Drawbridge Operation Regulation; Atlantic Intracoastal Waterway (AIWW), Wrightsville Beach, NC and Northeast Cape Fear River, Wilmington, NC, 71612-71613 [2016-25183]
Download as PDF
<![CDATA[
71612
Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations
PART 890—PHYSICAL MEDICINE
DEVICES
1. The authority citation for part 890
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 890.3450 to subpart D to read
as follows:
■
Lhorne on DSK30JT082PROD with RULES
§ 890.3450 Upper extremity prosthesis
including a simultaneously powered elbow
and/or shoulder with greater than two
simultaneous powered degrees of freedom
and controlled by non-implanted electrical
components.
(a) Identification. A upper extremity
prosthesis including a simultaneously
powered elbow and/or shoulder with
greater than two simultaneous powered
degrees of freedom and controlled by
non-implanted electrical components, is
a prescription device intended for
medical purposes, and is intended to
replace a partially or fully amputated or
congenitally absent upper extremity. It
uses electronic inputs (other than
simple, manually controlled electrical
components such as switches) to
provide greater than two independent
and simultaneously powered degrees of
freedom and includes a simultaneously
powered elbow and/or shoulder.
Prosthetic arm components that are
intended to be used as a system with
other arm components must include all
degrees of freedom of the total upper
extremity prosthesis system.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Appropriate analysis/testing must
validate electronic compatibility,
electrical safety, thermal safety,
mechanical safety, battery performance
and safety, and wireless performance, if
applicable.
(2) Appropriate software verification,
validation, and hazard analysis must be
performed.
(3) Non-clinical performance data
must demonstrate that the device
performs as intended under anticipated
conditions of use. Performance testing
must include:
(i) Mechanical bench data, including
durability testing, to demonstrate that
the device will withstand forces,
conditions, and environments
encountered during use.
(ii) Simulated use testing to
demonstrate performance of arm
commands and available safeguard(s)
under worst case conditions and after
durability testing.
(iii) Verification and validation of
force sensors and hand release button, if
applicable, are necessary.
(iv) Device functionality in terms of
flame retardant materials, liquid/
VerDate Sep<11>2014
12:31 Oct 17, 2016
Jkt 241001
particle ingress prevention, sensor and
actuator performance, and motor and
brake performance.
(v) The accuracy of the device features
and safeguards.
(4) Non-clinical and clinical
performance testing must demonstrate
the accuracy of device features and
safeguards.
(5) Elements of the device that may
contact the patient must be
demonstrated to be biocompatible.
(6) Documented clinical experience
and human factors testing must
demonstrate safe and effective use,
capture any adverse events observed
during clinical use and demonstrate the
accuracy of device features and
safeguards.
(7) Labeling for the Prosthetist and
User Guide must include:
(i) Appropriate instructions, warning,
cautions, limitations, and information
related to the necessary safeguards of
the device, including warning against
activities that may put the user at
greater risk (e.g., driving).
(ii) Specific instructions and the
clinical training needed for the safe use
of the device, which includes:
(A) Instructions on assembling the
device in all available configurations,
(B) Instructions on fitting the patient,
(C) Instructions and explanations of
all available programs and how to
program the device,
(D) Instructions and explanation of all
controls, input, and outputs,
(E) Instructions on all available modes
or states of the device,
(F) Instructions on all safety features
of the device, and
(G) Instructions for maintaining the
device.
(iii) Information on the patient
population for which the device has
been demonstrated to be effective.
(iv) A detailed summary of the nonclinical and clinical testing pertinent to
use of the device.
Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25001 Filed 10–17–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2016–0610]
Drawbridge Operation Regulation;
Atlantic Intracoastal Waterway (AIWW),
Wrightsville Beach, NC and Northeast
Cape Fear River, Wilmington, NC
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedules that govern the S.R. 74
(Wrightsville Beach) Bridge across the
Atlantic Intracoastal Waterway (AIWW),
mile 283.1, at Wrightsville Beach, NC
and the Isabel S. Holmes Bridge across
the Northeast Cape Fear River, mile 1.0,
at Wilmington, NC. The deviation is
necessary to facilitate the 2016 PPD
IRONMAN North Carolina
‘‘Beach2Battleship’’ Triathlon. This
deviation allows these bridges to remain
in their closed-to-navigation position.
DATES: The deviation is effective from
6:30 a.m. to 6 p.m. on October 22, 2016.
ADDRESSES: The docket for this
deviation, [USCG–2016–0610] 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: PPD
Ironman North Carolina, on behalf of
the North Carolina Department of
Transportation, who owns the S.R. 74
(Wrightsville Beach) Bridge across the
Atlantic Intracoastal Waterway (AIWW),
mile 283.1, at Wrightsville Beach, NC
and the Isabel S. Holmes Bridge across
the Northeast Cape Fear River, mile 1.0,
at Wilmington, NC, has requested a
temporary deviation from the current
operating regulations set out in 33 CFR
117.821(a)(4) and 33 CFR 117.829(a),
respectively, to ensure the safety of the
participants and spectators associated
with the 2016 PPD IRONMAN North
Carolina ‘‘Beach2Battleship’’ Triathlon.
Under this temporary deviation, the
S.R. 74 (Wrightsville Beach) Bridge will
be maintained in the closed-tonavigation position from 6:30 a.m. to 11
SUMMARY:
E:\FR\FM\18OCR1.SGM
18OCR1
Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations
a.m. on October 22, 2016, and the Isabel
S. Holmes Bridge will be maintained in
the closed-to-navigation position from
9:30 a.m. to 6 p.m. on October 22, 2016.
These bridges are both double bascule
drawbridges and have vertical
clearances in the closed-to-navigation
position of 20 feet and 40 feet,
respectively, above mean high water.
The Atlantic Intracoastal Waterway is
used by a variety of vessels including,
small commercial fishing vessels and
recreational vessels. The Northeast Cape
Fear River is used by a variety of vessels
including, small commercial fishing
vessels, recreational vessels, and tug
and barge traffic. The Coast Guard has
carefully coordinated the restrictions
with waterway users in publishing this
temporary deviation.
Vessels able to pass through these
bridges in their closed positions may do
so at any time. These bridges will be
able to open for emergencies and there
are no immediate alternative routes for
vessels to pass. The Coast Guard will
also inform the users of the waterway
through our Local and Broadcast
Notices to Mariners of the change in
operating schedules for these bridges so
that vessel operators can arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
these drawbridges must return to their
regular operating schedules
immediately at the end of the effective
periods of this temporary deviation.
This deviation from the operating
regulations is authorized under 33 CFR
117.35.
Dated: October 13, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard
District.
[FR Doc. 2016–25183 Filed 10–17–16; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 33
[EPA–HQ–OA–2016–0457; FRL–9954–30–
OA]
RIN 2090–AA40
Lhorne on DSK30JT082PROD with RULES
Participation by Disadvantaged
Business Enterprises in Procurements
Under EPA Financial Assistance
Agreements
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
Because EPA received
comments which could be construed as
SUMMARY:
VerDate Sep<11>2014
12:31 Oct 17, 2016
Jkt 241001
71613
adverse, we are withdrawing the direct
final rule to amend Part 33—
Participation by Disadvantaged Business
Enterprises in Procurements under EPA
Financial Assistance Agreements
published on July 28, 2016.
ENVIRONMENTAL PROTECTION
AGENCY
Effective October 18, 2016 the
rule published in the Federal Register
of July 28, 2016 (81 FR 49539) (FRL–
9946–27–OA) is withdrawn.
RIN 2060–AS59
FOR FURTHER INFORMATION CONTACT:
AGENCY:
DATES:
Teree Henderson, Office of the
Administrator, Office of Small Business
Programs (mail code: 1230A),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460; telephone number: 202–566–
2222; fax number: 202–566–0548; email
address: henderson.teree@epa.gov.
On July
28, 2016, we published a direct final
rule (81 FR 49539) and a parallel
proposal (81 FR 49591) amending the
provisions for Part 33—Participation by
Disadvantaged Business Enterprises in
Procurements under EPA Financial
Assistance Agreements. These
amendments were issued as a direct
final rule, along with a parallel proposal
to be used as the basis for final action
in the event EPA received any adverse
comments on the direct final
amendments. Because EPA received
comments which could be construed as
adverse, we are withdrawing the direct
final rule to amend the general
provisions for part 33 published on July
28, 2016.
We stated in the direct final rule that
if we received adverse comment by
August 29, 2016, the direct final rule
would not take effect and we would
publish a timely withdrawal in the
Federal Register. We subsequently
received comments that could be
construed as adverse on that direct final
rule. We will address those comments
in a subsequent final action based on
the parallel proposal published on July
28, 2016 (81 FR 49591). As stated in the
direct final rule and the parallel
proposed rule, we will not institute a
second comment period on this action.
SUPPLEMENTARY INFORMATION:
List of Subjects in 40 CFR Part 33
Environmental protection, Grant
programs.
Dated: October 12, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016–25169 Filed 10–17–16; 8:45 am]
BILLING CODE 6560–50–P
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
40 CFR Parts 51, 52, 55, 70, 71 and 124
[EPA–HQ–OAR–2015–0090; FRL–9954–10–
OAR]
Revisions to Public Notice Provisions
in Clean Air Act Permitting Programs
Environmental Protection
Agency (EPA).
ACTION: Final rule.
The U.S. Environmental
Protection Agency (EPA) is revising the
public notice rule provisions for the
New Source Review (NSR), title V and
Outer Continental Shelf (OCS) permit
programs of the Clean Air Act (CAA or
Act) and corresponding onshore area
(COA) determinations for
implementation of the OCS air quality
regulations. This final rule removes the
mandatory requirement to provide
public notice of a draft air permit (as
well as certain other program actions)
through publication in a newspaper.
Instead, this final rule requires
electronic notice (e-notice) for EPA
actions (and actions by permitting
authorities implementing the federal
permitting rules) and allows for e-notice
as an option for actions by permitting
authorities implementing EPA-approved
programs. When e-notice is provided,
the final rule requires, at a minimum,
electronic access (e-access) to the draft
permit. However, this final rule does not
preclude a permitting authority from
supplementing e-notice with newspaper
notice and/or additional means of
notification to the public. The EPA
anticipates that e-notice, which is
already being practiced by many
permitting authorities, will enable
permitting authorities to communicate
permitting and other affected actions to
the public more quickly and efficiently
and will provide cost savings over
newspaper publication. The EPA further
anticipates that e-access will expand
access to permit-related documents.
DATES: The effective date of this final
rule is November 17, 2016.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2015–0090. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
SUMMARY:
E:\FR\FM\18OCR1.SGM
18OCR1
]]>Agencies
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Pages 71612-71613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25183]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2016-0610]
Drawbridge Operation Regulation; Atlantic Intracoastal Waterway
(AIWW), Wrightsville Beach, NC and Northeast Cape Fear River,
Wilmington, NC
AGENCY: Coast Guard, DHS.
ACTION: Notice of deviation from drawbridge regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedules that govern the S.R. 74 (Wrightsville Beach) Bridge
across the Atlantic Intracoastal Waterway (AIWW), mile 283.1, at
Wrightsville Beach, NC and the Isabel S. Holmes Bridge across the
Northeast Cape Fear River, mile 1.0, at Wilmington, NC. The deviation
is necessary to facilitate the 2016 PPD IRONMAN North Carolina
``Beach2Battleship'' Triathlon. This deviation allows these bridges to
remain in their closed-to-navigation position.
DATES: The deviation is effective from 6:30 a.m. to 6 p.m. on October
22, 2016.
ADDRESSES: The docket for this deviation, [USCG-2016-0610] 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: PPD Ironman North Carolina, on behalf of the
North Carolina Department of Transportation, who owns the S.R. 74
(Wrightsville Beach) Bridge across the Atlantic Intracoastal Waterway
(AIWW), mile 283.1, at Wrightsville Beach, NC and the Isabel S. Holmes
Bridge across the Northeast Cape Fear River, mile 1.0, at Wilmington,
NC, has requested a temporary deviation from the current operating
regulations set out in 33 CFR 117.821(a)(4) and 33 CFR 117.829(a),
respectively, to ensure the safety of the participants and spectators
associated with the 2016 PPD IRONMAN North Carolina
``Beach2Battleship'' Triathlon.
Under this temporary deviation, the S.R. 74 (Wrightsville Beach)
Bridge will be maintained in the closed-to-navigation position from
6:30 a.m. to 11
[[Page 71613]]
a.m. on October 22, 2016, and the Isabel S. Holmes Bridge will be
maintained in the closed-to-navigation position from 9:30 a.m. to 6
p.m. on October 22, 2016. These bridges are both double bascule
drawbridges and have vertical clearances in the closed-to-navigation
position of 20 feet and 40 feet, respectively, above mean high water.
The Atlantic Intracoastal Waterway is used by a variety of vessels
including, small commercial fishing vessels and recreational vessels.
The Northeast Cape Fear River is used by a variety of vessels
including, small commercial fishing vessels, recreational vessels, and
tug and barge traffic. The Coast Guard has carefully coordinated the
restrictions with waterway users in publishing this temporary
deviation.
Vessels able to pass through these bridges in their closed
positions may do so at any time. These bridges will be able to open for
emergencies and there are no immediate alternative routes for vessels
to pass. The Coast Guard will also inform the users of the waterway
through our Local and Broadcast Notices to Mariners of the change in
operating schedules for these bridges so that vessel operators can
arrange their transits to minimize any impact caused by the temporary
deviation.
In accordance with 33 CFR 117.35(e), these drawbridges must return
to their regular operating schedules immediately at the end of the
effective periods of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.
Dated: October 13, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-25183 Filed 10-17-16; 8:45 am]
BILLING CODE 9110-04-P
