Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972, 48415-48417 [2017-22577]
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. In order for
a device to fall within this classification,
and thus avoid automatic classification
in class III, it would have to comply
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. This device is
subject to premarket notification
requirements under section 510(k).
III. Analysis of 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.
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
part 807, subpart E, regarding premarket
notification submissions have been
approved under OMB control number
0910–0120.
List of Subjects in 21 CFR Part 862
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 862 is
amended as follows:
PART 862—CLINICAL CHEMISTRY
AND CLINICAL TOXICOLOGY
DEVICES
1. The authority citation for part 862
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.3652 to subpart D to read
as follows:
■
ethrower on DSK3G9T082PROD with RULES
§ 862.3652
Organophosphate test system.
(a) Identification. An
organophosphate test system is a device
intended to measure organophosphate
metabolites quantitatively in human
urine from individuals who have signs
and symptoms consistent with
cholinesterase poisoning. The data
obtained by this device is intended to
aid in the confirmation and
VerDate Sep<11>2014
16:09 Oct 17, 2017
Jkt 244001
investigation of organophosphate
exposure.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The distribution of these devices is
limited to laboratories with experienced
personnel who are trained to measure
and evaluate organophosphate exposure
and guide public health response.
(2) Analytical testing must
demonstrate the device has appropriate
performance characteristics, including
adequate precision and accuracy across
the measuring range and near medical
decision points.
Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–22590 Filed 10–17–17; 8:45 am]
BILLING CODE 4164–01–P
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, as amended (72 COLREGS),
to reflect that the Deputy Assistant
Judge Advocate General
(DAJAG)(Admiralty and Maritime Law)
has determined that USS MICHAEL
MONSOOR (DDG 1001) 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 October 18,
2017 and is applicable beginning
October 3, 2017.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Kyle Fralick,
(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
SUMMARY:
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48415
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS MICHAEL MONSOOR (DDG 1001)
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
location of the forward masthead light at
a height not less than 6 meters above the
hull; Annex I, paragraph 2(g) pertaining
to the placement of sidelights above the
hull of the vessel; Rule 30(a)(i) and
Annex I, paragraph 2(k) pertaining to
the vertical separation between anchor
lights, and the location of the forward
anchor light at a height of not less than
6 meters above the hull; Annex I,
paragraph 3(a), pertaining to the
horizontal separation between the
forward and after masthead lights;
Annex I, paragraph 2(i)(iii), pertaining
to the vertical spacing of task lights; and
Annex I, paragraph 3(c), pertaining to
the task lights placed at a horizontal
distance of not less than 2 meters from
the fore and aft centerline of the vessel.
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
alphanumerical order by vessel number,
an entry for USS MICHAEL MONSOOR
(DDG 1001);
■
■
E:\FR\FM\18OCR1.SGM
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48416
Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations
■
b. In Table Three, adding in
alphanumerical order by vessel number,
an entry for USS MICHAEL MONSOOR
(DDG 1001);
■
■
c. In Table Four, under paragraph 15,
adding in alphanumerical order by
vessel number, an entry for USS
MICHAEL MONSOOR (DDG 1001);
■
e. In Table Four, under paragraph 22
adding, in alphanumerical order by
vessel number, an entry for USS
MICHAEL MONSOOR (DDG 1001); and
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
■
d. In Table Four, under paragraph 19,
adding in alphanumerical order by
vessel number, an entry for USS
MICHAEL MONSOOR (DDG 1001);
f. In Table Five, adding, in
alphanumerical order by vessel number,
an entry for USS MICHAEL MONSOOR
(DDG 1001).
The additions read as follows:
*
*
*
*
*
TABLE ONE
Vessel
Number
*
*
*
*
*
USS MICHAEL MONSOOR .................................................................................................................
*
*
*
*
*
*
Distance in meters of
forward
masthead light below
minimum
required height
§ 2(a)(i)Annex 1
*
*
*
*
2.33
*
*
DDG
*
*
TABLE THREE
Vessel
Number
Masthead
lights arc of
visibility;
rule 21(a)
USS MICHAEL MONSOOR ...............
DDG 1001
....................
*
*
*
*
*
*
*
*
*
Stern light
arc of
visibility;
rule 21(c)
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)
....................
....................
........................
........................
*
*
*
Side lights
arc of
visibility;
rule 21(b)
*
*
Forward
anchor light,
height above
hull in meters;
2(K) annex 1
*
5.3
Anchor lights
relationship of
aft light to
forward light
in meters
2(K) annex 1
2.99 below.
*
15. * * *
*
TABLE FOUR
Vessel
Number
*
*
*
*
USS MICHAEL MONSOOR .......................................................................................
*
*
*
*
*
DDG 1001
Horizontal distance from the fore
and aft centerline of the vessel in the
athwartship direction
*
FWD Lower: 10.33 meters.
FWD Middle: 10.31 meters.
FWD Upper: 10.30 meters.
AFT Lower: 11.05 meters.
AFT Middle: 11.05 meters.
AFT Upper: 11.05 meters.
*
*
1 On
*
*
ethrower on DSK3G9T082PROD with RULES
DDG 1000, the ship does not have a traditional mast. To achieve the effect of a ‘‘single, all-around light,’’ multiple sets of task lights are
embedded into each of the four faces of the ship’s superstructure. Except when viewing the ship from dead ahead, dead astern or broadside,
two deckhouse surfaces are visible; consequently, two sets of task lights are visible simultaneously. Because the deckhouse surfaces are sloped,
unless the lights are viewed dead-on, the three task lights do not present as being in a vertical line.
*
*
*
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*
*
17:20 Oct 17, 2017
19. * * *
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48417
Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations
Vessel
USS MICHAEL MONSOOR .......................................................................................
*
*
*
*
*
*
*
*
DDG 1001
*
*
*
*
*
*
*
22. * * *
Vertical Separation of the task light array
is not equally spaced, the separation between the middle and lower task light exceed the separation between the upper
and middle light by
Number
*
*
*
*
USS MICHAEL MONSOOR .......................................................................................
*
2.23 PORT.
2.52 STBD.
*
Vessel
*
Distance in meters of sidelights above
maximum allowed height
Number
*
*
DDG 1001
*
*
FWD: 0.01 meter.
AFT: 0.00 meter.
PORT: 0.17 meter.
STBD: 0.24 meter.
*
*
*
*
*
TABLE FIVE
Vessel
Number
*
*
*
USS MICHAEL MONSOOR ..............................................
*
Masthead
lights not
over all
other lights
and
obstructions;
annex I,
sec. 2(f)
*
*
*
DDG 1001
*
X
*
DEPARTMENT OF HOMELAND
SECURITY
A.M. Nichols,
Lieutenant Commander, Judge Advocate
General’s Corps, U.S. Navy,Federal Register
Liaison Officer.
[Docket Number USCG–2017–0858]
[FR Doc. 2017–22577 Filed 10–17–17; 8:45 am]
BILLING CODE 3810–FF–P
Coast Guard
33 CFR Part 100
Special Local Regulation; Clinch River,
Oak Ridge, TN
Coast Guard, DHS.
Temporary final rule.
AGENCY:
The Coast Guard is
establishing a special local regulation
for all navigable waters of the Clinch
River from mile marker (MM) 49.5 to
MM 54.0. This action is necessary to
provide for the safety of life on these
navigable waters near Oak Ridge, TN
during the Secret City Head Race. Entry
16:09 Oct 17, 2017
Jkt 244001
PO 00000
Frm 00029
Fmt 4700
X
*
*
77.2
*
into, transiting through, or anchoring
within this regulated area is prohibited
unless authorized by the Captain of the
Port Sector Ohio Valley (COTP) or a
designated representative.
This rule is effective from 6 a.m.
through 6 p.m. on October 21, 2017.
To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2017–
0858 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
ADDRESSES:
SUMMARY:
VerDate Sep<11>2014
*
Percentage
horizontal
separation
attained
DATES:
RIN 1625–AA08
ACTION:
After
masthead
light less
than 1⁄2 ship’s
length aft of
forward
masthead
light;
annex I,
sec.3(a)
X
*
Approved: October 3, 2017.
A.S. Janin,
Captain, JAGC, U.S. Navy, Deputy Assistant
Judge Advocate, General (Admiralty and
Maritime Law).
Dated: October 10, 2017.
ethrower on DSK3G9T082PROD with RULES
Forward
masthead
light not in
forward
quarter
of ship;
annex I,
sec. 3(a)
Sfmt 4700
If
you have questions on this rule, call
Petty Officer Vera Max, Marine Safety
Detachment Nashville, U.S. Coast
Guard; telephone 615–736–5421, email
MSDNashville@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18OCR1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Rules and Regulations]
[Pages 48415-48417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22577]
=======================================================================
-----------------------------------------------------------------------
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 MICHAEL MONSOOR (DDG 1001) 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 October 18, 2017 and is applicable
beginning October 3, 2017.
FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Kyle Fralick,
(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 MICHAEL MONSOOR (DDG 1001) 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 location of the forward masthead
light at a height not less than 6 meters above the hull; Annex I,
paragraph 2(g) pertaining to the placement of sidelights above the hull
of the vessel; Rule 30(a)(i) and Annex I, paragraph 2(k) pertaining to
the vertical separation between anchor lights, and the location of the
forward anchor light at a height of not less than 6 meters above the
hull; Annex I, paragraph 3(a), pertaining to the horizontal separation
between the forward and after masthead lights; Annex I, paragraph
2(i)(iii), pertaining to the vertical spacing of task lights; and Annex
I, paragraph 3(c), pertaining to the task lights placed at a horizontal
distance of not less than 2 meters from the fore and aft centerline of
the vessel. 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 alphanumerical order by vessel number, an
entry for USS MICHAEL MONSOOR (DDG 1001);
[[Page 48416]]
0
b. In Table Three, adding in alphanumerical order by vessel number, an
entry for USS MICHAEL MONSOOR (DDG 1001);
0
c. In Table Four, under paragraph 15, adding in alphanumerical order
by vessel number, an entry for USS MICHAEL MONSOOR (DDG 1001);
0
d. In Table Four, under paragraph 19, adding in alphanumerical order by
vessel number, an entry for USS MICHAEL MONSOOR (DDG 1001);
0
e. In Table Four, under paragraph 22 adding, in alphanumerical order
by vessel number, an entry for USS MICHAEL MONSOOR (DDG 1001); and
0
f. In Table Five, adding, in alphanumerical order by vessel number, an
entry for USS MICHAEL MONSOOR (DDG 1001).
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 1
----------------------------------------------------------------------------------------------------------------
* * * * * * *
USS MICHAEL MONSOOR........................... DDG 2.33
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Table Three
--------------------------------------------------------------------------------------------------------------------------------------------------------
Side lights Stern light, Anchor lights
Masthead Side lights Stern light distance distance Forward anchor relationship of
lights arc arc of arc of inboard of forward of light, height aft light to
Vessel Number of visibility; visibility; ship's sides stern in above hull in forward light in
visibility; rule 21(b) rule 21(c) in meters 3(b) meters; rule meters; 2(K) meters 2(K) annex
rule 21(a) annex 1 21(c) annex 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
USS MICHAEL MONSOOR........... DDG 1001 ........... ........... ........... .............. .............. 5.3 2.99 below.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
* * * * *
15. * * *
Table Four
------------------------------------------------------------------------
Horizontal
distance from
the fore and aft
Vessel Number centerline of
the vessel in
the athwartship
direction
------------------------------------------------------------------------
* * * * * * *
USS MICHAEL MONSOOR........... DDG 1001 FWD Lower:
\1\0.33 meters.
FWD Middle:
\1\0.31 meters.
FWD Upper:
\1\0.30 meters.
AFT Lower:
\1\1.05 meters.
AFT Middle:
\1\1.05 meters.
AFT Upper:
\1\1.05 meters.
* * * * * * *
------------------------------------------------------------------------
\1\ On DDG 1000, the ship does not have a traditional mast. To achieve
the effect of a ``single, all-around light,'' multiple sets of task
lights are embedded into each of the four faces of the ship's
superstructure. Except when viewing the ship from dead ahead, dead
astern or broadside, two deckhouse surfaces are visible; consequently,
two sets of task lights are visible simultaneously. Because the
deckhouse surfaces are sloped, unless the lights are viewed dead-on,
the three task lights do not present as being in a vertical line.
* * * * *
19. * * *
[[Page 48417]]
------------------------------------------------------------------------
Distance in
meters of
Vessel Number sidelights above
maximum allowed
height
------------------------------------------------------------------------
USS MICHAEL MONSOOR........... DDG 1001 2.23 PORT.
2.52 STBD.
* * * * * * *
------------------------------------------------------------------------
* * * * *
22. * * *
------------------------------------------------------------------------
Vertical
Separation of
the task light
array is not
equally spaced,
the separation
between the
Vessel Number middle and lower
task light
exceed the
separation
between the
upper and middle
light by
------------------------------------------------------------------------
* * * * * * *
USS MICHAEL MONSOOR........... DDG 1001 FWD: 0.01 meter.
AFT: 0.00 meter.
PORT: 0.17
meter.
STBD: 0.24
meter.
* * * * * * *
------------------------------------------------------------------------
* * * * *
Table Five
--------------------------------------------------------------------------------------------------------------------------------------------------------
After masthead
Masthead Forward light less
lights not masthead light than \1/2\ Percentage
over all other not in forward ship's length horizontal
Vessel Number lights and quarter of aft of forward separation
obstructions; ship; annex I, masthead attained
annex I, sec. sec. 3(a) light; annex
2(f) I, sec.3(a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
USS MICHAEL MONSOOR.......................... DDG 1001 X X X 77.2
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approved: October 3, 2017.
A.S. Janin,
Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General
(Admiralty and Maritime Law).
Dated: October 10, 2017.
A.M. Nichols,
Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy,Federal
Register Liaison Officer.
[FR Doc. 2017-22577 Filed 10-17-17; 8:45 am]
BILLING CODE 3810-FF-P
