Special Local Regulations; Recurring Marine Events in the Seventh Coast Guard District, 20783 [2014-08368]
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Federal Register / Vol. 79, No. 71 / Monday, April 14, 2014 / Rules and Regulations
(ii) Resistance to dynamic loads
(impact testing);
(iii) Effective use of the braking
mechanism and how the device stops in
case of an electrical brake failure;
(iv) Demonstration of adequate
stability of the device on inclined
planes (forward, backward, and lateral);
(v) Demonstration of the ability of the
device to safely ascend and descend
obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to
effectively use the device during
adverse temperatures and following
storage in adverse temperatures and
humidity conditions.
(3) The skin-contacting components of
the device must be demonstrated to be
biocompatible.
(4) Software design, verification, and
validation must demonstrate that the
device controls, alarms, and user
interfaces function as intended.
(5) Appropriate analysis and
performance testing must be conducted
to verify electrical safety and
electromagnetic compatibility of the
device.
(6) Performance testing must
demonstrate battery safety and evaluate
longevity.
(7) Performance testing must evaluate
the flammability of device components.
(8) Patient labeling must bear all
information required for the safe and
effective use of the device, specifically
including the following:
(i) A clear description of the
technological features of the device and
the principles of how the device works;
(ii) A clear description of the
appropriate use environments/
conditions, including prohibited
environments;
(iii) Preventive maintenance
recommendations;
(iv) Operating specifications for
proper use of the device such as patient
weight limitations, device width, and
clearance for maneuverability; and
(v) A detailed summary of the devicerelated adverse events and how to report
any complications.
(9) Clinician labeling must include all
the information in the Patient labeling
noted in paragraph (b)(8) of this section
but must also include the following:
(i) Identification of patients who can
effectively operate the device; and
(ii) Instructions on how to fit, modify,
or calibrate the device.
(10) Usability studies of the device
must demonstrate that the device can be
used by the patient in the intended use
environment with the instructions for
use and user training.
VerDate Mar<15>2010
16:13 Apr 11, 2014
Jkt 232001
Dated: April 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08257 Filed 4–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2014–0189]
Special Local Regulations; Recurring
Marine Events in the Seventh Coast
Guard District
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the Conch Republic Navy Parade and
Battle Special Local Regulation in the
Gulf of Mexico, from 7:00 p.m. until
8:00 p.m. on April 25, 2014. This action
is necessary to ensure the safety of event
participants, participant vessels,
spectators, and the general public from
the hazards associated with this event.
During the enforcement period, no
person or vessel may enter the regulated
area without permission from the
Captain of the Port.
DATES: The regulations in 33 CFR
100.701 Table 1 will be enforced from
7:00 p.m. until 8:00 p.m. on April 25,
2014.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or email Marine Science Technician
First Class Ian G. Bowes, Sector Key
West Prevention Department, U.S. Coast
Guard; telephone 305–292–8823, email
Ian.G.Bowes@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Conch Republic
Navy Parade and Battle Special Local
Regulation in the Gulf of Mexico in 33
CFR 100.701 on April 25, 2014. These
regulations can be found in the 2013
issue of the Federal Register 33 CFR
100.701.
On April 25, 2014, Conch Republic
Navy LLC. is hosting the Conch
Republic Navy Parade and Battle, a boat
parade and simulated naval battle event
that will take place approximately 150
yards offshore from Ocean Key Sunset
Pier, Mallory Square and the Hilton Pier
within the Key West Harbor. The event
will be held on the waters of the Gulf
of Mexico in Key West. Approximately
10 vessels will participate in the event.
The special local regulations
encompass certain waters of the Gulf of
SUMMARY:
PO 00000
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20783
Mexico located offshore from the island
of Key West. The special local
regulations will be enforced from 7:00
p.m. until 8:00 p.m. on April 25, 2014.
The special local regulations area will
consist of the following area: An event
area, where all persons and vessels,
except those persons and vessels
participating in the swim event, are
prohibited from entering, transiting,
anchoring, or remaining. The race area
is defined as all waters of the Gulf of
Mexico encompassed within the
following points: Starting at Point 1 in
position 24°33′41″ N, 81°48′25″ W;
thence to Point 2 in position 24°33′43″
N, 81°48′34″ W; thence to Point 3 in
position 24°33′32″ N, 81°48′38″ W;
thence to Point 4 in position 24°33′30″
N, 81°48′30″ W. Persons and vessels
may request authorization to enter,
transit through, anchor in, or remain
within the race area by contacting the
Captain of the Port Key West by
telephone at 305–292–8727, or a
designated representative via VHF radio
on channel 16. If authorization to enter,
transit through, anchor in, or remain
within the race area is granted by the
Captain of the Port Key West, or a
designated representative, all persons
and vessels receiving such authorization
must comply with the instructions of
the Captain of the Port Key West or the
designated representative. The Coast
Guard will provide notice of the
regulated area by Local Notice to
Mariners, Broadcast Notice to Mariners,
and on-scene designated
representatives. The Coast Guard may
be assisted by other Federal, State, or
local law enforcement agencies in
enforcing this regulation.
This notice is issued under authority
of 33 CFR 100.701 and 5 U.S.C. 552(a).
In addition to this notice in the Federal
Register, the Coast Guard will provide
the maritime community with advance
notification of this enforcement period
via a Broadcast Notice to Mariners.
Dated: March 31, 2014.
A.S. Young, Sr.,
Captain, U.S. Coast Guard, Captain of the
Port Key West.
[FR Doc. 2014–08368 Filed 4–11–14; 8:45 am]
BILLING CODE 9110–04–P
E:\FR\FM\14APR1.SGM
14APR1
Agencies
[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Rules and Regulations]
[Page 20783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08368]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG-2014-0189]
Special Local Regulations; Recurring Marine Events in the Seventh
Coast Guard District
AGENCY: Coast Guard, DHS.
ACTION: Notice of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce the Conch Republic Navy Parade
and Battle Special Local Regulation in the Gulf of Mexico, from 7:00
p.m. until 8:00 p.m. on April 25, 2014. This action is necessary to
ensure the safety of event participants, participant vessels,
spectators, and the general public from the hazards associated with
this event. During the enforcement period, no person or vessel may
enter the regulated area without permission from the Captain of the
Port.
DATES: The regulations in 33 CFR 100.701 Table 1 will be enforced from
7:00 p.m. until 8:00 p.m. on April 25, 2014.
FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Marine Science Technician First Class Ian G. Bowes,
Sector Key West Prevention Department, U.S. Coast Guard; telephone 305-
292-8823, email Ian.G.Bowes@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Conch
Republic Navy Parade and Battle Special Local Regulation in the Gulf of
Mexico in 33 CFR 100.701 on April 25, 2014. These regulations can be
found in the 2013 issue of the Federal Register 33 CFR 100.701.
On April 25, 2014, Conch Republic Navy LLC. is hosting the Conch
Republic Navy Parade and Battle, a boat parade and simulated naval
battle event that will take place approximately 150 yards offshore from
Ocean Key Sunset Pier, Mallory Square and the Hilton Pier within the
Key West Harbor. The event will be held on the waters of the Gulf of
Mexico in Key West. Approximately 10 vessels will participate in the
event.
The special local regulations encompass certain waters of the Gulf
of Mexico located offshore from the island of Key West. The special
local regulations will be enforced from 7:00 p.m. until 8:00 p.m. on
April 25, 2014. The special local regulations area will consist of the
following area: An event area, where all persons and vessels, except
those persons and vessels participating in the swim event, are
prohibited from entering, transiting, anchoring, or remaining. The race
area is defined as all waters of the Gulf of Mexico encompassed within
the following points: Starting at Point 1 in position 24[deg]33'41'' N,
81[deg]48'25'' W; thence to Point 2 in position 24[deg]33'43'' N,
81[deg]48'34'' W; thence to Point 3 in position 24[deg]33'32'' N,
81[deg]48'38'' W; thence to Point 4 in position 24[deg]33'30'' N,
81[deg]48'30'' W. Persons and vessels may request authorization to
enter, transit through, anchor in, or remain within the race area by
contacting the Captain of the Port Key West by telephone at 305-292-
8727, or a designated representative via VHF radio on channel 16. If
authorization to enter, transit through, anchor in, or remain within
the race area is granted by the Captain of the Port Key West, or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Key West or the designated representative. The Coast Guard will
provide notice of the regulated area by Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
The Coast Guard may be assisted by other Federal, State, or local law
enforcement agencies in enforcing this regulation.
This notice is issued under authority of 33 CFR 100.701 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with advance
notification of this enforcement period via a Broadcast Notice to
Mariners.
Dated: March 31, 2014.
A.S. Young, Sr.,
Captain, U.S. Coast Guard, Captain of the Port Key West.
[FR Doc. 2014-08368 Filed 4-11-14; 8:45 am]
BILLING CODE 9110-04-P