[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Rules and Regulations]
[Pages 39585-39587]
[FR Doc No: 2016-14282]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2016-0280; FRL-9947-81-Region 7]

Approval of Iowa's State Implementation Plan (SIP); Definition of
Greenhouse Gas and Prevention of Significant Deterioration (PSD)
Plantwide Applicability Limits (PALs) Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving two SIP
revisions submitted by the State of Iowa. First, EPA is approving the
definition of greenhouse gas, which will make the state's definition
consistent with the Federal definition, and add greenhouse gases to
emission inventory requirements. Second, EPA is approving Iowa's
revision to its Prevention of Significant Deterioration (PSD) program,
specifically to the definition of ``subject to regulation,'' and to
adopt by reference the most recent Federal plantwide applicability
limitations (PALs) provisions.

DATES: This direct final rule is effective August 16, 2016, without
further notice, unless EPA receives adverse comment by July 18, 2016.
If EPA receives adverse comment, we will publish a timely withdrawal of
the direct final rule in the Federal Register informing the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2016-0280, to http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refers to EPA.

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is EPA taking?

I. What is being addressed in this document?

    EPA is approving into the Iowa SIP the definition of greenhouse gas
which is consistent with the Federal definition, and approving the
requirement for facilities to include greenhouse gases in the emissions
inventory. On November 4, 2008, Iowa submitted a SIP revision to EPA
for several administrative revisions, including the request to amend
the definition of greenhouse gas, and to include greenhouse gases for
the purposes of emissions inventories. On December 9, 2009 (74 FR
68692), EPA approved many portions of the SIP revisions, but we did not
act on either of these particular provisions.
    EPA is also approving revisions to the Iowa Prevention of
Significant Deterioration (PSD) program rules to revise the definition
of ``subject to regulation,'' by citing the most recent Federal
reference to the greenhouse gas definition, and adding a sentence to
clarify that the stationary source shall not be subject to regulation
if the total sourcewide emissions are below the greenhouse gas
plantwide applicability limitations (PALs) and meet the requirements in
Iowa Administrative Code (IAC) 567-33.9(455B) (also being revised with
this action), and the source complies with the PALs permit containing
the greenhouse gases PALs.
    IAC 567-33.9(455B), ``Plantwide Applicability Limitations,'' is
being revised to adopt by reference to cite the Federal regulations as
of July 12, 2012, except that the term ``Administrator''

will mean ``the department of natural resources.''
    Additional information for this rulemaking can be found in the
Technical Support Document located in this docket.

II. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. Public hearings were
conducted for each of the submissions and no comments were received.
The submission also satisfied the completeness criteria of 40 CFR part
51, appendix V. In addition, as explained in the Technical Support
Document which is part of this docket, the revision meets the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations.

III. What action is EPA taking?

    With this direct final action, the greenhouse gas definition is
being added to the Iowa SIP as it is consistent with the Federal
definition. Greenhouse gases are also included as applied to emissions
inventories.
    EPA is also approving into the Iowa SIP revisions to the PSD
program rules, specifically revising the definition of ``subject to
regulation.'' This revision also adopts by reference the Federal PAL
provision for greenhouse gases. (77 FR 41051).
    We are publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and anticipate
no adverse comment. However, in the ``Proposed Rules'' section of this
Federal Register, we are publishing a separate document that will serve
as the proposed rule to approve the SIP revision if relevant adverse
comments are received on this direct final rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so at this time. For further information about
commenting on this rule, see the ADDRESSES section of this document. If
EPA receives adverse comment, we will publish a timely withdrawal in
the Federal Register informing the public that this direct final rule
will not take effect. We will address all public comments in any
subsequent final rule based on the proposed rule.

Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 16, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Greenhouse gases,
Incorporation by reference, Reporting and recordkeeping requirements.

    Dated: June 3, 2016.
Mark Hague,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart Q--Iowa

0
2. In Sec.  52.820, amend the table in paragraph (c) by revising the
entries for 567-20.2, 567-21.1, 567-33.3, and 567-33.9 to read as
follows:

Sec.  52.820  Identification of Plan.

* * * * *
    (c) * * *

                                          EPA-Approved Iowa Regulations
----------------------------------------------------------------------------------------------------------------
                                                         State
       Iowa citation                 Title          effective date    EPA approval date         Explanation
----------------------------------------------------------------------------------------------------------------
                 Iowa Department of Natural Resources Environmental Protection Commission [567]
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                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        Chapter 20--Scope of Title--Definitions--Forms--Rules of Practice
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
567-20.2...................  Definitions..........          5/7/08  6/17/16 and [Insert    The definitions for
                                                                     Federal Register       anaerobic lagoon,
                                                                     citation].             odor, and odorous
                                                                                substance are not
                                                                                SIP approved.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                             Chapter 21--Compliance
----------------------------------------------------------------------------------------------------------------
567-21.1...................  Compliance Schedule..          5/7/08  6/17/16 and [Insert    .....................
                                                                     Federal Register
                                                                     citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Chapter 33--Special Regulations and Construction Permit Requirements for Major Stationary Sources--Prevention of
                                 Significant Deterioration (PSD) of Air Quality
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
567-33.3...................  Special Construction          7/17/13  6/17/16 and [Insert    .....................
                              Permit Requirements                    Federal Register
                              for Major Stationary                   citation].
                              Sources in Areas
                              Designated
                              Attainment or
                              Unclassified (PSD).
567-33.9...................  Plantwide                     7/17/13  6/17/16 and [Insert    .....................
                              Applicability                          Federal Register
                              Limitations.                           citation].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-14282 Filed 6-16-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53430-53431]
[FR Doc No: 2014-21227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1049]

Exploring the Expansion of Conditional Approval to Appropriate
Categories of New Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is beginning the exploration process described in a stated performance
goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals
letter. Consistent with the performance goal, the FDA is inviting
comments in regard to the Agency exploring the use of statutory changes
to expand the use of conditional approval

beyond new animal drugs intended for minor species or for minor uses in
major species to additional categories of new animal drugs as
appropriate.

DATES: Although you can comment on this document at any time, to ensure
that the Agency considers your comment before finalizing work on the
exploration process described in this document, submit either
electronic or written comments by March 9, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E444,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA considers the timely review of the safety and effectiveness of
new animal drugs to be central to the Agency's mission to protect and
promote the public health. Before 2004, the timeliness and
predictability of the new animal drug review program was a concern. The
Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter
referred to as ``ADUFA I''), authorized FDA to collect user fees for 5
years--fiscal year (FY) 2004 to FY 2008--that were to be dedicated to
expediting the review of new animal drug applications according to
certain performance goals and to expand and modernize the new animal
drug review program. The Agency agreed to meet a comprehensive set of
performance goals established to show significant improvement in the
timeliness and predictability of the new animal drug review process.
The implementation of ADUFA I provided a significant funding increase
that enabled FDA to increase the number of staff dedicated to the new
animal drug application review process.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to
as ``ADUFA II'') which included an extension of ADUFA for an additional
5 years--FY 2009 to FY 2013. ADUFA II performance goals were
established based on ADUFA I FY 2008 review timeframes. In addition,
FDA provided program enhancements to reduce review cycles and improve
communications during reviews.
    In 2013, before ADUFA II expired, Congress passed the Animal Drug
User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter referred to as
ADUFA III), which was signed by the President on June 13, 2013. Like
its predecessors, ADUFA III included its own comprehensive set of
performance goals. One such goal, as stated in the ADUFA III goals
letter, was: ``Beginning in early FY 2014, the Agency agrees to
explore, in concert with industry, the feasibility of pursuing
statutory revisions, consistent with the Agency's mission to protect
and promote the public health, that may expand the use of conditional
approvals to other appropriate categories of new animal drug
applications and develop recommendations by September 30, 2015.''
    The conditional approval provisions are found in section 571 of the
Federal Food, Drug and Cosmetic Act (the FD&C Act). These provisions
allow an applicant to market a new animal drug intended for a minor
species or a minor use in a major species after the applicant has
demonstrated that the drug is safe and can be manufactured according to
standards applicable to approval of applications under section
512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)), but before meeting
the full requirements for demonstrating effectiveness by providing
``substantial evidence'' that the drug is effective. Instead, the
applicant seeking conditional approval must demonstrate a ``reasonable
expectation of effectiveness'' and has up to 5 years to meet the
requirements for demonstrating ``substantial evidence'' of
effectiveness and receive complete approval of an application filed
under section 512(b) of the FD&C Act.
    Today, FDA is announcing that it is beginning the exploration
process described in the ADUFA III goals letter. With this document,
FDA is requesting comments in regard to the Agency exploring the use of
statutory changes to expand the use of conditional approval to
appropriate categories of new animal drugs beyond those intended for
use either in minor species or for minor uses in major species. FDA is
opening a public docket to receive comments on the issue. In
particular, FDA is inviting comments on the following specific
questions:
    1. Which categories of new animal drugs, if any, beyond those
intended for minor species or minor uses in major species, should be
considered by FDA for conditional approval in accordance with the
current conditional approval process and why?
    2. How would expanding conditional approval positively or
negatively affect animal health?
    FDA will be reviewing the docket and considering comments submitted
as it moves forward with this process. The docket will remain open for
180 days following publication of this document in the Federal
Register.

II. Comments

    Interested persons may submit electronic comments regarding this
document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21227 Filed 9-8-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]
[Page 76686]
[DOCID:fr17de08-117]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 18, 2008 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), (8), 9(ii) and (10), permit consideration of
the scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
December 18, 2008 will be:
    Formal orders of investigation;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    Resolution of litigation claims;
    A regulatory matter regarding financial institution;
    Adjudicatory matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 11, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-29849 Filed 12-16-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Rules and Regulations]
[Pages 71568-71570]
[FR Doc No: 2021-27317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2021-N-0857]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Manual Percutaneous Surgical Set Assembled in the
Abdomen

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the manual percutaneous surgical set assembled in the abdomen into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the manual percutaneous surgical set assembled in
the abdomen's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective December 17, 2021. The classification
was applicable on April 30, 2012.

FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the manual percutaneous surgical
set assembled in the abdomen as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application
(PMA) to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.

II. De Novo Classification

    For this device, FDA issued an order on August 26, 2011, finding
the Percutaneous Surgical Set with 5mm or 10mm Attachments not
substantially equivalent to a predicate not subject to PMA. Thus, the
device remained in class III in accordance with section 513(f)(1) of
the FD&C Act when we issued the order.
    On September 21, 2011, FDA received Ethicon Endo-Surgery, Inc.'s
request for De Novo classification of the Percutaneous Surgical Set
with 5mm or 10mm Attachments. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 30, 2012, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
878.4805.\1\ We have named the

generic type of device manual percutaneous surgical set assembled in
the abdomen, and it is identified as a prescription device consisting
of a percutaneous surgical set used as a means to penetrate soft tissue
to access certain areas of the abdomen. The device's effectors or
attachments are provided separately from the percutaneous shaft and are
introduced to the site via a traditional conduit such as a trocar. The
attachment or effectors are connected to the shaft once the tip of the
shaft is inside the abdomen. Once inside the abdomen, the surgical set
is used to grasp, hold, and manipulate soft tissues. A surgical
instrument that has specialized uses in a specific medical specialty is
classified in separate regulations in 21 CFR parts 868 through 892.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Manual Percutaneous Surgical Set Assembled in the Abdomen Risks
                         and Mitigation Measures
------------------------------------------------------------------------
           Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction..............  Biocompatibility evaluation.
Device failure.......................  Non-clinical performance testing,
                                        Sterilization validation, and
                                        Shelf life testing.
User error...........................  Non-clinical performance testing,
                                        Simulated use testing, and
                                        Labeling.
Abdominal cavity damage..............  Non-clinical performance testing,
                                        Simulated use testing, and
                                        Labeling.
Infection............................  Sterilization validation and
                                        Shelf life testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.
    At the time of classification, manual percutaneous surgical sets
assembled in the abdomen are for prescription use only. Prescription
devices are exempt from the requirement for adequate directions for use
for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.4805 to subpart E to read as follows:

Sec.  878.4805  Manual percutaneous surgical set assembled in the
abdomen.

    (a) Identification. A manual percutaneous surgical set assembled in
the abdomen is a prescription device consisting of a percutaneous
surgical set used as a means to penetrate soft tissue to access certain
areas of the abdomen. The device's effectors or attachments are
provided separately from the percutaneous shaft and are introduced to
the site via a traditional conduit such as a trocar. The attachment or
effectors are connected to the shaft once the tip of the shaft is
inside the abdomen. Once inside the abdomen, the surgical set is used
to grasp, hold, and manipulate soft tissues. A surgical instrument that
has specialized uses in a specific medical specialty is classified in
separate regulations in parts 868 through 892 of this chapter.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the requested shelf life.
    (4) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following

performance characteristics must be tested:
    (i) Dimensional verification testing must be conducted.
    (ii) Force verification testing must be conducted. The force
testing must demonstrate the forces necessary to insert and operate
each component of the device during use as intended.
    (iii) Functional verification testing of the device components must
be conducted.
    (5) Simulated use testing in an anatomically relevant animal model
must demonstrate the device's ability to penetrate soft tissue, be
assembled in situ, and to grasp, hold and manipulate soft tissues in
the intended treatment area.
    (6) The labeling must include the following:
    (i) Instructions for use, including detailed instructions for
instrument assembly, disassembly, and removal; and
    (ii) A shelf life.

    Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27317 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12204-12206]
[FR Doc No: 2011-4888]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63970; File No. SR-BYX-2011-004]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change by BATS
Exchange, Inc. To Adopt BYX Rule 11.21, entitled ``Input of Accurate
Information''

February 25, 2011.
    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 February 18, 2011, BATS Y-Exchange, Inc. (``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the

Act \3\ and Rule 19b-4(f)(6)(iii) thereunder,\4\ which renders it
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).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange proposes to adopt new BYX Rule 11.21 to require
Members to identify each order accurately as a Principal, Agency, or
Riskless Principal Order.

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 parts 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 add new BYX Rule 11.21 for the purpose of
increasing transparency and to enhance the surveillance database and
audit trail of transaction data used by the Exchange in surveillance of
its market. The proposed rule change would require Members to identify
the capacity of each order accurately as a Principal, Agency, or
Riskless Principal Order. For purposes of surveillance, the Exchange
currently identifies the capacity of each order as Principal, Agency,
or Riskless Principal; however, several other capacities are accepted
upon order entry, including no response, which are thereafter mapped to
one of the above-listed order capacities. By limiting the order
capacity upon entry to Principal, Agency, or Riskless Principal and
requiring Members to accurately submit an order capacity for each
order, the Exchange will be able to more precisely identify the type of
order received and more effectively surveil for abusive trading.
    BYX does not have a rule that makes an explicit statement regarding
a Member's obligation to input accurate information into the System.
Notwithstanding, BYX believes that disciplinary cases against Members
entering inaccurate or incomplete information may be brought
appropriately under BYX Rule 3.1, which requires Members to observe
high standards of commercial honor and just and equitable principles of
trade. Rule 3.1 protects the investing public and the securities
industry from dishonest practices that are unfair to investors or
hinder the functioning of a free and open market, even though those
practices may not be illegal or violate a specific rule or regulation.
Because of the regulatory importance of accurate information input in
the System, BYX believes a rule that directly addresses Members'
obligation to provide accurate information is warranted. The proposed
rule makes clear Members' obligation to input accurate information into
the System and that failure to do so would be considered a violation of
BYX Rules.
    BYX notes that the Commission has previously approved rules
proposed by the Nasdaq Stock Market LLC (``Nasdaq'') requiring
participants to ensure that accurate information is entered into
Nasdaq's system, including but not limited to the capacity of the
participant.\5\ Thus, the proposed rule change would bring BYX Rules in
line with those of other self-regulatory organizations.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release 59547 (March 10, 2009),
74 FR 11386 (March 17, 2009).
---------------------------------------------------------------------------

    In order to allow Members sufficient time to review and complete
any systems changes necessitated by this filing, the Exchange has
proposed an operative date of April 4, 2011.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\6\ Specifically, for
the reasons described above, the proposed change is consistent with
Section 6(b)(5) of the Act,\7\ 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 to protect
investors and the public interest. Specifically, the changes proposed
herein will serve to promote the accuracy of information input into the
Exchange. Accurate information is necessary for the efficient and fair
operation of the Exchange, and will assist the Exchange in surveilling
the markets for fraudulent activity.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

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

III. Date of Effectiveness of the Proposed Rule Changes 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)(6) \9\ thereunder because
the proposal does not: (i) Significantly affect the protection of
investors or the public interest; (ii) impose any significant burden on
competition; and (iii) by its terms, 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.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's 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, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    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.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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-BYX-2011-004 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-BYX-2011-004. 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, 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 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-BYX-2011-004 and should be
submitted on or before March 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-4888 Filed 3-3-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Notices]
[Pages 64248-64254]
[FR Doc No: 2021-25018]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93554; File No. SR-MEMX-2021-16]

Self-Regulatory Organizations; MEMX LLC; Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change To Amend the
Exchange's Fee Schedule

November 10, 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 October 29, 2021, MEMX LLC (``MEMX'' or the ``Exchange'') 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 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.
---------------------------------------------------------------------------

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

    The Exchange is filing with the Commission a proposed rule change
to amend the Exchange's fee schedule applicable to Members \3\ (the
``Fee Schedule'') pursuant to Exchange Rules 15.1(a) and (c). The
Exchange proposes to implement the changes to the Fee Schedule pursuant
to this proposal on November 1, 2021. The text of the proposed rule
change is provided in Exhibit 5.
---------------------------------------------------------------------------

    \3\ See Exchange Rule 1.5(p).
---------------------------------------------------------------------------

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 purpose of the proposed rule change is to amend the Fee
Schedule to: (i) Adopt a new Targeted Step-Up Tier to provide an
additive rebate applicable to executions of orders (other than
displayed Retail Orders \4\) in securities priced at or above $1.00 per
share that add liquidity to the Exchange (such orders, ``Added
Volume''); (ii) modify the required criteria under Liquidity Removal
Tier 1; (iii) reduce the rebates provided under DLI Tier 1 and DLI Tier
2 for executions of displayed orders in securities priced at or above
$1.00 per share that add liquidity to the Exchange (such orders,
``Added Displayed Volume''); and (iv) increase the standard fee for
executions of orders in securities priced at or above $1.00 per share
that remove liquidity from the Exchange (such orders, ``Removed
Volume'').
---------------------------------------------------------------------------

    \4\ A ``Retail Order'' means an agency or riskless principal
order that meets the criteria of FINRA Rule 5320.03 that originates
from a natural person and is submitted to the Exchange by a Retail
Member Organization, provided that no change is made to the terms of
the order with respect to price or side of market and the order does
not originate from a trading algorithm or any other computerized
methodology. See Exchange Rule 11.21(a).
---------------------------------------------------------------------------

    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues, to
which market participants may direct their order flow. Based on
publicly available information, no single registered equities exchange
currently has more than approximately 15% of the total market share of
executed volume of equities trading.\5\ Thus, in such a low-
concentrated and highly competitive market, no single equities exchange
possesses significant pricing power in the execution of order flow, and
the Exchange currently represents approximately 4% of the overall
market share.\6\ The Exchange in particular operates a ``Maker-Taker''
model whereby it provides rebates to Members that add liquidity to the
Exchange and charges fees to Members that remove liquidity from the
Exchange. The Fee Schedule sets forth the standard rebates and fees
applied per share for orders that add and remove liquidity,
respectively. Additionally, in response to the competitive environment,
the Exchange also offers tiered pricing, which provides Members with
opportunities to qualify for higher rebates or lower fees where certain
volume criteria and thresholds are met. Tiered pricing provides an
incremental incentive for Members to strive for higher tier levels,
which provides increasingly higher benefits or discounts for satisfying
increasingly more stringent criteria.
---------------------------------------------------------------------------

    \5\ Market share percentage calculated as of October 28, 2021.
The Exchange receives and processes data made available through
consolidated data feeds (i.e., CTS and UTDF).
    \6\ Id.
---------------------------------------------------------------------------

Adoption of Targeted Step-Up Tier 1
    The Exchange proposes to adopt a new volume-based tier, referred to
by the Exchange as Targeted Step-Up Tier 1, in which the Exchange will
provide an additive rebate applicable to executions of orders (other
than displayed Retail Orders) in securities priced at or above $1.00
per share that add liquidity to the Exchange (i.e., Added Volume) for
Members that meet at least one of two specified volume thresholds
across a specified list of securities, referred to by the Exchange as
the Targeted Step-Up Securities,\7\ as further described below.
---------------------------------------------------------------------------

    \7\ As proposed, the term ``Targeted Step-Up Securities'' means
a list of securities designated as such, the universe of which will
be determined by the Exchange and published on the Exchange's
website. The Exchange anticipates that the initial Targeted Step-Up
Securities list will include between 30 and 50 securities. The
Exchange will not remove a security from the Targeted Step-Up
Securities list without at least 30 days' prior notice to Members as
published on the Exchange's website (unless the security is no
longer eligible for trading on the Exchange).
---------------------------------------------------------------------------

    Currently, the Exchange provides various rebates to Members for
executions of Added Volume ranging from $0.0020 per share to $0.0036
per share based on the type of order (e.g., displayed, non-displayed,
midpoint peg) and whether a Member qualifies for one of the Exchange's
existing pricing tiers.\8\ The Exchange now proposes to adopt Targeted
Step-Up Tier 1 in which it will provide an additive rebate of $0.0002
per share for all executions of Added Volume in a particular month for
a Member that qualifies for such tier in that month by achieving: (1) A
Step-Up ADAV \9\ from October 2021 that is equal to or greater than
0.05% of the TCV \10\ in the Targeted Step-Up Securities; or (2) an
ADAV that is equal to or greater than 0.08% of the TCV in the Targeted
Step-Up Securities.\11\ To determine if a Member meets either of these
volume thresholds, the Exchange will aggregate a Member's ADAV across
all Targeted Step-Up Securities for a given month.\12\ The $0.0002 per
share additive rebate will be provided in addition to the rebate that
is otherwise applicable to each of a qualifying Member's orders that
constitutes Added Volume (including a rebate provided under another
pricing tier).\13\
---------------------------------------------------------------------------

    \8\ The Exchange notes that it is proposing herein to reduce the
rebate of $0.0036 per share provided under DLI Tier 1 to $0.0035 per
share, as further described below, so after giving effect to the
changes proposed herein the range of rebates provided for executions
of Added Volume would be from $0.0020 per share to $0.0035 per
share.
    \9\ As set forth on the Fee Schedule, ``ADAV'' means the average
daily added volume calculated as the number of shares added per day,
which is calculated on a monthly basis, and ``Step-Up ADAV'' means
ADAV in the relevant baseline month subtracted from current ADAV.
    \10\ As set forth on the Fee Schedule, ``TCV'' means total
consolidated volume calculated as the volume reported by all
exchanges and trade reporting facilities to a consolidated
transaction reporting plan for the month for which the fees apply.
    \11\ This proposed pricing is referred to by the Exchange on the
Fee Schedule under the new description ``Targeted Step-Up Tier 1''
with a Fee Code of ``X'' to be appended to the otherwise applicable
Fee Code for qualifying executions (which include Fee Codes ``B'',
``D'', ``J'', ``B1'', ``D1'', ``J1'', ``B2'', ``D2'', ``J2'',
``Bq1'', ``Dq1'', ``Jq1'', ``Bq2'', ``Dq2'', ``Jq2'', ``H'' and
``M''). The Exchange notes that because the determination of whether
a Member qualifies for a certain pricing tier (including the
Targeted Step-Up Tier 1) for a particular month will not be made
until after the month-end, the Exchange will provide the Fee Codes
otherwise applicable to such transactions on the execution reports
provided to Members during the month and will only designate the Fee
Codes applicable to the achieved pricing tier on the monthly
invoices, which are provided after such determination has been made,
as the Exchange does for its tier-based pricing today.
    \12\ For example, if a Member achieved an ADAV of 0.01% of the
TCV in each of eight different Targeted Step-Up Securities in a
particular month, such Member would qualify for the Targeted Step-Up
Tier in that month because it would have achieved an ADAV that is
equal to 0.08% of the TCV in the Targeted Step-Up Securities.
    \13\ As defined above, Added Volume does not include executions
of displayed Retail Orders in securities priced at or above $1.00
per share that add liquidity to the Exchange (such orders, ``Added
Displayed Retail Volume''). The Exchange notes that the highest
rebate that it currently provides with respect to any transaction
effected on the Exchange is $0.0037 per share, which is for
executions of Added Displayed Retail Volume. The Exchange is not
seeking with this proposal to provide a rebate that is higher than
such current maximum rebate, and thus, as proposed, the additive
rebate provided under the Targeted Step-Up Tier would not apply to
executions of Added Displayed Retail Volume as such transactions
already receive a rebate of $0.0037 per share.
---------------------------------------------------------------------------

    The purpose of the proposed Targeted Step-Up Tier 1 is to encourage
Members to increase their volume on the Exchange in certain specified
securities for which the Exchange seeks to become a more competitive
trading venue (i.e., the Targeted Step-Up Securities). As a

general matter, the Targeted Step-Up Securities are higher-priced and
actively-traded names, many of which are actively-traded ETPs or
components thereof, and the Exchange believes that increased
participation in the trading of these securities would increase the
diversity of securities actively traded on the Exchange as well as the
notional market share traded on the Exchange, which would accrue
benefits to all Members through deeper and more diversified liquidity
on the Exchange. As such, the Exchange is seeking to improve its market
quality, and thus increase its attractiveness as a trading venue, with
respect to the Targeted Step-Up Securities by providing an incentive to
Members to increase their order flow in such securities to the
Exchange. Through the proposed additive rebate for executions of Added
Volume for Members that qualify for the Targeted Step-Up Tier 1, the
Exchange hopes to provide improved trading conditions on the Exchange
with respect to the Targeted Step-Up Securities through increased
execution opportunities and deeper liquidity in such securities
resulting from such increased order flow, thereby contributing to a
more robust and well-balanced market ecosystem on the Exchange to the
benefit of all Members.
    The Exchange notes that the Targeted Step-Up Tier 1 is similar to
other volume-based incentives and discounts, which have been widely
adopted by exchanges, including the Exchange. More specifically, the
Exchange believes the Targeted Step-Up Tier 1 is comparable to the
Exchange's Displayed Liquidity Incentive (``DLI'') Tiers \14\ as well
as other pricing tiers adopted by other exchanges that provide an
enhanced rebate or supplemental incentive for firms that achieve a
specified volume threshold in a specified group of securities.\15\
---------------------------------------------------------------------------

    \14\ The Exchange's DLI Tiers provide an enhanced rebate for
executions of Added Displayed Volume for Members that promote price
discovery and market quality by quoting at the NBBO for a
significant portion of each day in a broad base of securities,
generally, and in a targeted group of securities (the ``DLI Target
Securities''), in particular. See the Exchange's Fee Schedule
(available at https://info.memxtrading.com/fee-schedule/) for
additional details regarding the Exchange's DLI Tiers. See also
Securities Exchange Act Release No. 92150 (June 10, 2021), 86 FR
32090 (June 16, 2021) (SR-MEMX-2021-07) (notice of filing and
immediate effectiveness of fee changes adopted by the Exchange,
including the adoption of DLI).
    \15\ Cboe BZX Exchange, Inc. (``Cboe BZX'') currently provides
an additive rebate of $0.0001 or $0.0002 per share for executions of
Tape B securities for market participants that meet certain quoting
and trading requirements in a specified number of securities
included on a list of securities determined by Cboe BZX, including
both Cboe BZX listed securities and non-Cboe BZX listed securities
for which Cboe BZX wants to incentivize additional participation.
See the Cboe BZX equities trading fee schedule on its public website
(available at https://www.cboe.com/us/equities/membership/fee_schedule/bzx/); see also Securities Exchange Act Release No.
93405 (October 22, 2021), 86 FR 59763 (October 28, 2021) (SR-BX-
2021-047) (notice of filing and immediate effectiveness of fee
changes adopted by Nasdaq BX, Inc., including the adoption of an
enhanced market quality program focused on specified Tape A and Tape
B securities).
---------------------------------------------------------------------------

Modified Criteria Under Liquidity Removal Tier 1
    The Exchange is also proposing to modify the required criteria
under Liquidity Removal Tier 1. Currently, the Exchange charges a
standard fee of $0.0028 per share for executions of orders in
securities priced at or above $1.00 per share that remove liquidity
from the Exchange (i.e., Removed Volume), which the Exchange is
proposing to increase to $0.0029 per share, as further described below.
The Exchange also currently offers a Liquidity Removal Tier 1 in which
qualifying Members are charged a lower fee of $0.0027 per share for
executions of Removed Volume by achieving: (1) A Step-Up ADAV from July
2021 that is equal to or greater than 0.05% of the TCV; or (2) an ADV
\16\ that is equal to or greater than 0.30% of the TCV. Thus, Liquidity
Removal Tier 1 provides an opportunity for a Member to qualify for a
lower fee for executions of Removed Volume where such Member either
increases its ADAV on the Exchange by a specified amount over a
baseline month or achieves a specified ADV on the Exchange. The
Exchange notes that Liquidity Removal Tier 1 is designed to encourage
Members that add liquidity on the Exchange to increase their order
flow, which benefits all Members by providing greater execution
opportunities on the Exchange.
---------------------------------------------------------------------------

    \16\ As set forth on the Fee Schedule, ``ADV'' means average
daily volume calculated as the number of shares added or removed,
combined, per day, which is calculated on a monthly basis.
---------------------------------------------------------------------------

    Now, the Exchange proposes to modify the required criteria under
Liquidity Removal Tier 1 such that a Member would now qualify by
achieving: (1) A Step-Up ADAV from October 2021 that is equal to or
greater than 0.05% of the TCV; or (2) an ADV that is equal to or
greater than 0.55% of the TCV. Thus, such proposed changes would update
the Step-Up ADAV threshold to reference a more recent baseline month
(but keep the volume threshold the same) and modestly increase the ADV
threshold, each of which is designed to encourage additional order flow
to the Exchange. The Exchange is not proposing to modify the fees
associated with Liquidity Removal Tier 1. The Exchange believes that
the tier, as proposed, would further incentivize increased order flow
to the Exchange, thereby contributing to a deeper and more liquid
market to the benefit of all market participants and enhancing the
attractiveness of the Exchange as a trading venue. The Exchange notes
that Liquidity Removal Tier 1, as modified, would continue to be
available to all Members and provide Members an opportunity to pay a
lower fee for executions of Removed Volume. Additionally, the Exchange
believes that several Members that currently qualify for Liquidity
Removal Tier 1 would continue to qualify under the proposed new
criteria, which the Exchange believes does not represent a significant
departure from the criteria currently required under such tier.
Reduced Rebates Under DLI Tiers
    The Exchange is also proposing to reduce the rebates provided under
DLI Tier 1 and DLI Tier 2. The DLI Tiers are designed to encourage
Members to promote price discovery and market quality by quoting at the
NBBO for a significant portion of each day in a large number of
securities, generally, and in the DLI Target Securities,\17\ in
particular, thereby benefitting the Exchange and investors by providing
improved trading conditions for all market participants through
narrower bid-ask spreads and increased depth of liquidity available at
the NBBO in a broad base of securities, including the DLI Target
Securities specifically, and committing capital to support the
execution of orders.
---------------------------------------------------------------------------

    \17\ As set forth on the Fee Schedule, ``DLI Target Securities''
means a list of securities designated as such, the universe of which
will be determined by the Exchange and published on the Exchange's
website.
---------------------------------------------------------------------------

    Currently, the Exchange provides enhanced rebates of $0.0036 per
share under DLI Tier 1 and $0.0035 per share under DLI Tier 2 for
executions of Added Displayed Volume for Members that qualify for such
tiers.\18\ Now, the Exchange proposes to reduce the rebate provided
under DLI Tier 1 to $0.0035 per share and the rebate provided under DLI
Tier 2 to $0.0034 per share. The Exchange is not proposing to modify
the

required criteria for a Member to qualify for DLI Tier 1 or DLI Tier 2,
nor is the Exchange proposing to change the rebates provided under such
tiers for executions of orders in securities priced below $1.00 per
share that add displayed liquidity to the Exchange. The purpose of
reducing the enhanced rebates provided under DLI Tier 1 and DLI Tier 2
for executions of Added Displayed Volume is for business and
competitive reasons, as the Exchange believes the reduction of such
rebates would decrease the Exchange's expenditures with respect to the
Exchange's transaction pricing in a manner that is still consistent
with the Exchange's overall pricing philosophy of encouraging added
liquidity and promoting the price discovery and market quality
objectives of the DLI Tiers described above.
---------------------------------------------------------------------------

    \18\ The pricing for DLI Tier 1 is referred to by the Exchange
on the Fee Schedule under the description ``Added displayed volume,
DLI Tier 1'' with a Fee Code of ``Bq1'', ``Bq1'' or ``Jq1'', as
applicable, to be provided by the Exchange on the monthly invoices
provided to Members. The pricing for DLI Tier 2 is referred to by
the Exchange on the Fee Schedule under the description ``Added
displayed volume, DLI Tier 2'' with a Fee Code of ``Bq2'', ``Dq2''
or ``Jq2'', as applicable, to be provided by the Exchange on the
monthly invoices provided to Members.
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Increased Standard Fee for Removed Volume
    Lastly, the Exchange proposes to increase the standard fee charged
for executions of Removed Volume. Currently, the Exchange charges a
standard fee of $0.0028 per share for executions of Removed Volume.\19\
The Exchange now proposes to increase the standard fee charged for
executions of Removed Volume to $0.0029 per share. The purpose of
increasing the standard fee for executions of Removed Volume is also
for business and competitive reasons, as the Exchange believes that
increasing such fee as proposed would generate additional revenue to
offset some of the costs associated with the Exchange's transaction
pricing, which provides various rebates for liquidity-adding orders
(including the additive rebate for executions of Added Volume under the
Targeted Step-Up Tier 1 proposed herein), and the Exchange's operations
generally, in a manner that is still consistent with the Exchange's
overall pricing philosophy of encouraging added liquidity. The Exchange
notes that despite the modest increase proposed herein, the Exchange's
standard fee for executions of Removed Volume remains lower than, and
competitive with, the standard fee to remove liquidity in securities
priced at or above $1.00 per share charged by several other
exchanges.\20\
---------------------------------------------------------------------------

    \19\ The standard fee for Removed Volume is referred to by the
Exchange on the Fee Schedule under the description ``Removed volume
from MEMX Book'' with a Fee Code of ``R'' assigned by the Exchange.
    \20\ See, e.g., the Cboe BZX equities trading fee schedule on
its public website (available at https://www.cboe.com/us/equities/membership/fee_schedule/bzx/), which reflects a standard fee of
$0.0030 per share to remove liquidity in securities priced at or
above $1.00 per share; the Cboe EDGX Exchange, Inc. equities trading
fee schedule on its public website (available at https://www.cboe.com/us/equities/membership/fee_schedule/edgx/), which
reflects a standard fee of $0.0030 per share to remove liquidity in
securities priced at or above $1.00 per share; The Nasdaq Stock
Market LLC price list on its public website (available at http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2), which
reflects a standard fee of $0.0030 per share to remove liquidity in
securities priced at or above $1.00 per share.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\21\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\22\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among its Members and other persons using its facilities
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f.
    \22\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    As discussed above, the Exchange operates in a highly fragmented
and competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive or incentives to be insufficient, and the
Exchange represents only a small percentage of the overall market. The
Commission and the courts have repeatedly expressed their preference
for competition over regulatory intervention in determining prices,
products, and services in the securities markets. In Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and SRO revenues and also recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \23\
---------------------------------------------------------------------------

    \23\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005).
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to new or different pricing structures being
introduced into the market. Accordingly, competitive forces constrain
the Exchange's transaction fees and rebates, and market participants
can readily trade on competing venues if they deem pricing levels at
those other venues to be more favorable. The Exchange believes the
proposal reflects a reasonable and competitive pricing structure
designed to incentivize market participants to direct additional order
flow to the Exchange in the Targeted Step-Up Securities and more
generally, which the Exchange believes would enhance liquidity and
market quality on the Exchange to the benefit of all Members.
    The Exchange believes that the proposed Targeted Step-Up Tier 1 is
reasonable because it would provide Members with an additional
incentive to achieve certain volume thresholds on the Exchange. As
noted above, volume-based incentives and discounts have been widely
adopted by exchanges, including the Exchange, and are equitable and not
unfairly discriminatory because they are open to all Members on an
equal basis and provide additional benefits or discounts that are
reasonably related to the value to an exchange's market quality
associated with higher levels of market activity, such as higher levels
of liquidity provision and/or growth patterns and the introduction of
higher volumes of orders into the price and volume discovery process.
The Exchange believes the proposed Targeted Step-Up Tier 1 is equitable
and not unfairly discriminatory for these same reasons, as it is
available to all Members and is designed to encourage Members to
increase their order flow in the Targeted Step-Up Securities to the
Exchange, thereby contributing to a deeper and more liquid market in
such securities and a more robust and well-balanced market ecosystem on
the Exchange to the benefit of all Members, as well as enhancing the
attractiveness of the Exchange as a trading venue, as described above.
    The Exchange also believes that including qualification criteria
for Targeted Step-Up Tier 1 that is based on achieving a volume
threshold in certain specified securities (i.e., the Targeted Step-Up
Securities) is reasonable, equitable, and non-discriminatory because,
as noted above, the Exchange is seeking to improve its market quality,
and thus increase its attractiveness as a trading venue, with respect
to such securities by incentivizing Members to increase their order
flow in such securities to the Exchange. In turn, the Exchange believes
such increased order flow would provide increased execution
opportunities and deeper liquidity in such securities and that the
resulting increased participation in the trading of these securities
would increase the diversity of securities actively traded on the
Exchange as well as the notional market share traded on the Exchange,
thereby contributing to a more robust

and well-balanced market ecosystem on the Exchange to the benefit of
all Members and market participants. Additionally, the Exchange notes
that the Targeted Step-Up Tier 1 is comparable to the Exchange's DLI
Tiers, as well as other pricing tiers adopted by other exchanges that
provide an enhanced rebate or supplemental incentive for firms that
achieve a specified volume threshold in a specified group of
securities.\24\
---------------------------------------------------------------------------

    \24\ See supra notes 14-15.
---------------------------------------------------------------------------

    The Exchange believes the required criteria for the Targeted Step-
Up Tier 1 are reasonable, as they provide two different types of volume
thresholds that a Member may choose from in order to receive the
corresponding additive rebate (i.e., a Step-Up ADAV threshold and an
ADAV threshold), and the Exchange believes such criteria are attainable
for many market participants and are reasonably related to the enhanced
market quality that the Targeted Step-Up Tier 1 is designed to promote,
as described above. The Exchange also notes that the proposed tier/
rebate would not adversely impact any Member's ability to qualify for
other reduced fee or enhanced rebate tiers. Should a Member not meet
the proposed criteria under the proposed tier, the Member would merely
not receive the corresponding proposed additive rebate.
    The Exchange also believes the proposed additive rebate for
executions of Added Volume under Targeted Step-Up Tier 1 (i.e., $0.0002
per share) is reasonable, in that it represents only a modest addition
to the rebates otherwise applicable to executions of Added Volume and,
in conjunction with the other changes proposed herein, would not
provide for a rebate that is higher than the current maximum rebate
provided by the Exchange. Thus, the Exchange believes that it is
reasonable, consistent with an equitable allocation of fees, and not
unfairly discriminatory to provide such additive rebate for executions
of Added Volume to Members that qualify for the Targeted Step-Up Tier 1
in recognition of the benefits that such Members provide to the market
quality in the Targeted Step-Up Securities and more generally on the
Exchange, as described above, particularly as the magnitude of the
additive rebate is not unreasonably high and is, instead, reasonably
related to the enhanced market quality it is designed to achieve.
Additionally, the Exchange believes it is reasonable, equitable, and
non-discriminatory to provide the additive rebate for executions of all
Added Volume but not for executions of Added Displayed Retail Volume
because, as noted above, the Exchange currently provides its maximum
enhanced rebate of $0.0037 per share for executions of Added Displayed
Retail Volume, and the Exchange does not seek to provide for a rebate
that is higher than such current maximum with this proposal.\25\
---------------------------------------------------------------------------

    \25\ See supra note 13.
---------------------------------------------------------------------------

    The Exchange believes the proposed changes to modify the required
criteria under Liquidity Removal Tier 1 are reasonable because, as
noted above, such changes are intended to update the Step-Up ADAV
threshold to reference a more recent baseline month and to modestly
increase the ADV threshold, each of which is designed to encourage the
submission of additional order flow to the Exchange, thereby
contributing to a deeper and more liquid market to the benefit of all
market participants and enhancing the attractiveness of the Exchange as
a trading venue. The Exchange also believes the proposed new criteria
are equitable and non-discriminatory because all Members will continue
to be eligible to meet such criteria and qualify for Liquidity Removal
Tier 1, and therefore, have the opportunity to pay a lower fee for
executions of Removed Volume. Additionally, as noted above, the
Exchange believes that several Members that currently qualify for
Liquidity Removal Tier 1 would continue to qualify under the proposed
new criteria, which the Exchange believes does not represent a
significant departure from the criteria currently required under such
tier. The Exchange also believes that the lower fee charged under
Liquidity Removal Tier 1, which the Exchange is not proposing to
change, continues to be commensurate with the proposed new criteria.
That is, such discounted fee reasonably reflects the difficulty in
achieving the corresponding criteria as modified.
    The Exchange believes that the proposed changes to reduce the
enhanced rebates provided for executions of Added Displayed Volume
under DLI Tier 1 and DLI Tier 2 and to increase the standard fee
charged for executions of Removed Volume are reasonable, equitable, and
consistent with the Act because such changes are designed to generate
additional revenue and decrease the Exchange's expenditures with
respect to its transaction pricing in order to offset some of the costs
associated with the Exchange's current pricing structure, which
provides various rebates for liquidity-adding orders, and the
Exchange's operations generally, in a manner that is consistent with
the Exchange's overall pricing philosophy of encouraging added
liquidity, as described above.
    The Exchange believes that the proposed reduced rebates for
executions of Added Displayed Volume provided under DLI Tier 1 and DLI
Tier 2 (i.e., $0.0035 per share and $0.0034 per share, respectively)
are reasonable and appropriate because such rebates represent only a
modest reduction (i.e., $0.0001 per share) from the current enhanced
rebates provided under such tiers (i.e., $0.0036 per share and $0.0035
per share, respectively). Additionally, the Exchange believes that such
rebates are equitably allocated and not unfairly discriminatory because
they will continue to apply equally to all Members, in that all Members
will continue to have the opportunity to achieve the required criteria
under the DLI Tiers, which the Exchange is not proposing to modify with
this proposal, and in turn, qualify for an enhanced rebate for
executions of Added Displayed Volume. The Exchange further believes
that such rebates are reasonable and equitably allocated, in that the
rebate provided under DLI Tier 1 will remain higher than the rebate
provided under DLI Tier 2 commensurate with the more stringent criteria
of DLI Tier 1 than of DLI Tier 2.
    Similarly, the Exchange believes that the proposed increased
standard fee charged for executions of Removed Volume (i.e., $0.0029
per share) is reasonable and appropriate because it represents only a
modest increase (i.e., $0.0001 per share) from the current standard fee
charged for executions of Removed Volume (i.e., $0.0028 per share) and,
as noted above, remains lower than, and competitive with, the standard
fee to remove liquidity in securities priced at or above $1.00 per
share charged by several other exchanges.\26\ The Exchange further
believes that the proposed increased standard fee charged for
executions of Removed Volume is equitably allocated and not unfairly
discriminatory because it will apply equally to all Members.
---------------------------------------------------------------------------

    \26\ See supra note 20.
---------------------------------------------------------------------------

    For the reasons discussed above, the Exchange submits that the
proposal satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of
the Act \27\ in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its Members and other
persons using its facilities and is not designed to unfairly
discriminate between customers, issuers, brokers, or

dealers. As described more fully below in the Exchange's statement
regarding the burden on competition, the Exchange believes that its
transaction pricing is subject to significant competitive forces, and
that the proposed fees and rebates described herein are appropriate to
address such forces.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposal will result in any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. Instead, as discussed above,
the proposal is intended to enhance market quality on the Exchange in
the Targeted Step-Up Securities, and to encourage Members to maintain
or increase their order flow on the Exchange, thereby promoting price
discovery and contributing to a deeper and more liquid market to the
benefit of all market participants. As a result, the Exchange believes
the proposal would enhance its competitiveness as a market that
attracts actionable orders in the Targeted Step-Up Securities and more
generally, thereby making it a more desirable destination venue for its
customers. For these reasons, the Exchange believes that the proposal
furthers the Commission's goal in adopting Regulation NMS of fostering
competition among orders, which promotes ``more efficient pricing of
individual stocks for all types of orders, large and small.'' \28\
---------------------------------------------------------------------------

    \28\ See supra note 23.
---------------------------------------------------------------------------

Intramarket Competition
    The Exchange believes that the proposal would incentivize Members
to promote price discovery and market quality by increasing their
participation in the Targeted Step-Up Securities on the Exchange, and
to and maintain or increase their order flow on the Exchange generally,
thereby contributing to a deeper and more liquid market to the benefit
of all market participants and enhancing the attractiveness of the
Exchange as a trading venue, which the Exchange believes, in turn,
would continue to encourage market participants to direct additional
order flow to the Exchange. Greater liquidity benefits all Members by
providing more trading opportunities and encourages Members to send
additional orders to the Exchange, thereby contributing to robust
levels of liquidity, which benefits all market participants. The
opportunity to qualify for the Targeted Step-Up Tier 1, and thus
receive the corresponding additive rebate for executions of Added
Volume, or to qualify for the Liquidity Removal Tier, and thus receive
the corresponding reduced fee for executions of Removed Volume, would
be available to all Members that meet the associated requirements in
any month. As noted above, the Exchange believes the criteria under
Targeted Step-Up Tier 1 are attainable for many market participants and
are reasonably related to the enhanced market quality that such tier is
designed to promote. Further, as noted above, the Exchange also
believes that the proposed new criteria for Liquidity Removal Tier 1
are attainable for several Members and that the respective current
reduced fee charged under such tier is reasonably related to the
enhanced market quality that such tier is designed to promote. As such,
the Exchange believes the proposed changes would not impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
Intermarket Competition
    As noted above, the Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. Members have numerous
alternative venues that they may participate on and direct their order
flow to, including 15 other equities exchanges and numerous alternative
trading systems and other off-exchange venues. As noted above, no
single registered equities exchange currently has more than
approximately 15% of the total market share of executed volume of
equities trading. Thus, in such a low-concentrated and highly
competitive market, no single equities exchange possesses significant
pricing power in the execution of order flow. Moreover, the Exchange
believes that the ever-shifting market share among the exchanges from
month to month demonstrates that market participants can shift order
flow or discontinue to reduce use of certain categories of products, in
response to new or different pricing structures being introduced into
the market. Accordingly, competitive forces constrain the Exchange's
transaction fees and rebates, including with respect to executions of
Added Volume, Added Displayed Volume, and Removed Volume, and market
participants can readily choose to send their orders to other exchange
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. As described above, the proposed changes are
competitive proposals through which the Exchange is seeking to
encourage additional order flow on the Exchange and to promote market
quality through pricing incentives that are comparable to, and
competitive with, pricing programs in place at other exchanges,\29\ as
well as to generate additional revenue to offset some of the costs
associated with the Exchange's current pricing structure and its
operations generally. Accordingly, the Exchange believes the proposal
would not burden, but rather promote, intermarket competition by
enabling it to better compete with other exchanges that offer similar
incentives to market participants that enhance market quality and/or
achieve certain volume criteria and thresholds.
---------------------------------------------------------------------------

    \29\ See supra notes 15 and 20.
---------------------------------------------------------------------------

    Additionally, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \30\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. SEC, the D.C. Circuit stated as follows:
``[n]o one disputes that competition for order flow is `fierce.' . . .
As the SEC explained, `[i]n the U.S. national market system, buyers and
sellers of securities, and the broker-dealers that act as their order-
routing agents, have a wide range of choices of where to route orders
for execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''.\31\ Accordingly, the Exchange does not believe its
proposed pricing changes impose any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \30\ See supra note 23.
    \31\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSE-2006-21)).

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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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \32\ and Rule 19b-4(f)(2) \33\ thereunder.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \33\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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 change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-MEMX-2021-16 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-MEMX-2021-16. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MEMX-2021-16 and should be submitted on
or before December 8, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-25018 Filed 11-16-21; 8:45 am]
BILLING CODE 8011-01-P