81 FR 34268 - Delay of Discharge Requirements for U.S. Coast Guard Activities in Greater Farallones and Cordell Bank National Marine Sanctuaries

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range		34268-34269
FR Document		2016-12784

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.

Federal Register, Volume 81 Issue 104 (Tuesday, May 31, 2016)

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Rules and Regulations]
[Pages 34268-34269]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12784]


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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.

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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 http://farallones.noaa.gov/manage/expansion_cbgf.html.

FOR FURTHER INFORMATION CONTACT: Maria Brown, Greater Farallones 
National Marine Sanctuary Superintendent, at [email protected] 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

Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Rules and Regulations 34269

completion of an environmental and Radiological Health, Food and Drug device submitted is not of ‘‘low-
assessment, and subsequent rulemaking, Administration, 10903 New Hampshire moderate risk’’ or that general controls
as appropriate. Should NOAA decide to Ave., Bldg. 66, Rm. 2404, Silver Spring, would be inadequate to control the risks
amend the regulations governing MD 20993–0002, 301–796–6463. and special controls to mitigate the risks
discharges in CBNMS and GFNMS, it SUPPLEMENTARY INFORMATION: cannot be developed.
would publish a proposed rule followed
I. Background In response to a request to classify a
by an appropriate public comment
device under either procedure provided
period as required by the APA. The In accordance with section 513(f)(1) of
substance of the underlying regulations by section 513(f)(2) of the FD&C Act,
the Federal Food, Drug, and Cosmetic FDA will classify the device by written
remains unchanged. Therefore, Act (the FD&C Act) (21 U.S.C.
providing notice and opportunity for order within 120 days. This
360c(f)(1)), devices that were not in
public comment under the classification will be the initial
commercial distribution before May 28,
Administrative Procedure Act would classification of the device.
1976 (the date of enactment of the
serve no useful purpose. The delay in Medical Device Amendments of 1976), On April 28, 2014, Sensimed AG
effectiveness provided by this action generally referred to as postamendments submitted a request for classification of
will also enable NOAA to fully devices, are classified automatically by the SENSIMED Triggerfish® device
implement its statutory responsibilities statute into class III without any FDA under section 513(f)(2) of the FD&C Act.
under the NMSA to protect resources of rulemaking process. These devices The manufacturer recommended that
a national marine sanctuary. For the remain in class III and require the device be classified into class II (Ref.
reasons above, the Assistant premarket approval, unless and until 1).
Administrator also finds good cause the device is classified or reclassified
under 5 U.S.C. 553(d) to waive the 30- In accordance with section 513(f)(2) of
into class I or II, or FDA issues an order
day delay in effectiveness and make this the FD&C Act, FDA reviewed the
finding the device to be substantially
action effective immediately upon request in order to classify the device
equivalent, in accordance with section
publication. 513(i) of the FD&C Act, to a predicate under the criteria for classification set
device that does not require premarket forth in section 513(a)(1). FDA classifies
Authority: 16 U.S.C. 1431 et seq.
approval. The Agency determines devices into class II if general controls
Dated: May 24, 2016. by themselves are insufficient to
whether new devices are substantially
Christopher C. Cartwright, provide reasonable assurance of safety
equivalent to predicate devices by
Acting, Deputy Assistant Administrator for means of premarket notification and effectiveness, but there is sufficient
Ocean Services and Coastal Management. information to establish special controls
procedures in section 510(k) of the
[FR Doc. 2016–12784 Filed 5–27–16; 8:45 am] to provide reasonable assurance of the
FD&C Act (21 U.S.C. 360(k)) and part
BILLING CODE 3510–NK–P 807 (21 CFR part 807) of the regulations. safety and effectiveness of the device for
Section 513(f)(2) of the FD&C Act, as its intended use. After review of the
amended by section 607 of the Food and information submitted in the request,
DEPARTMENT OF HEALTH AND Drug Administration Safety and FDA determined that the device can be
HUMAN SERVICES Innovation Act (Pub. L. 112–144), classified into class II with the
provides two procedures by which a establishment of special controls. FDA
Food and Drug Administration person may request FDA to classify a believes these special controls, in
device under the criteria set forth in addition to general controls, will
21 CFR Part 886 section 513(a)(1) of the FD&C Act. provide reasonable assurance of the
[Docket No. FDA–2016–N–1268] Under the first procedure, the person safety and effectiveness of the device.
submits a premarket notification under Therefore, on March 4, 2016, FDA
Medical Devices; Ophthalmic Devices; section 510(k) of the FD&C Act for a
issued an order to the requestor
Classification of the Diurnal Pattern device that has not previously been
classifying the device into class II. FDA
Recorder System classified and, within 30 days of
is codifying the classification of the
receiving an order classifying the device
AGENCY: Food and Drug Administration, into class III under section 513(f)(1) of device by adding 21 CFR 886.1925.
HHS. the FD&C Act, the person requests a Following the effective date of this
ACTION: Final order. classification under section 513(f)(2). final classification order, any firm
Under the second procedure, rather than submitting a premarket notification
SUMMARY: The Food and Drug first submitting a premarket notification (510(k)) for a diurnal pattern recorder
Administration (FDA) is classifying the under section 510(k) of the FD&C Act system will need to comply with the
diurnal pattern recorder system into and then a request for classification special controls named in this final
class II (special controls). The special under the first procedure, the person order.
controls that will apply to the device are determines that there is no legally
identified in this order and will be part The device is assigned the generic
marketed device upon which to base a name diurnal pattern recorder system,
of the codified language for the diurnal determination of substantial
pattern recorder system’s classification. and it is identified as a nonimplantable,
equivalence and requests a classification
The Agency is classifying the device prescription device incorporating a
under section 513(f)(2) of the FD&C Act.
into class II (special controls) in order telemetric sensor to detect changes in
asabaliauskas on DSK3SPTVN1PROD with RULES

If the person submits a request to
to provide a reasonable assurance of ocular dimension for monitoring diurnal
classify the device under this second
safety and effectiveness of the device. procedure, FDA may decline to patterns of intraocular pressure (IOP)
DATES: This order is effective May 31, undertake the classification request if fluctuations.
2016. The classification was applicable FDA identifies a legally marketed device FDA has identified the following risks
on March 4, 2016. that could provide a reasonable basis for to health associated with this type of
FOR FURTHER INFORMATION CONTACT: review of substantial equivalence with device and the measures required to
Alexander Beylin, Center for Devices the device or if FDA determines that the mitigate these risks in Table 1:

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Document Created: 2016-05-28 03:57:55
Document Modified: 2016-05-28 03:57:55

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		Final rule; delay of effectiveness for discharge requirements with regard to U.S. Coast Guard activities.
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.
Contact		Maria Brown, Greater Farallones National Marine Sanctuary Superintendent, at [email protected] or 415-561-6622.
FR Citation		81 FR 34268
RIN Number		0648-BF99

81 FR 34268 - Delay of Discharge Requirements for U.S. Coast Guard Activities in Greater Farallones and Cordell Bank National Marine Sanctuaries

DEPARTMENT OF COMMERCENational Oceanic and Atmospheric Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration