[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Proposed Rules]
[Pages 43197-43198]
[FR Doc No: 2017-19491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-4511]

Arcadia Biosciences, Inc.; Filing of Food Additive Petition
(Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Petition for rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that Arcadia Biosciences, Inc. has filed a petition proposing that the
food additive regulations be amended to provide for the safe use of
gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty
acids in dry food for adult cats in the maintenance life stage.

DATES: The food additive petition was filed on May 1, 2017.

ADDRESSES: For access to the docket, 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: Carissa Doody, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a
food additive petition (FAP 2302) has been filed by Arcadia Biosciences
Inc., 202 Cousteau Pl., Suite 200, Davis, CA 95618. The petition
proposes to amend Title 21 of the Code of Federal Regulations (CFR) in
part 573 (21 CFR part 573) Food Additives Permitted in Feed and

Drinking Water of Animals to provide for the safe use of GLA safflower
oil as a source of omega-6 fatty acids in dry food for adult cats in
the maintenance life stage.
    The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that to their
knowledge, no extraordinary circumstances exist. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19491 Filed 9-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Notices]
[Page 61150-61151]
[DOCID:fr23no09-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0281]

Niaja Kane: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the agency) is issuing
an order under the Federal Food, Drug, and Cosmetic Act (the act)
permanently debarring Niaja Kane from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Ms. Kane was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the act. Ms. Kane was given notice
of the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of September
20, 2009, Ms. Kane failed to respond. Ms. Kane's failure to respond
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is effective November 23, 2009.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kenny Shade, Office of Regulatory
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct otherwise relating
to the regulation of any drug product under the act.
    On January 22, 2007, the U.S. District Court for the Eastern
District of Pennsylvania accepted Niaja Kane's guilty plea and entered
judgment against her for trafficking in counterfeit goods in violation
of 18 U.S.C. 2320(a), holding counterfeit drugs for sale with intent to
defraud in violation of 21 U.S.C. 331(i)(3) and 333(a)(2), and
attempted possession with intent to distribute a counterfeit controlled
substance in violation of 21 U.S.C. 846. The actions underlying these
convictions were associated with Ms. Kane's order of counterfeit
Percocet[reg], Viagra[reg], and Cialis[reg] on or about February 28,
2006. These drugs included approximately 2,040 tablets purporting to be
Viagra[reg], 1,200 tablets purporting to be Cialis[reg], 2,333 tablets
purporting to be Percocet[reg] 7.5 milligrams (mg), and 6,573 tablets
purporting to be Percocet[reg] 10 mg. All of these drugs, without
authorization, bore the trademark, trade name and identifying marks,
imprints and other characteristics of the products they purported to
be, thereby falsely purporting to be manufactured, processed, packed,
or distributed by the legitimate holders of such trademarks. Ms. Kane
intentionally trafficked and attempted to traffic in goods, all of
which were counterfeit. She knowingly used on and in connection with
such goods counterfeit marks, that is spurious marks identical to and
substantially indistinguishable from shape and imprints found on the
genuine products whose marks were in use and were registered for those
products by those companies on the principal register of the United
States Patent and Trademark Office. Ms. Kane also, with intent to
defraud and mislead, willfully caused a drug to be a counterfeit drug
and held for sale or dispensing the drugs referenced previously. With
respect to the tablets purporting to be Percocet[reg], Ms. Kane
knowingly and intentionally attempted to possess with intent to
distribute or dispense a mixture and substance containing oxycodone, a
Schedule II controlled substance contained in Percocet[reg], all of
which without authorization bore the identifying marks of the
manufacturer and distributor of the controlled substance, which did not
manufacture or distribute such substances.
    As a result of these convictions, FDA sent Ms. Kane by certified
mail on August 13, 2009, a notice proposing to permanently debar her
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(B) of the act that Niaja Kane was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the act. The proposal also offered
Ms. Kane an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Kane failed to respond within the timeframe prescribed by
regulation and has, therefore, waived her opportunity for a hearing and
waived any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the act, under
authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Niaja Kane has been convicted of felonies under
Federal law for conduct relating to the regulation of a drug product
under the act.
    As a result of the foregoing finding, Ms. Kane is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see section 306(c)(1)(B) and (c)(2)(A)(ii), and section 201(dd) of the
act (21 U.S.C. 321(dd)). Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Niaja Kane, in any
capacity, during Ms. Kane's debarment, will be subject to civil money
penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Ms.
Kane, during her period of debarment, provides services in any capacity
to a person with an approved or pending drug product application, she
will be subject to civil money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Ms. Kane
during her period of debarment (section 306(c)(1)(B) of the act).
    Any application by Ms. Kane for special termination of debarment
under section 306(d)(4) of the act should be identified with Docket No.
2009-N-0281 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 9, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-28083 Filed 11-20-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10167-10168]
[FR Doc No: 2013-03333]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0026; FRL-9378-5]

Pesticide Products; Registration Applications for a New Active
Ingredient

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products
containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice
of receipt and opportunity to comment on these applications.

DATES: Comments must be received on or before March 15, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EPA File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone, email, or mail. Mail correspondence to the Registration
Division (RD) (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received applications to register pesticide products
containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the provisions of FIFRA
section 3(c)(4), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications. For actions being evaluated under the Agency's public
participation process for registration actions, there will be an
additional opportunity for a 30-day public comment period on the
proposed decision. Please see the Agency's public participation Web
site for additional information on this process (http://www.epa.gov/pesticides/regulating/registration-public-involvement.html). EPA
received the following applications to register pesticide products
containing an active ingredient not included in any currently
registered products:
    EPA File Symbol: 62719-AAU, 62719-AAN, 62719-AAR, 62719-AAE, and
62719-AAG. Docket ID Number: EPA-HQ-OPP-2012-0919. Applicant: Dow
AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268. Active
ingredient: Halauxifen-methyl. Product Type: Herbicide. Proposed Uses:
Cereal grain crops, including winter wheat, spring wheat, barley and
triticale. Contact: Maggie Rudick,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: February 7, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-03333 Filed 2-12-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57893-57895]
[FR Doc No: 2020-20359]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89819; File No. SR-BX-2020-027]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Decommission
TradeInfo

September 10, 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 September 9, 2020, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to no longer offer TradeInfo, which interface
is described within Options 3, Section 23(b)(2).
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/bx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to no longer offer TradeInfo, which interface
is described within Options 3, Section

23(b)(2). TradeInfo is a user interface which permits a Participant to:
(i) Search all orders submitted in a particular security or all orders
of a particular type, regardless of their status (open, canceled,
executed, etc.); (ii) cancellation of open orders at the order, port or
firm mnemonic level; (iii) a view of orders and executions; and (iv)
download of orders and executions for recordkeeping purposes.\3\ This
interface is not utilized by BX Participants at this time \4\ and the
Exchange desires to decommission the TradeInfo interface in connection
with a technology migration to an enhanced Nasdaq, Inc. (``Nasdaq'')
functionality which will result in higher performance, scalability, and
more robust architecture.
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    \3\ See Options 3, Section 23(b)(2).
    \4\ No Participant logged into TradeInfo in 2020.
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    FIX,\5\ FIX DROP,\6\ and the Clearing Trade Interface,\7\ which are
available to all Participants,\8\ can be utilized to obtain order
information which is currently available within TradeInfo, and cancel
orders. The Exchange intends to decommission TradeInfo on September 14,
2020. The Exchange has issued an Options Trader Alert to provide notice
of the decommission.\9\
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    \5\ ``Financial Information eXchange'' or ``FIX'' is an
interface that allows Participants and their Sponsored Customers to
connect, send, and receive messages related to orders and auction
orders and responses to and from the Exchange. Features include the
following: (1) Execution messages; (2) order messages; and (3) risk
protection triggers and cancel notifications. See Options 3, Section
7(d)(1)(A).
    \6\ FIX DROP is a real-time order and execution update message
that is sent to a Participant after an order been received/modified
or an execution has occurred and contains trade details specific to
that Participant. The information includes, among other things, the
following: (i) Executions; (ii) cancellations; (iii) modifications
to an existing order and (iv) busts or post-trade corrections. See
Options 3, Section 23(b)(3).
    \7\ The Clearing Trade Interface or ``CTI'' is a real-time
clearing trade update message that is sent to a Participant after an
execution has occurred and contains trade details specific to that
Participant. The information includes, among other things, the
following: (i) The Clearing Member Trade Agreement or ``CMTA'' or
The Options Clearing Corporation or ``OCC'' number; (ii) Exchange
badge or house number; (iii) the Exchange internal firm identifier;
(iv) an indicator which will distinguish electronic and non-
electronically delivered orders; (v) liquidity indicators and
transaction type for billing purposes; and (vi) capacity. See
Options 3, Section 23(b)(1).
    \8\ Today, all Participants have at least FIX, FIX DROP, or CTI.
    \9\ See Options Trader Alert #2020-23. The Exchange contacted
Participants that are currently subscribed to TradeInfo and informed
them about the decommission date. As noted above, today, these
Participants utilize FIX, FIX DROP, or CTI to obtain or download
order information or to cancel orders. The Exchange did not receive
any comments from market participants regarding the proposed
decommission.
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    Today, Participants pay $95 per user, per month for the TradeInfo
interface. The Exchange intends to separately file a proposed rule
change to credit any fees paid by Participants for TradeInfo in
September 2020.
    Finally, the Exchange proposes to add the word ``has'' to Options
3, Section 23(b)(3) to correct a grammatical error.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by decommissioning TradeInfo, which is currently not being
utilized by BX Participants.
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    \10\ 15 U.S.C. 78f(b)
    \11\ 15 U.S.C. 78f(b)(5).
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    In connection with BX's upcoming technology migration, the Exchange
proposes to no longer support TradeInfo as the interface is not
utilized,\12\ and FIX, FIX DROP, and the CTI can be utilized to obtain
order information which is currently available within TradeInfo, and
cancel orders.
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    \12\ See note 4 above.
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    Today, Participants pay $95 per user, per month for the TradeInfo
interface. The Exchange intends to separately file a proposed rule
change to credit any fees paid by Participants for TradeInfo in
September 2020.
    The Exchange's proposal to correct a grammatical error within
Options 3, Section 23(b)(3) is non-substantive.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. No BX Participant \13\ will be
able to utilize TradeInfo after September 14, 2020. However, FIX, FIX
DROP, and CTI can be utilized to obtain order information that is
currently available within TradeInfo, or cancel orders.
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    \13\ Id.
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    The Exchange's proposal to correct a grammatical error within
Options 3, Section 23(b)(3) is non-substantive.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \14\ and Rule 19b-4(f)(6) thereunder.\15\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\16\
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    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \17\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\18\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing to permit the Exchange to
decommission TradeInfo on September 14, 2020 in connection with BX's
upcoming technology migration to an enhanced platform. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because the Exchange
has stated that the TradeInfo interface is not utilized, and FIX, FIX
DROP, and CTI can be utilized to obtain order information that is
currently available within TradeInfo, or cancel orders. The Commission
believes that waiver of the operative delay would allow the Exchange,
before September 14, 2020, to avoid any additional testing and other
technology efforts necessary to offer TradeInfo on the new platform.
Accordingly, the Commission waives the 30-day operative delay and

designates the proposed rule change operative upon filing.\19\
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    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 17 CFR 240.19b-4(f)(6)(iii).
    \19\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \20\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \20\ 15 U.S.C. 78s(b)(2)(B).
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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-BX-2020-027 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-BX-2020-027. 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. 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-BX-2020-027 and
should be submitted on or before October 7, 2020September 16, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-20359 Filed 9-15-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Pages 57774-57775]
[FR Doc No: 2017-26336]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4348-DR; Docket ID FEMA-2017-0001]

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-4348-DR), dated November 14,
2017, and related determinations.

DATES: The declaration was issued November 14, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 14, 2017, the President issued a major disaster
declaration

under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of New York resulting from flooding during the period of May 2 to
August 6, 2017, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the State of New York.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Seamus K. Leary, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of New York have been designated
as adversely affected by this major disaster:

    Jefferson, Niagara, Orleans, Oswego, St. Lawrence, and Wayne
Counties for Public Assistance.
    All areas within the State of New York are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-26336 Filed 12-6-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Notices]
[Pages 66441-66442]
[FR Doc No: 2019-26189]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0355; FMCSA-2012-0050; FMCSA-2013-0106; FMCSA-
2014-0214; FMCSA-2014-0381; FMCSA-2015-0115; FMCSA-2015-0117; FMCSA-
2017-0180]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew exemptions for 10
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2008-0355; FMCSA-2012-0050; FMCSA-2013-
0106; FMCSA-2014-0214; FMCSA-2014-0381; FMCSA-2015-0115; FMCSA-2015-
0117; FMCSA-2017-0180, in the keyword box, and click ``Search.'' Next,
click the ``Open Docket Folder'' button and choose the document to
review. If you do not have access to the internet, you may view the
docket online by visiting Docket Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On October 1, 2019, FMCSA published a notice announcing its
decision to renew exemptions for 10 individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (84 FR
52157). The public comment period ended on October 31, 2019, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 10 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    As of September 2, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), Daniel Maben (MI) has satisfied the renewal conditions
for obtaining an exemption from the epilepsy and seizure disorders
prohibition in the FMCSRs for interstate CMV drivers (84 FR 52157).
    This driver was included in docket number FMCSA-2017-0180. The
exemption is applicable as of September 2, 2019, and will expire on
September 2, 2021.
    As of September 12, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following nine individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR
52157):

Ronald Boogay (NJ)
Todd W. Brock (CO)
Jason Kirkham (WI)
Ivan M. Martin (PA)
Charles A. McCarthy, III (MA)
Douglas S. Slagel (OH)
Cory R. Wagner (IL)
Timothy M. Zahratka (MN)

    The drivers were included in docket number FMCSA-2008-0355; FMCSA-
2012-0050; FMCSA-2013-0106; FMCSA-2014-0214; FMCSA-2014-0381; FMCSA-
2015-0115; FMCSA-2015-0117. Their exemptions are applicable as of
September 12, 2019, and will expire on September 12, 2021.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals.

    Issued on: November 26, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-26189 Filed 12-3-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Notices]
[Pages 8348-8353]
[FR Doc No: 2019-04085]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85236; File No. SR-ICEEU-2018-010]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to Amendments to the ICE Clear
Europe CDS Risk Policy (the ``CDS Risk Policy''), CDS Clearing Back-
Testing Policy (the ``Back-Testing Policy'') and CDS Stress-Testing
Policy (the ``Stress-Testing Policy'') (Collectively, the ``CDS
Policies'')

March 1, 2019.

I. Introduction

    On November 13, 2018, ICE Clear Europe Limited (``ICE Clear
Europe'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify and update certain provisions of its
risk policies related to CDS Contracts. The proposed rule change was
published for comment in the Federal Register on December 4, 2018.\3\
On December 26, 2018, the Commission extended the period to take action
on the proposed rule change to March 4, 2019.\4\ The Commission did not
receive comments on the proposed rule change. For the reasons discussed
below, the Commission is approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 84667 (Nov. 28, 2018),
83 FR 62638 (Dec. 4, 2018) (SR-ICEEU-2018-010) (``Notice'').
    \4\ Securities Exchange Act Release No. 84957 (Dec. 26, 2018),
84 FR 855 (Jan. 31, 2019) (SR-ICEEU-2018-010).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

A. CDS Risk Policy

    The proposed rule change would incorporate into the CDS Risk Policy
a description of ICE Clear Europe's overall Board risk appetite and
limit framework.\5\ Currently the CDS Risk Policy does not reference
the framework, but other ICE Clear Europe policies, including the
Stress-Testing Policy, reference the framework. The description of the
framework that the proposed rule change would add to the CDS Risk
Policy would be consistent with the description of the framework that
other ICE Clear Europe policies, including the Stress-Testing Policy,
use. As described in the proposed change to the CDS Risk Policy, the
framework would use Board-level risk appetite statements, risk appetite
metrics, and management risk limits, and would be subject to review at
least annually.\6\ The proposed rule change would add description of
the framework to the CDS Risk Policy to make clear that the CDS Risk
Policy is part of ICE Clear Europe's overall risk management.
---------------------------------------------------------------------------

    \5\ Capitalized terms not otherwise defined herein shall have
the meanings given to them in the CDS Policies or ICE Clear Europe
Rulebook.
    \6\ Notice, 83 FR at 62638.
---------------------------------------------------------------------------

    The proposed rule change would specifically address periodic
reviews of margin requirements and the related margin methodology and
parameters. Currently, the CDS Risk Policy provides that ICE Clear
Europe conducts a statistical analysis of the margin levels and market
performance on at least a monthly basis. Similarly, under the proposed
revised policy, the clearing risk department would be required to
perform such a review at least monthly, consistent with applicable
legal requirements.\7\
---------------------------------------------------------------------------

    \7\ See 17 CFR 240.17Ad-22(e)(6)(vi).
---------------------------------------------------------------------------

    The proposed rule change would provide additional detail about the
use of the results of such reviews by ICE Clear Europe management.
Specifically, under the proposed rule change, the head of first line
clearing risk would present the results of the monthly review to ICE
Clear Europe's Model Oversight Committee (``MOC'').\8\ The head of
first line clearing risk would report to the President of ICE Clear
Europe and would manage ICE Clear Europe's first line clearing risk
team including default management, liquidity risk, market risk and
counterparty risk. Moreover, the proposed rule change would provide
that at the end of each quarter, the Clearing Risk Department would
share its monthly reviews from the quarter with the Risk Oversight
Department (``ROD''), which would perform a second-line review. The
head of second line clearing risk then would present the results of
this quarterly review to the MOC. The head of second line clearing risk
would be ICE Clear Europe's Chief Risk Officer and would report to the
President and the senior independent director of ICE Clear Europe.\9\
The CDS Risk Policy currently provides only that the Risk Management
Department recommends margin methodology changes to the President and
Board of Directors of ICE Clear Europe for their approval. Thus, the
proposed rule change would provide more explanation regarding ICE Clear
Europe's use of the monthly reviews of margin levels.
---------------------------------------------------------------------------

    \8\ Notice, 83 FR at 62638.
    \9\ Id.
---------------------------------------------------------------------------

    The proposed amendments would also clarify that the Clearing Risk
Department would recommend proposed margin methodology changes
resulting from the review process to the Board for approval. Currently,
the CDS Risk Policy provides that the ICE Clear Europe Risk Management
Department recommends margin methodology changes to the President and
the Board for their approval. Thus, this proposed change would update
the name of the responsible ICE Clear Europe department from Risk
Management Department to Clearing Risk Department. Moreover, this
proposed change would eliminate a redundancy in providing that ICE
Clear Europe's Board alone shall approve margin methodology changes.
Because ICE Clear Europe's President also serves on the Board, it would
not be necessary for both the President and the Board to separately
approve margin methodology changes.\10\
---------------------------------------------------------------------------

    \10\ See https://www.theice.com/publicdocs/clear_europe/Organisational_Structure_Objectives_Strategy.pdf.
---------------------------------------------------------------------------

    The proposed rule change would specify in further detail the timing
and extent of backtesting and stress testing.\11\ Currently, the CDS
Risk Policy provides that ICE Clear Europe conducts backtesting on a
daily basis, but the Policy does not specify that ICE Clear Europe uses
standard predetermined

parameters and assumptions, nor does it provide any information about
sensitivity analysis. Consistent with applicable law, the proposed rule
change would require that: (i) ICE Clear Europe's Clearing Risk
Department conduct backtesting at least once each day using standard
predetermined parameters and assumptions; (ii) ICE Clear Europe conduct
sensitivity analyses of its margin models and review parameters and
assumptions for backtesting on at least a monthly basis; and (iii) ICE
Clear Europe conduct sensitivity analyses and reviews more frequently
than monthly when the relevant products cleared or markets served
display high volatility or become less liquid or when the size or
concentration of positions held by Clearing Members increases or
decreases significantly.\12\ With respect to stress testing, the CDS
Risk Policy currently provides details regarding stress testing
scenarios and provides that ICE Clear Europe executes such scenarios on
a regular basis, but does not specify that ICE Clear Europe conducts
stress testing daily or uses standard predetermined parameters and
assumptions. Consistent with applicable law, the proposed rule change
would require that the clearing risk department conduct stress testing
at least once each day using standard predetermined parameters and
assumptions, which are reviewed on at least a monthly basis and more
frequently when the relevant products cleared or markets served display
high volatility or become less liquid or when the size or concentration
of positions held by Clearing Members increases or decreases
significantly.\13\
---------------------------------------------------------------------------

    \11\ Notice, 83 FR at 62638.
    \12\ See 17 CFR 240.17Ad-22(e)(6)(vi).
    \13\ See 17 CFR 240.17Ad-22(e)(4)(vi).
---------------------------------------------------------------------------

    The proposed rule change would also establish details regarding
policy governance and reporting. The proposed rule change would specify
that the models used to support the policy objectives of the policy are
subject to an annual independent validation and governance oversight
which may be performed by an independent member of the ROD or an
external validator.\14\ The CDS Risk Policy does not currently provide
any details regarding validation of the models used to support the
policy. The CDS Risk Policy owner, who is the CDS Risk Director and
part of the Clearing Risk Department, would be responsible for ensuring
that the policy remains up-to-date and is reviewed, with the support of
the ROD.\15\
---------------------------------------------------------------------------

    \14\ Notice, 83 FR at 62638.
    \15\ Notice, 83 FR at 62638.
---------------------------------------------------------------------------

    The proposed rule change would also provide a new process for
escalation and reporting of any deviations from the policy, as well as
compliance with regulatory reporting and filing requirements and would
make the policy owner responsible for both. Under the current policy,
any changes to the Policy that affect the risk profile of ICE Clear
Europe are subject to Board approval, and any exceptions or deviations
from the Policy must be reported to the Chief Risk Officer and
escalated to the CDS Risk Committee and Board Risk Committee, if
material. Under the proposed rule change, the policy owner must report
any deviations from the Policy or material breaches to the President of
ICE Clear Europe and the Risk Oversight Department, who will then
proceed with appropriate governance and further escalation. Thus, this
change ensures that deviations and material breaches are reported to
the President and Risk Oversight Department who can then proceed with
Board involvement if needed. This change also ensures the involvement
of the Risk Oversight Department, who supports other functions under
the Policy, such as the reviews discussed above. Finally, this change
would make the process for escalation and reporting consistent with the
process currently found in the Stress-Testing Policy.
    The proposed rule change would further specify the roles of various
departments and committees at ICEEU with respect to the CDS Risk
Policy.\16\ Currently, the CDS Risk Policy describes the roles of the
Risk Working Group (``RWG'') (which consists of risk personnel of
Clearing Members, and provides guidance on risk management matters,
including review of margin and stress testing parameters), Trading
Advisory Committee (which advises on pricing processes), and MOC (which
is responsible for overall model risk management of the Clearing House,
and for oversight of the periodic reviews described above) in advising
on and approving matters related to the Policy. The proposed rule
change would further specify the role of the RWG and MOC in providing
feedback and reviewing the results of ongoing monitoring of models that
support the CDS Risk Policy. The proposed rule change would also
provide further detail as to the composition and role of the RWG and
MOC. Finally, the proposed rule change would make the Clearing Risk
Department, with the support of the ROD, responsible for adherence to
the policy and relevant appetite metrics.
---------------------------------------------------------------------------

    \16\ Id.
---------------------------------------------------------------------------

    The proposed rule change would also update references to various
committees and departments of ICE Clear Europe, correct typographical
and similar errors, update cross-references, and remove an unnecessary
reference to ICE Clear Credit.

B. Back-Testing Policy

    The proposed rule change would make changes to the Back-Testing
Policy similar to those changes described above for the CDS Risk
Policy. Specifically, the proposed rule change would incorporate into
the Back-Testing Policy a description of ICE Clear Europe's overall
Board risk appetite and limit framework.\17\ Currently the Back-Testing
Policy does not reference the framework, but other ICE Clear Europe
policies, including the Stress-Testing Policy, reference the framework.
The description of the framework that the proposed rule change would
add to the Back-Testing Policy would be consistent with the description
of the framework that other ICE Clear Europe policies, including the
Stress-Testing Policy, use. As described in the proposed change to the
Back-Testing Policy, the framework would use Board-level risk appetite
statements, risk appetite metrics, and management risk limits, and
would be subject to review at least annually.\18\ The proposed rule
change would add description of the framework to the Back-Testing
Policy to make clear that the Back-Testing Policy is part of ICE Clear
Europe's overall risk management.
---------------------------------------------------------------------------

    \17\ Notice, 83 FR at 62638.
    \18\ Notice, 83 FR at 62638.
---------------------------------------------------------------------------

    The proposed rule change would also add the same provisions
relating to the timing of backtesting and related sensitivity analysis
discussed above in the context of the CDS Risk Policy.\19\ Currently,
the Back-Testing Policy provides that ICE Clear Europe conducts
backtesting on a daily basis, but the Policy does not specify that ICE
Clear Europe uses standard predetermined parameters and assumptions,
nor does it provide any information about sensitivity analysis.
---------------------------------------------------------------------------

    \19\ Id.
---------------------------------------------------------------------------

    In addition, the proposed rule change would clarify the meaning of,
and make other changes to, certain confidence levels used in the
backtesting process.\20\ Specifically, the proposed rule change would
specify that these confidence levels represent the confidence to which
models are expected to perform. Although the Back-Testing Policy
currently describes the confidence levels that ICE Clear Europe uses in
backtesting, it does not make clear what these confidence levels
represent. Thus, the proposed change would clarify the

meaning of the confidence levels and therefore how those confidence
levels are used in evaluating ICE Clear Europe's backtesting. The
proposed rule change would also remove a reference to the 99% quantile
used before EMIR implementation. ICE Clear Europe no longer uses this
confidence level in backtesting. Rather, in the guidelines relating to
remediation of poor backtesting, the proposed rule change would state
explicitly that portfolio backtesting is done using a confidence level
of 99.5% or higher.
---------------------------------------------------------------------------

    \20\ Notice, 83 FR at 62639.
---------------------------------------------------------------------------

    As with the amendments to the CDS Risk Policy, the proposed rule
change would also establish details regarding policy governance and
reporting.\21\ Specifically, the proposed rule change would specify
that the models used to support the objectives of the Back-Testing
Policy are subject to an annual independent validation and governance
oversight which may be performed by an independent member of the ROD or
an external validator. The Back-Testing Policy does not currently
provide details regarding independent validation of the models used to
support the Policy. The proposed rule change would make the Back-
Testing Policy owner, who is the CDS Risk Director and part of the
Clearing Risk Department, responsible for ensuring that the Back-
Testing Policy remains up-to-date and is reviewed, with the support of
the ROD.\22\ The proposed rule change would make the Clearing Risk
Department, with the support of the ROD, responsible for adherence to
the policy and relevant appetite metrics.\23\
---------------------------------------------------------------------------

    \21\ Notice, 83 FR at 62639.
    \22\ Id.
    \23\ Id.
---------------------------------------------------------------------------

    The proposed rule change would also provide a new process for
escalation and reporting of any deviations from the policy, as well as
compliance with regulatory reporting and filing requirements and would
make the policy owner responsible for both. Currently, the Back-Testing
Policy provides that the Policy will be reviewed and approved in
accordance with the Policy Governance Review Calendar, or whenever the
Clearing House identifies further issues requiring specific attention
under the Policy. The proposed rule change would provide that any
deviations from the Policy must be appropriately escalated and reported
in a timely manner by the policy owner and would also make the policy
owner responsible for reporting any material breaches or deviations to
the President and Risk Oversight Department. Thus, this proposed rule
change would provide additional detail to the escalation of changes to
the Policy as well as make the process for escalation and reporting
consistent with the process proposed to be added to the CDS Risk
Policy. Finally, this change would make the process for escalation and
reporting consistent with the process proposed for the CDS Risk Policy
and the process currently found in the Stress-Testing Policy.
    The proposed rule change would also update references to various
committees and departments of ICE Clear Europe, correct typographical
and similar errors, and update cross-references.

C. Stress-Testing Policy

    The proposed rule change would make changes to the Stress-Testing
Policy similar to those described above for the CDS Risk Policy.
Specifically, the proposed rule change would amend the Stress-Testing
Policy to include the same provisions relating to the timing of stress
testing discussed above in the context of the CDS Risk Policy.\24\
Currently, the Stress-Testing Policy provides details regarding stress
testing scenarios and provides that ICE Clear Europe executes such
scenarios on a regular basis, but does not specify that ICE Clear
Europe conducts stress testing daily or uses standard predetermined
parameters and assumptions.
---------------------------------------------------------------------------

    \24\ Notice, 83 FR at 62639.
---------------------------------------------------------------------------

    The proposed rule change would also amend the Stress-Testing Policy
to reflect the role of the Board Risk Committee, in addition to the CDS
Risk Committee, in reviewing and overseeing stress testing.
Specifically, the proposed rule change would amend the Stress-Testing
Policy to ensure that both the CDS Risk Committee and the Board Risk
Committee are sufficiently informed to advise the Board on the safety
and soundness of the risk management approach and to provide a
mechanism for management and the committees to test the level of
protection offered in the potential stress scenarios.\25\ Under the
current policy, the Board Risk Committee, in addition to the CDS Risk
Committee, reviews and advises on stress testing results. The current
policy does not specifically require that the Board Risk Committee be
sufficiently informed to advise the Board on the safety and soundness
of the risk management approach or provide a mechanism for the Board
Risk Committee to test the level of protection offered in the potential
stress scenario, however. Thus, the proposed rule change would correct
this situation and ensure that the Board Risk Committee is sufficiently
informed to fulfill its roll under the Policy.
---------------------------------------------------------------------------

    \25\ Notice, 83 FR at 62639.
---------------------------------------------------------------------------

III. Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\26\ For the reasons given below, the Commission finds
that the proposed rule change is consistent with Section 17A(b)(3)(F)
of the Act \27\ and Rules 17Ad-22(e)(2)(i) and (v), (e)(4)(vi), and
(e)(6)(vi) thereunder.\28\
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(2)(C).
    \27\ 15 U.S.C. 78q-1(b)(3)(F).
    \28\ 17 CFR 240.17Ad-22(e)(2)(i) and (v), (e)(4)(vi), and
(e)(6)(vi).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICE Clear Europe be designed to promote the prompt and
accurate clearance and settlement of securities transactions and, to
the extent applicable, derivative agreements, contracts, and
transactions, as well as to assure the safeguarding of securities and
funds which are in the custody or control of ICE Clear Europe or for
which it is responsible, and, in general, to protect investors and the
public interest.\29\
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As discussed above, the proposed rule change would amend the CDS
Policies to provide more detail with respect to the use of the results
of periodic reviews of margin requirements and the related methodology
by ICE Clear Europe management, including second-line reviews and
reporting to ICE Clear Europe's Chief Risk Officer, President, and
senior independent director. The proposed rule change would also
specify that ICE Clear Europe's daily backtesting uses standard
predetermined parameters and assumptions and that ICE Clear Europe
conducts sensitivity analyses of its margin models and reviews
parameters and assumptions for backtesting on at least a monthly basis,
and more frequently than monthly in certain cases, as discussed above.
Similarly, the proposed rule change would specify that ICE Clear Europe
conducts stress testing once each day and that in doing so, ICE Clear
Europe uses standard predetermined parameters and assumptions, which
are reviewed on at least a monthly basis and more

frequently, as discussed above. Finally, with respect to the Back-
Testing Policy, the proposed rule change would clarify the meaning of
confidence levels used in the backtesting process and eliminate a
confidence level no longer used in backtesting.
    The Commission believes that these changes, taken as a whole, would
help to improve ICE Clear Europe's stress testing and backtesting. In
providing more detail with respect to the use of the results of
periodic reviews of margin requirements and the related methodology by
ICE Clear Europe management, including second-line reviews and
reporting to ICE Clear Europe's Chief Risk Officer, President, and
senior independent director, the Commission believes that the proposed
rule change would help to improve ICE Clear Europe's evaluation and
revision of its margin requirements, related methodology, and
parameters. The Commission believes that this, in turn, would help to
ensure that ICE Clear Europe maintains effective margin requirements,
related methodology, and parameters.
    Similarly, in specifying that stress testing is conducted daily,
the Commission believes that the proposed rule change would help
improve the effectiveness of stress testing by ensuring that it is
conducted on a regular basis. Moreover, in specifying that in
conducting backtesting and stress testing ICE Clear Europe uses
standard predetermined parameters and assumptions, the Commission
believes that the proposed rule change would help ensure the accuracy
and reliability of backtesting and stress testing. Finally, the
Commission believes that in clarifying the meaning of confidence levels
used in the backtesting process and removing a confidence level no
longer used by ICE Clear Europe, the proposed rule change would help to
ensure the effectiveness of ICE Clear Europe's backtesting process by
helping to ensure that ICE Clear Europe conducts backtesting at the
correct confidence level. Because backtesting and stress testing can
help reveal inadequacies in ICE Clear Europe's margin requirements and
the models that support those requirements, the Commission believes
that the proposed rule change would help to ensure that ICE Clear
Europe maintains effective margin requirements.
    Given that an effective margin system is necessary to manage ICE
Clear Europe's credit exposures to its Clearing Members and the risks
associated with clearing security based swap-related portfolios, the
Commission believes that the proposed rule change would help improve
ICE Clear Europe's ability to avoid losses that could result from the
mismanagement of such credit exposures and risks. Because such losses
could disrupt ICE Clear Europe's ability to promptly and accurately
clear security based swap transactions, by making the above-described
improvements to the review and reporting of ICE Clear Europe's margin
requirements and timing and scope of backtesting and stress testing,
the Commission believes that the proposed rule change would help
promote the prompt and accurate clearance and settlement of securities
transactions.
    Similarly, appropriate management of ICE Clear Europe's credit
exposures to its Clearing Members and the risks associated with
clearing security based swap-related portfolios is critical to avoiding
the realization of losses on such portfolios that could threaten ICE
Clear Europe's ability to operate, thereby threatening access to
securities and funds in ICE Clear Europe's control. Because the
proposed changes would improve ICE Clear Europe's ability to manage
such credit exposures by improving the processes ICE Clear Europe uses
to review and maintain its margin system, including backtesting and
stress testing, the Commission believes that the proposed rule change
would help assure the safeguarding of securities and funds which are in
the custody or control of ICE Clear Europe or for which it is
responsible. Finally, for both of these reasons, the Commission
believes the proposed rule change is consistent with protecting
investors and the public interest.
    Therefore, the Commission finds that the proposed rule change would
promote the prompt and accurate clearance and settlement of securities
transactions, assure the safeguarding of securities and funds in ICE
Clear Europe's custody and control, and, in general, protect investors
and the public interest, consistent with the Section 17A(b)(3)(F) of
the Act.\30\
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    \30\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Consistency With Rules 17Ad-22(e)(2)(i) and (v)

    Rules 17Ad-22(e)(2)(i) and (v) require that ICE Clear Europe
establish, implement, maintain and enforce written policies and
procedures reasonably designed to provide for governance arrangements
that are clear and transparent and specify clear and direct lines of
responsibility.\31\
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    \31\ 17 CFR 240.17Ad-22(e)(2)(i) and (v).
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    As discussed above, the proposed rule change would revise the CDS
Policies to specify the roles of various departments and committees at
ICE Clear Europe, including the role of RWG and MOC in providing
feedback and reviewing the results of ongoing monitoring of models that
support the CDS Risk Policy and update references to ICE Clear Europe
committees. The Commission believes that this change would improve the
transparency of ICE Clear Europe's governance arrangements by
clarifying the role played by various departments and committees in
following and maintaining the CDS Policies.
    With respect to the CDS Risk Policy and Back-Testing Policy
specifically, the Commission believes that the proposed rule change, in
incorporating an overall Board risk appetite and limit framework, would
help to clarify the governance around the risk appetite associated with
the CDS Risk Policy and Back-Testing Policy and make clear that the
policies are part of ICE Clear Europe's overall risk management. The
Commission similarly believes that the proposed rule change would help
improve the transparency of ICE Clear Europe's governance arrangements
in specifying that the models used to support the CDS Risk Policy and
Back-Testing Policy are subject to an annual independent validation and
governance oversight. The Commission further believes that the proposed
rule change would help ICE Clear Europe specify clear and direct
responsibility for the CDS Risk Policy and Back-Testing Policy by
assigning an owner for each policy and making that owner responsible
for ensuring that the policy remains up-to-date and is reviewed.
Similarly, the Commission believes that in making the clearing risk
department, with the support of the ROD, responsible for adherence to
the policies and relevant appetite metrics, the proposed rule change
would specify who is responsible for compliance with the polices.
Finally, the Commission believes that, in amending the CDS Risk Policy
and Back-Testing Policy to provide a new process for escalation and
reporting of any deviations from the policies, as well as compliance
with regulatory reporting and filing requirements (and make the policy
owner responsible for both), the proposed rule change would clarify the
governance arrangements with respect to deviations from the policies.
This proposed change would also make the process for escalation and
reporting consistent across all of the CDS Policies, thus further
contributing to clarity and transparency of ICE Clear Europe's
governance arrangements.
    With respect to the Stress-Testing Policy, the Commission also
believes that the proposed rule change, in

specifically requiring that the Board Risk Committee be sufficiently
informed to advise the Board on the safety and soundness of the risk
management approach, would help to ensure that the Board Risk Committee
is sufficiently informed to carry out its roll under the Policy,
thereby helping to ensure that the Board Risk Committee has a clear and
direct responsibility under the Policy.
    Finally, the Commission believes that in correcting typographical
errors and updating cross-references, as discussed above, the proposed
rule change would clarify ICE Clear Europe's governance arrangements by
helping to ensure that the CDS Policies correctly reference the
positions, departments, and/or committees responsible under the CDS
Policies.
    Therefore, for the above reasons the Commission finds that the
proposed rule change is consistent with Rules 17Ad-22(e)(2)(i) and
(v).\32\
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    \32\ 17 CFR 240.17Ad-22(e)(2)(i) and (v).
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C. Consistency With Rule 17Ad-22(e)(4)(vi)

    Rule 17Ad-22(e)(4)(vi) requires that ICE Clear Europe establish,
implement, maintain and enforce written policies and procedures
reasonably designed to effectively identify, measure, monitor, and
manage its credit exposures to participants and those arising from its
payment, clearing, and settlement processes, including by testing the
sufficiency of its total financial resources available to meet the
minimum financial resource requirements under Rule 17Ad-22(e)(4)(i)
through (iii), as applicable, by (i) conducting stress testing of its
total financial resources once each day using standard predetermined
parameters and assumptions; (ii) conducting a comprehensive analysis on
at least a monthly basis of the existing stress testing scenarios,
models, and underlying parameters and assumptions, and considering
modifications to ensure they are appropriate for determining the
required level of default protection in light of current and evolving
market conditions; (iii) conducting a comprehensive analysis of stress
testing scenarios, models, and underlying parameters and assumptions
more frequently than monthly when the products cleared or markets
served display high volatility or become less liquid, or when the size
or concentration of positions held by its participants increases
significantly; and (iv) reporting the results of its analyses to
appropriate decision makers at ICE Clear Europe, including but not
limited to, its risk management committee or board of directors.\33\
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    \33\ 17 CFR 240.17Ad-22(e)(4)(vi).
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    As discussed above, ICE Clear Europe's policies do not currently
require that stress testing be conducted daily or that it use standard
predetermined parameters and assumptions. The proposed rule change
would amend the CDS Risk Policy and Stress-Testing Policy to require
that ICE Clear Europe's clearing risk department conduct stress testing
at least once each day using standard predetermined parameters and
assumptions, which are reviewed on at least a monthly basis and more
frequently when the relevant products cleared or markets served display
high volatility or become less liquid or when the size or concentration
of positions held by Clearing Members increases or decreases
significantly. Moreover, the proposed rule change would amend the CDS
Risk Policy to provide greater detail with respect to ICE Clear
Europe's periodic reviews, including second-line review and reporting,
of margin requirements, related methodology, and parameters.
    The Commission believes that these proposed amendments would help
ensure that ICE Clear Europe complies with the requirements of Rule
17Ad-22(e)(4)(vi) by establishing standards for frequency of testing
and review and use of standard predetermined parameters and assumptions
consistent with those of the rule. Therefore, the Commission finds that
the proposed rule change is consistent with Rule 17Ad-22(e)(4)(vi).\34\
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    \34\ 17 CFR 240.17Ad-22(e)(4)(vi).
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D. Consistency With Rule 17Ad-22(e)(6)(vi)

    Rule 17Ad-22(e)(6)(vi) requires that ICE Clear Europe establish,
implement, maintain and enforce written policies and procedures
reasonably designed to cover its credit exposures to its participants
by establishing a risk-based margin system that, at a minimum is
monitored by management on an ongoing basis and is regularly reviewed,
tested, and verified by (i) conducting backtests of its margin model at
least once each day using standard predetermined parameters and
assumptions; (ii) conducting a sensitivity analysis of its margin model
and a review of its parameters and assumptions for backtesting on at
least a monthly basis, and considering modifications to ensure the
backtesting practices are appropriate for determining the adequacy of
its margin resources; (iii) conducting a sensitivity analysis of its
margin model and a review of its parameters and assumptions for
backtesting more frequently than monthly during periods of time when
the products cleared or markets served display high volatility or
become less liquid, or when the size or concentration of positions held
by participants increases or decreases significantly; and (iv)
reporting the results of its analyses under to appropriate decision
makers, including but not limited to, its risk management committee or
board of directors, and using these results to evaluate the adequacy of
and adjust its margin methodology, model parameters, and any other
relevant aspects of its credit risk management framework.\35\
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    \35\ 17 CFR 240.17Ad-22(e)(6)(vi).
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    As discussed above, ICE Clear Europe's policies do not currently
require that ICE Clear Europe use standard predetermined parameters and
assumptions in conducting backtesting nor do they provide detail
regarding sensitivity analysis. The proposed rule change would amend
the CDS Risk Policy and Back-Testing Policy to require that (i) ICE
Clear Europe's clearing risk department conduct backtesting at least
once each day using standard predetermined parameters and assumptions
and (ii) ICE Clear Europe conduct sensitivity analyses of its margin
models and review parameters and assumptions for backtesting on at
least a monthly basis, and more frequently than monthly when the
relevant products cleared or markets served display high volatility or
become less liquid or when the size or concentration of positions held
by Clearing Members increases or decreases significantly. Moreover, the
proposed rule change would amend the CDS Risk Policy to provide greater
detail with respect to ICE Clear Europe's periodic reviews, including
second-line review and reporting, of margin requirements, related
methodology, and parameters.
    The Commission believes that these proposed amendments would help
ensure that ICE Clear Europe complies with the requirements of Rule
17Ad-22(e)(6)(vi) by establishing standards for frequency of testing
and review, use of standard predetermined parameters and assumptions,
and use of sensitivity analysis consistent with those of the rule.
Therefore, the Commission finds that the proposed rule change is
consistent with Rule 17Ad-22(e)(6)(vi).\36\
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    \36\ 17 CFR 240.17Ad-22(e)(6)(vi).

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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A(b)(3)(F) of the Act
\37\ and Rules 17Ad-22(e)(2)(i) and (v), (e)(4)(vi), and (e)(6)(vi)
thereunder.\38\
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    \37\ 15 U.S.C. 78q-1(b)(3)(F).
    \38\ 17 CFR 240.17Ad-22(e)(2)(i) and (v), (e)(4)(vi), and
(e)(6)(vi).
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    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\39\ that the proposed rule change (SR-ICEEU-2018-010) be, and hereby
is, approved.\40\
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    \39\ 15 U.S.C. 78s(b)(2).
    \40\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
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    \41\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-04085 Filed 3-6-19; 8:45 am]
 BILLING CODE 8011-01-P