[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 310-311]
[FR Doc No: 2012-31577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1256]

Draft Revision of Guidance for Industry on Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the Electronic Common
Technical Document Specifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications.'' The draft guidance announced in this notice is
being issued in accordance with the Food and Drug Administration Safety
and Innovation Act (FDASIA) which amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require that certain submissions under
the FD&C Act and Public Health Service Act (PHS Act) be submitted in
electronic format, beginning no earlier than 2 years after publication
of the final version of the draft guidance. The draft guidance
describes how FDA plans to implement the requirements for the
electronic submission of applications for certain human pharmaceutical
products and is being issued for public comment. In its final form,
this document will also supersede the guidance titled ``Guidance for
Industry Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' that was issued in October 2005 and revised in
April 2006 and June 2008.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 4, 2013.

ADDRESSES: Submit written requests for single copies of the documents
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
Virginia Hussong, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1161,
Silver Spring, MD 20993, email<EMAIL_ADDRESS>
or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The electronic Common Technical Document (eCTD) is an International
Conference on Harmonisation (ICH) standard based on specifications

developed by ICH and its member parties. FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) have been receiving submissions in the eCTD format
since 2003, and the eCTD has been the recommended format for electronic
submissions to CDER and CBER since January 1, 2008. The majority of new
electronic submissions are now received in eCTD format.
    FDASIA (Pub. L. 112-144, 126 Stat. 993 (2012)), signed by the
President on July 9, 2012, amended the FD&C Act to add section 745A,
titled ``Electronic Format for Submissions.'' Section 745A(a)(1) of the
FD&C Act requires that submissions under section 505(b), (i), or (j) of
the FD&C Act, and submissions under sections 351(a) or (k) of the PHS
Act, be submitted to FDA in electronic format no earlier than 24 months
after FDA issues the final guidance described in this section.
    In accordance with section 745A(a)(1) of the FD&C Act, FDA is
issuing this draft guidance, announcing its determination that
submission types identified in this draft guidance must be submitted
electronically (except for submissions that are exempted), in a format
that FDA can process, review, and archive. Currently, the Agency can
process, review, and archive electronic submissions made using the eCTD
version 3.2.2 specifications. Requirements for electronic submission
will be phased in according to the following schedule: (1) 24 months
after publication of the final version of this draft revised guidance,
the requirements will apply to new drug application (NDA), abbreviated
new drug application (ANDA), and biologics license application (BLA)
submissions and (2) 36 months after publication of the final guidance,
the requirements will apply to investigational new drug application
(IND) submissions. Section 745A(a) of the FD&C Act does not apply to
master files and advertising and promotional labeling submissions.
However, FDA accepts and strongly encourages the submission of master
files and advertising and promotional labeling materials
electronically, as described in the draft guidance.
    In Section 745A(a), Congress granted explicit authorization to FDA
to implement the statutory electronic submission requirements by
specifying the format for such submissions in guidance. To the extent
that the draft guidance provides such requirements under section
745A(a) of the FD&C Act, indicated by the use of the words must or
required, it is not subject to the usual restrictions in FDA's good
guidance practice (GGP) regulations, such as the requirement that
guidances not establish legally enforceable responsibilities. See 21
CFR 10.115(d).
    At the same time, the draft guidance also provides guidance on
FDA's interpretation of the statutory electronic submission requirement
and the Agency's current thinking on the best means for implementing
other aspects of the electronic submission program. Therefore, to the
extent that the draft guidance includes provisions that are not part of
the requirements under section 745A(a), it is being issued in
accordance with FDA's GGP regulation (21 CFR 10.115). Such parts of the
draft guidance, when finalized, will represent the Agency's current
thinking on this topic, and do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. You can use
an alternative approach for these recommendations if such an approach
would satisfy the requirements of the applicable statutes and
regulations. The use of the word should in the draft guidance means
that something is suggested or recommended, but not required.
Accordingly, the final guidance will contain both binding and
nonbinding provisions.

II. Paperwork Reduction Act of 1995

    The draft guidance 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 (the PRA) (44 U.S.C. 3501-3520).
The draft guidance pertains to sponsors and applicants making
regulatory submissions to FDA in electronic format for NDAs, ANDAs,
BLAs, INDs, master files, and advertising and promotional labeling. The
information collection discussed in the draft guidance is contained in
our IND regulations (21 CFR part 312) and approved under OMB control
number 0910-0014, our NDA regulations (including ANDAs) (21 CFR part
314) and approved under OMB control number 0910-0001, and our BLA
regulations (21 CFR part 601) and approved under OMB control number
0910-0338.
    Sponsors and applicants have been submitting NDAs, ANDAs, BLAs, and
INDs electronically since 2003, and the majority of these submissions
are already received in electronic format. Under FDASIA, sponsors and
applicants will be required to make all of these submissions
electronically. These requirements will be phased in over 2 and 3 year
periods after the issuance of the final guidance.
    There may be new costs, including capital costs or operating and
maintenance costs, which would result from the requirements under
FDASIA and the final guidance, because some sponsors and applicants
would have to convert from paper-based submissions to electronic
submissions. In accordance with the PRA, prior to publication of the
final guidance document, FDA intends to solicit public comment and
obtain OMB approval for any costs that are new or that would represent
material modifications to these previously approved collections of
information found in FDA regulations.

III. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: December 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31577 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93986-93988]
[FR Doc No: 2016-30794]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79583; File No. SR-Phlx-2016-104]

Self-Regulatory Organizations; NASDAQ PHLX LLC; Order Approving
Proposed Rule Change To Amend Phlx Rule 748, Supervision

December 16, 2016.

I. Introduction

    On October 14, 2016, NASDAQ PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend several provisions of
Rule 748 in order to modernize, upgrade, and strengthen the Exchange's
rules pertaining to supervisory obligations of its members and member
organizations.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    The proposed rule change was published for comment in the Federal
Register on November 3, 2016.\3\ The public comment period closed on
November 25, 2016. The Commission received no comments in response to
the Notice.
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    \3\ See Exchange Act Release No. 79185 (Oct. 28, 2016), 81 FR
76637 (Nov. 3, 2016) (File No. SR-Phlx-2016-104) (``Notice'').
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    This order grants approval of the proposed rule change.

II. Description of the Proposed Rule Change \4\
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    \4\ The subsequent description of the proposed rule change is
substantially excerpted from the Exchange's description in the
Notice.
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Rule 748(a)

    Rule 748(a) currently provides in the first paragraph that each
office, location, department, or business activity of a member or
member organization (including foreign incorporated branch offices)
shall be under the supervision and control of the member or member
organization establishing it and of an appropriately qualified
supervisor. The Exchange is amending the first paragraph of Rule 748(a)
to clarify and state clearly that each trading system and internal
surveillance system of a member or member organization (including
foreign incorporated branch offices) shall, inasmuch as they are
aspects of their business activity, be under the supervision and
control of the member or member organization establishing it and of an
appropriately qualified supervisor.

Rule 748(b)

    Rule 748(b), Designation of Supervisor by Member Organizations,
currently provides in relevant part that the general partners or
directors of each member organization shall provide for appropriate
supervisory control and shall designate a general partner or principal
executive officer to assume overall authority and responsibility for
internal supervision and control of the organization and compliance
with securities' (sic) laws and regulations, including the By-Laws and
Rules of the Exchange. It provides that the designated person shall
delegate to qualified principals or qualified employees responsibility
and authority for supervision and control of each office, location,
department, or business activity, (including foreign incorporated
branch offices), and provide for appropriate written procedures of
supervision and control. The Exchange proposes to amend Rule 748(b) to
provide that the delegated person shall likewise delegate to qualified
principals or qualified employees responsibility and authority for
supervision and control of each trading system and internal
surveillance system.\5\
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    \5\ The Exchange also proposes to delete the extraneous
apostrophe following the word ``securities.''
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Rule 748(c)

    Rule 748(c) currently provides that each person with supervisory
control, as described in paragraphs (a) and (b) of Rule 748, must meet
the Exchange's qualification requirements for supervisors, including
successful completion of the appropriate examination. The Exchange
proposes to add to Rule 748(c) a new requirement that each member or
member organization must make reasonable efforts to determine that each
person with supervisory control, as described in paragraphs (a) and (b)
of Rule 748, is qualified by virtue of experience or training to carry
out his or her assigned responsibilities.

Rule 748(g)

    Rule 748(g), Office Inspections, currently provides that each
member or member organization for which the Exchange is the Designated
Examining Authority shall inspect each office or location (including
foreign incorporated branch offices) of the member or member
organization according to a cycle that shall be established in its
written supervisory procedures. In establishing such inspection cycle,
the member or member organization shall give consideration to the
nature and complexity of the securities activities for which the office
or location is responsible, the volume of business done, and the number
of registered representatives, employees, and associated persons at
each office or location. Rule 748(g) is proposed to be amended to
provide that an inspection may not be conducted by any person within
that office or location who has supervisory responsibilities or by any
individual who is directly or indirectly supervised by such person. The
Exchange also proposes to add language requiring the examination
schedule and an explanation of the factors considered in determining
the frequency of the examinations in the cycle to be set forth in the
member or member organization's written supervisory procedures. It also
proposes to require that the inspection be reasonably designed to
assist in preventing and detecting violations of, and achieving
compliance with, applicable securities laws and regulations, and with
applicable Exchange rules.

Rule 748(h)

    Rule 748(h) in the first paragraph currently requires each member
or member organization to establish, maintain, and enforce written
supervisory procedures, and a system for applying such procedures, to
supervise the types of business(es) in which the member or member
organization engages and to supervise the activities of all registered
representatives, employees, and associated persons. The written
supervisory procedures and the system for applying such procedures
shall reasonably be expected to prevent and detect, insofar as
practicable, violations of the applicable securities laws and
regulations, including the By-Laws and Rules of the Exchange. The
Exchange proposes to substitute the word ``designed'' for the word
``expected.''
    Rule 748(h) in the second paragraph currently requires that the
written supervisory procedures set forth the supervisory system
established by the member or member organization and include the name,
title, registration status, and location of all supervisory personnel
required by this rule, the dates for which supervisory designations
were or are effective, and the responsibilities of supervisory
personnel as these relate to the types of business(es) the member or
member organization engages in, and securities laws and regulations,
including the By-Laws and Rules of the Exchange. The Exchange proposes
to add a requirement that this record be preserved for a period of not
less than three years, the first two in an easily accessible place.
    Rule 748(h) in the third paragraph currently requires a copy of the
written supervisory procedures to be kept and maintained at each
location where supervisory activities are conducted on behalf of the
member or member organization. It requires each member or member
organization to amend its written supervisory procedures as appropriate
within a reasonable time after changes occur in supervisory personnel
or supervisory procedures, and to communicate such changes throughout
its organization within a reasonable time. The Exchange proposes to
amend Rule 748(h) to likewise amend and communicate changes to its
written supervisory procedures as appropriate within a reasonable time
after changes occur in applicable securities laws and regulations and
Exchange rules.

III. Comment Summary

    As noted above, the Commission received no comments on the proposed
rule change.

IV. Discussion and Commission Findings

    The Commission has carefully considered the proposal. Based on its
review of the record, the Commission finds that the proposal is
consistent with the requirements of the Exchange Act and the rules and
regulations thereunder that are applicable to a national securities
exchange.\6\ Specifically, the Commission finds that the rule change is
consistent with Section 6(b)(5) of the Exchange Act,\7\ which requires,
among other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, and, in general, to
protect investors and the public interest.
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    \6\ In approving this rule change, the Commission has considered
the rule's impact on efficiency, competition, and capital formation.
See 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
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    As stated in the Notice, the Exchange believes that ``[r]equiring
increased comprehensive supervision by members and member organizations
of their activities should promote the Exchange's ability to enforce
compliance by members and member organizations with the [Exchange] Act
and the regulations thereunder.'' \8\ With respect to the proposed
amendments of Rule 748(a) and (b), the Exchange believes that these
amendments ``should protect investors and the public interest by
specifically requiring supervision and control'' of trading systems and
internal surveillance systems to be supervised and controlled by ``an
appropriately qualified individual.'' \9\ The Exchange believes that
the proposed amendments to Rule 748(c) ``should protect investors and
the public interest by requiring that each person with supervisory
control as described in Rules 748(a) and (b) to be qualified by virtue
of experience or training to carry out his or her assigned
responsibilities, such that the individual has the actual capacity to
fulfill those responsibilities.'' \10\
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    \8\ Notice at 76638.
    \9\ Id.
    \10\ Id.
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    Further, the Exchange believes that the proposed amendments to Rule
748(g) will ``minimiz[e] the potential for conflicts of interest in the
conduct of office inspections'' by prohibiting those inspections ``from
being conducted by any person within that office or location who has
supervisory responsibilities or by any individual who is directly or
indirectly supervised by such a person who may be incentivized to
minimize any compliance issues identified in the inspection.'' \11\ The
Exchange also believes ``[t]he proposed amendments to Rule 748(g)
concerning the examination schedule and specifically requiring that the
inspection be reasonably designed to assist in preventing and detecting
violations of, and achieving compliance with, applicable securities
laws and regulations and with applicable Exchange rules should assure
that inspections take place with a predictable and adequate frequency
and are reasonably designed to identify violations of applicable law
and rules.'' \12\
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    \11\ Id. at 76638-39.
    \12\ Id. at 76639.
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    The Exchange believes that the proposed amendments to Rule 748(h),
which address the design and maintenance of written supervisory
procedures, will ``facilitate identification of instances where the
procedures were not followed'' and also ``clarif[y] the affirmative
nature of the member or member organization's obligations under the
rule when creating such procedures.'' \13\ Finally, the Exchange
believes that the proposed amendment to Rule 748(h) with respect to
updating written supervisory procedures ``should promote the continued
usefulness of the procedures in the context of ongoing changes in the
regulatory environment in which members and member organizations
conduct their business.'' \14\
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    \13\ Id.
    \14\ Id.
---------------------------------------------------------------------------

    The Commission notes that the proposal received no comments from
the public. Taking into consideration the Exchange's views about the
proposed amendments, the Commission believes that the proposal will
help protect investors and the public interest by strengthening and
clarifying the supervisory obligations of Exchange members and member
organizations. The Commission believes that the approach proposed by
the Exchange is appropriate and designed to protect investors and the
public interest, consistent with Section 6(b)(5) of the Exchange Act.
For these reasons, the Commission finds that the proposed rule change
is consistent with the Exchange Act and the rules and regulations
thereunder.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) \15\ of the
Exchange Act,\16\ that the proposed rule change

(SR-Phlx-2016-104) be, and hereby is, approved.
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    \15\ Id.
    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-30794 Filed 12-21-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81335-81339]
[FR Doc No: 2015-32726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]

Medical Device User Fee and Modernization Act; Notice to Public
of Web Site Location of Fiscal Year 2016 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the Web site location where the Agency will post two lists
of guidance documents that the Center for Devices and Radiological
Health (CDRH or the Center) intends to publish in Fiscal Year (FY)
2016. In addition, FDA has established a docket, where interested
persons may comment on the priority of topics for guidance, provide
comments and/or propose draft language for those topics, suggest topics
for new or different guidance documents, comment on the applicability
of guidance documents that have issued previously, and provide early
input to support guidances that will be developed.

DATES: Although you can comment on any guidance at any time, submit
either electronic or written comments by February 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-1021 for ``Medical Device User Fee and Modernization Act;
Notice to Public of Web site Location of Fiscal Year 2016 Proposed
Guidance Development.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The

Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration,10903 New Hampshire
Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of
2012 (MDUFA III), Title II, Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of
quantitative and qualitative goals intended to help get safe and
effective medical devices to market more quickly. Among these
commitments included:
     Annually posting a list of priority medical device
guidance documents that the Agency intends to publish within 12 months
of the date this list is published each fiscal year (the ``A-list'')
and
     annually posting a list of device guidance documents that
the Agency intends to publish, as the Agency's guidance-development
resources permit each fiscal year (the ``B-list'').
    FDA invites interested persons to submit comments on any or all of
the guidance documents on the lists as explained in 21 CFR
10.115(f)(5). FDA has established the docket number (FDA-2012-N-1021)
where comments on the FY 2016 lists, draft language for guidance
documents on those topics, suggestions for new or different guidances,
and relative priority of guidance documents may be submitted and shared
with the public (see ADDRESSES). FDA believes this docket is an
important tool for receiving information from interested persons and
will update these lists annually on FDA's Web site at the beginning of
each fiscal year from 2013 to 2017. FDA anticipates that feedback from
interested persons, will allow CDRH to better prioritize and more
efficiently draft guidances.
    In addition to posting the lists of prioritized device guidance
documents, FDA has committed to updating its Web site in a timely
manner to reflect the Agency's review of previously published guidance
documents; including, the deletion of guidance documents that no longer
represent the Agency's interpretation of or policy on a regulatory
issue and notation of guidance documents that are under review by the
Agency.
    Fulfillment of these commitments will be reflected through the
issuance of updated guidance on existing topics, removal of guidances
that that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.

II. CDRH Guidance Development Initiative

    On June 5, 2014, CDRH held a public workshop to provide
stakeholders (e.g., industry, academia, public health advocacy groups,
and other interested persons) an opportunity to actively engage with
Center representatives about the guidance development process, provide
transparency into guidance priority development, promote dialogue on
guidance process improvements, and generate ideas for assessing the
impact of guidance (Ref. 1). The workshop also provided a forum to
discuss best practices and public participation in guidance
development. CDRH carefully considered the comments and suggestions
provided by stakeholders.
    At the 2014 workshop, stakeholders requested that draft guidance
documents be more clearly identified as ``draft'' to indicate to CDRH
stakeholders and staff that they are not for implementation. CDRH
revised its templates for new draft guidance documents by adding the
watermark ``DRAFT'' to all pages in order to more conspicuously mark
the guidance as not for implementation. CDRH implemented the use of the
new templates effective August 6, 2014, and continues to use these
templates.
    Stakeholders also recommended that CDRH's guidance documents Web
page (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm) list draft guidances separately from
those that had been finalized. CDRH revised its guidance document Web
page to include a left navigation item for ``Draft Guidance.'' In
addition, CDRH removed draft guidance documents from the office
guidance document lists and separated the link to ``Recent Medical
Device Guidance Documents'' into two separate links: ``Recent Medical
Device Final Guidance Documents'' and ``Recent Medical Device Draft
Guidance Documents.''
    CDRH is aware of draft guidance documents yet to be finalized.
Therefore, in order to assure the timely completion or re-issuance of
draft guidances in FY 2015, CDRH committed to performance goals for
current and future draft guidance documents. For draft guidance
documents issued after October 1, 2014, CDRH committed to finalize,
withdraw, reopen the comment period or issue another draft guidance on
the topic for 80 percent of the documents within 2 years of the close
of the comment period and for the remaining 20 percent, within 5 years.
In FY 2015, CDRH has withdrawn 14 of 20 draft guidances issued prior to
October 1, 2009, and has been continuing to work towards finalizing the
remaining draft guidances. Furthermore, in FY 2016, CDRH will finalize,
withdraw, or reopen the comment period for 50 percent of existing draft
guidances issued prior to October 1, 2010, CDRH expects to renew or
modify, as appropriate, these performance goals in FY 2017 and
subsequent years.

A. Earlier Stakeholder Involvement in Guidance Development

    At the 2014 workshop, stakeholders also expressed a desire to be
involved earlier in the guidance development process. CDRH
representatives discussed various ways in which the Center currently
encourages participation by external stakeholders in the guidance
development process. In the case of emerging technologies, CDRH uses
``leapfrog'' guidances to provide initial recommendations regarding the
type of information that would be appropriate in the review of these
emerging technologies. Input from external stakeholders help CDRH

formulate its initial thinking on the data necessary to support
marketing approval, clearance, or oversight of these devices. In FY
2015, CDRH issued two leapfrog draft guidances, ``Premarket Studies of
Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices'' (Ref.
2) and Radiation Biodosimetry Devices (Ref. 3). For the Premarket
Studies of Implantable MIGS Device guidance document, early stakeholder
input was obtained through discussions with glaucoma specialists
identified by the American Glaucoma Society through the Network of
Experts (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm289534.htm), as well as
through a workshop cosponsored with the American Glaucoma Society on
February 26, 2014 (Ref. 4). In addition, early stakeholder feedback was
obtained at a public workshop for the Radiation Biodosimetry Devices
guidance document (Ref. 5).
    Additionally, in FY 2015, in anticipation of guidance documents
expected to be developed, CDRH sought stakeholder input regarding
Patient Matched Instrumentation for Orthopedics, Medical Devices
Intended for Aesthetic Use, and Dual 510(k) and Clinical Laboratory
Improvement Amendments Act (CLIA) Waiver by Application. The feedback
received has been considered in the development of these guidances and
CDRH has included the Dual 510(k) and CLIA Waiver by Application
guidance and Patient Matched Instrumentation for Orthopedics on the
FY2016 B-List.
    CDRH is posing the following questions to interested persons for
consideration and comment, so that relevant future draft guidances on
these technologies can be as complete and useful as possible. We will
carefully consider the comments received in the development of new
guidance documents and incorporate the information where appropriate.
CDRH believes that public input during guidance development and after a
draft guidance is issued on the topic will lead to a comprehensive and
informed final guidance on the Agency's policy for the technologies and
processes in the following list:
1. Electromagnetic Compatibility (EMC) of Electrically-Powered Medical
Devices
    EMC assessment is a vital part of ensuring that risks associated
with performance degradation of electrically-powered medical devices
associated with electromagnetic interference are adequately addressed.
CDRH recently published a short draft guidance entitled ``Information
to Support a Claim of Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Devices'' (Ref. 6) to provide a framework
for promoting consistent submission and review of EMC information in
premarket submissions. In addition, CDRH plans to also draft a more
detailed guidance on this topic guidance to provide more comprehensive
information and transparency to stakeholders regarding the information
necessary to support an EMC claim. FDA invites comments on the
following questions:
    a. There has been increasing use of electromagnetic emitters (e.g.,
radio-frequency identification, electronic article surveillance gates,
metal detectors) in the environments where medical devices operate.
What methods are used to determine EMC of devices exposed to these
common emitters?
    b. Given that basic safety, as defined in the IEC 60601-1 family of
standards, does not include effectiveness, how is device performance
evaluated differently than device safety for EMC? Specifically, are
pass/fail criteria chosen such that they will address both performance
and safety for each EMC test? Alternatively, are safety and performance
tested separately?
    c. When networks (wired or wireless) are determined to be necessary
for device performance, how are they included as a system when tested
for EMC?
    d. The use of ``third party'' components can significantly affect
the EMC of the medical device system. How are device systems evaluated
for EMC when off-the-shelf components such as smartphones, tablets, or
PCs are intended to be used in the device system?
    e. Medical devices, like most electronic products, go through
various design changes that can affect the EMC of the device system.
The changes or modifications can occur after initial EMC testing. What
factors and methods are used to determine how device changes or
modifications (e.g., software, firmware, hardware) will affect EMC and
how is it determined when partial or complete EMC re-testing of a
device is needed?
    f. The use of magnetic resonance (MR) imaging technology on medical
device users and patients is increasing. MR imaging incorporates very
strong magnetic and electric fields that can have very significant
effects on the safety and effectiveness of medical devices, especially
electrically active devices. How is MR safety and compatibility
addressed for electrically active medical devices intended for use in
the MR environment? How is MR safety addressed (e.g. labeling or other)
for electrically active medical devices not intended for use in the MR
environment?
    g. Several medical device EMC consensus standards specify the
information to be conveyed to the user regarding device EMC. Is this
information sufficient? If not, what additional type of information is
typically provided to help the user manage the risks associated with
medical device EMC and how is this information conveyed?
2. Utilizing Animal Studies To Evaluate the Safety of Organ
Preservation Devices and Solutions
    While the national transplant waiting list continues to grow, rates
of donation and transplant remain stagnant. On average, 22 people die
each day waiting for a transplant. The dire deficit in organ
transplants has propelled a new wave of innovation in perfusion-based
organ preservation technologies. With such innovation also comes the
challenge of demonstrating that these new technologies, when evaluated
in animal models, are sufficiently safe for early clinical experience.
    After animal organs undergo preservation using a new organ
transport device or solution, there are generally two models to assess
post-reperfusion injury: (1) An in vivo model in which the organ is
transplanted into a surrogate recipient animal and (2) an ex vivo model
in which the organ is reperfused under simulated transplant conditions.
FDA intends to develop guidance to provide recommendations for
utilizing both in vivo and ex vivo models to evaluate emerging organ
preservation technologies. Prior to drafting our recommendations in a
future guidance document, FDA invites comments on the following
questions:
    a. What are the potential limitations of an ex vivo model in
assessing reperfusion injury, and how can these limitations be
mitigated? In addition to markers for cell injury and function,
histology, and the use of allogeneic blood during reperfusion, what
measures can be taken to improve the data generated in an ex vivo
model?
    b. In an in vivo model, what are strategies to limit confounding
factors, such as immunological responses and hemodynamic instability,
from affecting the assessment of device-related reperfusion injury?
    c. Is there a perceived hierarchy of evidence regarding data
obtained from an ex vivo model and those obtained from an in vivo
model? Or rather, is it

more judicious to view the two models as complements of each other?
    d. What role does the risk of the device play in the utilization of
in vivo and ex vivo models? Regarding specific experimental parameters
(e.g., length of preservation, total ischemic time), under what
circumstances is it appropriate to test the worst-case scenario?
    e. What are the organ-specific challenges in developing in vivo and
ex vivo models to assess reperfusion injury?
    f. What approaches would improve the in vivo and ex vivo study
designs to ensure the generation of sufficient, meaningful data while
limiting the number of animals used in such studies?

B. Stakeholder Feedback To Enhance the CDRH Guidance Program

    In addition, to enhance the CDRH guidance program, CDRH invites
interested persons to comment on the following questions:
    a. The cover page of each guidance document includes contact
information for questions regarding the guidance, and a list of CDRH
Offices that have generally contributed to the drafting of the
guidance. Is the list of CDRH Offices involved in the drafting of the
guidance informative? What other administrative information should be
included on the cover page?
    b. CDRH is committed to the continual improvement of the quality of
guidance documents and we are seeking to identify examples of quality
guidance documents. Are there specific guidance documents published in
the past 5 years that were particularly informative and helpful that
could serve as models for future guidance documents? Please provide the
title of the guidance documents and briefly describe what specific
aspects were informative and helpful?
    c. Has the enhanced Guidance Document Search feature on the FDA Web
site (http://www.fda.gov/RegulatoryInformation/Guidances/default.htm)
improved searchability of guidances? Are there any suggestions for how
the search feature could be improved?

C. Applicability of Previously-Issued Final Guidance

    CDRH has issued over 1,000 guidance documents to provide
stakeholders with the Agency's thinking on numerous topics. Each
guidance reflected the Agency's current position at the time that it
was issued. However, the guidance program has issued these guidances
over a period greater than 20 years, raising the question of how
current do previously issued final guidances remain? CDRH has resolved
to address this concern through a staged review of previously issued
final guidances in collaboration with stakeholders.
    At the Web site where CDRH has posted the ``A-list'' and ``B-list''
for FY 2016, CDRH has also posted a list of final guidance documents
that issued in 2006, 1996, 1986, and 1976.\1\
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    \1\ The retrospective list of final guidances does not include:
(1) Documents that are not guidances but were inadvertently
categorized as guidance such as scientific publications, advisory
opinions, and interagency agreements; (2) guidances actively being
revised by CDRH; and (3) special controls documents.
---------------------------------------------------------------------------

    The Center is interested in external feedback on whether any of
these final guidances should be revised or withdrawn. In addition, for
guidances that are recommended for revision, information explaining the
need for revision, such as, the impact and risk to public health
associated with not revising the guidance, would also be helpful as the
Center considers potential action with respect to these guidances. CDRH
intends to provide these lists of previously-issued final guidances
annually through FY 2025 so that by 2025, FDA and stakeholders will
have assessed the applicability of all guidances older than 10 years.
For instance, in the annual notice for FY 2017, CDRH expects to provide
a list of the final guidance documents that issued in 2007, 1997, 1987,
and 1977; the annual notice for FY 2018 is expected to provide a list
of the final guidance documents that issued in 2008, 1998, 1988, and
1978, and so on. CDRH will consider the comments received from this
retrospective review when determining priorities for updating guidance
documents, and will revise these as resources permit. During FY 2015,
CDRH received comments regarding guidances issued in 2005, 1995, and
1985, and is considering further actions on specific guidances in
response to comments received.
    Under the Good Guidance Practices regulation at Sec.  10.115(f)(4),
the public may, at any time, suggest that CDRH revise or withdraw an
already existing guidance document. The suggestion should clearly
explain why the guidance document should be revised or withdrawn and,
if applicable, how it should be revised. Interested persons are
requested to examine the list of previously issued final guidances
provided by CDRH on the annual agenda Web site but feedback on any
guidance is appreciated.

III. Web Site Location of Guidance Lists

    This notice announces the Web site location of the document that
provides the A and B lists of guidance documents, which CDRH is
intending to publish during FY 2016. To access these two lists, visit
FDA's Web site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm. We note
that the topics on this and past guidance priority lists may be removed
or modified based on current priorities. The Agency is not required to
publish every guidance on either list if the resources needed would be
to the detriment of meeting quantitative review timelines and statutory
obligations. In addition, the Agency is not precluded from issuing
guidance documents that are not on either list.
    FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. CDRH's experience in guidance development
has shown that there are many reasons that CDRH staff may not complete
the entire agenda of guidances it undertakes. Staff is frequently
diverted from guidance development to other priority activities. In
addition, at any time new issues may arise to be addressed in guidance
that could not have been anticipated at the time the annual list is
generated. These may involve newly identified public health issues.

IV. References

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

1. Center for Devices and Radiological Health Guidance Development
and Prioritization; Public Workshop; Requests for Comments,
available at http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm394821.htm.
2. Premarket Studies of Implantable Minimally Invasive Glaucoma
Surgical (MIGS) Devices Draft Guidance, available at<EMAIL_ADDRESS>3. Radiation Biodosimetry Devices; Draft Guidance for Industry and
Food and Drug Administration Staff, available at http://www.fda.gov/
downloads/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf.
4. American Glaucoma Society/Food and Drug Administration Workshop
on Supporting Innovation for Safe and Effective Minimally Invasive
Glaucoma Surgery; Public Workshop, available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm382508.htm.
5. Regulatory Science Considerations for Medical Countermeasure
Radiation Biodosimetry Devices, available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm308079.htm.
6. Information to Support a Claim of Electromagnetic Compatibility
(EMC) of Electrically-Powered Medical Devices, available at<EMAIL_ADDRESS>
    Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32726 Filed 12-28-15; 8:45 am]
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[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23119-23120]
[FR Doc No: 2020-08695]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88693 File No. SR-NYSECHX-2020-13]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 1.1 To Include Managed Portfolio Shares in the Definition of ``UTP
Exchange Traded Product''

April 20, 2020.
    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 April 16, 2020, the NYSE Chicago, Inc. (``NYSE Chicago'' or
the ``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 prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 1.1 to include Managed
Portfolio Shares in the definition of ``UTP Exchange Traded Product.''
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 1.1(k), which sets forth the
meanings of ``Exchange Traded Product'' and ``UTP Exchange Traded
Product'' as those terms are used in Exchange rules. Specifically, the
Exchange proposes to amend the definition of ``UTP Exchange Traded
Product'' to include Managed Portfolio Shares \4\ as an additional type
of Exchange Traded Product (``ETP'') that may trade on the Exchange
pursuant to unlisted trading privileges (``UTP'').
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    \4\ Managed Portfolio Shares are shares of actively managed
exchange-traded funds for which the portfolio is disclosed in
accordance with standard mutual fund disclosure rules. See, e.g.,
Cboe BZX Exchange, Inc. (``BZX'') Rule 14.11(k). On April 2, 2020,
BZX commenced trading its first securities listed under BZX Rule
14.11(k) (American Century Focused Dynamic Growth ETF (FDG) and
American Century Focused Large Cap Value ETF (FLV)).
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    To effect this change, the Exchange proposes to add a bullet point
listing ``Managed Portfolio Shares'' in Rule 1.1(k) to include them in
the enumerated list of ETPs that may trade on the Exchange on a UTP
basis. The Exchange also proposes a non-substantive grammatical change
to accommodate the addition of ``Managed Portfolio Shares'' as the
final item in the bulleted list in Rule 1.1(k).
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\6\ in particular, because it
is designed to remove impediments to and perfect the mechanism of a
free and open market, to promote just and equitable principles of
trade, and, in general, to protect investors and the public interest.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) & (5).
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    The proposed rule change is designed to remove impediments to and
perfect the mechanism of a free and open market, promote just and
equitable principles of trade, and, in general, to protect investors
and the public interest because it ensures that Rule 1.1(k) correctly
identifies and publicly states the complete list of ETPs that may trade
on a UTP basis on the Exchange, providing additional specificity,
clarity, and transparency in the Exchange's rules. Moreover, the
proposed rule change will facilitate the trading of an additional type
of ETP on the Exchange pursuant to UTP, thereby enhancing competition
among market participants for the benefit of investors and the
marketplace.

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 proposed change would
provide the public and investors with up-to-date information about the
types of ETPs that can trade on the Exchange on a UTP basis and would
promote competition by adding an additional type of ETP that may trade
on the Exchange pursuant to UTP.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give 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 satisfied this requirement.

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    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
waiver of the operative delay would allow trading of Managed Portfolio
Shares on the Exchange on a UTP basis without delay. The Exchange
further states that Managed Portfolio Shares listed on BZX commenced
trading on April 2, 2020. Based on the foregoing, the Commission
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest. Accordingly, the
Commission waives the 30-day operative delay and designates the
proposed rule change operative upon filing.\11\
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    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-NYSECHX-2020-13 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-NYSECHX-2020-13. 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-NYSECHX-2020-13 and should be submitted
on or before May 15, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-08695 Filed 4-23-20; 8:45 am]
 BILLING CODE 8011-01-P