of
non-standard equipment or manuals.
(iii) Detailed documentation of the
device software, including, but not
limited to, standalone software
applications and hardware-based
devices that incorporate software.
(iv) A detailed description of quality
controls including appropriate positive
and negative controls that are
recommended or provided.
(v) Detailed specifications for sample
collection, processing, and storage.
(vi) A detailed description of
methodology and assay procedure.
(vii) A description of the assay cut-off
(i.e., the medical decision point between
positive and negative results) or other
relevant criteria that distinguishes
positive and negative results, or ordinal
classes of marker expression, including
the rationale for the chosen cut-off or
other relevant criteria and results
supporting validation of the cut-off.
(viii) Detailed specification of the
criteria for test result interpretation and
reporting.
(ix) Detailed information
demonstrating the performance
characteristics of the device, including:
(A) Data from an appropriate study
demonstrating clinical accuracy using
well-characterized clinical specimens
representative of the intended use
population (i.e., concordance to
Deoxyribonucleic Acid (DNA)
sequencing results of the Lynch
syndrome associated genes or method
comparison to the predicate device
using samples with known alterations in
genes representative of Lynch
syndrome). Pre-specified acceptance
criteria must be provided and followed.
(B) Appropriate device
reproducibility data investigating all
sources of variance (e.g., for distributed
tests, data generated using a minimum
of three sites, of which at least two sites
must be external sites). Each site must
perform testing over a minimum of 5
nonconsecutive days evaluating a
sample panel that spans the claimed
measuring range, and includes the
clinical threshold. Pre-specified
acceptance criteria must be provided
and followed.
(C) Data demonstrating reader
reproducibility, both within-reader and
between-reader, assessed by three
readers over 3 nonconsecutive days at
each site, including a 2 week washout
period between reads, as appropriate.
(D) Device precision data using
clinical samples spanning the
measuring range and controls to
evaluate the within-lot, between-lot,
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8357
within-run, between run, and total
variation.
(E) Analytical specificity studies
including as appropriate, western blots,
peptide inhibition, testing in normal
tissues and neoplastic tissues,
interference by endogenous and
exogenous substances, and crossreactivity and cross contamination
testing.
(F) Device analytical sensitivity data
generated by testing an adequate
number of samples from individuals
with the target condition such that
prevalence of the biomarker in the target
population is established.
(G) Device stability data, including
real-time stability and in-use stability,
and stability evaluating various storage
times, temperatures, and freeze-thaw
conditions, as appropriate.
(H) The staining performance criteria
assessed must include overall staining
acceptability, background staining
acceptability, and morphology
acceptability, as appropriate.
(I) Appropriate training requirements
for users, including interpretation
manual, as applicable.
(J) Identification of risk mitigation
elements used by the device, including
a description of all additional
procedures, methods, and practices
incorporated into the instructions for
use that mitigate risks associated with
testing.
(2) The device’s § 809.10(b) of this
chapter compliant labeling must include
a detailed description of the protocol,
including the information described in
paragraphs (b)(1)(i) through (viii) of this
section, as appropriate, and a detailed
description of the performance studies
performed and the summary of the
results, including those that relate to
paragraph (b)(1)(ix) of this section, as
appropriate.
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03924 Filed 2–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2018–0074]
RIN 1625–AA00
Safety Zone; Wando Terminal Crane
Movement; Charleston, SC
AGENCY:
E:\FR\FM\27FER1.SGM
Coast Guard, DHS.
27FER1
8358
ACTION:
Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
Temporary final rule.
The Coast Guard is
establishing a temporary moving safety
zone in the Port of Charleston in
Charleston, SC around the vessel, M/V
Zhen Hua 16. This temporary safety
zone is necessary to provide for the
safety of waterway users and the M/V
Zhen Hua 16 during the vessel’s transit
into the Port of Charleston, its stay at
Columbus Street Terminal, its transit to
and stay at Wando Terminal, and its
outbound transit departing the Port of
Charleston. Entry of vessels or persons
into this zone is prohibited unless
specifically authorized by the Captain of
the Port Charleston.
DATES: This rule is effective without
actual notice from February 27, 2018
through March 31, 2018. For the
purposes of enforcement, actual notice
will be used from February 23, 2018
through February 27, 2018.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2018–
0074 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Lieutenant Justin Heck, Sector
Charleston Office of Waterways
Management, Coast Guard; telephone
(843) 740–3184, email Justin.c.heck@
uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Table of Abbreviations
daltland on DSKBBV9HB2PROD with RULES
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary 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)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because it is
impracticable. We must establish this
safety zone by February 23, 2018 and
VerDate Sep<11>2014
18:04 Feb 26, 2018
Jkt 244001
lack sufficient time to provide a
reasonable comment period and then
consider those comments before issuing
the rule because the details of the event
were not provided to the Coast Guard
until January 24, 2018. It is also contrary
to the public interest as it would delay
the planning and implementation of
safety measures necessary to protect the
public and mariners from the hazards
associated with the transit of the M/V
Zhen Hua 16.
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. Delaying the effective date of
this rule would be contrary to public
interest because immediate action is
needed to respond to the potential
safety hazards associated with the
transit of the M/V Zhen Hua 16.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1231. The
Captain of the Port (COTP) Charleston
has determined that potential hazards
exist and will be associated with
navigation and dockside operations of
the M/V Zhen Hua 16 while within the
Sector Charleston Captain of the Port
Zone. Due to the size of the cranes
aboard the vessel and the vessel’s
limited ability to maneuver this
temporary safety zone is necessary to
ensure the safety of, and reduce the risk
to, the public and mariners.
IV. Discussion of the Rule
This rule establishes a temporary
moving safety zone from 12:00 a.m. on
February 23, 2018, through 11:59 p.m.
on March 31, 2018, encompassing all
navigable waters from the surface to the
sea floor within 100 yards of the M/V
Zhen Hua 16 while the vessel is
underway, moored, or anchored in the
Sector Charleston Captain of the Port
Zone. No vessel or person is permitted
to enter the safety zone without
obtaining permission from the COTP or
a designated representative. Sector
Charleston may be contacted on VHFFM Channel 16 or (843) 740–7050.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
Executive orders, and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
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Frm 00038
Fmt 4700
Sfmt 4700
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13771 directs agencies
to control regulatory costs through a
budgeting process. This rule has not
been designated a ‘‘significant
regulatory action,’’ under Executive
Order 12866. Accordingly, this rule has
not been reviewed by the Office of
Management and Budget (OMB), and
pursuant to OMB guidance it is exempt
from the requirements of Executive
Order 13771.
This regulatory action determination
is based on the size, location, and
duration of the safety zone. The size of
the zone is the minimum necessary to
provide adequate protection for the
waterway users, adjoining areas, and the
public. The temporary safety zone will
be in place during the vessel’s time
inside the Sector Charleston Captain of
the Port Zone. Any hardships
experienced by persons or vessels are
considered minimal compared to the
interest in protecting the public.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires Federal agencies to consider
the potential impact of regulations on
small entities during rulemaking. 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.
While some owners or operators of
vessels intending to transit the safety
zone may be small entities, for the
reasons stated in section V.A. above,
this rule will not have a significant
economic impact on any vessel owner
or operator.
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this rule. If the rule
would affect your small business,
organization, or governmental
jurisdiction and you have questions
concerning its provisions or options for
compliance, please contact the person
listed in the FOR FURTHER INFORMATION
CONTACT section.
Small businesses may send comments
on the actions of Federal employees
who enforce, or otherwise determine
compliance with, Federal regulations to
the Small Business and Agriculture
Regulatory Enforcement Ombudsman
E:\FR\FM\27FER1.SGM
27FER1
Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Rules and Regulations
and the Regional Small Business
Regulatory Fairness Boards. The
Ombudsman evaluates these actions
annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call 1–
888–REG–FAIR (1–888–734–3247). The
Coast Guard will not retaliate against
small entities that question or complain
about this rule or any policy or action
of the Coast Guard.
C. Collection of Information
This rule will not call for a new
collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
daltland on DSKBBV9HB2PROD with RULES
D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect 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. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, 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
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. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section
above.
E. 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.
F. Environment
We have analyzed this rule under
Department of Homeland Security
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18:04 Feb 26, 2018
Jkt 244001
Directive 023–01, which guides the
Coast Guard in complying with the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves a
temporary safety zone that will prohibit
entry within a 100-yard radius of the
vessel, M/V Zhen Hua 16, during the
vessel’s transit, mooring and anchoring
in the Sector Charleston Captain of the
Port Zone. It is categorically excluded
from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023–01–001–01,
Rev. 01. A Record of Environmental
Consideration supporting this
determination is available in the docket
where indicated under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 165
Marine safety, Navigation (water),
Reporting and recordkeeping
requirements, Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T07–0074 to read as
follows:
■
§ 165.T07–0074 Safety Zone; Wando
Terminal Crane Movement; Charleston, SC.
(a) Regulated area. The following
regulated area is a moving safety zone:
All waters of the Charleston Harbor,
Cooper River, and Wando River in
Charleston, SC within a 100 yard radius
around the outer most points of the
M/V Zhen Hua 16 while the vessel is
underway, moored or anchored.
(b) Definition. As used in this section,
‘‘designated representative’’ means
Coast Guard Patrol Commanders,
including Coast Guard coxswains, petty
officers, and other officers operating
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Fmt 4700
Sfmt 4700
8359
Coast Guard vessels, and Federal, state,
and local officers designated by or
assisting the Captain of the Port
Charleston in the enforcement of the
regulated areas.
(c) Regulations. (1) All persons and
vessels are prohibited from entering,
transiting through, anchoring in, or
remaining within the regulated area
unless authorized by the Captain of the
Port Charleston or a designated
representative.
(2) Persons and vessels desiring to
enter, transit through, anchor in, or
remain within the regulated area may
contact the Captain of the Port
Charleston by telephone at (843) 740–
7050, or a designated representative via
VHF radio on channel 16, to request
authorization. If authorization to enter,
transit through, anchor in, or remain
within the regulated area is granted, all
persons and vessels receiving such
authorization must comply with the
instructions of the Captain of the Port
Charleston or a designated
representative.
(3) The Coast Guard will provide
notice of the regulated area by Marine
Safety Information Bulletins, Local
Notice to Mariners, Broadcast Notice to
Mariners, and on-scene designated
representatives.
(d) Enforcement period. This section
will be enforced beginning at 12:00 a.m.
on February 23, 2018, until 11:59 p.m.
on March 31, 2018. This rule will be
enforced while M/V Zhen Hua is
underway, moored, or anchored in the
Sector Charleston Captain of the Port
Zone.
Dated: February 21, 2018.
J.W. Reed,
Captain, U.S. Coast Guard, Captain of the
Port Charleston.
[FR Doc. 2018–03915 Filed 2–26–18; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2017–0077; FRL–9974–
51—Region 6]
Approval and Promulgation of
Implementation Plans; Texas;
Approval of Texas Motor Vehicle Rule
Revisions
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
Pursuant to the Federal Clean
Air Act (CAA or the Act), the
Environmental Protection Agency (EPA)
SUMMARY:
E:\FR\FM\27FER1.SGM
27FER1
]]>Agencies
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Rules and Regulations]
[Pages 8357-8359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03915]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG-2018-0074]
RIN 1625-AA00
Safety Zone; Wando Terminal Crane Movement; Charleston, SC
AGENCY: Coast Guard, DHS.
[[Page 8358]]
ACTION: Temporary final rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is establishing a temporary moving safety zone
in the Port of Charleston in Charleston, SC around the vessel, M/V Zhen
Hua 16. This temporary safety zone is necessary to provide for the
safety of waterway users and the M/V Zhen Hua 16 during the vessel's
transit into the Port of Charleston, its stay at Columbus Street
Terminal, its transit to and stay at Wando Terminal, and its outbound
transit departing the Port of Charleston. Entry of vessels or persons
into this zone is prohibited unless specifically authorized by the
Captain of the Port Charleston.
DATES: This rule is effective without actual notice from February 27,
2018 through March 31, 2018. For the purposes of enforcement, actual
notice will be used from February 23, 2018 through February 27, 2018.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2018-0074 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.
FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Justin Heck, Sector Charleston Office of
Waterways Management, Coast Guard; telephone (843) 740-3184, email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec. Section
U.S.C. United States Code
II. Background Information and Regulatory History
The Coast Guard is issuing this temporary 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)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone by February 23, 2018 and lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing the rule because the details of the event were
not provided to the Coast Guard until January 24, 2018. It is also
contrary to the public interest as it would delay the planning and
implementation of safety measures necessary to protect the public and
mariners from the hazards associated with the transit of the M/V Zhen
Hua 16.
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. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is needed to respond to the potential safety hazards associated with
the transit of the M/V Zhen Hua 16.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port (COTP) Charleston has determined that
potential hazards exist and will be associated with navigation and
dockside operations of the M/V Zhen Hua 16 while within the Sector
Charleston Captain of the Port Zone. Due to the size of the cranes
aboard the vessel and the vessel's limited ability to maneuver this
temporary safety zone is necessary to ensure the safety of, and reduce
the risk to, the public and mariners.
IV. Discussion of the Rule
This rule establishes a temporary moving safety zone from 12:00
a.m. on February 23, 2018, through 11:59 p.m. on March 31, 2018,
encompassing all navigable waters from the surface to the sea floor
within 100 yards of the M/V Zhen Hua 16 while the vessel is underway,
moored, or anchored in the Sector Charleston Captain of the Port Zone.
No vessel or person is permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.
Sector Charleston may be contacted on VHF-FM Channel 16 or (843) 740-
7050.
V. Regulatory Analyses
We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
This regulatory action determination is based on the size,
location, and duration of the safety zone. The size of the zone is the
minimum necessary to provide adequate protection for the waterway
users, adjoining areas, and the public. The temporary safety zone will
be in place during the vessel's time inside the Sector Charleston
Captain of the Port Zone. Any hardships experienced by persons or
vessels are considered minimal compared to the interest in protecting
the public.
B. Impact on Small Entities
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman
[[Page 8359]]
and the Regional Small Business Regulatory Fairness Boards. The
Ombudsman evaluates these actions annually and rates each agency's
responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.
C. Collection of Information
This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
D. Federalism and Indian Tribal Governments
A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
Also, 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 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
E. 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.
F. Environment
We have analyzed this rule under Department of Homeland Security
Directive 023-01, which guides the Coast Guard in complying with the
National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves a temporary safety zone that will
prohibit entry within a 100-yard radius of the vessel, M/V Zhen Hua 16,
during the vessel's transit, mooring and anchoring in the Sector
Charleston Captain of the Port Zone. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.
List of Subjects in 33 CFR Part 165
Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:
PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS
0
1. The authority citation for part 165 continues to read as follows:
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.
0
2. Add Sec. 165.T07-0074 to read as follows:
Sec. 165.T07-0074 Safety Zone; Wando Terminal Crane Movement;
Charleston, SC.
(a) Regulated area. The following regulated area is a moving safety
zone: All waters of the Charleston Harbor, Cooper River, and Wando
River in Charleston, SC within a 100 yard radius around the outer most
points of the M/V Zhen Hua 16 while the vessel is underway, moored or
anchored.
(b) Definition. As used in this section, ``designated
representative'' means Coast Guard Patrol Commanders, including Coast
Guard coxswains, petty officers, and other officers operating Coast
Guard vessels, and Federal, state, and local officers designated by or
assisting the Captain of the Port Charleston in the enforcement of the
regulated areas.
(c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port Charleston
or a designated representative.
(2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Charleston by telephone at (843) 740-7050, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the regulated area is granted, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Charleston or a designated representative.
(3) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
(d) Enforcement period. This section will be enforced beginning at
12:00 a.m. on February 23, 2018, until 11:59 p.m. on March 31, 2018.
This rule will be enforced while M/V Zhen Hua is underway, moored, or
anchored in the Sector Charleston Captain of the Port Zone.
Dated: February 21, 2018.
J.W. Reed,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2018-03915 Filed 2-26-18; 8:45 am]
BILLING CODE 9110-04-P
