Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA, 18993 [2023-06613]
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations
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DEPARTMENT OF HOMELAND
SECURITY
1. Orthopaedic and Rehabilitation Devices
Panel—Classification of Spinal Sphere
Devices Meeting, December 12, 2013,
available at https://wayback.archiveit.org/7993/20170114044038/https://
www.fda.gov/downloads/
AdvisoryCommittees/CommitteesMeeting
Materials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/
OrthopaedicandRehabilitation
DevicesPanel/UCM378083.pdf.
List of Subjects in 21 CFR Part 888
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 888 is
amended as follows:
PART 888—ORTHOPEDIC DEVICES
1. The authority citation for part 888
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. In § 888.3083, add paragraph (c) to
read as follows:
■
§ 888.3083 Spinal spheres for use in
intervertebral fusion procedures.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with the Food and
Drug Administration on or before
October 30, 2025, for any spinal sphere
for use in intervertebral fusion
procedures as identified in paragraph (a)
of this section that was in commercial
distribution before May 28, 1976, or that
has, on or before October 30, 2025, been
found to be substantially equivalent to
any spinal sphere device for use in
intervertebral fusion procedures
identified in paragraph (a) of this
section, that was in commercial
distribution before May 28, 1976. Any
other spinal sphere device for use in
intervertebral fusion procedures
identified in paragraph (a) of this
section shall have an approved PMA or
declared completed PDP in effect before
being placed in commercial
distribution.
Dated: March 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06565 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
15:57 Mar 29, 2023
33 CFR Part 165
[Docket No. USCG–2023–0259]
Safety Zone; Military Ocean Terminal
Concord Safety Zone, Suisun Bay,
Military Ocean Terminal Concord, CA
Coast Guard, DHS.
Notification of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the safety zone in the navigable waters
of Suisun Bay, off Concord, CA, in
support of explosive on-loading to
Military Ocean Terminal Concord
(MOTCO) from March 30, 2023, through
April 14, 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.
SUMMARY:
Medical devices.
VerDate Sep<11>2014
Coast Guard
Jkt 259001
The regulations in 33 CFR
165.1198 will be enforced from 12:01
a.m. on March 30, 2023, until 11:59 p.m.
on April 14, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
notification of enforcement, call or
email Lieutenant William Harris, Coast
Guard Sector San Francisco, Waterways
Management Division, 415–399–7443,
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 March
30, 2023, until 11:59 p.m. on April 14,
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 2 in position
38°03′30″ N, 122°01′14″ W and 3,000
yards of the pier. During the
enforcement periods, as reflected in
DATES:
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
18993
§ 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: March 23, 2023.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the
Port San Francisco.
[FR Doc. 2023–06613 Filed 3–29–23; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2022–0928]
RIN 1625–AA00
Safety Zones; Coast Guard Sector
Ohio Valley Annual and Recurring
Safety Zones Update
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is amending
and updating its safety zone regulations
for annual events that take place in the
Coast Guard Sector Ohio Valley area of
responsibility (AOR). This action is
necessary to update the current list of
recurring safety zones with revisions,
additional events, and removal of events
that no longer take place in the Sector
Ohio Valley. When these safety zones
are enforced, certain restrictions are
placed on marine traffic in specified
areas.
SUMMARY:
This rule is effective on March
30, 2023.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2022–
0928 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
DATES:
If
you have questions on this rule, call or
email Petty Officer William Miller,
Sector Ohio Valley, U.S. Coast Guard;
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\30MRR1.SGM
30MRR1
Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Rules and Regulations]
[Page 18993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06613]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG-2023-0259]
Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun
Bay, Military Ocean Terminal Concord, CA
AGENCY: Coast Guard, DHS.
ACTION: Notification of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce the safety zone in the navigable
waters of Suisun Bay, off Concord, CA, in support of explosive on-
loading to Military Ocean Terminal Concord (MOTCO) from March 30, 2023,
through April 14, 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 March 30, 2023, until 11:59 p.m. on April 14, 2023.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant William Harris,
Coast Guard Sector San Francisco, Waterways Management Division, 415-
399-7443, [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 March 30, 2023, until 11:59 p.m. on
April 14, 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 2 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: March 23, 2023.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2023-06613 Filed 3-29-23; 8:45 am]
BILLING CODE 9110-04-P