[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 52092-52099]
[FR Doc No: 2022-18097]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95529; File No. SR-CboeBZX-2022-038]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To Amend Rule 11.28(a) To Extend the
MOC Cut-Off Time

August 17, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 5, 2022, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III 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

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'') proposes to
amend Rule 11.28(a) to extend the MOC Cut-Off Time from 3:35 p.m.
Eastern Time to 3:49 p.m. Eastern Time. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, 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
    Exchange Rule 11.28 (Cboe Market Close, a Closing Match Process for
Non-BZX-Listed Securities) provides Members an optional closing match
process for non-BZX-Listed securities, known as Cboe Market Close
(``CMC''). Currently, per Rule 11.28(a) (Order Entry) Members \3\ may
enter, cancel, or replace Market-on-Close (``MOC'') orders designated
for participation in CMC beginning at 6:00 a.m. Eastern Time \4\ up to
3:35 p.m. (``MOC Cut-Off Time''). The Exchange now proposes to move the
MOC Cut-Off Time from 3:35 p.m. to 3:49 p.m. The Exchange is not
proposing to make any other changes to the CMC process.
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    \3\ The term ``Member'' shall mean any registered broker or
dealer that has been admitted to membership in the Exchange. A
Member will have the status of a ``member'' of the Exchange as that
term is defined in Section 3(a)(3) of the Act. Membership may be
granted to a sole proprietor, partnership, corporation, limited
liability company or other organization which is a registered broker
or dealer pursuant to Section 15 of the Act, and which has been
approved by the Exchange. See Rule 1.5(n), definition of ``Member''.
    \4\ All times noted throughout are in Eastern Time.
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    By way of background, on May 5, 2017, the Exchange filed a proposed
rule change to adopt CMC, a match process for MOC orders in non-BZX
listed securities and on December 1, 2017, filed Amendment No. 1 \5\ to
that proposal (the ``Original Proposal'').\6\ On January 17, 2018, the
Commission, acting through authority delegated to the Division of
Trading and Markets,\7\ approved the Original Proposal (``Approval
Order'').\8\ On January 31, 2018, NYSE Group, Inc. (``NYSE'') and the
Nasdaq Stock Market LLC (``Nasdaq'') filed petitions for review of the
Approval Order (``Petitions for Review''). Pursuant to Commission Rule
of Practice 431(e),\9\ the Approval Order was stayed by the filing with
the Commission of a notice of intention to petition for review.\10\ On
March 1, 2018, pursuant to Commission Rule of Practice 431, the
Commission issued a scheduling order granting the Petitions of Review
of the Approval Order, and provided until March 22, 2018, for any party
or other person to file a written statement in support of, or in
opposition to, the Approval Order.\11\ On April 12, 2018, NYSE and
Nasdaq submitted written statements opposing the Approval Order and BZX
submitted a statement in support of the Approval Order.\12\ On October
4, 2018, BZX filed Amendment No. 2 \13\ to the Original Proposal.
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    \5\ The only change in Amendment No. 1 was to rename the
proposed closing match process as Cboe Market Close. Per the
Commission, because Amendment No. 1 was a technical amendment and
did not materially alter the substance of the proposed rule change
or raise unique or novel regulatory issues, Amendment No. 1 was not
subject to notice and comment.
    \6\ See Securities Exchange Act Release No. 34-80683 (May 16,
2017), 82 FR 23320 (May 22, 2017) (SR-Bats-BZX-2017-34) (Notice of
Filing of a Proposed Rule Change to Introduce Bats Market Close, a
Closing Match Process for Non-BZX Listed Securities Under New
Exchange Rule 11.28).
    \7\ 17 CFR 200.30-3(a)(12).
    \8\ See Securities Exchange Act Release No. 34-82522 (January
17, 2018), 83 FR 3205 (January 23, 2018) (SR-Bats-BZX-2017-34)
(Notice of Filing of Amendment No. 1 and Order Granting Approval of
a Proposed Rule Change, as Modified by Amendment No. 1, To Introduce
Cboe Market Close, a Closing Match Process for Non-BZX Listed
Securities Under New Exchange Rule 11.28).
    \9\ 17 CFR 201.431(e).
    \10\ See Letter to Christopher Solgan, Assistant General
Counsel, Cboe Global Markets, Inc. (Jan. 24, 2018) (providing notice
of receipt of notices of intention to petition for review of
delegated action and stay of order), available at: https://www.sec.gov/rules/sro/batsbzx/2018/sr-batsbzx-2017-34-letter-from-secretary-to-cboe.pdf.
    \11\ See Securities Exchange Act Release No. 82794, 83 FR 9561
(Mar. 6, 2018). On March 16, 2018, the Office of the Secretary,
acting by delegated authority, issued an order on behalf of the
Commission granting a motion for an extension of time to file
statements on or before April 12, 2018. See Securities Exchange Act
Release No. 82896, 83 FR 12633 (Mar. 22, 2018)
    \12\ See Statement of NYSE Group, Inc., in Opposition to the
Division's Order Approving a Rule to Introduce Cboe Market Close
(``NYSE Statement''); Statement of the Nasdaq Stock Market LLC in
Opposition to Order Granting Approval of a Proposed Rule Change, as
Modified by Amendment No. 1, to Introduce Cboe Market Close
(``Nasdaq Statement''); and Statement of Cboe BZX Exchange, Inc., in
support of Commission Staff's Approval Order (``BZX Statement''),
available at: https://www.sec.gov/comments/sr-batsbzx-2017-34/batsbzx201734.htm.
    \13\ See Securities Exchange Act Release No. 34-84670 (November
28, 2018), 83 FR 62646 (December 4, 2018) (SR-BatsBZX-2017-34)
(``Notice of Filing of Amendment No. 2 to Proposed Rule Change to
Introduce Cboe Market Close, a Closing Match Process for Non-BZX
Listed Securities Under New Exchange Rule 11.28'').
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    The Commission conducted a de novo review of the CMC proposal and
associated public record, including

Amendment No. 2, the Petitions for Review, and all comments and
statements submitted by certain exchanges, issuers, and other market
participants,\14\ to determine whether the proposal was consistent with
the requirements of the Act and the rules and regulations issued
thereunder that are applicable to a national securities exchange.\15\
The Commission noted that under Rule 700(b)(3) of the Commission's Rule
of Practice, the ``burden to demonstrate that a proposed rule change is
consistent with the Exchange Act and the rules and regulations issued
thereunder . . . is on the self-regulatory organization that proposed
the rule change.'' \16\
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    \14\ See ``Statements on File No. SR-BatsBZX-2017-34'',
available at: https://www.sec.gov/comments/sr-batsbzx-2017-34/batsbzx201734.htm.
    \15\ See Securities Exchange Act Release No. 34-88008 (January
21, 2020), 85 FR 4726 (January 27, 2020) (SR-BatsBZX-2017-34)
(``Order Setting Aside Action by Delegated Authority and Approving a
Proposed Rule Change, as Modified by Amendments No. 1 and 2, To
Introduce Cboe Market Close, a Closing Match Process for Non-BZX
Listed Securities Under New Exchange Rule 11.28'').
    \16\ Id.
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    Importantly, after reviewing the entire record, the Commission
concluded that BZX met its burden to show that the proposed rule change
was consistent with the Act, and pursuant to its January 21, 2020,
order, set aside the Approval Order and approved BZX's CMC proposal, as
amended (``Final Approval Order'').\17\ Notably, the Commission stated
that the record ``demonstrate[d] that Cboe Market Close should
introduce and promote competitive forces among national securities
exchanges for the execution of MOC orders'' \18\ and that ``the record
demonstrate[d] that Cboe Market Close should not disrupt the closing
auction price discovery process nor should it materially increase the
risk of manipulation of official closing prices''.\19\ For the reasons
discussed more fully below, the Exchange believes that when applying
the Commission's analysis in the Final Approval Order to the current
proposal, such review would similarly conclude that this proposal is
consistent with the Act and should be approved.
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    \17\ Id.
    \18\ Id.
    \19\ Id.
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    Since the Original Proposal various exchanges have extended the MOC
cut-off times for their closing auctions, moving them closer to 4:00
p.m.\20\ Additionally, closing price match services offered by off-
exchange venues have grown in popularity,\21\ including alternative
trading systems (``ATS'') that offer a MOC cut-off time as close as 30-
seconds before the primary exchanges' cut-off times, as well as MOC
cut-off times aligned with those of NYSE, NYSE Arca, and Nasdaq.\22\ As
the market structure for closing auctions and closing price match
offerings has continued to evolve, and in response to customer feedback
and to better compete with off-exchange venues, the Exchange is
proposing this rule change to align CMC's MOC Cut-Off time more closely
with the other exchanges and off-exchange venues.
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    \20\ See Securities Exchange Act Release No. 34-84454 (October
19, 2018), 83 FR 53923 (October 25, 2018) (SR-Nasdaq-2018-068)
(Order approving a rule change by NYSE) (The Commission approved a
rule change by Nasdaq to move the cut-off times for the entry of MOC
and LOC orders from 3:50 p.m. to 3:55 p.m.); see also Securities
Exchange Act Release No. 34-85021 (January 31, 2019) (SR-NYSE-2018-
58) (Order approving a rule change by Nasdaq) (The Commission
approved a rule change by the NYSE to amend Rule 123C to extend the
cut-off times for order entry and cancellation for participation in
the closing auction, from 3:45 p.m. to 3:50 p.m.).
    \21\ See infra, ``Price Discovery and Fragmentation'', which
describes the growth of off-exchange closing volume.
    \22\ For example, JP Morgan Securities' ATS, JPB-X, offers Close
Price Match. This functionality utilizes a conditional order process
to match orders and crosses them at the security's official closing
prices, as determined by the closing auction at the primary exchange
for a security. The Close Price Match time for an NMS stock is
currently 30-seconds before the MOC cut-off time for that stock's
primary exchange. Additionally, Instinet, LLC's ATS, CBX provides
for three MOC Crossing Sessions, which consist of: a cross for
securities where the primary listing exchange is the Nasdaq
(``Nasdaq Cross''), a cross for securities where the primary listing
exchange is the NYSE Arca (``Arca Cross''), and a cross for
securities where the primary listing exchange is the NYSE (``NYSE
Cross''). Subscribers may submit orders for the MOC Crosses at any
time between 7:30 a.m. and the relevant crossing session's crossing
time. See Form ATS-N, JPB-X, available at: https://www.sec.gov/Archives/edgar//data/782124/000/xslATS-N_X01/primary_doc.xml; see
also Form ATS-N, Instinet, LLC's ATS, CBX, available at: https://www.sec.gov/Archives/edgar/data/310607/000031060722000009/xslATS-N_X01/primary_doc.xml.
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    The Exchange notes that Members have requested a MOC Cut-Off Time
that is closer to the end of Regular Trading Hours \23\ so that they
may retain control of their trading for a longer period and be better
able to manage their trading at the close.\24\ Generally speaking,
notional trading and trading volatility are typically at their highest
towards the end of Regular Trading Hours. Accordingly, market
participants often prefer to trade as close to 4:00 p.m. as possible,
because doing so can provide them with more time to seek better priced
liquidity for their orders in a variety of ways, including but not
limited to, finding contra-side liquidity in the marketplace and
trading directly against such interest, or guaranteeing a customer
order at a price better than the national best bid or offer by
committing capital to an order and filling it in a principal capacity,
as well as continuing to trade orders algorithmically into the close,
thus reducing the size of their outstanding orders that they may decide
to commit to CMC or the primary auctions.
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    \23\ The term ``Regular Trading Hours'' means the time between
9:30 a.m. and 4:00 p.m. Eastern Time. See Rule 1.2(w), definition
of, ``Regular Trading Hours.''
    \24\ The Exchange notes that part of its rationale for extending
CMC's MOC Cut-Off Time is substantively identical to that of other
exchanges moving their cut-off times later, namely, NYSE and Nasdaq.
See Securities Exchange Act Release No. 34-83988 (August 29, 2018),
86 FR 18580 (September 5, 2018) (SR-Nasdaq-2018-068)
(``Specifically, the Exchange believes that extending the cutoff
times for submitting on close orders will allow market participants
to retain control over their orders for a longer period of time, and
thereby assist those market participants in managing their trading
at the close.''); see also Securities Exchange Act Release No. 34-
84804 (December 12, 2018), 83 FR 64910 (December 18, 2018) (SR-NYSE-
2018-58) (``The Exchange believes that extending the cut-off times
for entry and cancellation of MOC and LOC Orders, cancellation of CO
orders, as well as when the Exchange would begin disseminating Order
Imbalance Information for the close would . . . allow market
participants to retain control over their orders for a longer period
of time, and thereby assist those market participants in managing
their trading at the close.'').
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    Additionally, Members have indicated that extending the MOC Cut-Off
Time to 3:49 p.m. will help to make CMC a more comparable alternative
to NYSE and Nasdaq, which have MOC cut-off times of 3:50 p.m.\25\ and
3:55 p.m.,\26\ respectively. For reasons discussed directly above, cut-
off times closer to 4:00 p.m. are beneficial to market participants,
and by extending CMC's MOC Cut-Off Time to 3:49 p.m., CMC will be
better positioned to serve as a viable option for market participants
to consider when deciding which venues to route their MOC orders, thus
enhancing intermarket competition.
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    \25\ See NYSE Rule 73.5(a)(8), Closing Auction Imbalance Freeze
Time.
    \26\ See Nasdaq Rule 4702(b)(11)(A), Market On Close Order.
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    The Exchange also notes that today's market participants, including
users of CMC,\27\ are technologically equipped \28\

to handle a 3:49 p.m. MOC Cut-Off time. As a general mater, today's
market participants, including CMC users, rely on electronic smart
order routers, order management systems, and trading algorithms, which
make routing and trading decisions on an automated basis, in times
typically measured in microseconds. In this regard, the Exchange
believes that if a CMC user receives a message that their MOC order was
not matched in CMC,\29\ such CMC user will have more than enough time
to reroute their MOC order to the primary exchange. Importantly, the
Exchange discussed the proposed change with both current CMC users and
potential new CMC users to gauge whether a MOC Cut-Off Time one-minute
closer to the NYSE cut-off time, and six-minutes closer to the Nasdaq
cut-off time, would present operational or technological challenges,
and confirmed that CMC users can in fact manage the proposed change.
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    \27\ Users of CMC are mainly broker-dealers that trade
electronically, utilizing a variety of automated trading tools such
as algorithmic strategies and routing protocols.
    \28\ The Exchange notes that today's equities markets involve
the widespread use of automated trading algorithms and routing
solutions, as well market connectivity options with speeds often
measured in microseconds. In this regard, a MOC Cut-Off Time of 3:49
p.m. should not present any operational or technological issues, in
terms of timing, for Members desiring to reroute any unmatched CMC
MOC orders to the primary exchanges. Should Members need additional
time to decide whether to send their CMC MOC orders to other
exchanges, Members may still cancel their CMC MOC orders any time
prior to 3:49 p.m. or may voluntarily choose to not participate in
CMC. See generally ``Staff Report on Algorithmic Trading in U.S.
Capital Markets'' (August 5, 2020), available at https://www.sec.gov/tm/reports-and-publications/special-studies/algo_trading_report_2020. (``Over the past decade, the `manual
handling of institutional orders is increasingly rare and has been
replaced by sophisticated institutional order execution algorithms
and smart order routing systems' '') (``The secondary market for
U.S.-listed equity securities that has developed within this
structure is now primarily automated. The process of trading has
changed dramatically primarily as a result of developments in
technologies for generating, routing, and executing orders, as well
as by the requirement imposed by law and regulation.'') (``Modern
equity markets are connected in part by the data flowing between
market centers. An enormous volume of data is available to market
participants. In recent years, there has been an exponential growth
in the amount of market data that is available, the speed with which
it is disseminated, and the computer power used to analyze and react
to price movements.'')
    \29\ The CMC Closing Match Process--i.e., the matching of all
buy and sell MOC orders entered into the System by time priority at
the MOC Cut-Off Time, the electronic notification to Members of any
unmatched MOC orders, and the dissemination by the Exchange of the
total size of all buy and sell orders matched via CMC via the Cboe
Auction Feed--generally occurs within microseconds. As such, a MOC
Cut-Off Time one-minute prior to the primary exchanges' cut-off
times is a sufficient period of time for Members to reroute their
unmatched MOC orders to the primary exchanges, should they choose to
do so.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\30\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \31\ requirements that the rules
of an exchange be designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \32\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \30\ 15 U.S.C. 78f(b).
    \31\ 15 U.S.C. 78f(b)(5).
    \32\ Id.
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    In particular, the Exchange believes that moving the MOC Cut-Off
Time to 3:49 p.m. would remove impediments to and perfect the mechanism
of a free and open market and a national market system because it would
allow Members to retain control over their orders for a longer period,
thereby assisting market participants in managing their trading at the
close. As discussed more fully above, market participants may prefer to
trade as close to 4:00 p.m. as possible, because doing so can provide
them with more time to seek better priced liquidity for their orders in
a variety of ways, as well as give them more time to determine the size
of their outstanding orders that they may decide to commit to CMC or
the primary auctions.
    Additionally, the Exchange believes that a MOC Cut-Off Time
fifteen-minutes (15) prior to NYSE's cut-off time, and twenty-five-
minutes (25) prior to Nasdaq's cut-off time, is no longer necessary.
Rather, the Exchange notes that today's market participants are
technologically equipped \33\ to handle a 3:49 p.m. MOC Cut-Off time.
As discussed above, today's market participants rely on electronic
smart order routers, order management systems, and trading algorithms,
which make routing and trading decision on an automated basis, in times
often measured in microseconds. As such, Members are technologically
equipped to efficiently respond to CMC's publication of matched shares
and should they so choose, reroute any unmatched MOC orders to the
respective primary closing auction. As noted above, the Exchange
discussed the extension of the MOC Cut-Off Time with CMC users and
confirmed that the proposed MOC Cut-Off Time will not present them with
any operational or technological issues.
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    \33\ Supra note 28.
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    Furthermore, the Exchange believes that the extension of cut-off
times by the primary exchanges since CMC's proposal, as well as the
growth of off-exchange venues \34\ with cut-off times in such close
proximity to the end of Regular Trading Hours is indicative of Members'
desires for such offerings. Logically, such a change in market
structure would not have occurred if Members did not already possess
the operational and technological wherewithal to effectively manage the
multitude of cut-off times offered by the exchanges and off-exchange
venues.
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    \34\ Supra note 22.
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    Moreover, the Exchange believes that the proposed rule change will
remove impediments to and perfect the mechanism of a free and open
market and a national market system because extending the MOC Cut-Off
Time to 3:49 p.m. would more closely align the CMC MOC Cut-Off Time to
the cut-off times in place for the other exchanges.\35\ For the reasons
discussed more fully above, the primary exchanges' cut-off times are
beneficial to market participants because of their proximity to 4:00
p.m. By moving the MOC Cut-Off Time closer to the other exchanges' cut-
off times, CMC can become a comparable alternative for Members to route
their unpriced MOC orders. Importantly, even with a MOC Cut-Off Time
closer to the primary exchanges' cut-off times, CMC removes any
perceived impact on the primary listing markets' close by publishing
the number of matched order shares, by security, in advance of the
primary markets' cut-off time. The total matched shares would still be
disseminated by the Exchange free of charge via the Cboe Auction Feed,
albeit at the new proposed MOC Cut-Off Time of 3:49 p.m. Because of the
speeds and widespread use of market technology, this information can
still be used by the primary markets' closing processes, and as
discussed above, CMC users will still have ample time \36\ to reroute
any MOC orders not matched via CMC to reach the primary market to be
included in their closing auction process.
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    \35\ As noted above, NYSE's cut-off time is 3:50 p.m., and
Nasdaq's cut-off time is 3:55 p.m. NYSE Arca's cut-off time for MOC
orders id 3:59 p.m. See ``Trading Information--Closing Auctions'',
available at: https://www.nyse.com/market/nyse-arca/trading-info.
    \36\ Supra note 28.
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    Additionally, the proposed rule change would more closely align
CMC's MOC Cut-Off Time with that of off-exchange venues that offer cut-
off times aligned with those currently offered by the primary
exchanges, and as little as

30-seconds prior to market close.\37\ As such, the Exchange believes
that the proposed rule change is supported by both ample precedent as
well as current market structure, and should not present any new or
novel issues that market participants must consider when managing their
trading and determining which exchange or off-exchange venue to route
their MOC orders.
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    \37\ Supra note 22.
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Price Discovery \38\
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    \38\ As part of this proposed rule change the Exchange is
addressing several questions considered by the Commission in
connection with the Exchange's Original Proposal, including price
discovery and fragmentation, market complexity and operational risk,
and manipulation. Importantly, in considering these questions, the
Commission found that based on CMC's design and the record before
the Commission, that the proposal was consistent with Section
6(b)(5) of the Act. Supra note 15.
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    The Exchange believes that the proposed rule change is consistent
with the Section 6(b)(5) requirements.\39\ As previously noted by the
Exchange,\40\ CMC accepts and matches only unpriced MOC orders. By
matching only unpriced MOC orders, and not Limit-On-Close (``LOC'')
orders and executing those matched MOC orders that naturally pair off
with each other and effectively cancel each other out, CMC is designed
to avoid impacting price discovery. While the proposed rule change
would have CMC accept MOC orders up to 3:49 p.m., such extension will
not change this underlying functionality. As previously noted by the
Exchange,\41\ matched MOC orders are merely recipients of price
formation and do not directly contribute to the price formation
process. Indeed, in its Final Approval Order for CMC, even the
Commission noted that unpriced, paired-off MOC orders do not directly
contribute to setting the official closing price of securities on the
primary listing exchanges but, rather, are inherently the recipients of
price formation information.\42\
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    \39\ The Exchange notes that the Commission, in its Final
Approval Order, carefully analyzed and considered CMC and its
potential effects, if any, on the primary listing exchanges' closing
auctions, including their price discovery functions. Importantly,
the Commission found that, based on CMC's design, CMC should not
disrupt the price discovery process in the closing auctions of the
primary listing exchanges. Supra note 15.
    \40\ See Letter from Joanne Moffic-Silver, Executive Vice
President, General Counsel, and Corporate Secretary, Bats Global
Markets, Inc. (August 2, 2017), available at: https://www.sec.gov//batsbzx-2017-34/batsbzx201734-2162452-157801.pdf; see also Letter
from Joanne Moffic-Silver (October 11, 2017), available at: https://www.sec.gov/comments/sr-batsbzx-2017-34/batsbzx201734-2634580-161229.pdf.
    \41\ Id.
    \42\ Supra note 15.
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    Moreover, the Exchange believes that even if extending the MOC Cut-
Off Time to 3:49 p.m. reduces the number of MOC orders routed to a
security's primary listing market, CMC is designed to remove any
perceived adverse impact on the primary listing markets' close because
the total matched shares would still be disseminated by the Exchange
free of charge via the Cboe Auction Feed prior to the primary
exchanges' cut-off times. Additionally, because of the technological
capabilities of today's market participants discussed more fully above,
this information can still be incorporated by the primary markets'
closing processes, and CMC users will still have ample time \43\ to
reroute any MOC orders not matched via CMC to the primary markets to be
included in their closing auction processes.
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    \43\ Supra note 28.
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Fragmentation \44\
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    \44\ Supra note 38.
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    Another matter addressed by the Commission in their review of the
Initial Proposal was fragmentation, and whether CMC would fragment the
markets beyond what currently occurs through off-exchange close price
matching venues.\45\ Importantly, as illustrated in the chart below, an
analysis by the Exchange shows that the closing auction volume on both
NYSE and Nasdaq has increased since the launch of CMC on March 6, 2022.
As such, the Exchange believes that the initial fragmentation concerns
raised by commenters during the Initial Proposal have not materialized,
and that merely extending the MOC Cut-Off Time, while leaving all other
CMC functionality intact, will not result in increased market
fragmentation.
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    \45\ Supra note 15.
    [GRAPHIC] [TIFF OMITTED] TN24AU22.000

    The Exchange also notes that even if the proposed rule change
results in fewer MOC orders participating in the primary exchanges'
closing auctions, that the fragmentation of MOC orders already occurs
in today's markets on off-exchange venues. As illustrated in the first
two charts below, a growing proportion of trading volume at the close
occurs on off-exchange venues, where the TRF close volume, as a percent
of Exchange close volume, has risen steadily since January 2019.\46\ In
the third chart the Exchange also studied the top ten most actively
traded securities during the same time period and found that a
significant portion of the total closing volume is executed off-
exchange, following the dissemination of the official closing price.
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    \46\ The Exchange conducted an analysis of off-exchange/Trade
Reporting Facility (``TRF'') closing volume that occurs after market
close, 4:00 p.m. Eastern Time, where the price is equal to the
closing price and for which such trades are reported with a Prior
Reference Price (``PRP'') trade reporting modifier. The TRF is a
trade reporting facility where FINRA members may report trades in
Nasdaq-listed and other exchange-listed securities, that were
executed otherwise than on an exchange. The first two charts
represent TRF executed volume at the close with the ``PRP'' flag
that equals the closing auction price, divided by total on exchange
auction volume.
---------------------------------------------------------------------------

BILLING CODE 8011-01-P
[GRAPHIC] [TIFF OMITTED] TN24AU22.001

[GRAPHIC] [TIFF OMITTED] TN24AU22.002

----------------------------------------------------------------------------------------------------------------
                                                                                TRF close %
                  Rank                             Symbol                 Primary exchange        inc. PRP \47\
----------------------------------------------------------------------------------------------------------------
1......................................  AAPL......................  Nasdaq....................                9
2......................................  T.........................  NYSE......................                6
3......................................  BAC.......................  NYSE......................               10
4......................................  INTC......................  Nasdaq....................                5
5......................................  MSFT......................  Nasdaq....................                7
6......................................  F.........................  NYSE......................                9
7......................................  PFE.......................  NYSE......................                5
8......................................  CSCO......................  Nasdaq....................                5
9......................................  CMCSA.....................  Nasdaq....................                7

10.....................................  WFC.......................  NYSE......................                9
----------------------------------------------------------------------------------------------------------------
Source: Internal Exchange Data.

BILLING CODE 8011-01-C
    Accordingly, the Exchange believes that approving this proposal
will allow the Exchange to compete on a more equal playing field with
off-exchange venues for closing volume already being executed away from
the primary listing venues. In better competing with off-exchange
venues, CMC can help increase transparency, reliability, and price
discovery by encouraging market participants that would otherwise seek
to match MOC orders off-exchange to re-direct their MOC orders to BZX,
a public exchange. Moreover, by attracting such order flow, CMC can
help to increase the amount of volume at the close executed on systems
subject to the resiliency requirements of Regulation SCI.\48\
---------------------------------------------------------------------------

    \47\ As defined above, ``PRP''.
    \48\ See Letter from Joanne Moffic-Silver, Executive Vice
President, General Counsel, and Corporate Secretary, Bats Global
Markets, Inc., a Cboe Company (Oct. 11, 2017) (``The Proposal is
further consistent with the Commission's assertion that closing
auctions are critical SCI systems . . . [CMC] would provide a much
needed, seamless, and easy way for the industry to address the
single point of failure risk that exists for closing auctions today,
especially when a primary listing market is experiencing system
issues and lacks full operational capability. As Bats previously
asserted, in the event of a system's disruption at the primary
listing market, [CMC] could provide an alternative pool of liquidity
to which market participants could send MOC orders for execution at
the official closing price. Therefore, it promotes just and
equitable principles of trade and competition among national
securities exchanges. [CMC] would also remove impediments to and
perfect the mechanism of a free and open market and a national
market system by providing a mechanism for market participants to
execute their orders at the official closing price should a system
disruption on the primary listing market prevent them from entering
orders.''); (``Furthermore, [CMC] would operate on the Exchange's
reliable SCI systems . . . significant MOC liquidity is conducted
today by off-exchange venues. These venues are not SCI systems and,
therefore, not subject to Regulation SCI's enhanced resiliency
requirements. [CMC] could attract MOC orders from these off-exchange
venues and its reliable SCI system, furthering the Commission's
presumed desire for liquidity at the close to be conducted on SCI
systems.'')
---------------------------------------------------------------------------

Market Complexity and Operational Risk \49\
---------------------------------------------------------------------------

    \49\ Supra note 38.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is simple and
straightforward, and as such will not significantly increase market
complexity or operational risk. The Exchange seeks only to extend the
MOC Cut-Off Time to 3:49 p.m., leaving all other aspects of the CMC
process intact. Members will not have to consider new operational
requirements of monitoring and consuming a new data feed or consider
the utilization of a new order type or implementation of new Exchange
code. Rather, Members may continue to monitor the same data feed as
they do today, the Cboe Auction Feed, and simply look for the
publication of the CMC information at the new proposed MOC Cut-Off
Time.
    Additionally, as discussed more fully above, the Exchange discussed
this proposal with current CMC users prior to submitting this proposal
and learned that CMC users are technologically equipped to manage a MOC
Cut-Off Time closer to the primary exchanges' cut-off times, and that
they can respond to CMC's publication of matched shares and quickly
reroute any unmatched MOC orders to the respective primary closing
auction. Moreover, CMC is a voluntary offering, and Members may freely
decide whether to participate.
    Furthermore, as noted throughout, both off-exchange venues and
other exchanges already offer MOC cut-off times that are closer in time
to the end of Regular Trading Hours. Specifically, as mentioned above,
in 2018 Nasdaq received approval to move the cut-off times for the
entry of MOC and Limit-On-Close (``LOC'') orders from 3:50 to 3:55
p.m.\50\ Similarly, in 2018 the NYSE received approval from the SEC to
extend their cut-off times for order entry and cancellation for
participation their closing auction, from 3:45 p.m. to 3:50 p.m.\51\
NYSE also offers discretionary-orders, which unlike MOC/LOC orders that
are subject to NYSE's 3:50 p.m. cut-off, may be entered for
participation in the closing auction until 3:59:50.\52\ Additionally,
market participants may enter MOC orders for participation in NYSE
Arca's closing auction up to 3:59 p.m..\53\ Finally, various off-
exchange venues offer closing match processes with cut-off times
aligned with those of the primary exchanges, and even as close to 30-
seconds before market close, 4:00 p.m.\54\
---------------------------------------------------------------------------

    \50\ Supra note 20.
    \51\ Id.
    \52\ See NYSE Rule 7.31 (c)(2)(C); see also ``The Floor Broker's
Modern Trading Tool'', available at: https://www.nyse.com/article/trading/d-order (``While D Orders are available for use throughout
the trading day, most executions occur in the closing auction, where
they're known as Closing D Orders. At 3:55 p.m., Closing D Order
interest eligible to participate in the closing auction is added to
the order imbalance feed at their discretionary price range. Closing
D Orders can also be submitted, modified or cancelled up to 3:59:50
p.m. These distinct features of Closing D Orders are designed to
facilitate the Floor Broker's traditional agency role on behalf of
larger institutional interest, allowing Floor Brokers to work in
conjunction with their customer to find larger liquidity
opportunities.'').
    \53\ See ``Closing Auction Timeline'', available at: https://www.nyse.com/markets/nyse-arca/trading-info.
    \54\ Supra note 22.
---------------------------------------------------------------------------

    Accordingly, the Exchange believes that market participants are
well accustomed to managing the various cut-off times in today's
marketplace, and in incorporating these timelines into their trading
decisions. The number of exchanges and off-exchange venues with
extended cut-off times indicates that market participants find value in
their ability to retain control of their trading heading into the end
of Regular Trading Hours, and the exchanges and off-exchange venues
have responded to such demand. Certainly, market participants would not
desire cut-off times closer to the end of Regular Trading Hours if they
could not technologically and operationally manage their trading
accordingly. Therefore, the extension of CMC's MOC Cut-Off Time should
not present market participants with any novel operational or
technological complexities.
Manipulation \55\
---------------------------------------------------------------------------

    \55\ Supra note 38.
---------------------------------------------------------------------------

    The Exchange does not expect that the proposed extension of the MOC
Cut-Off Time to 3:49 p.m. will result in an increase of manipulative
activity due to information asymmetries, or raise any unique
manipulation concerns relative to how CMC exists today with a current
MOC Cut-Time of 3:35 p.m. Specifically, any information CMC
participants may be able to glean from their paired-off MOC orders, or
from their unmatched MOC orders, is still limited in nature. For
instance, any information that CMC participants may learn from
receiving unmatched MOC order messages is still limited in nature
because the CMC participant would still only know the unexecuted size
of its own order.\56\ Moreover, even if a

Member chose to participate in CMC only to gather information about the
direction of an imbalance and use such information to manipulate the
closing price, the Member's orders were still eligible for execution.
Thus, in addition to any such information being of limited use, the
Member's actions still do not provide them with free information
unavailable to other market participants because the Member's orders
were eligible to for execution, subjecting the Member to economic risk.
---------------------------------------------------------------------------

    \56\ The Exchange notes that in its Final Approval Order, even
the Commission noted that, ``In particular, a market participant
would only be able to determine the direction of the imbalance and
would have difficulty determining the magnitude of any imbalance, as
it would only know the unexecuted size of its own order. In
addition, the information would only be with regard to the pool of
liquidity on BZX and would provide no insight into imbalances on the
primary listing exchange, competing auctions, ATSs, or other off-
exchange matching services which, as described above, can represent
a significant portion of trading volume at the close.'' Supra note
15.
---------------------------------------------------------------------------

    Furthermore, as with the current MOC Cut-Off Time, the proposed
extension does not present any information asymmetries that do not
already exist in today's markets, as the very nature of trading creates
short term asymmetries of information to those who are parties to a
trade.\57\ Indeed, as noted by the Commission, any party to a trade
gains valuable insight regarding the depth of the market when an order
is executed or partially executed.\58\ Additionally, NYSE imbalance
information is already disseminated to NYSE floor brokers, who are
permitted to share with their customers specific data from the
imbalance feed.\59\ Even in this case, though, the Commission stated
that the value of such information is limited because the imbalance
information does not represent overall supply and demand for a
security, is subject to change, and is only one relevant piece of
information.\60\ Similarly, because any information gleaned by a CMC
participant is limited only to the unexecuted size of their order, and
relative to the depth of only the BZX pool of liquidity, the Exchange
believes that the proposed extension of the MOC Cut-Off Time does not
create an increased risk of manipulative trading activity.
---------------------------------------------------------------------------

    \57\ The Exchange further notes that in its approval order, even
the Commission noted that, ``Further, the Commission believes
information asymmetries as those described by commenters exist today
and are inherent in trading, including with respect to closing
auctions. For example, any party to a trade gains valuable insight
regarding the depth of the market when an order is executed or
partially executed.'' Id.
    \58\ Id.
    \59\ Id.
    \60\ Id.
---------------------------------------------------------------------------

    While this proposal would result in the total shares for buy and
sell orders in CMC being disseminated closer in time to the primary
exchanges' cut-off times, this change does not suddenly make the value
of such information more valuable or useful in terms of enhancing
opportunities for gaming and manipulating the official closing price.
The proposed MOC Cut-off Time is one-minute prior to NYSE's cut-off
time of 3:50 p.m., and six-minutes prior to Nasdaq's cut-off time of
3:55 p.m. As noted above, today's markets are marked by technological
solutions which typically operate in durations of microseconds. In this
context, the separation between the CMC MOC Cut-Off Time and that of
NYSE's and Nasdaq's is a substantial duration of time, during which
much can change in the marketplace, thus limiting the value of
information, if any, that can be gleaned from CMC's dissemination of
matched shares at 3:49 p.m. Moreover, there are currently controls and
processes in place to monitor for manipulative trading activity, such
as the supervisory responsibilities and capabilities of exchanges and
the expansive cross market surveillance conducted by FINRA. Following
approval of this proposal, the Exchange, FINRA and others will continue
to surveil for potential manipulative activity and when appropriate,
bring enforcement actions against market participants engaged in
manipulative trading activity.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. Rather, the proposed rule
change seeks merely to extend the MOC Cut-Off Time from 3:35 p.m. to
3:49 p.m., enabling all Members to manage their trading for a longer
period. The Exchange is not proposing to make any other changes to the
CMC process. Moreover, CMC is a voluntary closing match process, and
Members are not required to participate in the CMC. Additionally, the
proposed rule change applies to equally to all Members. Importantly,
based on feedback from CMC users, the proposed MOC Cut-Off Time will
not prevent CMC's current user's from participating in CMC, as CMC's
current users are technologically equipped to manage a 3:49 p.m. MOC
Cut-Off Time, and should they choose to do so, reroute MOC orders not
matched in CMC to the primary exchanges' closing auctions.
    Furthermore, the Exchange does not believe that the proposed rule
change will impose any burden on intramarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act. As
noted above, the proposed rule change more closely aligns the CMC MOC
Cut-Off Time to the cut-off times of other exchanges, while still
providing CMC participants with an opportunity to reroute any of their
unpaired MOC orders to the primary exchanges. In this regard, the
proposed rule change may make CMC a more viable alternative to the
primary auctions and should therefore promote competition amongst the
exchanges. Additionally, the proposed MOC Cut-Off Time may also enable
the Exchange to more effectively compete with off-exchange venues that
have cut-off times much closer in time to the market close and comprise
a growing percentage of closing volume.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeBZX-2022-038 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-CboeBZX-2022-038. 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-CboeBZX-2022-038 and should be submitted
on or before September 14, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\61\
---------------------------------------------------------------------------

    \61\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-18097 Filed 8-23-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Proposed Rules]
[Pages 61145-61146]
[FR Doc No: 2016-21357]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 /
Proposed Rules

 DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Part 382

[Docket No. DOT-OST-2015-0246]
RIN 2105-AE12

Nondiscrimination on the Basis of Disability in Air Travel:
Negotiated Rulemaking Committee Fifth Meeting

AGENCY: Office of the Secretary, Department of Transportation.

ACTION: Notice of fifth public meeting of advisory committee.

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

SUMMARY: This notice announces the fifth meeting of the Advisory
Committee on Accessible Air Transportation (ACCESS Advisory Committee).

DATES: The fifth meeting of the ACCESS Advisory Committee will be held
on September 21-23, from 9:00 a.m. to 5:00 p.m., Eastern Daylight Time.

ADDRESSES: The meeting will be held at the Ritz Carlton, Pentagon City,
1250 Hayes Street, Arlington, VA 22202. Attendance is open to the
public up to the room's capacity of 150 attendees. Since space is
limited, any member of the general public who plans to attend this
meeting must notify the registration contact identified below no later
than September 14, 2016.

FOR FURTHER INFORMATION CONTACT: To register to attend the meeting,
please contact Kyle Ilgenfritz<EMAIL_ADDRESS>703-442-4575
extension 128). For other information, please contact Livaughn Chapman
or Vinh Nguyen, Office of the Aviation Enforcement and Proceedings,
U.S. Department of Transportation, by email at<EMAIL_ADDRESS>or<EMAIL_ADDRESS>or by telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Fifth Public Meeting of the ACCESS Committee

    The fifth meeting of the ACCESS Advisory Committee will be held on
September 21-23, 2016, from 9:00 a.m. to 5:00 p.m., Eastern Daylight
Time. The meeting will be held at the Ritz Carlton, Pentagon City, 1250
Hayes Street, Arlington, VA 22202. At the meeting, the ACCESS Advisory
Committee will continue to address whether to require accessible
inflight entertainment (IFE) and strengthen accessibility requirements
for other in-flight communications, whether to require an accessible
lavatory on new single-aisle aircraft over a certain size, and whether
to amend the definition of ``service animals'' that may accompany
passengers with a disability on a flight. We expect to negotiate on
proposals to amend the Department's disability regulation regarding one
or more of these issues. Prior to the meeting, the agenda will be
available on the ACCESS Advisory Committee's Web site,
www.transportation.gov/access-advisory-committee. Information on how to
access advisory committee documents via the FDMC is contained in
Section III, below.
    The meeting will be open to the public. Attendance will be limited
by the size of the meeting room (maximum 150 attendees). Because space
is limited, we ask that any member of the public who plans to attend
the meeting notify the registration contact, Kyle Ilgenfritz
<EMAIL_ADDRESS>703-442-4575 extension 128) at Linkvisum,
no later than September 14, 2016. At the discretion of the facilitator
and the Committee and time permitting, members of the public are
invited to contribute to the discussion and provide oral comments.

II. Submitting Written Comments

    Members of the public may submit written comments on the topics to
be considered during the meeting by September 15, 2016, to FDMC, Docket
Number DOT-OST-2015-0246. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. DOT recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that DOT can contact you if there are questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, DOT-OST-2015-0246, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit. If you submit your comments by
mail or hand delivery, submit them in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing.

III. Viewing Comments and Documents

    To view comments and any documents mentioned in this preamble as
being available in the docket, go to www.regulations.gov. Enter the
docket number, DOT-OST-2015-0246, in the keyword box, and click
``Search.'' Next, click the link to ``Open Docket Folder'' and choose
the document to review. If you do not have access to the Internet, you
may view the docket online by visiting the Docket Management Facility
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.,
E.T., Monday through Friday, except Federal holidays.

IV. ACCESS Advisory Committee Charter

    The ACCESS Advisory Committee is established by charter in
accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C.
App. 2. Secretary of Transportation Anthony Foxx approved the ACCESS
Advisory Committee charter on April 6, 2016. The committee's charter
sets forth policies for the operation of the advisory committee and is
available on the Department's Web site at www.transportation.gov/office-general-counsel/negotiated-regulations/charter.

V. 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.

VI. Future Committee Meeting

    DOT anticipates that the ACCESS Advisory Committee will have one
additional three-day meeting in

Washington, DC. The sixth and final meeting is tentatively scheduled
for October 12-14. Notices of all future meetings will be published in
the Federal Register at least 15 calendar days prior to each meeting.
    Notice of this meeting is being provided in accordance with the
Federal Advisory Committee Act and the General Services Administration
regulations covering management of Federal advisory committees. See 41
CFR part 102-3. Issued under the authority of delegation in 49 CFR
1.27(n).

    Dated: August 29, 2016.
Molly J. Moran,
Acting General Counsel.
[FR Doc. 2016-21357 Filed 9-2-16; 8:45 am]
BILLING CODE 4910-9X-P


After a review of original response to the ecological risk assessment, it appears that Syngenta's calculation of the mg/kg/day dose level may not have been clearly described, which has led to the Agency confusion.  The 50 mg a.i./kg  - bw/day value used in the preliminary ecological risk assessment appears to be a generic default value used in the T-REX model.  However, the study report used for this risk assessment contains data, which when used to calculate the actual exposures on a mg a.i./kg-bw/day basis, provides evidence that the actual time-weighted dose levels to these animals exceeded this default value.  Therefore, time-weighted average (TWA) dose levels were calculated using group mean values for body weight, food consumption, and dietary concentrations (ppm). These calculations were conducted as follows:
   1. The mean body weight recorded at the end of each dosing week was used in these calculations. This value was considered conservative, in that a mid-week body weight value is typically calculated for use in determining TWA doses.  Use of this higher body weight at the end of each measurement period results in lower TWA values than would be calculated using a mid-week value.
   2. Average food consumption values (g food/animal/day) were extracted from the study report (Table 5)
   3. Duplicate analyses were conducted on a weekly basis on all diets (Appendix H).  Therefore, the mean analytical values were utilized for diet concentrations rather than the nominal targeted value of 1000 ppm.
   4. Weekly dose levels were then calculated by dividing the average food consumption (g/animal/day) by mean body weight (kg/rat), and multiplied by the analytically determined concentrations (ppm) divided by 1000.

             Food Consumption (g/day) x Concentration (ppm= mg/kg)
                        Body weight (kg) x 1000 (g/kg)
Based on the use of these values, the TWA dose levels for the F0 males and females were 70.0 and 84.5 mg/kg/day, respectively.  It is important to note that calculation of the dose for the F1 males using this same scenario resulted in a TWA dose of 54.6 mg/kg/day.  However, as the 70 mg/kg/day dose level for the F0 males was considered an NOAEL, the use of this lower value in the risk assessment is not considered appropriate.


[Federal Register Volume 83, Number 46 (Thursday, March 8, 2018)]
[Proposed Rules]
[Pages 9818-9819]
[FR Doc No: 2018-04651]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 46 / Thursday, March 8, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0433; Product Identifier 2016-SW-078-AD]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Bell Helicopter Textron Canada (BHTC) Model 429 helicopters. This
proposed AD would require inspecting each main rotor pitch link rod end
bearing assembly (bearing) for wear and play. This proposed AD is
prompted by reports of worn bearings. The actions of this proposed AD
are intended to prevent an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by May 7, 2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0433; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the Transport Canada AD, the economic evaluation, any
comments received, and other information. The street address for Docket
Operations (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(450) 433-0272; or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued Canadian AD No. CF-2016-39, dated December 12, 2016, to correct
an unsafe condition for BHTC Model 429 helicopters, serial numbers
57001 and subsequent. Transport Canada advises of reports of worn
bearings adversely affecting the helicopters' handling qualities.
Transport Canada states the scheduled inspection interval of 12 months
or 800 hours is not sufficient to detect and correct a worn bearing
under the current wear rate. Additionally, according to Transport
Canada, the combination of the blade weight, positioning of the
swashplate, and the preload of elastomers can make bearing play
difficult to detect during a preflight exterior check. Transport Canada
determined it necessary to implement an inspection frequent enough to
detect a worn bearing in order to prevent a bearing from failing,
adversely affecting handling qualities, and damaging adjacent
components. These conditions could lead to loss of control of the
helicopter. Transport Canada AD CF-2016-39 therefore requires
inspecting bearing part number (P/N) 429-010-433-101/-103 for play and
potential wear and replacing it if necessary, within 30 days from the
effective date of its AD and at subsequent intervals not to exceed 50
hours air time.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada, its technical
representative, has notified us of the unsafe condition described its
AD. We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition is likely to exist
or develop on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Bell Helicopter Alert Service Bulletin 429-11-03,
Revision A, dated January 13, 2015 (ASB), which specifies inspecting
bearing P/N 429-010-433-101 and P/N 429-010-433-

103 within 10 flight hours and every 50 hours for play and potential
wear.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require, within 20 hours time-in-service
(TIS) and thereafter at intervals not to exceed 50 hours TIS, visually
inspecting each bearing for wear and play. This proposed AD also would
require replacing parts that exceed allowable limits before further
flight.

Differences Between This Proposed AD and the Transport Canada AD

    This proposed AD would require initially inspecting the bearing
within 20 hours TIS, while the Transport Canada AD requires the initial
inspection within 30 days.

Costs of Compliance

    We estimate that this proposed AD would affect 64 helicopters of
U.S. Registry and that labor costs average $85 per work-hour. Based on
these estimates, we expect the following costs:
     Inspecting the bearing would require 2 work-hours and no
parts for a cost of $170 per helicopter and $10,880 for the U.S. fleet
per inspection cycle.
     Replacing a -101 bearing would require 1 work-hour and
$3,560 for parts for a cost of $3,645 per bearing. Replacing a -103
bearing would require 1 work-hour and $3,365 for parts for a cost of
$3,450 per bearing.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bell Helicopter Textron Canada Limited: Docket No. FAA-2017-0433;
Product Identifier 2016-SW-078-AD.

(a) Applicability

    This AD applies to Bell Helicopter Textron Canada Limited Model
429 helicopters, serial numbers 57001 and larger, with a main rotor
pitch link rod end bearing assembly (bearing) part number (P/N) 429-
010-433-101 or 429-010-433-103 installed, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a worn bearing. This
condition could result in failure of a bearing, which could lead to
reduced helicopter handling, damage to other components, and
subsequent loss of helicopter control.

(c) Comments Due Date

    We must receive comments by May 7, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 20 hours time-in-service (TIS) and thereafter at
intervals not to exceed 50 hours TIS:
    (1) Inspect the upper and lower pitch link rod ends for axial
and radial bearing play by rolling the bearings through all angles,
paying particular attention to the areas depicted in Figure 1 of
Bell Helicopter Alert Service Bulletin 429-11-03, Revision A, dated
January 13, 2015.
    (2) If there is any play in a bearing, remove the pitch link
assembly and perform a dimensional inspection of the axial and
radial bearing play. Measure the play at the angle that results in
the maximum amount of play. Replace the rod end assembly before
further flight if bearing play exceeds 0.010 inch for axial
direction or 0.005 inch for radial direction.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy, Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in Transport Canada AD No.
CF-2016-39, dated December 12, 2016. You may view the Transport
Canada AD on the internet at http://www.regulations.gov in the AD
Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6200, Main Rotor
System.

    Issued in Fort Worth, Texas, on February 21, 2018.
Scott A. Horn,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2018-04651 Filed 3-7-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Notices]
[Page 40843-40844]
[DOCID:fr14jy10-92]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0344]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 13 on Bulk
Density and Tapped Density of Powders General Chapter; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 13: Bulk Density and Tapped Density of Powders General Chapter.''
The draft guidance was prepared under the auspices of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Bulk Density and Tapped
Density of Powders General Chapter harmonized text from each of the
three pharmacopoeias (United States, European, and Japanese)
represented by the Pharmacopoeial Discussion Group (PDG). The draft
guidance conveys recognition of the three pharmacopoeial methods by the
three ICH regulatory regions and provides specific information
regarding the recognition. The draft guidance is intended to recognize
the interchangeability between the local regional pharmacopoeias, thus
avoiding redundant testing in favor of a common testing strategy in
each regulatory region. This draft guidance is the thirteenth annex to
the core Q4B guidance, which was made available in the Federal Register
of February 21, 2008 (73 FR 9575).

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. The draft 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 draft guidance
document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation
and Research (HFM-25), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
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 among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2010, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped
Density of Powders General Chapter'' should be made available for
public comment. The draft guidance is the product of the Q4B Expert
Working Group of the ICH. Comments about this draft will be considered
by FDA and the Q4B Expert Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Bulk Density and Tapped Density of Powders
General Chapter harmonization proposal originating from the three-party
PDG. This draft guidance is in the form of an annex to the core ICH Q4B
guidance. Once finalized, the annex will provide guidance to assist
industry and regulators in the implementation of the

specific topic evaluated by the ICH Q4B process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

    Dated: July 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17055 Filed 7-13-10; 8:45 am]
BILLING CODE 4160-01-S