[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Notices]
[Pages 33862-33866]
[FR Doc No: 2022-11875]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95000; File No. SR-PEARL-2022-22]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange
Rule 519, MIAX Pearl Order Monitor (``MOM'')

May 27, 2022.
    Pursuant to the provisions of 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 May 13, 2022, MIAX PEARL, LLC (``MIAX Pearl''
or the ``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 proposes to amend Exchange 519, MIAX Pearl Order
Monitor (``MOM'').
    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 proposes to amend Exchange Rule 519, MIAX Pearl Order
Monitor (``MOM'') to (i) establish an Exchange default Threshold
Setting for market orders \3\ to sell an option when the national best
bid is zero; (ii) provide that an Electronic Exchange Member (``EEM'')
\4\ may supply their own pre-set value to be used as the Threshold
Setting; (iii) reorganize the rule text for ease of reference; and (iv)
adopt new rule text to add additional detail regarding the Exchange's
process for evaluating and reevaluating market orders to sell.
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    \3\ A market order is an order to buy or sell a stated number of
option contracts at the best price available at the time of
execution. See Exchange Rule 516(a).
    \4\ The term ``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 Exchange Rule 100.

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Background
    Currently, in order to avoid the occurrence of potential obvious or
catastrophic errors on the Exchange the MIAX Pearl Order Monitor will
prevent certain orders from executing or being placed on the Book \5\
at prices outside pre-set standard limits. Beginning after the Opening
Process \6\ is complete, the MIAX Pearl Order Monitor will be
operational each trading day until the close of trading.\7\ Exchange
Rule 519(a)(1)(i) provides that if the Exchange upon initial receipt or
reevaluation evaluates a market order from an EEM to sell an option
when the national best bid is zero and the Exchange's disseminated
offer is equal to or less than $0.10, the System \8\ will convert the
market order to sell to a limit order to sell with a limit price of one
Minimum Trading Increment.\9\ In this case, such sell orders will
automatically be placed on the Book in time priority and will be
displayed at the appropriate Minimum Price Variation.\10\ Exchange Rule
519(a)(1)(ii) provides that if the Exchange upon initial receipt or
reevaluation evaluates a market order from an EEM to sell an option
when the national best bid is zero and the national best offer is
greater than $0.10, the System will cancel the market order to sell.
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    \5\ The term ``Book'' means the electronic book of buy and sell
orders and quotes maintained by the System. See Exchange Rule 100.
    \6\ See Exchange Rule 503.
    \7\ See Exchange Rule 519(a).
    \8\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \9\ See Exchange Rule 510(b).
    \10\ See Exchange Rule 510(a).
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Proposal
    The Exchange now proposes to allow an Electronic Exchange Member to
determine their own pre-set value to be used as the threshold setting
(``Threshold Setting'') that the Exchange will use when evaluating
market orders to sell when the national best bid is zero and the
national best offer is less than, equal to, or greater than, the
Threshold Setting. EEM Members are not constrained by the Exchange in
determining their Threshold Setting and may set the threshold at any
value in accordance to their business and risk tolerances. EEM Members
will communicate their desired threshold value to the Exchange's Help
Desk \11\ in a form and manner to be determined by the Exchange and
communicated to Members via Regulatory Circular. The Exchange will
establish a default Threshold Setting of $0.10 (the current setting)
and communicate its value to Members via Regulatory Circular.\12\
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    \11\ The term ``Help Desk'' means the Exchange's control room
consisting of Exchange staff authorized to make certain
determinations on behalf of the Exchange. The Help Desk shall report
to and be supervised by a senior executive of the Exchange. See
Exchange Rule 100.
    \12\ The Exchange proposes to convert its current $0.10
threshold setting to the Exchange default Threshold Setting.
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    The Exchange proposes to adopt new subparagraph (i) to paragraph
(a)(1) of Rule 519 to provide that, for the purposes of this Rule an
EEM may establish a pre-set value to be used as the Threshold Setting
by communicating its value to the Exchange's Help Desk in a form and
manner to be determined by the Exchange and communicated via Regulatory
Circular. The Exchange will establish a default Threshold Setting of
$0.10 and communicate its value to Members via Regulatory Circular. If
an EEM does not establish a Threshold Setting the Exchange default
value will be used. Currently, the Exchange uses a value of $0.10 as
its threshold value for purposes of evaluating or reevaluating market
orders to sell when the national best bid is zero.\13\
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    \13\ See Exchange Rule 519(a)(i) and (ii).
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    The Exchange proposes to adopt new subparagraph (ii) to paragraph
(a)(1) of Rule 519 to provide that, if the Exchange receives a market
order from an EEM to sell an option when the national best bid is zero
and the national best offer is less than or equal to the Threshold
Setting, the System will convert the market order to sell, to a limit
order to sell, with a limit price of one Minimum Trading Increment.\14\
The Exchange proposes to use the national best offer as the reference
price in determining how to handle a market order to sell when the
national best bid is zero as the national best offer better represents
the current market conditions. This provision is consistent with the
operation of the current rule, however the Threshold Setting used for
evaluation purposes under the Exchange's proposal may now be either the
Exchange's default setting of $0.10 or the Member's Threshold Setting.
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    \14\ See Exchange Rule 510, Minimum Price Variations and Minimum
Trading Increments.
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    The Exchange proposes to adopt new subparagraph (iii) to paragraph
(a)(1) of Rule 519 to provide that, if the Exchange reevaluates \15\ a
market order from an EEM to sell an option when the resulting national
best bid is zero and either the trade price, route price, or national
best offer is less than or equal to the Threshold Setting, the System
will convert the market order to sell, to a limit order to sell, with a
limit price of one Minimum Trading Increment. In the event the Exchange
receives a market order to sell and the Exchange is zero bid but an
away market is not, the Exchange will route the order to that away
exchange at the away market price, the ``route price.'' For the
purposes of this rule, the execution price of a trade in the subject
series is considered the ``trade price.'' The Exchange uses the route
price, trade price, or national best offer to determine the proper
disposition of a market order to sell when the national best bid
becomes zero.
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    \15\ A reevaluation of an order occurs when the order has been
routed to an away exchange and is returned to the Exchange
partially, or completely, unfilled.
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    Current paragraph (i) describes the initial evaluation and
reevaluation process of a market order to sell whereas each process is
given separate treatment under this proposal. Specifically, new
proposed paragraph (ii) describes the initial evaluation process of a
market order to sell when the national best bid is zero and new
proposed paragraph (iii) describes the reevaluation process of a market
order to sell when the national best bid becomes zero. The Exchange
believes this format provides additional clarity to the Exchange's
rules regarding its order handling process when the Exchange
reevaluates a market order to sell when the national best bid becomes
zero.
    The Exchange proposes to adopt new subparagraph (iv) to paragraph
(a)(1) of Rule 519 to provide that, in either case of (ii) or (iii)
above, such sell orders will automatically be placed on the Book in
time priority and will be displayed at the appropriate Minimum Price
Variation.\16\ The Exchange notes that this language is identical to
the current rule text.\17\
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    \16\ Id.
    \17\ See Exchange Rule 519(a)(1)(i).
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    The Exchange proposes to adopt new subparagraph (v) to paragraph
(a)(1) of Rule 519 to provide that, if the Exchange receives a market
order from an EEM to sell an option when the national best bid is zero
and the national best offer is greater than the Threshold Setting, the
System will reject the order. This provision is consistent with the
operation of the current rule, however under the Exchange's proposal
the Threshold Setting used for evaluation purposes may now be either
the Exchange default setting of $0.10 or the Member's Threshold
Setting.
    The Exchange proposes to adopt new subparagraph (vi) to paragraph
(a)(1) of Rule 519 to provide that, if the Exchange reevaluates a
market order

from an EEM to sell an option when the resulting national best bid is
zero and both (A) the trade price or route price, and (B) the national
best offer are greater than the Threshold Setting, the System will
reject the order or cancel any unexecuted balance of the order. The
Exchange uses the route price or trade price, in conjunction with the
national best offer to determine the proper disposition of a market
order to sell when the national best bid becomes zero. The Exchange
believes considering both the route price or trade price, and the
national best offer, provides a clear indication of the current market
conditions when either the route price or trade price and the national
best offer is greater than the Threshold Setting and allows the
Exchange to make the proper determination regarding the disposition of
the order.
    The proposed rule text provides additional detail regarding the
System's behavior when the Exchange reevaluates a market order from an
EEM to sell and the national best bid is zero. Example 1 below
describes the System processing when the national best bid is below the
Threshold Setting, and Example 2 describes the System processing when
the national best bid is above the Threshold Setting.
Example 1
MPV: $0.05
Exchange default Threshold Setting: $0.10
EEM selected Threshold Setting: $0.25
PBBO \18\ (0) 0.00 x 5.00 (10)
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    \18\ The term ``PBBO'' means the best bid or offer on MIAX
Pearl. See Exchange Rule 100.
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ABBO \19\ (10) 0.10 x 0.15 (10)
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    \19\ The term ``ABBO'' or ``Away Best Bid or Offer'' means the
best bid(s) or offer(s) disseminated by other Eligible Exchanges
(defined in Rule 1400(g)) and calculated by the Exchange based on
market information received by the Exchange from OPRA. See Exchange
Rule 100.
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NBBO \20\ (10) 0.10 x 0.15 (10)
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    \20\ The term ``NBBO'' means the national best bid or offer as
calculated by the Exchange based on market information received by
the Exchange from OPRA. See Exchange Rule 100.

    Market order to sell 20 contracts is received by the Exchange.
    The Exchange routes the order to the 0.10 bid on the away exchange
by sending a limit order to sell 10 at $0.10 (the route price).
    The order is executed on the away exchange, sell 10 at $0.10, and
the away market becomes zero bid.

PBBO: (0) 0.00 x 5.00 (10)
ABBO: (0) 0.00 x 0.15 (10)
NBBO: (0) 0.00 x 0.15 (10)

    Using the EEM selected Threshold Setting of $0.25 to reevaluate the
order, the remainder of the order (10 contracts) would be converted to
a limit order to sell and placed on the Exchange as the national best
offer (0.15) (and the route price of $0.10) is less than or equal to
the EEM selected Threshold Setting of $0.25. The 10 contracts would
then be displayed on the Exchange at an offer price of one minimum
trading increment or $0.05.

PBBO: (0) 0.00 x 0.05 (10)
ABBO: (0) 0.00 x 0.15 (10)
NBBO: (0) 0.00 x 0.05 (10)

    If the Exchange default Threshold Setting was used for the
evaluation, the remainder of the order would be cancelled as the
national best offer (0.15) is greater than the Exchange default
Threshold Setting of $0.10.
Example 2
MPV: $0.05
Exchange default Threshold Setting: $0.10
Member selected Threshold Setting: $0.25
PBBO (0) 0.00 x 5.00 (10)
ABBO (10) 0.40 x 0.50 (10)
NBBO (10) 0.40 x 0.50 (10)

    Market order to sell 20 contracts is received by the Exchange. The
Exchange is zero bid for that series and routes the order to the away
exchange by sending a limit order to sell 10 at $0.40 (the route
price).
    The order is executed on the away exchange, sell 10 at $0.40, and
the away market becomes zero bid.

PBBO: (0) 0.00 x 5.00 (10)
ABBO: (0) 0.00 x 0.50 (10)
NBBO: (0) 0.00 x 0.50 (10)

    Using the Member selected Threshold Setting of $0.25 to reevaluate
the order, the remainder of the order (10 contracts) would be cancelled
as both (i) the route price ($0.40) and (ii) the national best offer
($0.50) are greater than the Threshold Setting ($0.25).
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \21\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \22\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in, securities, to remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, to protect investors and the public interest.
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    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes its proposal promotes just and equitable
principles of trade, removes impediments to and perfects the mechanisms
of a free and open market and a national market system, and in general,
protects investors and the public interest by allowing EEMs to
establish the threshold setting for the evaluation of market orders to
sell when the national best bid is zero. The Exchange believes that
allowing EEMs to determine the threshold setting provides greater
flexibility and allows the EEM to tailor the threshold setting to the
business and risk tolerances of the Member.
    The Exchange believes its proposal to allow EEMs the flexibility to
establish their own pre-set value to be used for evaluation purposes of
market orders to sell when the national best bid is zero allows EEMs to
align their risk protections with their risk tolerance. EEMs have the
discretion to set their pre-set value to whatever value best aligns to
their risk profile, which may be as low as $0.00.\23\ The Exchange
provides EEMs the ability to tailor risk protection functionality to
the risk profile of the EEM, and has allowed EEMs to customize their
risk protection setting for other risk protections offered on the
Exchange. Specifically, the Exchange allows EEMs to set the maximum
size of an order for the purposes of the MIAX Pearl Order Monitor Size
Protection, and if the EMM does not designate the maximum size, the
Exchange provides a default value.\24\ Additionally, the Exchange
provides Members the option to set a price protection limit on a per
order basis, and orders received without a price protection limit
receive the Exchange defined default value.\25\ The current proposal to
allow EEMs to determine a pre-set value to be used as the Threshold
Setting continues the Exchange's approach of allowing a Member to
customize its risk

protections to better align to the risk tolerance of the Member.
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    \23\ The Exchange notes that the Nasdaq Phlx does not have a
threshold evaluation and, in the case where the bid price for any
options series is $0.00, a Market Order accepted into the System to
sell that series shall be considered a Limit Order to sell at a
price equal to the minimum trading increment as defined in Nasdaq
Phlx Options 3, Section 3. Orders will be placed on the Limit Order
book in the order in which they were received by the System. With
respect to Market Orders to sell which are submitted prior to the
Opening Process and persist after the Opening Process, those orders
are posted at a price equal to the minimum trading increment as
defined in Options 3, Section 3. See Nasdaq Phlx Options 3, Section
10(b).
    \24\ See Exchange Rule 519(b).
    \25\ See Exchange Rule 515(c).
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    The Exchange believes its proposal to reorganize the current rule
text to describe each scenario separately (i.e., evaluation of a market
order to sell when the national best bid is zero and the national best
offer is less than or equal to the Threshold Setting (proposed
paragraph (ii)); reevaluation of a market order to sell when the
national best bid becomes zero and the national best offer is less than
or equal to the Threshold Setting (proposed paragraph (iii)); initial
evaluation of a market order to sell when the national best bid is zero
and the national best offer is greater than the Threshold Setting
(proposed paragraph (v)); and reevaluation of a market order to sell
when the national best bid becomes zero and the national best offer is
greater than the Threshold Setting (proposed paragraph vi))) better
organizes the rule text. The Exchange believes discussing each scenario
separately and describing the evaluations that are performed by the
System to determine the proper disposition of the order provides
transparency and clarity in the Exchange's rules.
    The Exchange believes its proposal promotes just and equitable
principles of trade, removes impediments to and perfects the mechanisms
of a free and open market and a national market system, and in general,
protects investors and the public interest by providing additional
detail regarding the Exchange's process for reevaluating market orders
from an EEM to sell when the national best bid becomes zero. The
Exchange believes it is in the best interest of investors and the
public to accurately describe the behavior of the Exchange's System in
its rules as this information may be used by investors to make
decisions concerning the submission of their orders. Transparency and
clarity are consistent with the Act because it removes impediments to
and perfects the mechanism of a free and open market and a national
market system, and, in general, protects investors and the public
interest by accurately describing how market orders to sell in zero bid
series are handled on the Exchange. It is in the public interest for
rules to be accurate and concise so as to eliminate the potential for
confusion.
    Additionally, the Exchange believes its proposal promotes just and
equitable principles of trade, removes impediments to and perfects the
mechanisms of a free and open market and a national market system, and
in general, protects investors and the public interest by re-organizing
the rule text for ease of reference. The Exchange believes that
Exchange rules should be clear and transparent so as to avoid the
potential for confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
    The Exchange does not believe that its proposal will impose any
burden on intra-market competition as all EEMs that submit market
orders to the Exchange will be treated equally and the Rules of the
Exchange apply equally to all Exchange Members. Additionally, the
proposal allows each EEM to determine the pre-set value to be used as
the Threshold Setting and allows each EEM to align their Threshold
Setting to their risk tolerance.
    The Exchange does not believe that its proposal will impose any
burden on inter-market competition as the Exchange's proposal is not a
competitive filing but one that provides additional detail regarding
the Exchange's process for reevaluating market orders from an EEM to
sell when the national bid becomes zero. Additionally, the Exchange's
proposal is similar to the rules of at least one other options
exchange.\26\
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    \26\ See Cboe Rule 5.34(a)(1)(A) which provides that if the
System receives a sell market order in a series after it is open for
trading with an NBB of zero: (i) If the NBO in the series is less
than or equal to $0.50, then the System converts the market order to
a limit order with a limit price equal to the minimum trading
increment applicable to the series and enters the order into the
Book with a timestamp based on the time it enters the Book. If the
order has a Time-in-Force of GTC or GTD that expires on a subsequent
day, the order remains on the Book as a limit order until it
executes, expires, or the User cancels it. (ii) if the NBO in the
series is greater than $0.50, then the System cancels or rejects the
market order, or routes the market order to PAR for manual handling,
subject to a User's instructions.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \27\ and Rule 19b-4(f)(6) \28\
thereunder.
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    \27\ 15 U.S.C. 78s(b)(3)(A).
    \28\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    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.

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-2022-22 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-2022-22. 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-2022-22, and should be submitted on or before June 24, 2022.
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    \29\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-11875 Filed 6-2-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 89 (Tuesday, May 9, 2023)]
[Notices]
[Pages 29957-29959]
[FR Doc No: 2023-09756]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97426; File No. SR-Phlx-2023-15]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 7,
Section 4

May 3, 2023.
    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 May 1, 2023, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 4, ``Multiply Listed Options Fees (Includes options
overlying equities, ETFs, ETNs and indexes which are Multiply Listed)
(Excludes SPY).''
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    Phlx proposes to amend its Pricing Schedule at Options 7, Section
4, ``Multiply Listed Options Fees (Includes options overlying equities,
ETFs, ETNs and indexes which are Multiply Listed) (Excludes SPY).''
Specifically, Phlx proposes to amend its Qualified Contingent Cross
(``QCC'') Growth Tier Rebate, in Section B of Options 7, Section 4.
    Today, the Exchange offers a QCC Growth Tier Rebate to encourage
Phlx members and member organizations to transact a greater number of
QCC Orders on Phlx. In order to qualify for the QCC Growth Tier Rebate,
a member's or member organization's total floor transaction,\3\ and
electronic QCC Orders and Floor QCC Orders volume (``QCC transaction
volume'') must exceed 12,500,000 contracts in a given month. In
addition to the aforementioned criteria, the member's or member
organization's respective Phlx House Account \4\ must execute QCC
transaction volume of 250,000 or more contracts in excess of the
member's or member organization's QCC transaction volume in January
2023. For members or member organizations with no QCC transaction
volume in January 2023, the QCC transaction volume, in their respective
Phlx House Account, must be 250,000 or more contracts in a given month.
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    \3\ The term ``floor transaction'' is a transaction that is
effected in open outcry on the Exchange's trading floor. See Phlx
Options 7, Section 1(c). Of note, the term ``floor transaction'' is
more broadly defined than the term ``Open Outcry Floor Transaction''
which is discussed herein and is a subset of the term ``floor
transaction''.
    \4\ Each Phlx member or member organization is required to
establish one Phlx House Account with the Exchange's Membership
Department. Only one Phlx House Account is required to transact
business on Phlx. The Exchange assesses a $50.00 a month account fee
for this account as provided for within Options 7, Section 8A. A
Phlx member or member organization has the option of acquiring
multiple Phlx House Accounts depending on a member's or member
organization's business model and how they elect to organize their
business.
---------------------------------------------------------------------------

    The Exchange also offers an alternative qualification to achieve
the QCC Growth Tier Rebate. A member's or member organization's Open
Outcry Floor Transaction volume \5\ in a given month must exceed
500,000 contracts. In addition to the aforementioned criteria, a
member's or member organization's respective Phlx House Account must
execute QCC transaction volume of 2,500,000 or more contracts in excess
of the member's or member organization's QCC transaction volume in
January 2023. For members or member organizations with no QCC
transaction volume in January 2023, the QCC transaction volume, in
their respective Phlx House Account, must be 2,500,000 or more
contracts in a given month.
---------------------------------------------------------------------------

    \5\ The term ``Open Outcry Floor Transaction'' includes all
transactions executed in open outcry on Phlx's trading floor except:
(1) dividend, merger, short stock interest, reversal and conversion,
jelly roll, and box spread strategy executions as defined in this
Options 7, Section 4; (2) Cabinet Transactions as defined in Options
8, Section 33; and (3) Customer-to-Customer transactions.
---------------------------------------------------------------------------

    Today, the Exchange pays a $0.20 per contract QCC Growth Tier
Rebate on a QCC Order comprised of a Customer or Professional order on
one side and a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on the other side. Further, the Exchange pays a $0.26 per
contract QCC Growth Tier Rebate on a QCC Order comprised of a Lead
Market Maker, Market Maker, Broker-Dealer, or Firm order on one side
and a Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on
the other side. The Exchange pays the QCC Growth Tier Rebate on all
qualifying executed electronic QCC Orders, as defined in Options 3,
Section 12, and Floor QCC Orders, as defined in Options 8, Section
30(e), except where the transaction is either: (i) Customer-to-
Customer; (ii) Customer-to-Professional; (iii) Professional-to-
Professional; or (iv) a dividend, merger, short stock interest,
reversal and conversion, jelly roll, and box spread strategy executions
(as defined in Options 7, Section 4). Finally, members and member
organizations are entitled to one QCC Rebate in a given month, either
the QCC Rebate in Section A or the QCC Growth Tier Rebate in Section B
in a given month, but not both.\6\
---------------------------------------------------------------------------

    \6\ The QCC Growth Tier Rebate is available through July 31,
2023.
---------------------------------------------------------------------------

    At this time, the Exchange proposes to increase the QCC Growth Tier
Rebates. The Exchange proposes to increase the current $0.20 per
contract rebate to $0.22 per contract provided the QCC Order comprised
of a Customer or Professional order on one side and a Lead Market
Maker, Market Maker, Broker-Dealer, or Firm order on the

other side. Further, the Exchange proposes to increase the current
$0.26 per contract rebate to $0.27 per contract provided the QCC Order
comprised of a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on one side and a Lead Market Maker, Market Maker, Broker-Dealer,
or Firm order on the other side.
    The Exchange believes that the increased rebates will incentivize
members and member organizations to engage in substantial amounts of
trading activity which would serve to bring additional open outcry
liquidity to the trading floor and additional QCC Order Flow to Phlx.
Also, this incentive should continue to encourage members and member
organizations to commence sending such order flow to Phlx for the
opportunity to earn this rebate until the program expires.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\8\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
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.'' \9\
---------------------------------------------------------------------------

    \9\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission
10 (``NetCoalition'') the D.C. Circuit upheld the
Commission's use of a market-based approach in evaluating the fairness
of market data fees against a challenge claiming that Congress mandated
a cost-based approach.\11\ As the court emphasized, the Commission
``intended in Regulation NMS that `market forces, rather than
regulatory requirements' play a role in determining the market data . .
. to be made available to investors and at what cost.'' \12\
---------------------------------------------------------------------------

    \10\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \11\ See NetCoalition, at 534-535.
    \12\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[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'. . . .'' \13\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
---------------------------------------------------------------------------

    \13\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    The Exchange's proposal to increase the current $0.20 per contract
rebate to $0.22 per contract, provided the QCC Order comprised of a
Customer or Professional order on one side and a Lead Market Maker,
Market Maker, Broker-Dealer, or Firm order on the other side, is
reasonable because the Exchange believes that the increased rebate will
encourage members and member organizations to earn larger QCC rebates
by executing a larger amount of floor transactions, QCC transaction
volume, and Open Outcry Floor Transaction volume on Phlx's trading
floor during the remaining months of the program.
    The Exchange's proposal to increase the current $0.20 per contract
rebate to $0.22 per contract, provided the QCC Order comprised of a
Customer or Professional order on one side and a Lead Market Maker,
Market Maker, Broker-Dealer, or Firm order on the other side, is
equitable and not unfairly discriminatory because all members and
member organizations may qualify for this rebate, provided they
transact the requisite volume.
    The Exchange's proposal to increase the current $0.26 per contract
rebate to $0.27 per contract, provided the QCC Order comprised of a
Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on one
side and a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on the other side, is reasonable because the Exchange believes
that the increased rebate will encourage members and member
organizations to earn larger QCC rebates by executing a larger amount
of floor transactions, QCC transaction volume, and Open Outcry Floor
Transaction volume on Phlx's trading floor during the remaining months
of the program.
    The Exchange's proposal to increase the current $0.26 per contract
rebate to $0.27 per contract, provided the QCC Order comprised of a
Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on one
side and a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on the other side, is equitable and not unfairly discriminatory
because all members and member organizations may qualify for this
rebate, provided they transact the requisite volume.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.
Intra-Market Competition
    The proposed amendments do not impose an undue burden on intra-
market competition. In terms of intra-market competition, the
Exchange's proposal to increase the current $0.20 per contract rebate
to $0.22 per contract, provided the QCC Order comprised of a Customer
or Professional order on one side and a Lead Market Maker, Market
Maker, Broker-Dealer, or Firm order on the other side, does not impose
an undue burden on intra-market competition because all members and

member organizations may qualify for this rebate, provided they
transact the requisite volume.
    The Exchange's proposal to increase the current $0.26 per contract
rebate to $0.27 per contract, provided the QCC Order comprised of a
Lead Market Maker, Market Maker, Broker-Dealer, or Firm order on one
side and a Lead Market Maker, Market Maker, Broker-Dealer, or Firm
order on the other side, does not impose an undue burden on intra-
market competition because all members and member organizations may
qualify for this rebate, provided they transact the requisite volume.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\14\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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.

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-PHLX-2023-15 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-PHLX-2023-15. 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. Do not include
personal identifiable information in submissions; you should submit
only information that you wish to make available publicly. We may
redact in part or withhold entirely from publication submitted material
that is obscene or subject to copyright protection. All submissions
should refer to File Number SR-PHLX-2023-15 and should be submitted on
or before May 30, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09756 Filed 5-8-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 12, 2009 (Volume 74, Number 47)]
[Notices]
[Page 10750-10751]
[DOCID:fr12mr09-76]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2009-0116]

Information Collection Request to Office of Management and
Budget; OMB Control Numbers: 1625-0033 and 1625-0039

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit Information Collection Requests
(ICRs) and Analyses to the Office of Management and Budget (OMB)
requesting an extension of its approval for the following collections
of information: (1) 1625-0033, Display of Fire Control Plans for
Vessels; and (2) 1625-0039, Declaration of Inspection Before Transfer
of Liquid Cargo in Bulk. Before submitting these ICRs to OMB, the Coast
Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or May 11, 2009.

ADDRESSES: To avoid duplicate submissions to the docket [USCG-2009-
0116], please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: Docket Management Facility (DMF) (M-30), U.S. Department
of Transportation (DOT), West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand Deliver: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from
Commandant (CG-611), U.S. Coast Guard Headquarters, (Attn: Mr. Arthur
Requina), 2100 2nd Street, SW., Washington, DC 20593-0001. The
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    The Coast Guard invites comments on whether these ICRs should be
granted based on the collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the collections; and (4) ways to minimize the
burden of the collections on respondents, including the use of
automated collection techniques or other forms of information
technology.
    We encourage you to respond to this request by submitting comments
and related materials. We will post all comments received, without
change, to http://www.regulations.gov. They will include any personal
information you provide. We have an agreement with DOT to use its DMF.
Please see the ``Privacy Act'' paragraph below.
    Submitting Comments: If you submit a comment, please include the
docket number [USCG-2009-0116], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit your comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES; but please
submit them by only one means. If you submit them by mail or delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit them by mail
and would like to know that they reached the Facility, please enclose a
stamped, selfaddressed postcard or envelope. We will consider all
comments and material received during the comment period. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing Comments and Documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Enter the docket number for this Notice [USCG-2009-0116] in the
Search box, and click ``Go >>.'' You may also visit the DMF in room
W12-140 on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act Statement regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

Information Collection Request

    1. Title: Display of Fire Control Plans for Vessels.
    OMB Control Number: 1625-0033.
    Summary: This information collection is for the posting or display
of specific plans on certain categories of commercial vessels. The
availability of these plans aid firefighters and damage control efforts
in responding to emergencies.
    Need: Under 46 U.S.C. 3305 and 3306, the Coast Guard is responsible
for ensuring the safety of inspected vessels and has promulgated
regulations in 46 CFR parts 35, 78, 97, 109, 131, 169, and 196 to
ensure safety standards are met.
    Forms: None.
    Respondents: Owners and operators of vessels.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 859 hours
to 514 hours a year.
    2. Title: Declaration of Inspection Before Transfer of Liquid Cargo
in Bulk.
    OMB Control Number: 1625-0039.

    Summary: A Declaration of Inspection (DOI) documents the transfer
of oil and hazardous materials to help prevent spills and damage to a
facility or vessel. Persons-in-charge of the transfer operations must
review and certify compliance with procedures specified by the terms of
the DOI.
    Need: Title 33 U.S.C. 1321(j) authorizes the Coast Guard to
establish regulations to prevent the discharge of oil and hazardous
material from vessels and facilities. The DOI regulations appear at 33
CFR 156.150 and 46 CFR 35.35-30.
    Forms: None.
    Respondents: Persons-in-charge of transfers.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has decreased from 68,534
hours to 67,825 hours a year.

    Dated: March 2, 2009.
D.T. Glenn,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
 [FR Doc. E9-5373 Filed 3-11-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Page 2924]
[FR Doc No: 2015-00796]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP15-334-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Section 4(d) rate filing per 154.204: 01/13/15
Negotiated Rates--ConEdison Energy Inc. (HUB) 2275-89 to be effective
1/12/2015.
    Filed Date: 1/13/15.
    Accession Number: 20150113-5033.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: RP15-335-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Section 4(d) rate filing per 154.204: 2015 Third
Revised Volume No. 1 Title Page Change to be effective 1/14/2015.
    Filed Date: 1/13/15.
    Accession Number: 20150113-5041.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: RP15-336-000.
    Applicants: Northern Natural Gas Company.
    Description: Section 4(d) rate filing per 154.204: 20150113 Contact
Information Change to be effective 1/14/2015.
    Filed Date: 1/13/15.
    Accession Number: 20150113-5063.
    Comments Due: 5 p.m. ET 1/26/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 14, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-00796 Filed 1-20-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62694-62697]
[FR Doc No: 2018-26393]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0871; Product Identifier 2018-NE-24-AD; Amendment
39-19511; AD 2018-25-01]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding airworthiness directive (AD) 2018-13-07 for
all Rolls-Royce plc (RR) Trent 1000-A, Trent 1000-C, Trent 1000-D,
Trent 1000-E, Trent 1000-G, and Trent 1000-H turbofan engine models. AD
2018-13-07 required initial inspections of the intermediate-pressure
compressor (IPC) stage 1 rotor blades, IPC stage 2 rotor blades, and
IPC shaft stage 2 dovetail posts, and removing any cracked parts from
service. This AD requires initial inspections and adds repetitive
inspections of the IPC stage 1 rotor blades, IPC stage 2 rotor blades,
and IPC shaft stage 2 dovetail posts, and removing any cracked parts
from service. This AD was prompted by the manufacturer determining the
need for repetitive inspections of the IPC stage 1 rotor blades, IPC
stage 2 rotor blades, and IPC shaft stage 2 dovetail posts. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective December 21, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 21,
2018.
    We must receive any comments on this AD by January 22, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England,
DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
royce.com">[email protected]royce.com; internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this service information
at the FAA, Engine & Propeller Standards Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2018-0871.

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-2018-
0871; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the mandatory continuing airworthiness information, regulatory
evaluation, any comments received, and other information. The street
address for Docket Operations (phone:<PHONE_NUMBER>) is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kevin M. Clark, Aerospace Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
781-238-7088; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued AD 2018-13-07, Amendment 39-19319 (83 FR 34758, July 23,
2018), (``AD 2018-13-07''), for all RR Trent 1000-A, Trent 1000-C,
Trent 1000-D, Trent 1000-E, Trent 1000-G, and Trent 1000-H turbofan
engine models. AD 2018-13-07 required inspecting the IPC stage 1 rotor
blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts,
and removing any cracked parts from service. AD 2018-13-07 resulted
from crack findings on the IPC rotor blades and IPC shaft stage 2
dovetail posts, which could lead to rotor blade separations resulting
in engine failures. We issued AD 2018-13-07 to prevent failure of the
IPC, which could result in failure of one or more engines, loss of
thrust control, and loss of the airplane.

Actions Since AD 2018-13-07 Was Issued

    Since we issued AD 2018-13-07, the manufacturer determined the need
for repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2
rotor blades, and IPC shaft stage 2 dovetail posts. Also, since we
issued AD 2018-13-07, the European Aviation Safety Agency (EASA) issued
AD 2018-0167R2, dated October 16, 2018, which requires initial and
repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2
rotor blades, and IPC shaft stage 2 dovetail posts. We are issuing this
AD to address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    We reviewed RR Alert Non-Modification Service Bulletin (NMSB) Trent
1000 72-AK130, Revision 2, dated July 26, 2018, and RR Alert NMSB Trent
1000 72-K132, dated June 29, 2018. RR Alert NMSB Trent 1000 72-AK130
describes procedures for performing initial and repetitive inspections
of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC
shaft stage 2 dovetail posts, and lists engine serial numbers. RR Alert
NMSB Trent 1000 72-K132, describes procedures for replacement of the
IPC stage 1 rotor blades, IPC stage 2 rotor blades, and the IP
compressor drum during refurbishment. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Other Related Service Information

    We reviewed RR NMSB Trent 1000 72-K099, Initial Issue, dated June
11, 2018; RR NMSB Trent 1000 72-K099, Revision 1, dated July 3, 2018;
RR NMSB Trent 1000 72-K100, Initial Issue, dated June 11, 2018; RR NMSB
Trent 1000 72-K129, Initial Issue, dated June 11, 2018; and RR NMSB
Trent 1000 72-K129, Revision 1, dated July 2, 2018. RR NMSB Trent 1000
72-K099, Initial Issue, and RR NMSB Trent 1000 72-K099, Revision 1,
describe procedure for an ultrasonic inspection of the IPC stage 1
rotor blades. RR NMSB Trent 1000 72-K100 Initial Issue describes
procedures for a visual borescope inspection of the IPC stage 2 rotor
blades and IPC shaft stage 2 dovetail posts. RR NMSB Trent 1000 72-
K129, Initial Issue, and RR NMSB Trent 1000 72-K129, Revision 1,
describe procedures for an ultrasonic inspection of the IPC stage 2
rotor blades.

FAA's Determination

    This product has been approved by EASA and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires initial and repetitive inspections of the IPC
stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2
dovetail posts, and removing any cracked parts from service.

Differences Between This AD and the MCAI or Service Information

    This AD allows inspections of any affected IPC part to be completed
within 15 days of the effective date of this AD. EASA AD 2018-0167R2,
dated October 16, 2018, and RR Alert NMSB Trent 1000 72-AK130, Revision
2, dated July 26, 2018, allow certain affected IPC parts to be
completed within 45 days of the effective date of EASA AD 2018-0167R1.
We expect most operators to have already complied with EASA AD and find
that completing the inspections within 15 days of the effective date of
this AD provides an appropriate level of safety.

Interim Action

    We consider this AD interim action. The manufacturer is still
reviewing this unsafe condition and may develop follow-on actions.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, we find that
notice and opportunity for prior public comment are unnecessary and
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this final
rule. Send your comments to an address listed under the ADDRESSES
section. Include the docket number FAA-2018-0871 and product identifier
2018-NE-24-AD at the beginning of your comments. We specifically invite
comments on the overall regulatory, economic, environmental, and energy
aspects of this final rule. We will consider all comments received by
the closing date and may amend this final rule because of 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 final rule.

Costs of Compliance

    We estimate that this AD affects 0 engines installed on airplanes
of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspect IPC blades and dovetail post..  20 work-hours x $85 per               $0          $1,700              $0
                                         hour = $1,700.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace IPC Stage 1 Rotor blade...............  0 work-hours x $85 per hour = $0          $1,528          $1,528
Replace IPC Stage 2 Rotor blade...............  0 work-hours x $85 per hour = $0             993             993
Replace IPC 1-8 drum..........................  0 work-hours x $85 per hour = $0       1,365,219       1,365,219
----------------------------------------------------------------------------------------------------------------

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends part 39 of the Federal Aviation
Regulations (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 removing airworthiness directive (AD)
2018-13-07, Amendment 39-19319 (83 FR 34758, July 23, 2018), and adding
the following new AD:

2018-25-01 Rolls-Royce plc: Amendment 39-19511; Docket No. FAA-2018-
0871; Product Identifier 2018-NE-24-AD.

(a) Effective Date

    This AD is effective December 21, 2018.

(b) Affected ADs

    This AD replaces AD 2018-13-07, Amendment 39-19319 (83 FR 34758,
July 23, 2018).

(c) Applicability

    This AD applies to all Rolls Royce plc (RR) Trent 1000-A, Trent
1000-C, Trent 1000-D, Trent 1000-E, Trent 1000-G, and Trent 1000-H
turbofan engine models.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by reports of intermediate-pressure
compressor (IPC) rotor blade cracks, which could lead to rotor blade
separations resulting in engine failures. We are issuing this AD to
prevent failure of the IPC. The unsafe condition, if not addressed,
could result in failure of one or more engines, loss of thrust
control, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 15 days of the effective date of this AD, or within
the compliance times specified in Table 1 of RR Alert Non-
Modification Service Bulletin (NMSB) Trent 1000 72-AK130, Revision
2, dated July 26, 2018, whichever occurs later, perform on-wing
inspection of the IPC stage 1 rotor blades in accordance with
paragraph 3.A.(1) of RR Alert NMSB Trent 1000 72-AK130.
    (2) Repeat the on-wing inspection of the IPC stage 1 rotor
blades in accordance with paragraph 3.A.(1) of RR Alert NMSB Trent
1000 72-AK130, Revision 2, dated July 26, 2018, and within the
compliance times specified in Table 1 of that NMSB.
    (3) Within 15 days of the effective date of this AD, or within
the compliance times specified in Table 1 of RR Alert NMSB Trent
1000 72-AK130 Revision 2, dated July 26, 2018, whichever occurs
later, perform on-wing inspection of the IPC stage 2 rotor blades
and IPC shaft stage 2 dovetail posts in accordance with paragraph
3.B.(1) and 3.C.(1) of RR Alert NMSB Trent 1000 72-AK130.
    (4) Repeat the on-wing inspection of the IPC stage 2 rotor
blades and IPC shaft stage 2 dovetail posts in accordance with
paragraphs 3.B.(1) and 3.C.(1) of RR Alert NMSB Trent 1000 72-AK130,
Revision 2, dated July 26, 2018, and within the compliance times
specified in Table 1 of RR Alert NMSB Trent 1000 72-AK130.
    (5) For the on-wing inspection required by paragraphs (g)(1)
through (4) of this AD, provided the stated thresholds and intervals
are not exceeded, you may substitute:
    (i) An in-shop inspection of an engine or module performed in
accordance with the instructions of paragraphs 3.A.2, 3.B.2, and
3.C.2 of the RR Alert NMSB Trent 1000 72-AK130, Revision 2, dated
July 26, 2018; or
    (ii) an in-shop piece part inspection during refurbishment in
accordance with the Accomplishment Instructions, paragraphs
3.B.(2)(f)(vi), 3.B.(2)(g)(v), and 3.B.(3)(d)(iii) of RR Trent 1000
NMSB 72-K132, dated June 29, 2018.
    (6) If any IPC stage 1 rotor blade, IPC stage 2 rotor blade, or
an IPC shaft stage 2 dovetail post is found cracked during any
inspection required by this AD, remove the part from service and
replace the part with a part eligible for installation before
further flight.

(h) Inspection After Operation Under Asymmetric Power

    As of the effective date of this AD, before the next flight
after each occurrence where engine operation in asymmetric power
conditions was sustained for more than 30 minutes at less than
25,000 feet, either resulting from engine power reduction, or from
engine in-flight shut-down (IFSD), inspect the IPC stage 1 rotor
blades, stage 2 rotor blades and IPC shaft stage 2 dovetail posts in
accordance with the paragraphs 3.A.(1), 3.B.(1), and 3.C.(1) of the
RR Alert NMSB Trent1000 72-AK130, Revision 2, dated July 26, 2018 on
the engine that did not experience the power reduction or IFSD
installed on the airplane.

(i) Credit for Previous Actions

    You may take credit for the inspections required by paragraph
(g)(1) and (3) of this AD if you performed these inspections before
the effective date of this AD using RR Alert NMSB Trent 1000 72-
AK130, Revision 1, dated June 29, 2018, or RR Alert NMSB Trent 1000
72-AK130, Initial Issue, dated June 11, 2018.

(j) Special Flight Permits

    (1) Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are subject to the requirements of paragraph (k)(1)(i)
of this AD.
    (i) Operators who are prohibited from further flight due to an
IPC stage 1 rotor blade, IPC stage 2 rotor blade, or an IPC shaft
stage 2 dovetail post being found cracked, may perform a one-time
non-revenue ferry flight to a location where the engine can be
removed from service. This ferry flight must be performed without
passengers, involve non-extended operations (ETOPS), and consume no
more than three flight cycles.
    (ii) [Reserved]
    (2) [Reserved]

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (l)(1) of this AD. You may email your
request to: [email protected].
    (2) 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.

(l) Related Information

    (1) For more information about this AD, contact Kevin M. Clark,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Aviation Safety Agency (EASA) AD 2018-
0167R2, dated October 16, 2018, for more information. You may
examine the EASA AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2018-0871.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin
(NMSB) Trent 1000 72-AK130, Revision 2, dated July 26, 2018.

    (ii) RR Alert NMSB Trent 1000 72-K132, dated June 29, 2018.
    (3) For RR service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: royce.com">[email protected]royce.com; internet: https://customers.rolls-royce.com/public/rollsroycecare.
    (4) You may view this service information at FAA, Engine &
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on November 28, 2018.
Robert J. Ganley,
Manager, Engine & Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-26393 Filed 12-4-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86333-86336]
[FR Doc No: 2023-27309]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4974]

Advanced Manufacturing Technologies Designation Program; Draft
Guidance for Industry; Availability; Agency Information Collection
Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a

draft guidance for industry entitled ``Advanced Manufacturing
Technologies Designation Program.'' FDA encourages the early adoption
of advanced manufacturing technologies (AMTs) that have the potential
to benefit patients by improving manufacturing and supply dependability
and optimizing development time of drug and biological products. These
technologies can be integral to ensuring quality and supporting a
robust supply of drugs that are life-supporting, life-sustaining, of
critical importance to providing healthcare, or in shortage. AMTs can
directly improve product quality through higher capability
manufacturing designs and enhanced controls (e.g., leading to fewer
human errors). This draft guidance provides recommendations to persons
and organizations interested in participating in FDA's Advanced
Manufacturing Technologies Designation Program, which is intended to
facilitate the development of drugs, including biological products,
manufactured using an AMT that has been designated as such under the
program.

DATES: Submit either electronic or written comments on the draft
guidance by February 12, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by February
12, 2024.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-4974 for ``Advanced Manufacturing Technologies Designation
Program.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance: Ranjani Prabhakara, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993, 240-402-
4652; or Anne Taylor, 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>.
    With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Advanced Manufacturing Technologies Designation Program.''
On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022
(FDORA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by
adding section 506L (21 U.S.C. 356l), which requires the establishment
of an Advanced Manufacturing Technologies Designation Program and the
publication of a related guidance. FDA's

Advanced Manufacturing Technologies Designation Program offers a
framework for persons or organizations (e.g., applicants, contract
manufacturers, technology developers) to request designation of a
method or combination of methods of manufacturing a drug as an AMT. The
program is intended to facilitate the development of drugs that are
manufactured using a designated AMT, submitted in an application under
section 505 of the FD&C Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (PHS Act) (42 U.S.C. 262), and regulated by
the Center for Drug Evaluation and Research (CDER) or the Center for
Biologics Evaluation and Research (CBER). FDA will expedite development
and assessment of an application, including supplements, for drugs that
are manufactured using a designated AMT as described in section
506L(d)(1) of the FD&C Act.
    The development of this guidance takes into consideration feedback
provided at a public meeting (see section 506L(e) of the FD&C Act) and
comments submitted to the public docket (Docket No. FDA-2023-N-1259)
about the public meeting. The meeting was held on June 8, 2023 (April
24, 2023, 88 FR 24807), to discuss the use of innovative manufacturing
technologies for CDER- and CBER-regulated products and to solicit
industry and public feedback regarding the Advanced Manufacturing
Technologies Designation Program.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Advanced
Manufacturing Technologies Designation Program.'' 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. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Advanced Manufacturing Technologies Designation Program

OMB Control Number 0910-0139--Revision
    This information collection supports implementation of requirements
under section 506L of the FD&C Act. The Advanced Manufacturing
Technologies Designation Program encourages early adoption of new
technological advances in manufacturing processes by the pharmaceutical
industry or other drug/biologic developers to ensure that regulatory
assessments and new drug and biologic development are based on state-
of-the-art pharmaceutical science. Any request for AMT designation will
be reviewed by a team of FDA experts in quality assessment to evaluate
the data and information submitted and to determine if the method of
manufacturing or combination of methods meets the criteria of an AMT in
section 506L of the FD&C Act. If AMT designation is granted, then
future new drug application (NDA), abbreviated new drug application
(ANDA), or biologics license application (BLA) applicants may use or
reference the designated AMT, noting specific application of the
designated AMT to specific product development and inclusion in NDA,
ANDA, or BLA submissions describing development and manufacturing
processes.
    We are issuing a draft guidance for industry entitled ``Advanced
Manufacturing Technologies Designation Program,'' which outlines the
process for submitting an AMT designation request; when and how FDA
will communicate receipt of and provide advice on AMT designation
requests; when and how FDA will assess AMT designation requests; the
process by which FDA will engage with designated AMT holders and
applicants for drugs manufactured using, referencing, or relying upon a
designated AMT; and benefits related to drug development and
application assessment.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                              Number of       Total       Average
       Section 506L of the FD&C Act           Number of     responses per     annual     burden per  Total hours
                                             respondents     respondent     responses     response
----------------------------------------------------------------------------------------------------------------
AMT designation request; Guidance for                  20               1           20           10          200
 industry section III.B..................
                                          ----------------------------------------------------------------------
    Total................................  ..............  ..............           20  ...........          200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

    This draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 312 regarding product development including chemistry, proposed
manufacturing procedures and controls, and requests for meetings have
been approved under OMB control number 0910-0014. The collections of
information in 21 CFR part 314 regarding applicable manufacturing
information for NDAs are approved under OMB control number 0910-0001;
and the collections of information in 21

CFR part 601 regarding applicable manufacturing information for BLAs
are approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27309 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P