[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52445-52449]
[FR Doc No: 2016-18672]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1805]

Retrospective Review of Premarket Approval Application Devices;
Striking the Balance Between Premarket and Postmarket Data Collection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
completion of the target of the goal established to address the Center
for Devices and Radiological Health's (CDRH) 2014-2015 Strategic
Priority ``Strike the Right Balance Between Premarket and Postmarket
Data Collection.'' To achieve this Strategic Priority, CDRH established
a goal to assure the appropriate balance between premarket and
postmarket data

collection to facilitate and expedite the development and review of
medical devices, in particular high-risk devices of public health
importance. We established a target date of December 31, 2015, by which
to review 100 percent of product codes subject to a premarket approval
application (PMA) that are legally marketed and were approved prior to
2010 to determine, for each such product code, whether or not, based on
our current understanding of the technology, to reduce premarket data
collection by relying more on postmarket controls, and whether to shift
some premarket data collection to the postmarket setting or to pursue
down-classification.

DATES: Submit either electronic or written comments by October 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-1805 for ``Retrospective Review of Premarket Approval
Application Devices; Striking the Balance Between Premarket and
Postmarket Data Collection.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    One of three Strategic Priorities for 2014-2015 in CDRH is to
``Strike the Right Balance Between Premarket and Postmarket Data
Collection'' (Ref. 1).\1\ CDRH's vision is for patients in the United
States to have first-in-the-world access to high-quality, safe, and
effective medical devices of public health importance. A key
determinant of early U.S. patient access to high-quality, safe, and
effective devices is the extent of premarket data that device
developers provide to FDA. Once a device developer decides to seek U.S.
marketing approval or clearance, the extent of data that are collected
premarket has an impact upon the length of time needed to complete a
premarket submission--the more data to be collected premarket, the
longer it may take to acquire the data and make the submission.
Consequently, such data collection issues affect when U.S. patients
have access to a medical device. On the other hand, it is also
important that there are sufficient data to demonstrate a reasonable
assurance of safety and effectiveness before a device that is subject
to a premarket approval application (PMA) is approved for marketing in
the United States. For this reason, it is important that CDRH strike
the right balance between premarket and postmarket data collection. If
CDRH can shift, when appropriate, some premarket data collection to the
postmarket setting, CDRH could improve patient access to high-quality,
safe, and effective medical devices of public health importance.
However, patient safety could be undermined if, after determining that
certain data could appropriately be shifted from the premarket to the
postmarket setting, CDRH shifted that data collection to the postmarket
setting without adequate assurances that necessary and timely
postmarket data collection will occur. For this reason, CDRH strives to
balance the premarket data and postmarket collection, in accordance
with section 513(a)(3)(C) (21 U.S.C. 360c(a)(3)(C)) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), which directs CDRH to
consider whether the extent of data that otherwise would be required
for

approval of a PMA with respect to effectiveness can be reduced through
reliance on postmarket controls.
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    \1\ CDRH's 2014-2015 Strategic Priorities include ``Strengthen
the Clinical Trial Enterprise'' and ``Provide Excellent Customer
Service'' in addition to ``Strike the Right Balance Between
Premarket and Postmarket Data Collection'' (Ref. 1).
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    In order to achieve the proper balance between premarket and
postmarket data collection, CDRH resolved in its Strategic Priorities
for 2014-2015 to take several actions. CDRH committed to developing and
seeking public comment on a framework for when it would be appropriate
to shift premarket data collection to the postmarket setting. Pursuant
to this commitment, CDRH and the Center for Biologics Evaluation and
Research (CBER) issued the guidance, ``Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket Approval,''
on April 13, 2015 (80 FR 19672), which provided FDA's policy of
balancing premarket and postmarket data collection during the Agency's
review of PMAs (Ref. 2). This guidance outlines how FDA would consider
the role of postmarket information in determining the appropriate type
and amount of data that should be collected in the premarket setting to
support premarket approval, while still meeting the statutory standard
of a reasonable assurance of safety and effectiveness. Furthermore,
under existing authorities, CDRH and CBER issued a guidance document on
April 13, 2015 (80 FR 19669), entitled ``Expedited Access for Premarket
Approval Medical Devices Intended for Unmet Medical Need for Life
Threatening or Irreversibly Debilitating Diseases or Conditions'' (Ref.
3). This guidance describes FDA's voluntary expedited access PMA
program for certain medical devices to facilitate patient access to
these devices by expediting the development, assessment, and review of
certain devices that demonstrate the potential to address unmet medical
needs for life threatening or irreversibly debilitating diseases or
conditions. To expedite access for devices addressing unmet needs, this
pathway to market shifts appropriate components of premarket data
collection to the postmarket setting, while maintaining the statutory
standard of a reasonable assurance of safety and effectiveness. In
addition, CDRH has developed a mechanism to assure prospectively the
appropriate balance of premarket and postmarket data collection for new
devices subject to a PMA. Specifically, when CDRH issues a final
decision for an original PMA or panel-track supplement to a PMA, CDRH
conducts a prospective assessment to determine if the device type is a
candidate for shifting some premarket data collection to the
postmarket, reducing premarket data collection through reliance on
postmarket controls or reclassification.
    Another action in pursuit of the goal to strike the right balance
between premarket and postmarket data collection was to commit to
conducting a retrospective review of all PMA product codes (procodes)
with active PMAs approved prior to 2010 to determine whether data
typically collected premarket could be shifted to the postmarket
setting, and whether premarket data collection could be reduced through
reliance on postmarket controls or devices could be reclassified (down-
classified) in light of our current understanding of the technology
(Ref. 1). In general, some premarket data collections for class III
devices that are currently marketed may be reduced through reliance on
postmarket controls or shifted to the postmarket setting if warranted,
based on CDRH's review experience as well as the postmarket performance
and the current body of evidence regarding the benefit-risk profile of
these devices. CDRH currently receives PMA submissions on the majority
of these class III devices, and a change in premarket data collection
is expected to expedite the approval of future PMA submissions. CDRH
has periodically taken such actions consistent with the medical device
statutory framework but has typically done so on an ad hoc basis. On
the other hand, when FDA determines that it is necessary to provide
reasonable assurance that a device is safe and effective, CDRH may
require more data based on our current understanding of that type of
technology or based on an issue raised by the data submitted by a
sponsor for their device. CDRH will also up-classify a device, if
warranted, based on the current state of the science. For example, on
January 5, 2016, CDRH issued a final order up-classifying surgical mesh
when intended for use for pelvic organ prolapse (81 FR 354), and on
June 2, 2014, CDRH issued a final order up-classifying sunlamps and
sunlamp products (tanning beds/booths) (79 FR 31205). However, up-
classification is not warranted for the devices subject to this
retrospective review, because they are already in the highest risk
classification.
    During this retrospective review, devices were analyzed according
to procodes. CDRH targeted the date of December 31, 2014, by which to
review 50 percent of the procodes for devices that are subject to a PMA
and are legally marketed to determine whether or not to change
premarket data collection by shifting the data collection to the
postmarket setting, reducing premarket data collection through reliance
on postmarket controls, or pursuing reclassification (Ref. 1). This
target extended to have 75 percent completed by June 30, 2015, and 100
percent completed by December 31, 2015.
    On April 29, 2015, CDRH announced its progress on this priority and
solicited comments on the procodes that were identified as candidates
for reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2014 (80 FR 23798). FDA received 11 sets of comments, which
generally supported FDA's retrospective review effort and provided
input on specific procodes that were identified as candidates for
reclassification or were determined to remain class III with no changes
in data collection. FDA will consider these comments when making final
determinations on the reclassification of these procodes.
    During 2015, FDA reviewed the remaining procodes that were
identified for the retrospective review. While completing the
retrospective review, FDA found that the LMX procode was included in
the retrospective review in error, because the jaundice meter device
type is covered by a different procode, not within the scope of the
retrospective review. The jaundice meter device type is classified
under 21 CFR 862.1113 and assigned the procode MQM, and accordingly,
this device type requires a 510(k) premarket notification. Therefore,
the procode LMX has been excluded from the analysis.
    The purpose of this Federal Register notice is to solicit comments
on the remaining procodes that have been identified as candidates for
reclassification, a reduction in premarket data collection through
reliance on postmarket controls, or a shift in premarket data
collection to postmarket for those procodes reviewed through December
31, 2015. Efforts to reclassify and to communicate changes to data
collections with stakeholders will be prioritized based on both the
public health impact and Center resources.

II. Achievement of Goal Targets

    Retrospective analysis of the class III medical device procodes was
intended to determine if current classifications and data collections
remain appropriate for determining a reasonable assurance of safety and
effectiveness. As our understanding of the technology associated with
individual medical devices has increased and we have a better
understanding of the risks

associated with the technology of each device, our understanding of the
type and amount of data that are needed to demonstrate a reasonable
assurance of safety and effectiveness also evolves. We use this
evolution in our understanding to require the least burdensome amount
of data necessary to evaluate device effectiveness, following the least
burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii)). Under
section 513 of the FD&C Act, a device is a class III device and
requires premarket approval if general controls and special controls
are insufficient to provide reasonable assurance of the safety and
effectiveness of the device, and if the device is to be used for
supporting or sustaining human life or of substantial importance in
preventing impairment of human health or if the device presents a
potential unreasonable risk of illness or injury. In order to
reclassify a class III device into class II, the device must meet the
statutory criteria for class II: A device that cannot be classified as
a class I device, because general controls are insufficient to provide
reasonable assurance of the safety and effectiveness of the device, and
for which there is sufficient information to establish special controls
to provide such assurance. As new information becomes available over
time, the accumulated information available for a device may be
sufficient to establish special controls to provide a reasonable
assurance of safety and effectiveness; therefore, the classification of
the device may be changed either up or down.
    In February 2014, CDRH began its retrospective review with procodes
associated with active PMAs approved prior to 2010. PMA procodes
created since 2010 were not included in this retrospective review
because these recently created procodes do not yet have sufficient new
information for a change in FDA's current understanding of the device's
postmarket performance profile. As of December 31, 2015, CDRH reviewed
all procodes included in this retrospective review, meeting its 100
percent review target.
    The results of this analysis include recommendations for procodes
that are candidates for reclassification, a reduction in premarket data
collection through reliance on postmarket controls, or a shift in
premarket data collection to postmarket collection. These results are
published online, along with the results of the first cohort of
procodes at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm
(Ref. 4). The results of this second cohort of procodes reviewed for
this analysis are additive to those previously reported. CDRH is
continuing to consider the comments received on the first cohort of
procodes reported in April 2015, and efforts to reclassify and to
communicate changes to data collections with stakeholders are being
prioritized based on both the public health impact and Center
resources. The following paragraph describes the organization of the
results into tables, which are available for public review online (Ref.
4).
    As discussed in further detail below, for the purposes of this
retrospective review, we evaluated each procode on a balance of factors
to determine the current benefit-risk profile and if our review
indicates special controls could be established to provide a reasonable
assurance of safety and effectiveness. If so, the corresponding procode
was listed in the category ``Candidates for Reclassification to Class
II'' (table 1). If it was determined that special controls would not be
sufficient to provide reasonable assurance of the safety and
effectiveness of the device, then the procode was evaluated to
determine if some premarket data collection for PMA submission could be
shifted to postmarket collection, or if premarket data collection could
be reduced through reliance on postmarket controls. If it was
determined that a change of data collection could continue to provide
reasonable assurance of the safety and effectiveness of the device,
then the procode was listed in the category ``Candidates for reduction
of data collection through reliance on postmarket controls or shift of
data collection from premarket to postmarket'' (table 2). This category
includes procodes for which premarket data collection could be shifted
to postmarket data collection, premarket data collection could be
decreased through reliance on postmarket controls, or postmarket data
could no longer be needed. Finally, table 3 includes procodes for which
a reduction in data collection through reliance on postmarket controls
or shift in data collection from premarket to postmarket and/or
reclassification occurred in 2015 during FDA's retrospective review of
PMAs.
    In this retrospective review, postmarket performance data,
technology and performance considerations, and other relevant
considerations were evaluated for each procode. These factors were used
to evaluate the current benefit-risk profile to determine if the
devices are good candidates for a reduction in premarket data
collection through reliance on postmarket controls, a shift of
premarket data collection to postmarket, or reclassification.
Postmarket performance data (including recent PMA Annual Reports,
literature reviews, total product lifecycle reports, medical device
reporting analysis, market penetration, and recall analysis) were
investigated for any performance concerns or problems that outpace any
increases in device use or acceptance. In evaluating the technology and
performance considerations for the procodes, performance concerns or
problems that were uncovered in the review of postmarket data were
considered unfavorable factors for a change in data collection or
reclassification. Favorable factors to indicate that a device is a good
candidate for a change in data collection or reclassification included:
Whether risks are now well understood and are determined to be moderate
to low; technology uncertainties have been alleviated; performance
standards or non-clinical tests have been developed that could be
surrogates for some clinical testing; the need for a controlled study
could be eliminated due to defined objective performance criteria; the
device has been shown to have good short-term performance; or concerns
are limited to long-term performance or rare adverse events.
    Finally, several relevant considerations were evaluated for each
procode. Unfavorable factors for devices to be considered candidates
for a change in data collection or reclassification included: Whether
there have been significant changes implemented to address safety or
effectiveness since the devices have been on the market; whether the
review of annual reports and manufacturing changes has been important
to maintain safety of the devices; whether there were a limited number
of approvals or limited clinical use of the devices, due to inadequate
data needed to conduct this scientific assessment.
    After completion of this retrospective review, FDA will prioritize
the procodes identified as candidates for reclassification (table 1,
Ref. 4) according to public health impact and Center resources, in
order to determine the top priority procodes for which reclassification
would have the greatest impact. The procodes identified as top priority
candidates for reclassification will proceed through the
reclassification procedures according to 21 CFR part 860. FDA will also
prioritize the procodes identified as candidates for a change in data
collection (table 2, Ref. 4) according to public health impact and
Center resources, in order to determine which reductions of or shifts
to data collection would have the greatest

impact. FDA encourages firms to submit a presubmission to get feedback
on their data collection plan or contact the appropriate review branch
for additional information if they are in the process of developing a
device in one of these categories.

III. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of
information found in FDA regulations. 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. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.

1. FDA, ``CDRH 2014-2015 Strategic Priorities,'' 2014, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM384576.pdf.
2. ``Guidance for Industry and FDA Staff: Balancing Premarket and
Postmarket Data Collection for Devices Subject to Premarket
Approval,'' April 2015<EMAIL_ADDRESS>3. ``Guidance for Industry and FDA Staff: Expedited Access for
Premarket Approval and De Novo Medical Devices Intended for Unmet
Medical Need for Life Threatening or Irreversibly Debilitating
Diseases or Conditions,'' April 2015<EMAIL_ADDRESS>4. ``Second and final cohort of Results of the 2014-2015 Strategic
Priority: Strike the Right Balance between Premarket and Postmarket
Data Collection, '' available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/default.htm.

    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18672 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Pages 36989-36993]
[FR Doc No: 2019-16093]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86447; File No. SR-BX-2019-026]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Transaction Fees and Credits at Equity 7, Section 118(a)

July 24, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 11, 2019, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's transaction fees and
credits at Equity 7, Section 118(a), as described further below.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange operates on the ``taker-maker'' model, whereby it
generally pays credits to members that take liquidity and charges fees
to members that provide liquidity. Currently, the Exchange has a
schedule, at Equity 7, Section 118(a), which consists of several
different credits that it provides for orders in securities priced at
$1 or more per share that access liquidity on the Exchange and several
different charges that it assesses for orders in such securities that
add liquidity on the Exchange.
    As a result of a recent rule change,\3\ the Exchange presently
offers a different system of credits and charges for orders in
securities in Tapes A and C than it does for orders in securities in
Tape B. The recent changes that the Exchange made to its credits and
charges for orders in securities in Tape B, including

increases in the liquidity removal credits offered for such orders,
have proven to be successful in increasing liquidity removal activity
on the Exchange and in making the Exchange a more attractive market for
Tape B securities.
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    \3\ See Securities Exchange Act Release No. 34-85912 (May 22,
2019); 84 FR 24834 (May 29, 2019) (SR-BX-2019-013).
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    The Exchange now proposes to replicate this success for orders in
securities in Tapes A and C while also building on it with respect to
orders in securities in Tape B. Specifically, the Exchange proposes to
replace, in large part, its existing schedule of credits and charges
with a new schedule that is simpler, flatter, and which offers members
more robust incentives to increase their liquidity removal activity in
securities in all Tapes.
Description of the Changes
Credits for Accessing Liquidity Through the Exchange
    The Exchange proposes to eliminate its schedule of existing credits
(except as described below) and replace it with a new schedule of
credits for orders in securities in all Tapes that remove liquidity
from the Exchange (the ``New Credits''). Generally speaking, the
proposed New Credits will be higher than the existing credits,\4\
higher than the existing credits for the same qualifying criteria,\5\
or they will have qualifying criteria which will be more readily
achievable than the existing credits. The Exchange believes that higher
overall credits will incentivize members to increase their liquidity
removal activity in securities in all Tapes. In certain instances,
moreover, the availability of the proposed New Credits will also be
tied to the level of a member's liquidity adding activity as a means of
incentivizing liquidity adding activity even as the Exchange proposes
to increase its charges for orders that add liquidity.
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    \4\ Whereas the highest credit under the existing schedule is
$0.0026 per share executed for orders in securities in Tape B and
$0.0018 per share executed for orders in securities in Tapes A and
C, the top credit in the proposed schedule for orders in securities
in all Tapes is $0.0027 per share executed.
     The Exchange notes that, whereas under the existing schedule,
the Exchange provides a $0.0024 per share executed credit for orders
in securities in Tape B that access liquidity (excluding orders with
Midpoint pegging and excluding orders that receive price improvement
and execute against an order with a non-displayed price) entered by
members that add at least an average daily volume of 50,000 shares
to the Exchange during a month, the proposed schedule will provide a
lower credit of $0.0015 per share executed for the same level of
activity.
    \5\ For example, whereas the existing schedule provides a
$0.0001 per share executed credit for orders in securities in Tapes
A and C that access liquidity (excluding orders with Midpoint
pegging and excluding orders that receive price improvement and
execute against an order with a non-displayed price) entered by
members that add at least an average daily volume of 50,000 shares
to the Exchange during a month, the proposed schedule will provide a
credit of $0.0015 per share executed for the same level of activity.
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    Specifically, the Exchange proposes to adopt the following New
Credits:
     $0.0027 per share executed for orders that access
liquidity (excluding orders with Midpoint pegging and excluding orders
that receive price improvement and execute against an order with a Non-
displayed price) entered by a member that: (i) Adds liquidity equal to
or exceeding 0.03% of total Consolidated Volume \6\ during a month; and
(ii) accesses liquidity equal to or exceeding 0.25% of total
Consolidated Volume during a month.
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    \6\ The term ``Consolidated Volume'' means the total
consolidated volume reported to all consolidated transaction
reporting plans by all exchanges and trade reporting facilities
during a month in equity securities, excluding executed orders with
a size of less than one round lot. For purposes of calculating
Consolidated Volume and the extent of a member's trading activity
the date of the annual reconstitution of the Russell Investments
Indexes is excluded from both total Consolidated Volume and the
member's trading activity. See Equity 7, Section 118(a).
---------------------------------------------------------------------------

     $0.0025 per share executed for orders that access
liquidity (excluding orders with Midpoint pegging and excluding orders
that receive price improvement and execute against an order with a Non-
displayed price) entered by a member that accesses liquidity equal to
or exceeding 0.07% of total Consolidated Volume during month.
     $0.0015 per share executed credit for orders that access
liquidity (excluding orders with Midpoint pegging and excluding orders
that receive price improvement and execute against an order with a Non-
displayed price) entered by a member that adds liquidity equal to or
exceeding an average daily volume of 50,000 shares in a month.
    As noted above, the proposed New Credits will not supplant all of
the existing credits. Instead, the Exchange proposes that the following
existing credits will continue to apply to orders in securities in all
Tapes:
     $0.0000 per share executed for an order that receives
price improvement and executes against an order with a Non-displayed
price; and
     $0.0000 per share executed for an order with Midpoint
pegging that removes liquidity.

The Exchange also proposes to continue charging a fee of $0.0003 per
share executed for an order in securities in any Tape (excluding an
order with midpoint pegging and excluding an order that receives price
improvement and executes against an order with a non-displayed price)
that removes liquidity from the Exchange and that is entered by a
member that does not add at least an average daily volume of 50,000
shares to the Exchange during a month.
Charges for Adding Liquidity to the Exchange
    As a means of offsetting the costs of providing the New Credits,
the Exchange proposes to largely replace its existing schedule of
charges with a new schedule of charges for displayed and non-displayed
orders in securities in all Tapes that add liquidity to the Exchange
(the ``New Charges''). Generally speaking, the proposed New Charges
will be higher than the existing charges.\7\
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    \7\ Whereas under the existing schedule, other than for midpoint
pegging orders, the Exchange charges between $0.0014 and $0.0030 per
share executed for orders in Tapes A and C and between $0.0026 and
$0.0030 per share executed for orders in Tape B that add liquidity
to the Exchange, the proposed schedule will charge fees ranging from
$0.0025 to $0.0030 per share executed for orders in securities in
all Tapes (entered by members that add designated volumes of
liquidity).
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    Specifically, the Exchange proposes to delete all of the existing
charges for providing liquidity through the Exchange (except as
provided below) and replace them with the following New Charges:
     $0.0025 per share executed charge for a displayed order
entered by a member that adds liquidity equal to or exceeding 0.25%
total Consolidated Volume during a month;
     $0.0028 per share executed charge for a non-displayed
order (other than orders with Midpoint pegging) entered by a member
that adds liquidity equal to or exceeding 0.25% total Consolidated
Volume during a month;
     $0.0030 per share executed charge for all other non-
displayed orders; and
     $0.0029 per share executed charge for all other orders.
    The Exchange proposes that following existing charges will continue
to apply to orders in securities in all Tapes:
     $0.0005 per share executed for an order with Midpoint
pegging entered by a member that adds 0.02% of total Consolidated
Volume of non-displayed liquidity excluding a buy (sell) order that
receives an execution price that is lower (higher) than the midpoint of
the NBBO;
     $0.0015 per share executed for an order with Midpoint
pegging entered by entered by other member excluding a buy (sell) order
that receives an execution price that is lower (higher) than the
midpoint of the NBBO;

     $0.0024 per share executed for a buy (sell) order with
Midpoint pegging that receives an execution price that is lower
(higher) than the midpoint of the NBBO; and
     charges for entering BSTG, BSCN, BMOP, BTFY, BCRT, BDRK,
BCST, and SCAR orders that execute in a venue other than the Nasdaq BX
Equities System.
Applicability to and Impact on Participants
    The proposed rule change is a broad restatement of the Exchange's
schedule of credits and charges. The Exchange has designed the restated
schedule to increase liquidity removal activity on the Exchange for
orders in securities in all Tapes and to thereby improve the overall
quality and attractiveness of the Nasdaq BX market. The Exchange
intends to accomplish this objective by providing overall higher
credits to those participants that engage in large volumes of liquidity
removal activity on the Exchange, while offsetting the costs of the
higher credits by charging participants higher fees for adding
liquidity to the Exchange.
    Those participants that act as net removers of liquidity from the
Exchange will benefit directly from the proposed rule change through
the receipts of higher credits. Those participants that act as net
adders of liquidity to the Exchange will also benefit indirectly from
any improvement in the overall quality of the market. However, net
liquidity adders will bear the costs of higher fees for adding
liquidity to the Exchange. The Exchange notes that its proposal is not
otherwise targeted at or expected to be limited in its applicability to
a specific segment(s) of market participants nor will it apply
differently to different types of market participants.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. The proposal is also consistent with
Section 11A of the Act relating to the establishment of the national
market system for securities.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposal Is Reasonable
    The Exchange's proposed change to its schedule of credits and
charges is reasonable in several respects. As a threshold matter, the
Exchange is subject to significant competitive forces in the market for
equity securities transaction services that constrain its pricing
determinations in that market. The fact that this market is competitive
has long been recognized by the courts. In NetCoalition v. Securities
and Exchange Commission, 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'. . . .'' \10\
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    \10\ 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-NYSEArca-2006-
21)).
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    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \11\
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    \11\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
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    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
equity security transaction services. The Exchange is only one of
several equity venues to which market participants may direct their
order flow, and it represents a small percentage of the overall market.
It is also only one of several taker-maker exchanges. Competing equity
exchanges offer similar tiered pricing structures to that of the
Exchange, including schedules of rebates and fees that apply based upon
members achieving certain volume thresholds.\12\
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    \12\ CBOE EDGA provides a standard rebate for liquidity removers
of $0.0024 per share executed (or $0.0026 per share executed if a
member qualifies for a volume tier), and a standard charge of
$0.0030 per share executed for liquidity adders (or between $0.0022
and $0.0026 if a member qualifies for a volume tier). NYSE National
has a range of rebates from $0.0010 to $0.0020 per share executed
for liquidity removers, and a range of charges from $0.0008 to
$0.0027 per share executed for liquidity adders. CBOE BYX provides
standard rebates for liquidity removers of $0.0005 per share
executed and a range of tiered rebates from $0.0015 to $0.0017 per
share executed for liquidity removers; it imposes standard charges
ranging from $0.00190 to $0.0030 per share executed and tiered
charges ranging from $0.0012 to $0.0014 per share executed for
liquidity adders.
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    Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules.\13\
Separately, the Exchange has provided the SEC staff with multiple
examples of instances where pricing changes by BX and other exchanges
have resulted in shifts in exchange market share. Within the foregoing
context, the proposal represents a reasonable attempt by the Exchange
to increase its liquidity and market share relative to its competitors.
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    \13\ The Exchange perceives no regulatory, structural, or cost
impediments to market participants shifting order flow away from it.
In particular, the Exchange notes that these examples of shifts in
liquidity and market share, along with many others, have occurred
within the context of market participants' existing duties of Best
Execution and obligations under the Order Protection Rule under
Regulation NMS.
---------------------------------------------------------------------------

    The Exchange has designed its proposed schedule of credits and
charges to provide increased overall incentives to members to increase
their liquidity removal activity on the Exchange, and to do so broadly
in orders in securities in all Tapes. An increase in overall liquidity
removal activity on the Exchange will, in turn, improve the quality of
the Nasdaq BX market and increase its attractiveness to existing and
prospective participants. Generally, the proposed New Credits will be
comparable to, if not favorable to, those that its competitors
provide.\14\
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    \14\ See n. 12, supra.
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    Meanwhile, the Exchange believes that it is reasonable to offset
the costs of providing the New Credits by increasing its charges for
members that add liquidity to the Exchange. Although the New Charges
will be higher, in many cases, than the existing charges, the Exchange
believes that the New Charges will continue to be comparable to
liquidity adding charges imposed by its competitors.\15\ That said, the
Exchange

again notes that those participants that do not wish to pay the costs
of increased charges are free to shift their order flow to competing
venues that offer them lower charges.
---------------------------------------------------------------------------

    \15\ See id.
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The Proposal Is an Equitable Allocation of Credits
    The Exchange believes its proposal will allocate its New Credits
and New Charges fairly among its market participants. The proposal will
flatten and simplify the Exchange's schedule of credits and charges,
including by reducing the number of credit and fee tiers and by
eliminating tiers, such as growth tiers.
    Moreover, it is equitable for the Exchange to increase its overall
credits to participants whose orders remove liquidity from the Exchange
as a means of incentivizing increased liquidity removal activity and to
do so broadly in orders in securities in all Tapes. An increase in
overall liquidity removal activity on the Exchange will improve the
quality of the Nasdaq BX market and increase its attractiveness to
existing and prospective participants.
    Likewise, the Exchange believes it is equitable to increase its
charges for orders entered by members that add liquidity to the
Exchange as a means of offsetting the costs of providing the New
Credits. Although participants that are net adders of liquidity to the
Exchange will bear the costs of the New Charges, these participants
will also benefit from any improvements in the quality and
attractiveness of the market that the New Credits provide. Moreover,
any participant that wishes to avoid paying higher charges for adding
liquidity to the Exchange is free to shift their order flow to
competing venues that charge lower fees.
The Proposed Fee Is Not Unfairly Discriminatory
    The Exchange believes that the proposal is not unfairly
discriminatory. As an initial matter, the Exchange believes that
nothing about its volume-based tiered pricing model is inherently
unfair; instead, it is a rational pricing model that is well-
established and ubiquitous in today's economy among firms in various
industries--from co-branded credit cards to grocery stores to cellular
telephone data plans--that use it to reward the loyalty of their best
customers that provide high levels of business activity and incent
other customers to increase the extent of their business activity. It
is also a pricing model that the Exchange and its competitors have long
employed with the assent of the Commission. It is fair because it
incentivizes customer activity that increases liquidity, enhances price
discovery, and improves the overall quality of the equity markets.
    The Exchange intends for the proposal to improve market quality for
all members on the Exchange and by extension attract more liquidity to
the market, improving market wide quality and price discovery. Although
net removers of liquidity will benefit most from the proposed increase
in credits and charges, this result is fair insofar as increased
liquidity removal activity will help to improve market quality and the
attractiveness of the Nasdaq BX market to all existing and prospective
participants. And although net adders of liquidity to the Exchange will
bear the costs of the proposed rule change, this too is fair because
net adders of liquidity will also benefit from improvements in market
quality. Moreover, any participant that does not wish to pay higher
charges to add liquidity to the Exchange is free to shift its order
flow to a competing venue.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intramarket Competition
    The Exchange does not believe that its proposal will place any
category of Exchange participant at a competitive disadvantage. As
noted above, all members of the Exchange will benefit from an increase
in the removal of liquidity by those that choose to meet the tier
qualification criteria. Members may grow their businesses so that they
have the capacity to receive the higher credits. Moreover, members are
free to trade on other venues to the extent they believe that the fees
assessed and credits provided are not attractive. As one can observe by
looking at any market share chart, price competition between exchanges
is fierce, with liquidity and market share moving freely between
exchanges in reaction to fee and credit changes. The Exchange notes
that the tier structure is consistent with broker-dealer fee practices
as well as the other industries, as described above.
Intermarket Competition
    Addressing whether the proposed fee could impose a burden on
competition on other SROs that is not necessary or appropriate, the
Exchange believes that its proposed modifications to its schedule of
credits and charges will not impose a burden on competition because the
Exchange's execution services are completely voluntary and subject to
extensive competition both from the other 12 live exchanges and from
off-exchange venues, which include 32 alternative trading systems. The
Exchange notes that it operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive, or rebate opportunities
available at other venues to be more favorable. In such an environment,
the Exchange must continually adjust its fees to remain competitive
with other exchanges and with alternative trading systems that have
been exempted from compliance with the statutory standards applicable
to exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.
    The proposed restated schedule of credits and charges is reflective
of this competition because, as a threshold issue, the Exchange is a
relatively small market so its ability to burden intermarket
competition is limited. In this regard, even the largest U.S. equities
exchange by volume only has 17-18% market share, which in most markets
could hardly be categorized as having enough market power to burden
competition. Moreover, as noted above, price competition between
exchanges is fierce, with liquidity and market share moving freely
between exchanges in reaction to fee and credit changes. This is in
addition to free flow of order flow to and among off-exchange venues
which comprised more than 37% of industry volume for the month of April
2019.
    The Exchange intends for the proposed changes, in the aggregate, to
increase member incentives to remove liquidity from the Exchange while
maintaining adequate incentives for members to continue to add
meaningful levels of liquidity to the Exchange. The Exchange proposes
to achieve these objectives by replacing the existing schedule of
credits with a simpler, flatter, and more generous schedule of credits.
It also intends to replace its existing schedule of charges with a
schedule of New Charges to offset the costs of the New Credits.
    In the aggregate, all of these changes are procompetitive and
reflective of the Exchange's efforts to make it an attractive and
vibrant venue to market participants.

    In sum, if the changes proposed herein are unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposed
changes will impair the ability of members or competing order execution
venues to maintain their competitive standing in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\16\
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    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2019-026 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-BX-2019-026. 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-BX-2019-026 and should be submitted on
or before August 20, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-16093 Filed 7-29-19; 8:45 am]
 BILLING CODE 8011-01-P