[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Proposed Rules]
[Pages 17890-17895]
[FR Doc No: 2013-06723]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-0234]

Effective Date of Requirement for Premarket Approval for
Automated External Defibrillator System.

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the following
class III preamendments devices: Automated external defibrillators
systems (AEDs), which includes the AED device and its accessories
(i.e., pad electrodes, batteries, and adapters). The Agency is also
summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring
this device to meet the statute's premarket approval requirements and
the benefits to the public from the use of the device. In addition, FDA
is announcing the opportunity for interested persons to request that
the Agency change the classification of the automated external
defibrillator based on new information. This action implements certain
statutory requirements.

DATES: Submit either electronic or written comments by June 24, 2013.
FDA intends that, if a final order based on this proposed order is
issued, anyone who wishes to continue to market the device will need to
submit a PMA within 90 days of the publication date of the final order.
Please see section III for more information about submitting a PMA.
Please also see section IX for the proposed effective date of any final
order that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0234, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:

     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0234 for this order. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), 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: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act of 2004
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) establish a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type may be marketed without submission of a PMA
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the
FD&C Act directs FDA to issue an order requiring premarket approval for
a preamendments class III device.
    Although, under the FD&C Act, the manufacturer of a class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a PDP, in practice, the option of filing a
notice of completion of a PDP has not been used. For simplicity,
although corresponding requirements for PDPs remain available to
manufacturers in response to a final order under section 515(b) of the
FD&C Act, this document will refer only to the requirement for the
filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(b) of FDASIA (126
Stat. 1056) amended section 515(b) of the FD&C Act, changing the
process for requiring premarket approval for a preamendments class III
device from rulemaking to an administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: publication of a proposed order in
the Federal Register, a meeting of a device classification panel
described in section 513(b) of the FD&C Act, and consideration of
comments from all affected stakeholders, including patients, payors,
and providers. FDA has held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to AEDs, and
therefore, has met this requirement under section 515(b)(1) of the FD&C
Act. As explained further in section IV, a meeting of a device
classification panel described in section 513(b) of the FD&C Act took
place in 2011 (Ref. 1) to discuss whether AEDs should be reclassified
or remain in class III. The panel recommended that because AEDs are
lifesaving devices it is appropriate to regulate them in class III.
Furthermore, the problems with medical device reporting (MDR) systems
and recalls indicate that having these devices regulated under 510(k)
has not been successful. FDA also considered information it received,
pertaining to AEDs, in response to the Agency's order (74 FR 16214,
April 9, 2009) requiring manufacturers to submit information about a
number of preamendments devices under section 515(i) of the FD&C Act.
Moreover, FDA is not aware of new information that would provide a
basis for a different recommendation or findings. Information received
since the 2011 panel meeting and discussed further in section IV.B only
further highlights the need to review these devices under a PMA and
reinforces the recommendation and findings of the panel.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order; (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA or a declared completed PDP and the benefit to the
public from the use of the device; (3) an opportunity for the
submission of comments on the proposed order and the proposed findings;
and (4) an opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed

order, consideration of any comments received, and a meeting of a
device classification panel described in section 513(b) of the FD&C
Act, issue a final order to require premarket approval or publish a
document terminating the proceeding together with the reasons for such
termination. If FDA terminates the proceeding, FDA is required to
initiate reclassification of the device under section 513(e) of the
FD&C Act, unless the reason for termination is that the device is a
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later (section 501(f)
of the FD&C Act). For AEDs, the preamendments class III devices that
are the subject of this proposal, the later of these two time periods
is the 90-day period. Since these devices were classified in 2003, the
30-month period has expired (see 68 FR 61342, October 28, 2003). If a
PMA is not filed for such devices within 90 days after the issuance of
a final order, the devices would be deemed adulterated under section
501(f) of the FD&C Act.
    However, because of the widespread distribution of AEDs, we are
proposing to consider exercising enforcement discretion for devices
lawfully distributed before the requirement to have a PMA goes into
effect as long as manufacturers of such devices timely notify FDA of
their intent to file a PMA within 90 days from the issuance of the
final order. FDA intends to consider exercising enforcement discretion
for 15 months from the date the final order is issued.
    In accordance with section 515(b) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of AEDs and AED accessories, the preamendments class III devices that
are the subject of this proposed order.

II. Regulatory History of the Device

    Low energy DC-defibrillators are preamendment class II devices
under 21 CFR 870.5300. Arrhythmia detectors and alarms are also
preamendment devices that were once classified as class III devices
under 21 CFR 870.1025. AEDs were found substantially equivalent to the
preamendment class III arrhythmia detector and alarm devices in
response to a 510(k) in 1985, because the submission was a combination
of the class II low energy defibrillator and the class III arrhythmia
detector and alarm. FDA found AEDs equivalent to the higher class of
the combined devices, and thus, AEDs were classified as class III
devices. On October 28, 2003 (68 FR 61342), FDA published a final rule
reclassifying arrhythmia detector and alarm devices into class II
(special controls). In that rule, FDA also established a separate
classification regulation for AEDs under Sec.  870.5310 (21 CFR
870.5310) that retained these devices in class III and stated that it
would address, at a later date, the possible reclassification of AEDs.

III. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA be filed with the Agency for AED devices and
accessories within 90 days after issuance of any final order based on
this proposal. An applicant whose device was legally in commercial
distribution before May 28, 1976, or whose device has been found to be
substantially equivalent to such a device, will be permitted to
continue marketing such class III devices during FDA's review of the
PMA provided that a PMA is timely filed. FDA intends to review any PMA
for the device within 180 days. FDA cautions that under section
515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an
agreement to extend the review period for a PMA beyond 180 days unless
the Agency finds that ``the continued availability of the device is
necessary for the public health.''
    Under the FD&C Act, AEDs and AED accessories currently in
distribution for which no PMA is submitted within 90 days of a final
order calling for PMAs, or for which a denial is rendered on its filed
PMA, will be considered adulterated under section 501(f)(1) of the FD&C
Act. As discussed in the paragraphs that follow, FDA believes that most
AED manufacturers already have the clinical data they need to support a
PMA. Nonetheless, because FDA recognizes that continued access to AEDs
is important to the public health, FDA is proposing to consider
exercising enforcement discretion for manufacturers of currently
marketed AEDs, AED devices or accessories who cannot timely submit a
PMA, but instead notify FDA of their intent to file a PMA within 90
days from the issuance of the final order based on this proposal. The
notification of the intent to file a PMA submission should include a
list of all model numbers for which a manufacturer plans to seek
marketing approval through its PMA. FDA proposes further to consider
exercising enforcement discretion for 15 months from the issuance of a
final order requiring the filing of a PMA for such devices.
Manufacturers should be able to collect additional scientific evidence,
to the extent any is necessary, and prepare PMA submissions, in this
time. No new devices will be allowed into interstate commerce without
approval of a PMA. We request comment on whether it is appropriate to
exercise enforcement discretion and, if so, whether the 15-month period
proposed is reasonable.
    FDA intends that under Sec.  812.2(d) (21 CFR 812.2(d)), the
publication in the Federal Register of any final order based on this
proposal will include a statement that, as of the date on which the
filing of a PMA is required, the exemptions from the requirements of
the investigational device exemption (IDE) regulations for
preamendments class III devices in Sec.  812.2(c)(1) and (c)(2) will
cease to apply to any device that is: (1) Not legally on the market on
or before that date, or (2) legally on the market on or before that
date but for which a PMA is not filed by that date, or for which PMA
approval has been denied or withdrawn.
    However, FDA intends to exercise enforcement discretion concerning
IDE and PMA requirements for manufacturers of AEDs, AED devices and/or
accessories who notify FDA of their intent to file a PMA for such
devices within 90 days and file a PMA within 15 months after the date
of issuance of any final order requiring premarket approval for these
devices. FDA is aware that many existing AED manufacturers have already
obtained significant clinical data on their devices. In most cases, FDA
believes the clinical data that has been submitted for AEDs in 510(k)
applications will suffice as valid scientific evidence necessary to
support a PMA. However, a small number of manufacturers may need to
conduct an additional investigation to support approval. In those
circumstances, FDA will consider the least burdensome means of
gathering information, and will consider whether reliance on post-
market controls can reduce the extent of data that would otherwise be
required to show effectiveness. FDA recommends that manufacturers file
a pre-submission to discuss data requirements that may be necessary to
support their individual PMA submission.

IV. Benefits of AED Systems

A. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA, and (2) the benefits to the public from
the use of the device.
    These findings are based on the reports and recommendations of the
advisory committee for the classification of this device along with
information submitted in response to the 515(i) order (74 FR 16214) and
any additional information that FDA has obtained. Additional
information regarding the risks as well as classification associated
with this device type can be found in the following proposed and final
orders and notices published in the Federal Register on the following
dates: October 28, 2003 (68 FR 61342) and March 8, 2004 (69 FR 10615).

B. Device Subject to This Proposal--Automated External Defibrillator
(Sec.  870.5310)

1. Identification
    An AED system consists of an AED device and its accessories, i.e.,
battery, pad electrode and, if applicable, an adapter. An AED system
analyzes the patient's electrocardiogram, interprets the cardiac
rhythm, and automatically delivers an electrical shock (fully automated
AED), or advises the user to deliver the shock (semi-automated or shock
advisory AED) to treat ventricular fibrillation or pulseless
ventricular tachycardia.
2. Summary of Data
    In response to the 515(i) order (74 FR 16214), manufacturers
provided information to FDA that they believe supports reclassification
of AED devices from class III to class II. One manufacturer submitted a
reclassification petition to the Docket (FDA-2009-M-0101). The primary
basis presented by the manufacturer for reclassification was that
special controls could provide reasonable assurance of the safety and
effectiveness of AEDs. Examples of applicable special controls that
were cited include testing to industry standards, guidelines, device
labeling, guidance documents, and postmarket surveillance.
    A meeting of the Circulatory System Devices Panel (``Panel'') was
held on January 25, 2011 (Ref. 1). The Panel discussed and made
recommendations regarding the regulatory classification of AEDs to
either reconfirm to class III (subject to premarket approval
application) or reclassify to class II (subject to special controls),
as directed by section 515(i) of the FD&C Act (21 U.S.C. 360e(i)).
    FDA's presentation to the Panel included a summary of the adverse
event reports and recalls received by FDA on AED systems. This summary
indicated that the total number of MDRs submitted annually more than
doubled from 2005 to 2010. A review of reports submitted from 2011 and
2012 shows that the number of submitted adverse events reports has
continued to increase. Annual reporting (which occurs with PMA devices)
would improve overall surveillance by providing denominator data for
device distribution as well as current trend information on issues
being followed by the manufacturer.
    FDA's analysis of recalls associated with AEDs systems indicated
that the majority of recalls were associated with a manufacturer's
handling of purchasing controls (21 CFR 820.50) or design controls (21
CFR 820.30). In addition, FDA's analysis also noted the significant
number of violative AED manufacturing facility inspections. FDA
concluded from the recall and inspection information that the following
requirements that are a part of the PMA process should be placed on AED
manufacturers: (1) Premarket review of manufacturing information,
including procedures and processes to ensure compliance with the
requirements of 21 CFR part 820 (Quality System (QS) Regulation), (2)
pre-approval inspections to determine manufacturers' compliance with
the QS regulation to assure that the manufacturer's quality system is
in place and appears to be adequate prior to manufacture and
distribution of devices, (3) review of changes in manufacturing
facilities to ensure facility, procedures, and systems are adequate,
and (4) additional postmarket assurances available for PMA devices
including the postmarket review of significant manufacturing changes to
ensure that the changes are adequately evaluated.
    Accordingly, FDA stated that the devices should remain in class
III, and require PMAs, because of the level of regulatory control
necessary to provide reasonable assurance of safety and effectiveness,
including: premarket review of manufacturing information; pre-approval
inspections; review of changes in manufacturing facility location where
finished devices are manufactured; postmarket review of significant
manufacturing changes to ensure that the changes are adequately
evaluated and tested prior to implementation; and annual reporting of
device performance. The majority of the Panel members recommended the
reconfirmation of AEDs as class III devices. The Panel expressed
significant concerns that the number of adverse events reported in MDRs
and the increase in recalls indicate that regulating these devices
under premarket notification has not been successful. Therefore,
increased regulatory oversight would be prudent. The panel transcript
and other meeting materials are available on FDA's Web site (Ref. 1).
    The AED system is composed of the AED device and its accessories,
i.e., pad electrodes, battery, and adapters. The reports of MDRs and
recalls associated with AED devices have also included failures related
to pad electrodes, batteries and adapters. Because failure of the pad
electrode, battery or adapter results in the same risks to health as
failure of the AED, these devices should be subject to the same
regulatory oversight as the AEDs themselves to provide reasonable
assurance of safety and effectiveness for the entire AED system. Thus,
this proposed order confirms the classification of AED accessories as
class III devices and requires that manufacturers of AED accessories
submit PMAs for their devices.
 3. Risks to Health
    AEDs are devices that diagnose life-threatening abnormal heart
rhythms, and treat them by delivering defibrillation shocks to the
heart to restore its normal rhythm. Defibrillation shocks are used to
treat patients with ventricular fibrillation (VF) or pulseless
ventricular tachycardia (VT). AEDs should be able to be deployed
quickly to provide defibrillation shocks to patients with VF or
pulseless VT. These patients' survival depends upon a rapid sequence of
rescue events that includes the successful delivery of a defibrillation
shock from an AED. Rescuers have only minutes before these patients'
heart rhythms degenerate beyond rescue capabilities.
    a. Failure or delay to deliver a defibrillation shock. One risk to
health associated with AEDs is that these devices can malfunction and
fail to deliver a defibrillation shock to a patient in VF or pulseless
VT. Such failure can result in permanent injury or prevent the rescue
of the patient.
    b. Inappropriate cardiac rhythm detection. AEDs should be able to
recognize shockable and non-shockable algorithms. Shockable rhythms
include VF and pulseless VT. Non-shockable

rhythms include normal sinus rhythm, supraventricular tachycardia,
asystole, atrial fibrillation, sinus bradycardia, atrial flutter, and
pulseless electrical activity. If the AED does not appropriately
recognize a patient's cardiac rhythm it can fail to deliver or
recommend a defibrillation shock to a shockable rhythm, or deliver or
recommend a defibrillation shock to a non-shockable rhythm. Failure to
deliver a defibrillation shock to a patient in VF or VT may result in
death or permanent impairment of the patient. If the device delivers an
inappropriate defibrillation shock to a patient in normal sinus rhythm
it may induce ventricular fibrillation.
    c. Inadvertent shocks to rescuers or bystanders. There is the
potential risk of delivering an electrical shock during defibrillation
of a patient to a rescuer or bystander if there is physical contact
between them and the patient, or if there is a malfunction in the pad
electrodes or device. There is concern that an inadvertent shock to a
rescuer or bystander could induce cardiac arrhythmias or ventricular
fibrillation.
4. Benefits of AED Systems
    AEDs have a rhythm recognition detection system that delivers an
electrical shock to treat VF or pulseless VT. The delivery of this
therapy can be either fully automatic or semiautomatic. These devices
are intended to be used on suspected victims of sudden cardiac arrest
who are unresponsive and not breathing normally. AEDs are an important
tool in providing a rapid response to victims of cardiac arrest and are
successful at resuscitating victims of cardiac arrest by restoring
normal cardiac rhythm.

V. PMA Requirements

    A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously, as well as a
discussion of the effectiveness of the device for which premarket
approval is sought. In addition, a PMA must include all data and
information on: (1) Any risks known, or that should be reasonably
known, to the applicant that have not been identified in this document;
(2) the effectiveness of the device that is the subject of the
application; and (3) full reports of all preclinical and clinical
information from investigations on the safety and effectiveness of the
device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (Sec.  860.7(c)(2) (21 CFR 860.7(c)(2))). Valid
scientific evidence is ``evidence from well-controlled investigations,
partially controlled studies, studies and objective trials without
matched controls, well-documented case histories conducted by qualified
experts, and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use. * * * Isolated
case reports, random experience, reports lacking sufficient details to
permit scientific evaluation, and unsubstantiated opinions are not
regarded as valid scientific evidence to show safety or
effectiveness.'' (Sec.  860.7(c)(2)).
    For those manufacturers with multiple AED devices in their
portfolio, a single PMA may be submitted for AEDs that are intended for
lay users (public access AEDs) and another PMA for AEDs that
incorporate additional functionality for medical professionals such as
manual defibrillation, monitoring features, etc. (hospital use and
emergency responder AEDs). Manufacturers of pad electrodes, batteries,
and adapters may submit PMAs for the accessories they manufacture,
which must be supported by valid scientific evidence that these
accessory devices operate as intended when paired with a given AED(s)
and are appropriately labeled to ensure use only with supported AEDs.
    AED manufacturers will need to submit performance testing,
including clinical trials of their device, in order to support PMA
approval. FDA anticipates that many existing AED manufacturers have
already obtained significant clinical data that may be sufficient to
support PMA approval. Existing published clinical literature may also
be leveraged as part of the PMA submission. Manufacturers of batteries,
adapters, and pad electrode manufacturers may need to submit non-
clinical performance testing with confirmatory animal studies in order
to support independent PMA approval. Battery and adapter manufacturers
may need to submit only bench testing. However, pad electrode
manufacturers may need to submit animal studies in addition to bench
testing if concerns arise during the premarket review process on
defibrillation success or post-shock dysfunction. We request comment on
the performance and clinical data requirements for AEDs and related
devices.

VI. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA, FDA is required by section
515(b)(2)(D) of the FD&C Act to provide an opportunity for interested
persons to request a change in the classification of the device based
on new information relevant to the classification. Any proceeding to
reclassify the device will be under the authority of section 513(e) of
the FD&C Act.
    A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by 21 CFR 860.123, including new information
relevant to the classification of the device.

VII. 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.

VIII. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that 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. The collections of
information in part 807, subpart E, have been approved under OMB
control number 0910-0120. The effect of this order, if finalized, is to
shift certain devices from the 510(k) premarket notification process to
the PMA process. To account for this change, FDA intends to transfer
some of the burden from OMB control number 0910-0120, which is the
control number for the 510(k) premarket notification process, to OMB
control number 0910-0231, which is the control number for the PMA
process. As noted previously, FDA estimates that it will receive 12 new
PMAs for AED devices and 21.5 for AED accessories as a result of this
order, if finalized. Based on FDA's most recent estimates, this will
result in 22,378 hours burden increase to OMB control number 0910-0231.
FDA also estimates that there will be 3.4 fewer 510(k) submissions as a
result of this order, if finalized. Based on FDA's most recent
estimates, this will result in a 269 hours burden decrease to OMB
control number 0910-0120. Therefore, on net, FDA expects a burden hour
increase of

22,109 hours due to this proposed regulatory change.

IX. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.

X. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require approval of an
application for premarket approval for preamendments devices or devices
found substantially equivalent to preamendments devices. Section 515(b)
of the FD&C Act, as amended by FDASIA, provides for FDA to require
approval of an application for premarket approval for such devices by
issuing a final order, following the issuance of a proposed order in
the Federal Register. FDA will continue to codify the requirement for
an application for premarket approval, resulting from changes issued in
a final order, in the Code of Federal Regulations (CFR). Therefore,
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in
this proposed order, we are proposing to require approval of an
application for premarket approval for AEDs and if this proposed order
is finalized, we will make the language in 21 CFR 870.5310 consistent
with the final version of this proposed order.

XI. Comments

    Interested persons may submit either 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.

XII. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
    1. The panel transcript and other meeting materials are available
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

0
2. Section 870.5310 is amended by revising the section heading and
paragraphs (a) and (c) to read as follows:

Sec.  870.5310  Automated external defibrillator system.

    (a) Identification. An automated external defibrillator (AED)
system consists of an AED device and its accessories, i.e., battery,
pad electrode and, if applicable, an adapter. An AED system analyzes
the patient's electrocardiogram, interprets the cardiac rhythm, and
automatically delivers an electrical shock (fully automated AED), or
advises the user to deliver the shock (semi-automated or shock advisory
AED) to treat ventricular fibrillation or pulseless ventricular
tachycardia.
* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA is
required to be submitted to the Food and Drug Administration by [A DATE
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER
IN THE FEDERAL REGISTER], for any automated external defibrillator that
was in commercial distribution before May 28, 1976, or that has, by [A
DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL
ORDER IN THE FEDERAL REGISTER], been found to be substantially
equivalent to any automated external defibrillator that was in
commercial distribution before May 28, 1976. Any other automated
external defibrillator and automated external defibrillator
accessories, i.e., pad electrodes, adaptors, and batteries shall have
an approved PMA or declared completed PDP in effect before being placed
in commercial distribution.

    Dated: March 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06723 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Proposed Rules]
[Pages 16593-16595]
[FR Doc No: 2011-6975]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-0004-201109; FRL-9285-9]

Approval and Promulgation of Implementation Plans; South
Carolina: Prevention of Significant Deterioration and Nonattainment New
Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to convert a conditional approval of a
revision to the South Carolina State Implementation Plan (SIP) to a
full approval. South Carolina, through the South Carolina Department of
Health and Environment Control (SC DHEC), Bureau of Air Quality,
submitted a SIP revision on April 14, 2009, in response to the
conditional approval of its New Source Review (NSR) permitting program.
South Carolina's April 14, 2009, SIP revision consists of adopting
requirements of the Nonattainment New Source Review (NNSR) construction
permit program under the Clean Air Act (CAA or Act). This program
affects major stationary sources in South Carolina that are subject to
or potentially subject to the NNSR construction permit program. As
required by the conditional approval, South Carolina's April 14, 2009,
SIP revision includes requirements for calculating emissions reductions
that will be used for offsets and ensures those reductions are surplus
to other Federal requirements. EPA is proposing approval of the April
14, 2009, SIP revision because the Agency has determined that South
Carolina addresses the conditions identified in the conditional
approval, and is in accordance with the CAA.

DATES: Comments must be received on or before April 25, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2005-0004, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2005-0004, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960.
    5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Chief,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2005-0004. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the South
Carolina SIP, contact Ms. Twunjala Bradley, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. Ms. Bradley's telephone
number is<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>For
information regarding NSR, contact Ms. Yolanda Adams, Air Permits
Section, at the same address above. Ms. Adams' telephone number is
(404) 562-9241; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA proposing?
II. Why is EPA proposing this action?
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. What action is EPA proposing?

    On April 14, 2009, the State of South Carolina, through SC DHEC,
submitted a revision to the South Carolina SIP, which consists of
changes to the South Carolina Air Pollution Control Regulations and
Standards (hereafter referred to as ``South Carolina Regulations'').
Specifically, the proposed SIP revision includes changes to South
Carolina Regulation 61-62.5, Standard No. 7.1 entitled ``Nonattainment
New Source Review.'' SC DHEC submitted this SIP revision in response to
EPA's June 2, 2008 (73 FR 31368), rule which conditionally approved
South Carolina's NNSR program.
    South Carolina's April 14, 2009, SIP revision also includes the
removal of provisions which existed in South Carolina regulations that
relate to requirements that were vacated from the Federal program by
the United States Court of Appeals for the District of Columbia Circuit
(DC Circuit Court) on June 24, 2005. The provisions vacated from the
Federal rules pertain to pollution control projects (PCPs) and clean
units (CUs). Since these

provisions were not approved into South Carolina's SIP, no action is
required by EPA.\1\ As a result of the removal of the CU and PCP
provisions, the SIP revision also includes minor administrative
reference changes at Regulation 61-62.5, Standard No. 7--Prevention of
Significant Deterioration (PSD) and Standard No. 7.1 Nonattainment New
Source Review which are now being proposed for inclusion in the SIP.
---------------------------------------------------------------------------

    \1\ On June 2, 2008 (73 FR 31368), EPA disapproved provisions in
South Carolina's PSD and NNSR programs relating to PCP and CUs.
Therefore, these provisions were not approved into South Carolina's
SIP.
---------------------------------------------------------------------------

    In addition to changes to address the conditional approval of South
Carolina's NNSR program and the aforementioned administrative changes,
South Carolina's April 14, 2009, SIP revision also includes provisions
in Regulation 61-62.5, Standards No. 7 and 7.1 to exclude facilities
that produce ethanol through a natural fermentation process (hereafter
referred to as the ``Ethanol Rule'') from the definition of ``chemical
process plants'' in the major NSR permitting program. See 72 FR 24060
(May 1, 2007). At this time, EPA is not proposing to take action on
South Carolina's changes to its NSR program to incorporate the
provisions of the Ethanol Rule.

II. Why is EPA proposing this action?

    South Carolina Regulation 61-62.5, Standard No. 7.1 was submitted
to EPA by SC DHEC on July 1, 2005, for inclusion in the South Carolina
SIP. This regulation relates to the South Carolina's NNSR permit
program. Revisions to Regulation 61-62.5, Standard No. 7.1 became
State-effective on June 24, 2005. EPA proposed to conditionally approve
South Carolina's NNSR rules on September 12, 2007 (72 FR 52031). EPA
did not receive any comments on the proposal. EPA finalized its
conditional approval of Regulation 61-62.5, Standards No. 7.1 into the
South Carolina SIP on June 2, 2008 (73 FR 31368). As part of the
conditional approval, South Carolina had twelve months from the June 2,
2008, final conditional approval to submit changes to its NNSR program
as described herein to be consistent with EPA Federal regulations.
    On April 14, 2009, SC DHEC submitted a revision to the SIP,
incorporating the corrections required by EPA in the conditional
approval. Specifically, South Carolina revised Regulation 61-62.5,
Standard No. 7.1 to include a methodology for calculating emission
reductions to be used as offsets that include a baseline for
determining credit for emissions offsets that meet the requirements set
out in 40 CFR 51.165(a)(3)(i) and Appendix S, section IV.C. This
particular issue was highlighted as a basis for the conditional
approval in the June 2, 2008 Federal Register. See 73 FR 31369-31370.
The emission offsets provisions also specify that the reductions must
be surplus and cannot be used for offsets if they are otherwise
required by the South Carolina SIP or other Federal standards, such as
New Source Performance Standards and National Emissions Standards for
Hazardous Air Pollutants, including the Maximum Achievable Control
Technology standards. EPA has determined that South Carolina's April
14, 2009, SIP revision satisfies the conditions listed in EPA's June 2,
2008, conditional approval, and today is proposing to convert its prior
conditional approval to full approval. See 73 FR 31368.

III. Proposed Action

    EPA is proposing to convert a conditional approval of a July 1,
2005, revision to the South Carolina SIP regarding requirements for the
State's NNSR construction permit program to a full approval. South
Carolina's April 14, 2009, SIP revision consists of changes to South
Carolina Regulation 61-62.5, Standard No. 7.1 entitled ``Nonattainment
New Source Review.'' SC DHEC submitted the April 14, 2009, SIP revision
in response to EPA's June 2, 2008 (73 FR 31368), rule, which
conditionally approved South Carolina's NNSR program as provided in the
State's July 1, 2005, SIP revision. SC DHEC has satisfied the
conditions listed in EPA's conditional approval. Therefore, EPA is
proposing to convert its conditional approval of South Carolina's July
1, 2005, SIP revision to a full approval. The April 14, 2009, SIP
revision satisfies the conditions of EPA's conditional approval of
South Carolina's July 1, 2005 SIP revision, and is are consistent with
Federal regulations and in accordance with the CAA. In addition, EPA is
proposing to approve minor administrative reference changes at South
Carolina Regulation 61-62.5 Standards No. 7 and 7.1 as a result of the
removal of CU and PCP provisions.

IV. 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
proposed 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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).

In addition, this proposed rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, and Reporting and recordkeeping
requirements.

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

    Dated: March 16, 2011.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2011-6975 Filed 3-23-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Notices]
[Pages 21493-21494]
[FR Doc No: 2020-08122]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-616, OMB Control No. 3235-0671]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 613 of Regulation NMS

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in connection with a National
Market System (NMS) Plan filed with the Commission under Rule 613 (17
CFR 242.613), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 613 of Regulation NMS (17 CFR part 242) required national
securities exchanges and national securities associations
(``Participants'') to jointly submit to the Commission a national
market system (``NMS'') plan to govern the creation, implementation,
and maintenance of a consolidated audit trail (``CAT'') and Central
Repository for the collection of information for NMS securities. On
February 27, 2015, the Participants submitted the CAT NMS Plan to the
Commission.\1\ On April 27, 2016, the Commission published a notice
soliciting comments from the public (``CAT NMS Plan Notice'').\2\ On
November 15, 2016, the Commission approved the CAT NMS Plan (``CAT NMS
Plan Order''), including the information collections proposed in the
CAT NMS Plan Notice, and certain additional information collections.\3\
---------------------------------------------------------------------------

    \1\ See Letter from Participants to Brent J. Fields, Secretary,
Commission, dated February 27, 2015. The Participants filed the CAT
NMS Plan on September 30, 2014. See Letter from the Participants, to
Brent J. Fields, Secretary, Commission, dated September 30, 2014.
The CAT NMS Plan filed on February 27, 2015, was an amendment to and
replacement of the Initial CAT NMS Plan (the ``Amended and Restated
CAT NMS Plan''). On December 24, 2015, the Participants submitted an
Amendment to the Amended and Restated CAT NMS Plan. See Letter from
Participants to Brent J. Fields, Secretary, Commission, dated
December 23, 2015 (the ``Amendment''). On February 9, 2016, the
Participants filed with the Commission an identical, but unmarked,
version of the Amended and Restated CAT NMS Plan, dated February 27,
2015, as modified by the Amendment, as well as a copy of the request
for proposal issued by the Participants to solicit Bids from parties
interested in serving as the Plan Processor for the consolidated
audit trail. Unless the context otherwise requires, the ``CAT NMS
Plan'' shall refer to the Amended and Restated CAT NMS Plan, as
modified by the Amendment.
    \2\ See Securities Exchange Act Release No. 77724 (April 27,
2016), 81 FR 30613 (May 17, 2016). The burdens associated with the
CAT NMS Plan Notice were submitted under OMB number 3235-0671 which
relates to the NMS Plan required to be filed under Rule 613.
    \3\ See Securities Exchange Act Release No. 79318 (November 15,
2016), 81 FR 84696 (November 23, 2016), available at https://www.sec.gov/rules/sro/nms/2016/34-79318.pdf (``CAT NMS Plan
Order'').
---------------------------------------------------------------------------

    Since November 15, 2016, the Commission believes that three
information collection requirements have been completed, specifically:
(1) A document outlining how the Participants could incorporate into
the consolidated audit trail information regarding certain products
that are not NMS securities; \4\ (2) a one-time assessment of the clock
synchronization standards in the Plan before reporting begins for
Industry Members, which assessment shall take into account the
diversity of CAT Reporters and systems; \5\ and (3) a one-time report
that discusses the Participants' assessment of implementing coordinated
surveillance.\6\
---------------------------------------------------------------------------

    \4\ See 17 CFR 242.613(i). See also ``One-Time Written
Assessments,'' Consolidated Audit Trail, LLC at: https://www.catnmsplan.com/one-time-written-assessments/index.html.
    \5\ See CAT NMS Plan Order, supra note 3, at 84940.
    \6\ Id. at 84940-84941.
---------------------------------------------------------------------------

    This Notice addresses the remaining information collection
requirements noticed in the CAT NMS Plan Notice and certain additional
information collections of the CAT NMS Plan Order, which are: (1)
Development of a Central Repository tasked with the receipt,
consolidation, and retention of reported order and execution
information submitted by Participants and their members; \7\ (2) the
requirement that each Participant, and any member of such Participant,
record and electronically report to the Central Repository details for
each order and Reportable Event documenting the life of an order
through the process of original receipt or origination, routing,
modification, cancellation, and execution (in whole or in part) for
each NMS security; \8\ (3) the requirement that the CAT NMS Plan
require the Central Repository to collect and retain on a current and
continuous basis NBBO information for each NMS security, transaction
reports reported pursuant to an effective transaction reporting plan,
and Last Sale Reports reported pursuant to the Options Price Reporting
Authority Plan; \9\ (4) the requirement that the CAT NMS Plan must
require that every national securities exchange and national securities
association develop and implement a surveillance system, or enhance
existing surveillance systems, reasonably designed to make use of the
consolidated information contained in the consolidated audit trail;
\10\ (5) a one-time independent audit of the fees, costs, and expenses
incurred by the Participants on behalf of CAT NMS, LLC prior to the
Effective Date \11\ of the Plan; \12\ (6) a one-time report from the
Participants discussing the feasibility and advisability of allowing
Industry Members to bulk download the Raw Data that it has submitted to
the Central Repository; \13\ (7) a one-time assessment of the nature
and extent of errors in the Customer information submitted to the
Central Repository and whether the

correction of certain data fields over others should be prioritized
from the Participants; \14\ (8) a one-time report on the impact of
tiered fees on market liquidity, including an analysis of the impact of
the tiered-fee structure on Industry Members provision of liquidity
from the Participants; \15\ (9) an assessment of the projected impact
of any Material Systems Change on the Maximum Error Rate, prior to the
implementation of such Material Systems Change from the Participants;
\16\ (10) an annual requirement that that the CAT LLC financials be (i)
in compliance with GAAP, (ii) be audited by an independent public
accounting firm, and (iii) be made publicly available; \17\ (11) a
requirement that each Participant conduct background checks for its
employees and contractors that will use the CAT System.\18\
---------------------------------------------------------------------------

    \7\ See 17 CFR 242.613.
    \8\ See 17 CFR 242.613(c)(1), (c)(5), (c)(6), (c)(7).
    \9\ See 17 CFR 242.613(e)(7).
    \10\ See 17 CFR 242.613(f).
    \11\ The ``Effective Date'' is the date the Commission approved
the CAT NMS Plan, which is November 15, 2016. See id.
    \12\ See CAT NMS Plan Order, supra note, at 84940.
    \13\ Id. at 84941.
    \14\ Id.
    \15\ Id. at 84941-84942.
    \16\ Id. at 84942. The Commission believes that four assessments
would be filed annually.
    \17\ Id.
    \18\ Id. The Commission believes that these background checks
are necessary to ensure that only authorized and qualified persons
are using the CAT System.
---------------------------------------------------------------------------

    The Commission believes that the CAT NMS Plan, once fully
implemented, will improve the quality of the data available to
regulators in four areas that affect the ultimate effectiveness of core
regulatory efforts--completeness, accuracy, accessibility and
timeliness.\19\ The improvements in these data qualities would
substantially improve regulators' ability to perform analysis and
reconstruction of market events, and market analysis and research to
inform policy decisions, as well as perform regulatory activities, in
particular market surveillance, examinations, investigations, and other
enforcement functions.
---------------------------------------------------------------------------

    \19\ See CAT NMS Plan Order, supra note 3, at 45727 (discussing
four ``qualities'' of trade and order data that impact the
effectiveness of core Participant and Commission regulatory efforts:
accuracy, completeness, accessibility, and timeliness).
---------------------------------------------------------------------------

    The Commission estimates that 1524 respondents \20\ will require an
aggregate total of approximately 7,572,610 hours per year to comply
with the collection of information. The Commission further estimates
that the aggregate cost to comply with the collection of information
will be approximately $463,322,593 per year.
---------------------------------------------------------------------------

    \20\ The Commission notes that 24 Participants (the 23 national
securities exchanges and one national securities association) and
1,500 broker-dealers subject to information collections requirements
pursuant to Rule 613 and the CAT NMS Plan.
---------------------------------------------------------------------------

    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street, NE, Washington, DC 20549, or send an
email to<EMAIL_ADDRESS>
    Dated: April 14, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08122 Filed 4-16-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 15, 2008 (Volume 73, Number 159)]
[Notices]
[Page 48007-48008]
[DOCID:fr15au08-115]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Privacy Act of 1974: System of Records

AGENCY: Federal Highway Administration, Department of Transportation
(DOT).

ACTION: Notice to establish a system of records.

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

SUMMARY: DOT intends to establish a system of records under the Privacy
Act of 1974 entitled the ``Dwight David Eisenhower Transportation
Fellowship Program'' (DDETFP). The system will contain information
about students who apply to and participate in the DDETFP. Additional
information on this system is described in the Supplementary
Information section of this notice.

EFFECTIVE DATE: September 24, 2008. If no comments are received, the
proposal will become effective on the above date. If comments are
received, the comments will be considered and, where adopted, the
documents will be republished with changes.

FOR FURTHER INFORMATION CONTACT: Habib Azarsina, Departmental Privacy
Officer, Department of Transportation, Office of the Secretary, 1200
New Jersey Avenue, SE., Washington, DC 20003,<PHONE_NUMBER> (telephone),
202-366-7870 (fax<EMAIL_ADDRESS>(Internet address).

SUPPLEMENTARY INFORMATION: The Department of Transportation system of
records notice subject to the Privacy Act of 1974 (5 U.S.C. 552a), as
amended, has been published in the Federal Register and is available
from the above mentioned address.

System number:
    DOT/FHWA 220.

System name:
    Dwight David Eisenhower Transportation Fellowship Program.

Security classification:
    Sensitive, unclassified.

System location:
    This system of records is in the Office of Professional and
Corporate Development, Federal Highway Administration.

Categories of individuals covered by the system of records:
    This system contains information on students that participate in
FHWA's DDETFP.

Categories of records in the system:
    The information in the system consists of documents related to the
administration of the program that include the students' name, home
mailing address, e-mail address, date of birth, education records, home
telephone number, race (optional), gender (optional), and citizenship.

Authority for maintenance of the system:
    Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA-LU), Public Law 109.59.

Purposes:
    The DDETFP aims to attract qualified students to the field of
transportation education and research and advance transportation
workforce development. The DDETFP includes seven fellowship categories
including the Graduate Fellowships, Historically Black Colleges and
Universities Fellowships, Hispanic Serving Institutions Fellowships,
Tribal Colleges Fellowships, People with Disabilities Fellowships,
Grants for Research, and Intern Fellowships. DDETFP is supported by an
automated system that allows for the centralized collection and
analysis of vital program information. Information in this system is
used to track student progress throughout the education pipeline,
identify gaps and evaluate program performance and effectiveness in
meeting federal transportation workforce recruitment and development
goals. Records contained in this system only will be used for program
analysis and evaluation purposes.

Routine uses of records maintained in the system, including categories
of users and the purposes of such uses:
    To FHWA program staff and contractors directly involved in the
administration of the program and system, and to other government
agencies when authorized by law. See Prefatory Statement of Routine
Uses.

Disclosure to consumer reporting agencies:
    None.

Policies and practices for storing, retrieving, accessing, retaining,
and disposing of records in the system:
Storage:
    Documents are stored in locked cabinets and secured electronically
in a database.

Retrievability:
    Records are retrievable by name.

Safeguards:
    Access to electronic information is limited to program staff and
protected via password controls. Physical access to the server and
paper files is limited to appropriate personnel through building key
cards and room-access keypads. Other security measures include
firewalls, routine scans and monitoring, back-up activities, and
security background checks.

Retention and disposal:
    Pending approval by the National Archives and Records
Administration, this system has a proposed record retention of five (5)
years for paper and permanent for electronic records.

System manager and address:
    Program Manager, Office of Professional and Corporate Development,
Federal Highway Administration, 4600 N. Fairfax Drive, Suite 800,
Arlington, VA 22203.

Notification procedure:
    Same as ``System Manager''.

Record access procedures:
    Same as ``System Manager''.

Contesting record procedures:
    Same as ``System Manager''.

Record source categories:
    Records are obtained via applications/forms that students complete
and that come to FHWA directly or via their university.

Exemptions claimed for the system:
    None.

    Dated: August 11, 2008.
Habib Azarsina,
Departmental Privacy Officer,<PHONE_NUMBER>.
[FR Doc. E8-18922 Filed 8-14-08; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1442-1445]
[FR Doc No: 2018-00306]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82447; File No. SR-NYSEAMER-2017-40]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 7.31E Relating to Mid-Point Liquidity Orders and the MTS Modifier
and Rule 7.36E To Add a Definition of ``Aggressing Order''

January 5, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on December 22, 2017, NYSE American LLC (``Exchange'' or ``NYSE
American'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 7.31E relating to Mid-Point
Liquidity Orders and the MTS Modifier and Rule 7.36E to add a
definition of ``Aggressing Order.'' The proposed rule change is
available on the Exchange's website at www.nyse.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 self-regulatory organization
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 those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 7.31E (Orders and Modifiers)
relating to Mid-Point Liquidity (``MPL'') Orders and the MTS Modifier
and Rule 7.36E (Order Ranking and Display) to add a definition of
``Aggressing Order.'' For MPL Orders, the Exchange proposes to amend
the price at which a marketable MPL Order would trade when there are
resting orders priced better than the midpoint. The Exchange also
proposes to amend how resting orders with an MTS Modifier would trade
in specified circumstances.
Background
    As provided for in current Rule 7.31E(d)(3)(C), on arrival, an MPL
Order to buy (sell) that is eligible to trade will trade with resting
orders to sell (buy) with a working price at or below (above) the
midpoint of the PBBO (i.e., priced better than the midpoint of the
PBBO). The rule further provides that resting MPL Orders to buy (sell)
will trade at the midpoint of the PBBO against all incoming orders to
sell (buy) priced at or below (above) the midpoint of the PBBO (i.e.,
priced better than the midpoint of the PBBO).
    Current Rule 7.31E(i)(3) describes the MTS Modifier, including how
a resting order with an MTS Modifier will trade. Current Rule
7.31E(i)(3)(E)(i) provides that if a sell (buy) order does not meet the
MTS of the resting order to buy (sell) with an MTS Modifier, that sell
(buy) order will not trade with and may trade through such order with
an MTS Modifier. Current Rule 7.31E(i)(3)(E)(ii) provides that if a
resting sell (buy) order did not meet the MTS of a same-priced resting
order to buy (sell) with an MTS Modifier, a subsequently arriving sell
(buy) order that meets the MTS will trade ahead of the resting sell
(buy) order. Finally, current Rule 7.31E(i)(3)(E)(iii) provides that a
resting order to buy (sell) with an MTS Modifier will not be eligible
to trade if sell (buy) order(s) ranked Priority 2--Display Orders are
displayed on the Exchange Book at a price lower (higher) than the
working price of such MTS Order. Similarly, Rule 7.46E(f)(5)(I) (Tick
Size Pilot Plan) provides that for Pilot Securities in Test Group
Three, a resting order to buy (sell) with an MTS Modifier will not be
eligible to trade if sell (buy) order(s) ranked Priority 2--Display
Orders are displayed on the Exchange Book at a price equal to or lower
(higher) than the working price of such MTS Order.
Proposed Definition of ``Aggressing Order''
    The Exchange proposes to amend Rule 7.36E to add a definition that
would be used for purposes of Rule 7E. Proposed Rule 7.36E(a)(5) would
define the term ``Aggressing Order'' to mean a buy (sell) order that is
or becomes marketable against sell (buy) interest on the Exchange
Book.\4\ This term would therefore refer to orders that are marketable
against other orders on the Exchange Book, such as incoming orders and
orders that have returned unexecuted after routing.
---------------------------------------------------------------------------

    \4\ The term ``marketable'' is defined in Rule 1.1E(u) to mean
for a Limit Order, an order than can be immediately executed or
routed.
---------------------------------------------------------------------------

    This term would also be applicable to resting orders that become
marketable due to one or more events. For the most part, resting orders
will have already traded with contra-side orders against

which they are marketable. However, there are circumstances when a
resting order may become marketable, such as orders that become
eligible to trade when a PBBO unlocks or uncrosses (e.g., MPL and
Pegged Orders) or orders that have a trading restriction at specified
prices (e.g., as discussed in greater detail below, orders with an MTS
Modifier). To maximize the potential for orders to trade, the Exchange
continually evaluates whether resting orders may become marketable.
Events that could trigger a resting order to become marketable include
updates to the working price of such order, updates to the PBBO or
NBBO, changes to other orders on the Exchange Book, or processing of
inbound messages (e.g., an update to Price Bands under the Regulation
NMS Plan to Address Extraordinary Market Volatility). To address such
circumstances, the Exchange proposes to include in proposed Rule
7.36E(a)(5) that a resting order may become an Aggressing Order if its
working price changes, if the PBBO or NBBO is updated, because of
changes to other orders on the Exchange Book, or when processing
inbound messages.
    The order that becomes the Aggressing Order is the liquidity-taking
order. Generally, if resting orders on both sides are determined to be
an Aggressing Order, e.g., a locked PBBO becomes unlocked and as a
result, MPL Orders are repriced, the later-arriving order will be the
liquidity-taking order.\5\ However, if the evaluation results in only
one side becoming an Aggressing Order, e.g., an order with an MTS
Modifier becomes eligible to trade and the contra-side order(s) have no
working price changes, the order with the MTS Modifier would become the
liquidity-taking Aggressing Order. As described below, the Exchange
proposes to use the term ``Aggressing Order'' in the rule text relating
to the MTS Modifier. Because an Aggressing Order becomes a liquidity
taker, such term could be applicable to other circumstances. For
example, an order with a Non-Display Remove Modifier [sic] that trades
as a liquidity taker would also be considered an Aggressing Order.
However, at this time, the Exchange does not propose to amend its rules
to use the term ``Aggressing Order'' because the rule already specifies
which order is the liquidity taker.
---------------------------------------------------------------------------

    \5\ See, e.g., Rule 7.31-E(d)(3)(B).
---------------------------------------------------------------------------

Proposed Amendments Relating to MPL Orders
    The Exchange proposes to amend the first sentence of current Rule
7.31E(d)(3)(C) to make this text applicable to any marketable MPL
Order, and not just an arriving MPL Order. To effect this change, the
Exchange proposes to use the term ``Aggressing Order'' and replace the
phrase ``[o]n arrival, an MPL Order to buy (sell) that is eligible to
trade'' with the phrase, ``[a]n Aggressing MPL Order to buy (sell).''
    The Exchange also proposes to amend the first sentence of current
Rule 7.31E(d)(3)(C) to describe at what price an Aggressing MPL Order
would trade with contra-side resting orders that are priced better than
the midpoint. The rule currently provides that an arriving MPL Order to
buy (sell) would trade with resting orders to sell (buy) with a working
price at or below (above) the midpoint of the PBBO. The Exchange
proposes to specify that when an Aggressing MPL Order trades with
resting orders priced better than the midpoint, it will trade at the
working price of the resting orders, which is current functionality.
For example, if the PBB is 10.10 and the midpoint is 10.13, and there
are non-displayed sell orders of 100 shares with working prices of
10.11 and 10.12, an Aggressing MPL Order to buy with a limit of 10.13
for 200 shares would trade with such non-displayed sell orders at 10.11
and 10.12, respectively. The Exchange believes that this proposed
amendment would promote transparency in Exchange rules regarding at
what price an Aggressing MPL Order would trade.
    By using the term ``Aggressing Order,'' this rule would be
applicable to a resting MPL Order that becomes marketable, such as
after a PBBO unlocks or uncrosses. In the above example, if the MPL
Order to buy is ineligible to trade because of a crossed PBBO, and
while the PBBO is crossed, the Exchange receives the two non-displayed
sell orders, when the PBBO uncrosses and the new midpoint is 10.13, the
resting MPL Order would become an Aggressing Order and would trade with
the non-displayed sell orders at 10.11 and 10.12, respectively.
    The Exchange also proposes to amend the second sentence of Rule
7.31E(d)(3)(C) to replace the term ``incoming orders'' with the term
``Aggressing Orders.'' This proposed rule change would provide greater
specificity that any contra-side order that is an Aggressing Order, as
defined in proposed Rule 7.36E(a)(5), would trade with a resting MPL
Order at the midpoint of the PBBO.
Proposed Amendments Relating to the MTS Modifier
    The Exchange proposes to amend Rules 7.31E(i)(3)(C) and (E) to
specify circumstances when a resting order with an MTS Modifier would
not be eligible to trade.
    Current Rule 7.31E(i)(3)(C) provides that an order with an MTS
Modifier that is designated Day and cannot be satisfied on arrival
would not trade and would be ranked in the Exchange Book. The Exchange
proposes to describe new functionality relating to when an order with
an MTS Modifier that is designated Day would not be eligible to trade.
In short, if a later-arriving contra-side order can meet the MTS of a
resting order with an MTS Modifier, the two orders would trade unless
the execution would be inconsistent with either intra-market price
priority or would result in a non-displayed order trading ahead of a
same-side, same-priced displayed order.\6\ Therefore, as proposed, the
Exchange would not permit an order with an MTS Modifier that crosses
other displayed or non-displayed orders on the Exchange Book to trade
at prices that are worse than the price of such contra-side orders. As
further proposed, the Exchange would not permit a resting order with an
MTS Modifier to trade at a price equal to a displayed contra-side
order.\7\
---------------------------------------------------------------------------

    \6\ Rule 7.36E(c) provides that the Exchange ranks all non-
marketable orders on the Exchange Book according to price--time
priority.
    \7\ A displayed odd-lot order that is not included in the
calculation of the PBBO could be at the same price as an MPL Order.
---------------------------------------------------------------------------

    To reflect these changes, the second sentence of Rule
7.31E(i)(3)(C) would provide that when a buy (sell) order with an MTS
Modifier that is designated Day is ranked in the Exchange Book, it
would not be eligible to trade:
    (i) At a price equal to or above (below) any sell (buy) orders that
are displayed and that have a working price equal to or below (above)
the working price of such order with an MTS Modifier, or
    (ii) at a price above (below) any sell (buy) orders that are not
displayed and that have a working price below (above) the working price
of such order with an MTS Modifier.
    For example,
     if the PBBO is 10.10 x 10.16, on the Exchange Book there
is a sell order (``Order A'') ranked Priority 3--Non-Display Orders for
50 shares at 10.12 and a sell order (``Order B'') ranked Priority 2--
Display Orders for 25 shares at 10.11, and the Exchange receives a buy
MPL Order (``Order C'') with an MTS Modifier for 100 shares with a
10.16 limit, because the MTS cannot be met, Order C will not trade and
will be ranked in the Exchange Book at the midpoint of 10.13. At this
point, the Exchange would have a non-displayed buy order crossing both
non-displayed

and displayed sell orders on the Exchange Book. If the Exchange then
receives a non-displayed sell order (``Order D'') for 100 shares at
10.11, even though Order D would be marketable against Order C, it
would not trade because a trade at 10.13 would be above the price of
resting sell orders.\8\ Order D would be added to the Exchange Book at
10.11.
---------------------------------------------------------------------------

    \8\ Pursuant to Rule 7.31E(d)(3)(C), an Aggressing Order will
trade with a resting MPL Order at the midpoint of the PBBO.
---------------------------------------------------------------------------

     If next, the Exchange receives a buy order (``Order E'')
to buy 25 shares at 10.11, it would trade with Order B. As discussed
above, this execution would trigger the Exchange to evaluate whether
Order C becomes marketable against contra-side orders.\9\ In this
scenario, because Order B has now executed, Order C is no longer
restricted from trading at 10.11. Because Order C's restriction has
been lifted and Order D does not have a working price change, Order C
would become an Aggressing Order and trade as the liquidity taker with
Order D at 10.11.
---------------------------------------------------------------------------

    \9\ See discussion infra regarding the second sentence to
proposed Rule 7.36E(a)(5).
---------------------------------------------------------------------------

    Because proposed Rule 7.31E(i)(3)(C)(i) would be applicable to all
securities that trade on the exchange, including Pilot Securities in
the Tick Pilot Plan, the Exchange proposes to delete Rule
7.46E(f)(5)(I) as duplicative of the proposed new rule text.
    The Exchange also proposes to amend Rules 7.31E(i)(3)(E)(i), (ii),
and (iii) relating to the behavior of resting orders with an MTS
Modifier.\10\ The Exchange proposes a non-substantive change to Rule
7.31E(i)(3)(E) to change the term ``order(s)'' to ``orders,'' which the
Exchange believes is a more technically accurate way to describe that a
resting order with an MTS Modifier will be evaluated against individual
orders.
---------------------------------------------------------------------------

    \10\ A resting order with an MTS Modifier that becomes an
Aggressing Order would trade consistent with Rule 7.31E(i)(3)(E) and
therefore would trade with individual orders that each meet the MTS.
---------------------------------------------------------------------------

    First, the Exchange proposes to amend Rule 7.31E(i)(3)(E)(i) to use
the term ``Aggressing Order.'' Use of this proposed new definition
would not change the functionality associated with this rule.
Accordingly, as proposed, the rule would provide that if an Aggressing
Order to sell (buy) does not meet the MTS of the resting order to buy
(sell) with an MTS Modifier, that Aggressing Order will not trade with
and may trade through such order with an MTS Modifier (proposed new
text in italics). The Exchange believes that use of the term
``Aggressing Order'' in the context of this rule would promote
transparency of which order is trading with the resting order with an
MTS Modifier.
    Second, the Exchange proposes to amend Rule 7.31E(i)(3)(E)(ii) to
provide that if a resting sell (buy) non-displayed order did not meet
the MTS of a same-priced resting order to buy (sell) with an MTS
Modifier, a subsequently arriving sell (buy) order that meets the MTS
would trade ahead of such resting non-displayed sell (buy) order at
that price (proposed new text in italics), e.g., at the internal
locking price. The Exchange proposes to amend this rule to provide that
the subsequently arriving order could trade ahead of a resting non-
displayed order at that price. As described above, the proposed
amendment to Rule 7.31E(i)(3)(C)(i) would address circumstances when an
order with an MTS Modifier is locked by a displayed order. In such
case, the subsequently arriving order would not trade with the order
with an MTS Modifier.
    Finally, the Exchange proposes to delete current Rule
7.31E(i)(3)(iii) as superseded by proposed Rule 7.31E(i)(3)(C)(i) and
(ii) and the amendments to Rule 7.31E(i)(3)(E)(i) and (ii).
    Because of the technology changes associated with these proposed
rule change, the Exchange will announce the implementation date of this
proposed rule change by Trader Update. The Exchange anticipates that
the implementation date will be in the first quarter of 2018.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\11\ in general, and
furthers the objectives of Section 6(b)(5),\12\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to, and perfect the
mechanism of, a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed definition of ``Aggressing
Order'' in Rule 7.36E would remove impediments to, and perfect the
mechanism of, a free and open market and a national market system and,
in general, protect investors and the public interest because it would
provide for a definition in Exchange rules that describes orders that
are or become marketable. The Exchange believes that the proposed
definition would promote transparency in Exchange rules by providing
detail regarding circumstances when a resting order may become
marketable, and thus would be an Aggressing Order. The Exchange further
believes that use of such definition would promote clarity in Exchange
rules, particularly in the context of the amendments to MPL Orders and
orders with an MTS Modifier.
    The Exchange believes that the proposed amendments to Rule
7.31E(d)(3)(C) to use the term ``Aggressing Order'' and to describe the
prices at which an Aggressing MPL Order would trade would remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system and, in general, protect investors and the
public interest because it would promote clarity and transparency in
Exchange rules regarding the behavior of marketable MPL Orders. In
particular, the rule would provide greater specificity regarding how a
resting MPL Order that becomes an Aggressing Order would trade.
    Finally, the Exchange believes that the proposed amendments
relating to when a resting order with an MTS Modifier would be eligible
to trade would remove impediments to, and perfect the mechanism of, a
free and open market and a national market system and, in general,
protect investors and the public interest, because the proposed rule
change would ensure that there would not be an execution of a resting
order with an MTS Modifier that either would be inconsistent with
intra-market price priority or would result in a non-displayed order
trading ahead of a same-side, same-priced displayed order. This
proposed rule change would therefore promote just and equitable
principles of trade by ensuring that displayed interest does not get
traded through by a non-displayed order.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change is not designed to address any competitive
issues, but rather to add further clarity to Exchange rules by defining
the term ``Aggressing Order'' and using that term in connection with
MPL Orders. In addition, the rule is

designed to ensure that resting orders with an MTS Modifier would not
trade through displayed orders or violate intra-market priority.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \13\ and Rule 19b-4(f)(6) thereunder.\14\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEAMER-2017-40 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-NYSEAMER-2017-40. 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-NYSEAMER-2017-40 and should be submitted
on or before February 1, 2018.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00306 Filed 1-10-18; 8:45 am]
 BILLING CODE 8011-01-P