Special Local Regulation; Ohio River, Cincinnati, OH, 19645-19647 [2025-08200]
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Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Rules and Regulations
intended to stabilize microbial nucleic
acids in human specimens for
subsequent isolation and purification of
nucleic acids for further molecular
testing. The device is not intended for
preserving morphology or viability of
microorganisms.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
19645
required to mitigate these risks in table
1.
TABLE 1—MICROBIAL NUCLEIC ACID STORAGE AND STABILIZATION DEVICE RISKS AND MITIGATION MEASURES
Identified risks to health
Mitigation measures
Failure to stabilize pathogen nucleic acid resulting in a false negative result.
Failure to inactivate the specimen ......................
General Controls and Special Controls (1) (21 CFR 866.2950(b)(1)), (2) (21 CFR
866.2950(b)(2)), and (3) (21 CFR 866.2950(b)(3)).
General Controls and Special Controls (1) (21 CFR 866.2950(b)(1)); (2)(i) (21 CFR
866.2950(b)(2)(i)), (2)(ii) (21 CFR 866.2950(b)(2)(ii)), and (2)(iv) (21 CFR
866.2950(b)(2)(iv)); and (3)(i) ( 21 CFR 866.2950(b)(3)(i)), (3)(ii) (21 CFR 866.2950(b)(3)(ii)),
and (3)(iv) (21 CFR 866.2950(b)(3)(iv)).
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. For a device
to fall within this classification, and
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
OMB control number 0910–0073; and
the collections of information in 21 CFR
parts 801 and 809, regarding labeling,
have been approved under OMB control
number 0910–0485.
III. Analysis of Environmental Impact
PART 866—IMMUNOLOGY AND
MICORBIOLOGY DEVICES
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
lotter on DSK11XQN23PROD with RULES1
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. 3501–3521). The
collections of information in part 860,
subpart D, regarding De Novo
Classification have been approved
under OMB control number 0910–0844;
the collections of information in 21 CFR
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; the
collections of information in 21 CFR
part 820, regarding quality system
regulation, have been approved under
VerDate Sep<11>2014
16:02 May 08, 2025
Jkt 265001
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:
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.2950 to subpart C to read
as follows:
■
§ 866.2950 Microbial nucleic acid storage
and stabilization device.
(a) Identification. A microbial nucleic
acid storage and stabilization device is
a device that consists of a container and
reagents intended to stabilize microbial
nucleic acids in human specimens for
subsequent isolation and purification of
nucleic acids for further molecular
testing. The device is not intended for
preserving morphology or viability of
microorganisms.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The intended use for the labeling
required under § 809.10 of this chapter
must include a detailed description of
microorganisms and types of human
specimens intended to be preserved.
(2) The labeling required under
§ 809.10(b) of this chapter must include
the following:
(i) A detailed device description,
including all device components;
(ii) Performance characteristics from
applicable analytical studies, including
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Frm 00023
Fmt 4700
Sfmt 4700
nucleic acid stability and
microorganism inactivation;
(iii) A limiting statement that
erroneous results may occur when the
transport device is not compatible with
molecular testing; and
(iv) A limiting statement that the
device has only been validated to
preserve the representative
microorganisms used in the analytical
studies.
(3) Design verification and validation
must include the following:
(i) Overall device design, including all
device components and all control
elements incorporated into the
analytical validation procedures;
(ii) Thorough description of the
microorganisms and methodology used
in the validation of the device
including, extraction platforms and
assays used for the detection of
preserved nucleic acids; and
(iii) The limit of detection (LoD) of the
molecular test used to establish
microorganism nucleic acid stability.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–08145 Filed 5–8–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2025–0218]
RIN 1625–AA08
Special Local Regulation; Ohio River,
Cincinnati, OH
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary special local
SUMMARY:
E:\FR\FM\09MYR1.SGM
09MYR1
19646
Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Rules and Regulations
regulation on the navigable waters of the
Ohio River, extending the entire width
of the river, between mile marker (MM)
469.6–470.2 in Cincinnati, OH. This
special local regulation is necessary to
provide for the safety of life on these
navigable waters near Cincinnati, OH,
during the Queen City Triathlon on June
22, 2025.
DATES: This rule is effective from 6:30
a.m. through 9:30 a.m. on June 22, 2025.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2025–
0218 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
If
you have questions about this rule, call
or email MST1 Jean Jimenez Sosa,
Marine Safety Detachment Cincinnati,
U.S. Coast Guard; telephone 513–921–
9033, email MSDCincinnati@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
MM Mile Marker
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
lotter on DSK11XQN23PROD with RULES1
II. Background Information and
Regulatory History
16:02 May 08, 2025
Jkt 265001
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70041. The
Captain of the Port Sector Ohio Valley
(COTP) has determined that this action
is necessary to provide for the safety of
life on these navigable waters near
Cincinnati, OH during the Queen City
Triathlon on June 22, 2025. This rule is
needed to protect personnel, vessels,
and the marine environment in the
navigable waters within the special
local regulation from MM 469.6–470.2
from 6:30 a.m. through 9:30 a.m.
IV. Discussion of the Rule
This rule establishes a temporary
special local regulation from 6:30 a.m.
until 9:30 a.m. on June 22, 2025. The
regulation will prevent mariners and
persons not participating in the
triathlon from entering the Ohio River
between MM 469.6–470.2. The duration
of the zone is intended to ensure the
safety of vessels and these navigable
waters before, during, and after the
schedule event. No vessel or person will
be permitted to enter the regulated area
without obtaining permission from the
COTP or a designated representative.
V. Regulatory Analyses
The Coast Guard is issuing this
temporary rule under the authority in 5
U.S.C. 553(b)(B). This statutory
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.’’ 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. This action is necessary
to publish an NPRM because the Coast
Guard must establish this special local
regulation by June 22, 2025, and lacks
sufficient time to provide a reasonable
comment period and then consider
those comments before issuing the rule.
Also, 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 in ensuring the safety of
participants and vessels during the
event because immediate action is
necessary to prevent possible loss of life
VerDate Sep<11>2014
and property on June 22, 2025. The
Coast Guard will issue Broadcast Notice
to Mariners (BNM) to update mariners
of the restrictions and enforcement
times during this event.
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.
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
section 3(f) of 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, location, duration,
and time of year of the temporary
special local regulation. The temporary
special local regulation will be in effect
for only three hours and will cover an
area less than one mile in length on the
Ohio River. The Coast Guard expects
minimum adverse impact to mariners
from the temporary special local
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
regulation activation as the event has
been advertised to 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 regulated
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 will
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
E:\FR\FM\09MYR1.SGM
09MYR1
Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Rules and Regulations
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.
lotter on DSK11XQN23PROD with RULES1
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
special local regulation that will
prohibit entry from MM 469.6–470.2 of
the Ohio River lasting from 6:30 a.m.
through 9:30 a.m. It is categorically
excluded from further review under
paragraph L61of Appendix A, Table 1 of
DHS Instruction Manual 023–01–001–
01, Rev. 1. A Memorandum for the
Record supporting this determination is
available in the docket. For instructions
on locating the docket, see the
ADDRESSES section of this preamble.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water),
Reporting and recordkeeping
requirements, Waterways.
VerDate Sep<11>2014
16:02 May 08, 2025
Jkt 265001
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 100 as follows:
19647
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
PART 100—SAFETY OF LIFE ON
NAVIGABLE WATERS
1. The authority citation for part 100
continues to read as follows:
■
Authority: 46 U.S.C. 70041; 33 CFR 1.05–
1.
2. Add § 100.T08–0218 to read as
follows:
■
§ 100.T08–0218 Special Local Regulation;
Ohio River, Cincinnati, OH.
(a) Regulated area. The regulations in
this section apply to the following area:
All navigable waters of the Ohio River
extending from mile marker 469.6–470.2
in Cincinnati, OH.
(b) Definitions. As used in this
section—
Designated representative means a
Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty
officer, or other officer operating a Coast
Guard vessel and a Federal, State, and
local officer designated by or assisting
the Captain of the Port Sector Ohio
Valley (COTP) in the enforcement of the
regulations in this section.
Participant means all persons and
vessels registered with the event
sponsor as participants in the event.
(c) Regulations. All non-participants
are prohibited from entering, transiting
through, anchoring in, or remaining
within the regulated area described in
paragraph (a) of this section unless
authorized by the Captain of the Port
Sector Ohio Valley or their designated
representative.
(2) To seek permission to enter,
contact the COTP or the COTP’s
representative on VFH–FM radio
channel 16 or phone at 1–800–253–
7465. Those in the regulated area must
comply with all lawful orders or
directions given to them by the COTP or
the COTP’s designated representative.
(3) The COTP will provide notice of
the regulated area through advanced
notice via broadcast notice to mariners
and by on-scene designated
representatives.
(d) Enforcement period. This
temporary special local regulation will
be enforced from 6:30 a.m. until 9:30
a.m. on June 22, 2025.
Dated: April 29, 2025.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the
Port Sector Ohio Valley.
[FR Doc. 2025–08200 Filed 5–8–25; 8:45 am]
BILLING CODE 9110–04–P
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Frm 00025
Fmt 4700
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33 CFR Part 165
[Docket No. USCG–2025–0391]
Safety Zone; Fireworks Displays
Within the Fifth Coast Guard District;
The Wharf, Washington, DC
Coast Guard, DHS.
Notification of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
a safety zone for a fireworks display at
‘‘The Wharf DC,’’ in Washington, DC, to
provide for the safety of life on
navigable waterways during this event.
Our regulation, ‘‘Safety Zones;
Fireworks Displays within the Fifth
Coast Guard District,’’ identifies the
precise location. During the
enforcement period, vessels may not
enter, remain in, or transit through the
safety zone unless authorized to do so
by the COTP or his representative, and
vessels in the vicinity must comply with
directions from the Patrol Commander
or any Official Patrol displaying a Coast
Guard ensign.
DATES: The regulation in 33 CFR
165.506 will be enforced for the location
identified in line no. 1 of table 2 to 33
CFR 165.506(h)(2) from 8 p.m. until 10
p.m., on June 07, 2025.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
notification of enforcement, call or
email LCDR Kate M. Newkirk, Sector
Maryland-NCR, Waterways Management
Division, U.S. Coast Guard: telephone
410–576–2596, email
MDNCRMarineEvents@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the safety zone
regulation for a fireworks display at The
Wharf DC from 8 p.m. to 10 p.m. on
June 07, 2025. This action is being taken
to provide for the safety of life on
navigable waterways during this event.
Our regulation, ‘‘Safety Zones;
Fireworks Displays within the Fifth
Coast Guard District,’’ § 165.506,
specifies the location of the safety zone
for the fireworks show, which
encompasses portions of the
Washington Channel in the Upper
Potomac River. As reflected in 33 CFR
165.23, vessels in the vicinity of the
safety zone may not enter, remain in, or
transit through the safety zone during
the enforcement period unless
authorized to do so by the COTP or his
representative, and they must comply
with directions from the Patrol
SUMMARY:
E:\FR\FM\09MYR1.SGM
09MYR1
]]>Agencies
[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Rules and Regulations]
[Pages 19645-19647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08200]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG-2025-0218]
RIN 1625-AA08
Special Local Regulation; Ohio River, Cincinnati, OH
AGENCY: Coast Guard, DHS.
ACTION: Temporary final rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is establishing a temporary special local
[[Page 19646]]
regulation on the navigable waters of the Ohio River, extending the
entire width of the river, between mile marker (MM) 469.6-470.2 in
Cincinnati, OH. This special local regulation is necessary to provide
for the safety of life on these navigable waters near Cincinnati, OH,
during the Queen City Triathlon on June 22, 2025.
DATES: This rule is effective from 6:30 a.m. through 9:30 a.m. on June
22, 2025.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2025-0218 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''
FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email MST1 Jean Jimenez Sosa, Marine Safety Detachment
Cincinnati, U.S. Coast Guard; telephone 513-921-9033, email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
MM Mile Marker
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 under the authority
in 5 U.S.C. 553(b)(B). This statutory 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.'' 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. This action is necessary to publish an NPRM because the
Coast Guard must establish this special local regulation by June 22,
2025, and lacks sufficient time to provide a reasonable comment period
and then consider those comments before issuing the rule.
Also, 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 in ensuring the safety
of participants and vessels during the event because immediate action
is necessary to prevent possible loss of life and property on June 22,
2025. The Coast Guard will issue Broadcast Notice to Mariners (BNM) to
update mariners of the restrictions and enforcement times during this
event.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The Captain of the Port Sector Ohio Valley (COTP) has determined
that this action is necessary to provide for the safety of life on
these navigable waters near Cincinnati, OH during the Queen City
Triathlon on June 22, 2025. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
special local regulation from MM 469.6-470.2 from 6:30 a.m. through
9:30 a.m.
IV. Discussion of the Rule
This rule establishes a temporary special local regulation from
6:30 a.m. until 9:30 a.m. on June 22, 2025. The regulation will prevent
mariners and persons not participating in the triathlon from entering
the Ohio River between MM 469.6-470.2. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters
before, during, and after the schedule event. No vessel or person will
be permitted to enter the regulated area without obtaining permission
from the COTP or a designated representative.
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.
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 section 3(f) of 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,
location, duration, and time of year of the temporary special local
regulation. The temporary special local regulation will be in effect
for only three hours and will cover an area less than one mile in
length on the Ohio River. The Coast Guard expects minimum adverse
impact to mariners from the temporary special local regulation
activation as the event has been advertised to 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
regulated 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 will 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
[[Page 19647]]
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
special local regulation that will prohibit entry from MM 469.6-470.2
of the Ohio River lasting from 6:30 a.m. through 9:30 a.m. It is
categorically excluded from further review under paragraph L61of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Memorandum for the Record supporting this determination is available in
the docket. For instructions on locating the docket, see the ADDRESSES
section of this preamble.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:
PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS
0
1. The authority citation for part 100 continues to read as follows:
Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.
0
2. Add Sec. 100.T08-0218 to read as follows:
Sec. 100.T08-0218 Special Local Regulation; Ohio River, Cincinnati,
OH.
(a) Regulated area. The regulations in this section apply to the
following area: All navigable waters of the Ohio River extending from
mile marker 469.6-470.2 in Cincinnati, OH.
(b) Definitions. As used in this section--
Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Sector Ohio Valley
(COTP) in the enforcement of the regulations in this section.
Participant means all persons and vessels registered with the event
sponsor as participants in the event.
(c) Regulations. All non-participants are prohibited from entering,
transiting through, anchoring in, or remaining within the regulated
area described in paragraph (a) of this section unless authorized by
the Captain of the Port Sector Ohio Valley or their designated
representative.
(2) To seek permission to enter, contact the COTP or the COTP's
representative on VFH-FM radio channel 16 or phone at 1-800-253-7465.
Those in the regulated area must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
(3) The COTP will provide notice of the regulated area through
advanced notice via broadcast notice to mariners and by on-scene
designated representatives.
(d) Enforcement period. This temporary special local regulation
will be enforced from 6:30 a.m. until 9:30 a.m. on June 22, 2025.
Dated: April 29, 2025.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2025-08200 Filed 5-8-25; 8:45 am]
BILLING CODE 9110-04-P
