 [Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Rules and Regulations] [Pages 39355-39357] [FR Doc No: 2017-16438]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0068; Product Identifier 2014-SW-076-AD; Amendment

39-18981; AD 2017-16-04]

RIN 2120-AA64

Airworthiness Directives; Romtex Anjou Aeronautique (Romtex)

Torso Restraint Systems

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Romtex

torso restraint systems (restraint systems) installed on but not

limited to Airbus Helicopters Model AS350B2, AS350B3, EC130B4, EC130T2,

and AS355NP helicopters. This AD requires replacing certain restraint

system buckles. This AD was prompted by a report of several restraint

system buckle knobs breaking. The actions of this AD are intended to

correct an unsafe condition on these products.

DATES: This AD is effective September 22, 2017.

    The Director of the Federal Register approved the incorporation by

reference of a certain document listed in this AD as of September 22,

2017.

ADDRESSES: For service information identified in this final rule,

contact Romtex Anjou Aeronautique, Strada Livezii nr. 98, 550042,

Sibiu, Romania; telephone +40 269 243 918; email

<EMAIL_ADDRESS>You may review the referenced service

information at the FAA, Office of the Regional Counsel, Southwest

Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. It is

also available on the Internet at http://www.regulations.gov by

searching for and locating Docket No. FAA-2017-0068.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-

0068; or in person at the Docket Operations Office between 9 a.m. and 5

p.m., Monday through Friday, except Federal holidays. The AD docket

contains this AD, the European Aviation Safety Agency (EASA) AD, any

incorporated-by-reference service information, the economic evaluation,

any comments received, and other information. The street address for

the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S. Department

of Transportation, Docket Operations Office, M-30, West Building Ground

Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety

Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,

10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;

email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Discussion

    On February 17, 2017, at 82 FR 10971, the Federal Register

published our notice of proposed rulemaking (NPRM), which proposed to

amend 14 CFR part 39 by adding an AD that would apply to Romtex

restraint systems with a rotary buckle sub-assembly (buckle assembly)

with a part number and serial number listed in Romtex Service Bulletin

No. 358SB-14-101, Revision 1, dated December 12, 2014. These restraint

systems are installed on, but not limited to, Airbus Helicopters Model

AS350B2, AS350B3, EC130B4, EC130T2, and AS355NP helicopters. The NPRM

proposed to require inspecting the buckle assembly to determine whether

the straps release, marking the seat as inoperative if the buckle fails

to release the straps, and replacing the buckle assembly within 180

hours time-in-service (TIS). The NPRM also proposed to prohibit

installing the affected buckle assemblies on any helicopter. The

proposed requirements were intended to prevent a restraint system strap

from failing to release from the buckle, preventing occupants from

exiting the helicopter during an emergency.

    The NPRM was prompted by AD No. 2014-0279, dated December 19, 2014,

issued by EASA, which is the Technical Agent for the Member States of

the European Union, to correct an unsafe condition for Romtex Model 358

torso restraint systems installed on Airbus Helicopters Model EC130T2,

AS350B2, and AS350B3 helicopters. EASA advises that ruptures have

occurred on the upper side (knob) of several rotary buckles installed

on these restraint systems. EASA states the material used in two

batches of the buckle assembly were altered by a supplier, resulting in

a specification different from the approved design data. The EASA AD

states that this condition could prevent the release of the restraint

system straps as intended after an emergency landing. To address this

unsafe condition, the EASA AD requires inspecting the buckle

assembly for proper operation, replacing or marking as inoperative any

buckle assembly that fails to release the straps before further flight,

and replacing all buckle assemblies within 6 months. The EASA AD also

prohibits installing these buckle assemblies on any aircraft.

Comments

    We gave the public the opportunity to participate in developing

this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    These products have been approved by the aviation authority of

Romania and are approved for operation in the United States. Pursuant

to our bilateral agreement with Romania, EASA, its technical

representative, has notified us of the unsafe condition described in

the EASA AD. We are issuing this AD because we evaluated all

information provided by EASA and determined the unsafe condition exists

and is likely to exist or develop on other helicopters of these same

type designs and that air safety and the public interest require

adopting the AD requirements as proposed except we are correcting the

name in the related service bulletin from Romtex to Anjou Aero. This

change is consistent with the intent of the proposals in the NPRM and

will not increase the economic burden on any operator nor increase the

scope of this AD.

Differences Between This AD and the EASA AD

    The EASA AD requires compliance within 30 days for the buckle

inspection and 6 months for replacement; this AD requires the

inspection within 30 hours TIS and replacement within 180 hours TIS.

The EASA AD does not apply to Model EC130B4 and AS355NP helicopters,

and this AD does.

Related Service Information Under 1 CFR Part 51

    We reviewed Anjou Aero Service Bulletin No. 358SB-14-101, Revision

1, dated December 12, 2014 (SB 358SB-14-101), which specifies removing

from service certain part-numbered and serial-numbered buckle

assemblies, consisting of the rotary buckle, belt, and attachment.

    This service information is reasonably available because the

interested parties have access to it through their normal course of

business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 893 helicopters of U.S. Registry.

    We estimate that operators will incur the following costs in order

to comply with this AD. At an average labor rate of $85 per hour,

inspecting the buckle assembly requires about .5 work-hour, for a cost

per helicopter of $43 and a total cost of $38,399 for the fleet.

Replacing each buckle assembly requires about .5 work-hour, and

required parts will cost $42,000, for a cost per helicopter of $42,043

and a total cost to U.S. operators of $37,544,399.

    According to the Anjou Aero service information, some of the costs

of this AD may be covered under warranty, thereby reducing the cost

impact on affected individuals. We do not control warranty coverage by

Anjou Aero. Accordingly, we have included all costs in our cost

estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to

issue rules on aviation safety. Subtitle I, section 106, describes the

authority of the FAA Administrator. Subtitle VII: Aviation Programs,

describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in

Subtitle VII, Part A, Subpart III, Section 44701: ``General

requirements.'' Under that section, Congress charges the FAA with

promoting safe flight of civil aircraft in air commerce by prescribing

regulations for practices, methods, and procedures the Administrator

finds necessary for safety in air commerce. This regulation is within

the scope of that authority because it addresses an unsafe condition

that is likely to exist or develop on helicopters identified in this

rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order

13132. This AD will not have a substantial direct effect on the States,

on the relationship between the national government and the States, or

on the distribution of power and responsibilities among the various

levels of government.

    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive

Order 12866;

    (2) Is not a ``significant rule'' under DOT Regulatory Policies and

Procedures (44 FR 11034, February 26, 1979);

    (3) Will not affect intrastate aviation in Alaska to the extent

that it justifies making a regulatory distinction; and

    (4) Will not have a significant economic impact, positive or

negative, on a substantial number of small entities under the criteria

of the Regulatory Flexibility Act.

    We prepared an economic evaluation of the estimated costs to comply

with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by

reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the

Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0

1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0

2. The FAA amends Sec.  39.13 by adding the following new airworthiness

directive (AD):

2017-16-04 Romtex Anjou Aeronautique (Romtex) Torso Restraint

Systems: Amendment 39-18981; Docket No. FAA-2017-0068; Product

Identifier 2014-SW-076-AD.

(a) Applicability

    This AD applies to Romtex torso restraint systems (restraint

systems) with a rotary buckle sub-assembly (buckle assembly) with a

part number and serial number as listed in the Effectivity,

paragraph 1.2, of Anjou Aero Service Bulletin No. 358SB-14-101,

Revision 1, dated December 12, 2014. These restraint systems are

installed on, but not limited to, Airbus Helicopters Model AS350B2,

AS350B3, EC130B4, EC130T2, and AS355NP helicopters, certificated in

any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a broken buckle knob.

This condition could result in a restraint system strap failing to

release from the buckle, preventing occupants from exiting the

helicopter during an emergency.

(c) Effective Date

    This AD becomes effective September 22, 2017.

(d) Compliance

    You are responsible for performing each action required by this

AD within the specified compliance time unless it has already been

accomplished prior to that time.

(e) Required Actions

    (1) Within 30 hours time-in-service (TIS), inspect each

restraint system for correct operation.

    (i) If the straps do not release from the buckle assembly,

placard the seat as inoperative. Within 180 hours TIS, replace

the buckle assembly with a buckle assembly not identified in

paragraph (a) of this AD.

    (ii) If the straps release, within 180 hours TIS, replace the

buckle assembly with a buckle assembly not identified in paragraph

(a) of this AD.

    (2) Do not install a restraint system with a buckle assembly

identified in paragraph (a) of this AD on any helicopter.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, FAA, may approve

AMOCs for this AD. Send your proposal to: David Hatfield, Aviation

Safety Engineer, Safety Management Section, Rotorcraft Standards

Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone

(817) 222-5116; email<EMAIL_ADDRESS>     (2) For operations conducted under a 14 CFR part 119 operating

certificate or under 14 CFR part 91, subpart K, we suggest that you

notify your principal inspector, or lacking a principal inspector,

the manager of the local flight standards district office or

certificate holding district office, before operating any aircraft

complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety

Agency (EASA) AD No. 2014-0279, dated December 19, 2014. You may

view the EASA AD on the Internet at http://www.regulations.gov in

Docket No. FAA-2017-0068.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 2500 Cabin

Equipment/Furnishings.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the

incorporation by reference of the service information listed in this

paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do

the actions required by this AD, unless the AD specifies otherwise.

    (i) Anjou Aero Service Bulletin No. 358SB-14-101, Revision 1,

dated December 12, 2014.

    (ii) Reserved.

    (3) For Anjou Aero service information identified in this AD,

contact Romtex Anjou Aeronautique, Strada Livezii nr. 98, 550042,

Sibiu, Romania; telephone +40 269 243 918; email

<EMAIL_ADDRESS>     (4) You may view this service information at FAA, Office of the

Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-

321, Fort Worth, TX 76177. For information on the availability of

this material at the FAA, call<PHONE_NUMBER>.

    (5) You may view this service information that is incorporated

by reference at the National Archives and Records Administration

(NARA). For information on the availability of this material at

NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on July 27, 2017.

Scott A. Horn,

Deputy Director for Regulatory Operations, Compliance & Airworthiness

Division, Aircraft Certification Service.

[FR Doc. 2017-16438 Filed 8-17-17; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Notices]
[Pages 58183-58187]
[FR Doc No: 2019-23632]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87392; File No. SR-NSCC-2019-003]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing of Proposed Rule Change To Require
Confirmation of Cybersecurity Program

October 24, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 15, 2019, National Securities Clearing Corporation
(``NSCC'') 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 clearing agency.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of modifications to NSCC's Rules
and Procedures (``Rules'') \3\ in order to (1) define ``Cybersecurity
Confirmation'' as a signed, written representation that addresses the
submitting firm's cybersecurity program; (2) enhance the NSCC
application requirements and ongoing requirements for Members to (a)
require that a Cybersecurity Confirmation be provided as part of the
application materials for all Members, and (b) require that all Members
deliver to NSCC a complete, updated Cybersecurity Confirmation at least
every two years; and (3) provide that NSCC may require a Cybersecurity
Confirmation from organizations that report trade data to NSCC for
comparison and trade recording, as described in greater detail below.
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    \3\ Capitalized terms not defined herein are defined in the
Rules, available at http://www.dtcc.com/legal/rules-and-procedures.
References to ``Members'' in this filing include both Members and
Limited Members, as such terms are defined in the Rules.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
(i) Overview
    NSCC is proposing to modify the Rules in order to (1) define
``Cybersecurity Confirmation'' as a signed, written representation that
addresses the submitting firm's cybersecurity program; (2) enhance the
NSCC application requirements and ongoing requirements for Members to
(a) require that a Cybersecurity Confirmation be provided as part of
the application materials for all Members, and (b) require that all
Members deliver to NSCC a complete, updated Cybersecurity Confirmation
at least every two years; and (3) provide that NSCC may require a
Cybersecurity Confirmation from organizations that report trade data to
NSCC for comparison and trade recording.
    The proposed change would require all Members and applicants to
deliver to NSCC a signed, written Cybersecurity Confirmation, which
includes representations regarding the submitting firm's cybersecurity
program and framework. The Cybersecurity Confirmation would be required
to be (1) delivered with the application materials for every applicant
for membership, and (2) updated and re-delivered at least every two
years by all Members. NSCC is also proposing to modify the Rules to
provide that it may require any organization from which it may accept
trade data for comparison and trade recording to deliver a
Cybersecurity Confirmation.
    As described in more detail below, the Cybersecurity Confirmation
would help NSCC to assess the cybersecurity risks that may be
introduced to it by Members and other entities that connect to NSCC
either through the Securely Managed and Reliable Technology (``SMART'')
network \4\ or through other connections. The proposed Cybersecurity
Confirmation would allow NSCC to better understand its Members'
cybersecurity programs and frameworks and identify possible
cybersecurity risk exposures. Based on this information, NSCC would be
able to establish appropriate controls to mitigate these risks and
their possible impacts to NSCC's operations.
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    \4\ The SMART network is a technology managed by NSCC's parent
company, The Depository Trust & Clearing Corporation (``DTCC''),
that connects a nationwide complex of networks, processing centers
and control facilities. This network extends between NSCC's and its
Members' operating premises. DTCC operates on a shared services
model with respect to NSCC and DTCC's other subsidiaries pursuant to
intercompany agreements under which it is generally DTCC that
provides a relevant service to its subsidiaries, including NSCC.
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(ii) Background of Proposal
    NSCC believes it is prudent to better understand the cybersecurity
risks that it may face through its interconnections to Members. As a
designated systemically important financial market utility, or
``SIFMU,'' NSCC occupies a unique position in the marketplace such that
a failure or a disruption to NSCC could increase the risk of
significant liquidity problems spreading among

financial institutions or markets and thereby threaten the stability of
the financial system in the United States.\5\ Given its designation as
a SIFMU, NSCC believes it is prudent to develop an enhanced endpoint
security framework designed so that its SMART network or other
connectivity is adequately protected against cyberattacks.
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    \5\ NSCC and its affiliates, The Depository Trust Company and
Fixed Income Clearing Corporation, were designated SIFMUs under
Title VIII of the Dodd-Frank Wall Street Reform and Consumer
Protection Act of 2010. 12 U.S.C. 5465(e)(1).
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    Currently, NSCC does not obtain any information regarding the
security of a firm's systems or cybersecurity program prior to
permitting that firm to connect either directly to the SMART network or
to NSCC through another means, such as through a third party service
provider, service bureau, network, or the internet. Given NSCC's
critical role in the marketplace, NSCC is proposing to address the
risks that could be posed by these connections.
    Members may currently be subject to regulations that are designed,
in part, to enhance the safeguards used by these entities to protect
themselves against cyberattacks.\6\ In order to comply with such
regulations, Members and applicants would be required to follow
standards established by national or international organizations
focused on information security management, and would have already
established protocols to allow their senior management to verify that
they have sufficient cybersecurity programs in place to fulfill
existing regulatory obligations. Other Members have established and
follow substantially similar protocols because of evolving expectations
by regulators or by institutional customers as to the sufficiency of
their cyber safeguards. NSCC believes that it should require
confirmation of the cybersecurity standards utilized by its Members and
applicants that connect to its network.
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    \6\ For example, depending on the type of entity, Members may be
subject to one or more of the following regulations: (1) Regulation
S-ID, which requires ``financial institutions'' or ``creditors''
under the rule to adopt programs to identify and address the risk of
identity theft of individuals (17 CFR 248.201-202); (2) Regulation
S-P, which requires broker-dealers, investment companies, and
investment advisers to adopt written policies and procedures that
address administrative, technical, and physical safeguards for the
protection of customer records and information (17 CFR 248.1-30);
and (3) Rule 15c3-5 under the Act, known as the ``Market Access
Rule,'' which requires broker-dealers to establish, document, and
maintain a system for regularly reviewing the effectiveness of its
management controls and supervisory procedures (17 CFR 240.15c3-5).
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    The proposed Cybersecurity Confirmation would require Members and
applicants to represent that they have established adequate controls
and security to help limit (1) cybersecurity risks to NSCC and to the
other Members' networks and (2) access by unauthorized third parties
while the firm is connected to NSCC either directly through the SMART
network or through other connectivity such as a service provider,
service bureau, network, or the internet.
(iii) Proposed Rule Changes
    NSCC is proposing to modify its Rules to (1) define ``Cybersecurity
Confirmation;'' (2) require that firms deliver a completed
Cybersecurity Confirmation (a) as part of their initial application
with NSCC, and (b) on an ongoing basis, at least every two years; and
(3) provide that NSCC may require a Cybersecurity Confirmation from
organizations that report trade data to NSCC. Each of these proposed
rule changes is described in greater detail below.
(1) Proposed Cybersecurity Confirmation
    NSCC is proposing to adopt a definition of ``Cybersecurity
Confirmation.'' Each Cybersecurity Confirmation would be required to be
in writing on a form provided by NSCC and signed by a designated senior
executive of the submitting firm who is authorized to attest to these
matters. Based on the form provided by NSCC, each Cybersecurity
Confirmation would contain representations regarding the submitting
firm's cybersecurity program and framework. Such representations by the
submitting firm would cover the two years prior to the date of the most
recently provided Cybersecurity Confirmation.
    NSCC is proposing to require that the following representations be
included in the form of Cybersecurity Confirmation:
    First, the Cybersecurity Confirmation would include a
representation that the submitting firm has defined and maintains a
comprehensive cybersecurity program and framework that considers
potential cyber threats that impact the organization and protects the
confidentiality, integrity and availability requirements of its systems
and information.
    Second, the Cybersecurity Confirmation would include a
representation that the submitting firm has implemented and maintains a
written enterprise cybersecurity policy or policies approved by the
submitting firm's senior management or board of directors, and the
organization's cybersecurity framework is in alignment with standard
industry best practices and guidelines.\7\
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    \7\ Examples of recognized frameworks, guidelines and standards
that NSCC believes are adequate include the Financial Services
Sector Coordinating Council Cybersecurity Profile, the National
Institute of Standards and Technology Cybersecurity Framework
(``NIST CSF''), International Organization for Standardization
(``ISO'') standard 27001/27002 (``ISO 27001''), Federal Financial
Institutions Examination Council (``FFIEC'') Cybersecurity
Assessment Tool, Critical Security Controls Top 20, and Control
Objectives for Information and Related Technologies. NSCC would
identify recognized frameworks, guidelines and standards in the form
of Cybersecurity Confirmation and in an Important Notice that NSCC
would issue from time to time. NSCC would also consider accepting
other standards upon request by a Member or applicant.
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    Third, the Cybersecurity Confirmation would include a
representation that, if the submitting firm is using a third party
service provider or service bureau(s) to connect or transact business
or to manage the connection with NSCC, the submitting firm has an
appropriate program to (a) evaluate the cyber risks and impact of these
third parties, and (b) review the third party assurance reports.
    Fourth, the Cybersecurity Confirmation would include a
representation that the submitting firm's cybersecurity program and
framework protect the segment of their system that connects to and/or
interacts with NSCC.
    Fifth, the Cybersecurity Confirmation would include a
representation that the submitting firm has in place an established
process to remediate cyber issues identified to fulfill the submitting
firm's regulatory and/or statutory requirements.
    Sixth, the Cybersecurity Confirmation would include a
representation that the submitting firm's cybersecurity program's and
framework's risk processes are updated periodically based on a risk
assessment or changes to technology, business, threat ecosystem, and/or
regulatory environment.
    And, finally, the Cybersecurity Confirmation would include a
representation that the review of the submitting firm's cybersecurity
program and framework has been conducted by one of the following: (1)
The submitting firm, if it has filed and maintains a current
Certification of Compliance with the Superintendent of the New York
State Department of Financial Services confirming compliance with its
Cybersecurity Requirements for Financial Services Companies; \8\ (2) a

regulator who assesses the program against an industry cybersecurity
framework or industry standard, including those that are listed on the
form of Cybersecurity Confirmation and in an Important Notice that is
issued by NSCC from time to time; \9\ (3) an independent external
entity with cybersecurity domain expertise in relevant industry
standards and practices, including those that are listed on the form of
Cybersecurity Confirmation and in an Important Notice that is issued by
NSCC from time to time; \10\ or (4) an independent internal audit
function reporting directly to the submitting firm's board of directors
or designated board of directors committee, such that the findings of
that review are shared with these governance bodies.
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    \8\ 23 N.Y. Comp. Codes R. & Regs. tit. 23, Sec.  500 (2017).
This regulation requires firms to confirm that they have a
comprehensive cybersecurity program, as described in the regulation,
which NSCC believes is sufficient to meet the objectives of the
proposed Cybersecurity Confirmation.
    \9\ Industry cybersecurity frameworks and industry standards
could include, for example, the Office of the Comptroller of the
Currency or the FFIEC Cybersecurity Assessment Tool. NSCC would
identify acceptable industry cybersecurity frameworks and standards
in the form of Cybersecurity Confirmation and in an Important Notice
that NSCC would issue from time to time. NSCC would also consider
accepting other industry cybersecurity frameworks and standards upon
request by a Member or applicant.
    \10\ A third party with cybersecurity domain expertise is one
that follows and understands industry standards, practices and
regulations that are relevant to the financial sector. Examples of
such standards and practices include ISO 27001 certification or NIST
CSF assessment. NSCC would identify acceptable industry standards
and practices in the form of Cybersecurity Confirmation and in an
Important Notice that NSCC would issue from time to time. NSCC would
also consider accepting other industry standards and practices upon
request by a Member or applicant.
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    Together, the required representations are designed to provide NSCC
with evidence of each Member's or applicant's management of
cybersecurity with respect to their connectivity to NSCC. By requiring
these representations from Members and applicants, the proposed
Cybersecurity Confirmation would provide NSCC with information that it
could use to make decisions about risks or threats, perform additional
monitoring, target potential vulnerabilities, and protect the NSCC
network.
    NSCC is proposing to amend Rule 1 (Definitions and Descriptions) of
the Rules to include a definition of ``Cybersecurity Confirmation'' as
described above.
(2) Initial and Ongoing Membership Requirement
    NSCC is proposing to require that a Cybersecurity Confirmation be
submitted to NSCC by any applicant, as part of their application
materials, and at least every two years by all Members. With respect to
the requirement to deliver a Cybersecurity Confirmation at least every
two years, NSCC would provide all Members with notice of the date on
which such Cybersecurity Confirmations would be due no later than 180
calendar days prior to such due date.
    In order to implement these proposed changes, NSCC would amend Rule
2A (Initial Membership Requirements), Section 1.C of the Rules to
require applicants to complete and deliver a Cybersecurity Confirmation
as part of their application materials. Further, NSCC would amend Rule
2B (Ongoing Membership Requirements and Monitoring), Section 2.A of the
Rules to require each Member to complete and deliver a Cybersecurity
Confirmation at least every two years, on a date that is set by NSCC
and following notice that is provided no later than 180 calendar days
prior to such due date.
(3) Organizations Reporting Trade Data to NSCC
    NSCC is also proposing to modify the Rules to provide that, when
determining whether to accept trade data from an organization for
comparison and trade recording, as provided for under Rule 7
(Comparison and Trade Recording Operation) of the Rules, NSCC may
require such organization to provide a Cybersecurity Confirmation.
These organizations are not Members of NSCC and, as such, NSCC's
relationship with these organizations is governed by a contract that is
separate from the Rules. Therefore, this change would provide
transparency regarding the steps NSCC may take when determining whether
to accept trade data from another organization.
    To implement this change, NSCC would amend Rule 7 (Comparison and
Trade Recording Operation), Section 6 of the Rules to provide that NSCC
may require organizations that deliver trade data to NSCC as described
in that Rule to provide a Cybersecurity Confirmation before agreeing to
accept such trade data.
(iv) Implementation Timeframe
    Subject to approval by the Commission, the proposed rule change
would become effective immediately. The proposed requirement that
applicants deliver a Cybersecurity Confirmation with their application
materials would be implemented immediately and would apply to
applications that have been submitted at that time but have not yet
been approved or rejected. Following the effective date of the proposed
rule change, NSCC would provide Members with notice of the due date of
their Cybersecurity Confirmations, no later than 180 days prior to such
due date, and would provide such notice at least every two years going
forward.
2. Statutory Basis
    NSCC believes the proposed rule changes are consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a registered clearing agency. In particular, NSCC
believes that the proposed rule changes are consistent with Section
17A(b)(3)(F) of the Act,\11\ and Rules 17Ad-22(e)(17)(i) and
(e)(17)(ii), each promulgated under the Act,\12\ for the reasons
described below.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
    \12\ 17 CFR 240.17Ad-22(e)(17)(i) and (e)(17)(ii).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires that the rules of NSCC be
designed to, among other things, promote the prompt and accurate
clearance and settlement of securities transactions and assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible.\13\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As described above, the proposed requirement that Members and
applicants provide a Cybersecurity Confirmation regarding their
cybersecurity program that includes the representations described above
would provide NSCC with evidence of each Member's or applicant's
management of endpoint security with respect to the SMART network or
other connectivity and would enhance the protection of NSCC against
cyberattacks. The proposed Cybersecurity Confirmation would provide
NSCC with information that it could use to make decisions about risks
or threats, perform additional monitoring, target potential
vulnerabilities, and protect the NSCC network. The proposed
Cybersecurity Confirmation would give NSCC the ability to further
identify its exposure and enable it to take steps to mitigate risks.
These requirements would help reduce risk to NSCC's network with
respect to its communications with Members and their submission of
instructions and transactions to NSCC by requiring all entities
connecting to NSCC to have appropriate cybersecurity programs in place.
    Risks, threats and potential vulnerabilities could impact NSCC's
ability to clear and settle securities transactions, or to safeguard
the securities and funds which are in its custody or control, or for
which it is responsible. Therefore, by implementing a tool that would
help to mitigate these risks, NSCC believes the proposal would

promote the prompt and accurate clearance and settlement of securities
transactions and assure the safeguarding of securities and funds which
are in the custody or control of the clearing agency or for which it is
responsible, consistent with the requirements of Section 17A(b)(3)(F)
of the Act.\14\
---------------------------------------------------------------------------

    \14\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(17)(i) under the Act requires that each covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to manage the covered
clearing agency's operational risks by identifying the plausible
sources of operational risk, both internal and external, and mitigating
their impact through the use of appropriate systems, policies,
procedures, and controls.\15\ The proposed Cybersecurity Confirmation
would reduce cybersecurity risks to NSCC by requiring all Members and
applicants to confirm they have defined and maintain cybersecurity
programs that meet standard industry best practices and guidelines. The
proposed representations in the Cybersecurity Confirmations would help
NSCC to mitigate its exposure to cybersecurity risk and, thereby,
decrease the operational risks to NSCC that are presented by
connections to NSCC through the SMART network or otherwise. The
proposed Cybersecurity Confirmations would identify to NSCC potential
sources of external operational risks and enable it to mitigate these
risks and their possible impacts to NSCC's operations. As a result,
NSCC believes the proposal is consistent with the requirements of Rule
17Ad-22(e)(17)(i) under the Act.\16\
---------------------------------------------------------------------------

    \15\ 17 CFR 240.17Ad-22(e)(17)(i).
    \16\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(17)(ii) under the Act requires that each covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to manage the covered
clearing agency's operational risks by ensuring, in part, that systems
have a high degree of security, resiliency, and operational
reliability.\17\ The proposed Cybersecurity Confirmation would enhance
the security, resiliency, and operational reliability of the endpoint
security with respect to the SMART network or other connectivity
because, as noted above, by making the Cybersecurity Confirmation an
application requirement and an ongoing membership requirement, NSCC
would be able to prevent the connection by any applicant, and take
action against any Member, that may pose an increased cyber risk to
NSCC by not having a defined and ongoing cybersecurity program that
meets appropriate standards. Members or applicants that are not in
alignment with a recognized framework, guideline, or standard that NSCC
believes is adequate to guide and assess such organization's
cybersecurity program may present increased risk to NSCC. By enabling
NSCC to identify these risks, the proposed changes would allow NSCC to
more effectively secure its environment against potential
vulnerabilities. NSCC's controls are strengthened when NSCC's Members,
and other organizations that connect to NSCC, have similar technology
risk management controls and programs within their computing
environment. Control weaknesses within a Member's environment could
allow for malicious or unauthorized usage of the link between NSCC and
the Member. As a result, NSCC believes the proposal would improve
NSCC's ability to ensure that its systems have a high degree of
security, resiliency, and operational reliability, and, as such, is
consistent with the requirements of Rule 17Ad-22(e)(17)(ii) under the
Act.\18\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.17Ad-22(e)(17)(ii).
    \18\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC believes the proposed rule change could have an impact on
competition. Specifically, NSCC believes that the proposed rule change
could burden competition because it would require Members and
applicants that do not already have cybersecurity programs that meet
the standards set out in the Cybersecurity Confirmation to incur
additional costs including, but not limited to, establishing a
cybersecurity program and framework, engaging an internal audit
function or appropriate third party to review that program and
framework, and remediating any findings from such review. In addition,
those Members and applicants that do not connect directly to the SMART
network, but connect through a third party service provider or service
bureau would have the additional burden of evaluating the cyber risks
and impact of these third parties and reviewing the third party's
assurance reports.
    NSCC believes the above described burden on competition that could
be created by the proposed changes would be both necessary and
appropriate in furtherance of the purposes of the Act, as permitted by
Section 17A(b)(3)(I) of the Act, for the reasons described below.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

    First, NSCC believes the proposed rule change would be necessary in
furtherance of the Act, specifically Section 17A(b)(3)(F) of the Act,
because the Rules must be designed to promote the prompt and accurate
clearance and settlement of securities transactions and assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible.\20\ By
requiring Members and applicants to provide a Cybersecurity
Confirmation, the proposed rule change would allow NSCC to better
understand, assess, and, therefore, mitigate the cyber risks that NSCC
could face through its connections to its Members. As described above,
these risks could impact NSCC's ability to clear and settle securities
transactions, or to safeguard the securities and funds which are in
NSCC's custody or control, or for which it is responsible. Implementing
a tool as described above would help to mitigate these risks, and
therefore NSCC believes the proposal is necessary in furtherance of the
requirements of Section 17A(b)(3)(F) of the Act.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ Id.
---------------------------------------------------------------------------

    The proposed changes are also necessary in furtherance of the
purposes of Rules 17Ad-22(e)(17)(i) and (e)(17)(ii) under the Act.\22\
The proposed Cybersecurity Confirmations would identify to NSCC
potential sources of external operational risks and allow it to
establish appropriate controls that would mitigate these risks and
their possible impacts to NSCC's operations. The proposed changes would
also improve NSCC's ability to ensure that its systems have a high
degree of security, by enabling NSCC to identify the cybersecurity
risks that may be presented to it by Members and other entities that
connect to NSCC.
---------------------------------------------------------------------------

    \22\ 17 CFR 240.17Ad-22(e)(17)(i) and (e)(17)(ii).
---------------------------------------------------------------------------

    Second, NSCC believes that the proposed rule change would be
appropriate in furtherance of the purposes of the Act. The proposed
rule change would apply equally to all Members and applicants. As
described above, NSCC believes Members may already be subject to one or
more regulatory requirements that include the implementation of a
cybersecurity program, and these firms would already follow a widely
recognized framework, guideline, or standard to guide and assess their
organization's cybersecurity program to comply with these regulations.
Therefore, NSCC believes any burden that may be imposed by the proposed
rule change would be appropriate.

    Further, while the proposed Cybersecurity Confirmation would
identify certain standards and guidelines that would be appropriate,
NSCC would consider requests by applicants and Members to allow other
standards in accepting a Cybersecurity Confirmation. Additionally, the
proposed Cybersecurity Confirmation would provide differing options to
conduct the review of the applicant's or Member's cybersecurity
program. As such, NSCC has endeavored to design the Cybersecurity
Confirmation in a way that is reasonable and does not require one
approach for meeting its requirements.
    Finally, NSCC is proposing to provide Members with a minimum of 180
calendar days' notice before the deadline for providing a Cybersecurity
Confirmation. This notice would allow Members to address any impact
this change may have on their business. Applicants would be required to
provide the Cybersecurity Confirmation as part of their application
materials upon the effective date of this proposed rule change. This
implementation schedule is designed to be fair and not
disproportionately impact any Members more than others. The proposal is
designed to provide all impacted Members with time to review their
cybersecurity programs with respect to the required representations,
and identify, if necessary, internal or third party cybersecurity
reviewers.
    For the reasons described above, NSCC believes any burden on
competition that may result from the proposed rule change would be both
necessary and appropriate in furtherance of the purposes of the Act, as
permitted by Section 17A(b)(3)(I) of the Act.\23\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not solicited or received any written comments relating to
this proposal. NSCC will notify the Commission of any written comments
received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2019-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2019-003. 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 NSCC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). 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-NSCC-2019-003 and should be submitted on
or before November 20, 2019.
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-23632 Filed 10-29-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 19, 2007 (Volume 72, Number 202)]
[Notices]
[Page 59329-59331]
[DOCID:fr19oc07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56656; File No. SR-NYSEArca-2007-94]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change and Amendment No. 1
Thereto To Eliminate Position and Exercise Limits for Options on the
Russell 2000 Index, and To Specify That Certain Reduced-Value Options
on Broad-Based Security Indexes Have No Position and Exercise Limits

October 12, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 14, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been substantially prepared by NYSE Arca. On October 1, 2007, NYSE
Arca submitted Amendment No. 1 to the proposed rule change. The
Exchange has filed the proposal as a ``non-controversial'' rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    NYSE Arca proposes to amend its rules to eliminate the position and
exercise limits for options on the Russell 2000 Index (``RUT''), and to
specify that reduced-value options on broad-based security indexes for
which full-value options have no position and exercise limits will
similarly have no position and exercise limits. The text of the
proposed rule change is available at NYSE Arca, the Commission's Public
Reference Room, and http://www.nysearca.com.

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

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

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

1. Purpose
    NYSE Arca proposes to amend Rules 5.15(a) and 5.17(a)(13) in order
to: (1) Eliminate position and exercise limits for options on RUT, a
multiply listed and heavily traded broad-based security index; and (2)
specify that reduced-value options on broad-based security indexes for
which full-value options have no position limits will similarly have no
position limits.
    Eliminate Position and Exercise Limits for RUT Options
    NYSE Arca presently trades options on one broad-based index, RUT.
However, the Exchange believes that the circumstances and
considerations that the Commission relied upon in approving the
elimination of position and exercise limits for another heavily traded
broad-based index options (e.g., NASDAQ-100 Index (``NDX''), listed on
the Chicago Board Options Exchange (``CBOE'')) \5\ equally apply to
NYSE Arca's proposal to eliminate position and exercise limits for
options on RUT. In addition, the Commission recently approved similar
proposals by CBOE and the American Stock Exchange LLC (``Amex'') to
eliminate position and exercise limits for RUT options.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 52650 (October 21,
2005), 70 FR 62147 (October 28, 2005) (SR-CBOE-2005-41) (``NDX
Approval Order'').
    \6\ See Securities Exchange Act Release Nos. 56351 (September 4,
2007), 72 FR 51875 (September 11, 2007) (SR-Amex-2007-81); and 56350
(September 4, 2007), 72 FR 51878 (September 11, 2007) (SR-CBOE-2007-
79) (collectively, ``RUT Approval Orders'').
---------------------------------------------------------------------------

    In approving the elimination of position and exercise limits for
NDX options on CBOE, the Commission considered the capitalization of
this index and the deep and liquid markets for the securities
underlying the index that significantly reduced the concerns of market
manipulation or disruption in the underlying markets.\7\ The Commission
also noted the active trading volume for options on the index. The
Exchange believes that RUT shares these factors in common with NDX. As
of July 31, 2007, the approximate market capitalization of NDX was
$2.28 trillion, the average daily trading volume (``ADTV'') for the
component of NDX was 572 million shares and the ADTV for options on NDX
was approximately 64,000 contracts per day. NYSE Arca believes that RUT
has comparable characteristics. The market capitalization for RUT is
$1.73 trillion, the ADTV for the underlying securities is 535 million
shares, and the ADTV for the option is approximately 79,000 contracts.
---------------------------------------------------------------------------

    \7\ See NDX Approval Order, supra note 5.
---------------------------------------------------------------------------

    In approving the elimination of position and exercise limits for
NDX, the Commission also noted that financial requirements imposed by
the options exchanges and the Commission serve to address concerns that
an exchange member, an Options Trading Permit (``OTP'') Holder \8\ in
the case of NYSE Arca, or its customer, may try to maintain an
inordinately large unhedged position in NDX options. These same
financial requirements also apply to RUT options. Under NYSE Arca
rules, the Exchange also has the authority to impose additional margin
upon accounts maintaining underhedged positions, and is further able to
monitor accounts to determine when such action is warranted. As noted
in the Exchange's rules, the clearing firm carrying such an account
would be subject to capital charges under Rule 15c3-1 under the Act \9\
to the extent of any resulting margin deficiency.\10\
---------------------------------------------------------------------------

    \8\ OTP Holder is defined in NYSE Arca Rule 1.1(q). OTP Holders
have the status of a ``member'' of the Exchange as that term is
defined in Section 3 of the Act. See 15 U.S.C. 78c.
    \9\ 17 CFR 240.15c3-1.
    \10\ See NYSE Arca Rule 5.17(a)(14).
---------------------------------------------------------------------------

    In approving the elimination of position and exercise limits for
NDX, the Commission relied heavily on

CBOE's ability to provide surveillance and reporting safeguards to
detect and deter trading abuses arising from the elimination of
position and exercise limits on the index. NYSE Arca represents that
the current Exchange surveillance procedures are adequate to continue
monitoring RUT options, once the position and exercise limits are
eliminated. In addition, the Exchange intends to impose a reporting
requirement on NYSE Arca OTP Holders and OTP Firms (other than NYSE
Arca market-makers) that trade RUT options. This reporting requirement
would require OTP Holders and OTP Firms who maintain in excess of
100,000 RUT option contracts on the same side of the market, for their
own accounts or for the account of customers, to report information as
to whether the positions are hedged and provide documentation as to how
such contracts are hedged, in a manner and form required by the
Exchange's Options Surveillance Department. The Exchange would take
prompt action, including timely communication with the Commission and
other marketplace self-regulatory organizations responsible for
oversight of trading in component stocks, should any unanticipated
adverse market effects develop.\11\ The Exchange may also specify other
reporting requirements, as well as the limit at which the reporting
requirement may be triggered.
---------------------------------------------------------------------------

    \11\ Telephone conversation between Andrew Stevens, Assistant
General Counsel, NYSE Arca, and Theodore S. Venuti, Special Counsel,
Division of Market Regulation, Commission, on October 12, 2007.
---------------------------------------------------------------------------

    The Exchange believes that eliminating position and exercise limits
for RUT options is consistent with approved rules relating to similar
broad-based index products currently trading on other exchanges. The
Exchange believes that eliminating the position and exercise limits for
options on RUT will allow NYSE Arca OTP Holders and OTP Firms greater
hedging and investment opportunities.
    Elimination of Position Limits for reduced value Options on Broad-
Based Indexes for which there are not Position and Exercise Limits for
Full Value Options
    The Exchange may list and trade reduced-value options on broad-
based indexes for which the Exchange also lists and trades full-value
options.\12\ The Exchange proposes to amend Rule 5.15(a) to state that
reduced-value options on broad-based security indexes for which full
value options have no position and exercise limits will similarly have
no position and exercise limits.
---------------------------------------------------------------------------

    \12\ NYSE Arca does not presently list or trade reduced-value
options.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act,\13\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\14\ in particular, in that it is designed
to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts and practices, 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Because the forgoing rule change does not: (1) Significantly affect
the protection of investors or the public interest; (2) impose any
significant burden on competition; and (3) become operative for 30 days
after the date of this filing, or such shorter time as the Commission
may designate, it has become effective pursuant to Section 19(b)(3)(A)
of the Act \15\ and Rule 19b-4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\17\
However, Rule 19b-4(f)(6)(iii) \18\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because such waiver
will allow NYSE Arca members and their customers greater hedging and
investment opportunities in RUT options without further delay. The
Commission notes that it recently approved substantially similar
proposals filed by Amex and CBOE.\19\ The Commission believes that NYSE
Arca's proposal to eliminate position and exercise limits for RUT
options raises no new issues. For these reasons, the Commission
designates the proposed rule change to be operative upon filing with
the Commission.\20\
---------------------------------------------------------------------------

    \17\ CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has requested the Commission to waive
this five-day pre-filing notice requirement. The Commission hereby
grants this request.
    \18\ Id.
    \19\ See RUT Approval Orders, supra note 6.
    \20\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.\21\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(C). For purposes of calculating the 60-
day period within which the Commission may summarily abrogate the
proposal, the Commission considers the period to commence on October
1, 2007, the date on which the Exchange submitted Amendment No. 1.
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NYSEArca-2007-94 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-94. This
file number should be included on the

subject line if e-mail is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all

subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
filing also will be available for inspection and copying at the
principal office of NYSE Arca. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2007-94 and should be submitted on or before
November 9, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-20587 Filed 10-18-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58106-58108]
[FR Doc No: 2022-20626]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1894]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric Device Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of

1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Yale-Mayo Clinic Centers of Excellence in
Regulatory Science and Innovation (CERSI) B12 Pediatric Device
Survey.''

DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-1894 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of
Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric
Device Survey.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey

OMB Control Number NEW

    Despite numerous legislative, regulatory, and scientific efforts,
there has been little change in the number of devices approved for use
in pediatric patients. This has often led to devices being adapted for
use in children without an appropriate level of evidence, exposing them
to inconsistent benefit risk profiles. This health inequity highlights
the need for devices that are designed, evaluated, and labelled for
pediatric patients. To address these challenges, this collection is
being done to survey industry and

other key stakeholders in the medical device ecosystem to identify the
barriers that prevent product developers from entering the pediatric
device market as well as the proper incentives that would motivate them
to innovate and sustain within this market.
    This survey is a followup to the public meeting that FDA held in
August 2018, entitled, ``Pediatric Medical Device Development.'' As
mandated by section 502(d) of the FDA Reauthorization Act of 2017 (Pub.
L. 115-52) the meeting was convened to address several topics,
including consideration of ways to: (1) increase FDA assistance to
medical device manufacturers in developing devices for pediatric
populations that are approved or cleared, and labeled, for their use
and (2) identify current barriers to pediatric device development and
incentives to address such barriers.
    Feedback from this meeting clarified the need to better understand
factors influencing suboptimal engagement and participation by diverse
innovators in the pediatric medical device space. Information garnered
from this survey may help inform strategic plans to optimize existing
programs for the needs of pediatric medical device innovators and
develop new programs that will support sustained development in this
space.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response          \2\
----------------------------------------------------------------------------------------------------------------
Phone Survey..................              17               1              17  0.5 (30 minutes)               9
Online Survey.................              56               1              56  1...............              56
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................              65
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest hour.

    The targeted groups for this collection of information include
representatives from the medical device industry, academia, recipients
of funding under section 305 of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Pub. L. 110-85; 42 U.S.C. 282 note), and trade
organizations, medical provider organizations, organizations and
individuals involved with financing and reimbursement associated with
medical devices, pediatric healthcare leaders, clinicians who regularly
use medical devices in caring for children, and organizations and
individuals representing patients and consumers.
    Phone survey: Respondents participating in the phone survey will be
executives from companies either producing products in pediatrics or
from companies that produce products that could be used in pediatrics.
Executives will be invited to engage in the 30-minute phone survey.
    Online survey: The 1-hour online survey will be administered to
leaders within pediatric companies and key decision makers in the
pediatric medical device industry (e.g., venture capitalists, banking
investors, leaders in children's hospitals and research networks, and
pediatric patient advocates).

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20626 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P