[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55276-55277]
[FR Doc No: 2020-19607]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-509-000]

Columbia Gas of Pennsylvania, Inc.; Notice of Application

    Take notice that on August 20, 2020, Columbia Gas of Pennsylvania,
Inc (CPA), 121 Champion Way, Suite 100, Canonsburg, Pennsylvania 15317,
filed in the above referenced docket an application pursuant to section
7(f) of the Natural Gas Act (NGA) requesting authorization to expand
its service area determination granted in Docket No. CP18-49-000 to
include a delivery point in Columbiana County, Ohio. CPA also requests:
(1) Confirmation that CPA continues to qualify as a local distribution
company for purposes of transportation under section 311 of the Natural
Gas Policy Act (NGPA); (2) confirmation that CPA may continue to make
off-system sales in support of its Pennsylvania distribution
operations; and (3) continuation of the waiver of the Commission's
accounting, reporting, and other regulatory requirements under the NGA
and NGPA.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Brooke
E. Wancheck, Assistant General Counsel, 290 W. Nationwide Blvd.,
Columbus, Ohio 43215, by telephone at<PHONE_NUMBER>.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list

maintained by the Secretary of the Commission and will receive copies
of all documents filed by the applicant and by all other parties. A
party must submit five copies of filings made with the Commission and
must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new NGA section 3 or
section 7 proceeding.\1\ Persons desiring to become a party to a
certificate proceeding are to intervene in a timely manner. If seeking
to intervene out-of-time, the movant is required to ``show good cause
why the time limitation should be waived,'' and should provide
justification by reference to factors set forth in Rule 214(d)(1) of
the Commission's Rules and Regulations.\2\
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    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC ] 61,167 at
] 50 (2018).
    \2\ 18 CFR 385.214(d)(1).
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    The Commission strongly encourages electronic filings of comments
in lieu of paper using the ``eFile'' link at http://www.ferc.gov. In
lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comment Date: 5:00 p.m. Eastern Time on September 21, 2020.

    Dated: August 31, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-19607 Filed 9-3-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25563-25564]
[FR Doc No: 2017-11078]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0315; Airspace Docket No. 17-ANM-5]

Proposed Establishment of Class E Airspace, Dixon, WY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface at Dixon Airport, Dixon, WY, to
support the development of instrument flight rules (IFR) operations
under standard instrument approach and departure procedures at the
airport, for the safety and management of aircraft within the National
Airspace System.

DATES: Comments must be received on or before July 17, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0315; Airspace Docket No. 17-ANM-5, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish Class E airspace extending upward from 700 feet
above the surface at Dixon Airport, Dixon, WY to support IFR operations
in standard instrument approach and departure procedures at the airport
for the safety and management of aircraft within the National Airspace
System.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2017-0315; Airspace Docket No. 17-ANM-5) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and phone number).
    Persons wishing the FAA to acknowledge receipt of their comments on
this notice must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2017-0315 and Airspace Docket No. 17-ANM-5''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
will be considered before taking action on the proposed rule. The
proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at  http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points,

dated August 3, 2016, and effective September 15, 2016. FAA Order
7400.11A is publicly available as listed in the ADDRESSES section of
this document. FAA Order 7400.11A lists Class A, B, C, D, and E
airspace areas, air traffic service routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E airspace extending
upward from 700 feet above the surface at Dixon Airport, Dixon, WY.
Class E airspace would be established within a 7-mile radius of Dixon
Airport with a segment 8 miles wide (4 miles each side of a 045[deg]
bearing from the airport) extending to 15.5 miles northeast of the
airport. This airspace is necessary to support IFR operations in
standard instrument approach and departure procedures at the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current,
and is non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM WY E5 Dixon, WY [New]

Dixon Airport
    (Lat. 41[deg]02'15'' N., long. 107[deg]29'33'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-miles radius of the Dixon Airport, and within 4 miles
each side of a 045[deg] bearing from the airport extending from the
7-mile radius to 15.5 miles northeast of the airport.

    Issued in Seattle, Washington, on May 22, 2017.
Sam S.L. Shrimpton,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-11078 Filed 6-1-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Notices]
[Page 54043-54044]
[DOCID:fr13se06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-72-002]

PPL EnergyPlus, LLC v. New York Independent System Operator,
Inc.; Notice of Filing

September 7, 2006.
    Take notice that on August 28, 2006, New York Independent System
Operator, Inc. filed changed pages of its Installed Capacity Manual
(ICAP), and a report concerning changes to the underlying allocation
methodology in compliance with the Commission's June 29, 2006 order.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to

become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed on or before the comment date. On or before the comment date, it
is not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 27, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-15175 Filed 9-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Notices]
[Page 36799]
[FR Doc No: 2014-15220]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3586-004]

Hoosier Hydroelectric, Inc. Rocky River Hydro, LLC; Notice of
Transfer of Exemption

    1. By letter filed May 16, 2014, Rocky River Hydro, LLC informed
the Commission that the exemption from licensing for the Rocky River
Hydroelectric Project, FERC No. 3586, originally issued December 16,
1981,\1\ has been transferred to Rocky River Hydro, LLC. The project is
located on the Rocky River in Chatham County, North Carolina. The
transfer of an exemption does not require Commission approval.
---------------------------------------------------------------------------

    \1\ 17 FERC ] 62,442, Order Granting Exemption from Licensing of
a Small Hydroelectric Project of 5 Megawatts or Less.
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    2. Rocky River Hydro, LLC, located at 3409 Birk Bluff Court, Cary,
NC 27518 is now the exemptee of the Rocky River Hydroelectric Project,
FERC No. 3586.

    Dated: Issued June 24, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-15220 Filed 6-27-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76570-76571]
[FR Doc No: 2016-26591]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14510-001]

FFP Project 124, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14510-001.
    c. Date Filed: August 24, 2016.
    d. Submitted By: FFP Project 124, LLC.
    e. Name of Project: Red River Lock and Dam No. 1 Hydroelectric
Project.
    f. Location: On the Red River, at the U.S. Army Corps of Engineers'
Red River Lock and Dam No. 1, near the Town of Marksville in Catahoula
Parish, Louisiana.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Erik Steimle, Vice President,
Development, Rye Development, LLC, 745 Atlantic Avenue, 8th Floor,
Boston, MA 02111;<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Allan Creamer at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. FFP Project 124, LLC filed its request to use the Traditional
Licensing Process on August 24, 2016. FFP Project 124, LLC provided
public notice of its request on October 20, 2016. In a letter dated
October 26, 2016, the Director of the Division of Hydropower Licensing
approved FFP Project 124, LLC's request to use the Traditional
Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Louisiana State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating FFP Project 124, LLC as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the

Endangered Species Act and section 305(b) of the Magnuson-Stevens
Fishery Conservation and Management Act; and consultation pursuant to
section 106 of the National Historic Preservation Act.
    m. FFP Project 124, LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field, to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: October 26, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-26591 Filed 11-2-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16266-16269]
[FR Doc No: 2015-07010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2015-N-0802]

Medical Devices; Neurological Devices; Classification of the
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment
Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
brain injury adjunctive interpretive electroencephalograph assessment
aid 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 brain injury adjunctive interpretive
electroencephalograph assessment aid'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 March 27, 2015. The classification was
applicable on November 17, 2014.

FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G312, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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).
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 device submitted is not of ``low-moderate 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 August 20, 2014, BrainScope Company, Inc., submitted a request
for classification of the BrainScope Ahead 100, Models CV-100 and M-100
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 November 17, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  882.1450.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a brain
injury adjunctive interpretive electroencephalograph assessment aid
will need to comply with the special controls named in this final
order. The device is assigned the generic name brain injury adjunctive
interpretive electroencephalograph assessment aid, and it is identified
as a prescription device that uses a patient's electroencephalograph
(EEG) to provide an interpretation of the structural condition of the
patient's brain in the setting of trauma. A brain injury adjunctive
interpretive EEG assessment aid is for use as an adjunct to standard
clinical practice only as an assessment aid for a medical condition for
which there exists other valid methods of diagnosis.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks in table 1.

   Table 1--Brain Injury Adjunctive Interpretive Electroencephalograph
              Assessment Aid Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to user/patient (shock, burn, or         mechanical testing.
 mechanical failure).                    Electromagnetic compatibility
                                          testing.
                                         Labeling.
Delay in treatment or unnecessary        Performance testing.
 treatment due to hardware or software   Hardware and software
 failure.                                 verification, validation and
                                          hazard analysis.
                                         Electromagnetic compatibility
                                          testing.
                                         Technical parameters
                                         Labeling.
False result due to incorrect artifact   Software verification and
 reduction.                               validation.
                                         Labeling.
False result due to incorrect placement  Clinical performance testing.
 of electrodes.                          Labeling.
False result when a brain injury         Clinical performance testing.
 adjunctive interpretive EEG assessment  Device design characteristics.
 aid impacts the clinical decision.      Labeling.
Use error..............................  Clinical performance testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
     The technical parameters of the device, hardware and
software, must be fully characterized and include the following
information:
    [cir] Hardware specifications must be provided. Appropriate
verification, validation, and hazard analysis must be performed.
    [cir] Software, including any proprietary algorithm(s) used by the
device to arrive at its interpretation of the patient's condition, must
be described in detail in the software requirements specification (SRS)
and software design specification (SDS). Appropriate software
verification, validation, and hazard analysis must be performed.
     The device parts that contact the patient must be
demonstrated to be biocompatible.
     The device must be designed and tested for electrical
safety, electromagnetic compatibility (EMC), thermal, and mechanical
safety.
     Clinical performance testing must demonstrate the
accuracy, precision-repeatability and reproducibility, of determining
the EEG-based

interpretation, including any specified equivocal zones (cut-offs).
     Clinical performance testing must demonstrate the ability
of the device to function as an assessment aid for the medical
condition for which the device is indicated. Performance measures must
demonstrate device performance characteristics per the intended use in
the intended use environment. Performance measurements must include
sensitivity, specificity, positive predictive value (PPV), and negative
predictive value (NPV) with respect to the study prevalence per the
device intended use.
     The device design must include safeguards to ensure
appropriate clinical interpretation of the device output (e.g., use in
appropriate patient population, or for appropriate clinical decision).
     The labeling and training information must include:
    [cir] A warning that the device is not to be used as a stand-alone
diagnostic.
    [cir] A detailed summary of the clinical performance testing,
including any adverse events and complications.
    [cir] The intended use population and the intended use environment.
    [cir] Any instructions technicians should convey to patients
regarding the collection of EEG data.
    [cir] Information allowing clinicians to gauge clinical risk
associated with integrating the EEG interpretive assessment aid into
their diagnostic pathway.
    [cir] Information allowing clinicians to understand how to
integrate the device output into their diagnostic pathway when the
device is unable to provide a classification or final result.
    Brain injury adjunctive interpretive electroencephalograph
assessment aid devices are prescription devices restricted to patient
use only upon the authorization of a practitioner licensed by law to
administer or use the device; see 21 CFR 801.109 (Prescription
devices)). Prescription-use restrictions are a type of general controls
as defined in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the brain injury adjunctive
interpretive electroencephalograph assessment aid they intend to
market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 807, subpart E, regarding premarket notification submissions
have been approved under OMB control number 0910-0120, and the
collections of information in 21 CFR part 801, regarding labeling have
been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. [DEN140025]: De Novo Request per 513(f)(2) from BrainScope
Company, Inc., dated August 20, 2014.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  882.1450 to subpart B to read as follows:

Sec.  882.1450  Brain injury adjunctive interpretive
electroencephalograph assessment aid.

    (a) Identification. A brain injury adjunctive interpretive
electroencephalograph assessment aid is a prescription device that uses
a patient's electroencephalograph (EEG) to provide an interpretation of
the structural condition of the patient's brain in the setting of
trauma. A brain injury adjunctive interpretive EEG assessment aid is
for use as an adjunct to standard clinical practice only as an
assessment aid for a medical condition for which there exists other
valid methods of diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The technical parameters of the device, hardware and software,
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Appropriate
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the
device to arrive at its interpretation of the patient's condition, must
be described in detail in the software requirements specification (SRS)
and software design specification (SDS). Appropriate software
verification, validation, and hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated
to be biocompatible.
    (3) The device must be designed and tested for electrical safety,
electromagnetic compatibility (EMC), thermal, and mechanical safety.
    (4) Clinical performance testing must demonstrate the accuracy,
precision-repeatability and reproducibility, of determining the EEG-
based interpretation, including any specified equivocal zones
(cutoffs).
    (5) Clinical performance testing must demonstrate the ability of
the device to function as an assessment aid for the medical condition
for which the device is indicated. Performance measures must
demonstrate device performance characteristics per the intended use in
the intended use environment. Performance measurements must include
sensitivity, specificity, positive predictive value (PPV), and negative
predictive value (NPV) with respect to the study prevalence per the
device intended use.
    (6) The device design must include safeguards to ensure appropriate
clinical interpretation of the device output (e.g.,

use in appropriate patient population, or for appropriate clinical
decision).
    (7) The labeling and training information must include:
    (i) A warning that the device is not to be used as a stand-alone
diagnostic.
    (ii) A detailed summary of the clinical performance testing,
including any adverse events and complications.
    (iii) The intended use population and the intended use environment.
    (iv) Any instructions technicians should convey to patients
regarding the collection of EEG data.
    (v) Information allowing clinicians to gauge clinical risk
associated with integrating the EEG interpretive assessment aid into
their diagnostic pathway.
    (vi) Information allowing clinicians to understand how to integrate
the device output into their diagnostic pathway when the device is
unable to provide a classification or final result.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07010 Filed 3-26-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Notices]
[Pages 36904-36906]
[FR Doc No: 2020-13120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89060; File No. SR-ICEEU-2020-005]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change Relating to Amendments to the ICE
Clear Europe Clearing Rules

June 12, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 2, 2020, ICE Clear Europe Limited (``ICE Clear Europe'' or the
``Clearing House'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes described in Items I, II,
and III below, which Items have been prepared primarily by ICE Clear
Europe. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe is proposing to make certain changes to its
Clearing Rules (the ``Rules'') \3\ to address the receipt of proceeds
from default insurance.
---------------------------------------------------------------------------

    \3\ Capitalized terms used but not defined herein have the
meanings specified in the Rules.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe proposes amendments to Parts 9 and 11 of the Rules
relating to default insurance that is intended to cover losses
resulting from a Clearing Member default. Among other changes, the
proposed amendments address the potential receipt of proceeds from
default insurance. Although ICE Clear Europe is not, and would not be,
required to obtain or maintain default insurance, the proceeds of any
such insurance would, under the Rules as proposed to be revised, be
applied as part of the resources available to ICE Clear Europe in the
event of a Clearing Member default. Such default insurance would
provide additional default resources to cover losses from Clearing
Member defaults, prior to the need to use guaranty fund resources from
non-defaulting Clearing Members. This would provide a potential extra
layer of protection for the non-defaulting Clearing Members' guaranty
fund contributions and assessments. ICE Clear Europe is also proposing
certain additional conforming amendments to the Rules. The proposed
revisions are described in detail below.
    ICE Clear Europe proposes to amend the default waterfalls in Rules
908(b) (for F&O-only Clearing Members or Sponsored Principals), (c)
(for CDS-only Clearing Members or Sponsored Principals), (d) (for FX-
only Clearing Members or Sponsored Principals) and (g) (for Clearing
Members or Sponsored Principals in multiple membership categories) such
that default insurance proceeds would be placed third in the waterfall
of assets used to meet the obligations and liabilities of a Defaulter
and any shortfall, loss or liability to the Clearing House upon an
Event of Default. (In the case of a defaulter with multiple membership
categories, the proceeds of default insurance would be applied to each
Default Amount on a pro rata basis, as provided in Rule 908(g)(iii) as
proposed to be revised.) Default insurance proceeds would thus be
applied following the Clearing House initial contribution and before
the Clearing Member guaranty fund contributions and assessment
contributions. Conforming amendments would be made to the Rule 101
definitions of ``Clearing House CDS GF Contribution'', ``Clearing House
F&O GF Contribution'' and ``Clearing House FX GF Contribution'' as well
as to Rule 909(a), reflecting the placement of default insurance
proceeds in the applicable waterfalls under Rule 908.
    Rule 1103(e) (which states certain limitations with respect to the
benefits of default insurance) would be amended to provide that the
Clearing House is not obliged to obtain or maintain any default
insurance policy or make or receive the proceeds under any claim prior
to processing to the next levels of assets in the applicable waterfall
in Rule 908, and subject to the payment order specified in Rule
1102(k). The amendments would further reflect that there could be a
delay in receiving insurance proceeds such that other assets applicable
under Rule 908 may be called prior to insurance proceeds being received
and proceeds of any claim may need to be applied to meet losses across
more than one Event of Default if there are multiple defaulters. The
amendments would further set out the order in which proceeds of default
insurance claims would be paid out if there are multiple defaulters
within a certain period, such that insurance proceeds would not be
applied to a default in respect of which there were no further losses
after applying default resources up to and including the Clearing House
contribution, and would be applied to remaining losses based on which
default occurred first in time, and to losses from defaults occurring
simultaneously (including defaults occurring on the same day) on a pro
rata basis.
    Rule 1102(k) (which addresses allocation of amounts recovered from
a Defaulter) would be amended to address application of recoveries to
pay amounts owed to default insurers in respect of default insurance,
as well as reimbursements to Clearing Members and the Clearing House in
respect of their contributions that have been used, in the reverse
order in which assets were applied under Rule 908 (i.e., to non-
defaulting Clearing Members in respect of their Guaranty Fund
Contributions that had been applied, then to the default insurance
provider in respect of amounts owed to it, and then to the Clearing
House in respect of its default contribution). Rule 1102(k) would also
be revised to clarify that application of such amounts would be subject
to (i) retaining or repaying amounts applied by the Clearing House
(which would no longer include claims under insurance policies) or
other third parties applied to meet shortfalls; (ii) if applicable,
reimbursing payments to Persons that made Assessment Contributions in
the reverse order specified in Rule 908; and (iii) if applicable,
meeting certain repayment obligations under Rules 909(j), 914(j) or
916(n).
    Rule 909(j) (which addresses reimbursement of Assessment
Contributions) would also be amended to reflect the application of
default insurance. The amendments would expand the existing provision
to provide that if, after any Assessment Contribution has been paid in
relation to an Event of Default, the Clearing House collects on the
defaulted obligation, loss or shortfall in whole or in part from an
insurer, the Clearing House would refund the collected

amount, less expenses, to non-defaulting Clearing Members in respect of
their paid Assessment Contributions. The amendment would also add a
drafting clarification that such reimbursements are subject to the
Clearing House retaining or repaying amounts applied to meet any
shortfall and certain repayment obligations, if applicable, under Rules
914(j) (addressing payment of recoveries to persons that were subject
to reduced gains distributions under Rule 914) and 916(n) (addressing
payments of recoveries to persons that received reduced amounts in the
case of product termination under Rule 916), which is consistent with
the existing language of Rule 914(j) and 916(n).
    The term ``Available Non-Defaulter Resources'' in Rule 913 would be
amended to include claims under default insurance policies available to
be applied pursuant to Rule 908, provided that they were received in
cleared funds at the time the Clearing House performs a calculation of
Available Non-Defaulter Resources.
    Rule 914(j) (which addresses application of recoveries in the
context of reduced gains distribution) would be extended such that it
would also apply where the Clearing House receives insurance proceeds.
Existing Rule 914(j) provides that if the Clearing House receives an
amount that would, had it been paid on time, have increased the
Clearing House's available resources on a day on which a Margin Account
Adjustment was made in connection with Reduced Gains Distributions, the
Clearing House would distribute the amounts received first to non-
defaulting Contributors who were liable to pay an adjustment on a pro
rata basis and second in accordance with Rule 1102(k) (as described
above). The amendment would include default insurance proceeds in the
type of received amounts subject to the rule.
    Similarly, Rule 916(n) (which addresses application of recoveries
in the context of product termination) would be amended such that it
also applies to insurance proceeds. Existing Rule 916 in general
permits the Clearing House to terminate the open contracts in a
relevant contract category (e.g., F&O or CDS) under specified
circumstances, including in certain cases following an Under-priced
Auction or where the Clearing House determines there are not sufficient
Clearing Members to support continued clearing of the relevant contract
category. In the case of such a termination of a contract category,
under existing Rule 916(n), where ICE Clear Europe receives an amount
that would, had it been paid on time, have increased the amount owed to
(or decreased the amount owed by) Clearing Members or Sponsored
Principals upon termination of a contract category, ICE Clear Europe
would distribute the amount received first to non-defaulting Clearing
Members or Sponsored Principals who received less in respect of product
termination than they were otherwise owed, then in accordance with Rule
914(j) (as discussed above), and then in accordance with Rule 1102(k)
(as discussed above). The amendment would include default insurance
proceeds in the type of received amounts subject to distribution under
Rule 916(n).
(b) Statutory Basis
    ICE Clear Europe believes that the proposed rule changes are
consistent with the requirements of Section 17A of the Act \4\ and the
regulations thereunder applicable to it, including the applicable
standards under Rule 17Ad-22.\5\ In particular, Section 17A(b)(3)(F) of
the Act requires that the rule change be consistent with the prompt and
accurate clearance and settlement of securities transactions and
derivative agreements, contracts and transactions cleared by ICE Clear
Europe, the safeguarding of securities and funds in the custody or
control of ICE Clear Europe or for which it is responsible, and the
protection of investors and the public interest.\6\ The proposed
changes amend the default waterfalls in Rule 908 to apply the proceeds
of default insurance, if any, as an additional default resource after
the application of ICE Clear Europe's own initial contributions and
prior to the application of guaranty fund contributions or assessment
contributions of non-defaulting Clearing Members. Placing the proceeds
from any default insurance that ICE Clear Europe may receive before the
guaranty fund resources of non-defaulting Clearing Members in the
default waterfall is generally favorable to non-defaulting Clearing
Members and enhances ICE Clear Europe's procedures that are designed to
protect and ensure the safety of Clearing Member funds and assets.
Although ICE Clear Europe is not relying on the additional default
resources from default insurance to meet regulatory minimum financial
requirements, in ICE Clear Europe's view, the proposed changes to the
Rules nonetheless enhance ICE Clear Europe's ability to manage the risk
of defaults by providing resources to cover losses from Clearing Member
defaults, prior to the need to use guaranty fund resources from non-
defaulting Clearing Members, thereby promoting the prompt and accurate
clearance and settlement of securities transactions, derivatives
agreements, contracts, and transactions and the safeguarding of
securities and funds which are in the custody or control of ICE Clear
Europe or for which it is responsible within the meaning of Section
17A(b)(3)(F) of the Act.\7\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1.
    \5\ 17 CFR 240.17Ad-22.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The amendments will also satisfy relevant requirements of Rule
17Ad-22,\8\ as set forth in the following discussion.
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(4) \9\ requires ICE Clear Europe to maintain
financial resources at a minimum sufficient to enable it to cover a
wide range of foreseeable stress scenarios that include, but are not
limited to, the default of the two participant families that would
potentially cause the largest aggregate credit exposure in extreme but
plausible market conditions. ICE Clear Europe is not relying on default
insurance to meet its regulatory financial resource requirements,
including for purposes of Rule 17Ad-22(e)(4), and is not reducing the
amount of its other relevant financial resources. ICE Clear Europe
believes that the proposed revisions will nonetheless enhance its
default waterfall and default management procedures. As described
above, the proposed amendments contemplate the possibility of ICE Clear
Europe receiving proceeds from default insurance, which would provide
additional default resources to cover losses from Clearing Member
defaults, prior to the need to use guaranty fund resources from non-
defaulting Clearing Members. Conforming changes proposed to Rule
1103(e) would permit the use of Guaranty Fund Contributions to occur
prior to receipt of any default insurance proceeds and the application
of default insurance proceeds to meet losses across multiple Events of
Default. As such, default insurance would, in ICE Clear Europe's view,
represents a tool that strengthens ICE Clear Europe's ability to manage
its financial resources and withstand the pressures of defaults,
consistent with the requirements of Rule 17Ad-22(b)(3).\10\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.17Ad-22(e)(r).
    \10\ 17 CFR 240.17Ad-22(e)(4).
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(13) \11\ requires ICE Clear Europe to establish,
implement, maintain and enforce written policies and procedures
reasonably designed to ensure it has the authority and operational
capacity to take timely

action to contain losses and liquidity demands and continue to meet its
obligations in the case of participant default. The proposed changes to
the Rules integrate default insurance into the default waterfall,
providing additional potential default resources to cover losses from
Clearing Member defaults, prior to the need to use guaranty fund
resources from non-defaulting Clearing Members. Amended Rule 1103(e)
provides that ICE Clear Europe may use the contributions of non-
defaulting Clearing Members to the guaranty fund prior to the receipt
of proceeds owed under the default insurance provided that those
Clearing Members are reimbursed from the insurance proceeds when
received. Given that there may be delays in making and processing an
insurance claim, this provision ensures that the existence and use of
default insurance does not interfere with ICE Clear Europe's default
management and allows ICE Clear Europe to continue its default
management process without having to wait for the payment of insurance
proceeds. The proposed amendments thus ensure that ICE Clear Europe can
take timely action to contain losses and liquidity pressures and to
continue meeting its obligations in the event of a participant default,
consistent with the requirements of Rule 17Ad-22(e)(13).\12\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17Ad-22(e)(13).
    \12\ 17 CFR 240.17Ad-22(e)(13).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purpose of the Act. The amendments
will apply consistently across all Clearing Members or across all
Clearing Members in a particular product category, their customers and
other market participants. Furthermore, as the amendments would place
the application of proceeds from default insurance above Clearing
Member guaranty fund contributions and contemplates certain repayments
to Clearing Members upon collection from default insurers, the
amendments are generally consistent with the interests of Clearing
Members. As a result, ICE Clear Europe does not expect that the
proposed changes will adversely affect access to clearing or the
ability of Clearing Members, their customers or other market
participants to continue to clear contracts. ICE Clear Europe also does
not believe the amendments would materially affect the cost of clearing
or otherwise limit market participants' choices for selecting clearing
services. Accordingly, ICE Clear Europe does not believe the amendments
would impose any burden on competition not necessary or appropriate in
furtherance of the purpose of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    ICE Clear Europe has conducted a public consultation the proposed
amendments \13\ and received one written response. The commenter
inquired into whether the total default insurance coverage covers both
F&O and CDS clearing together and, if both, how the insurance policy
will be applied if the defaulting clearing member was active in both
clearing segments. ICE Clear Europe noted that these points were
addressed in the consultation Circular, which states that the coverage
includes both F&O and CDS Contract Categories, and proposed Rule
908(g)(iii), which states that proceeds of any insurance policy claim
shall be applied to each segment on a basis pro rata to the shortfall,
loss or liability of each Default Amount (as defined in Rule 908(g))
less Clearing House Contributions applied to such amount. No changes
were made as a result of the comments.
---------------------------------------------------------------------------

    \13\ ICE Clear Europe Circular C20/037 (March 24, 2020),
available at https://www.theice.com/publicdocs/clear_europe/circulars/C20037.pdf (the ``Circular'').
---------------------------------------------------------------------------

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2020-005 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2020-005. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2020-005 and should be
submitted on or before July 9, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-13120 Filed 6-17-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43744]
[DOCID:fr28jy08-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 516-452]

South Carolina Electric and Gas Company; Notice of Availability
of Environmental Assessment

July 18, 2008.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
prepared an environmental assessment (EA) for an application filed by
South Carolina Electric and Gas Company (SCE&G) (licensee) on January
17, 2008, for a non-project use of project lands and waters at the
Saluda Hydroelectric Project (FERC Project No.516). Specifically, the
licensee requests authorization to issue a permit to Lighthouse
Developments, Inc. (Lighthouse) to install a community dock that would
accommodate 84 watercraft, a boat launch ramp, and parking lot. The
proposed facilities would provide boating access to the project's
reservoir (Lake Murray) for homeowners in a new residential development
known as Paradise Cove. The EA evaluates the environmental impacts that
would likely result from Lighthouse's development proposal. The EA
finds that approval of SCE&G's application would not constitute a major
federal action significantly affecting the quality of the human
environment.
    A copy of the EA is on file with the Commission and is available
for public inspection. The EA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number (P-516) excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support at FERCOnlineSupport@ferc.gov,or toll-free at 1-866-208-
3676, or for TTY,<PHONE_NUMBER>.
    Any comments should be filed by July 31, 2008, and should be
addressed to the Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Room 1-A, Washington, DC 20426. Please reference the
project name and project number (P-2686) on all comments. Comments may
be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. For further information, contact Brian
Romanek at<PHONE_NUMBER>.

Kimberly D. Bose,
 Secretary.
[FR Doc. E8-17170 Filed 7-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Page 73071]
[FR Doc No: 2014-28810]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9920-25-Region 6]

Underground Injection Control Program; Hazardous Waste Injection
Restrictions; Reissuance of a Petition for Exemption--Class I Hazardous
Waste Injection; Pergan Marshall, LLC Marshall, TX

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a final decision on a no migration petition
reissuance.

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SUMMARY: Notice is hereby given that a reissuance of an exemption to
the land disposal Restrictions, under the 1984 Hazardous and Solid
Waste Amendments to the Resource Conservation and Recovery Act, has
been denied to Pergan Marshall, LLC for two Class I injection wells
located at Marshall, TX. The company was unable to demonstrate to the
satisfaction of the Environmental Protection Agency by the petition
reissuance application and supporting documentation that, to a
reasonable degree of certainty, there would be no migration of
hazardous constituents from the injection zone for as long as the waste
remains hazardous. This final decision prohibits the underground
injection by Pergan, of restricted hazardous wastes, into Class I
hazardous waste injection wells WDW-180 and WDW-243. A public notice
was issued October 2, 2014. The public comment period closed on
November 18, 2014. No comments were received. This decision constitutes
final Agency action and there is no Administrative appeal. This
decision may be reviewed/appealed in compliance with the Administrative
Procedure Act.

DATES: This action is effective as of November 24, 2014.

ADDRESSES: Copies of the petition reissuance and all pertinent
information relating thereto are on file at the following location:
Environmental Protection Agency, Region 6, Water Quality Protection
Division, Source Water Protection Branch (6WQ-S), 1445 Ross Avenue,
Dallas, Texas 75202-2733.

FOR FURTHER INFORMATION CONTACT: Philip Dellinger, Chief Ground Water/
UIC Section, EPA--Region 6, telephone<PHONE_NUMBER>.

    Dated: November 24, 2014.
William K. Honker,
Director, Water Quality Protection Division.
[FR Doc. 2014-28810 Filed 12-8-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15188-15190]
[FR Doc No: 2020-05447]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0908]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Petitions: Food Additive, Color Additive
(Including Labeling), Submission of Information to a Master File in
Support of Petitions; and Electronic Submission Using Food and Drug
Administration Form 3503

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's regulations for submission of petitions, including food and color
additive petitions (FAPs and CAPs) (including labeling) submission of
information to a master file in support of petitions, and electronic
submission using Form FDA 3503.

DATES: Submit either electronic or written comments on the collection
of information by May 18, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 18, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-0908 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Submission of Petitions: Food
Additive, Color Additive (Including Labeling), Submission of
Information to a Master File in Support of Petitions; and Electronic
Submission Using Food and Drug Administration Form 3503.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Submission of Petitions: Food Additive, Color Additive (Including
Labeling); Submission of Information to a Master File in Support of
Petitions; Electronic Submission Using FDA Form 3503--21 CFR 70.25,
71.1, 171.1, 172, 173, 179, and 180

OMB Control Number 0910-0016--Revision

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe, unless: (1) The additive and its use, or intended use,
are in conformity with a regulation issued under Sec.  409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under Sec.  409(h) is effective. FAPs are
submitted by individuals or companies to obtain approval of a new food
additive or to amend the conditions of use permitted under an existing
food additive regulation. Section 171.1 of FDA's regulations (21 CFR
171.1) specifies the information that a petitioner must submit in order
to establish that the proposed use of a food additive is safe and to
secure the publication of a food additive regulation describing the
conditions under which the additive may be safely used. Parts 172, 173,
179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling
requirements for certain food additives to ensure their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under Sec.  721(f). CAPs are submitted by individuals or companies to
obtain approval of a new color additive or a change in the conditions
of use permitted for a color additive that is already approved. Section
71.1 of the Agency's regulations (21 CFR 71.1) specifies the
information that a petitioner must submit to establish the safety of a
color additive and to secure the issuance of a regulation permitting
its use. FDA's color additive labeling requirements in Sec.  70.25 (21
CFR 70.25) require that color additives that are to be used in food,
drugs, devices, or cosmetics be labeled with sufficient information to
ensure their safe use.
    FDA scientific personnel reviews FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
    Respondents may transmit FAP or CAP regulatory submissions in
electronic format or paper format to the Office of Food Additive Safety
in the Center for Food Safety and Applied Nutrition (CFSAN) using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete Form FDA 3503 will
continue to be 1 hour.
    We are revising the information collection to reflect ongoing
modernization efforts. We have augmented our FDA Unified Registration
and Listing System (FURLS) with the CFSAN Online Submission Module
(``COSM''). The COSM provides a real-time user interface process we
believe will assist respondents in preparing and making submissions to
Offices in CFSAN. The COSM is a web-based tool that supports electronic
submissions, thereby eliminating the need for printing and mailing of
paper submissions. COSM is available 24 hours a day and seven days a
week. Information submitted to COSM is the same information respondents
would submit to the FURLS system. Information about COSM, including
user instruction, is available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
    Description of respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                   21 CFR section/form                      respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Color Additive Petitions
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70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
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                                                                 Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
Form FDA 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,959           5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    Our estimate of burden attributable to food additive or color
additive petitions is based on our experience with the information
collection, which has not changed since our last review, and we
therefore retain the currently approved burden. This estimate reflects
the average number of petitions we have received annually over a period
of 10 years. The attendant burden we estimate also reflects an industry
average, although burden associated with individual petitions may vary
depending on the complexity of the petition, and the amount and type of
data needed for scientific analysis.
    Color additive petitions are subject to fees. The listing fee for a
color additive petition ranges from $1,600 to $3,000, depending on the
intended use of the color additive and the scope of the requested
amendment. A complete schedule of fees is set forth in Sec.  70.19. An
average of one Category A and one Category B color additive petition is
expected per year. The maximum color additive petition fee for a
Category A petition is $2,600 and the maximum color additive petition
fee for a Category B petition is $3,000. Because an average of 2 CAPs
are expected per calendar year, the estimated total annual cost burden
to petitioners for this startup cost would be less than or equal to
$5,600 ((1 x $2,600) + (1 x $3,000) listing fees = $5,600). There are
no capital costs associated with CAPs. The labeling requirements for
food and color additives were designed to specify the minimum
information needed for labeling in order that food and color
manufacturers may comply with all applicable provisions of the FD&C Act
and other specific labeling acts administered by FDA. Label information
does not require any additional information gathering beyond what is
already required to assure conformance with all specifications and
limitations in any given food or color additive regulation. Label
information does not have any specific recordkeeping requirements
unique to preparing the label. Therefore, because labeling requirements
under Sec.  70.25 for a particular color additive involve information
required as part of the CAP safety review process, the estimate for
number of respondents is the same for Sec. Sec.  70.25 and 71.1, and
the burden hours for labeling are included in the estimate for Sec.
71.1. Also, because labeling requirements under parts 172, 173, 179,
and 180 for particular food additives involve information required as
part of the FAP safety review process under Sec.  171.1, the burden
hours for labeling are included in the estimate for Sec.  171.1.

    Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05447 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P