Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA, 77200-77201 [2023-24845]
Download as PDF
77200
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
(1) The intended use of the device
must specify:
(i) The Red Blood Cell components
that can be processed and stored
including acceptable anticoagulants and
additive solutions;
(ii) The hold time after Red Blood Cell
component collection;
(iii) The processing capacity (volume)
of the device; and
(iv) The storage temperature and
dating period of processed Red Blood
Cell components.
(2) Studies must demonstrate that the
device is biocompatible and include
detailed documentation of the
biocompatibility evaluation.
(3) Performance testing and
nonclinical studies must include a
detailed study of leached materials
extracted under conditions similar to
clinical usage of the device, and a
toxicologic risk assessment of those
extracted or leached materials.
(4) Performance testing must support
sterility of the device and include
sterilization validation, endotoxin
testing, and container closure integrity
evaluation.
(5) Nonclinical and clinical studies
must include evaluation of red blood
cell quality throughout the duration of
storage based on in vitro and in vivo
studies, including hemolysis and red
blood cell survival and recovery.
(6) Performance studies must include:
(i) Detailed documentation of
functional and mechanical testing,
including evaluation of oxygen and, if
applicable, carbon dioxide levels during
Red Blood Cell components storage; and
(ii) Detailed documentation of device
shelf-life testing demonstrating
continued sterility, package integrity,
and functionality over the identified
shelf life.
(7) The labeling must include a
contraindication against processing Red
Blood Cell components collected from
donors with hemoglobin S.
Dated: November 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ddrumheller on DSK120RN23PROD with RULES1
[FR Doc. 2023–24717 Filed 11–8–23; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:21 Nov 08, 2023
Jkt 262001
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2023–0783]
Special Local Regulations; OPA World
Championships; Gulf of Mexico;
Englewood, FL
Coast Guard, DHS.
Notification of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
special local regulations for the OPA
World Championships to provide for the
safety of life on navigable waterways
during this event. Our regulation for
marine events within the Seventh Coast
Guard District identifies the regulated
area for this event in Englewood Beach,
FL. During the enforcement periods, the
operator of any vessel in the regulated
area must comply with directions from
the Patrol Commander or any
designated representative.
DATES: The regulations in 33 CFR
100.703 will be enforced daily from 8
a.m. until 6 p.m. on November 18, 2023,
through November 19, 2023, for the
location identified in Item 8 in table 1
to § 100.703.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
notification of enforcement, call or
email Marine Science Technician First
Class Mara Brown, Sector St. Petersburg
Prevention Department, Coast Guard;
telephone 813–228–2191, email
mara.j.brown@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local
regulations in 33 CFR 100.703 for the
OPA World Championships identified in
Table 1 to § 100.703, Item No. 8, from
8 a.m. until 6 p.m., on November 18,
2023, through November 19, 2023. This
action is being taken to provide for the
safety of life on navigable waterways
during this event. Our regulation for
recurring marine events, Sector St.
Petersburg, § 100.703, Table 1 to
§ 100.703, Item No. 8, specifies the
locations of the regulated area for the
OPA World Championships which
encompasses portions of the Gulf of
Mexico near Englewood, FL. During the
enforcement periods, as reflected in
§ 100.703(c), if you are the operator of
a vessel in the regulated area you must
comply with directions from the Patrol
Commander or any designated
representative.
In addition to this notice of
enforcement in the Federal Register, the
SUMMARY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Coast Guard plans to provide
notification of this enforcement period
via the Local Notice to Mariners, marine
information broadcasts, or both.
Dated: November 2, 2023.
Michael P. Kahle,
Captain, U.S. Coast Guard, Captain of the
Port St. Petersburg.
[FR Doc. 2023–24787 Filed 11–8–23; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2023–0883]
Safety Zone; Military Ocean Terminal
Concord Safety Zone, Suisun Bay,
Military Ocean Terminal Concord, CA
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Notification of enforcement of
regulation.
AGENCY:
The Coast Guard will enforce
a safety zone in the navigable waters of
Suisun Bay, off Concord, CA, in support
of explosive on-loading to Military
Ocean Terminal Concord (MOTCO) on
November 13, 2023, through November
20, 2023. This safety zone is necessary
to protect personnel, vessels, and the
marine environment from potential
explosion within the explosive arc. The
safety zone is open to all persons and
vessels for transitory use, but vessel
operators desiring to anchor or
otherwise loiter within the safety zone
must obtain the permission of the
Captain of the Port San Francisco or a
designated representative. All persons
and vessels operating within the safety
zone must comply with all directions
given to them by the Captain of the Port
San Francisco or a designated
representative.
DATES: The regulations in 33 CFR
165.1198 will be enforced from 12:01
a.m. on November 13, 2023, until 11:59
p.m. on November 20, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
notification of enforcement, call, or
email LT Abby Hamann, U.S. Coast
Guard Sector San Francisco, Waterways
Management Division, at 415–399–3585,
SFWaterways@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the safety zone in 33
CFR 165.1198 for the Military Ocean
Terminal Concord, CA (MOTCO)
regulated area from 12:01 a.m. on
November 13, 2023, until 11:59 p.m. on
SUMMARY:
E:\FR\FM\09NOR1.SGM
09NOR1
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
November 20, 2023, or as announced via
marine local broadcasts. This safety
zone is necessary to protect personnel,
vessels, and the marine environment
from potential explosion within the
explosive arc. The regulation for this
safety zone, § 165.1198, specifies the
location of the safety zone which
encompasses the navigable waters in the
area between 500 yards of MOTCO Pier
in position 38°03′30″ N, 122°01′14″ W
and 3,000 yards of the pier. During the
enforcement periods, as reflected in
§ 165.1198(d), if you are the operator of
a vessel in the regulated area you must
comply with the instructions of the
COTP or the designated on-scene patrol
personnel. Vessel operators desiring to
anchor or otherwise loiter within the
safety zone must contact Sector San
Francisco Vessel Traffic Service at 415–
556–2760 or VHF Channel 14 to obtain
permission.
In addition to this notification of
enforcement in the Federal Register, the
Coast Guard plans to provide
notification of this enforcement period
via marine information broadcasts.
Dated: November 4, 2023.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the
Port San Francisco.
[FR Doc. 2023–24845 Filed 11–8–23; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2023–0861]
RIN 1625–AA87
Security Zones; San Francisco Bay,
San Francisco, CA
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Temporary final rule.
AGENCY:
The Coast Guard is
establishing temporary security zones in
the navigable waters of the San
Francisco Bay, and the Pacific Ocean
within the San Francisco Captain of the
Port (COTP) zone. The security zones
are along San Francisco Pier 15/17,
approximately 1,000 yards from shore,
and the Legion of Honor, approximately
450 yards from shore. The security
zones are necessary to protect the
harbors, ports, and waterfront facilities
during a visit from high-ranking
government officials and members of
the official party. Entry of vessels or
persons into these zones is prohibited
ddrumheller on DSK120RN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
16:21 Nov 08, 2023
Jkt 262001
unless specifically authorized by the
Captain of the Port San Francisco or a
designated representative.
DATES: This rule is effective from
November 15, 2023, through November
18, 2023.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2023–
0861 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 LT William Harris, U.S. Coast
Guard Sector San Francisco, Waterways
Management Division; telephone 415–
399–7443, email SFWaterways@
uscg.mil.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
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 and contrary to the public
interest. The Coast Guard was not
notified with ample time to allow for
public comment. The visit by highranking government officials and
members of their official party will
conclude prior to the publication and
completion of a comment period.
Additionally, it is impracticable to
publish a NPRM because the visit is
scheduled to occur from November 15
through November 16, 2023, and we
must establish these security zones by
those dates. We lack sufficient time to
solicit comments and review prior to
issuing a final action.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
77201
days after publication in the Federal
Register. Delaying the effective date
would be impracticable because action
is needed starting November 15, 2023,
to provide for the protection of highranking government officials, members
of their official party, and the security
of harbors, ports, and waterfront
facilities, and the mitigation of
subversive acts.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70051 and
70124. The Captain of the Port San
Francisco (COTP) has determined that
high-ranking government officials and
members of their official party plan to
visit the San Francisco area and will be
in the areas of San Francisco Pier 15/17,
and the Legion of Honor. These are
located adjacent to U.S. navigable
waters in the San Francisco COTP Zone.
This rule is needed to ensure the safety
of the high-ranking government officials
and members of their official party.
IV. Discussion of the Rule
This rule establishes two security
zones on November 15 and November
16, 2023. These security zones will
cover all navigable waters of the San
Francisco Bay and Pacific Ocean, from
surface to bottom, and be for the areas
and times described below or as
otherwise noted by Marine Information
Broadcast, and will be referred to as
Zones A, and B.
Zone A is a security zone along San
Francisco Pier 15/17, approximately
1,000 yards from shore. Zone A will be
within the area formed by connecting
the following latitude and longitude
points in the following order:
37°48′29.13″ N, 122°24′10.27″ W; thence
to 37°48′34.68″ N, 122°24′3.44″ W;
thence to 37°48′39.4″ N, 122°23′47.2″ W;
thence to 37°48′28.4″ N, 122°23′19.04″
W; thence to 37°48′9.85″ N,
122°23′10.34″ W; thence to 37°47′47.89″
N, 122°23′41.35″ W; thence along the
shore and piers to the point of
beginning. This zone will be in effect
from 6 a.m. through 11:59 p.m. on
November 15, 2023.
Zone B is a security zone along the
Legion of Honor in the San Francisco
Bay, approximately 450 yards from
shore. Zone B will be within the area
formed by connecting the following
latitude and longitude points in the
following order: 37°47′17.72″ N,
122°30′21.74″ W; thence to 37°47′30.86″
N, 122°30′13.6″ W; thence to
37°47′30.87″ N, 122°29′54.91″ W; thence
to 37°47′14.68″ N, 122°29′45.43″ W;
thence along the shore to the point of
beginning. This zone will be in effect
E:\FR\FM\09NOR1.SGM
09NOR1
Agencies
[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Rules and Regulations]
[Pages 77200-77201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24845]
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG-2023-0883]
Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun
Bay, Military Ocean Terminal Concord, CA
AGENCY: Coast Guard, Department of Homeland Security (DHS).
ACTION: Notification of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce a safety zone in the navigable
waters of Suisun Bay, off Concord, CA, in support of explosive on-
loading to Military Ocean Terminal Concord (MOTCO) on November 13,
2023, through November 20, 2023. This safety zone is necessary to
protect personnel, vessels, and the marine environment from potential
explosion within the explosive arc. The safety zone is open to all
persons and vessels for transitory use, but vessel operators desiring
to anchor or otherwise loiter within the safety zone must obtain the
permission of the Captain of the Port San Francisco or a designated
representative. All persons and vessels operating within the safety
zone must comply with all directions given to them by the Captain of
the Port San Francisco or a designated representative.
DATES: The regulations in 33 CFR 165.1198 will be enforced from 12:01
a.m. on November 13, 2023, until 11:59 p.m. on November 20, 2023.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call, or email LT Abby Hamann, U.S. Coast
Guard Sector San Francisco, Waterways Management Division, at 415-399-
3585, [email protected].
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in 33 CFR 165.1198 for the Military Ocean Terminal Concord, CA (MOTCO)
regulated area from 12:01 a.m. on November 13, 2023, until 11:59 p.m.
on
[[Page 77201]]
November 20, 2023, or as announced via marine local broadcasts. This
safety zone is necessary to protect personnel, vessels, and the marine
environment from potential explosion within the explosive arc. The
regulation for this safety zone, Sec. 165.1198, specifies the location
of the safety zone which encompasses the navigable waters in the area
between 500 yards of MOTCO Pier in position 38[deg]03'30'' N,
122[deg]01'14'' W and 3,000 yards of the pier. During the enforcement
periods, as reflected in Sec. 165.1198(d), if you are the operator of
a vessel in the regulated area you must comply with the instructions of
the COTP or the designated on-scene patrol personnel. Vessel operators
desiring to anchor or otherwise loiter within the safety zone must
contact Sector San Francisco Vessel Traffic Service at 415-556-2760 or
VHF Channel 14 to obtain permission.
In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via marine information broadcasts.
Dated: November 4, 2023.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2023-24845 Filed 11-8-23; 8:45 am]
BILLING CODE 9110-04-P