Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972, 48764-48766 [2017-22578]
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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
sequences from patients suspected of
meningitis or encephalitis. A device to
detect and identify microbial pathogen
nucleic acids in cerebrospinal fluid is
intended to aid in the diagnosis of
meningitis or encephalitis when used in
conjunction with clinical signs and
symptoms and other clinical and
laboratory findings.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Premarket notification
submissions must include detailed
device description documentation,
including the device components,
ancillary reagents required but not
provided, and a detailed explanation of
the methodology, including primer/
probe sequence, design, and rationale
for sequence selection.
(2) Premarket notification
submissions must include detailed
documentation from the following
analytical studies: Analytical sensitivity
(limit of detection), inclusivity,
reproducibility, interference, cross
reactivity, and specimen stability.
(3) Premarket notification
submissions must include detailed
documentation from a clinical study.
The study, performed on a study
population consistent with the intended
use population, must compare the
device performance to results obtained
from well-accepted comparator
methods.
(4) Premarket notification
submissions must include detailed
documentation for device software,
including, but not limited to, software
applications and hardware-based
devices that incorporate software.
(5) The Intended Use statement in the
device labeling must include a
statement that the device is intended to
be used in conjunction with standard of
care culture.
(6) A detailed explanation of the
interpretation of results and acceptance
criteria must be included in the device’s
21 CFR 809.10(b)(9) compliant labeling.
(7) The device labeling must include
a limitation stating that the negative
results do not preclude the possibility of
central nervous system infection.
(8) The device labeling must include
a limitation stating that device results
are not intended to be used as the sole
basis for diagnosis, treatment, or other
patient management decisions.
(9) The device labeling must include
a limitation stating that positive results
do not mean that the organism detected
is infectious or is the causative agent for
clinical symptoms.
(10) As part of the risk management
activities performed as part of your 21
CFR 820.30 design controls, you must
VerDate Sep<11>2014
14:59 Oct 19, 2017
Jkt 244001
document an appropriate end user
device training program that will be
offered as part of your efforts to mitigate
the risk of failure to correctly operate
the instrument.
Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–22769 Filed 10–19–17; 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 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
General (DAJAG) (Admiralty and
Maritime Law) has determined that
certain vessels of the VIRGINIA SSN
Class are vessels of the Navy which, due
to their special construction and
purpose, cannot fully comply with
certain provisions of the 72 COLREGS
without interfering with their special
function as a naval ships. The intended
effect of this rule is to warn mariners in
waters where 72 COLREGS apply.
DATES: This rule is effective October 20,
2017 and is applicable beginning
September 30, 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
certain vessels of the SSN Class are
vessels of the Navy which, due to their
special construction and purpose,
cannot fully comply with the following
specific provisions of 72 COLREGS
without interfering with their special
function as a naval ship: Rule 23(a) and
Annex I, paragraph 2(a)(i), pertaining to
the vertical placement of the masthead,
SUMMARY:
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light and Annex I, paragraph 2(f)(i),
pertaining to the masthead light being
above and clear of all other lights and
obstructions; Rule 30 (a), Rule 21(e), and
Annex I, paragraph 2(k), pertaining to
the vertical separation of the anchor
lights, vertical placement of the forward
anchor light above the hull, and the arc
of visibility of all around lights; Rule 23
(a) and 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 these vessels in
a manner differently from that
prescribed herein will adversely affect
these vessels’ ability to perform their
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 INDIANA (SSN 789);
■ b. In Table Three, adding, in alpha
numerical order, by vessel number, an
entry for USS INDIANA (SSN 789); and
■ c. In Table Four:
■ i. In paragraph 25, adding, in alpha
numerical order, by vessel number, an
entry for USS INDIANA (SSN 789); and
■ ii. In paragraph 26, adding, in alpha
numerical order, by vessel number, an
entry for USS INDIANA (SSN 789).
The additions read as follows:
■
■
§ 706.2 Certifications of the Secretary of
the Navy under Executive Order 11964 and
33 U.S.C. 1605.
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48765
Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
TABLE ONE
Vessel
Number
Distance in meters of
forward masthead light
below minimum
required height
§ 2(a)(i) Annex I
*
*
*
USS INDIANA .....................................................................
*
*
*
SSN 789 .............................................................................
*
2.76
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
TABLE THREE
Masthead
lights arc of
visibility;
rule 21(a)
Vessel
Number
*
*
USS INDIANA ....................................................
*
SSN 789 ....
*
*
*
*
*
*
*
*
*
Stern light
arc of
visibility;
rule 21(c)
....................
*
....................
*
206.0°
*
*
*
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
relationship
of aft light
to forward
light in
meters 2(K)
annex 1
*
2.8
0.30
*
4.37
*
11.05
*
*
25. * * *
*
TABLE FOUR
Vessel
Number
Distance in meters of
masthead light below
the submarine
identification lights
*
*
*
USS INDIANA .....................................................................
*
*
*
SSN 789 .............................................................................
*
0.81
26. * * *
Obstruction angle relative to ship’s
headings
Vessel
Number
Forward anchor
light
nlaroche on DSK9F9SC42PROD with RULES
*
*
*
*
*
USS INDIANA ...................................................... SSN 789 ...............................................................
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*
172° to 188° ..........
E:\FR\FM\20OCR1.SGM
20OCR1
Aft anchor
light
*
359° to 1°.
48766
*
*
Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
*
*
*
Approved: September 30, 2017.
A.S. Janin,
Captain, JAGC, U.S. Navy, Deputy Assistant
Judge Advocate, General (Admiralty and
Maritime Law Division).
Dated: October 10, 2017.
A.M. Nichols,
Lieutenant Commander, Judge Advocate
General’s Corps, U.S. Navy, Federal Register
Liaison Officer.
[FR Doc. 2017–22578 Filed 10–19–17; 8:45 am]
BILLING CODE 3810–FF–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2017–0157; FRL–9969–87–
Region 5]
Air Plan Approval; Wisconsin;
Regional Haze Progress Report
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving the regional
haze progress report under the Clean Air
Act as a revision to the Wisconsin State
Implementation Plan (SIP). Wisconsin
has satisfied the progress report
requirements of the Regional Haze Rule.
Wisconsin has also met the
requirements for a determination of the
adequacy of its regional haze plan with
its negative declaration submitted with
the progress report.
DATES: This direct final rule will be
effective December 19, 2017, unless EPA
receives adverse comments by
November 20, 2017. If adverse
comments are received, EPA will
publish a timely withdrawal of the
direct final rule in the Federal Register
informing the public that the rule will
not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R05–
OAR–2017–0157 at https://
www.regulations.gov or via email to
aburano.douglas@epa.gov. For
comments submitted at Regulations.gov,
follow the online instructions for
submitting comments. Once submitted,
comments cannot be edited or removed
from Regulations.gov. For either manner
of submission, EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
nlaroche on DSK9F9SC42PROD with RULES
SUMMARY:
VerDate Sep<11>2014
14:59 Oct 19, 2017
Jkt 244001
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. EPA will generally not consider
comments or comment contents located
outside of the primary submission (i.e.,
on the web, cloud, or other file sharing
system). For additional submission
methods, please contact the person
identified in the FOR FURTHER
INFORMATION CONTACT section. For the
full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Gilberto Alvarez, Environmental
Scientist, Attainment Planning and
Maintenance Section, Air Programs
Branch (AR–18J), Environmental
Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois
60604, (312) 886–6143,
alvarez.gilberto@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA. This supplementary information
section is arranged as follows:
I. Background
II. Requirements for the Regional Haze
Progress Report SIPs and Adequacy of
Determinations
III. What is EPA’s analysis?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews
I. Background
States are required to submit a
progress report every five years that
evaluates progress towards the
Reasonable Progress Goals (RPGs) for
each mandatory Class I Federal area
within the State and in each mandatory
Class I Federal area outside the State
which may be affected by emissions
from within the State. See 40 CFR
51.308(g). States are also required to
submit, at the same time as the progress
report, a determination of the adequacy
of the State’s existing regional haze SIP.
See 40 CFR 51.308(h). The first progress
report is due five years after the
submittal of the initial regional haze
SIP.
Wisconsin submitted its regional haze
plan on January 18, 2012. EPA approved
Wisconsin’s regional haze plan into its
SIP on August 7, 2012, 77 FR 46952.
Wisconsin submitted its five-year
progress report on March 17, 2017. This
is a report on progress made in the first
implementation period towards RPGs
for Class I areas outside of Wisconsin.
Wisconsin does not have any Class I
PO 00000
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areas within its borders. This progress
report SIP included a determination that
Wisconsin’s existing regional haze SIP
requires no substantive revision to
achieve the established regional haze
visibility improvement and emissions
reduction goals for 2018. EPA is
proposing to approve Wisconsin’s
progress report on the basis that it
satisfies the applicable requirements of
the rule at 40 CFR 51.308.
II. Requirements for the Regional Haze
Progress Report SIPs and Adequacy of
Determinations
Under 40 CFR 51.308(g), states must
periodically (every five years) submit a
regional haze progress report that
address the seven elements found in 40
CFR 51.308(g).
Under 40 CFR 51.308(h), states are
required to submit, at the same time as
the progress report, a determination of
the adequacy of their existing regional
haze SIP and to take one of four possible
listed actions based on information in
the progress report.
III. What is EPA’s analysis?
The Regional Haze Rule provides the
required elements for five-year progress
reports in 40 CFR 51.308(g). EPA finds
that Wisconsin satisfied the 40 CFR
51.308(g) requirements with its progress
report. EPA finds that, with its negative
declaration, Wisconsin also satisfied the
requirements for the determination of
adequacy provided in 40 CFR 51.308(h).
The following sections discuss the
information provided by Wisconsin in
the progress report submission, along
with EPA’s analysis and determination
of whether the submission met the
applicable requirements of § 51.308.
1. Status of Implementation of all
Measures Included in the Regional Haze
SIP
In its progress report, Wisconsin
summarizes the status of the emissions
reduction measures that were included
in its 2012 regional haze SIP.
Specifically, the report addresses the
status of the on-the-books emissions
reduction measures. The measures
include applicable Federal programs
(e.g., Clean Air Interstate Rule—CAIR,
Cross State Pollution Rule—CSAPR, onand off-highway mobile source rules,
area source rules, point sources, Title IV
programs, nitrogen oxides (NOX) SIP
Call, Maximum Achievable Control
Technology (MACT) standards, Federal
and State consent agreements, and
Federal and State control strategies for
electric generating units (EGUs)). This
summary includes a discussion of the
benefits associated with each measure.
E:\FR\FM\20OCR1.SGM
20OCR1
]]>Agencies
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Rules and Regulations]
[Pages 48764-48766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22578]
=======================================================================
-----------------------------------------------------------------------
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 certain vessels of the VIRGINIA SSN Class are
vessels of the Navy which, due to their special construction and
purpose, cannot fully comply with certain provisions of the 72 COLREGS
without interfering with their special function as a naval ships. The
intended effect of this rule is to warn mariners in waters where 72
COLREGS apply.
DATES: This rule is effective October 20, 2017 and is applicable
beginning September 30, 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 certain vessels of the SSN Class are vessels of the
Navy which, due to their special construction and purpose, cannot fully
comply with the following specific provisions of 72 COLREGS without
interfering with their special function as a naval ship: Rule 23(a) and
Annex I, paragraph 2(a)(i), pertaining to the vertical placement of the
masthead, light and Annex I, paragraph 2(f)(i), pertaining to the
masthead light being above and clear of all other lights and
obstructions; Rule 30 (a), Rule 21(e), and Annex I, paragraph 2(k),
pertaining to the vertical separation of the anchor lights, vertical
placement of the forward anchor light above the hull, and the arc of
visibility of all around lights; Rule 23 (a) and 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 these vessels in a manner differently from that prescribed
herein will adversely affect these vessels' ability to perform their
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 INDIANA (SSN 789);
0
b. In Table Three, adding, in alpha numerical order, by vessel number,
an entry for USS INDIANA (SSN 789); and
0
c. In Table Four:
0
i. In paragraph 25, adding, in alpha numerical order, by vessel number,
an entry for USS INDIANA (SSN 789); and
0
ii. In paragraph 26, adding, in alpha numerical order, by vessel
number, an entry for USS INDIANA (SSN 789).
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.
* * * * *
[[Page 48765]]
Table One
------------------------------------------------------------------------
Distance in meters of
forward masthead light
Vessel Number below minimum required
height Sec. 2(a)(i)
Annex I
------------------------------------------------------------------------
* * * * * * *
USS INDIANA.................. SSN 789........ 2.76
* * * * * * *
------------------------------------------------------------------------
* * * * *
* * * * *
Table Three
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anchor
Side lights, Stern light, Forward lights
Masthead Side lights Stern light distance distance anchor relationship
lights arc arc of arc of inboard of forward of light, of aft light
Vessel Number of visibility; visibility; ship's sides stern in height above to forward
visibility; rule 21(b) rule 21(c) in meters meters; rule hull in light in
rule 21(a) 3(b) annex 1 21(c) meters; 2(K) meters 2(K)
annex 1 annex 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
USS INDIANA....................... SSN 789........... ............ ............ 206.0[deg] 4.37 11.05 2.8 0.30
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
* * * * *
25. * * *
Table Four
------------------------------------------------------------------------
Distance in meters of
masthead light below the
Vessel Number submarine identification
lights
------------------------------------------------------------------------
* * * * * * *
USS INDIANA.................. SSN 789........ 0.81
------------------------------------------------------------------------
26. * * *
----------------------------------------------------------------------------------------------------------------
Obstruction angle relative to ship's headings
Vessel Number ----------------------------------------------------------
Forward anchor light Aft anchor light
----------------------------------------------------------------------------------------------------------------
* * * * * * *
USS INDIANA..................... SSN 789............ 172[deg] to 188[deg]........ 359[deg] to 1[deg].
----------------------------------------------------------------------------------------------------------------
[[Page 48766]]
* * * * *
Approved: September 30, 2017.
A.S. Janin,
Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General
(Admiralty and Maritime Law Division).
Dated: October 10, 2017.
A.M. Nichols,
Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy,
Federal Register Liaison Officer.
[FR Doc. 2017-22578 Filed 10-19-17; 8:45 am]
BILLING CODE 3810-FF-P
