[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Notices]
[Pages 19956-19958]
[FR Doc No: 2014-07995]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71881; File No. SR-MIAX-2014-14]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Extend the Pilot Period Applicable to Rule 530
Relating to Limit Up/Limit Down

April 4, 2014.
    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 April 3, 2014, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Rule 530 to extend the
pilot period for the treatment of erroneous transactions during a Limit
or Straddle State.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX'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 Rule 530 (Limit Up-Limit Down) in
order to (i) extend the pilot period for the treatment of erroneous
transactions that occur in a Limit or Straddle State until February 20,
2015; and (ii) to provide that paragraphs (a)-(i) of the Rule shall be
in effect during a pilot period to coincide with the pilot period for
the Plan to Address Extraordinary Market Volatility Pursuant to Rule
608 of Regulation NMS.
    Exchange Rule 530(j) provides for the treatment of erroneous
transactions occurring during Limit and Straddle States. Specifically,
once an NMS Stock has entered a Limit or Straddle State, the Exchange
will nullify a transaction in an option overlying such an NMS Stock as
provided in the Rule 530(j). This provision was adopted for a one year
pilot period beginning on the date of the implementation of the Plan to
Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS, April 8, 2013.\3\ The Exchange proposes extending the
pilot period for Rule 530(j) until February 20, 2015 in order to allow
the Exchange and the Commission additional time to collect and analyze
data regarding the impact of Rule 530(j) on liquidity and market
quality in the options markets.
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    \3\ See Exchange Rule 503(j). See also Securities Exchange Act
Release Nos. 69210 (March 22, 2013), 78 FR 18637 (March 27, 2013)
(SR-MIAX-2013-12); 69342 (April 8, 2013), 78 FR 22017 (April 12,
2013) (SR-MIAX-2013-12); 69234 (March 25, 2013), 78 FR 19344 (March
29, 2013) (SR-MIAX-2013-15); 69354 (April 9, 2013), 78 FR 22357
(April 15, 2013) (SR-MIAX-2013-15).
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    To assist the Commission in its analysis, the Exchange will
continue to provide the Commission with data and analysis during the
duration of the pilot in order to evaluate the impact of Limit and
Straddle States on liquidity and market quality in the options markets.
Specifically, by September 30, 2014, the Exchange represents that it
shall provide the Commission assessments relating to the impact of the
obvious error Rules during Limit and Straddle States that (i) evaluate
the statistical and economic impact of Limit and Straddle States on
liquidity and market quality in the options markets; and (ii) assess
whether the lack of obvious error rules in effect during the Straddle
and Limit States are problematic. Additionally, each month during the
pilot period the Exchange shall provide to the Commission and the
public a dataset containing the data for each Straddle and Limit State
in optionable stocks. For each stock that reaches a Straddle or Limit
State, the number of options included in the dataset can be reduced by
selecting options in which at least one (1) trade occurred on the
Exchange during the Straddle or Limit State. For each of those options
affected, each data record should contain the following information:
(i) Stock symbol, option symbol, time at the start of the straddle or
limit state, an indicator for whether it is a straddle or limit state;
and (ii) for activity on the exchange--(A) executed volume, time-
weighted quoted bid-ask spread, time-weighted average quoted depth at
the bid, time-weighted average quoted depth at the offer, (B) high
execution price, low execution price, (C) number of trades for which a
request for review for error was received during Straddle and Limit
States, (D) an indicator variable for whether those options outlined
above have a price change exceeding 30% during the underlying stock's
Limit or Straddle state compared to the last available option price as
reported by OPRA before the start of the Limit or Straddle state (1 if
observe 30% and 0 otherwise) and another indicator variable for whether
the option price within five minutes of the underlying stock leaving
the Limit or Straddle state (or halt if applicable) is 30% away from
the price before the

start of the Limit or Straddle state. The Exchange notes that it will
also update the data available on the Exchange's Web site for the
period April 2013 through January 2014 with the revised parameters
described above once the Exchange has completed its analysis and review
of such data.
    The Exchange also proposes to amend Rule 530 to provide that
paragraphs (a)-(i) of the Rule shall be in effect during a pilot period
to coincide with the pilot period for the Plan to Address Extraordinary
Market Volatility Pursuant to Rule 608 of Regulation NMS. The proposed
change will allow the Exchange's Limit Up-Limit Down Rule to continue
without interruption for as long as corresponding pilot period for the
Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS remains in effect and will also more closely align the
pilot language to that of other options exchanges.\4\
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    \4\ See NYSE MKT Rule 953.1NY; NYSE Arca Options Rule 6.65A.
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2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) \5\ of the Act in general, and furthers the
objectives of Section 6(b)(5) \6\ of the Act 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 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. Specifically,
the proposal supports the objectives of perfecting the mechanism of a
free and open market and the national market system because it promotes
uniformity across markets concerning when and how to halt trading in
all stock options as a result of extraordinary market volatility. In
addition, the Exchange believes that the extension of the pilot will
help ensure that market participants continue to benefit from the
protections of the Limit Up-Limit Down Rules which will protect
investors and the public interest while allowing the Exchange and the
Commission additional time to collect and analyze data regarding the
impact of Rules on liquidity and market quality in the options markets.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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 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. The proposed changes are being
made to extend the pilot program that provides for how the Exchange
shall treat orders and quotes in options overlying NMS stocks when the
Limit Up-Limit Down Plan is in effect and will not impose any burden on
competition while providing certainty of treatment and execution of
options orders during periods of extraordinary volatility in the
underlying NMS stock, and facilitating appropriate liquidity during a
Limit State or Straddle State.

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 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 from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6)(iii) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of 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.
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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Exchange stated that waiver of this requirement will allow
the Exchange to extend the pilot program prior to its expiration on
April 8, 2014. For this reason, the Commission believes that the
proposed rule change presents no novel issues and that waiver of the
30-day operative delay is consistent with the protection of investors
and the public interest. Therefore, the Commission designates the
proposed rule change to be operative upon filing.\9\
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    \9\ For purposes only of waiving the 30-day operative delay, the
Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of 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_ADDRESS>Please include
File Number SR-MIAX-2014-14 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-MIAX-2014-14. 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 Web site (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 Web site 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; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-MIAX-2014-14 and should be submitted on or before May 1,
2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07995 Filed 4-9-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95232-95236]
[FR Doc No: 2016-31107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79615; File No. SR-BX-2016-069]

Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4770
(Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)

December 20, 2016.
    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 December 13, 2016, NASDAQ BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II 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 Rule 4770 (Compliance with
Regulation NMS Plan to Implement a Tick Size Pilot) relating to the
handling to certain Order Types in Test Group Three Pilot Securities in
connection with the Regulation NMS Plan to Implement a Tick Size Pilot
Program (``Plan'' or ``Pilot'').\3\ Relatedly, BX also proposes to
delete Commentary .14, which addresses the current handling of those
Order Types. Finally, BX proposes to add language to Rule 4770(d)(1) to
clarify the treatment of orders in a Test Group Three Security entered
through the RASH or FIX protocols.
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    \3\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order'').
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
    On September 7, 2016, the Exchange filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') a proposed rule change
(``Proposal'') to adopt paragraph (d) to Exchange Rule 4770 to describe
changes to system functionality necessary to implement the Plan. The
Exchange also proposed amendments to Rule 4770(a) and (c) to clarify
how the Trade-at exception may be satisfied. The SEC published the
Proposal in the Federal Register for notice and comment on September
20, 2016.\4\ BX subsequently filed three Partial Amendments to clarify
aspects of the Proposal. The Commission approved the Proposal, as
amended, on October 7, 2016.\5\
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    \4\ See Securities Exchange Act Release No. 78838 (September 14,
2016), 81 FR 64566 (September 20, 2016) (Notice of filing of SR-BX-
2016-050).
    \5\ See Securities Exchange Act Release No. 79076 (October 7,
2016) (Order approving SR-BX-2016-050).
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    In SR-BX-2016-050, BX had initially proposed a re-pricing
functionality for Price to Comply Orders, Non-Displayed Orders, and
Post-Only Orders entered through the OUCH and FLITE protocols in Group
Three Pilot Securities.\6\ BX subsequently determined that it would not
offer this re-pricing functionality for Price to Comply Orders, Non-
Displayed Orders, and Post-Only Orders entered through the OUCH and
FLITE protocols in Test Group Three Pilot securities. As part of
Partial Amendment No. 2 to SR-BX-2016-050, BX proposed to delete the
relevant language from Rule 4770 related to this re-pricing
functionality.
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    \6\ As originally proposed, Rule 4770(d)(2) stated that Price to
Comply Orders in a Test Group Three Pilot Security will be adjusted
repeatedly in accordance with changes to the NBBO until such time as
the Price to Comply Order is able to be ranked and displayed at its
original entered limit price. Rule 4770(d)(3) stated that, if market
conditions allow, a Non-Displayed Order in a Test Group Three Pilot
Security will be adjusted repeatedly in accordance with changes to
the NBBO up (down) to the Order's limit price. Rule 4770(d)(4)
stated that, if market conditions allow, the Post-Only Order in a
Test Group Three Pilot Security will be adjusted repeatedly in
accordance with changes to the NBBO or the best price on the BX
Book, as applicable until such time as the Post-Only Order is able
to be ranked and displayed at its original entered limit price.
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    In that amendment, BX noted that this change would only impact the
treatment of Price to Comply Orders, Non-Displayed Orders, and Post-
Only orders that are submitted through the OUCH and FLITE protocols in
Test Group Three Pilot Securities, as these types of Orders that are
currently submitted to BX through the RASH or FIX protocols are already
subject to this re-pricing functionality and will remain subject to
this functionality under the Pilot.
    In the Amendment, BX further noted that its systems are currently
programmed so that Price to Comply Orders, Non-Displayed Orders and
Post-Only Orders entered through the OUCH and FLITE protocols in Test
Group Three Pilot Securities may be adjusted repeatedly to reflect
changes to the NBBO and/or the best price on the BX book. BX stated
that it was re-programming its systems to remove this functionality for
Price to Comply Orders, Non-Displayed Orders and Post-Only Orders
entered through the OUCH and FLITE protocols in Test Group Three Pilot
Securities. In the Amendment, BX stated that it anticipated that this
re-programming shall be completed no later than November 30, 2016. If
it appeared that this functionality would remain operational by October
17, 2016, BX indicated that it would file a proposed rule change with
the SEC and will provide notice to market participants sufficiently in
advance of that date to provide effective notice. The rule change and
the notice to market participants will describe the current operation
of the BX systems in this regard, and the timing related to the re-
programming.
    On October 17, 2016, BX filed a proposal to extend the date by
which it would complete the re-programing of its systems to eliminate
the re-pricing functionality in Test Group Three Pilot Securities for
Price to Comply Orders, Price to Display Orders, Non-Displayed Orders,
and Post-Only Orders that are entered through the OUCH or FLITE
protocols.\7\ In that proposal, BX stated

that it anticipated that this re-programming shall be complete on or
before October 31, 2016.\8\ As BX continued to re-program its systems
to eliminate the re-pricing functionality in Test Group Three Pilot
Securities for Price to Comply Orders, Price to Display Orders, Non-
Displayed Orders, and Post-Only Orders that are entered through the
OUCH or FLITE protocols, it extended the date by which the re-
programming shall be complete to the current date of December 12,
2016.\9\
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    \7\ See Securities Exchange Act Release No. 79154 (October 25,
2016), 81 FR 75468 (October 31, 2016) (SR-BX-2016-054).
     Subsequent to the approval of SR-BX-2016-050, BX become aware
that this re-pricing functionality also applies to Price to Display
Orders that are entered through the OUCH and FLITE protocols in Test
Group Three Securities, and amended Commentary .14 to indicate that
Price to Display Orders will be treated in the same manner as Price
to Comply Orders under the re-pricing functionality. Id.
    \8\ Id.
    \9\ See Securities Exchange Act Release Nos. 79262 (November 8,
2016), 81 FR 80123 (November 15, 2016) (SR-BX-2016-153) (extending
current re-pricing functionality to November 14, 2016); 79409
(November 28, 2016), 81 FR 87091 (December 2, 2016) (SR-BX-2016-061)
(extending current re-pricing functionality to December 12, 2016).
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    The Exchange has now completed the re-programming its systems to
eliminate the re-pricing functionality in Test Group Three Pilot
Securities for Price to Comply Orders, Price to Display Orders, Non-
Displayed Orders, and Post-Only Orders that are entered through the
OUCH or FLITE protocols. However, as a result of removing the re-
pricing functionality, there are instances, due to the different
functionality of the OUCH and FLITE protocols in comparison to the
other applicable Exchange protocols, where the behavior of certain
Order Types entered through the OUCH and FLITE protocols in Test Group
Three Pilot Securities will differ from the behavior of those Order
Types as set forth in Rule 4770; specifically, the behavior of Price to
Comply Orders, Non-Displayed Orders, and Post-Only Orders entered
through the OUCH and FLITE protocols when the Order locks or crosses a
Protected Quotation. As discussed below, BX is therefore amending Rule
4770 to clarify these differences. Although the changes made to Price
to Comply Orders, Non-Displayed Orders, and Post-Only Orders entered
through OUCH and FLITE reflect the different functionality of the OUCH
and FLITE protocols in comparison with the other BX protocols, the
proposed changes treat Price to Comply Orders, Non-Displayed Orders and
Post-Only Orders entered through OUCH and FLITE protocols in Test Group
Three Securities as consistently as possible with such orders entered
through OUCH and FLITE in Control Group Securities, and Test Group One
and Test Group Two Securities. These changes will adjust Price to
Comply Orders, Non-Displayed Orders, and Post-Only Orders entered
through OUCH and FLITE when the Order has been ranked at a midpoint of
the NBBO that then becomes impermissible due to changes in the NBBO.
Price to Comply Orders
    Currently, Rule 4770(d)(2) states that a Price to Comply Order in a
Test Group Pilot Security will operate as described in Rule 4702(b)(1)
except as provided under this paragraph. If a Price to Comply Order for
a Test Group Three Pilot Security is partially executed upon entry and
the remainder would lock a Protected Quotation of another market
center, the unexecuted portion of the Order will be cancelled. If the
Order is not executable against any previously posted orders on the
Exchange Book, and the limit price of a buy (sell) Price to Comply
Order in a Test Group Three Pilot Security would lock or cross a
Protected Quotation of another market center, the Order will display at
one minimum price increment below (above) the Protected Quotation, and
the Order will be ranked on the Exchange Book at the current midpoint
of the NBBO.
    BX proposes to augment this provision to clarify the behavior of
Price to Comply Orders entered through the OUCH or FLITE protocols in
Test Group Three Pilot Securities that lock or cross a Protected
Quotation. Specifically, a Price to Comply Order in a Test Group Three
Pilot Security entered through OUCH or FLITE may be adjusted in the
following manner after initial entry and posting to the BX Book.
    If entered at a price that locked a Protected Quotation, and if the
NBBO changes such that its price will no longer lock a Protected
Quotation, the Price to Comply Order will be adjusted to rank and
display at its original entered limit price.\10\
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    \10\ BX notes that a Price to Comply Order will always be
adjusted in this scenario, regardless of its port setting.
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    If entered at a price that crossed a Protected Quotation, and if
the NBBO changes such that it can be ranked at the price of the
Protected Quotation it crossed, the Price to Comply Order, based on the
participant's choice, may either be (i) cancelled or (ii) adjusted to
rank at the price of the Protected Quotation it crossed upon entry with
its displayed price remaining unchanged.
    If, after being posted on the BX Book, the non-displayed price of a
Price to Comply Order becomes locked or crossed by a Protected
Quotation due to a change in the NBBO, or if the Price to Comply Order
is at an impermissible price under Regulation NMS or the Plan and it
cannot otherwise be adjusted as above, the Price to Comply Order will
be cancelled.\11\
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    \11\ For example, if the National Best Bid is $10.00 and the
National Best Offer is $10.10, and a Price to Comply Order to buy at
$10.15 is entered, the Price to Comply Order will be displayed at
$10.05 and ranked at $10.075. If the National Best Offer then
changes to $10.15, the Price to Comply Order will be adjusted to
rank at $10.10, and will remain displayed at $10.05. If the National
Best Offer subsequently changes to $10.10, the Price to Comply Order
will be cancelled.
    BX notes that a Price to Comply Order, Non-Displayed Order, or
Post-Only Order entered through OUCH or FLITE in either a Control
Group Security, a Test Group One Pilot Security or a Test Group Two
Pilot Security would only cancel if the resting order is crossed
(not locked) by a Protected Quotation due to a change in the NBBO.
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Non-Displayed Orders
    Currently, Rule 4770(d)(3) states that a Non-Displayed Order in a
Test Group Pilot Security will operate as described in Rule 4702(b)(3)
except as provided under this paragraph. A resting Non-Displayed Order
in a Test Group Three Pilot security cannot execute at the price of a
Protected Quotation of another market center unless the incoming Order
otherwise qualifies for an exception to the Trade-at prohibition
provided under Rule 4770(c)(3)(D). If the limit price of a buy (sell)
Non-Displayed Order in a Test Group Three Pilot Security would lock or
cross a Protected Quotation of another market center, the Order will be
ranked on the Exchange Book at either one minimum price increment below
(above) the National Best Offer (National Best Bid) or at the midpoint
of the NBBO, whichever is higher (lower). For a Non-Displayed Order in
a Test Group Three Pilot Security entered through RASH or FIX, if after
being posted to the Exchange Book, the NBBO changes so that the Non-
Displayed Order would no longer be executable at its posted price due
to the requirements of Regulation NMS or the Plan, the Non-Displayed
Order will be repriced to a price that is at either one minimum price
increment below (above) the National Best Offer (National Best Bid) or
at the midpoint of the NBBO, whichever is higher (lower) and will
receive a new timestamp.\12\ For

a Non-Displayed Order in a Test Group Three Pilot Security entered
through OUCH or FLITE, if after such a Non-Displayed Order is posted to
the Exchange Book, the NBBO changes so that the Non-Displayed Order
would no longer be executable at its posted price due to the
requirements of Regulation NMS or the Plan, the Non-Displayed Order
will be cancelled back to the Participant.
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    \12\ As part of this proposal, BX also proposes to clarify the
operation of this provision so that it is structurally consistent
with provisions in the descriptions of Price to Comply and Post-Only
Orders. Specifically, BX will amend this language to provide that,
if a resting Non-Displayed Order in a Test Group Three Pilot
Security entered through RASH or FIX becomes locked or crossed by a
Protected Quotation due to a change in the NBBO, or if the Non-
Displayed Order is at an impermissible price under Regulation NMS or
the Plan, the Non-Displayed Order will be repriced to a price that
is at either one minimum price increment below (above) the National
Best Offer (National Best Bid) or at the midpoint of the NBBO,
whichever is higher (lower) and will receive a new timestamp.
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    BX proposes to amend this provision to clarify the behavior of Non-
Displayed Orders entered through the OUCH or FLITE protocols in Test
Group Three Pilot Securities that lock or cross a Protected Quotation.
Specifically, a Non-Displayed Order in a Test Group Three Pilot
Security entered through OUCH or FLITE may be adjusted in the following
manner after initial entry and posting to the BX Book.
    If entered at a price that locked a Protected Quotation, and if the
NBBO changes such that its price would no longer lock a Protected
Quotation, the Non-Displayed Order will be adjusted to rank at its
original entered limit price.\13\
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    \13\ BX notes that a Non-Displayed Order will always be adjusted
in this scenario, regardless of its port setting.
---------------------------------------------------------------------------

    If entered at a price that crossed a Protected Quotation, and if
the NBBO changes such that it can be ranked at the price of the
Protected Quotation it crossed, the Order, based on the Participant's
choice, may either be (i) cancelled or (ii) adjusted to rank at the
price of the Protected Quotation it crossed.\14\
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    \14\ For example, if the National Best Bid is $10.00 and the
National Best Offer is $10.10, and a Non-Displayed Order to buy at
$10.15 is entered, the Non-Displayed Order will be ranked at $10.05.
If the National Best Offer then changes to $10.15, the Non-Displayed
Order may either be adjusted to rank at $10.10, or may be cancelled
back to the Participant.
---------------------------------------------------------------------------

    If entered at a price that locked or crossed a Protected Quotation,
and if the NBBO changes such that it cannot be ranked at the price of
the Protected Quotation it locked or crossed but can be ranked closer
to its original limit price, the Non-Displayed Order will be adjusted
to the new midpoint of the NBBO.\15\
---------------------------------------------------------------------------

    \15\ For example, if the National Best Bid is $10.00 and the
National Best Offer is $10.10, and a Non-Displayed Order to buy at
$10.10 is entered, the Non-Displayed Order will be ranked at $10.05.
If the National Best Bid then changes to $10.05, the price of the
Non-Displayed Order will be adjusted to $10.075.
    BX notes that a Non-Displayed Order entered through OUCH or
FLITE in either a Control Group Security, a Test Group One Pilot
Security or a Test Group Two Pilot Security would be ranked at the
locking price upon entry.
---------------------------------------------------------------------------

    If, after being posted on the BX Book, the Non-Displayed Order
becomes locked or crossed by a Protected Quotation due to a change in
the NBBO, or if the Non-Displayed Order is at an impermissible price
under Regulation NMS or the Plan and it cannot otherwise be adjusted as
above, the Non-Displayed Order will be cancelled.\16\
---------------------------------------------------------------------------

    \16\ For example, if the National Best Bid is $10.00 and the
National Best Offer is $10.10, and a Non-Displayed Order to buy at
$10.10 is entered, the Non-Displayed Order will be ranked at $10.05.
If the National Best Offer then changes to $10.05, the Non-Displayed
Order will be cancelled back to the Participant.
---------------------------------------------------------------------------

Post-Only Orders
    Currently, Rule 4770(d)(4) states that a Post-Only Order in a Test
Group Pilot Security will operate as described in Rule 4702(b)(4)
except as provided under this paragraph. For orders that are not
attributable, if the limit price of a buy (sell) Post-Only Order in a
Test Group Three Pilot Security would lock or cross a Protected
Quotation of another market center, the Order will display at one
minimum price increment below (above) the Protected Quotation, and the
Order will be ranked on the Exchange Book at the current midpoint of
the NBBO.
    BX proposes to augment this provision to clarify the behavior of
Post-Only Orders entered through the OUCH or FLITE protocols in Test
Group Three Pilot Securities that lock or cross a Protected Quotation.
Specifically, a Non-Attributable Post-Only Order in a Test Group Three
Pilot Security entered through OUCH or FLITE may be adjusted in the
following manner after initial entry and posting to the BX Book.
    If entered at a price that locked a Protected Quotation, and if the
NBBO changes such that its price will no longer lock a Protected
Quotation, the Post-Only Order will be adjusted to rank and display at
its original entered limit price.\17\
---------------------------------------------------------------------------

    \17\ BX notes that a Post-Only Order will always be adjusted in
this scenario, regardless of its port setting.
---------------------------------------------------------------------------

    If entered at a price that crossed a Protected Quotation, and if
the NBBO changes such that it can be ranked at the price of the
Protected Quotation it crossed, the Post-Only Order, based on the
Participant's choice, may either be (i) cancelled or (ii) adjusted to
rank at the price of the Protected Quotation it crossed upon entry with
its displayed price remaining unchanged.
    If, after being posted on the BX Book, the non-displayed price of a
resting Post-Only Order becomes locked or crossed by a Protected
Quotation due to a change in the NBBO, or if the Post-Only Order is at
an impermissible price under Regulation NMS or the Plan and it cannot
otherwise be adjusted as above, the Post-Only Order will be cancelled.
Commentary .14
    In removing the current re-pricing functionality, Commentary .014
[sic], which addresses the behavior of current treatment of Price to
Comply Orders, Price to Display Orders, Non-Displayed Orders, and Post-
Only Orders that are entered through the OUCH or FLITE protocols in
Test Group Three Pilot Securities, is no longer necessary.\18\ The
Exchange therefore proposes to delete this Commentary from the Rule.
---------------------------------------------------------------------------

    \18\ Under Commentary .14, the current treatment of Price to
Comply Orders, Price to Display Orders, Non-Displayed Orders, and
Post-Only Orders that are entered through the OUCH or FLITE
protocols in Test Group Three securities is as follows:
    Following entry, and if market conditions allow, a Price to
Comply Order in a Test Group Three Pilot Security will be adjusted
repeatedly in accordance with changes to the NBBO until such time as
the Price to Comply Order is able to be ranked and displayed at its
original entered limit price.
    Following entry, and if market conditions allow, a Price to
Display Order in a Test Group Three Pilot Security will be adjusted
repeatedly in accordance with changes to the NBBO until such time as
the Price to Display Order is able to be ranked and displayed at its
original entered limit price.
    Following entry, and if market conditions allow, a Non-Displayed
Order in a Test Group Three Pilot Security will be adjusted
repeatedly in accordance with changes to the NBBO up (down) to the
Order's limit price.
    Following entry, and if market conditions allow, the Post-Only
Order in a Test Group Three Pilot Security will be adjusted
repeatedly in accordance with changes to the NBBO or the best price
on the Exchange Book, as applicable until such time as the Post-Only
Order is able to be ranked and displayed at its original entered
limit price.
---------------------------------------------------------------------------

    Finally, BX proposes to add language to Rule 4770(d)(1) to clarify
the treatment of orders in a Test Group Three Security entered through
the RASH or FIX protocols. Specifically, subject to the provisions set
forth in the remainder of Rule 4770(d), if the entered limit price of
an Order in a Test Group Three Pilot Security, entered through RASH or
FIX, locked or crossed a Protected Quotation and the NBBO changes so
that the Order can be ranked closer to its original entered limit
price, the price of the Order will be adjusted repeatedly in accordance
with changes to the NBBO. BX is proposing to make this change to
clarify the current treatment of orders in Test Group Three Pilot
Securities entered through RASH or FIX.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b)

of the Act,\19\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\20\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is consistent
with the Act because it clarifies the changes the Exchange is making to
the handling of certain Order Types necessary to implement the
requirements of the Plan on its System and, in the case of the changes
of Rule 4770(d)(1), to clarify the current treatment of orders in Test
Group Three Pilot Securities entered through RASH or FIX.
    As a result of removing the current re-pricing functionality that
applies to certain Order Types in Test Group Three Securities entered
through the OUCH and FLITE protocols, and due to the different
functionality of the OUCH and FLITE protocols in comparison to the
other applicable BX protocols, these Order Types will behave
differently than is currently set forth in Rule 4770 when entered
through the OUCH or FLITE protocols in certain instances. As noted
above, these changes will adjust Price to Comply Orders, Non-Displayed
Orders, and Post-Only Orders entered through OUCH and FLITE when the
Order has been ranked at a midpoint of the NBBO that then becomes
impermissible due to changes in the NBBO. These changes also will
adjust Price to Comply Orders, Non-Displayed Orders, and Post-Only
Orders entered through OUCH and FLITE in scenarios where the subsequent
movement of the NBBO implicates the Trade-at prohibition with respect
to the resting order.
    By clarifying the behavior of certain Order Types in Test Group
Three Pilot Securities entered through the OUCH or FLITE protocols, the
proposal will help allow market participants to continue to trade NMS
Stocks, within quoting and trading requirements that are in compliance
with the Plan, with certainty on how certain orders and trading
interests would be treated. This, in turn, will help encourage market
participants to continue to provide liquidity in the marketplace.
    More generally, BX also notes that the Plan, which was approved by
the Commission pursuant to an order issued by the Commission in
reliance on Section 11A of the Act,\21\ provides the Exchange authority
to establish, maintain, and enforce written policies and procedures
that are reasonably designed to comply with applicable quoting and
trading requirements specified in the Plan. The Exchange believes that
the proposed rule change is consistent with the authority granted to it
by the Plan to establish specifications and procedures for the
implementation and operation of the Plan that are consistent with the
provisions of the Plan. Likewise, the Exchange believes that the
proposed rule change provides interpretations of the Plan that are
consistent with the Act, in general, and furthers the objectives of the
Act, in particular.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78k-1.
---------------------------------------------------------------------------

    Finally, BX believes that the proposal is consistent with the Act
because the proposed functionality will more closely align the handling
of Price to Comply Orders, Non-Displayed Orders, and Post-Only Orders
that are entered through the OUCH or FLITE protocols for Test Group
Three Pilot Securities with the handling of such Orders entered through
the OUCH or FLITE protocols for Control Group, Test Group One and Test
Group Two Securities than the current functionality in place for these
Orders.

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. The proposed changes are being
made to establish, maintain, and enforce written policies and
procedures that are reasonably designed to comply with the trading and
quoting requirements specified in the Plan, of which other equities
exchanges are also Participants. Other competing national securities
exchanges are subject to the same trading and quoting requirements
specified in the Plan, and must take the same steps that the Exchange
has to conform its existing rules to the requirements of the Plan.
Therefore, the proposed changes would not impose any burden on
competition, while providing certainty of treatment and execution of
trading interests on the Exchange to market participants in NMS Stocks
that are acting in compliance with the requirements specified in the
Plan.

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

    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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \22\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\23\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \23\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \24\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\25\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. In this filing, the
Exchange has asked that the Commission waive the requirement that the
proposed rule change not become operative for 30 days after the date of
the filing.
---------------------------------------------------------------------------

    \24\ Id.
    \25\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange notes the proposed rule is intended to clarify the
differences in the handling of certain orders entered into the system
by different protocols. The Exchange notes that orders will be treated
as consistently as possible across the Test Groups and the Control
Group while complying with each grouping's varied quoting and trading
requirements. Additionally, the Exchange proposed to remove Commentary
.14 because it is no longer necessary.
    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because the proposal clarifies the Exchange's rules and provides
transparency to members with regards to the handling of certain orders
entered via OUCH and FLITE as well as RASH or FIX protocols for locked
or crossed orders in Test Group Three Pilot Securities. The Commission
notes that the Exchange proposed to remove the functionality described
in Commentary .14 and make the necessary corresponding systems changes
in Partial Amendment No. 2 to BX-2016-050, which the Commission
approved.\26\ The Exchange notes that it was able to implement the
systems changes and that they became fully operational on the December
14, 2016. Therefore, the

Commission hereby waives the 30-day operative delay and designates the
proposed rule change to be operative on December 14, 2016.\27\
---------------------------------------------------------------------------

    \26\ See supra note 5.
    \27\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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_ADDRESS>Please include
File Number SR-BX-2016-069 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2016-069. 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 Web site (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 Web site 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; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2016-069 and should be
submitted on or before January 17, 2017.

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

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-31107 Filed 12-23-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34691-34692]
[FR Doc No: 2022-12176]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1138]

Effects of the COVID-19 Public Health Emergency on Formal
Meetings and User Fee Applications for Medical Devices--Questions and
Answers (Revised); Withdrawal of Guidance

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

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance document entitled ``Effects of the
COVID-19 Public Health Emergency on Formal Meetings and User Fee
Applications for Medical Devices--Questions and Answers (Revised),''
which was issued in June 2020 (and updated December 2020). FDA is
withdrawing this guidance document in recognition that the conditions
that created the need for these policies have evolved, such that these
policies are no longer needed.

DATES: The withdrawal date is July 7, 2022.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in June 2020, the Agency published this guidance
document (June 23, 2020 at 85 FR 34638) and updated it in December
2020, to recognize that the COVID-19 public health emergency was
affecting the public health in numerous direct and indirect ways,
including device development programs.\2\ This guidance document
answered frequently asked questions and implemented temporary policies
to reduce industry burden.
---------------------------------------------------------------------------

    \1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
    \2\ The term ``device(s)'' in this document refers to devices
regulated by the Center for Devices and Radiological Health (CDRH)
as well as devices regulated by the Center for Biologics Evaluation
and Research (CBER), including devices regulated as biological
products under section 351 of the Public Health Service (PHS) Act.
---------------------------------------------------------------------------

    FDA has continually assessed the needs and circumstances related to
these temporary policies, and as relevant needs and circumstances
evolved, the Agency made updates and modifications to these temporary
policies. FDA has determined that the needs and circumstances related
to the temporary policies described in the guidance document have
evolved, such that they are no longer needed, and the guidance document
should be withdrawn. In weighing the current burden to industry and the
Agency relating to the COVID-19 response efforts with the need to
ensure patients have timely access to new devices, FDA is withdrawing
this guidance document. Below is a brief description of the guidance
document and temporary policies that will be withdrawn:
    The guidance articulated FDA's policy that for marketing
submissions and applications on hold, FDA did not intend to consider a
submission or application to be withdrawn for an additional 180 days
beyond the relevant response date. Returning to pre-pandemic policies
for marketing submissions and applications placed on hold after the
withdrawal of this guidance means FDA will generally consider the
submission or application to be withdrawn if the submitter or applicant
does not provide a complete response to major deficiency letters for
Premarket Approval Applications (PMAs) (original and supplements) \3\
and Humanitarian Device Exemption (HDE) applications (original and
supplements) \4\ within 360 days or to additional information letters
for 510(k) \5\ and De Novo requests \6\ within

180 days, consistent with preexisting guidance.
---------------------------------------------------------------------------

    \3\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on Premarket Approval
Applications (PMAs): Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals).
    \4\ For more information, please see the FDA guidance document
entitled ``Humanitarian Device Exemption (HDE) Program'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program).
    \5\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on Premarket Notification
(510(k)) Submissions: Effect on FDA Review Clock and Goals''
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals).
    \6\ For more information, please see the FDA guidance document
entitled ``FDA and Industry Actions on De Novo Classification
Requests: Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals).
---------------------------------------------------------------------------

    When the COVID-19 public health emergency began, FDA understood
that applicants may face challenges affecting their ability to meet
their applicable response date for submissions placed on hold. FDA also
recognized our potential difficulty in processing a high volume of
individual extension requests on a timely basis. To alleviate these
concerns, the guidance document articulated that FDA did not intend to
consider an application or submission to be withdrawn for an additional
180 days beyond the relevant response date, regardless of whether the
applicant submitted an extension request.
    By weighing the current burdens on industry with FDA's interest in
patients receiving timely access to new devices, FDA has determined it
is in the interest of the public health to return to pre-pandemic
policies regarding hold times. Reverting to policies regarding hold
times described in the preexisting guidance documents should facilitate
more timely premarket review of innovative and potentially lifesaving
devices. In addition, closing out files that have been abandoned in a
timelier manner allows for better management of the device review
program. The Agency acknowledges that the circumstances giving rise to
the public health emergency declaration for the COVID-19 pandemic
continue to exist. However, the conditions that created the need for
these policies have evolved, such that these policies are no longer
needed, and it is in the best interest of patients and providers to
reinstitute the original hold times to ensure patients have timely
access to advanced technologies, diagnostics, and therapeutics without
unnecessary delay.
    The guidance document also discussed FDA's ability to host advisory
committee meetings virtually and FDA's intention to work with relevant
stakeholders to host all advisory committee meetings virtually. In
returning to pre-pandemic policies, FDA will assess the appropriate
venue for advisory committee meetings, keeping in mind FDA's successful
implementation of virtual advisory committee meetings. Consistent with
existing policy, the venue will be announced via the Federal Register.
    Therefore, after careful review of current Agency processes,
industry practices with regard to resolving submission deficiencies,
and comments submitted to the public docket associated with the
guidance, FDA is withdrawing the ``Effects of the COVID-19 Public
Health Emergency on Formal Meetings and User Fee Applications for
Medical Devices--Questions and Answers (Revised)'' guidance in its
entirety.

II. Withdrawal Date

    The withdrawal date for the guidance document discussed in this
document is July 7, 2022. For submissions or applications that receive
a major deficiency letter for PMA and HDE applications or additional
information letters for 510(k) and De Novo requests prior to or on the
guidance withdrawal date, FDA does not intend to consider the
submission or application to be withdrawn for an additional 180 days
beyond the relevant response date. For submissions or applications that
receive a major deficiency letter or additional information letter
after the guidance withdrawal date, FDA will generally consider the
application or submission to be withdrawn if a complete response is not
received by the relevant response date identified in that letter.
    Authority: 21 U.S.C. 371(h).

    Dated: June 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12176 Filed 6-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 16, 2007 (Volume 72, Number 199)]
[Notices]
[Page 58710-58711]
[DOCID:fr16oc07-125]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56622; File No. SR-Phlx-2007-77]

Self-Regulatory Organizations; The Philadelphia Stock Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Web CRD Fingerprinting Fees

October 5, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 1, 2007, the Philadelphia Stock Exchange, Inc.
(``Phlx'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Phlx. The Phlx has designated this proposal as one
establishing or changing a due, fee, or other charge applicable only to
a member under section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-
4(f)(2) thereunder,\4\ which renders the proposal effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to amend its fingerprinting fees, which appear on
Appendix A of its fee schedule, so that the charge for the first and
third submission of a fingerprint card will be lowered from $35.00 to
$30.25. The Exchange also proposes to replace references to ``NASD'' on
the Exchange's fee schedules with references to ``FINRA.''
    The text of the proposed rule change is available at the Exchange,
the Commission's Public Reference Room, and at http://www.phlx.com.

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 Phlx 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 Phlx 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
    Currently, the Exchange's fee schedule includes fees that are
imposed in connection with participation in the National Association of
Securities Dealers, Inc. (``NASD,'' n/k/a/ the Financial Industry
Regulatory Authority, Inc., ``FINRA'') Web Central Registration
Depository (``Web CRD''). The fingerprinting fees are paid directly to
FINRA and vary depending on the submission: for a first card
submission, the fee is $35.00; for a second card submission, the fee is
$13.00; and for a third card submission, the fee is $35.00. For
processing fingerprint results for a member who had prints processed
through a self-regulatory organization and not FINRA, the fee is
$13.00.
    FINRA intends to amend the fingerprinting fees effective for
fingerprints processed on or after October 1, 2007, so that the charge
for the first and third submission of a fingerprint card will be
lowered from $35.00 to $30.25.\5\ The fees for processing a second
fingerprint card submission and for processing fingerprint cards where
the member had prints processed through a self-regulatory organization
and not FINRA will remain at $13.00.
---------------------------------------------------------------------------

    \5\ See FINRA Information Notice titled ``Fingerprint Processing
Fees'' dated September 20, 2007.
---------------------------------------------------------------------------

    Therefore, the Exchange proposes to amend its fee schedule to
reflect the lower Web CRD fingerprinting fees charged by FINRA. The
Exchange also proposes to update its fee schedule to replace references
to the NASD with references to FINRA.
2. Statutory Basis
    The Exchange believes that its proposal to amend its schedule of
fees is consistent with section 6(b) of the Act \6\ in general, and
furthers the objectives of section 6(b)(4) of the Act \7\ in
particular. The Exchange believes that it is an equitable allocation of
reasonable fees and other charges among Exchange members because it
will reflect FINRA's reduction for the first and third submission of a
fingerprint card from $35.00 to $30.25.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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.

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) of the Act \8\ and Rule 19b-4(f)(2) \9\ thereunder because
it establishes or changes a due, fee, or other charge applicable only
to a member. At any time within 60 days of the filing of such proposed
rule change, the Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-Phlx-2007-77 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2007-77. This file
number should be included on the subject line if e-mail 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 Web site (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 inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Phlx. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-Phlx-2007-77 and should be submitted on or before
November 6, 2007.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-20329 Filed 10-15-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 11, 2008 (Volume 73, Number 239)]
[Notices]
[Page 75428-75429]
[DOCID:fr11de08-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL07-79-001]

Midwest Independent Transmission System Operator, Inc.; Notice of
Filing

December 4, 2008.
    Take notice that on November 26, 2008, the Midwest Independent
Transmission System Operator, Inc. (Midwest ISO) filed a Large
Generator Interconnection Agreement between Endeavor Power Partners
LLC, Interstate Power and Light Company, and the Midwest ISO,
designated as Second Substitute Service Agreement No. 1632, under
Midwest ISO's FERC Electric Tariff, Third Revised Vol. No. 1.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to

become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed on or before the comment date. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 17, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-29352 Filed 12-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Pages 49515-49517]
[FR Doc No: 2011-20274]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65038; File No. SR-NASDAQ-2011-100]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify the Defined Term ``Closed-End Fund'' in Rules 5910 and 5920

August 5, 2011.
    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 July 26, 2011, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been substantially prepared by Nasdaq. Nasdaq has designated the
proposed rule change as effecting a change described under Rule 19b-
4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq proposes to modify the defined term ``Closed-End Fund'' in
Rules 5910 and 5920 to include business development companies.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\4\
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    \4\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://nasdaq.cchwallstreet.com.
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5910. The NASDAQ Global Market

    (a) Entry Fee
    (1)-(2) No change.
    (3) A closed-end management investment company [registered]
regulated under the Investment Company Act of 1940, as amended (a
``Closed-End Fund''), that submits an application for listing on the
Nasdaq Global Market shall pay to Nasdaq an

entry fee of $5,000 (of which $1,000 represents a non-refundable
application fee).
    (4)-(10) No change.
    (b)-(f) No change.

5920. The Nasdaq Capital Market

    (a) Entry Fee
    (1)-(2) No change.
    (3) A closed-end management investment company [registered]
regulated under the Investment Company Act of 1940, as amended (a
``Closed-End Fund''), that submits an application for listing on the
Nasdaq Capital Market shall pay to Nasdaq an entry fee of $5,000 (of
which $1,000 represents a non-refundable application fee).
    (4)-(9) No change.
    (b)-(e) No change.
* * * * *

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    A business development company is a type of closed-end management
investment company that is regulated under the Investment Company Act
of 1940 (the ``1940 Act'').\5\ While Nasdaq has historically treated
business development companies as closed-end funds for purposes of
computing listing fees, in defining a closed-end fund for these
purposes Nasdaq inadvertently excluded business development companies.
Specifically, Nasdaq defines a closed-end fund in Rules 5910(a)(3) and
5920(a)(3) as a closed-end management investment company that is
registered under the 1940 Act. While business development companies are
regulated under the 1940 Act, they are not registered under the 1940
Act.\6\
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    \5\ 15 U.S.C. 80a-1 et seq.
    \6\ Under Section 2(a)(48) of the 1940 Act, 15 U.S.C. 80a-
2(a)(48), a business development company is a closed-end company
which elects to be subject to certain provisions of the 1940 Act.
Such a company is exempt from the other requirements of the 1940
Act, including the registration requirements of Section 8, 15 U.S.C.
80a-8, pursuant to Section 6(f)(1), 15 U.S.C. 80a-6(f)(1).
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    It was never Nasdaq's intent to exclude business development
companies from the definition of a closed-end fund and Nasdaq has
historically treated them as closed-end funds \7\ and charged them the
fees applicable to closed-end funds. In this filing, Nasdaq proposes to
modify the definition of a closed-end fund contained in Rules
5910(a)(3) and 5920(a)(3) to include business development companies. As
revised, a closed-end fund will be defined as a closed-end management
investment company regulated under the 1940 Act.
---------------------------------------------------------------------------

    \7\ For example, when Nasdaq recently adopted a cap on Listing
of Additional Shares fees for closed-end funds, Nasdaq described a
closed-end fund as a type of company ``regulated'' under the 1940
Act. Exchange Act Release No. 63732 (January 19, 2011), 76 FR 4401
(January 25, 2011) (SR-NASDAQ-2011-007). In adopting this cap,
Nasdaq's intent was for it to apply to business development
companies and, in fact, the rule change adopting a cap for all
closed-end funds replaced a filing where Nasdaq proposed to adopt
the cap only for business development companies. See SR-NASDAQ-2010-
119 (withdrawn), available at http://nasdaq.cchwallstreet.com/NASDAQ/pdf/nasdaq-filings/2010/SR-NASDAQ-2010-119.pdf.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\8\ in general, and Section
6(b)(5) of the Act,\9\ in particular, because 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 mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Specifically, Nasdaq
believes the proposed rule change will clarify Nasdaq's treatment of
business development companies as closed-end funds, thereby eliminating
any confusion surrounding Nasdaq's rules.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) \11\ thereunder in
that it effects a change that: (i) Does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) by its terms, does not
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest. In addition, Nasdaq
provided the Commission with written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date of
filing of the proposed rule change. The proposed rule change will
clarify the treatment of business development companies under Nasdaq's
rules and consistent with the way Nasdaq has historically applied those
rules. Therefore, Nasdaq believes it does not significantly affect the
protection of investors or the public interest or raise any novel or
significant regulatory issues.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission 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 of 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 e-mail to<EMAIL_ADDRESS>Please include File
Number SR-NASDAQ-2011-100 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2011-100. This
file number should be included on the subject line if e-mail 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 Web site (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 on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of the filing also will be available for inspection and copying at the
principal office of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly.
    All submissions should refer to File Number SR-NASDAQ-2011-100 and
should be submitted on or before August 31, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Elizabeth M. Murphy,
Secretary.
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    \12\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. 2011-20274 Filed 8-9-11; 8:45 am]
BILLING CODE 8011-01-P