80 FR 63674 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas

DEPARTMENT OF HOMELAND SECURITY
Coast Guard

Federal Register Volume 80, Issue 203 (October 21, 2015)

Page Range		63674-63675
FR Document		2015-26623

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.

Federal Register, Volume 80 Issue 203 (Wednesday, October 21, 2015)

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63674-63675]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-26623]

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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

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 http://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

63674 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations

(iii) Statistical performance of the evaluation, and a description must be DEPARTMENT OF HOMELAND
device within clinical risk strata (e.g., provided for the computations and SECURITY
age, relevant comorbidities, disease statistical analyses used to evaluate the
stability) must be reported; data; Coast Guard
(iv) The dataset must be adequately (5) Human factors evaluation and
representative of the intended use validation must be provided to 33 CFR Parts 100, 117, 147, and 165
population for the device (e.g., patients, demonstrate adequate performance of [USCG–2015–0242]
range of vessel sizes, imaging device the user interface to allow for users to
models). Any selection criteria or accurately measure intended Quarterly Listings; Safety Zones,
limitations of the samples must be fully parameters, particularly where Security Zones, Special Local
described and justified; parameter settings that have impact on Regulations, Drawbridge Operation
(v) Statistical methods must consider measurements require significant user Regulations and Regulated Navigation
the predefined endpoints: intervention; and Areas
(A) Estimates of probabilities of
incorrect results must be provided for (6) Device labeling must be provided AGENCY: Coast Guard, DHS.
each endpoint, that adequately describes the following: ACTION: Notice of expired temporary
(B) Where multiple samples from the (i) The device’s intended use, rules issued.
same patient are used, statistical including the type of imaging data used,
analysis must not assume statistical what the device measures and outputs SUMMARY: This document provides
independence without adequate to the user, whether the measure is notice of substantive rules issued by the
justification, and qualitative or quantitative, the clinical Coast Guard that were made temporarily
(C) The report must provide indications for which it is to be used, effective between January 2015 and
appropriate confidence intervals for and the specific population for which March 2015 but expired before they
each performance metric; the device use is intended; could be published in the Federal
(vi) Sensitivity and specificity must Register. This notice lists temporary
be characterized across the range of (ii) Appropriate warnings specifying safety zones, security zones, special
available measurements; the intended patient population, local regulations, drawbridge operation
(vii) Agreement of the simulated identifying anatomy and image regulations and regulated navigation
measure(s) with clinically acceptable acquisition factors that may impact areas, all of limited duration and for
measure(s) must be assessed across the measurement results, and providing which timely publication in the Federal
full range of measurements; cautionary guidance for interpretation of Register was not possible.
(viii) Comparison of the measurement the provided measurements;
DATES: This document lists temporary
performance must be provided across (iii) Key assumptions made in the Coast Guard rules that became effective
the range of intended image acquisition calculation and determination of between January 2015 and March 2015
hardware; and simulated measurements; and were terminated before they could
(ix) If the device uses a cutoff (iv) The measurement performance of be published in the Federal Register.
threshold or operates across a spectrum the device for all presented parameters, ADDRESSES: Temporary rules listed in
of disease, it must be established prior with appropriate confidence intervals, this document may be viewed online,
to validation, and it must be justified as and the supporting evidence for this under their respective docket numbers,
to how it was determined and clinically performance. Per-vessel clinical using the Federal eRulemaking Portal at
validated; performance, including where http://www.regulations.gov.
(4) Adequate validation must be
applicable localized performance FOR FURTHER INFORMATION CONTACT: For
performed and controls implemented to
according to vessel and segment, must questions on this notice contact Yeoman
characterize and ensure consistency
be included as well as a characterization First Class Maria Fiorella Villanueva,
(i.e., repeatability and reproducibility)
of the measurement error across the Office of Regulations and
of measurement outputs:
expected range of measurement for key Administrative Law, telephone (202)
(i) Acceptable incoming image quality
parameters based on the clinical data; 372–3862.
control measures and the resulting
image rejection rate for the clinical data (v) A detailed description of the SUPPLEMENTARY INFORMATION: Coast
must be specified, and patients studied in the clinical Guard District Commanders and
(ii) Data must be provided within the validation (e.g., age, gender, race or Captains of the Port (COTP) must be
clinical validation study or using ethnicity, clinical stability, current immediately responsive to the safety
equivalent datasets demonstrating the treatment regimen) as well as and security needs within their
consistency (i.e., repeatability and procedural details of the clinical study jurisdiction; therefore, District
reproducibility) of the output that is (e.g., scanner representation, calcium Commanders and COTPs have been
representative of the range of data scores, use of beta-blockers or nitrates); delegated the authority to issue certain
quality likely to be encountered in the and local regulations. Safety zones may be
intended use population and relevant (vi) Where significant human established for safety or environmental
use conditions in the intended use interface is necessary for accurate purposes. A safety zone may be
environment; analysis, adequately detailed stationary and described by fixed limits
(A) Testing must be performed using description of the analysis procedure or it may be described as a zone around
multiple operators meeting planned using the device and any data features a vessel in motion. Security zones limit
qualification criteria and using the that could affect accuracy of results. access to prevent injury or damage to
tkelley on DSK3SPTVN1PROD with RULES

procedure that will be implemented in vessels, ports, or waterfront facilities.
Dated: October 14, 2015. Special local regulations are issued to
the production use of the device, and
(B) The factors (e.g., medical imaging Leslie Kux, enhance the safety of participants and
dataset, operator) must be identified Associate Commissioner for Policy. spectators at regattas and other marine
regarding which were held constant and [FR Doc. 2015–26658 Filed 10–20–15; 8:45 am] events. Drawbridge operation
which were varied during the BILLING CODE 4164–01–P regulations authorize changes to

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Document Created: 2018-02-27 08:53:53
Document Modified: 2018-02-27 08:53:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Notice of expired temporary rules issued.
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.
Contact		For questions on this notice contact Yeoman First Class Maria Fiorella Villanueva, Office of Regulations and Administrative Law, telephone (202) 372-3862.
FR Citation		80 FR 63674
CFR Citation		33 CFR 100 33 CFR 117 33 CFR 147 33 CFR 165

80 FR 63674 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas

DEPARTMENT OF HOMELAND SECURITYCoast Guard

Federal Register Volume 80, Issue 203 (October 21, 2015)

DEPARTMENT OF HOMELAND SECURITY
Coast Guard