Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas, 63674-63675 [2015-26623]
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63674
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations
(iii) Statistical performance of the
device within clinical risk strata (e.g.,
age, relevant comorbidities, disease
stability) must be reported;
(iv) The dataset must be adequately
representative of the intended use
population for the device (e.g., patients,
range of vessel sizes, imaging device
models). Any selection criteria or
limitations of the samples must be fully
described and justified;
(v) Statistical methods must consider
the predefined endpoints:
(A) Estimates of probabilities of
incorrect results must be provided for
each endpoint,
(B) Where multiple samples from the
same patient are used, statistical
analysis must not assume statistical
independence without adequate
justification, and
(C) The report must provide
appropriate confidence intervals for
each performance metric;
(vi) Sensitivity and specificity must
be characterized across the range of
available measurements;
(vii) Agreement of the simulated
measure(s) with clinically acceptable
measure(s) must be assessed across the
full range of measurements;
(viii) Comparison of the measurement
performance must be provided across
the range of intended image acquisition
hardware; and
(ix) If the device uses a cutoff
threshold or operates across a spectrum
of disease, it must be established prior
to validation, and it must be justified as
to how it was determined and clinically
validated;
(4) Adequate validation must be
performed and controls implemented to
characterize and ensure consistency
(i.e., repeatability and reproducibility)
of measurement outputs:
(i) Acceptable incoming image quality
control measures and the resulting
image rejection rate for the clinical data
must be specified, and
(ii) Data must be provided within the
clinical validation study or using
equivalent datasets demonstrating the
consistency (i.e., repeatability and
reproducibility) of the output that is
representative of the range of data
quality likely to be encountered in the
intended use population and relevant
use conditions in the intended use
environment;
(A) Testing must be performed using
multiple operators meeting planned
qualification criteria and using the
procedure that will be implemented in
the production use of the device, and
(B) The factors (e.g., medical imaging
dataset, operator) must be identified
regarding which were held constant and
which were varied during the
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evaluation, and a description must be
provided for the computations and
statistical analyses used to evaluate the
data;
(5) Human factors evaluation and
validation must be provided to
demonstrate adequate performance of
the user interface to allow for users to
accurately measure intended
parameters, particularly where
parameter settings that have impact on
measurements require significant user
intervention; and
(6) Device labeling must be provided
that adequately describes the following:
(i) The device’s intended use,
including the type of imaging data used,
what the device measures and outputs
to the user, whether the measure is
qualitative or quantitative, the clinical
indications for which it is to be used,
and the specific population for which
the device use is intended;
(ii) Appropriate warnings specifying
the intended patient population,
identifying anatomy and image
acquisition factors that may impact
measurement results, and providing
cautionary guidance for interpretation of
the provided measurements;
(iii) Key assumptions made in the
calculation and determination of
simulated measurements;
(iv) The measurement performance of
the device for all presented parameters,
with appropriate confidence intervals,
and the supporting evidence for this
performance. Per-vessel clinical
performance, including where
applicable localized performance
according to vessel and segment, must
be included as well as a characterization
of the measurement error across the
expected range of measurement for key
parameters based on the clinical data;
(v) A detailed description of the
patients studied in the clinical
validation (e.g., age, gender, race or
ethnicity, clinical stability, current
treatment regimen) as well as
procedural details of the clinical study
(e.g., scanner representation, calcium
scores, use of beta-blockers or nitrates);
and
(vi) Where significant human
interface is necessary for accurate
analysis, adequately detailed
description of the analysis procedure
using the device and any data features
that could affect accuracy of results.
Dated: October 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26658 Filed 10–20–15; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 100, 117, 147, and 165
[USCG–2015–0242]
Quarterly Listings; Safety Zones,
Security Zones, Special Local
Regulations, Drawbridge Operation
Regulations and Regulated Navigation
Areas
Coast Guard, DHS.
Notice of expired temporary
rules issued.
AGENCY:
ACTION:
This document provides
notice of substantive rules issued by the
Coast Guard that were made temporarily
effective between January 2015 and
March 2015 but expired before they
could be published in the Federal
Register. This notice lists temporary
safety zones, security zones, special
local regulations, drawbridge operation
regulations and regulated navigation
areas, all of limited duration and for
which timely publication in the Federal
Register was not possible.
DATES: This document lists temporary
Coast Guard rules that became effective
between January 2015 and March 2015
and were terminated before they could
be published in the Federal Register.
ADDRESSES: Temporary rules listed in
this document may be viewed online,
under their respective docket numbers,
using the Federal eRulemaking Portal at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
questions on this notice contact Yeoman
First Class Maria Fiorella Villanueva,
Office of Regulations and
Administrative Law, telephone (202)
372–3862.
SUPPLEMENTARY INFORMATION: Coast
Guard District Commanders and
Captains of the Port (COTP) must be
immediately responsive to the safety
and security needs within their
jurisdiction; therefore, District
Commanders and COTPs have been
delegated the authority to issue certain
local regulations. Safety zones may be
established for safety or environmental
purposes. A safety zone may be
stationary and described by fixed limits
or it may be described as a zone around
a vessel in motion. Security zones limit
access to prevent injury or damage to
vessels, ports, or waterfront facilities.
Special local regulations are issued to
enhance the safety of participants and
spectators at regattas and other marine
events. Drawbridge operation
regulations authorize changes to
SUMMARY:
E:\FR\FM\21OCR1.SGM
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations
drawbridge schedules to accommodate
bridge repairs, seasonal vessel traffic,
and local public events. Regulated
Navigation Areas are water areas within
a defined boundary for which
regulations for vessels navigating within
the area have been established by the
regional Coast Guard District
Commander.
Timely publication of these rules in
the Federal Register may be precluded
when a rule responds to an emergency,
or when an event occurs without
sufficient advance notice. The affected
public is, however, often informed of
these rules through Local Notices to
Mariners, press releases, and other
means. Moreover, actual notification is
provided by Coast Guard patrol vessels
enforcing the restrictions imposed by
the rule. Because Federal Register
publication was not possible before the
end of the effective period, mariners
were personally notified of the contents
of these safety zones, security zones,
special local regulations, regulated
navigation areas or drawbridge
operation regulations by Coast Guard
officials on-scene prior to any
enforcement action. However, the Coast
Guard, by law, must publish in the
Federal Register notice of substantive
rules adopted. To meet this obligation
without imposing undue expense on the
public, the Coast Guard periodically
publishes a list of these temporary
safety zones, security zones, special
tkelley on DSK3SPTVN1PROD with RULES
local regulations, regulated navigation
areas and drawbridge operation
regulations. Permanent rules are not
included in this list because they are
published in their entirety in the
Federal Register. Temporary rules are
also published in their entirety if
sufficient time is available to do so
before they are placed in effect or
terminated.
The following unpublished rules were
placed in effect temporarily during the
period between January 2015 and March
2015 unless otherwise indicated. To
view copies of these rules, visit
www.regulations.gov and search by the
docket number indicated in the list
below.
Location
Type
Effective
date
Clearwater Beach, FL ...............................
Wilmington, DE .........................................
Miami, FL ..................................................
Oahu, HI ...................................................
Owensboro, KY .........................................
St. Petersburg, FL ....................................
Wilmington, NC .........................................
Chicago, IL ................................................
Buffalo, NY ................................................
Tampa, FL ................................................
Township, MI ............................................
St. Clair Shores, MI ..................................
Ecorse, MI .................................................
Toledo, OH ...............................................
Cincinnati, OH ...........................................
Orange Beach, AL ....................................
Cleveland, OH ..........................................
Ledbetter, KY ............................................
Oak Island, NC .........................................
Washington, DC ........................................
Tracy, CA ..................................................
Wilmington, NC .........................................
Walnut Grove, CA .....................................
Queen Ann County, MD ...........................
Mt. Vernon, IN ..........................................
Rockport, KY .............................................
Fort Pierce, FL ..........................................
Port NY Zone, NY .....................................
Pacific Ocean, CA ....................................
Wilmington, NC .........................................
Los Angeles, CA .......................................
Naples, FL ................................................
Alameda, CA .............................................
Tacoma, WA .............................................
Miami, FL ..................................................
Fort Myers, FL ..........................................
Marcus Hook, PA ......................................
San Francisco, CA ....................................
Boston, MA ...............................................
Biloxi, MS ..................................................
New Orleans, LA ......................................
Pensacola, FL ...........................................
Fort Walton Beach, FL .............................
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Security Zones (Part 165) ........................
Security Zones (Part 165) ........................
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Special Local Regulations (Part 100) .......
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Security Zones (Part 165) ........................
Drawbridges (Part 117) ............................
Safety Zones (Parts 147 and 165) ...........
Drawbridges (Part 117) ............................
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Security Zones (Part 165) ........................
Security Zones (Part 165) ........................
Anchorages ...............................................
Safety Zones (Parts 147 and 165) ...........
Security Zones (Part 165) ........................
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
Safety Zones (Parts 147 and 165) ...........
12/21/2014
12/9/2014
12/31/2014
12/18/2014
10/21/2014
12/25/2014
1/8/2015
9/5/2014
9/6/2014
1/11/2015
9/4/2014
9/6/2014
9/2/2014
8/29/2014
8/31/2014
8/22/2014
7/27/2014
4/27/2014
1/4/2015
1/20/2015
2/11/2015
1/23/2015
2/17/2015
2/16/2015
12/1/2014
12/1/2014
2/26/2015
2/17/2015
2/17/2015
3/8/2015
1/20/2015
3/7/2015
2/9/2015
1/22/2015
2/13/2015
1/30/2015
3/20/2015
3/21/2015
3/29/2015
3/27/2015
3/26/2015
3/24/2015
3/11/2015
Docket No.
USCG–2014–1035
USCG–2014–1033
USCG–2014–1046
USCG–2014–1010
USCG–2014–0957
USCG–2014–1014
USCG–2014–1067
USCG–2014–0826
USCG–2014–0081
USCG–2014–1058
USCG–2014–0817
USCG–2014–0810
USCG–2014–0815
USCG–2014–0779
USCG–2014–0682
USCG–2014–0615
USCG–2014–0595
USCG–2014–0346
USCG–2014–1072
USCG–2015–0009
USCG–2015–0080
USCG–2015–0043
USCG–2015–0081
USCG–2015–0091
USCG–2014–0989
USCG–2014–1022
USCG–2015–0124
USCG–2015–0015
USCG–2015–0106
USCG–2015–0147
USCG–2015–0026
USCG–2015–0089
USCG–2015–0033
USCG–2015–0032
USCG–2015–0077
USCG–2015–0047
USCG–2014–0139
USCG–2015–0116
USCG–2015–0153
USCG–2015–0044
USCG–2015–0143
USCG–2015–0160
USCG–2015–0173
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K. Kroutil,
Chief, Office of Regulations and
Administrative Law.
[FR Doc. 2015–26623 Filed 10–20–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63674-63675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26623]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Parts 100, 117, 147, and 165
[USCG-2015-0242]
Quarterly Listings; Safety Zones, Security Zones, Special Local
Regulations, Drawbridge Operation Regulations and Regulated Navigation
Areas
AGENCY: Coast Guard, DHS.
ACTION: Notice of expired temporary rules issued.
-----------------------------------------------------------------------
SUMMARY: This document provides notice of substantive rules issued by
the Coast Guard that were made temporarily effective between January
2015 and March 2015 but expired before they could be published in the
Federal Register. This notice lists temporary safety zones, security
zones, special local regulations, drawbridge operation regulations and
regulated navigation areas, all of limited duration and for which
timely publication in the Federal Register was not possible.
DATES: This document lists temporary Coast Guard rules that became
effective between January 2015 and March 2015 and were terminated
before they could be published in the Federal Register.
ADDRESSES: Temporary rules listed in this document may be viewed
online, under their respective docket numbers, using the Federal
eRulemaking Portal at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For questions on this notice contact
Yeoman First Class Maria Fiorella Villanueva, Office of Regulations and
Administrative Law, telephone (202) 372-3862.
SUPPLEMENTARY INFORMATION: Coast Guard District Commanders and Captains
of the Port (COTP) must be immediately responsive to the safety and
security needs within their jurisdiction; therefore, District
Commanders and COTPs have been delegated the authority to issue certain
local regulations. Safety zones may be established for safety or
environmental purposes. A safety zone may be stationary and described
by fixed limits or it may be described as a zone around a vessel in
motion. Security zones limit access to prevent injury or damage to
vessels, ports, or waterfront facilities. Special local regulations are
issued to enhance the safety of participants and spectators at regattas
and other marine events. Drawbridge operation regulations authorize
changes to
[[Page 63675]]
drawbridge schedules to accommodate bridge repairs, seasonal vessel
traffic, and local public events. Regulated Navigation Areas are water
areas within a defined boundary for which regulations for vessels
navigating within the area have been established by the regional Coast
Guard District Commander.
Timely publication of these rules in the Federal Register may be
precluded when a rule responds to an emergency, or when an event occurs
without sufficient advance notice. The affected public is, however,
often informed of these rules through Local Notices to Mariners, press
releases, and other means. Moreover, actual notification is provided by
Coast Guard patrol vessels enforcing the restrictions imposed by the
rule. Because Federal Register publication was not possible before the
end of the effective period, mariners were personally notified of the
contents of these safety zones, security zones, special local
regulations, regulated navigation areas or drawbridge operation
regulations by Coast Guard officials on-scene prior to any enforcement
action. However, the Coast Guard, by law, must publish in the Federal
Register notice of substantive rules adopted. To meet this obligation
without imposing undue expense on the public, the Coast Guard
periodically publishes a list of these temporary safety zones, security
zones, special local regulations, regulated navigation areas and
drawbridge operation regulations. Permanent rules are not included in
this list because they are published in their entirety in the Federal
Register. Temporary rules are also published in their entirety if
sufficient time is available to do so before they are placed in effect
or terminated.
The following unpublished rules were placed in effect temporarily
during the period between January 2015 and March 2015 unless otherwise
indicated. To view copies of these rules, visit www.regulations.gov and
search by the docket number indicated in the list below.
----------------------------------------------------------------------------------------------------------------
Effective
Docket No. Location Type date
----------------------------------------------------------------------------------------------------------------
USCG-2014-1035........................... Clearwater Beach, FL....... Safety Zones (Parts 147 and 12/21/2014
165).
USCG-2014-1033........................... Wilmington, DE............. Safety Zones (Parts 147 and 12/9/2014
165).
USCG-2014-1046........................... Miami, FL.................. Safety Zones (Parts 147 and 12/31/2014
165).
USCG-2014-1010........................... Oahu, HI................... Security Zones (Part 165).. 12/18/2014
USCG-2014-0957........................... Owensboro, KY.............. Security Zones (Part 165).. 10/21/2014
USCG-2014-1014........................... St. Petersburg, FL......... Safety Zones (Parts 147 and 12/25/2014
165).
USCG-2014-1067........................... Wilmington, NC............. Safety Zones (Parts 147 and 1/8/2015
165).
USCG-2014-0826........................... Chicago, IL................ Safety Zones (Parts 147 and 9/5/2014
165).
USCG-2014-0081........................... Buffalo, NY................ Safety Zones (Parts 147 and 9/6/2014
165).
USCG-2014-1058........................... Tampa, FL.................. Safety Zones (Parts 147 and 1/11/2015
165).
USCG-2014-0817........................... Township, MI............... Safety Zones (Parts 147 and 9/4/2014
165).
USCG-2014-0810........................... St. Clair Shores, MI....... Safety Zones (Parts 147 and 9/6/2014
165).
USCG-2014-0815........................... Ecorse, MI................. Safety Zones (Parts 147 and 9/2/2014
165).
USCG-2014-0779........................... Toledo, OH................. Safety Zones (Parts 147 and 8/29/2014
165).
USCG-2014-0682........................... Cincinnati, OH............. Safety Zones (Parts 147 and 8/31/2014
165).
USCG-2014-0615........................... Orange Beach, AL........... Special Local Regulations 8/22/2014
(Part 100).
USCG-2014-0595........................... Cleveland, OH.............. Safety Zones (Parts 147 and 7/27/2014
165).
USCG-2014-0346........................... Ledbetter, KY.............. Safety Zones (Parts 147 and 4/27/2014
165).
USCG-2014-1072........................... Oak Island, NC............. Safety Zones (Parts 147 and 1/4/2015
165).
USCG-2015-0009........................... Washington, DC............. Security Zones (Part 165).. 1/20/2015
USCG-2015-0080........................... Tracy, CA.................. Drawbridges (Part 117)..... 2/11/2015
USCG-2015-0043........................... Wilmington, NC............. Safety Zones (Parts 147 and 1/23/2015
165).
USCG-2015-0081........................... Walnut Grove, CA........... Drawbridges (Part 117)..... 2/17/2015
USCG-2015-0091........................... Queen Ann County, MD....... Safety Zones (Parts 147 and 2/16/2015
165).
USCG-2014-0989........................... Mt. Vernon, IN............. Safety Zones (Parts 147 and 12/1/2014
165).
USCG-2014-1022........................... Rockport, KY............... Safety Zones (Parts 147 and 12/1/2014
165).
USCG-2015-0124........................... Fort Pierce, FL............ Safety Zones (Parts 147 and 2/26/2015
165).
USCG-2015-0015........................... Port NY Zone, NY........... Safety Zones (Parts 147 and 2/17/2015
165).
USCG-2015-0106........................... Pacific Ocean, CA.......... Safety Zones (Parts 147 and 2/17/2015
165).
USCG-2015-0147........................... Wilmington, NC............. Safety Zones (Parts 147 and 3/8/2015
165).
USCG-2015-0026........................... Los Angeles, CA............ Safety Zones (Parts 147 and 1/20/2015
165).
USCG-2015-0089........................... Naples, FL................. Safety Zones (Parts 147 and 3/7/2015
165).
USCG-2015-0033........................... Alameda, CA................ Safety Zones (Parts 147 and 2/9/2015
165).
USCG-2015-0032........................... Tacoma, WA................. Safety Zones (Parts 147 and 1/22/2015
165).
USCG-2015-0077........................... Miami, FL.................. Security Zones (Part 165).. 2/13/2015
USCG-2015-0047........................... Fort Myers, FL............. Security Zones (Part 165).. 1/30/2015
USCG-2014-0139........................... Marcus Hook, PA............ Anchorages................. 3/20/2015
USCG-2015-0116........................... San Francisco, CA.......... Safety Zones (Parts 147 and 3/21/2015
165).
USCG-2015-0153........................... Boston, MA................. Security Zones (Part 165).. 3/29/2015
USCG-2015-0044........................... Biloxi, MS................. Safety Zones (Parts 147 and 3/27/2015
165).
USCG-2015-0143........................... New Orleans, LA............ Safety Zones (Parts 147 and 3/26/2015
165).
USCG-2015-0160........................... Pensacola, FL.............. Safety Zones (Parts 147 and 3/24/2015
165).
USCG-2015-0173........................... Fort Walton Beach, FL...... Safety Zones (Parts 147 and 3/11/2015
165).
----------------------------------------------------------------------------------------------------------------
K. Kroutil,
Chief, Office of Regulations and Administrative Law.
[FR Doc. 2015-26623 Filed 10-20-15; 8:45 am]
BILLING CODE P
