Delay of Discharge Requirements for U.S. Coast Guard Activities in Greater Farallones and Cordell Bank National Marine Sanctuaries, 34268-34269 [2016-12784]
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34268
§ 71.1
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Rules and Regulations
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, dated August 6, 2015, effective
September 15, 2015, is amended as
follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
AGL ND E5 Lisbon, ND [New]
Lisbon Municipal Airport, ND
(Lat. 46°26′49″ N., long. 097°43′42″ W.)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of Lisbon Municipal Airport.
Issued in Fort Worth, TX, on May 9, 2016.
Robert W. Beck
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. 2016–12508 Filed 5–27–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
15 CFR Part 922
[Docket Number [160413330–6330–01]]
RIN 0648–BF99
Delay of Discharge Requirements for
U.S. Coast Guard Activities in Greater
Farallones and Cordell Bank National
Marine Sanctuaries
Office of National Marine
Sanctuaries (ONMS), National Ocean
Service (NOS), National Oceanic and
Atmospheric Administration (NOAA),
Department of Commerce (DOC).
ACTION: Final rule; delay of effectiveness
for discharge requirements with regard
to U.S. Coast Guard activities.
AGENCY:
The National Oceanic and
Atmospheric Administration (NOAA)
expanded the boundaries of Gulf of the
Farallones National Marine Sanctuary
(now renamed Greater Farallones
National Marine Sanctuary or GFNMS)
and Cordell Bank National Marine
Sanctuary (CBNMS) to an area north
and west of their previous boundaries
with a final rule published on March 12,
2015. The final rule entered into effect
on June 9, 2015. At that time, NOAA
postponed the effectiveness of the
discharge requirements in both
sanctuaries’ regulations in the areas
added to GFNMS and CBNMS
boundaries in 2015 with regard to U.S.
Coast Guard activities for 6 months.
asabaliauskas on DSK3SPTVN1PROD with RULES
SUMMARY:
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16:39 May 27, 2016
Jkt 238001
This notice extends the postponement
of the discharge requirements for these
activities for another 6 months to
provide adequate time for completion of
an environmental assessment, and
subsequent rulemaking, as appropriate.
DATES: The effectiveness for the
discharge requirements in both CBNMS
and GFNMS expansion areas with
regard to U.S. Coast Guard activities is
December 9, 2016.
ADDRESSES: Copies of the FEIS, final
management plans, and the final rule
published on March 12, 2015, can be
viewed or downloaded at https://
farallones.noaa.gov/manage/expansion_
cbgf.html.
FOR FURTHER INFORMATION CONTACT:
Maria Brown, Greater Farallones
National Marine Sanctuary
Superintendent, at Maria.Brown@
noaa.gov or 415–561–6622.
SUPPLEMENTARY INFORMATION:
certain USCG activities in sanctuary
regulations. The public, other federal
agencies, and interested stakeholders
will be given an opportunity to
comment on various alternatives that
are being considered. This will include
the opportunity to review any proposed
rule and related environmental analysis.
In the course of the rule making to
expand GFNMS and CBNMS, NOAA
learned from USCG that the discharge
regulations had the potential to impair
the operations of USCG vessels and air
craft conducting law enforcement and
on-water training exercises in GFNMS
and CBNMS. The USCG supports
national marine sanctuary management
by providing routine surveillance and
dedicated law enforcement of the
National Marine Sanctuaries Act and
sanctuary regulations.
I. Background
On March 12, 2015, NOAA expanded
the boundaries of Gulf of the Farallones
National Marine Sanctuary (now
renamed Greater Farallones National
Marine Sanctuary or GFNMS) and
Cordell Bank National Marine Sanctuary
(CBNMS) to an area north and west of
their previous boundaries with a final
rule (80 FR 13078). The final rule
entered into effect on June 9, 2015 (80
FR 34047). To ensure that the March 12,
2015, rule does not undermine USCG’s
ability to perform its duties, at that time,
NOAA postponed the effectiveness of
the discharge requirements in both
sanctuaries’ regulations with regard to
U.S. Coast Guard (USCG) activities for 6
months. An additional six month
postponement of the effectiveness of the
discharge requirements was published
in the Federal Register on December 1,
2015 (80 FR 74985), to provide adequate
time for completion of an environmental
assessment and to determine NOAA’s
next steps. Without further NOAA
action, the discharge regulations would
become effective with regard to USCG
activities June 9, 2016. However, NOAA
needs more time to assess USCG
activities, conduct public scoping, and
develop alternatives for an
environmental assessment developed
pursuant to the requirements of the
National Environmental Policy Act.
Therefore, this notice postpones the
effectiveness of the discharge
requirements in the expansion areas of
both sanctuaries with regard to USCG
activities for another 6 months, until
December 9, 2016. During this time,
NOAA will consider how to address
USCG’s concerns and will consider,
among other things, whether to exempt
NOAA previously conducted an
environmental analysis under the
National Environmental Policy Act
(NEPA) as part of the rulemaking
process leading to the expansion of
CBNMS and GFNMS, which addressed
regulations regarding the discharge of
any matter or material in the
sanctuaries. The environmental impacts
of the decision to postpone effectiveness
reflect a continuation of the
environmental baseline and the no
action alternative presented in that
analysis. Should NOAA decide to
amend the regulations governing
discharges for USGS activities in
CBNMS and GFNMS, any additional
environmental analysis required under
NEPA would be prepared and released
for public comment.
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Fmt 4700
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II. Classification
A. National Environmental Policy Act
B. Executive Order 12866: Regulatory
Impact
This action has been determined to be
not significant for purposes of the
meaning of Executive Order 12866.
C. Administrative Procedure Act
The Assistant Administrator of
National Ocean Service (NOS) finds
good cause pursuant to 5 U.S.C.
553(b)(B) to waive the notice and
comment requirements of the
Administrative Procedure Act (APA)
because this action is administrative in
nature. This action postpones the
effectiveness of the discharge
requirements in the regulations for
CBNMS and GFNMS in the areas added
to the sanctuaries’ boundaries in 2015
(subject to notice and comment review)
with regard to U.S. Coast Guard
activities for 6 months to provide
adequate time for public scoping,
E:\FR\FM\31MYR1.SGM
31MYR1
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Rules and Regulations
completion of an environmental
assessment, and subsequent rulemaking,
as appropriate. Should NOAA decide to
amend the regulations governing
discharges in CBNMS and GFNMS, it
would publish a proposed rule followed
by an appropriate public comment
period as required by the APA. The
substance of the underlying regulations
remains unchanged. Therefore,
providing notice and opportunity for
public comment under the
Administrative Procedure Act would
serve no useful purpose. The delay in
effectiveness provided by this action
will also enable NOAA to fully
implement its statutory responsibilities
under the NMSA to protect resources of
a national marine sanctuary. For the
reasons above, the Assistant
Administrator also finds good cause
under 5 U.S.C. 553(d) to waive the 30day delay in effectiveness and make this
action effective immediately upon
publication.
Authority: 16 U.S.C. 1431 et seq.
Dated: May 24, 2016.
Christopher C. Cartwright,
Acting, Deputy Assistant Administrator for
Ocean Services and Coastal Management.
[FR Doc. 2016–12784 Filed 5–27–16; 8:45 am]
BILLING CODE 3510–NK–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA–2016–N–1268]
Medical Devices; Ophthalmic Devices;
Classification of the Diurnal Pattern
Recorder System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
diurnal pattern recorder system into
class II (special controls). The special
controls that will apply to the device are
identified in this order and will be part
of the codified language for the diurnal
pattern recorder system’s classification.
The Agency is classifying the device
into class II (special controls) in order
to provide a reasonable assurance of
safety and effectiveness of the device.
DATES: This order is effective May 31,
2016. The classification was applicable
on March 4, 2016.
FOR FURTHER INFORMATION CONTACT:
Alexander Beylin, Center for Devices
asabaliauskas on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:39 May 27, 2016
Jkt 238001
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2404, Silver Spring,
MD 20993–0002, 301–796–6463.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1) of the FD&C Act.
Under the first procedure, the person
submits a premarket notification under
section 510(k) of the FD&C Act for a
device that has not previously been
classified and, within 30 days of
receiving an order classifying the device
into class III under section 513(f)(1) of
the FD&C Act, the person requests a
classification under section 513(f)(2).
Under the second procedure, rather than
first submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
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Fmt 4700
Sfmt 4700
34269
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On April 28, 2014, Sensimed AG
submitted a request for classification of
the SENSIMED Triggerfish® device
under section 513(f)(2) of the FD&C Act.
The manufacturer recommended that
the device be classified into class II (Ref.
1).
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
devices into class II if general controls
by themselves are insufficient to
provide reasonable assurance of safety
and effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on March 4, 2016, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 886.1925.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a diurnal pattern recorder
system will need to comply with the
special controls named in this final
order.
The device is assigned the generic
name diurnal pattern recorder system,
and it is identified as a nonimplantable,
prescription device incorporating a
telemetric sensor to detect changes in
ocular dimension for monitoring diurnal
patterns of intraocular pressure (IOP)
fluctuations.
FDA has identified the following risks
to health associated with this type of
device and the measures required to
mitigate these risks in Table 1:
E:\FR\FM\31MYR1.SGM
31MYR1
]]>Agencies
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Rules and Regulations]
[Pages 34268-34269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12784]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
15 CFR Part 922
[Docket Number [160413330-6330-01]]
RIN 0648-BF99
Delay of Discharge Requirements for U.S. Coast Guard Activities
in Greater Farallones and Cordell Bank National Marine Sanctuaries
AGENCY: Office of National Marine Sanctuaries (ONMS), National Ocean
Service (NOS), National Oceanic and Atmospheric Administration (NOAA),
Department of Commerce (DOC).
ACTION: Final rule; delay of effectiveness for discharge requirements
with regard to U.S. Coast Guard activities.
-----------------------------------------------------------------------
SUMMARY: The National Oceanic and Atmospheric Administration (NOAA)
expanded the boundaries of Gulf of the Farallones National Marine
Sanctuary (now renamed Greater Farallones National Marine Sanctuary or
GFNMS) and Cordell Bank National Marine Sanctuary (CBNMS) to an area
north and west of their previous boundaries with a final rule published
on March 12, 2015. The final rule entered into effect on June 9, 2015.
At that time, NOAA postponed the effectiveness of the discharge
requirements in both sanctuaries' regulations in the areas added to
GFNMS and CBNMS boundaries in 2015 with regard to U.S. Coast Guard
activities for 6 months. This notice extends the postponement of the
discharge requirements for these activities for another 6 months to
provide adequate time for completion of an environmental assessment,
and subsequent rulemaking, as appropriate.
DATES: The effectiveness for the discharge requirements in both CBNMS
and GFNMS expansion areas with regard to U.S. Coast Guard activities is
December 9, 2016.
ADDRESSES: Copies of the FEIS, final management plans, and the final
rule published on March 12, 2015, can be viewed or downloaded at https://farallones.noaa.gov/manage/expansion_cbgf.html.
FOR FURTHER INFORMATION CONTACT: Maria Brown, Greater Farallones
National Marine Sanctuary Superintendent, at Maria.Brown@noaa.gov or
415-561-6622.
SUPPLEMENTARY INFORMATION:
I. Background
On March 12, 2015, NOAA expanded the boundaries of Gulf of the
Farallones National Marine Sanctuary (now renamed Greater Farallones
National Marine Sanctuary or GFNMS) and Cordell Bank National Marine
Sanctuary (CBNMS) to an area north and west of their previous
boundaries with a final rule (80 FR 13078). The final rule entered into
effect on June 9, 2015 (80 FR 34047). To ensure that the March 12,
2015, rule does not undermine USCG's ability to perform its duties, at
that time, NOAA postponed the effectiveness of the discharge
requirements in both sanctuaries' regulations with regard to U.S. Coast
Guard (USCG) activities for 6 months. An additional six month
postponement of the effectiveness of the discharge requirements was
published in the Federal Register on December 1, 2015 (80 FR 74985), to
provide adequate time for completion of an environmental assessment and
to determine NOAA's next steps. Without further NOAA action, the
discharge regulations would become effective with regard to USCG
activities June 9, 2016. However, NOAA needs more time to assess USCG
activities, conduct public scoping, and develop alternatives for an
environmental assessment developed pursuant to the requirements of the
National Environmental Policy Act. Therefore, this notice postpones the
effectiveness of the discharge requirements in the expansion areas of
both sanctuaries with regard to USCG activities for another 6 months,
until December 9, 2016. During this time, NOAA will consider how to
address USCG's concerns and will consider, among other things, whether
to exempt certain USCG activities in sanctuary regulations. The public,
other federal agencies, and interested stakeholders will be given an
opportunity to comment on various alternatives that are being
considered. This will include the opportunity to review any proposed
rule and related environmental analysis. In the course of the rule
making to expand GFNMS and CBNMS, NOAA learned from USCG that the
discharge regulations had the potential to impair the operations of
USCG vessels and air craft conducting law enforcement and on-water
training exercises in GFNMS and CBNMS. The USCG supports national
marine sanctuary management by providing routine surveillance and
dedicated law enforcement of the National Marine Sanctuaries Act and
sanctuary regulations.
II. Classification
A. National Environmental Policy Act
NOAA previously conducted an environmental analysis under the
National Environmental Policy Act (NEPA) as part of the rulemaking
process leading to the expansion of CBNMS and GFNMS, which addressed
regulations regarding the discharge of any matter or material in the
sanctuaries. The environmental impacts of the decision to postpone
effectiveness reflect a continuation of the environmental baseline and
the no action alternative presented in that analysis. Should NOAA
decide to amend the regulations governing discharges for USGS
activities in CBNMS and GFNMS, any additional environmental analysis
required under NEPA would be prepared and released for public comment.
B. Executive Order 12866: Regulatory Impact
This action has been determined to be not significant for purposes
of the meaning of Executive Order 12866.
C. Administrative Procedure Act
The Assistant Administrator of National Ocean Service (NOS) finds
good cause pursuant to 5 U.S.C. 553(b)(B) to waive the notice and
comment requirements of the Administrative Procedure Act (APA) because
this action is administrative in nature. This action postpones the
effectiveness of the discharge requirements in the regulations for
CBNMS and GFNMS in the areas added to the sanctuaries' boundaries in
2015 (subject to notice and comment review) with regard to U.S. Coast
Guard activities for 6 months to provide adequate time for public
scoping,
[[Page 34269]]
completion of an environmental assessment, and subsequent rulemaking,
as appropriate. Should NOAA decide to amend the regulations governing
discharges in CBNMS and GFNMS, it would publish a proposed rule
followed by an appropriate public comment period as required by the
APA. The substance of the underlying regulations remains unchanged.
Therefore, providing notice and opportunity for public comment under
the Administrative Procedure Act would serve no useful purpose. The
delay in effectiveness provided by this action will also enable NOAA to
fully implement its statutory responsibilities under the NMSA to
protect resources of a national marine sanctuary. For the reasons
above, the Assistant Administrator also finds good cause under 5 U.S.C.
553(d) to waive the 30-day delay in effectiveness and make this action
effective immediately upon publication.
Authority: 16 U.S.C. 1431 et seq.
Dated: May 24, 2016.
Christopher C. Cartwright,
Acting, Deputy Assistant Administrator for Ocean Services and Coastal
Management.
[FR Doc. 2016-12784 Filed 5-27-16; 8:45 am]
BILLING CODE 3510-NK-P
