[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68217-68222]
[FR Doc No: 2022-24650]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96249; File No. SR-PEARL-2022-47]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
PEARL Options Fee Schedule To Remove a Monthly Credit Associated With
Trading Permit Fees

November 7, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 2, 2022, MIAX PEARL, LLC (``MIAX Pearl'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
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

    The Exchange is filing a proposal to amend the MIAX Pearl Options
Fee Schedule (the ``Fee Schedule'') to remove a monthly credit
associated with Trading Permit (defined below) fees.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
Pearl's principal office, and at the Commission's Public Reference
Room.

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

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

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

1. Purpose
    The Exchange commenced operations in February 2017 \3\ and adopted
its initial fee schedule that waived fees for Trading Permits \4\ to
trade on the Exchange.\5\ In 2018, as the Exchange's market share
increased,\6\ the Exchange adopted nominal fees for Trading Permits
based on the type of interface used--MEO \7\ or FIX \8\--and according
to the volume-based tier \9\ each Member \10\ achieved during the month
along with that of its Affiliates.\11\ At the same time, the Exchange
adopted a nominal monthly credit known as the ``Trading Permit Fee
Credit,'' a $100 per month credit for Members that connected to the
Exchange via both the MEO and FIX Interfaces.\12\
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    \3\ See MIAX PEARL Successfully Launches Trading Operations,
dated February 6, 2017, available at https://www.miaxoptions.com/sites/default/files/alert-files/MIAX_Press_Release_02062017.pdf.
    \4\ The term ``Trading Permit'' means a permit issued by the
Exchange that confers the ability to transact on the Exchange. See
Exchange Rule 100.
    \5\ See Securities Exchange Act Release No. 80061 (February 17,
2017), 82 FR 11676 (February 24, 2017) (SR-PEARL-2017-10).
    \6\ The Exchange experienced a monthly average trading volume in
equity options of 3.94% for the month of March 2018. See Market at a
Glance, available at www.miaxoptions.com (last visited November 2,
2022).
    \7\ The term ``MEO Interface'' or ``MEO'' means a binary order
interface for certain order types as set forth in Rule 516 into the
MIAX Pearl System. See the Definitions Section of the Fee Schedule
and Exchange Rule 100.
    \8\ The term ``FIX Interface'' means the Financial Information
Exchange interface for certain order types as set forth in Exchange
Rule 516. See the Definitions Section of the Fee Schedule and
Exchange Rule 100.
    \9\ The tiers were determined by the defined term ``Non-
Transaction Fees Volume Based Tiers''. See the Definitions Section
of the Fee Schedule.
    \10\ The term ``Member'' means an individual or organization
that is registered with the Exchange pursuant to Chapter II of
Exchange Rules for purposes of trading on the Exchange as an
``Electronic Exchange Member'' or ``Market Maker.'' Members are
deemed ``members'' under the Exchange Act. See Exchange Rule 100 and
the Definitions Section of the Fee Schedule.
    \11\ See Securities Exchange Act Release No. 82867 (March 13,
2018), 83 FR 12044 (March 19, 2018) (SR-PEARL-2018-07). See the
Definitions Section of the Fee Schedule for the definition of
``Affiliate.''
    \12\ See Securities Exchange Act Release No. 82867 (March 13,
2018), 83 FR 12044 (March 19, 2018) (SR-PEARL-2018-07).
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    The Exchange has two types of Members, Electronic Exchange Members
(``EEMs'') \13\ and Market Makers.\14\ The Exchange recently filed a
proposal with the Commission to amend the calculation and amount of
Trading Permit fees assessed to Market Makers, and adopt a flat Trading
Permit fee for EEMs, based on the type of interface used, MEO and/or
FIX. Pursuant to that proposal, the Exchange moved away from the volume
tier-based Trading Permit fee structure for Market Maker Trading Permit
fees; instead, Market Makers are assessed Trading Permit fees based
upon the number of classes in which the Market Maker was registered to
quote on any given day within the calendar month, or upon the class
volume percentages set forth in the table in Section 3)b) of the Fee
Schedule.\15\
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    \13\ ``Electronic Exchange Member'' or ``EEM'' means the holder
of a Trading Permit who is a Member representing as agent Public
Customer Orders or Non-Customer Orders on the Exchange and those
non-Market Maker Members conducting proprietary trading. Electronic
Exchange Members are deemed ``members'' under the Exchange Act. See
the Definitions Section of the Fee Schedule and Exchange Rule 100.
    \14\ The term ``Market Maker'' or ``MM'' means a Member
registered with the Exchange for the purpose of making markets in
options contracts traded on the Exchange and that is vested with the
rights and responsibilities specified in Chapter VI of the Exchange
Rules. See the Definitions Section of the Fee Schedule and Exchange
Rule 100.
    \15\ See Securities Exchange Act Release No. 95780 (September
15, 2022), 87 FR 57732 (September 21, 2022) (SR-PEARL-2022-39).
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    The Exchange established the Trading Permit Fee Credit to continue
to attract order flow and increase membership by lowering Trading
Permit costs for Members.\16\ The Exchange adopted the Trading Permit
Fee Credit to incentivize market participants to trade on the Exchange
and help the Exchange's market share grow.\17\ This practice is not
uncommon. New exchanges often do not charge fees or offer pricing
incentives for certain services such as memberships/trading permits to
attract order flow to an exchange, and later amend their fees to
reflect the true value of those services, absorbing costs to provide
those services in the meantime. Allowing new exchange entrants time to
build and sustain market share through various pricing incentives
before increasing non-transaction fees encourages market entry and
promotes competition. It also enables new exchanges to mature their
markets and allow market participants to trade on the new exchanges
without fees serving as a potential barrier to attracting memberships
and order flow.\18\ Not allowing exchanges to modify or amend such
pricing incentives as their markets mature, especially when other
options exchanges do not offer similar incentives, could discourage
exchanges from offering such incentives if they believe the Commission
would later require that exchange to continue to offer such incentives,
like a nominal $100 credit that is the subject of this proposal, and
lower prices than those of its competitor exchanges. In that case, the
Commission alone, and not market forces, would dictate exchange
pricing.
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    \16\ See supra note 12.
    \17\ The Exchange experienced a monthly average trading volume
in equity options of 4.35% for the month of October 2022. See Market
at a Glance, supra note 6 (last visited November 2, 2022).
    \18\ See Securities Exchange Act Release No. 94894 (May 11,
2022), 87 FR 29987 (May 17, 2022) (SR-BOX-2022-17) (stating, ``[t]he
Exchange established this lower (when compared to other options
exchanges in the industry) Participant Fee in order to encourage
market participants to become Participants of BOX. . .''). See also
Securities Exchange Act Release No. 90076 (October 2, 2020), 85 FR
63620 (October 8, 2020) (SR-MEMX-2020-10) (``MEMX Membership Fee
Proposal'') (proposing to adopt the initial fee schedule and stating
that ``[u]nder the initial proposed Fee Schedule, the Exchange
proposes to make clear that it does not charge any fees for
membership, market data products, physical connectivity or
application sessions.''). MEMX has seen its market share increase
and recently proposed to adopt a membership fee and fees for
connectivity. See Securities Exchange Act Release Nos. 93927
(January 7, 2022), 87 FR 2191 (January 13, 2022) (SR-MEMX-2021-19)
(proposing to adopt membership fees); and 95299 (July 15, 2022), 87
FR 43563 (July 21, 2022) (SR-MEMX-2022-17) (proposing to adopt fees
for connectivity). See also, e.g., Securities Exchange Act Release
No. 88211 (February 14, 2020), 85 FR 9847 (February 20, 2020) (SR-
NYSENAT-2020-05), available at https://www.nyse.com/publicdocs/nyse/markets/nyse-national/rule-filings/filings/2020/SR-NYSENat-2020-05.pdf (initiating market data fees for the NYSE National exchange
after initially setting such fees at zero).
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    The Exchange proposes to amend Section (3)(b) of the Fee Schedule
to remove the Trading Permit Fee Credit that is denoted in footnote
``*'' below the Trading Permit fee table. During periods when the
Trading Permit Fee Credit was in effect (the history of filings to
remove the Trading Permit Fee Credit is described below), the Trading
Permit Fee Credit was applicable to Members that connected via both the
MEO and FIX Interfaces. Members who connected via both the MEO and FIX
Interfaces were assessed the rates for both types of Trading Permits,
but these Members received a $100 monthly credit towards the Trading
Permit fees applicable to the MEO Interface. The Exchange proposes to
remove the Trading Permit Fee Credit and delete footnote ``*'' from
Section (3)(b) of the Fee Schedule.
    The Exchange established the Trading Permit fee credit when it
first launched operations to attract order flow and increase membership
by lowering the costs for Members that connect via the

MEO Interface and FIX Interface. The Exchange believes the Trading
Permit Fee Credit has achieved its purpose and the Exchange believes
that it is appropriate to remove this credit in light of the current
operating conditions and membership population on the Exchange.
Implementation and Procedural History
    The proposed rule change will be immediately effective. The
Exchange initially filed this proposal on July 1, 2021 (along with the
removal of a separate credit), with the proposed changes being
immediately effective.\19\ In that proposal, the Exchange also proposed
to increase its Trading Permit fees. Between August 2021 and September
2022, the Exchange withdrew and refiled the proposed rule change, each
time to meaningfully attempt to provide additional justification for
the proposed fee changes, provide enhanced details regarding the
Exchange's cost methodology or to supplement its competition based
arguments.\20\ The Commission received three comment letters from one
commenter on the various filings.\21\ On October 25, 2022, the Exchange
withdrew its latest proposal and submitted a revised proposal to only
remove the Trading Permit Fee Credit (SR-PEARL-2022-45, which was not
noticed by the Commission). On November 2, 2022, the Exchange withdrew
SR-PEARL-2022-45 and now resubmits a revised proposal to only remove
the Trading Permit Fee Credit.
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    \19\ See Securities Exchange Act Release No. 92366 (July 9,
2021), 86 FR 37379 (SR-PEARL-2021-32).
    \20\ See Securities Exchange Act Release Nos. 92797 (August 27,
2021), 86 FR 49399 (September 2, 2021) (SR-PEARL-2021-32)
(``Suspension Order 1''); 93555 (November 10, 2021), 86 FR 64254
(November 17, 2021) (SR-PEARL-2021-54); 93895 (January 4, 2022), 87
FR 1217 (January 10, 2022) (SR-PEARL-2021-59); 94287 (February 18,
2022), 87 FR 10837 (February 25, 2022) (SR-PEARL-2022-05)
(``Suspension Order 2''); 94696 (April 12, 2022), 87 FR 22987 (April
18, 2022) (SR-PEARL-2022-09); 94993 (May 26, 2022), 87 FR 33518
(June 2, 2022) (SR-PEARL-2022-23); SR-PEARL-2022-28; 95419 (August
4, 2022), 87 FR 48702 (August 10, 2022 (SR-PEARL-2022-30); 95775
(September 15, 2022), 87 FR 57544 (September 20, 2022) (SR-PEARL-
2022-35).
    \21\ See Letters from Richard J. McDonald, Susquehanna
International Group, LLC (``SIG''), to Vanessa Countryman,
Secretary, Commission, dated September 28, 2021 and March 15, 2022,
and Letter from Brian Sopinsky, General Counsel, SIG, to Vanessa
Countryman, Secretary, Commission, dated May 9, 2022.
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2. Statutory Basis
    The Exchange believes that its proposal to amend the Fee Schedule
is consistent with Section 6(b) of the Act \22\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \23\ in
particular, in that it is an equitable allocation of reasonable dues,
fees and other charges among its members and issuers and other persons
using its facilities. The Exchange also believes the proposal furthers
the objectives of Section 6(b)(5) of the Act in that it is not designed
to permit unfair discrimination between customers, issuers, brokers and
dealers.\24\
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    \22\ 15 U.S.C. 78f(b).
    \23\ 15 U.S.C. 78f(b)(4).
    \24\ 15 U.S.C. 78f(b)(5).
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    The proposed changes to the Fee Schedule are reasonable in several
respects. As a threshold matter, the Exchange is subject to significant
competitive forces in the market for order flow, which constrains its
pricing determinations. The fact that the market for order flow is
competitive has long been recognized by the courts. In NetCoalition v.
Securities and Exchange Commission, the D.C. Circuit stated, ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers' . . . .'' \25\
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    \25\ See NetCoalition, 615 F.3d at 539 (D.C. Cir. 2010) (quoting
Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR
74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-21)).
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    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention to determine
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, 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.'' \26\
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    \26\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
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    The Exchange believes its proposal to remove the nominal Trading
Permit Fee Credit of $100 for EEMs that connect via both the MEO
Interface and FIX Interface is reasonable, equitable and not unfairly
discriminatory because all market participants will no longer be
offered the ability to receive the credit. The Exchange believes it is
reasonable and equitable to remove the nominal $100 Trading Permit Fee
Credit for business and competitive reasons. The Exchange established
the Trading Permit Fee Credit to lower the costs for EEMs that connect
via the MEO Interface and FIX Interface as a means to attract order
flow and memberships after the Exchange first launched operations. The
Exchange now believes that it is appropriate to remove this credit in
light of the current operating conditions and membership on the
Exchange.
    The Exchange commenced operations in February 2017 \27\ and adopted
its initial fee schedule that waived fees for Trading Permits to trade
on the Exchange.\28\ Although Trading Permit fees were waived, an
initial fee structure was put in place to communicate the Exchange's
intent to charge Trading Permit fees in the future. As a new exchange
entrant, the Exchange chose to offer Trading Permits free of charge to
encourage market participants to trade on the Exchange and experience,
among things, the quality of the Exchange's technology and trading
functionality. This practice is not uncommon. New exchanges often do
not charge fees or charge lower fees for certain services such as
memberships or trading permits to attract order flow to a new market,
and later amend their fees to reflect the true value of those services,
absorbing all costs to provide those services in the meantime. Allowing
new exchange entrants time to build and sustain market share through
various pricing incentives before increasing non-transaction fees
encourages market entry and promotes competition. It also enables new
exchanges to mature their markets and allow market participants to
trade on the new exchanges without fees serving as a potential barrier
to attracting memberships and order flow.\29\ Later in 2018, as the
Exchange's market share increased,\30\ the Exchange adopted nominal
fees for Trading Permits along with the Trading Permit Fee Credit.\31\
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    \27\ See supra note 3.
    \28\ See supra note 5.
    \29\ See supra note 18.
    \30\ The Exchange experienced a monthly average trading volume
of 3.94% for the month of March 2018. See supra note 6, Market at a
Glance (last visited November 2, 2022).
    \31\ See supra note 12. At that time, the Exchange chose to
adopt a volume tier-based fee for Trading Permits along with the
type of interface used--FIX or MEO--as a way to provide different
choices regarding how potential Members could access the Exchange's
System. This was for business and competitive reasons and to provide
choice regarding Trading Permits and membership that had not
previously existed. The Exchange has since proposed to move away
from the volume tier-based Trading Permit fee structure and filed a
proposal with the Commission so that its Trading Permit fee
structure aligns with that of the Exchange's affiliates, MIAX and
MIAX Emerald, as well as other options exchanges by assessing Market
Makers Trading Permit fees based on options classes assigned. See
also Securities Exchange Act Release No. 95780 (September 15, 2022),
87 FR 57732 (September 21, 2022) (SR-PEARL-2022-39) (amending the
Trading Permit Fees in the MIAX Pearl Options Fee Schedule).

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    The Exchange recently reviewed the calculation and amount of its
Trading Permit fees. In its review, the Exchange determined that the
nominal Trading Permit Fee Credit of $100 is no longer necessary to
attract market share or memberships. The Exchange believes that even
with the proposal to remove the nominal $100 Trading Permit Fee Credit,
the Exchange's Trading Permit fees for EEMs ($1,000 for EEMs that
connect via the FIX Interface and $3,000 for EEMs that connect via the
MEO Interface) will be similar to the rates charged by the Exchange's
affiliates, Miami International Securities Exchange, LLC (``MIAX'')
\32\ and MIAX Emerald, LLC (``MIAX Emerald''),\33\ and competing
options exchanges in the industry for similar Trading Permits for such
market participants. For example, BOX Options Exchange LLC (``BOX'')
\34\ assesses a ``Participant Fee'' of $1,500 per month; NYSE Arca,
Inc. (``NYSE Arca'') \35\ assesses Office and Clearing Firms Trading
Permit fees of $1,000 per month; NYSE American, LLC (``NYSE American'')
\36\ assesses Clearing Members and Order Flow Providers ``ATP Trading
Permit'' fees of $1,000 per month; Nasdaq ISE LLC (``Nasdaq ISE'') \37\
assesses Electronic Access Members ``Access Fees'' of $500 per month;
Cboe Exchange, Inc. (``Cboe'') \38\ assesses Electronic Access Permit
fees of $3,000 per month and Clearing TPH Permit fees of $2,000 per
month; and Cboe C2 Exchange, Inc. (``Cboe C2'') \39\ assesses
Electronic Access Permit fees of $1,000 per month. None of these
exchanges offer a related credit.
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    \32\ See MIAX Fee Schedule, Section (3)(b) (assessing MIAX EEMs
a flat fee of $1,500 per month for Trading Permits).
    \33\ See MIAX Emerald Fee Schedule, Section (3)(b) (assessing
MIAX Emerald EEMs a flat fee of $1,500 per month for Trading
Permits).
    \34\ See BOX fee schedule, Section 1, available at https://boxexchange.com/assets/BOX-Fee-Schedule-as-of-June-1-2022-1.pdf
(last visited October 19, 2022). BOX's Participant Fee is the analog
to the Exchange's Trading Permit fee for EEMs who use the FIX
interface. BOX had an average daily market share of 6.64% for the
month of October (as of October 19, 2022). See supra note 6, Market
at a Glance.
    \35\ See NYSE Arca Options Fees and Charges, OTP Trading
Participant Rights, p. 1, available at https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf (last visited October 19, 2022).
    \36\ See NYSE American Options Fee Schedule, Section III,
Monthly Trading Permit, Rights, Floor Access and Premium Product
Fees, p. 23-24, available at https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf
(last visited October 19, 2022). NYSE American's ATP Trading Permit
fee for Clearing Members and Order Flow Providers is the analog for
the Exchange's Trading Permit fee for EEMs that use the FIX
interface.
    \37\ See Nasdaq ISE Options 7 Pricing Schedule, Section 8.A.
Access Services, available at https://listingcenter.nasdaq.com/rulebook/ise/rules/ISE%20Options%207 (last visited October 19,
2022). Nasdaq ISE Options' EAM Access Fee is the analog to the
Exchange's Trading Permit fee for EEMs that use the FIX Interface.
Nasdaq ISE had an average daily market share of 6.35% for the month
of October (as of October 19, 2022). See supra note 6, Market at a
Glance.
    \38\ See Cboe Fee Schedule, Electronic Trading Permit Fees,
available at https://cdn.cboe.com/resources/membership/Cboe_FeeSchedule.pdf (last visited October 19, 2022). Cboe's
Electronic Access Permit fee and Clearing TPH fee are the analog to
the Exchange's Trading Permit fee for EEMs that use the FIX
Interface.
    \39\ See Cboe C2 Fee Schedule, Access Fees, available at https://www.cboe.com/us/options/membership/fee_schedule/ctwo/ (last visited
October 19, 2022). Cboe C2's Electronic Access Permit fee is the
analog to the Exchange's Trading Permit fee for EEMs that use the
FIX Interface. Cboe C2 had an average daily market share of 4.65%
for the month of October (as of October 19, 2022). See supra note 6,
Market at a Glance.
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    There is no requirement, regulatory or otherwise, that any broker-
dealer connect to and access any (or all of) the available options
exchanges. One other exchange recently noted in a proposal to amend
their own trading permit fees that of the 62 market making firms that
are registered as Market Makers across Cboe, MIAX, and BOX, 42 firms
access only one of the three exchanges.\40\ Further, the Exchange and
its affiliates, MIAX and MIAX Emerald, have a total of 47 members. Of
those 47 total members, 35 are members of all three exchanges, four are
members of only two (2) exchanges, and eight (8) are members of only
one exchange. Of those that are Market Makers today on the Exchange,
two (2) are not registered as Market Makers on MIAX and one (1) is not
registered as a Market Maker on MIAX Emerald. Broken down even further,
of those Market Makers that use the MEO Interface and reached the
Exchange's top tier for the Trading Permit fee for June 2022, one (1)
Market Maker was only a Member of the Exchange and not its two
affiliates, MIAX and MIAX Emerald. The above data evidences that a
Member need not be a member of all options exchanges, let alone the
Exchange and its two affiliates, and market participants elect to do so
based on their own business decisions and need to directly access each
exchange's liquidity pool. Not only is there not an actual regulatory
requirement to connect to every options exchange, the Exchange believes
there is also no ``de facto'' or practical requirement as well, as
further evidenced by the market maker membership analysis of the
options exchanges discussed above. Indeed, Members choose if and how to
access a particular exchange and because it is a choice, the Exchange
must set reasonable pricing, otherwise prospective market makers would
not connect and existing Market Makers would disconnect from the
Exchange.
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    \40\ See Securities Exchange Act Release No. 94894 (May 11,
2022), 87 FR 29987 (May 17, 2022) (SR-BOX-2022-17) (Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change to Amend the
Fee Schedule on the BOX Options Market LLC Facility To Adopt
Electronic Market Maker Trading Permit Fees). The Exchange believes
that BOX's observation demonstrates that market making firms can,
and do, select which exchanges they wish to access, and,
accordingly, options exchanges must take competitive considerations
into account when setting fees for such access.
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    The Exchange believes that elasticity of demand for Exchange
Membership exists when it comes to purchasing a Trading Permit and, as
evidenced by the below data, prior fee proposals have resulted in
Members terminating their memberships.\41\ For example, over the course
of those prior filings, three (3) Members terminated their memberships
in the time since the proposed fee increase first went into effect. In
June 2021, the month immediately preceding the initial implementation
of the prior proposed fee change, the Exchange had 20 users of the MEO
Interface and 28 users of the FIX Interface. These numbers remained
stagnant until August 2021, where one Member that utilized the MEO
Interface ceased utilizing the MEO Interface and again in December 2021
where one Member that utilized the FIX Interface ceased utilizing the
FIX Interface. These numbers again remained stagnant until March 2022,
where another Member that utilized the FIX Interface ceased utilizing
the FIX Interface. This resulted in 19 users of the MEO Interface and
26 users of the FIX Interface. Further, other exchanges have also
experienced termination of memberships if their members deem permit or
membership fees to be unreasonable or excessive. For example, the
Exchange notes that a BOX participant modified its access to BOX in
connection with the implementation of a proposed change to BOX's permit
fees.\42\ The absence of new memberships

coupled with the termination of two memberships on the Exchange, as
well as similar membership changes on another options exchange in
relation to a trading permit fee increase, clearly shows that
elasticity of demand exists.
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    \41\ See Securities Exchange Act Release No. 95419 (August 4,
2022), 87 FR 48702 (August 10, 2022) (SR-PEARL-2022-30).
    \42\ According to BOX, a Market Maker on BOX terminated its
status as a Market Maker in response to BOX's proposed modification
of Market Maker trading permit fees. See Securities Exchange Act
Release No. 94894 (May 11, 2022), 87 FR 29987 (May 17, 2022) (SR-
BOX-2022-17). BOX noted, and the Exchange agrees, that this Market
Maker's decision demonstrates that Market Makers can, and do, alter
their membership status if they deem permit fees at an exchange to
be unsuitable for their business needs, thus demonstrating the
competitive environment for Market Maker permit fees and the
constraints on options exchanges when setting Market Maker permit
fees.
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    The Exchange notes that there are material costs associated with
providing the infrastructure and headcount to fully-support access to
the Exchange. The Exchange incurs technology expenses related to
establishing and maintaining Information Security services, enhanced
network monitoring and customer reporting associated with its network
technology. While some of the expense is fixed, much of the expense is
not fixed, and thus increases as the expenses associated with access
services for Members increases. For example, new Members to the
Exchange may require the purchase of additional hardware to support
those Members as well as enhanced monitoring and reporting of customer
performance that the Exchange provides. Further, as the total number of
Members increase, the Exchange may need to increase its data center
footprint and consume more power, resulting in increased costs charged
by their third-party data center provider. Accordingly, the cost to the
Exchange to provide access to its Members is not fixed. The Exchange
believes the proposal to remove the Trading Permit Fee Credit is
reasonable in order to offset a portion of the costs to the Exchange
associated with providing access to its quote and order infrastructure.
    The Exchange again notes that it operates in a highly competitive
market in which market makers can readily favor competing venues if
they deem fee levels at a particular venue to be excessive. In such an
environment, the Exchange must continually adjust its fees for services
and products, in addition to order flow, to remain competitive with
other exchanges. The Exchange believes that the proposed changes
reflect this competitive environment. The Exchange again notes it is
not aware of any reason why Members could not simply drop their access
to an exchange (or not initially access an exchange) if an exchange
were to establish prices for its non-transaction fees that, in the
determination of such market participant, did not make business or
economic sense to access such exchange. The Exchange again notes that
no broker-dealer is required by rule, regulation, or competitive forces
to be a Member on the Exchange.
    Accordingly, the Exchange believes removal of the nominal $100
Trading Permit Fee Credit is reasonable and equitable. It is also not
unfairly discriminatory as the removal of the credit applies equally to
all EEMs and the Exchange's Trading Permit fees for EEMs are in line
with similar fees charged by competitor exchanges.

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

    In accordance with Section 6(b)(8) of the Act,\43\ the Exchange
believes that the proposed rule change would not impose any burden on
intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \43\ 15 U.S.C. 78f(8).
---------------------------------------------------------------------------

Intra-Market Competition
    The Exchange believes the removal of the Trading Permit fee credit
will not place certain market participants at a relative disadvantage
to other market participants because, in order to attract order flow
when the Exchange first launched operations, the Exchange established
this credit to lower the initial fixed cost for Members. The Exchange
now believes that it is appropriate to remove this credit in light of
the current operating conditions, including the Exchange's overall
membership and the current type and amount of volume executed on the
Exchange. The Exchange believes that the Exchange's current rebates and
fees will still allow the Exchange to remain highly competitive such
that the Exchange should continue to attract order flow and maintain
market share. The proposed fee change will not impact intra-market
competition because it will apply to all Members equally.
Inter-Market Competition
    The Exchange operates in a highly competitive market in which
market participants can readily favor one of the 15 competing options
venues if they deem fee levels at a particular venue to be excessive.
Based on publicly-available information, and excluding index-based
options, no single exchange has more than approximately 16% market
share. Therefore, no exchange possesses significant pricing power
regarding memberships or in the execution of multiply-listed equity and
exchange-traded fund (``ETF'') options order flow. Over the course of
2021 and 2022, the Exchange's market share has fluctuated between
approximately 3-6% of the U.S. equity options industry.\44\ The
Exchange is not aware of any evidence that a market share of
approximately 3-6% provides the Exchange with anti-competitive pricing
power when it comes to competition for memberships. The Exchange
believes that the ever-shifting market share among exchanges from month
to month demonstrates that market participants can discontinue
memberships in response to fee changes. In such an environment, the
Exchange must continually adjust its fees to remain competitive with
other exchanges and to attract and retain memberships on the Exchange.
---------------------------------------------------------------------------

    \44\ See supra note 6.
---------------------------------------------------------------------------

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

    The Exchange responded to comment letters in a prior proposal.\45\
---------------------------------------------------------------------------

    \45\ See supra note 20.
---------------------------------------------------------------------------

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\46\ and Rule 19b-4(f)(2) \47\ thereunder.
At any time within 60 days of the filing of the 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 to determine whether
the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \46\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \47\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-PEARL-2022-47 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-PEARL-2022-47. 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-PEARL-2022-47 and should be submitted on
or before December 5, 2022.
    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\48\
---------------------------------------------------------------------------

    \48\ 17 CFR 200.30-3(a)(12).

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-24650 Filed 11-10-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Notices]
[Page 52528]
[DOCID:fr26au10-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-2268-000]

FC Landfill Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

August 19, 2010.
    This is a supplemental notice in the above-referenced proceeding,
of FC Landfill Energy, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is September 8, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-21229 Filed 8-25-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Notices]
[Page 14717]
[FR Doc No: 2014-05796]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3368-EM; Docket ID FEMA-2014-0003]

Georgia; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Georgia (FEMA-3368-EM), dated February 11,
2014, and related determinations.

DATES: Effective Date: February 11, 2014.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated February 11, 2014, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Georgia resulting from a severe winter storm
beginning on February 10, 2014, and continuing are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of Georgia.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, W.
Michael Moore, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Georgia have been designated as
adversely affected by this declared emergency:

    Banks, Barrow, Bartow, Carroll, Catoosa, Chattooga, Cherokee,
Clarke, Cobb, Dade, Dawson, DeKalb, Douglas, Elbert, Fannin, Floyd,
Forsyth, Franklin, Fulton, Gilmer, Gordon, Gwinnett, Habersham,
Hall, Haralson, Hart, Jackson, Lincoln, Lumpkin, Madison, Murray,
Oconee, Oglethorpe, Paulding, Pickens, Polk, Rabun, Stephens, Towns,
Union, Walker, Walton, White, Whitfield, and Wilkes Counties for
emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-05796 Filed 3-14-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30534-30535]
[FR Doc No: 2016-11551]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD16-18-000]

Competitive Transmission Development, Technical Conference;
Supplemental Notice of Technical Conference and Request for Speakers

    As announced in the Notice of Technical Conference issued in this
proceeding on March 17, 2016, the Federal Energy Regulatory Commission
will hold a Commissioner-led technical conference on June 27, 2016,
from approximately 1:00 p.m. to 5:00 p.m., and on June 28, 2016, from
approximately 9:00 a.m. to 5:00 p.m., at the Commission's headquarters
at 888 First Street NE., Washington, DC 20426. The purpose of the
technical conference is to discuss issues related to competitive
transmission development processes, including, but not limited to, the
use of cost containment provisions, the relationship of competitive
transmission development to transmission incentives, and other
ratemaking issues.\1\ In addition, participants will have the
opportunity to discuss issues relating to interregional transmission
coordination, regional transmission planning and other transmission
development issues.\2\
---------------------------------------------------------------------------

    \1\ Topics to be discussed include, but are not limited to,
those that the Commission described in NextEra Energy Transmission
West, LLC, 154 FERC ] 61,009, at PP 76-78 (2015) and ITC Grid
Development, LLC, 154 FERC ] 61,206, at P 49 (2016).
    \2\ See Northern Indiana Public Service Co. v. Midcontinent
Independent System Operator, Inc. and PJM Interconnection L.L.C.,
155 FERC ] 61,058, at P 54 (2016).
---------------------------------------------------------------------------

    Attached to this Supplemental Notice is a preliminary agenda for
the technical conference and a description of key concepts.
    Those interested in speaking at the technical conference should
notify the Commission by May 17, 2016, by completing the online form at
the following Web page: https://www.ferc.gov/whats-new/registration/06-27-16-speaker-form.asp. At this Web page, please describe the topic(s)
you wish to address and provide biographical information. Due to time
constraints, we anticipate that we may not be able to accommodate all
those interested in speaking. We will notify selected speakers as soon
as possible.
    Interested parties may submit pre-technical conference comments
(with a ten page limit) for consideration in Docket No. AD16-18-000 no
later than May 31, 2016.
    The conference will be open for the public to attend. Information
on the technical conference will also be posted on the Calendar of
Events on the Commission's Web site, http://www.ferc.gov, prior to the
event. Advance registration is not required but is encouraged.
Attendees may register at the following Web page: https://www.ferc.gov/whats-new/registration/06-27-16-form.asp.
    This event will be webcast and transcribed. Anyone with internet
access can navigate to the ``FERC Calendar'' at www.ferc.gov, and
locate the technical conference in the Calendar

of Events. Opening the technical conference in the Calendar of Events
will reveal a link to its webcast. The Capitol Connection provides
technical support for the webcast and offers the option of listening to
the meeting via phone-bridge for a fee. If you have any questions,
visit www.capitolconnection.org or call<PHONE_NUMBER>. The webcast will
be available on the Calendar of Events at www.ferc.gov for three months
after the conference. Transcripts of the conference will be immediately
available for a fee from Ace-Federal Reporters, Inc.<PHONE_NUMBER>).
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about this technical conference, please
contact:

Sarah McKinley (Logistical Information), Office of External Affairs,
(202) 502-8004<EMAIL_ADDRESS>David Tobenkin (Technical Information), Office of Energy Policy and
Innovation,<PHONE_NUMBER><EMAIL_ADDRESS>Zeny Magos (Technical Information), Office of Energy Market Regulation,
(202) 502-8244<EMAIL_ADDRESS>Erica Siegmund Hough (Legal Information), Office of General Counsel,
(202) 502-8251<EMAIL_ADDRESS>
    Dated: May 10, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-11551 Filed 5-16-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24311-24313]
[FR Doc No: 2022-08740]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1975-N-0336 (formerly 1975N-0184)]

Drugs for Human Use; Drug Efficacy Study Implementation; Oral
Prescription Drugs Containing an Anticholinergic or Antispasmodic in
Combination With a Sedative, and Single-Entity Antispasmodic Drug
Products, in Oral Dosage Form; Withdrawal of Hearing Requests; Final
Resolution of Drug Efficacy Study Implementation

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that all outstanding hearing requests regarding drug products
containing an anticholinergic or antispasmodic in combination with a
sedative, and single-entity antispasmodic drug products, in oral dosage
form, under Docket FDA-1975-N-0336 (formerly 75N-0184) (DESI 10837)
have been withdrawn. Therefore, shipment in interstate commerce of any
such product identified in Docket FDA-1975-N-0336 covered by DESI
10837, or any identical, related, or similar (IRS) product, that is not
the subject of an approved new drug application (NDA) or abbreviated
new drug application (ANDA) is unlawful as of the date of this notice.
This notice does not affect products covered by DESI 597 under the same
docket.

DATES: This notice is applicable April 25, 2022.

ADDRESSES: For access to the docket to read background documents or the
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff (HFA-305), 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. The most relevant
background documents regarding this matter are available in the docket.
However, additional background documents are available upon request
(see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Jeffrey Trunzo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5111,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    When enacted in 1938, the Federal Food, Drug, and Cosmetic Act
(FD&C Act) required that ``new drugs'' (21 U.S.C. 321(p)) be approved
for safety by FDA before they could legally be sold in interstate
commerce. Between 1938 and 1962, if a drug obtained approval, FDA
considered drugs that were IRS (see 21 CFR 310.6(b)(1)) to the approved
drug to be covered by that approval and allowed those IRS drugs to be
marketed without independent approval.
    In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe, in
order to obtain FDA approval. This amendment also required FDA to
conduct a retrospective evaluation of the effectiveness of the drug
products that FDA had approved as safe between 1938 and 1962. FDA
contracted with the National Academy of Sciences/National Research
Council (NAS/NRC) to make an initial evaluation of the effectiveness of
over 3,400 products that had been approved only for safety between 1938
and 1962. The NAS/NRC reports for these drug products were submitted to
FDA in the late 1960s and early 1970s. The Agency reviewed and
reevaluated the reports and published its findings in Federal Register
notices. FDA's administrative implementation of the NAS/NRC reports was
called the Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.
    All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as lacking substantial evidence of effectiveness for one or more
indications, that drug product and those IRS to it may no longer be
marketed for such indications and are subject to enforcement action as
unapproved new drugs. If FDA's final DESI determination classifies the
drug product as effective for one or more of its labeled indications,
the drug can be marketed for such indications, provided it is the
subject of an application approved for safety and effectiveness.
Sponsors of drug products that have been found to be effective for one
or more indications through the DESI process may rely on FDA's
effectiveness determinations, but typically must update their labeling
to conform to the indication(s) found to be effective by FDA and
include any additional safety information required by FDA. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if one or more
indications are found to be effective under DESI; IRS drug products
require an approved NDA or ANDA, as appropriate. Furthermore, labeling
for drug products classified as effective may contain only those
indications for which the review found the product effective unless the
firm marketing the product has received an approval for the additional
indication(s).

II. Final Resolution of Hearing Requests Regarding Oral Prescription
Drugs Containing an Anticholinergic or Antispasmodic in Combination
With a Sedative, and Single-Entity Antispasmodic Drug Products, in Oral
Dosage Form Under Docket No. FDA-1975-N-0336 (Formerly 75N-0184); DESI
10837

    In a Federal Register notice published on June 22, 1971 (36 FR
11875) (1971 Federal Register notice), FDA announced its evaluation of
reports received from NAS/NRC under DESI 10837, regarding
anticholinergic drug products containing the following active
ingredients: Prochlorperazine maleate and isopropamide iodide;
oxyphencyclimine hydrochloride and meprobamate; oxyphencyclimine
hydrochloride and hydroxyzine hydrochloride; tridihexethyl chloride and
meprobamate; and propantheline bromide and thiopropazate hydrochloride.
The drugs were found to be possibly effective as adjunctive therapy in
peptic ulcer and in the irritable bowel syndrome (irritable colon,
spastic colon, mucous colitis, functional gastrointestinal disorders);
functional diarrhea; drug induced diarrhea; ulcerative colitis, and
urinary bladder spasm, and urethral spasm (i.e., smooth muscle spasm).
In addition, oxyphencyclimine and meprobamate preparations were found
to be possibly effective for dysmenorrhea. These drugs were found to
lack substantial evidence of effectiveness for their other labeled
indications.
    In a Federal Register notice published November 11, 1975 (40 FR
52644) (1975 Federal Register notice), the Agency explained that
several of the products listed in the 1971 Federal Register notice may
remain on the market while clinical studies were being conducted to
determine their efficacy for the indications rated as ``possibly
effective,'' because they were widely used in the treatment of peptic
ulcer disease and functional bowel syndrome and were perceived as
important and useful tools of therapy by many gastroenterologists and
general practitioners (40 FR 52644 at 52648). In addition to the
products from the 1971 Federal Register notice, the 1975 Federal
Register notice included several products, among them Librax Capsules,
NDA 12-750, containing clidinium bromide and chlordiazepoxide, now
manufactured by Bausch Health Companies, Inc. (Bausch), that had been
the subject of safety-only applications approved before 1962 and that
had not been reviewed by NAS/NRC. Librax Capsules was included in the
1975 Federal Register notice notwithstanding the Stipulation for
Dismissal in Hoffman-La Roche, Inc. v. Richardson, et. al., Civil
Action 11-73 (D.N.J. August 2, 1973), discussed below. The 1975 Federal
Register notice set forth a timetable for conducting clinical efficacy
studies for drug products subject to the notice. In a Federal Register
notice published June 20, 1978 (43 FR 26490) (1978 Federal Register
notice), FDA announced a change in its previous policy for testing and
marketing of the drugs that were subject of the November 11, 1975,
notice (e.g., Librax), including an extension of deadline for
completion of the studies for 1 year.
    In a Federal Register notice published January 16, 1981(46 FR 3977)
(1981 Federal Register notice), FDA announced its evaluation of study
reports received in response to the 1975 Federal Register notice. FDA
concluded that there was a lack of substantial evidence demonstrating
the effectiveness of the drugs listed in the 1975 notice, proposed to
withdraw approval of the new drug applications, and offered an
opportunity for hearing to manufacturers of the drugs listed in the
notice, as well as to the manufacturers of IRS products.
    As set forth in a Federal Register notice published July 24, 2012
(77 FR 43337) (2012 Federal Register notice), several companies
submitted timely hearing requests in response to the 1981 Federal
Register notice, but the only such request that had not been withdrawn
as of July 2012, was the request regarding Librax Capsules, filed by
Roche Laboratories, manufacturer of Librax Capsules in 1981 (77 FR
43337 at 43341). In response to the 2012 Federal Register notice,
Valeant Pharmaceuticals North America LLC (now Bausch) affirmed the
hearing request regarding Librax Capsules by letter dated August 22,
2012.
    On May 23, 2016, FDA posted a Notice to Docket 1975-N-0336,

explaining that Librax is not subject to review under DESI because a
new drug application for Librax was approved by the Agency on September
1, 1966, and at that time the Agency determined that Librax was safe
and effective for the indications set forth in its labeling,
(consistent with the Stipulation for Dismissal in Hoffman-La Roche,
Inc. v. Richardson, et al., Civil Action 11-73 (D.N.J. August 2,
1973)). On June 2, 2016, Valeant responded by withdrawing its hearing
request.
    There are no longer outstanding hearing requests pertaining to drug
products containing an anticholinergic or antispasmodic in combination
with a sedative, and single-entity antispasmodic drug products, in oral
dosage form under Docket No. FDA-1975-N-0336, DESI 10837. Shipment in
interstate commerce of any drug product identified in this docket under
DESI 10837, or any IRS product, that is not the subject of an approved
NDA or ANDA is unlawful as of the applicable date of this notice (see
DATES). Any person who wishes to determine whether a specific product
is covered by this notice should write to Jeffrey Trunzo (see FOR
FURTHER INFORMATION CONTACT). Firms should be aware that, after the
applicable date of this notice (see DATES), FDA intends to take
enforcement action without further notice against any firm that
manufactures or ships in interstate commerce any unapproved product
covered by this notice.

III. Discontinued Products

    Firms must notify the Agency of certain product discontinuations in
writing under section 506C(a) of the FD&C Act (21 U.S.C. 356c) (see
https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm). Some
firms may have previously discontinued manufacturing or distributing
products covered by this notice without discontinuing the listing as
required under section 510(j) of the FD&C Act (21 U.S.C. 360(j)). Other
firms may discontinue manufacturing or distributing listed products in
response to this notice. All firms are required to electronically
update the listing of their products under 510(j) of the FD&C Act to
reflect discontinuation of unapproved products covered by this notice
(21 CFR 207.57(b)). Questions on electronic drug listing updates should
be sent to [email protected]. In addition to the required update, firms
can also notify the Agency of product discontinuation by sending a
letter, signed by the firm's chief executive officer and fully
identifying the discontinued product(s), including the product National
Drug Code (NDC) number(s), and stating that the manufacturing and/or
distribution of the product(s) have been discontinued. The letter
should be sent electronically to Jeffrey Trunzo (see FOR FURTHER
INFORMATION CONTACT). FDA plans to rely on its existing records,
including its drug listing records, the results of any future
inspections, or other available information, when it identifies
violative products for enforcement action.

IV. Reformulated Products

    FDA cautions firms against reformulating products and marketing
under the same name or substantially the same name (including a new
name that contains the old name). Reformulated products marketed under
a name previously identified with a different active ingredient or
combinations of active ingredients have the potential to confuse
healthcare practitioners and harm patients.

    Dated: April 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08740 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54375-54376]
[FR Doc No: 2020-19253]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 935-140; 2071-082; 2111-080; Project No. 2213-043]

PacifiCorp; Public Utility District No. 1 of Cowlitz County;
Notice of Application Accepted for Filing and Soliciting Comments,
Motions to Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Non-capacity License Amendment.
    b. Project Nos: 935-140, 2071-082, 2111-080, and 2213-043.
    c. Date Filed: July 2, 2020.
    d. Applicants: PacifiCorp, and Public Utility District No. 1 of
Cowlitz County (licensees).
    e. Name of Projects: Merwin Hydroelectric Project, Yale
Hydroelectric Project, Swift No. 1 Hydroelectric Project, and Swift No.
2 Hydroelectric Project.
    f. Location: The project is located on the Lewis River in Clark,
Cowlitz, and Skamania Counties, Washington.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contacts: PacifiCorp, Mr. Todd Olson, 825 NE Multnomah
Street, Suite 1800, Portland, OR 97232; phone<PHONE_NUMBER>,
<EMAIL_ADDRESS>Public Utility District No. 1 of Cowlitz
County, Washington, Ms. Amanda Froberg, 961 12th Ave., Longview, WA
98632; phone<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Erich Gaedeke<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: September 21, 2020.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street, NE, Washington, DC 20426. Submissions sent via any
other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
MD 20852. The first page of any filing should include docket number P-
935-140, P-2071-082, P-2111-080, and P-2213-043. Comments emailed to
Commission staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensees must provide fish passage
facilities for each project as per fishway prescriptions issued by the
National Marine Fisheries Service and U.S. Fish and Wildlife Service
(Services) under Section 18 of the Federal Power Act, which are
incorporated into their licenses. The licenses include provisions that
allow the licensees to present new information to the Services
regarding whether the construction of the fish passage facilities is
appropriate.

The licensees provided this information to the Services, who concurred
and provided new fish passage determinations. As such, the licensees
are requesting the following modifications: (1) Requiring PacifiCorp to
implement an aquatic habitat restoration program in lieu of
constructing fish passage facilities into and out of Merwin Reservoir;
(2) delaying decisions regarding the appropriateness of constructing
fish passage facilities into and out of the Yale Reservoir until 2031
and 2035; and (3) requiring PacifiCorp to construct the Yale
Downstream, Yale Upstream, and Swift Upstream bull trout passage
facilities. Additional areas potentially impacted by the proposed
modifications include: the three Project reservoirs; the river reach
below Merwin Dam; and river and creek reaches above Swift Reservoir.
The licensees' applications provided additional detail on the proposed
modifications and associated resource enhancement measures.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the eLibrary link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. You may also register online at
http://www.ferc.gov/docs-filing/esubscription.asp to be notified via
email of new filings and issuances related to this or other pending
projects. For assistance, call<PHONE_NUMBER> or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title COMMENTS; PROTEST, or MOTION TO INTERVENE as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the application to which the filing responds; (3)
furnish the name, address, and telephone number of the person
commenting, protesting or intervening; and (4) otherwise comply with
the requirements of 18 CFR 385.2001 through 385.2005. All comments,
motions to intervene, or protests, must set forth their evidentiary
basis. Any filing made by an intervenor must be accompanied by proof of
service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: August 26, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-19253 Filed 8-31-20; 8:45 am]
BILLING CODE 6717-01-P