[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5778-5780]
[FR Doc No: 2018-02582]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1271]

Determination of Regulatory Review Period for Purposes of Patent
Extension; KAMRA INLAY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for KAMRA INLAY and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
10, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 8, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 10, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2016-E-1271 for ``Determination of Regulatory Review Period for
Purposes

of Patent Extension; KAMRA INLAY.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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.
     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 Sec.  10.20 (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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device KAMRA INLAY.
KAMRA INLAY is indicated for intrastromal corneal implantation to
improve near vision by extending the depth of focus in the non-dominant
eye of phakic, presbyopic patients between the ages of 45 and 60 years
old who have cycloplegic refractive spherical equivalent of +0.50
diopters (D) to-0.75 D with less than or equal to 0.75 D of refractive
cylinder, who do not require glasses or contact lenses for clear
distance vision, and who require near correction of +1.00 D to +2.50 D
of reading add. Subsequent to this approval, the USPTO received a
patent term restoration application for KAMRA INLAY (U.S. Patent No.
8,460,374) from AcuFocus, Inc., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated July 12, 2016, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of KAMRA INLAY represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
KAMRA INLAY is 2,347 days. Of this time, 1,541 days occurred during the
testing phase of the regulatory review period, while 806 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: November 14, 2008. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was November 14, 2008.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): February
1, 2013. The applicant claims December 7, 2012, as the date the
premarket approval application (PMA) for KAMRA INLAY (PMA P120023) was
initially submitted. However, FDA records indicate that PMA P120023 was
submitted on February 1, 2013.
    3. The date the application was approved: April 17, 2015. FDA has
verified the applicant's claim that PMA P120023 was approved on April
17, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 676 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must

contain sufficient facts to merit an FDA investigation, and must
certify that a true and complete copy of the petition has been served
upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02582 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57205-57208]
[FR Doc No: 2021-22276]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93270; File No. SR-CboeBZX-2021-065]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Rule 21.1 in Connection With Time-In-Force Instructions Available for
Bulk Messages and To Make a Clarifying Change

October 7, 2021.
    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 September 24, 2021, Cboe BZX Exchange, Inc. (the ``Exchange''
or ``BZX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule
19b-4(f)(6) thereunder.\4\ 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)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX Options'')
proposes to amend Rule 21.1 in connection with Time-in-Force
instructions available for bulk messages and to make a clarifying
change. The text of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rules 21.1(f) and (l) to allow Users
to instruct bulk messages with a Time-in-Force of Immediate or Cancel
(``IOC''). Currently, Users may not designate bulk messages as IOC,
which, pursuant to Rule 21.1(f)(2), instructs a limit order to be
executed in whole or in part as soon

as such order is received. The portion not so executed immediately on
the Exchange or another options exchange is cancelled and is not posted
to the BZX Options Book. A bulk message is a bid or offer included in a
single electronic message a User submits with an M Capacity (i.e., for
the account of a Market Maker) to the Exchange in which the User may
enter, modify, or cancel up to an Exchange-specified number of bids and
offers. More, specifically, bulk message functionality is available to
Market Makers and permits them to update their electronic quotes in
block quantities across series in a class. Rule 21.1(l)(3)(A)(i)
currently provides that a bulk message submitted through a dedicated
logical port (i.e., a ``bulk port'') has a Time-in-Force of Day.
Pursuant to Rule 21.1(f)(3), the term ``Day'' means, for an order so
designated, a limit order to buy or sell which, if not executed expires
at the RTH market close. All bulk messages have a Time in Force of DAY,
as set forth in Rule 21.1(l).
    The Exchange proposes to allow Market Makers to designate bulk
messages as IOC by amending the following: Rule 21.1(l)(3)(A)(i) to
provide that a bulk message submitted through a bulk port has a Time-
in-Force of Day or IOC; the definition of IOC in Rule 21.1(f)(2) to
provide that Users may designate bulk messages as IOC; and the
definition of ``Day'' in Rule 21.1(f)(3) to remove the language that
all bulk messages have a Time-in-Force of DAY, as set forth in Rule
21.1(l), and instead provide that Users may designate bulk messages as
Day.
    A Market Maker's primary purpose is to provide liquidity to the
market, which it may do in various ways, including resting quotes on
the Book as well as submitting quotes to trade against other resting
interest on the Book. In addition to providing liquidity via continuous
quotes in a Market Maker's appointed classes,\5\ as part of its quoting
obligations, a Market Maker is also required to maintain active markets
in its appointed classes, update quotations in response to changed
market conditions in its appointed classes and compete with other
Market Makers in its appointed classes.\6\ As part of a Market Maker's
efforts to satisfy these obligations, a Market Maker may update quotes
with the specific purpose of removing interest resting in the Book.
This may provide additional execution opportunities for customers,
thereby encouraging an increase in overall participation in an
appointed class.
---------------------------------------------------------------------------

    \5\ See Rule 22.5(a)(1).
    \6\ See Rule 22.5(a)(3),(5) and (6).
---------------------------------------------------------------------------

    Currently, if a Market Maker wishes to execute against interest in
the Book, a Market Maker will enter a Book Only bulk message or modify
an existing bulk message to attempt to execute against such interest,
followed immediately by a bulk message to cancel the preceding bulk
message (or unexecuted portion) so that no portion of that bulk message
will remain displayed on the Book. Essentially, in order to execute
against interest on the Book, Market Makers may currently send a
sequence of bulk messages that mimic the result of an IOC instruction--
ultimately the bulk message is cancelled and does not post to the Book
if it is not executed immediately against resting interest. Sending a
bulk message to cancel immediately following the submission of a bulk
message or a bulk message modification to execute against resting
interest creates an extra step for Market-Makers (compared to Options
Members that may use IOC orders to accomplish this) using bulk message
functionality and requires the System to process additional messages.
As such, the proposed rule change to permit Market Makers to designate
their bulk messages as IOC would allow them to attempt more effectively
and efficiently to execute against interest in the Book and would
reduce message traffic by eliminating the need for Market Makers to
send multiple messages to attempt this. The Exchange notes that Market
Makers may already use bulk messages to remove liquidity from the Book
(if they so elect) using the ``Book Only'' instruction and, as
described above, Market Makers may already use bulk messages to remove
liquidity without letting nonexecuted size rest on the Book. The
proposed rule change merely streamlines the manner in which Market
Makers may already utilize bulk messages to execute against interest on
the Book without sending an unexecuted bulk message (or unexecuted
portion) to the Book thereafter. Also, Market Makers may already
designate their quotes submitted in an order as IOC.\7\
---------------------------------------------------------------------------

    \7\ The Exchange notes that a Market-Maker may submit their
quotes electronically in an order or bulk message. The Exchange also
notes that, while Market-Makers may currently instruct their orders,
including quotes submitted as orders, as IOC, the Exchange
understands that Market-Makers predominantly conduct their trading
activity through and design their business models around the use
bulk messages.
---------------------------------------------------------------------------

    The Exchange notes that bulk message functionality is designed to
facilitate Market Makers quoting on the Exchange in connection with
their responsibility as liquidity providers. For example, the current
requirement that bulk messages have a Time-in-Force of Day is
consistent with general practice of Market Makers to enter new quotes
at the beginning of each trading day, as well as a Market Maker's
obligation to update its quotes in response to changed market
conditions in its appointed classes. The provision that allows Market
Makers to designate their bulk messages as Post Only or Book Only is
intended to provide Market Makers with flexibility to use these
instructions to permit them to execute against resting interest upon
entry or add liquidity to the Book in connection with their various
obligations in a manner they deem appropriate.\8\ The Exchange believes
that the proposed rule change likewise permits Market Makers to use an
instruction with respect to their bulk messages as an additional tool
to provide liquidity to the market and meet their various obligations
(such as maintaining active markets in an appointed class, updating
quotations in response to changed market conditions in an appointed
class and competing with other Market Makers in an appointed class) in
a manner they deem appropriate, which may include removing interest in
the Book to subsequently post updated quotes at potentially tighter
spreads and to provide additional execution opportunities at
potentially improved prices. The Exchange also believes that the
proposed rule change enhances a current means by which Market Makers
use bulk messages to facilitate the provision of liquidity on the
Exchange. That is, Market Makers using bulk messages with an IOC
instruction, as proposed, may more efficiently execute against resting
interest, thereby increasing execution opportunities for orders resting
on the Book. An increase in transactions on the Exchange may facilitate
tighter spreads and price discovery, and, as a result, encourage
increased participation and additional order flow from other market
participants. The Exchange notes that

the submission of bulk messages to the Exchange is voluntary and that
Market Makers may continue to elect to use bulk messages designated as
Day in the same manner as they do today, including sending a bulk
message immediately followed by a cancel to attempt to execute against
resting interest.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Release Nos. 84928 (December 21,
2018) 83 FR 67794 (December 31, 2018) (SR-CboeBZX-2018-092); and
88817 (May 6, 2020), 85 FR 28112 (May 12, 2020) (SR-CboeBZX-2020-
037). The Exchange notes that SR-CboeBZX-2018-092 implemented bulk
message functionality to be consistent with the bulk message
functionality, also adopted at that time, by its affiliated options
exchange, Cboe Exchange, Inc. (``Cboe Options''). The Exchange notes
that Cboe Option's bulk message functionality replaced its prior
block quoting functionality, which likewise allowed a Market Maker
to submit a single message containing bids and offers in multiple
series; however, Cboe Options Rules did not prohibit an IOC
designation for quotes submitted in block quantities.
---------------------------------------------------------------------------

    The proposed rule change also updates Rule 21.1(d), which defines
the term ``Order Type'', and Rule 21.1(f), which defines the term
``Time-in-Force'', to clarify the manner in which an Order Type or
Time-in-Force, respectively, applies to a bulk message. Currently, an
Order Type or Time-in-Force applied to a bulk message applies to each
bid and offer within that bulk message. The proposed rule change
updates Rules 21.1(d) and (f) to make this explicit for Order Type and
Time-in-Force designations, respectively. The proposed rule change does
not alter any current functionality, but instead adds clarity to the
definition of Order Type and Time-in Force by more accurately
reflecting the current application of such designations to bulk
messages.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \11\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes that the proposed rule change
allowing Market Makers to designate their bulk messages as IOC will
remove impediments to and perfect the mechanism of a free and open
market and national market system and benefit investors by permitting
Market Makers to more effectively and efficiently execute bulk messages
against specific interest on the Book without posting an unexecuted
bulk message (or unexecuted portion) to the Book thereafter. As
described above, Market Makers already submit bulk messages in a manner
that mimics an IOC instruction; the proposed rule change merely
streamlines this process for Market Makers by allowing them to use a
Time-in-Force instruction currently available for their orders (which
may also contain a Market Maker's quotes) on the Exchange today. In
addition to this, Market Makers may already include Book Only
instructions that permit their bulk messages to remove liquidity from
the Book. The proposed rule change is designed to benefit market
participants by increasing efficiency and reducing additional message
traffic by eliminating the need for Market Makers to send an additional
bulk message to cancel along with their bulk messages in instances in
which they wish to execute against interest that appears on the Book.
The proposed rule change allows Market Makers to elect to use their
bulk messages as additional tools to meet their various obligations in
a manner they deem appropriate, consistent with the purpose of bulk
message functionality to facilitate Market Makers' provision of
liquidity, which may include removing interest in the Book to
subsequently post updated quotes at potentially tighter spreads and to
provide additional execution opportunities at potentially improved
prices. Also, the use of IOC bulk messages for Market Makers may
ultimately facilitate the provision of additional liquidity on the by
increasing execution opportunities on the Exchange, as an increase in
transactions on the Exchange may facilitate tighter spreads and price
discovery, thereby encouraging increased participation and additional
order flow from other market participants, to the benefit of all
investors. Market Makers may continue to elect to use bulk messages
designated as Day in the same manner as they do today, including
sending a bulk message immediately followed by a cancel to attempt to
execute against resting interest.
    Additionally, the Exchange does not believe that the proposed rule
change would permit unfair discrimination as bulk message functionality
is principally designed to facilitate the provision of liquidity by
Market Makers to the Exchange and help Market Makers satisfy their
obligations. The Exchange believes that Market Makers play a unique and
critical role in the options market by providing liquid and active
markets and are subject to various quoting obligations (which other
market participants are not), including an obligation to maintain
active markets, to update quotations in response to changed market
conditions and to compete with other Market Makers in its appointed
classes. Bulk message functionality, including an IOC bulk message,
provides Market Makers with a means to help them satisfy these
obligations. As noted above, Market Makers are already able to use Book
Only bulk messages to execute against resting liquidity in multiple
series across a class and to cancel quotes in multiple series across a
class. The proposed rule change simply allows Market Makers to utilize
their bulk messages in the same manner, just with a single message.
    Additionally, the Exchange believes that the proposed rule change
regarding the manner in which an Order Type and Time-in-Force
instruction is applied to bulk messages removes impediments to and
perfects the mechanism of a free and open market and national market
system by amending Rules 21.1(d) and (f) to reflect current
functionality. The proposed rule change is merely a clarification in
the Rule intended to more accurately reflect how bulk message
functionality currently works, thereby increasing transparency in the
Rule and ultimately benefitting investors. The proposed clarification
does not alter any current functionality and is simply intended to
provide clarity to the Rule.

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 the proposed rule change in connection with IOC bulk
messages will impose any burden on intramarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act
because the IOC instruction for bulk messages will be available for all
Market Makers that choose to submit bulk messages. Use of the IOC
instruction for bulk messages is voluntary, and Market Makers may
choose to continue to only apply the Day Time-in-Force to bulk messages
and continue to attempt to execute bulk messages against resting
interest using multiple messages as they

do today. The proposed rule change permits Market Makers to use a Time-
in-Force that is already available to all Options Members, including
Market Makers, to apply to their orders. While only Market Makers may
submit IOC bulk messages (as only Market Makers may currently submit
any bulk messages), the Exchange believes this is appropriate given the
various obligations Market Makers must satisfy under the Rules and the
unique and critical role Market Makers play in the options market by
providing liquid and active markets. The Exchange believes providing
Market Makers with flexibility to use the IOC instruction with respect
to bulk messages will provide Market Makers with an enhanced tool to
provide liquidity to the market and satisfy their obligations in a
manner they deem appropriate, as they are similarly able to do today by
electing the Book Only and Post Only instructions for their bulk
messages.
    The Exchange does not believe that the proposed rule change in
connection with IOC bulk messages will impose any burden on intermarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act as it relates to quoting functionality available to
Market Makers on the Exchange. The Exchange notes that market
participants on other exchanges are welcome to become Market Makers on
the Exchange if they determine that this proposed rule change has made
participation as a Market Maker on the Exchange more attractive or
favorable.
    The proposed rule change in connection with the application of
Order Type and Time-in-Force instructions to bulk messages is not
competitive in nature but is merely a clarification in the Rule,
consistent with existing bulk message functionality and intended to
provide clarity to the Rule by more accurately reflecting the current
bulk message functionality. All Order Type and Time-in-Force
instructions will continue to apply to bulk messages in the same manner
as they do today.

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

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

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. 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) of the Act \12\ and
Rule 19b-4(f)(6) \13\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeBZX-2021-065 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2021-065. 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 such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2021-065, and should be
submitted on or before November 4, 2021.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-22276 Filed 10-13-21; 8:45 am]
BILLING CODE 8011-01-P