Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972, 15165-15167 [2015-06298]
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations
MedWatch if they experience any
adverse events with this device.
Æ The anticipated number of device
uses prior to failure.
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k) of the
FD&C Act, if FDA determines that
premarket notification is not necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
For this type of device, FDA has
determined that premarket notification
is not necessary to provide reasonable
assurance of the safety and effectiveness
of the device. Therefore, this device
type is exempt from premarket
notification requirements. Persons who
intend to market this type of device
need not submit to FDA a premarket
notification, prior to marketing the
device, which contains information
about the limited output transcutaneous
piezoelectric stimulator for skin
reactions associated with insect bites
they intend to market.
II. Environmental Impact
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.
III. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations. 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–
3520). The collections of information in
part 807, subpart E, regarding premarket
notification submissions have been
approved under OMB control number
0910–0120, and the collections of
information in 21 CFR part 801,
regarding labeling have been approved
under OMB control number 0910–0485.
mstockstill on DSK4VPTVN1PROD with RULES
IV. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
VerDate Sep<11>2014
16:11 Mar 20, 2015
Jkt 235001
15165
1. DEN100024: De Novo Request per 513(f)(2)
from Ecobrands, Ltd., dated September 8,
2010.
2. DEN130019: De Novo Request per 513(f)(2)
from Tecnimed S.r.l., dated February 14,
2013.
(iii) Language to direct end users to
contact the device manufacturer and
MedWatch if they experience any
adverse events with this device.
(iv) The anticipated number of device
uses prior to failure.
List of Subjects in 21 CFR Part 882
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 882 is
amended as follows:
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06499 Filed 3–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF DEFENSE
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for 21 CFR
part 882 continues to read as follows:
Department of the Navy
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Add § 882.5894 to subpart F to read
as follows:
■
§ 882.5894 Limited output transcutaneous
piezoelectric stimulator for skin reactions
associated with insect bites.
(a) Identification. A limited output
transcutaneous piezoelectric stimulator
for skin reactions associated with insect
bites is a device intended to alleviate
skin reactions associated with insect
bites via cutaneous, piezoelectric
stimulation at the local site of the bite.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Appropriate testing to characterize
the electrical output specifications of
the device (i.e., total charge delivered,
maximum instantaneous output current,
maximum instantaneous output voltage,
pulse duration, charge density) must be
conducted.
(2) Mechanical bench testing must
demonstrate that the device will
withstand the labeled number duration
of uses.
(3) All elements of the device that
may contact the patient must be
assessed to be biocompatible.
(4) Labeling must include:
(i) Validated instructions which
addresses the following:
(A) Identification of areas of the body
which are appropriate and not
appropriate for contact with the device.
(B) Whether use of the device in
conjunction with flammable materials
(e.g., insect repellent) is appropriate.
(C) Use of the device on or near
implanted devices.
(D) How to identify the correct type of
skin condition.
(ii) Technical parameters of the device
(maximum output voltage
(instantaneous), maximum output
current (instantaneous), and pulse
duration).
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32 CFR Part 706
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Department of the Navy, DoD.
Final rule.
AGENCY:
ACTION:
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972, as amended (72 COLREGS),
to reflect that the Deputy Assistant
Judge Advocate General
(DAJAG)(Admiralty and Maritime Law)
has determined that USS JOHN
WARNER (SSN 785) is a vessel of the
Navy which, due to its special
construction and purpose, cannot fully
comply with certain provisions of the 72
COLREGS without interfering with its
special function as a naval ship. The
intended effect of this rule is to warn
mariners in waters where 72 COLREGS
apply.
DATES: This rule is effective March 23,
2015 and is applicable beginning
January 28, 2015.
FOR FURTHER INFORMATION CONTACT:
Commander Theron R. Korsak,
(Admiralty and Maritime Law), Office of
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave. SE.,
Suite 3000, Washington Navy Yard, DC
20374–5066, telephone 202–685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706.
This amendment provides notice that
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS JOHN WARNER (SSN 785) is a
vessel of the Navy which, due to its
special construction and purpose,
cannot fully comply with the following
specific provisions of 72 COLREGS
without interfering with its special
function as a naval ship: Annex I,
SUMMARY:
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15166
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations
paragraph 2(a)(i), pertaining to the
vertical placement of the masthead
light; Annex I, paragraph 2(f)(i),
pertaining to Virginia class submarine
masthead light location below the
submarine identification lights; Annex I,
paragraph 2(k), pertaining to the vertical
separation of the anchor lights and
vertical placement of the forward
anchor light above the hull; Rule 30(a)
and Rule 21(e), pertaining to arc of
visibility of the forward and after anchor
lights; Annex I, paragraph 3(b),
pertaining to the location of the
sidelights; and Rule 21(c), pertaining to
the location and arc of visibility of the
sternlight. The DAJAG (Admiralty and
Maritime Law) has also certified that the
lights involved are located in closest
possible compliance with the applicable
72 COLREGS requirements.
Moreover, it has been determined, in
accordance with 32 CFR parts 296 and
701, that publication of this amendment
for public comment prior to adoption is
impracticable, unnecessary, and
contrary to public interest since it is
based on technical findings that the
placement of lights on this vessel in a
manner differently from that prescribed
herein will adversely affect the vessel’s
ability to perform its military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water),
Vessels.
For the reasons set forth in the
preamble, the DoN amends part 706 of
title 32 of the Code of Federal
Regulations as follows:
PART 706—CERTIFICATIONS AND
EXEMPTIONS UNDER THE
INTERNATIONAL REGULATIONS FOR
PREVENTING COLLISIONS AT SEA,
1972
1. The authority citation for part 706
continues to read as follows:
■
Authority: 33 U.S.C. 1605.
2. Section 706.2 is amended by:
a. In Table One, adding, in alpha
numerical order, by vessel number, an
entry for USS JOHN WARNER (SSN
785);
■ b. In Table Three, adding, in alpha
numerical order, by vessel number, an
entry for USS JOHN WARNER (SSN
785);
■ c. In Table Four, under paragraph 25,
adding, in alpha numerical order, by
vessel number, an entry for USS JOHN
WARNER (SSN 785); and
■ d. In Table Four, paragraph 26,
adding, in alpha numerical order, by
vessel number, an entry for USS JOHN
WARNER (SSN 785).
The additions read as follows:
■
■
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
*
*
*
*
*
TABLE ONE
Vessel
Number
Distance in meters of
forward masthead light
below minimum required
height.
§ 2(a)(i), Annex I
*
*
*
USS JOHN WARNER .........................................................
*
*
*
SSN 785 .............................................................................
*
2.76
*
*
*
*
*
*
*
*
*
*
*
*
TABLE THREE
Number
*
USS JOHN WARNER.
Masthead
lights arc of
visibility; rule
21(a)
*
SSN 785 ....
Vessel
......................
*
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*
*
*
*
*
VerDate Sep<11>2014
*
Stern light
arc of visibility; rule
21(c)
*
......................
*
*
16:50 Mar 20, 2015
Side lights
arc of visibility; rule
21(b)
Side lights
distance
inboard of
ship’s sides
in meters
3(b) annex 1
Stern light,
distance forward of stern
in meters;
rule 21(c)
Forward
anchor light,
height above
hull in
meters; 2(K)
annex 1
Anchor
lights relation-ship of
aft light to
forward light
in meters
2(K) annex
1
*
11.05
2.8
*
0.30 below.
*
206.4°
*
4.37
*
*
25. * * *
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15167
Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations
TABLE FOUR
Vessel
Number
Distance in meters of
masthead light below
the submarine
identification lights
*
*
*
USS JOHN WARNER .........................................................
*
*
*
SSN 785 .............................................................................
*
0.81
26. * * *
Obstruction angle relative to
ship’s heading
Vessel
Forward Anchor
Light
Number
Aft Anchor Light
*
172° to 188°
*
359° to 1°
*
*
*
*
*
USS JOHN WARNER ............................................ SSN 785 .................................................................
*
*
*
*
*
Approved: January 28, 2015.
A.B. Fischer,
Captain, JAGC, U.S. Navy, Deputy Assistant
Judge Advocate, General (Admiralty and
Maritime Law).
Dated: March 11, 2015.
N.A. Hagerty-Ford,
Commander, Office of the Judge Advocate
General, U.S. Navy, Federal Register Liaison
Officer.
[FR Doc. 2015–06298 Filed 3–20–15; 8:45 am]
BILLING CODE 3810–FF–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2015–0062]
Special Local Regulation; Annual
Marine Events on the Colorado River,
Between Davis Dam (Bullhead City,
Arizona) and Headgate Dam (Parker,
Arizona) Within the San Diego Captain
of the Port Zone
AGENCY: Coast Guard, DHS.
ACTION: Notice of enforcement
of
regulation.
The Coast Guard will enforce
the 2015 Lake Havasu Desert Storm
marine event special local regulations
from 8 a.m. through 3 p.m. on April 25,
2015. This annual marine event occurs
on the navigable waters of the Colorado
River in Lake Havasu, Arizona. This
action is necessary to provide for the
safety of the participants, crew,
spectators, safety vessels, and general
users of the waterway. During the
enforcement period, persons and vessels
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:50 Mar 20, 2015
Jkt 235001
are prohibited from entering into,
transiting through, or anchoring within
this regulated area unless authorized by
the Captain of the Port, or his
designated representative.
DATES: The regulations in 33 CFR
100.1102, Table 1, Item 4 will be
enforced from 8 a.m. through 3 p.m. on
April 25, 2015. If the event is delayed
by inclement weather, these regulations
will also be enforced from 8 a.m.
through 3 p.m. on April 26, 2015.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this document,
call or email Petty Officer Nick
Bateman, Waterways Management, U.S.
Coast Guard Sector San Diego, CA;
telephone 619–278–7656, D11-PFMarineEventsSanDiego@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Special Local
Regulations in Lake Havasu for the 2015
Desert Storm Shootout in 33 CFR
100.1102, Table 1, Item 4 from 8 a.m.
through 3 p.m. on April 25, 2015. If the
event is delayed by inclement weather,
these regulations will also be enforced
from 8 a.m. through 3 p.m. on April 26,
2015.
Under provisions of 33 CFR 100.1102,
persons and vessels are prohibited from
entering into, transiting through, or
anchoring within the regulated area,
unless authorized by the Coast Guard
Captain of the Port or his designated
representative. Persons or vessels
desiring to enter into or pass through
the special local regulations may request
permission from the Captain of the Port
or a designated representative. If
permission is granted, all persons and
vessels shall comply with the
instructions of the Captain of the Port or
his designated representative. Spectator
vessels may safely transit outside the
regulated area but may not anchor,
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Fmt 4700
Sfmt 4700
block, loiter, or impede the transit of
participants or official patrol vessels.
The Coast Guard may be assisted by
other Federal, State, or Local law
enforcement agencies in enforcing this
regulation.
This document is issued under
authority of 33 CFR 100.1102 and 5
U.S.C. 552(a). In addition to this
document in the Federal Register, the
Coast Guard will provide the maritime
community with extensive advance
notification of this enforcement period
via the Local Notice to Mariners,
Broadcast Notice to Mariners, and local
advertising by the event sponsor.
If the Captain of the Port Sector San
Diego or his designated representative
determines that the regulated area need
not be enforced for the full duration
stated on this document, he or she may
use a Broadcast Notice to Mariners to
grant general permission to enter the
regulated area.
Dated: March 6, 2015.
J.A. Janszen,
Commander, U.S. Coast Guard, Acting,
Captain of the Port San Diego.
[FR Doc. 2015–06603 Filed 3–20–15; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2015–0129]
RIN 1625–AA00
Safety Zone, Delaware River; Marcus
Hook, PA
AGENCY:
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Coast Guard, DHS.
23MRR1
]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Rules and Regulations]
[Pages 15165-15167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06298]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under the International Regulations
for Preventing Collisions at Sea, 1972
AGENCY: Department of the Navy, DoD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of the Navy (DoN) is amending its
certifications and exemptions under the International Regulations for
Preventing Collisions at Sea, 1972, as amended (72 COLREGS), to reflect
that the Deputy Assistant Judge Advocate General (DAJAG)(Admiralty and
Maritime Law) has determined that USS JOHN WARNER (SSN 785) is a vessel
of the Navy which, due to its special construction and purpose, cannot
fully comply with certain provisions of the 72 COLREGS without
interfering with its special function as a naval ship. The intended
effect of this rule is to warn mariners in waters where 72 COLREGS
apply.
DATES: This rule is effective March 23, 2015 and is applicable
beginning January 28, 2015.
FOR FURTHER INFORMATION CONTACT: Commander Theron R. Korsak, (Admiralty
and Maritime Law), Office of the Judge Advocate General, Department of
the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC
20374-5066, telephone 202-685-5040.
SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33
U.S.C. 1605, the DoN amends 32 CFR part 706.
This amendment provides notice that the DAJAG (Admiralty and
Maritime Law), under authority delegated by the Secretary of the Navy,
has certified that USS JOHN WARNER (SSN 785) is a vessel of the Navy
which, due to its special construction and purpose, cannot fully comply
with the following specific provisions of 72 COLREGS without
interfering with its special function as a naval ship: Annex I,
[[Page 15166]]
paragraph 2(a)(i), pertaining to the vertical placement of the masthead
light; Annex I, paragraph 2(f)(i), pertaining to Virginia class
submarine masthead light location below the submarine identification
lights; Annex I, paragraph 2(k), pertaining to the vertical separation
of the anchor lights and vertical placement of the forward anchor light
above the hull; Rule 30(a) and Rule 21(e), pertaining to arc of
visibility of the forward and after anchor lights; Annex I, paragraph
3(b), pertaining to the location of the sidelights; and Rule 21(c),
pertaining to the location and arc of visibility of the sternlight. The
DAJAG (Admiralty and Maritime Law) has also certified that the lights
involved are located in closest possible compliance with the applicable
72 COLREGS requirements.
Moreover, it has been determined, in accordance with 32 CFR parts
296 and 701, that publication of this amendment for public comment
prior to adoption is impracticable, unnecessary, and contrary to public
interest since it is based on technical findings that the placement of
lights on this vessel in a manner differently from that prescribed
herein will adversely affect the vessel's ability to perform its
military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), Vessels.
For the reasons set forth in the preamble, the DoN amends part 706
of title 32 of the Code of Federal Regulations as follows:
PART 706--CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL
REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972
0
1. The authority citation for part 706 continues to read as follows:
Authority: 33 U.S.C. 1605.
0
2. Section 706.2 is amended by:
0
a. In Table One, adding, in alpha numerical order, by vessel number, an
entry for USS JOHN WARNER (SSN 785);
0
b. In Table Three, adding, in alpha numerical order, by vessel number,
an entry for USS JOHN WARNER (SSN 785);
0
c. In Table Four, under paragraph 25, adding, in alpha numerical order,
by vessel number, an entry for USS JOHN WARNER (SSN 785); and
0
d. In Table Four, paragraph 26, adding, in alpha numerical order, by
vessel number, an entry for USS JOHN WARNER (SSN 785).
The additions read as follows:
Sec. 706.2 Certifications of the Secretary of the Navy under
Executive Order 11964 and 33 U.S.C. 1605.
* * * * *
Table One
------------------------------------------------------------------------
Distance in meters of
forward masthead light
Vessel Number below minimum required
height. Sec. 2(a)(i),
Annex I
------------------------------------------------------------------------
* * * * * * *
USS JOHN WARNER.............. SSN 785........ 2.76
* * * * * * *
------------------------------------------------------------------------
* * * * *
Table Three
--------------------------------------------------------------------------------------------------------------------------------------------------------
Forward
Masthead Side lights Stern light, anchor Anchor lights
lights arc Side lights Stern light distance distance light, relation-ship of
Vessel Number of arc of arc of inboard of forward of height above aft light to
visibility; visibility; visibility; ship's sides stern in hull in forward light in
rule 21(a) rule 21(b) rule 21(c) in meters meters; rule meters; 2(K) meters 2(K)
3(b) annex 1 21(c) annex 1 annex 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
USS JOHN WARNER................ SSN 785.......... ............ ............ 206.4[deg] 4.37 11.05 2.8 0.30 below.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
25. * * *
[[Page 15167]]
Table Four
------------------------------------------------------------------------
Distance in meters of
masthead light below the
Vessel Number submarine
identification lights
------------------------------------------------------------------------
* * * * * * *
USS JOHN WARNER.............. SSN 785........ 0.81
------------------------------------------------------------------------
26. * * *
----------------------------------------------------------------------------------------------------------------
Obstruction angle relative to ship's heading
-----------------------------------------------------------------------------------------------------------------
Forward Anchor
Vessel Number Light Aft Anchor Light
----------------------------------------------------------------------------------------------------------------
* * * * * * *
USS JOHN WARNER........................... SSN 785..................... 172[deg] to 359[deg] to 1[deg]
188[deg]
----------------------------------------------------------------------------------------------------------------
* * * * *
Approved: January 28, 2015.
A.B. Fischer,
Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General
(Admiralty and Maritime Law).
Dated: March 11, 2015.
N.A. Hagerty-Ford,
Commander, Office of the Judge Advocate General, U.S. Navy, Federal
Register Liaison Officer.
[FR Doc. 2015-06298 Filed 3-20-15; 8:45 am]
BILLING CODE 3810-FF-P
