[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28241-28243]
[FR Doc No: 2018-12975]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2569]

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--
Questions and Answers; International Council for Harmonisation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``S9
Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and
Answers.'' The guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), formerly the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use. The guidance consists of questions
and answers that were developed to provide additional clarity about
anticancer pharmaceutical development described in the ICH guidance
``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was
published in 2010 (ICH S9 (2010)), as well as to continue progress in
the 3Rs of Reduction, Refinement, and Replacement in the use of
animals.

DATES: The announcement of the guidance is published in the Federal
Register on June 18, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2016-D-2569 for ``S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals--Questions and Answers.'' Received comments 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 office 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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John K.
Leighton, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2204, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Anne M. Pilaro, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 4023, Silver Spring, MD 20993-0002,
240-402-8341.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically-
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the ICH Association and
includes representatives from each of the ICH members and observers.
The

ICH Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidances.
    ICH S9 (2010) was a significant advance in harmonizing anticancer
drug development. Implementation of ICH S9 (2010) has revealed areas
that are open to broad and divergent interpretation by both regulatory
authorities and industry. For this reason, an Implementation Working
Group (IWG) was formed in October 2014 to provide additional clarity
about anticancer pharmaceutical development. The questions and answers
developed by the IWG are intended to facilitate the implementation of
ICH S9 (2010), as well as to continue progress in the 3Rs of Reduction,
Refinement, and Replacement in the use of animals.
    In the Federal Register of September 19, 2016 (81 FR 64178), FDA
published a notice announcing the availability of a draft guidance
entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--
Questions and Answers.'' The notice gave interested persons an
opportunity to submit comments by November 18, 2016.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in June 2016.
    The guidance provides recommendations on development of anticancer
pharmaceuticals, including small molecule and biotechnology-derived
products. The questions and answers are intended to provide clarity and
to facilitate a harmonized approach to the implementation of ICH S9
(2010). Since the publication of the draft questions and answers and
receipt of public comments, some questions were combined for brevity
and clarity or were deleted as redundant or due to lack of
harmonization. Several areas of particular importance include
additional clarity around the scope of the guidance, additional
recommendations regarding development of antibody-drug conjugates, and
the need for recovery animals in general toxicology studies.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``S9 Nonclinical Evaluation for Anticancer
Pharmaceuticals--Questions and Answers.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12975 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Notices]
[Pages 16693-16696]
[FR Doc No: 2020-06102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88410; File No. SR-NYSECHX-2020-08]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Amending
Rule 7.12 Concerning the Resumption of Trading Following a Level 3
Market-Wide Circuit Breaker Halt

March 18, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 16, 2020, the NYSE Chicago, Inc. (``NYSE Chicago''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 amend Rule 7.12 concerning the resumption
of trading following a Level 3 market-wide circuit breaker halt. The
proposed rule change is available on the Exchange's website at
www.nyse.com, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Rule 7.12 concerning the resumption
of trading following a Level 3 market-wide circuit breaker halt. The
Exchange is proposing this rule change in conjunction with other
national securities exchanges and the Financial Industry Regulatory
Authority (``FINRA'').
    Rule 7.12 provides a methodology for determining when to halt
trading in all stocks due to extraordinary market volatility (i.e.,
market-wide circuit breakers). The market-wide circuit breaker
mechanism (``MWCB'') under Rule 7.12 was approved by the Commission to
operate on a pilot basis,\4\ the term of which was to coincide with the
pilot period for the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS (the ``LULD Plan''),\5\
including any extensions to the pilot period for the LULD Plan.\6\ In
April 2019, the Commission approved an amendment to the LULD Plan for
it to operate on a

permanent, rather than pilot, basis.\7\ In light of the proposal to
make the LULD Plan permanent, the Exchange amended Rule 7.12 to untie
the pilot's effectiveness from that of the LULD Plan and to extend the
pilot's effectiveness to the close of business on October 18, 2019.\8\
The Exchange then filed to extend the pilot for an additional year to
the close of business on October 18, 2020.\9\
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    \4\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-CHX-2011-30) (approving
amendments to Article 20, Rule 2). Rule 7.12 replaced Article 20,
Rule 2 without any substantive differences. See Securities Exchange
Act Release No. 87264 (October 9, 2019), 84 FR 55345 (October 16,
2019) (SR-NYSECHX-2019-08).
    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a
mechanism to address extraordinary market volatility in individual
securities.
    \6\ See Securities Exchange Act Release Nos. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-CHX-2011-30) (Approval Order);
and 68777 (January 31, 2013), 78 FR 8673 (February 6, 2013) (SR-CHX-
2013-02) (Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Delaying the Operative Date of a Rule Change to CHX
Article 20, Rule 2).
    \7\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019).
    \8\ See Securities Exchange Act Release No. 85565 (April 9,
2019), 84 FR 15239 (April 15, 2019) (SR-NYSECHX-2019-05).
    \9\ See Securities Exchange Act Release No. 87027 (September 19,
2019), 84 FR 50484 (September 25, 2019) (SR-NYSECHX-2019-09).
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    The market-wide circuit breaker under Rule 7.12 provides an
important, automatic mechanism that is invoked to promote stability and
investor confidence during a period of significant stress when
securities markets experience extreme broad-based declines. All U.S.
equity exchanges and FINRA adopted uniform rules on a pilot basis
relating to market-wide circuit breakers in 2012 (``MWCB Rules''),
which are designed to slow the effects of extreme price movement
through coordinated trading halts across securities markets when severe
price declines reach levels that may exhaust market liquidity.\10\
Market-wide circuit breakers provide for trading halts in all equities
and options markets during a severe market decline as measured by a
single-day decline in the S&P 500 Index.
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    \10\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-
025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-
30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-
2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SR-
NYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (``MWCB
Approval Order'').
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    Pursuant to Rule 7.12, a market-wide trading halt will be triggered
if the S&P 500 Index declines in price by specified percentages from
the prior day's closing price of that index. Currently, the triggers
are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level
2), and 20% (Level 3). A market decline that triggers a Level 1 or
Level 2 halt after 9:30 a.m. ET and before 3:25 p.m. ET would halt
market-wide trading for 15 minutes, while a similar market decline at
or after 3:25 p.m. ET would not halt market-wide trading. A market
decline that triggers a Level 3 halt at any time during the trading day
would halt market-wide trading until the primary listing market opens
the next trading day.
    Today, in the event that a Level 3 market decline occurs, the
Exchange would halt trading for the remainder of the trading day, and
would not resume until the primary listing market opens the next
trading day. On the next trading day, all NYSE Group exchanges (i.e.,
the Exchange, New York Stock Exchange (``NYSE''), NYSE American, Inc.
(``NYSE American''), NYSE Arca, Inc. (``NYSE Arca''), and NYSE
National, Inc.) would remain closed for all symbols until 9:30 a.m. ET,
at which time NYSE, NYSE American, and NYSE Arca would begin their Core
Open Auction processes for their primary-listed securities.
    Upon feedback from industry participants, the Exchange has been
working with other national securities exchanges and FINRA to establish
a standardized approach for resuming trading in all NMS Stocks
following a Level 3 halt. The proposed approach would allow for the
opening of all securities the next trading day after a Level 3 halt as
a regular trading day, and is designed to ensure that Level 3 MWCB
events are handled in a more consistent manner that is transparent for
market participants.\11\
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    \11\ Of note, the U.S. futures markets, which have similar rules
for coordinated MWCB halts, normally begin their ``next day''
trading session at 6:00 p.m. ET (for CFE and CME) or at 8:00 p.m. ET
(for ICE). If the U.S. futures markets amend their MWCB rules, as
needed, to allow for normal course trading following a Level 3 halt,
the futures markets would resume trading in their normal course at
6:00 p.m. ET (CFE and CME) or 8:00 p.m. ET (ICE) the same day as the
Level 3 halt.
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    As proposed, a Level 3 halt would end at the end of the trading day
on which it is declared. This proposed change would allow for next-day
trading to resume in all NMS Stocks no differently from any other
trading day. In other words, an exchange could resume trading in any
security when it first begins trading under its rules and would not
need to wait for the primary listing market to re-open trading in a
security before it could start trading such security.\12\ Accordingly,
under the proposal, the Exchange could begin trading all securities at
the beginning of the Exchange's Early Trading Session at 7:00 a.m.
ET,\13\ regardless of whether the primary listing markets for those
securities have actually opened.
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    \12\ The Exchange anticipates that the other national securities
exchanges and FINRA will also file similar proposals to amend their
MWCB rules on the resumption of trading following Level 3 halts, and
amend their rules, where required, to have their Level 3 next-day
openings happen normally.
    \13\ Early Trading Session means the trading session that begins
at 7:00 a.m. ET and continues until 9:30 a.m. ET. See Rule
7.34(a)(1).
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    To effect this change, the Exchange proposes to delete the language
in Rule 7.12(b)(ii) requiring the Exchange to wait until the primary
listing exchange opens the next trading day following a Level 3 market
decline, and specify that the Exchange will halt trading for the
remainder of the trading day. The proposed rule change would therefore
allow each exchange to resume trading in all securities the next
trading day following a Level 3 halt at whatever time such exchange
normally begins trading under its rules, which for the Exchange would
be at the beginning of the Early Trading Session at 7:00 a.m. ET under
its current rules. The Exchange also expects that the primary listing
exchanges will facilitate this change by sending resume messages to the
applicable securities information processor (``SIP'') to lift the Level
3 trading halt message in all securities. The resumption messages will
be disseminated after the SIP has started on the next trading day and
before the start of the earliest pre-market trading session of all
exchanges. If a security is separately subject to a regulatory halt
that has not ended, the primary listing exchange would replace the
Level 3 halt message with the applicable regulatory halt message.
    Having a consistent approach for all securities will make the
opening process the day after a Level 3 halt more uniform and reduce
complexity, which the Exchange believes is important after a
significant market event. Based on industry feedback, the Exchange
believes that resuming trading in the normal course in all equity
securities will be more beneficial to the marketplace. By allowing
trading to resume after a Level 3 halt in all securities no differently
from any normal trading day under the respective rules of each
exchange, the proposed rule change would provide greater certainty to
the marketplace by ensuring a familiar experience for all market
participants that trade NMS Stocks and balances out potential concerns
around volatility. While the Exchange recognizes that the impact of
this proposal is to permit all securities to be traded in the various
exchanges' early trading sessions, which do not have certain price
protections for volatility such as LULD Bands or MWCB protections, the
Exchange nonetheless believes that this outcome is outweighed by the
benefits provided by resuming trading in the early trading sessions in
a manner that is more familiar to the marketplace. Moreover, allowing
the resumption of trading to occur on the various exchanges at the
beginning of their early trading sessions in all NMS Stocks will allow
for price formation to occur earlier in the trading

day, which in turn allows market participants to react to news that has
developed. As such, trading at the beginning of regular hours may be
more orderly.
    The Exchange will announce the implementation date of the amendment
to Rule 7.12(b)(ii) by Trader Update.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\14\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\15\ 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. The market-wide circuit breaker mechanism under Rule 7.12 is
an important, automatic mechanism that is invoked to promote stability
and investor confidence during a period of significant stress when
securities markets experience extreme broad-based declines. The
Exchange believes that the proposed rule change promotes just and
equitable principles of trade in that it promotes transparency and
uniformity across markets concerning when and how to halt trading in
all stocks as a result of extraordinary market volatility, and how the
markets will resume trading following a Level 3 market decline. As
described above, the Exchange, together with other national securities
exchanges and FINRA, is seeking to adopt a standardized approach
related to resuming trading in NMS Stocks after a Level 3 MWCB halt. In
this regard, the Exchange believes that the proposal to resume trading
in all securities following a Level 3 halt in the same manner that
securities would open trading on a regular trading day will benefit
investors, the national market system, Exchange members, and the
Exchange market by promoting a fair and orderly market and reducing
confusion during a significant cross-market event. By allowing trading
to resume after a Level 3 halt in all securities no differently from
any normal trading day under the respective rules of each exchange, the
proposed rule change would provide greater certainty to the marketplace
by ensuring a familiar experience for all market participants that
trade NMS Stocks.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
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    Based on the foregoing, the Exchange believes the benefits to
market participants from the MWCB under Rule 7.12 with the proposed
standardized process for resuming trading in all securities following a
Level 3 halt will promote fair and orderly markets, and protect
investors and the public interest.

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 because the proposed Level 3
rule change described above would standardize the opening process for
all securities on the Exchange, which would make the opening process
the day after a Level 3 halt more uniform and reduce complexity.
Further, the Exchange understands that FINRA and other national
securities exchanges will file similar proposals to adopt the proposed
Level 3 rule change.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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 \16\ and Rule 19b-4(f)(6) thereunder.\17\
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.\18\
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 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 Commission has waived the pre-filing requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \19\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\20\ 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. The Commission notes that
it approved a substantively similarly proposed rule change submitted by
The Nasdaq Stock Market LLC.\21\ Waiver of the operative delay will
ensure consistency across the market centers and the timely
implementation of the proposed rule change. Accordingly, the Commission
waives the 30-day operative delay and designates the proposed rule
change operative upon filing.\22\
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    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii).
    \21\ See Securities Exchange Act Release No. 88360 (March 11,
2020) (SR-NASDAQ-2020-03).
    \22\ 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) \23\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \23\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSECHX-2020-08 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-NYSECHX-2020-08. 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-
NYSECHX-2020-08 and should be submitted on or before April 14, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06102 Filed 3-23-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Page 46938]
[FR Doc No: 2013-18588]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR13-28-000]

St. Paul Park Refining Co. LLC v. Enbridge Pipelines (North
Dakota) LLC; Notice of Complaint

    Take notice that on July 25, 2013, St. Paul Park Refining Co. LLC
(Complainant) filed a formal complaint against Enbridge Pipelines
(North Dakota) LLC (Respondent) pursuant to sections 1(5), 3(1), 8, 9,
13(1), 15(1), and 16(1) of the Interstate Commerce Act (ICA), 49 USC
App. 1(5), 3(1), 8, 9, 13(1), 15(1), and 16(1), Rule 206 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.206, and
section 343.1(a) of the Commission's Procedural Rules Applicable to Oil
Pipeline Proceedings, 18 CFR 343.1(a), alleging that the settlement
agreement dealing with the Phase 6 Expansion Project of Enbridge
Pipelines (North Dakota) LLC is no longer fair and reasonable and that
the surcharge derived from the Settlement Agreement no longer has any
regulatory basis.
    St. Paul Park Refining Co. LLC certifies that copies of the
complaint were served on the contacts for Enbridge Pipelines (North
Dakota) LLC as listed on the Commission's list of Corporate Officials.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 5 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 14, 2013.

    Dated: July 26, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-18588 Filed 8-1-13; 8:45 am]
BILLING CODE 6717-01-P