Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972, 60867-60869 [2017-27759]
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Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
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. 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
the guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in part 814, subparts A
through E, regarding premarket
approval, have been approved under
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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.
List of Subjects in 21 CFR Part 868
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 868 is
amended as follows:
PART 868—ANESTHESIOLOGY
DEVICES
1. The authority citation for part 868
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 868.5105 to subpart F to read
as follows:
■
ethrower on DSK3G9T082PROD with RULES
BILLING CODE 4164–01–P
(a) Identification. An external
negative pressure airway aid is a
prescription device that applies negative
pressure to a patient’s neck to aid in
providing a patent airway during
procedures requiring anesthesia.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Clinical performance testing must
document any adverse events observed
during clinical use, including impaired
blood flow, and demonstrate that the
device performs as intended under
anticipated conditions.
(2) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
patient positions, does not fail during
use, and does not lose negative pressure
16:22 Dec 22, 2017
Jkt 244001
Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27784 Filed 12–22–17; 8:45 am]
§ 868.5105 External negative pressure
airway aid.
VerDate Sep<11>2014
capability. The following testing should
be performed:
(i) Ability of the device to maintain a
seal during various patient positions;
(ii) Device leakage testing to
demonstrate the device maintains
vacuum;
(iii) Drop testing to ensure the device
does not incur functional damage after
dropping the device; and
(iv) Functional testing after high and
low storage temperature.
(3) All patient contacting components
must be demonstrated to be
biocompatible.
(4) Labeling must include:
(i) A summary of clinical testing
results, including any adverse events
and evidence that effectiveness has been
achieved.
(ii) Technical specifications of the
device, including collar sizes, maximum
duration of use, operating temperature,
and storage temperature range.
(iii) Technical specifications of the
vacuum source, including maximum
vacuum level and operational vacuum
level.
(iv) Instructions for use that includes
how to place the device, determination
of size, verification of suction, reference
to training materials, and information
on troubleshooting the device if it does
not attach properly.
(v) A warning to screen patients for
carotid artery disease due to the
probable risk of the device to dislodge
arterial plaques in the carotid artery.
(vi) A warning to exclude patients
with anatomical abnormalities.
(vii) A warning not to use the device
during medical procedures involving
medications that contain propofol.
DEPARTMENT OF DEFENSE
Department of the Navy
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 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
SUMMARY:
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
60867
General (DAJAG) (Admiralty and
Maritime Law) has determined that USS
TULSA (LCS 16) 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 December
26, 2017 and is applicable beginning
December 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Kyle Fralick,
JAGC, U.S. Navy, Admiralty Attorney,
(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 number: 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 TULSA (LCS 16) 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 paragraph 2 (a)(i),
pertaining to the height of the forward
masthead light above the hull; Annex I,
paragraph 2(f)(i), pertaining to the
placement of the masthead light or
lights above and clear of all other lights
and obstructions; Annex I, paragraph
2(f)(ii), pertaining to the vertical
placement of task lights; Annex I,
paragraph 3(a), pertaining to the
location of the forward masthead light
in the forward quarter of the ship, and
the horizontal distance between the
forward and after masthead light; Rule
27(b)(i) and Annex I, paragraph 9(b)(i),
pertaining to the arc of visibility of
middle tasks lights. 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.
E:\FR\FM\26DER1.SGM
26DER1
60868
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and
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 TULSA (LCS 16);
■ b. In Table Four, under paragraph 15,
adding, in alpha numerical order, by
vessel number, an entry for USS TULSA
(LCS 16);
■ c. In Table Four, under paragraph 16,
adding, in alpha numerical order, by
vessel number, an entry for USS TULSA
(LCS 16);
■ d. In Table Four, under paragraph 27,
adding, in alpha numerical order, by
■
vessel number, an entry for USS TULSA
(LCS 16); and
■ e. In Table Five, adding, in alpha
numerical order, by vessel number, an
entry for USS TULSA (LCS 16).
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
*
*
*
*
*
TABLE ONE
Vessel
Number
*
*
*
*
*
USS TULSA ...............................................................................................................................................
*
*
*
*
*
*
*
*
*
*
*
*
*
15. * * *
*
*
Horizontal distances from
the fore and aft centerline
of the vessel in the
athwartship direction
Number
*
*
*
*
*
USS TULSA ..........................................................................................................................................
*
*
4.2
*
Vessel
*
*
LCS 16
*
Table Four
Distance in meters of
forward masthead
light below minimum
required height
§ 2(a)(i) Annex I
*
*
*
LCS 16
*
*
Upper—0.20 meters.
Middle—1.32 meters.
Lower—1.40 meters.
*
16. * * *
Vessel
*
*
*
*
*
USS TULSA ..........................................................................................................................................
*
*
Obstruction angle relative
ship’s headings
Number
*
*
*
LCS 16
*
72° thru 74°.
286° thru 288°.
*
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27. * * *
Vessel
*
*
*
*
*
USS TULSA ..........................................................................................................................................
VerDate Sep<11>2014
16:22 Dec 22, 2017
Jkt 244001
PO 00000
Obstruction angle relative
ship heading
Number
Frm 00024
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*
LCS 16
E:\FR\FM\26DER1.SGM
26DER1
47° thru 59°.
301° thru 313°.
60869
Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Rules and Regulations
Vessel
*
*
*
*
*
*
Obstruction angle relative
ship heading
Number
*
*
*
*
*
TABLE FIVE
Vessel
Number
*
USS TULSA ............
*
*
LCS 16
Mastheadlights not over
all other lights and
obstructions
annex I, sec. 2(f)
*
........................................
*
*
*
*
Approved: December 7, 2017.
A.S. Janin,
Captain, USN, JAGC, Deputy Assistant Judge
Advocate General (Admiralty and Maritime
Law).
Dated: December 13, 2017.
E.K. Baldini,
Lieutenant Commander, Judge Advocate
General’s Corps, U.S. Navy, Federal Register
Liaison Officer.
[FR Doc. 2017–27759 Filed 12–22–17; 8:45 am]
BILLING CODE 3810–FF–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2017–0967]
Drawbridge Operation Regulation;
Atlantic Intracoastal Waterway,
Alligator River, Columbia, NC
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation; modification.
AGENCY:
ACTION:
The Coast Guard has modified
a temporary deviation from the
operating schedule that governs the US
64/Alligator River Bridge which carries
US 64 over the Atlantic Intracoastal
Waterway (AICW), Alligator River, mile
84.2, near Columbia, NC. The deviation
is necessary to facilitate bridge
maintenance. This deviation allows the
bridge to remain in the closed-tonavigation position.
DATES: This deviation is effective
without actual notice from December
26, 2017 through 6 p.m. on March 29,
2018. For the purposes of enforcement,
actual notice will be used from 7 a.m.
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SUMMARY:
VerDate Sep<11>2014
16:22 Dec 22, 2017
Forward masthead light
not in forward
quarter of ship
annex I, sec. 3(a)
Jkt 244001
After masthead light less
than 1⁄2 ship’s length aft
of forward
masthead light
annex I, sec. 3(a)
*
PO 00000
Frm 00025
*
Fmt 4700
*
X
*
Sfmt 4700
*
15.0
*
X
on November 6, 2017, until December
26, 2017.
ADDRESSES: The docket for this
deviation, USCG–2017–0967, is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Michael
Thorogood, Bridge Administration
Branch Fifth District, Coast Guard,
telephone 757–398–6557, email
Michael.R.Thorogood@uscg.mil.
SUPPLEMENTARY INFORMATION: On
November 1, 2017, the Coast Guard
published a temporary deviation
entitled ‘‘Drawbridge Operation
Regulation; Atlantic Intracoastal
Waterway, Alligator River, Columbia,
NC’’ in the Federal Register (82 FR
50577). That document resulted from
North Carolina Department of
Transportation’s request for a temporary
deviation, occurring from 7 a.m. on
November 6, 2017, through 7 p.m. on
November 17, 2017, from normal
operation of the drawbridge to facilitate
bridge maintenance. Subsequent to the
approval of that request, North Carolina
Department of Transportation requested
a modification, extending the temporary
deviation from 7:01 p.m. on November
17, 2017, through 6 p.m. on March 29,
2018, to allow more time to perform and
complete additional bridge maintenance
discovered during the previous
temporary deviation. Therefore, through
this document, the Coast Guard
modifies the dates of the previously
approved temporary deviation to allow
the US 64/Alligator River Bridge that
carries US 64 over the AICW, Alligator
River, mile 84.2, at near Columbia, NC,
Percentage horizontal
separation attained
to remain in the closed-to-navigation
position from 7 a.m. to 7 p.m., on
Wednesday, December 27, 2017,
through Saturday, December 30, 2017;
Monday, January 1, 2018, through
Saturday, January 5, 2018; and Monday,
January 8, 2018, through Tuesday,
January 9, 2018. During these closure
periods the bridge will open on signal,
if at least 2 hours notice is given. The
bridge will also remain in the closed-tonavigation position 24 hours a day, 7
days a week, from 6 a.m. on Wednesday,
January 10, 2018, through 6 p.m. on
Wednesday, January 17, 2018; and from
6 a.m. on Wednesday, March 14, 2018,
through 6 p.m. on Wednesday, March
21, 2018. Alternative work dates for
these closure periods will be from noon
on Thursday, January 18, 2018, through
6 p.m. on Wednesday, January 24, 2018;
and from noon on Thursday, March 22,
2018, through 6 p.m. on Thursday,
March 29, 2018. If the alternative work
dates from noon on Thursday, January
18, 2018, through 6 p.m. on Wednesday,
January 24, 2018 are used, the bridge
will also remain in the closed-tonavigation position from 7 a.m. to 6
p.m., Monday through Saturday, from
January 22, 2018, through March 14,
2018; except for scheduled daily
openings at noon, if at least 2 hours
notice is given. If the alternative work
dates from noon on Thursday, January
18, 2018, through 6 p.m. on Wednesday,
January 24, 2018 are not used, the
bridge will also remain in the closed-tonavigation position from 7 a.m. to 6
p.m., Monday through Saturday, from
January 17, 2018, through March 14,
2018; except for scheduled daily
openings at noon, if at least 2 hours
notice is given. The Coast Guard will
inform the users of the waterway
through our Broadcast Notices to
Mariners, if the alternative work dates
E:\FR\FM\26DER1.SGM
26DER1
]]>Agencies
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60867-60869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27759]
=======================================================================
-----------------------------------------------------------------------
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 (72 COLREGS), to reflect that the
Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime
Law) has determined that USS TULSA (LCS 16) 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 December 26, 2017 and is applicable
beginning December 7, 2017.
FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Kyle Fralick,
JAGC, U.S. Navy, Admiralty Attorney, (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 number: 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 TULSA (LCS 16) 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 paragraph 2 (a)(i),
pertaining to the height of the forward masthead light above the hull;
Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead
light or lights above and clear of all other lights and obstructions;
Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of
task lights; Annex I, paragraph 3(a), pertaining to the location of the
forward masthead light in the forward quarter of the ship, and the
horizontal distance between the forward and after masthead light; Rule
27(b)(i) and Annex I, paragraph 9(b)(i), pertaining to the arc of
visibility of middle tasks lights. 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.
[[Page 60868]]
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and 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 TULSA (LCS 16);
0
b. In Table Four, under paragraph 15, adding, in alpha numerical order,
by vessel number, an entry for USS TULSA (LCS 16);
0
c. In Table Four, under paragraph 16, adding, in alpha numerical order,
by vessel number, an entry for USS TULSA (LCS 16);
0
d. In Table Four, under paragraph 27, adding, in alpha numerical order,
by vessel number, an entry for USS TULSA (LCS 16); and
0
e. In Table Five, adding, in alpha numerical order, by vessel number,
an entry for USS TULSA (LCS 16).
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 TULSA................... LCS 16 4.2
* * * * * * *
------------------------------------------------------------------------
* * * * *
Table Four
* * * * *
15. * * *
----------------------------------------------------------------------------------------------------------------
Horizontal distances from the fore and aft
Vessel Number centerline of the vessel in the athwartship
direction
----------------------------------------------------------------------------------------------------------------
* * * * * * *
USS TULSA.............................. LCS 16 Upper--0.20 meters.
Middle--1.32 meters.
Lower--1.40 meters.
* * * * * *
----------------------------------------------------------------------------------------------------------------
16. * * *
----------------------------------------------------------------------------------------------------------------
Vessel Number Obstruction angle relative ship's headings
----------------------------------------------------------------------------------------------------------------
* * * * * *
USS TULSA.............................. LCS 16 72[deg] thru 74[deg].
286[deg] thru 288[deg].
* * * * * *
----------------------------------------------------------------------------------------------------------------
27. * * *
----------------------------------------------------------------------------------------------------------------
Vessel Number Obstruction angle relative ship heading
----------------------------------------------------------------------------------------------------------------
* * * * * *
USS TULSA.............................. LCS 16 47[deg] thru 59[deg].
301[deg] thru 313[deg].
[[Page 60869]]
* * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Table Five
--------------------------------------------------------------------------------------------------------------------------------------------------------
After masthead light
Mastheadlights not over Forward masthead light less than \1/2\ ship's
Vessel Number all other lights and not in forward quarter length aft of forward Percentage horizontal
obstructions annex I, of ship annex I, sec. masthead light annex I, separation attained
sec. 2(f) 3(a) sec. 3(a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
USS TULSA.................... LCS 16 ........................ X X 15.0
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approved: December 7, 2017.
A.S. Janin,
Captain, USN, JAGC, Deputy Assistant Judge Advocate General (Admiralty
and Maritime Law).
Dated: December 13, 2017.
E.K. Baldini,
Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy,
Federal Register Liaison Officer.
[FR Doc. 2017-27759 Filed 12-22-17; 8:45 am]
BILLING CODE 3810-FF-P
