Regulated Navigation Area; Biscayne Bay Causeway Island Slip, Miami Beach, FL, 66189-66191 [2021-25432]
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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vi) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Discard the entire device after use.’’
(B) ‘‘Warning: Not intended for more
than one use. Do not use on more than
one patient. Improper use of blood
lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested.’’
(b) Single use only blood lancet
without an integral sharps injury
prevention feature—(1) Identification. A
disposable blood lancet intended for a
single use that is comprised of a single
use blade attached to a solid, nonreusable base that is used to puncture
the skin to obtain a drop of blood for
diagnostic purposes.
(2) Classification. Class II (special
controls). The special controls are:
(i) The design characteristics of the
device must ensure that the structure
and material composition are consistent
with the intended use and address the
risk of sharp object injuries and
bloodborne pathogen transmissions.
(ii) Mechanical performance testing
must demonstrate that the device will
withstand forces encountered during
use.
(iii) The device must be demonstrated
to be biocompatible.
(iv) Sterility testing must demonstrate
the sterility of any device component
that breaches the skin (e.g., blade).
(v) Labeling must include:
(A) Detailed descriptions, with
illustrations, of the proper use of the
device.
(B) Handwashing instructions for the
user before and after use of the device.
(C) Instructions on preparation (e.g.,
cleaning, disinfection) of the skin to be
pierced.
(D) Instructions for the safe disposal
of the device.
(E) Labeling must be appropriate for
the intended use environment.
(1) For those devices intended for
health care settings, labeling must
address the health care facility use of
these devices, including how these
lancets are to be used with personal
protective equipment, such as gloves.
(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vi) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Discard the entire device after use.’’
(B) ‘‘Warning: Not intended for more
than one use. Do not use on more than
VerDate Sep<11>2014
17:19 Nov 19, 2021
Jkt 256001
one patient. Improper use of blood
lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested.’’
(c) Multiple use blood lancet for single
patient use only—(1) Identification. A
multiple use capable blood lancet
intended for use on a single patient that
is comprised of a single use blade
attached to a solid, reusable base that is
used to puncture the skin to obtain a
drop of blood for diagnostic purposes.
(2) Classification. Class II (special
controls). The special controls are:
(i) The design characteristics of the
device must ensure that:
(A) The lancet blade can be changed
with every use, either manually or by
triggering a blade storage unit to discard
the used blade and reload an unused
blade into the reusable base; and
(B) The structure and material
composition are consistent with the
intended use and address the risk of
sharp object injuries and bloodborne
pathogen transmissions and allow for
validated cleaning and disinfection.
(ii) Mechanical performance testing
must demonstrate that the device will
withstand forces encountered during
use.
(iii) The device must be demonstrated
to be biocompatible.
(iv) Sterility testing must demonstrate
the sterility of any device component
that breaches the skin (e.g., blade).
(v) Validation testing must
demonstrate that the cleaning and
disinfection instructions are adequate to
ensure that the reusable lancet base can
be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with
illustrations, of the proper use of the
device.
(B) The Environmental Protection
Agency (EPA) registered disinfectant’s
contact time for disinfectant use.
(C) Handwashing instructions for the
user before and after use of the device.
(D) Instructions on preparation (e.g.,
cleaning, disinfection) of the skin to be
pierced.
(E) Instructions on the cleaning and
disinfection of the device.
(F) Instructions for the safe disposal of
the device.
(G) Instructions for use must address
the safe storage of the reusable blood
lancet base between uses to minimize
contamination or damage and the safe
storage and disposal of the refill lancet
blades.
(H) Labeling must be appropriate for
the intended use environment.
(1) For those devices intended for
health care settings, labeling must
address the health care facility use of
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Fmt 4700
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66189
these devices, including how these
lancets are to be used with personal
protective equipment, such as gloves.
(2) For those devices intended for use
in the home, labeling must be written so
that it is understandable to lay users.
(vii) Labeling must also include the
following statements, prominently
placed:
(A) ‘‘For use only on a single patient.
Disinfect reusable components
according to manufacturer’s instructions
between each use.’’
(B) ‘‘Used lancet blades must be safely
discarded after a single use.’’
(C) ‘‘Warning: Do not use on more
than one patient. Improper use of blood
lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings
where multiple patients are tested. The
cleaning and disinfection instructions
for this device are intended only to
reduce the risk of local use site
infection; they cannot render this device
safe for use for more than one patient.’’
(d) Multiple use blood lancet for
multiple patient use—(1) Identification.
A multiple use capable blood lancet
intended for use on multiple patients
that is comprised of a single use blade
attached to a solid, reusable base that is
used to puncture the skin to obtain a
drop of blood for diagnostic purposes.
(2) Classification. Class III (premarket
approval).
Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25376 Filed 11–19–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2021–0077]
RIN 1625–AA11
Regulated Navigation Area; Biscayne
Bay Causeway Island Slip, Miami
Beach, FL
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a Regulated Navigation
Area over certain navigable waters of
the Biscayne Bay Causeway Island Slip,
immediately west of the Coast Guard
Base Miami Beach, Miami Beach, FL.
This action is necessary to provide for
the safety of life and federal property on
SUMMARY:
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22NOR1
66190
Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
this navigable water. This rulemaking
will require all persons and vessels to
transit the Regulated Navigation Area at
a speed that creates minimum wake,
seven miles per hour or less, to
safeguard damage to Coast Guard assets,
disrupting operations, and/or injuring
Coast Guard personnel. Additionally,
this rulemaking will prohibit vessels
from passing other vessels making way
within the regulated area.
DATES: Effective December 22, 2021.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2021–
0077 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 Omar Beceiro, Sector Miami
Waterways Management Division, Coast
Guard at 305–535–4317 or by email
Omar.Beceiro@uscg.mil.
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
jspears on DSK121TN23PROD with RULES1
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
In October 2020, the Fisher Island
Ferry Communities Association
relocated its ferry terminal to the
Biscayne Bay Causeway Island Slip
(Slip), west of the Coast Guard Base
Miami Beach, Miami Beach, FL. The
Slip is the primary terminal for the
movement of residents, workers, and
goods from Terminal Island to Fisher
Island. Prior to October 2020, maritime
traffic in the Biscayne Bay Causeway
Island Basin (Basin) was limited in
scope to occasional private yachts and
Coast Guard assets. The addition of ferry
traffic at the Slip has resulted in a
substantial increase in maritime traffic
in the Basin. The Basin has a length of
approximately 380 yards and a width of
approximately 97 yards. The increase in
traffic, particularly of the Fisher Island
Ferry, presents a hazard to Coast Guard
assets operating in the Basin as the
ferries occasionally pass within the
Basin, dangerously close to Coast Guard
assets. Additionally, and particularly
when passing within the Basin, the
ferries create a disrupting, and at times
dangerous wake, adversely affecting
Coast Guard routine operations and
personnel. The passing maneuvers and
resultant wake also create hazardous
VerDate Sep<11>2014
17:19 Nov 19, 2021
Jkt 256001
conditions during certain cutter
operations, such as onloading and
offloading of ammunition or refueling.
The Coast Guard’s Seventh District
Commander has determined the
increased ferry traffic, passing
maneuvers, and resultant wake presents
a safety and operational concern to
Coast Guard personnel and assets
moored in the Biscayne Bay Causeway
Island Basin.
In response, on April 14, 2021, the
Coast Guard published a notice of
proposed rulemaking (NPRM) titled,
‘‘Regulated Navigation Area: Biscayne
Bay Causeway Island Slip, Miami
Beach, FL’’ (86 FR 19599). There we
stated why we issued the NPRM, and
invited comments on our proposed
regulatory action related to this
Regulated Navigation Area. During the
comment period that ended May 14,
2021, we received 0 comments.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70034. The
Coast Guard’s Seventh District
Commander has determined that
potential hazards associated with the
increased maritime traffic in the
Biscayne Bay Causeway Island Basin
(Basin), where ferries occasionally pass
within the Basin dangerously close to
Coast Guard assets, is a safety and
operational concern. The purpose of this
regulation is to ensure navigational
safety, protection of Coast Guard assets
and personnel, and to facilitate safe
execution of Coast Guard statutory
missions.
IV. Discussion of Comments, Changes,
and the Rule
As noted above, we received no
comments on the NPRM published
April 14, 2021. We are making one
change in the regulatory text. We
discovered that the section number in
the CFR, 33 CFR 165.789 is already in
use. Section 165.789 contains a safety
zone regulation. Therefore, we are
revising the section number for this
Regulated Navigation Area in the final
rule regulatory text. We are deleting
‘‘165.789,’’ and replacing it with
‘‘165.790.’’
This rule establishes a permanent
Regulated Navigation Area that will
require all persons and vessels to transit
the regulated area at a speed that creates
minimum wake, seven miles per hour or
less, to safeguard damage to Coast Guard
assets, disrupting operations, and/or
injuring Coast Guard personnel.
Additionally, this rule will prohibit
vessels from passing other vessels
making way within the regulated area.
This Regulated Navigation Area covers
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Fmt 4700
Sfmt 4700
all navigable waters within the Biscayne
Bay Causeway Island Slip, immediately
west of the Coast Guard Base Miami
Beach, Miami Beach, FL.
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.
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).
This regulatory action determination
is based on the size, and location of the
Regulated Navigation area. The
Regulated Navigation Area will only
affect vessels entering, and passing
within, the Biscayne Bay Causeway
Island Slip in Miami Beach, Miami
Beach, FL. Vessels will continue to
operate within the Biscayne Bay
Causeway Island Slip with the only
restriction being the requirement to
operate at speeds below seven miles per
hour and avoid passing other vessels
making way within the regulated area.
Moreover, upon activating the Regulated
Navigation Area, the Coast Guard will
notify the local maritime community
through various means including, Local
Notice to Mariners and Broadcast Notice
to Mariners issued on VHF–FM marine
radio channel 16.
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 received 0 comments
from the Small Business Administration
on this rulemaking. 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.
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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
While some owners or operators of
vessels intending to transit the
Regulated Navigation Area 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 call or email 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
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).
jspears on DSK121TN23PROD with RULES1
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
VerDate Sep<11>2014
17:19 Nov 19, 2021
Jkt 256001
responsibilities between the Federal
Government and Indian tribes.
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, Rev. 1, associated
implementing instructions, and
Environmental Planning COMDTINST
5090.1 (series), which guide 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
Regulated Navigation Area requiring all
persons and vessels to transit the
regulated area at a speed that creates
minimum wake, seven miles or less, and
to avoid passing other vessels making
way within the regulated area. Normally
such actions are categorically excluded
from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023–01–001–01,
Rev. 1. A Record of Environmental
Consideration supporting this
determination is available in the docket.
For instructions on locating the docket,
see the ADDRESSES section of this
preamble.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to call or email 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
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PO 00000
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Fmt 4700
Sfmt 9990
66191
PART 165—REGULATED NAVIGATION
AREA; BISCAYNE BAY CAUSEWAY
ISLAND SLIP, MIAMI BEACH, FL
1. The authority citation for part 165
continues to read as follows:
■
Authority: 46 U.S.C. 70034, 70051; 33 CFR
1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
■
2. Add § 165.790 to read as follows:
§ 165.790 Regulated Navigation Area;
Biscayne Bay Causeway Island Slip, Miami
Beach, FL.
(a) Regulated area. The following area
is a Regulated Navigation Area: All
waters of Biscayne Bay Causeway Island
Slip within the following points:
Beginning at Point 1 in position
25°46′18″ N, 080°08′50″ W; thence east
to Point 2 in position 25°46′19″ N,
080°08′47″ W; thence southeast to Point
3 in position 25°46′10″ N, 080°08′41″ W;
thence west to Point 4 in position
25°46′10″ N, 080°08′45″ W; thence back
to origin at Point 1.
(b) Applicability. This section applies
to all vessels operating within the RNA,
except vessels that are engaged in law
enforcement or search and rescue
operations.
(c) Regulations. (1) The general
regulations governing Regulated
Navigation Areas found in 33 CFR
165.10, 165.11, and 165.13, including
the Regulated Navigation Area
described in paragraph (a) of this
section and the following regulations,
apply.
(2) All persons and vessels are
required to transit the Regulated
Navigation Area at a speed that creates
minimum wake, seven miles per hour or
less, to prevent damage to Coast Guard
assets, disrupting operations, and/or
injuring Coast Guard personnel.
(3) All persons and vessels are
required to avoid passing other vessels
making way within the Regulated
Navigation Area.
(d) Enforcement. The Coast Guard
may be assisted in the patrol and
enforcement of the Regulated
Navigation Area by other Federal, State,
and local agencies.
Dated: November 8, 2021.
B.C. McPherson,
Rear Admiral, U.S. Coast Guard, District
Commander.
[FR Doc. 2021–25432 Filed 11–19–21; 8:45 am]
BILLING CODE 9110–04–P
E:\FR\FM\22NOR1.SGM
22NOR1
]]>Agencies
[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66189-66191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25432]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG-2021-0077]
RIN 1625-AA11
Regulated Navigation Area; Biscayne Bay Causeway Island Slip,
Miami Beach, FL
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is establishing a Regulated Navigation Area
over certain navigable waters of the Biscayne Bay Causeway Island Slip,
immediately west of the Coast Guard Base Miami Beach, Miami Beach, FL.
This action is necessary to provide for the safety of life and federal
property on
[[Page 66190]]
this navigable water. This rulemaking will require all persons and
vessels to transit the Regulated Navigation Area at a speed that
creates minimum wake, seven miles per hour or less, to safeguard damage
to Coast Guard assets, disrupting operations, and/or injuring Coast
Guard personnel. Additionally, this rulemaking will prohibit vessels
from passing other vessels making way within the regulated area.
DATES: Effective December 22, 2021.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0077 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 Omar Beceiro, Sector Miami Waterways Management Division,
Coast Guard at 305-535-4317 or by 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
In October 2020, the Fisher Island Ferry Communities Association
relocated its ferry terminal to the Biscayne Bay Causeway Island Slip
(Slip), west of the Coast Guard Base Miami Beach, Miami Beach, FL. The
Slip is the primary terminal for the movement of residents, workers,
and goods from Terminal Island to Fisher Island. Prior to October 2020,
maritime traffic in the Biscayne Bay Causeway Island Basin (Basin) was
limited in scope to occasional private yachts and Coast Guard assets.
The addition of ferry traffic at the Slip has resulted in a substantial
increase in maritime traffic in the Basin. The Basin has a length of
approximately 380 yards and a width of approximately 97 yards. The
increase in traffic, particularly of the Fisher Island Ferry, presents
a hazard to Coast Guard assets operating in the Basin as the ferries
occasionally pass within the Basin, dangerously close to Coast Guard
assets. Additionally, and particularly when passing within the Basin,
the ferries create a disrupting, and at times dangerous wake, adversely
affecting Coast Guard routine operations and personnel. The passing
maneuvers and resultant wake also create hazardous conditions during
certain cutter operations, such as onloading and offloading of
ammunition or refueling. The Coast Guard's Seventh District Commander
has determined the increased ferry traffic, passing maneuvers, and
resultant wake presents a safety and operational concern to Coast Guard
personnel and assets moored in the Biscayne Bay Causeway Island Basin.
In response, on April 14, 2021, the Coast Guard published a notice
of proposed rulemaking (NPRM) titled, ``Regulated Navigation Area:
Biscayne Bay Causeway Island Slip, Miami Beach, FL'' (86 FR 19599).
There we stated why we issued the NPRM, and invited comments on our
proposed regulatory action related to this Regulated Navigation Area.
During the comment period that ended May 14, 2021, we received 0
comments.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Coast Guard's Seventh District Commander has determined that
potential hazards associated with the increased maritime traffic in the
Biscayne Bay Causeway Island Basin (Basin), where ferries occasionally
pass within the Basin dangerously close to Coast Guard assets, is a
safety and operational concern. The purpose of this regulation is to
ensure navigational safety, protection of Coast Guard assets and
personnel, and to facilitate safe execution of Coast Guard statutory
missions.
IV. Discussion of Comments, Changes, and the Rule
As noted above, we received no comments on the NPRM published April
14, 2021. We are making one change in the regulatory text. We
discovered that the section number in the CFR, 33 CFR 165.789 is
already in use. Section 165.789 contains a safety zone regulation.
Therefore, we are revising the section number for this Regulated
Navigation Area in the final rule regulatory text. We are deleting
``165.789,'' and replacing it with ``165.790.''
This rule establishes a permanent Regulated Navigation Area that
will require all persons and vessels to transit the regulated area at a
speed that creates minimum wake, seven miles per hour or less, to
safeguard damage to Coast Guard assets, disrupting operations, and/or
injuring Coast Guard personnel. Additionally, this rule will prohibit
vessels from passing other vessels making way within the regulated
area. This Regulated Navigation Area covers all navigable waters within
the Biscayne Bay Causeway Island Slip, immediately west of the Coast
Guard Base Miami Beach, Miami Beach, FL.
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. 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).
This regulatory action determination is based on the size, and
location of the Regulated Navigation area. The Regulated Navigation
Area will only affect vessels entering, and passing within, the
Biscayne Bay Causeway Island Slip in Miami Beach, Miami Beach, FL.
Vessels will continue to operate within the Biscayne Bay Causeway
Island Slip with the only restriction being the requirement to operate
at speeds below seven miles per hour and avoid passing other vessels
making way within the regulated area. Moreover, upon activating the
Regulated Navigation Area, the Coast Guard will notify the local
maritime community through various means including, Local Notice to
Mariners and Broadcast Notice to Mariners issued on VHF-FM marine radio
channel 16.
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 received 0 comments from the Small Business
Administration on this rulemaking. 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.
[[Page 66191]]
While some owners or operators of vessels intending to transit the
Regulated Navigation Area 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
call or email 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 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.
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, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide 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
Regulated Navigation Area requiring all persons and vessels to transit
the regulated area at a speed that creates minimum wake, seven miles or
less, and to avoid passing other vessels making way within the
regulated area. Normally such actions are categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.
G. Protest Activities
The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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
Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:
PART 165--REGULATED NAVIGATION AREA; BISCAYNE BAY CAUSEWAY ISLAND
SLIP, MIAMI BEACH, FL
0
1. The authority citation for part 165 continues to read as follows:
Authority: 46 U.S.C. 70034, 70051; 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. 165.790 to read as follows:
Sec. 165.790 Regulated Navigation Area; Biscayne Bay Causeway Island
Slip, Miami Beach, FL.
(a) Regulated area. The following area is a Regulated Navigation
Area: All waters of Biscayne Bay Causeway Island Slip within the
following points: Beginning at Point 1 in position 25[deg]46'18'' N,
080[deg]08'50'' W; thence east to Point 2 in position 25[deg]46'19'' N,
080[deg]08'47'' W; thence southeast to Point 3 in position
25[deg]46'10'' N, 080[deg]08'41'' W; thence west to Point 4 in position
25[deg]46'10'' N, 080[deg]08'45'' W; thence back to origin at Point 1.
(b) Applicability. This section applies to all vessels operating
within the RNA, except vessels that are engaged in law enforcement or
search and rescue operations.
(c) Regulations. (1) The general regulations governing Regulated
Navigation Areas found in 33 CFR 165.10, 165.11, and 165.13, including
the Regulated Navigation Area described in paragraph (a) of this
section and the following regulations, apply.
(2) All persons and vessels are required to transit the Regulated
Navigation Area at a speed that creates minimum wake, seven miles per
hour or less, to prevent damage to Coast Guard assets, disrupting
operations, and/or injuring Coast Guard personnel.
(3) All persons and vessels are required to avoid passing other
vessels making way within the Regulated Navigation Area.
(d) Enforcement. The Coast Guard may be assisted in the patrol and
enforcement of the Regulated Navigation Area by other Federal, State,
and local agencies.
Dated: November 8, 2021.
B.C. McPherson,
Rear Admiral, U.S. Coast Guard, District Commander.
[FR Doc. 2021-25432 Filed 11-19-21; 8:45 am]
BILLING CODE 9110-04-P
