[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20589-20594]
[FR Doc No: 2023-07142]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97234; File No. SR-NYSEARCA-2023-28]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Modify the NYSE
Arca Options Fee Schedule

March 31, 2023.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on March 24, 2023, NYSE Arca, Inc. (``NYSE Arca'' 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 modify the NYSE Arca Options Fee Schedule
(``Fee Schedule'') regarding (1) credits for Qualified Contingent Cross
(``QCC'') transactions, (2) fees applicable to routed orders, and (3)
certain Market Maker incentives. The Exchange proposes to implement the
fee changes effective March 24, 2023.\4\ 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.
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    \4\ The Exchange originally filed to amend the Fee Schedule on
March 1, 2023 (SR-NYSEARCA-2023-22), then withdrew such filing and
amended the Fee Schedule on March 15, 2023 (SR-NYSEARCA-2023-25),
which latter filing the Exchange withdrew on March 24, 2023.
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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 purpose of this filing is to amend the Fee Schedule to (1)
provide for additional credits to qualifying Submitting Brokers for QCC
transactions \5\ and clarify the cap applicable to QCC credits and
Floor Broker rebates earned through the Manual Billable Rebate Program
(``FB Rebates''), (2) modify the Routing Fees applicable to routed
orders, and (3) eliminate the Market Maker Incentive For Penny Issues
and the Market Maker Incentive For Non-Penny Issues (collectively, the
``Market Maker Incentives''). The Exchange proposes to implement the
rule change on March 24, 2023.
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    \5\ A QCC Order is defined as an originating order to buy or
sell at least 1,000 contracts that is identified as being part of a
qualified contingent trade coupled with a contra-side order or
orders totaling an equal number of contracts. See Rule 6.62P-
O(g)(1)(A).
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QCC Transaction Credits
    Currently, the Exchange offers Submitting Brokers a credit of
($0.22) per contract for Non-Customer vs. Non-Customer QCC transactions
or ($0.16) per contract for Customer vs. Non-Customer QCC
transactions.\6\ QCC executions in which a Customer is on both sides of
the QCC trade are not eligible for a credit.\7\
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    \6\ See Fee Schedule, QUALIFIED CONTINGENT CROSS (``QCC'')
TRANSACTION FEES AND CREDITS.
    \7\ See id.
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    The Exchange proposes to offer additional credits on QCC
transactions to Submitting Brokers that meet certain monthly volume
thresholds. Submitting Brokers who achieve 1.5 million QCC contracts in
a month will receive an additional ($0.01) credit on Customer vs. Non-
Customer QCC transactions, and an additional ($0.03) credit on Non-
Customer vs. Non-Customer QCC transactions. Submitting Brokers who
achieve 3 million QCC contracts in a month will receive an additional
($0.02) credit on Customer vs. Non-Customer QCC transactions, and an
additional ($0.06) credit on Non-Customer vs. Non-Customer QCC
transactions. The proposed additional credits would be applicable back
to the first QCC contract executed by a Submitting Broker in a month,
but would not be cumulative across tiers (e.g., a Submitting Broker who
transacts 3.1 million QCC contracts in a month would be eligible for an
additional ($0.02) credit on Customer vs. Non-Customer QCC transactions
or an additional ($0.06) credit on Non-Customer vs. Non-Customer QCC
transactions, but would not also earn the additional credits offered to
Submitting Brokers that achieve 1.5 million QCC contracts in a month).
Although the Exchange cannot predict with certainty whether the
proposed change would encourage Submitting Brokers to increase their
QCC volume, the proposed change is intended to continue to incentivize
additional QCC executions by Submitting Brokers by increasing the
credits available on such orders.
    Endnote 13 of the Fee Schedule currently provides that QCC
executions in which a Customer is on both sides of the QCC trade will
not be eligible for the Submitting Broker credit and that there is a
$375,000 maximum monthly credit per firm on QCC transactions by a
Submitting Broker.\8\ The Exchange recently modified the Fee Schedule
to

provide that Submitting Broker QCC credits and Floor Broker rebates
earned through the Manual Billable Rebate Program may not combine to
exceed $2,000,000 per month per firm (the ``Monthly Credit and Rebate
Cap'').\9\ To improve the clarity of the Fee Schedule and obviate
potential confusion regarding the applicability of the Monthly Credit
and Rebate Cap, the Exchange proposes to delete the second sentence of
Endnote 13 (which describes the $375,000 maximum monthly credit on QCC
transactions by a Submitting Broker), add new Endnote 17, and modify
the table setting forth Submitting Broker QCC credits to reference
Endnote 17. Endnote 17 would contain the same text already reflected in
the Fee Schedule describing the Monthly Credit and Rebate Cap.\10\ The
Exchange believes that Endnote 17 would add clarity to the Fee Schedule
regarding the maximum amount that a firm could earn per month from
Submitting Broker QCC credits and FB Rebates combined.
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    \8\ See Fee Schedule, Endnote 13.
    \9\ See Fee Schedule, FLOOR BROKER FIXED COST PREPAYMENT
INCENTIVE PROGRAM (the ``FB Prepay Program'').
    \10\ The Exchange also proposes a conforming change to delete
the text describing the Monthly Credit and Rebate Cap in the section
of the Fee Schedule setting forth the Floor Broker Fixed Cost
Prepayment Incentive Program and add a reference to Endnote 17, as
proposed.
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Routing Fees
    The Exchange currently charges an $0.11 per contract fee on orders
routed and executed on another exchange, plus (i) any transaction fees
assessed by the away exchange (calculated on an order-by-order basis
since different away exchanges charge different amounts) or (ii) if the
actual transaction fees assessed by the away exchange(s) cannot be
determined prior to the execution, the highest per contract charge
assessed by the away exchange(s) for the relevant option class and type
of market participant (e.g., Customer, Firm, Broker/Dealer,
Professional Customer or Market Maker).\11\ The Exchange applies the
Routing Fees in addition to any customary execution fees applicable to
the order.
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    \11\ See Fee Schedule, ROUTING FEES.
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    The Exchange now proposes to modify the Routing Fees to be based on
whether the routed order is in a Penny or non-Penny issue and to
establish a single fee that would be applicable to all routed orders in
Penny issues, and a single fee for routed orders in non-Penny issues.
Specifically, the Exchange proposes that the fee for routed orders
would be set at a fixed amount intended to counterbalance the internal
resources required to support the handling of orders routed away from
the Exchange. The Exchange proposes to implement a flat fee structure
for routing fees, which the Exchange believes would streamline the
process of calculating fees applied to orders routed away from the
Exchange because it would, among other things, reduce the
administrative burden of recalibrating routing fees each time an away
exchange modifies its relevant transaction fees. Accordingly, the
Exchange proposes a Routing Fee of $0.61 in Penny issues, and $1.21 in
non-Penny issues. The Exchange believes that having a single published
rate for all routed orders in Penny issues and single published rate
for all routed orders in non-Penny issues would also reduce potential
confusion relating to the amount of the Routing Fee for a given order
(particularly in light of the variability in transaction fees across
other options markets) and would permit market participants to
determine execution costs at the time of order entry, thereby promoting
clarity and transparency in the Fee Schedule. The Exchange believes the
proposed routing fee structure is not novel, as at least one other
options exchange similarly applies fixed routing fees based on whether
the routed order is in a Penny or non-Penny issue, and that the
proposed amounts of the fees are within the range of fees applied by
other markets to routed orders.\12\
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    \12\ See, e.g., BOX Options Exchange Fee Schedule, available at:
https://boxexchange.com/assets/BOX-Fee-Schedule-as-of-March-6-2023.pdf (providing for fixed routing fees of $0.60 per contract fee
for customer orders in Penny classes and $0.85 per contract fee for
customer orders in non-Penny class); Cboe Exchange, Inc. Options Fee
Schedule, available at: https://cdn.cboe.com/resources/membership/Cboe_FeeSchedule.pdf (providing, for example, Customer routing fees
of $0.75 for orders in Penny issues or $1.25 for orders in non-Penny
issues routed to certain away markets and Non-Customer routing fees
of $1.17 for all orders in Penny issues or $1.45 for all orders in
non-Penny issues routed away).
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Market Maker Incentives
    The Exchange currently offers a Market Maker Incentive For Penny
Issues, which provides an enhanced posting credit of $0.41 applied to
electronic executions of Market Maker posted interest in Penny issues
to Market Makers that achieve the volume requirement of at least 0.75%
TCADV from Customer posted interest in all issues and an ADV from
Market Maker posted interest in all issues other than SPY equal to
0.40% of TCADV.
    The Exchange also offers a similar Market Maker Incentive For Non-
Penny Issues. Market Makers that meet the volume requirement of either
(1) at least 0.55% of TCADV from Market Maker posted interest in all
issues, or (2) at least 1.60% of TCADV from all interest in all issues,
all account types, with at least 0.15% of TCADV from Market Maker
posted interest in all issues qualify for a $0.55 credit applied to
electronic executions of Market Maker posted interest in non-Penny
issues.
    The Exchange now proposes to eliminate the Market Maker Incentives
because they have not been as effective in encouraging Market Maker
posted interest as other similar incentive programs. Market Makers are
entitled to the highest credit on posted interest they achieve, and
because the Market Maker Incentives have similar qualifying criteria
but offer lower credit amounts than other volume incentive programs
available to Market Makers (such as the Market Maker Penny and SPY
Posting Credit Tiers or the Non-Customer, Non-Penny Posting Credit
Tiers),\13\ Market Makers have availed themselves of the Market Maker
Incentives less frequently. Accordingly, the Exchange believes that
Market Markers would not be significantly impacted by the elimination
of the Market Maker Incentives, as the programs generally provided
benefits that were superseded by the incentives available through
other, more utilized volume incentive programs (which would continue to
be available to Market Makers).
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    \13\ See Fee Schedule, MARKET MAKER PENNY AND SPY POSTING CREDIT
TIERS & NON-CUSTOMER, NON-PENNY POSTING CREDIT TIERS.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\14\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\15\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposed Rule Change Is Reasonable
    The Exchange operates in a highly competitive market. The
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. In Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized

that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \16\
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    \16\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (S7-10-04) (``Reg NMS
Adopting Release'').
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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than 16% of the market
share of executed volume of multiply-listed equity and ETF options
trades.\17\ Therefore, no exchange possesses significant pricing power
in the execution of multiply-listed equity and ETF options order flow.
More specifically, in January 2023, the Exchange had less than 13%
market share of executed volume of multiply-listed equity and ETF
options trades.\18\
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    \17\ The OCC publishes options and futures volume in a variety
of formats, including daily and monthly volume by exchange,
available here: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Monthly-Weekly-Volume-Statistics.
    \18\ Based on a compilation of OCC data for monthly volume of
equity-based options and monthly volume of equity-based ETF options,
see id., the Exchange's market share in equity-based options
decreased from 13.06% for the month of January 2022 to 12.58% for
the month of January 2023.
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    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees. Stated otherwise,
modifications to exchange transaction fees can have a direct effect on
the ability of an exchange to compete for order flow.
    The Exchange believes that the proposed additional QCC credits are
reasonable because they are designed to incent OTP Holders to increase
the number of QCC transactions sent to the Exchange by offering
increased credits on QCC transactions for Submitting Brokers that meet
the qualifying volume thresholds. In addition, the Exchange believes it
is reasonable to offer a higher additional credit on Non-Customer vs.
Non-Customer QCC transactions than on Customer vs. Non-Customer QCC
transactions because Non-Customer vs. Non-Customer QCC transactions are
billable on both sides, whereas Customer vs. Non-Customer QCC
transactions are billable on one side only. The Exchange also believes
that modifying the Fee Schedule regarding the Monthly Credit and Rebate
Cap is reasonable because it would add clarity to the Fee Schedule
regarding the maximum monthly amount that firms may earn from
Submitting Broker QCC credits and FB Rebates combined. To the extent
that the proposed change attracts more volume to the Exchange, this
increased order flow would continue to make the Exchange a more
competitive venue for order execution, which, in turn, promotes just
and equitable principles of trade and removes impediments to and
perfects the mechanism of a free and open market and a national market
system. The Exchange notes that all market participants stand to
benefit from any increase in volume entered by Submitting Brokers,
which could promote market depth, facilitate tighter spreads and
enhance price discovery, to the extent the proposed change encourages
OTP Holders to utilize the Exchange as a primary trading venue, and may
lead to a corresponding increase in order flow from other market
participants. In addition, any increased liquidity on the Exchange
would result in enhanced market quality for all participants.
    The Exchange believes the proposed change to Routing Fees is
reasonable because it would establish a single fee that would be
applicable to all routed orders in Penny issues and a single fee that
would be applicable to all routed orders in non-Penny issues, and such
fees would be applicable to all market participants equally. In
addition, the Exchange believes the proposed change is reasonable
because it would provide for routing fees that would counterbalance the
internal resources required to support the handling of orders routed
away from the Exchange and would streamline the process of calculating
routing fees by obviating the need to recalibrate fees based on
individual away market fees (which are variable and subject to frequent
change) and eliminating any potential confusion as to routing fees
applicable to a given order. The Exchange also notes that a fixed fee
structure for routing fees is not novel and that the amounts of the
proposed Routing Fees are within the range of routing fees currently
charged by other options exchanges.\19\
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    \19\ See note 12, supra.
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    The Exchange believes that eliminating the Market Maker Incentives
is reasonable because the programs have been underutilized in favor of
incentive programs offering higher credits on posted interest, and the
Exchange will continue to offer alternative incentives for Market
Makers with similar qualifying bases and credits (including the Market
Maker Penny and SPY Posting Credit Tiers or the Non-Customer, Non-Penny
Posting Credit Tiers). Accordingly, although Market Makers would no
longer be able to qualify for credits through the Market Maker
Incentives, they would still benefit from the availability of other
similar incentive programs that have, to date, more successfully
incentivized Market Maker posted interest.
    Finally, to the extent the proposed change continues to attract
greater volume and liquidity, the Exchange believes the proposed change
would improve the Exchange's overall competitiveness and strengthen its
market quality for all market participants. In the backdrop of the
competitive environment in which the Exchange operates, the proposed
rule change is a reasonable attempt by the Exchange to increase the
depth of its market and improve its market share relative to its
competitors. The Exchange's fees are constrained by intermarket
competition, as OTP Holders may direct their order flow to any of the
16 options exchanges, including those offering rebates on QCC
transactions.\20\ Thus, OTP Holders have a choice of where they direct
their order flow, including their QCC transactions. The proposed rule
change is designed to continue to incent OTP Holders to direct
liquidity and, in particular, QCC transactions to the Exchange. In
addition, to the extent OTP Holders are incentivized to aggregate their
trading activity at the Exchange, that increased liquidity could
promote market depth, price discovery and improvement, and enhanced
order execution opportunities for market participants.
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    \20\ See, e.g., EDGX Options Exchange Fee Schedule, QCC
Initiator/Solicitation Rebate Tiers (applying ($0.14) per contract
rebate up to 999,999 contracts for QCC transactions when only one
side of the transaction is a non-customer or ($0.22) per contract
rebate up to 999,999 contracts for QCC transactions with non-
customers on both sides); BOX Options Fee Schedule at Section
IV.D.1. (QCC Rebate) (providing for ($0.14) per contract rebate up
to 1,499,999 contracts for QCC transactions when only one side of
the QCC transaction is a broker-dealer or market maker or ($0.22)
per contract rebate up to 1,499,999 contracts for QCC transactions
when both parties are a broker-dealer or market maker); Nasdaq ISE,
Options 7, Section 6.B. (QCC Rebate) (offering rebates on QCC
transactions of ($0.14) per contract when only one side of the QCC
transaction is a non-customer or ($0.22) per contract when both
sides of the QCC transaction are non-customers).
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The Proposed Rule Change Is an Equitable Allocation of Credits and Fees
    The Exchange believes the proposed rule change is an equitable
allocation of its fees and credits. The proposed QCC credits are based
on the amount and type of business transacted on the

Exchange, and Submitting Brokers can attempt to submit QCC transactions
to earn the credits or not. In addition, the proposed credits are
equally available to all qualifying Submitting Brokers. The Exchange
also believes the proposed changes regarding the Monthly Credit and
Rebate Cap are equitable because they would add clarity and
transparency to the Fee Schedule regarding the current maximum monthly
amount that a firm could earn from combined Submitting Broker QCC
credits and FB Rebates, thereby obviating potential confusion regarding
the applicability of the Monthly Credit and Rebate Cap. To the extent
the proposed changes continue to incent Submitting Brokers to direct
increased liquidity to the Exchange, all market participants would
benefit from enhanced opportunities for price improvement and order
execution. Moreover, the proposed credits are designed to incent
Submitting Brokers to encourage OTP Holders to aggregate their
executions--including QCC transactions--at the Exchange as a primary
execution venue. To the extent that the proposed change achieves its
purpose in attracting more volume to the Exchange, this increased order
flow would continue to make the Exchange a more competitive venue for,
among other things, order execution. Thus, the Exchange believes the
proposed rule change would improve market quality for all market
participants on the Exchange and, as a consequence, attract more order
flow to the Exchange, thereby improving market-wide quality and price
discovery.
    The Exchange also believes the proposed change to the Routing Fees
is equitable because the proposed single fee for all routed orders in
Penny issues and single fee for all routed orders in non-Penny issues
would apply to all market participants equally and the proposed amounts
are designed to offset internal resources necessary to support the
handling of orders routed away from the Exchange. The proposed change
would also streamline the process of calculating routing fees for all
market participants and provide increased clarity regarding execution
costs at the time of order entry.
    The Exchange believes that the elimination of the Market Maker
Incentives is equitable because these incentives, which did not achieve
their intended purpose of encouraging Market Maker posted interest,
would no longer be available to any Market Makers, and, moreover, the
Exchange offers Market Makers alternative methods to achieve credits of
an equal or higher amount.
The Proposed Rule Change Is Not Unfairly Discriminatory
    The Exchange believes the proposed change is not unfairly
discriminatory because the proposed credits on QCC transactions would
be available to all qualifying Submitting Brokers on an equal and non-
discriminatory basis. The proposed change is based on the amount and
type of business transacted on the Exchange, and Submitting Brokers are
not obligated to execute QCC transactions. Rather, the proposal is
designed to encourage Submitting Brokers to increase QCC volume sent to
the Exchange and to utilize the Exchange as a primary trading venue for
all transactions (if they have not done so previously). To the extent
that the proposed change attracts more QCC transactions to the
Exchange, this increased order flow would continue to make the Exchange
a more competitive venue for order execution. Thus, the Exchange
believes the proposed rule change would improve market quality for all
market participants on the Exchange and, as a consequence, attract more
order flow to the Exchange, thereby improving market-wide quality and
price discovery. The resulting increased volume and liquidity would
provide more trading opportunities and tighter spreads to all market
participants and thus would promote just and equitable principles of
trade, remove impediments to and perfect the mechanism of a free and
open market and a national market system and, in general, protect
investors and the public interest.
    The Exchange also believes that the proposed change to eliminate
the Market Maker Incentives is also not unfairly discriminatory because
the incentives, which were underutilized by Market Makers, would be
eliminated in their entirety and would no longer be available to any
Market Makers. In addition, Market Makers would continue to be eligible
for alternative incentives currently available to them with similar
credits and qualifying criteria. The Exchange also believes that the
proposed changes to the Routing Fees are not unfairly discriminatory
because the proposed fees are intended to assess streamlined routing
fees in amounts that would appropriately account for the internal
resources necessary to support orders routed away from the Exchange and
would apply equally to all market participants' routed orders, based on
whether such order is in a Penny or non-Penny issue. The proposed
change would simplify the calculation of routing fees for all market
participants and add clarity and transparency to the Fee Schedule
regarding the fees applicable to routed orders.
    Thus, the Exchange believes that, to the extent the proposed rule
change would continue to improve market quality for all market
participants on the Exchange by promoting clarity and transparency in
the Fee Schedule and attract more order flow to the Exchange, thereby
improving market-wide quality and price discovery, the resulting
increased volume and liquidity would provide more trading opportunities
and tighter spreads to all market participants and thus would promote
just and equitable principles of trade, remove impediments to and
perfect the mechanism of a free and open market and a national market
system and, in general, protect investors and the public interest.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.

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

    In accordance with Section 6(b)(8) of the Act, the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed change would encourage the submission of additional
liquidity to a public exchange, thereby promoting market depth, price
discovery and transparency and enhancing order execution opportunities
for all market participants. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering integrated competition among orders, which
promotes ``more efficient pricing of individual stocks for all types of
orders, large and small.'' \21\
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    \21\ See Reg NMS Adopting Release, supra note 16, at 37499.
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    Intramarket Competition. The proposed change with respect to QCC
credits is designed to attract additional order flow to the Exchange
(particularly in QCC transactions), which could increase the volumes of
contracts traded on the Exchange. Greater liquidity benefits all market
participants on the Exchange, and increased QCC transactions could
increase opportunities for execution of other trading interest. The
proposed credit would be available to all similarly-situated Submitting
Brokers that execute

QCC trades and achieve the volume thresholds for the additional
credits. The Exchange does not believe that the proposed changes
regarding Routing Fees or the Monthly Credit and Rebate Cap would
impose any burden on competition that is not necessary or appropriate,
as they are intended to add clarity and transparency to the Fee
Schedule with respect to fees for orders routed away from the Exchange
and the monthly cap on combined Submitting Broker QCC credits and FB
Rebates earned by a firm. The Exchange also does not believe that the
proposed changes to the Market Maker Incentives would impose any burden
on intramarket competition that is not necessary or appropriate because
the incentives would be eliminated for all Market Makers.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily favor one
of the 16 competing option exchanges if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges and to attract order flow to the Exchange. Based on publicly-
available information, and excluding index-based options, no single
exchange has more than 16% of the market share of executed volume of
multiply-listed equity and ETF options trades.\22\ Therefore, currently
no exchange possesses significant pricing power in the execution of
multiply-listed equity and ETF options order flow. More specifically,
in January 2023, the Exchange had less than 13% market share of
executed volume of multiply-listed equity and ETF options trades.\23\
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    \22\ The OCC publishes options and futures volume in a variety
of formats, including daily and monthly volume by exchange,
available here: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Monthly-Weekly-Volume-Statistics.
    \23\ Based on a compilation of OCC data for monthly volume of
equity-based options and monthly volume of equity-based ETF options,
see id., the Exchange's market share in equity-based options
decreased from 13.06% for the month of January 2022 to 12.58% for
the month of January 2023.
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    The Exchange believes that the proposed rule change reflects this
competitive environment because it modifies the Exchange's fees in a
manner designed to continue to incent OTP Holders to direct trading
interest (particularly QCC transactions) to the Exchange, to provide
liquidity and to attract order flow. To the extent that Submitting
Brokers are incentivized to utilize the Exchange as a primary trading
venue for all transactions, all of the Exchange's market participants
should benefit from the improved market quality and increased
opportunities for price improvement.
    The Exchange does not believe that the proposed changes regarding
Routing Fees or the Monthly Credit and Rebate Cap would impose any
burden on competition that is not necessary or appropriate, as they are
intended to improve the clarity and transparency of the Fee Schedule
with respect to fees for orders routed away from the Exchange and the
maximum monthly amount that a firm could earn from Submitting Broker
QCC credits and FB Rebates combined. The Exchange also does not believe
that the proposed elimination of the Market Maker Incentives would
impose any burden on competition that is not necessary or appropriate
because the incentives would no longer be available to any Market
Makers, and the Exchange would continue to offer Market Makers similar,
alternative incentives.
    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment. The
Exchange further believes that the proposed changes could promote
competition between the Exchange and other execution venues, including
those that currently offer similarly structured routing charges or that
currently offer credits on QCC transactions, by encouraging additional
orders (and, in particular, QCC transactions) to be sent to the
Exchange for execution.\24\
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    \24\ See notes 12 & 20, supra.
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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 foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \25\ of the Act and subparagraph (f)(2) of Rule
19b-4 \26\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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) \27\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \27\ 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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEARCA-2023-28 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-NYSEARCA-2023-28. 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 (https://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-NYSEARCA-2023-28, and should
be submitted on or before April 27, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-07142 Filed 4-5-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Page 25257]
[FR Doc No: 2019-11381]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9045-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 05/20/2019 Through 05/24/2019.
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20190116, Final, FRA, VA, DC to Richmond Southeast High Speed
Rail, Review Period Ends: 07/01/2019, Contact: John A. Winkle 202-493-
6067.
EIS No. 20190117, Final, NOAA, MD, Mallows Bay-Potomac River National
Marine Sanctuary Designation Final Environmental Impact Statement and
Final Management Plan, Review Period Ends: 07/01/2019, Contact: Paul
Orlando<PHONE_NUMBER>.
EIS No. 20190118, Final, USFWS, WA, Skookumchuck Wind Energy Project
Proposed Habitat Conservation Plan and Incidental Take Permit for
Marbled Murrelet, Bald Eagle, and Golden Eagle Lewis and Thurston
Counties, Washington, Review Period Ends: 07/01/2019, Contact: Curtis
Tanner<PHONE_NUMBER>.
EIS No. 20190119, Draft, BLM, OR, Draft Southeastern Oregon RMP/EIS,
Comment Period Ends: 08/28/2019, Contact: Brent Grasty<PHONE_NUMBER>.
EIS No. 20190120, Final, BIA, WI, Beloit Fee-to-Trust and Casino
Project, Review Period Ends: 07/01/2019, Contact: Scott Doig 612-725-
4514.
EIS No. 20190121, Final, BIA, CA, Tule River Indian Tribe Fee-to-Trust
and Eagle Mountain Casino Relocation Project, Review Period Ends: 07/
01/2019, Contact: Chad Broussard<PHONE_NUMBER>.
EIS No. 20190122, Final, USACE, NY, East Rockaway Inlet to Rockaway
Inlet and Jamaica Bay Reformulation, Atlantic Coast of New York, Review
Period Ends: 07/01/2019, Contact: Peter Weppler<PHONE_NUMBER>.

    Dated: May 28, 2019.
Candi Schaedle,
Acting Director, Office of Federal Activities.
[FR Doc. 2019-11381 Filed 5-30-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Pages 44357-44358]
[FR Doc No: 2015-18270]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0103]

Analytical Procedures and Methods Validation for Drugs and
Biologics; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Analytical
Procedures and Methods Validation for Drugs and Biologics.'' This
guidance supersedes the draft of the same name that published on
February 19, 2014, and replaces the 2000 draft guidance for industry on
``Analytical Procedures and Methods Validation'' and the 1987 FDA
guidance for industry on ``Submitting Samples and Analytical Data for
Methods Validation.'' This guidance discusses how to submit analytical
procedures and methods validation data to support the documentation of
the identity, strength, quality, purity, and potency of drug substances
and drug products.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Communications, Division of Drug Information, Center
for Drug Evaluation and Research, Food and Drug Administration, 10001
New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD
20993, or to 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lucinda Buhse, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993-0002, 240-
402-4595, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Analytical Procedures and Methods Validation for Drugs and
Biologics.'' This guidance supersedes the draft of the same name that
published on February 19, 2014, and replaces the 2000 draft guidance
for industry on ``Analytical Procedures and Methods Validation'' and
the 1987 FDA guidance for industry on ``Submitting Samples and
Analytical Data for Methods Validation.'' It discusses how to submit
analytical procedures and methods validation data to support the
documentation of the identity, strength, quality, purity, and potency
of drug substances and drug products, and how to assemble information
and present

data to support analytical methodologies. The recommendations in this
guidance apply to new drug applications, abbreviated new drug
applications, biologics license applications, and supplements to these
applications. The principles in this guidance also apply to Type II
drug master files. This guidance does not address investigational new
drug application (IND) methods validation specifically, but the
principles being discussed may be helpful to sponsors preparing INDs.
    This guidance complements the International Conference on
Harmonisation guidance ``Q2(R1) Validation of Analytical Procedures:
Text and Methodology.''
    In the Federal Register of February 19, 2014 (79 FR 9467), this
guidance was published as a draft guidance. We have carefully reviewed
and considered the comments that were received on the draft guidance
and have made changes for clarification.
    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 analytical procedures and methods
validation. 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.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 211, 21 CFR part
314, and 21 CFR part 601 have been approved under OMB control numbers
0910-0139, 0910-0001, and 0910-0338.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: July 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18270 Filed 7-24-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Proposed Rules]
[Pages 19570-19572]
[FR Doc No: 2015-08073]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0823; Directorate Identifier 2014-NM-211-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 &
440) airplanes. This proposed AD was prompted by results of a design
review indicating that the burst pressure of the flexible hose, used to
vent oxygen from the high-pressure relief valve of the oxygen cylinder
overboard, was lower than the opening pressure of the high-pressure
relief valve, which could cause the flexible hose to burst before it
can vent the excess oxygen overboard. This proposed AD would require
replacing the oxygen hose assembly with a new, improved assembly. We
are proposing this AD to prevent the accumulation of oxygen in an
enclosed space, which could result in an uncontrolled oxygen-fed fire
if an ignition source is nearby.

DATES: We must receive comments on this proposed AD by May 28, 2015.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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-2015-
0823; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0823;
Directorate Identifier 2014-NM-211-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the airworthiness
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-36, dated October 17, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Bombardier, Inc. Model CL-600-
2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Design review found that the burst pressure of the flexible
hose, used to vent oxygen from the high-pressure relief valve of the
oxygen cylinder overboard, is lower than the opening pressure of the
high-pressure relief valve. This could cause the flexible hose to
burst before it is able to vent the excess oxygen overboard. If an
ignition source is present, the accumulation of oxygen in an
enclosed space may result in an uncontrolled oxygen-fed fire.
    This [Canadian] AD mandates the replacement of the oxygen hose
assembly with a new design oxygen hose assembly.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0823.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 601R-35-018, dated May 21,
2013. The service information describes procedures for replacing the
oxygen hose assembly with a new, improved assembly. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI. This service information is
reasonably available; see ADDRESSES for ways to access this service
information.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 575 airplanes of U.S.
registry.
    We also estimate that it would take about 2 work-hours per product
to comply with the basic requirements of this proposed AD. Required
parts would cost about $0 per product. The average labor rate is $85
per work-hour. Based on these figures, we estimate the cost of this
proposed AD on U.S. operators to be $97,750, or $170 per airplane.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate

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 above, 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; 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.

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):

Bombardier, Inc.: Docket No. FAA-2015-0823; Directorate Identifier
2014-NM-211-AD.

(a) Comments Due Date

    We must receive comments by May 28, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by results of a design review indicating
that the burst pressure of the flexible hose, used to vent oxygen
from the high-pressure relief valve of the oxygen cylinder
overboard, was lower than the opening pressure of the high-pressure
relief valve, which could cause the flexible hose to burst before it
can vent the excess oxygen overboard. We are issuing this AD to
prevent the accumulation of oxygen in an enclosed space, which could
result in an uncontrolled oxygen-fed fire if an ignition source is
nearby.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement

    Before the accumulation of 5,800 total flight hours or within 44
months after the effective date of this AD, whichever occurs first,
replace all oxygen hose assemblies having part number (P/N) 38026-4-
0280-000 with new, improved assemblies having P/N 601R44045-1, in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 601R-35-018, dated May 21, 2013.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
oxygen hose assembly, P/N 38026-4-0280-000, on any airplane.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2014-36, dated October
17, 2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-0823.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 27, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-08073 Filed 4-10-15; 8:45 am]
 BILLING CODE 4910-13-P


region facility species. orig stage year impinged. est entrained. est notes dummy dummy dummy dummy  999  999  999 dummy river eastman longear. sunfish age01 1980 43 . RM # 35904; pg 45 46 river eastman chestnut. lamprey age01 1980 7 . RM # 35904; pg 45 46 river eastman gizzard. shad age01 1980 14 . RM # 35904; pg 45 46 river eastman banded. sculpin age01 1980 7 . RM # 35904; pg 45 46 river eastman carp age01 1980 7 . RM # 35904; pg 45 46 river eastman ouachita. map. turtle age01 1980 7 . 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App D 1 lefer, a. d may etheostominae larvae 0.16 3.652968037 4,311 RM # 35904; App D 1 lefer, a. d may percina. spp larvae 0.16 3.652968037 4,311 RM # 35904; App D 1 lefer, a. d may unknown larvae 0.49 11.18721461 13,201 RM # 35904; App D 1 lefer, a. d may cyprinidae larvae 0.49 11.18721461 13,201 RM # 35904; App D 1 lefer, a. d may percidae larvae 0.16 3.652968037 4,311 RM # 35904; App D 1 lefer, a. d may unknown larvae 0.49 11.18721461 13,201 RM # 35904; App D 1 lefer, a. d may unknown larvae 0.65 14.84018265 17,511 RM # 35904; App D 1 lefer, a. d may cyprinidae larvae 0.16 3.652968037 4,311 RM # 35904; App D 1 lefer, a. d may cyprinidae larvae 0.49 11.18721461 13,201 RM # 35904; App D 1 lefer, a. d may catostomidae larvae 0.33 7.534246575 8,890 RM # 35904; App D 1 lefer, a. d may unknown larvae 0.07 1.598173516 1,886 RM # 35904; App D 1 lefer, a. d may unknown larvae 0.24 5.479452055 6,466 RM # 35904; App D 1 lefer, a. d june catostomidae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june unknown larvae 0.22 12.02185792 8,175 RM # 35904; App D 1 lefer, a. d june centrarchidae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june unknown larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june unknown larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d june cyprinidae larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d june cyprinidae larvae 0.22 12.02185792 8,175 RM # 35904; App D 1 lefer, a. d june etheostominae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june unknown larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d june acipenseridae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june cyprinidae larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d june petromyzontidae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june cyprinidae larvae 0.07 3.825136612 2,601 RM # 35904; App D 1 lefer, a. d june catostomidae larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d june unknown larvae 0.15 8.196721311 5,574 RM # 35904; App D 1 lefer, a. d july centrarchidae larvae 0.07 5.46875 2,352 RM # 35904; App D 1 lefer, a. d july cyprinidae larvae 0.07 5.46875 2,352 RM # 35904; App D 1 lefer, a. d july percidae larvae 0.06 4.6875 2,016 RM # 35904; App D 1 lefer, a. d july catostomidae larvae 0.07 5.46875 2,352 RM # 35904; App D 1 lefer, a. d july unknown larvae 0.32 25 10,750 RM # 35904; App D 1 lefer, a. d july lepomis. spp larvae 0.06 4.6875 2,016 RM # 35904; App D 1 lefer, a. d july percidae larvae 0.06 4.6875 2,016 RM # 35904; App D 1 lefer, a. d july catostomidae larvae 0.06 4.6875 2,016 RM # 35904; App D 1 lefer, a. d july percidae larvae 0.38 29.6875 12,766 RM # 35904; App D 1 lefer, a. d july unknown larvae 0.13 10.15625 4,367 RM # 35904; App D 1 lefer, a. d august cyprinidae larvae 0.06 7.894736842 2,053 RM # 35904; App D 1 lefer, a. d august percidae larvae 0.06 7.894736842 2,053 RM # 35904; App D 1 lefer, a. d august percidae larvae 0.06 7.894736842 2,053 RM # 35904; App D 1 lefer, a. d august unknown larvae 0.13 17.10526316 4,447 RM # 35904; App D 1 lefer, a. d august cyprinidae larvae 0.13 17.10526316 4,447 RM # 35904; App D 1 lefer, a. d august lepomis. spp larvae 0.13 17.10526316 4,447 RM # 35904; App D 1 lefer, a. d august unknown larvae 0.19 25 6,500 RM # 35904; App D 1 lefer, a. d month species stage no/ 10m3 may cyprinidae eggs 0.16 lefer may cyprinidae eggs 0.82 lefer may unknown eggs 0.58 lefer may unknown eggs 0.08 lefer june centrarchidae eggs 0.07 lefer june cyprinidae eggs 0.07 lefer june acipenseridae eggs 0.15 lefer july cyprinidae eggs 0.15 lefer july lepomis. spp eggs 0.19 lefer august unknown eggs 0.07 lefer month species stage no/ 10m3 larvae ratio may cyprinidae eggs 0.98 1.63 1.66 2.71 dc may unknown eggs 0.66 1.94 2.94 5.70 dc june centrarchidae eggs 0.07 0.07 1.00 0.07 dc june cyprinidae eggs 0.07 0.59 8.43 4.97 dc june acipenseridae eggs 0.15 0.07 0.47 0.03 dc july cyprinidae eggs 0.15 0.07 0.47 0.03 dc july lepomis. spp eggs 0.19 0.06 0.32 0.02 dc august unknown eggs 0.07 0.32 4.57 1.46 dc unweighted divisor weighted divisor annual cyprinidae 1.2 3.52 1.12 unknown 0.73 3.76 4.91 centrarchidae 0.07 1.00 1.00 acipenseridae 0.15 0.47 0.47 lepomis. spp 0.19 0.32 0.32 sumcheks 2.34 2.34 Pump rate 0.101 source Conversion factor 2678400 RM # 35904; pg 41 month no. entrained per month x 106 no. entrained per month source march 0  RM # 35904; pg 41 april 0  RM # 35904; pg 41 may 0.118 118,000 RM # 35904; pg 41 june 0.068 68,000 RM # 35904; pg 41 july 0.043 43,000 RM # 35904; pg 41 august 0.026 26,000 RM # 35904; pg 41 sept 0  RM # 35904; pg 41 Sum of extrap. ent species Total acipenseridae 2601.092896 catostomidae 21432.46185 centrarchidae 4952.655396 cyprinidae 74688.30178 etheostominae 6911.595179 lepomis. spp 6462.993421 percidae 25212.64044 percina. spp 4310.502283 petromyzontidae 2601.092896 unknown 105826.6639 Grand Total 255000 species extrap. egg. ent acipenseridae 5573.770492 centrarchidae 4952.655396 cyprinidae 66493.73523 lepomis. spp 20466.14583 unknown 21563.27448 weighted multiplier 0.89 0.20 1.00 2.14 3.17 species stage imp extrap. imp source qc longear. sunfish age01 6 43 RM # 35904; pg 45 46 lefer chestnut. lamprey age01 1 7 RM # 35904; pg 45 46 lefer gizzard. shad age01 2 14 RM # 35904; pg 45 46 lefer banded. sculpin age01 1 7 RM # 35904; pg 45 46 lefer carp age01 1 7 RM # 35904; pg 45 46 lefer ouachita. map. turtle age01 1 7 RM # 35904; pg 45 46 lefer Losses data for the Arkansas Eastman Plant ( Arkansas). Cooling water source: White River Intake 316( b) Phase III A. Gage, 12/ 2/ 2003 Notes: Impingement sampling was conducted weekly for 51 24 hour periods from March 1980 March 1981. Impinged fish were washed from the travellin Entrainment sampling was conducted weekly for 2 2 hr periods ( one at day, one at night) from March Sept 1980. Larval nets were used to sample Extrapolated impingement by multiplying number imp. from sampling by sampling days ( 51 sampling days, pg 43) divided by 365. Extrapolated entrainment by converting the density entrained per month to a percent fraction per month, and multiplying this by the monthly estima Extrapolated egg entrainment using scaling factors based on an assumption that egg: larvae proportions are constant for each species.

QC checked data entry agains documents for " entry" worksheets. For losses worksheet, checked total # of imp/ ent agains entry page. Did not confirm values for each species. M. Lefer 12/ 8/ 03. elling screens and tallied. ple water from the CWIS water tap.

imates on pg 41.


[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18918-18919]
[FR Doc No: 2014-07546]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0147]

Types of Communication During the Review of Medical Device
Submissions; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Types of Communication During
the Review of Medical Device Submissions.'' The purpose of this
guidance is to update the Agency's approach to Interactive Review and
other additional types of communication, to reflect FDA's
implementation of the Medical Device User Fee Act of 2007 (MDUFA II)
Commitment Letters and of undertakings agreed to in connection with the
Medical Device User Fee Amendments of 2012 (MDUFA III). These new
Agency communication commitments are to increase the efficiency of the
review process.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for single copies of the guidance document entitled ``Types of
Communication During the Review of Medical Device Submissions'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002 or the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1533, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the letters dated September 27, 2007, from the Secretary of
Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the U.S. Senate and the Chairman of
the Committee on Energy and Commerce of the U.S. House of
Representatives setting out the goals of section 201(c) of MDUFA II,
Title II of the Food and Drug Administration Amendments of 2007 (FDAAA)
(21 U.S.C. 379i note), FDA committed to developing a guidance document
that describes an interactive review process between FDA and industry
for specific medical device premarket submissions. Further, during
discussions with representatives of the medical device industry in the
development of the Agency's recommendations for MDUFA III, Title II of
the Food and Drug Administration Safety and Innovation Act, Public Law
112-144 (July 9, 2012) (21 U.S.C. 301 note), the Agency proposed
process improvements to provide further transparency into the review
process, including new communication commitments.
    In the Federal Register on March 5, 2013 (78 FR 14305), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by June 3, 2013. Four comments were
received and, in general, were supportive of the guidance. However, the
comments contained multiple recommendations pertaining to the content
of the guidance and the need for clarification, particularly for the
Interactive Review section. In response to these comments, FDA revised
the guidance document to restructure the Interactive Review section to
clarify how this process works and to include references to additional
submission types for which Interactive Review pertains. Although
several commenters expressed concern about FDA's intention to limit the
last round of Interactive Review to 7 days, we did not modify the
guidance because this approach is needed in order to appropriately
balance the intent of interactive review with FDA's commitment to meet
the performance goals agreed upon as part of MDUFA III. In response to
comments regarding our intention to limit the issuance of second
Additional Information (AI) letters for 510(k) submissions, the
guidance was modified slightly to clarify the circumstances in which a
second AI letter might be issued, but remains unchanged in explaining
that these circumstances will remain limited and at FDA's discretion.
FDA will continually assess any impacts that the limited use of a
second AI letter may have, and, if needed, may consider modifications
to this approach. In addition to modifications to the Interactive
Review section, we clarified other items throughout the guidance, and
included Pre-Submissions as a submission type subject to Acceptance
Communication. This document supersedes ``Interactive Review for
Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements'' dated February 28, 2008.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on communication during a medical device
premarket submission review to provide further transparency into, and
to increase the efficiency of, the review process. 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 statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all Center for Devices and
Radiological Health guidance documents is available at http://
www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``Types
of Communication During the Review of Medical Device Submissions,'' you
may either send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1804 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; and the collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07546 Filed 4-3-14; 8:45 am]
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[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Page 52405]
[FR Doc No: 2014-20994]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: General
Aviation Awards Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection is used to nominate private citizens for
recognition of their significant voluntary contribution to aviation
education and flight safety.

DATES: Written comments should be submitted by November 3, 2014.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, ASP-110, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0574.
    Title: General Aviation Awards Program.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The collection is used to nominate private citizens for
recognition of their significant voluntary contribution to aviation
education and flight safety. The agency/industry committee uses the
information collected to select eight regional winners and one national
winner from each group. The respondents are private citizens involved
in aviation.
    Respondents: Approximately 150 applicants.
    Frequency: Information is collected annually.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 150 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

     Issued in Washington, DC, on August 27, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-20994 Filed 9-2-14; 8:45 am]
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