[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86591-86592]
[FR Doc No: 2020-28892]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90794; File No. SR-FICC-2020-017]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Designation of Longer Period for Commission Action and Longer
Period for Comment on Proposed Rule Change To Modify the Calculation of
the MBSD VaR Floor To Incorporate a Minimum Margin Amount

December 23, 2020.
    On November 20, 2020, Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ proposed rule change SR-
FICC-2020-017 to introduce a new ``Minimum Margin Amount'' to
complement the existing VaR Floor calculation.\3\ The proposed rule
change was published for comment in the Federal Register on December
10, 2020.\4\ As of December 23, 2020, the Commission has received five
comment letters to the proposed rule change.\5\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ On November 27, 2020, FICC also filed the proposal contained
in the proposed rule change as advance notice SR-FICC-2020-804 with
the Commission pursuant to Section 806(e)(1) of the Dodd-Frank Wall
Street Reform and Consumer Protection Act entitled the Payment,
Clearing, and Settlement Supervision Act of 2010 (``Clearing
Supervision Act''), 12 U.S.C. 5465(e)(1), and Rule 19b-4(n)(1)(i) of
the Act, 17 CFR 240.19b-4(n)(1)(i).
    \4\ Securities Exchange Act Release No. 90568 (December 4,
2020), 85 FR 79541 (December 10, 2020) (SR-FICC-2020-017)
(``Notice'').
    \5\ See Letter from Kelli McMorrow, Head of Government Affairs,
American Securities Association, dated December 18, 2020, to Vanessa
Countryman, Secretary, Commission, available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017.htm (``ASA Letter''); Letter
from Pete Mills, Senior Vice President, Mortgage Bankers
Association, dated December 17, 2020, to Jay Clayton, Chairman,
Commission, available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017-8155338-226778.pdf (``MBA Letter''); Letter from
Christopher Killian, Managing Director, Securities Industry and
Financial Markets Association, dated December 16, 2020, to Vanessa
Countryman, Secretary, Commission, available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017-8154310-226759.pdf (``SIFMA
Letter''); Letter from Curtis Richins, President & CEO, Mortgage
Capital Trading, Inc., dated December 15, 2020, to Vanessa
Countryman, Secretary, Commission, available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017-8156568-226839.pdf (``MCT
Letter''); and Letter from James Tabacchi, Chairman, Independent
Dealer and Trader Association, dated December 10, 2020, to Vanessa
Countryman, Secretary, Commission, available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017-8127766-226454.pdf (``IDTA
Letter''). See comments on the proposed rule change (SR-FICC-2020-
017), available at https://www.sec.gov/comments/sr-ficc-2020-017/srficc2020017.htm. Because the proposal contained in the proposed
rule change was also filed as an advance notice, supra note 3, the
Commission is considering all public comments received on the
proposal regardless of whether the comments were submitted to the
advance notice or the proposed rule change.

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    Section 19(b)(2) of the Act \6\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the proposed rule change
is January 24, 2020.
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    \6\ 15 U.S.C. 78s(b)(2).
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    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the proposed rule change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \7\ and for
the reasons stated above, the Commission designates March 10, 2020 as
the date by which the Commission shall either approve, disapprove, or
institute proceedings to determine whether to disapprove the proposed
rule change (File No. SR-FICC-2020-017).
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    \7\ Id.
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    The Commission also seeks to extend the comment period to help
further inform its analysis of the proposed rule change. The comment
period for the proposed rule change ends on December 31, 2020.\8\ As of
December 23, 2020, the Commission has received five comment letters to
the proposed rule change.\9\ The Commission is extending the comment
period for the proposed rule change to allow interested persons
additional time to analyze the issues and prepare their comments.
Accordingly, the Commission designates January 29, 2021 as the date
comments should be submitted on or before.
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    \8\ Notice, 85 FR at 79548.
    \9\ See supra note 5.
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    Specifically, the Commission invites interested persons to provide
views, data, and arguments concerning the proposed rule change,
including whether the proposed rule change is consistent with the Act
and the applicable rules or regulations thereunder. Please note that
comments previously received on the substance of the proposed rule
change will be considered together with comments submitted in response
to this notice. Therefore, while commenters are free to submit
additional comments at this time, they need not re-submit earlier
comments.
    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-FICC-2020-017 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-FICC-2020-017. 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 FICC 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-FICC-2020-017 and should be submitted on
or before January 21, 2021.
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    \10\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2020-28892 Filed 12-29-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14192-14193]
[FR Doc No: 2020-04899]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7580-003]

South Sutter Water District; Notice of Application for Surrender
of Conduit Exemption, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application for surrender of conduit
exemption from licensing.
    b. Project No.: 7580-003.
    c. Date Filed: December 31, 2019.
    d. Exemptee: South Sutter Water District (SSWD).
    e. Name of Project: Vanjop No. 1 Hydroelectric Project.
    f. Location: The project is located on SSWD's Conveyance Canal
which is part of SSWD's water delivery system near Sheridan in Placer
County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Brad Arnold, General Manager, South Suter
Water District, 2464 Pacific Avenue, Trowbridge, CA 95659, (530) 656-
2242<EMAIL_ADDRESS>    i. FERC Contact: Kim Nguyen,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests is
April 3, 2020. The Commission strongly encourages electronic filing.
Please file motions to intervene, protests and comments using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-7580-003.
    k. Description of Project Facilities: The project consists of a
radial gate, a bypass gate, an intake structure, a catch basin, a
discharge structure, three turbine-generator units with total
generating capacity of 415 kilowatts, and a short transmission line.

    l. Description of Request: The licensee is proposing to surrender
its exemption. The project operated until 2018 when significant repairs
necessitated an extended outage until now. SSWD evaluated repair along
with future operations and maintenance costs for the project, and
concluded that the project is no longer economical, especially since
the power purchase contract with Pacific Gas and Electric expired on
October 14, 2019. The facilities would remain in place, except for the
turbine-generator units which would be removed.
    m. This filing may be viewed on the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction in the Commission's Public Reference Room located at 888
First Street NE, Room 2A, Washington, DC 20426, or by calling (202)
502-8371.
    n. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.212 and .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    p. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to the surrender application that is the subject of this notice.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    q. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described proceeding. If any agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.

    Dated: March 4, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-04899 Filed 3-10-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66844-66845]
[FR Doc No: 2015-27705]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1696]

Minimal Manipulation of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry and Food and Drug
Administration Staff; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the draft document entitled ``Minimal Manipulation
of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft
Guidance for Industry and Food and Drug Administration Staff,''
published in the Federal Register of December 23, 2014. FDA is
reopening the comment period to allow interested persons additional
time to submit comments and any new information.

DATES: Submit either electronic or written comments on the draft
guidance by April 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-2014-D-1696 for ``Minimal Manipulation of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Draft Guidance for Industry and
Food and Drug Administration Staff; Reopening the Comment Period.''
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: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 23, 2014 (79 FR 77012), FDA
announced the availability of a draft document entitled ``Minimal
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based
Products; Draft Guidance for Industry and Food and Drug Administration
Staff'' dated December 2014. The draft guidance document provides human
cells, tissues, and cellular and tissue-based product (HCT/P)
manufacturers, health care providers, and FDA staff with
recommendations for meeting the 21 CFR 1271.10(a)(1) criterion of
minimal manipulation. Interested persons were originally given until
February 23, 2015, to comment on the draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is announcing
four other related documents. In a separate document, FDA is announcing
a public hearing entitled ``Draft Guidances Relating to the Regulation
of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public
Hearing; Request for Comments'' (part 15 hearing) to be held on April
13, 2016, to provide stakeholders with the opportunity to discuss FDA's
policy on regulation of HCT/Ps related to the four draft guidances on
the following topics: Homologous use, same surgical procedure
exception, minimal manipulation, and adipose tissue.
    In a separate document, FDA is announcing the availability of a
draft document entitled ``Homologous Use of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA
Staff.''
    In separate documents, FDA is also reopening the comment periods to
FDA's public dockets on the previously issued draft guidance documents
on the following topics related to HCT/Ps: Adipose tissue (Docket No.
FDA-2014-D-1856) and same surgical procedure exception (Docket No. FDA-
2014-D-1584).

II. Reopening of Comment Period

    Following publication of December 23, 2014, notice of availability,
FDA received a request to allow interested persons additional time to
comment. In conjunction with the part 15 hearing and announcement of
availability of the homologous use draft guidance, FDA is reopening the
comment period to allow potential respondents to thoroughly evaluate
and address pertinent issues. The minimal manipulation draft guidance
and other related guidances (homologous use, same surgical procedure
exception, adipose tissue) all deal with the interpretation of the
regulations under 21 CFR part 1271 that will be addressed as part of
the part 15 hearing.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27705 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59687-59694]
[FR Doc No: 2017-27012]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82290; File No. SR-NASDAQ-2017-123]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To List and Trade the Shares
of the Causeway International Value NextSharesTM and the
Causeway Global Value NextSharesTM

December 11, 2017.
    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 November 28, 2017, The Nasdaq Stock Market LLC (``Nasdaq'' 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 prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.

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

    The Exchange proposes to list and trade under Nasdaq Rule 5745
(Exchange-Traded Managed Fund Shares (``NextShares'')) the common
shares (``Shares'') of the exchange-traded managed funds described
herein (each a ``Fund'' and together, the ``Funds'').\3\
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    \3\ Except for the specific Fund information set forth below,
this rule filing conforms to the rule filing, as modified by
amendments 1 and 2 thereto, relating to the listing and trading on
Nasdaq of the shares of 18 series of the Eaton Vance ETMF Trust and
the Eaton Vance ETMF Trust II, as approved by the Commission in
Securities Exchange Act Release No. 75499 (July 21, 2015) (SR-
NASDAQ-2015-036).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    The Exchange proposes to list and trade the Shares of the Funds
under Nasdaq Rule 5745, which governs the listing and trading of
exchange-traded managed fund shares, as defined in Nasdaq Rule
5745(c)(1), on the Exchange.\4\ Causeway ETMF Trust, which is discussed
below, is registered with the Commission as an open-end investment
company and has filed a registration statement on Form N-1A
(``Registration Statement'') with the Commission. The Funds are each a
series of Causeway ETMF Trust and will be advised by an investment
adviser registered under the Investment Advisers Act of 1940
(``Advisers Act''), as described below. The Funds will be actively
managed and will pursue the principal investment strategies noted
below.\5\
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    \4\ The Commission approved Nasdaq Rule 5745 in Securities
Exchange Act Release No. 34-73562 (Nov. 7, 2014), 79 FR 68309 (Nov.
14, 2014) (SR-NASDAQ-2014-020).
    \5\ Additional information regarding the Funds will be available
on the free public website for the Funds at www.causewayfunds.com
and in the Registration Statement for the Funds.
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I. Causeway ETMF Trust
    Causeway ETMF Trust is registered with the Commission as an open-
end investment company and has filed a Registration Statement with the
Commission.\6\ The following Funds are each a series of Causeway ETMF
Trust.\7\
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    \6\ See initial Registration Statement on Form N-1A for Causeway
ETMF Trust dated September 20, 2017 (File Nos. 333-220536 and 811-
23294). The descriptions of the Funds and the Shares contained
herein conform to the initial Registration Statement.
    \7\ The Commission has issued an order granting Causeway ETMF
Trust and certain affiliates exemptive relief under the Investment
Company Act of 1940, as amended (the ``Investment Company Act'').
See Investment Company Act Release No. 32485 (February 22, 2017)
(File No. 812-14729).
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    Causeway Capital Management LLC (the ``Adviser'') will be the
adviser to the Funds. The Adviser is not a registered broker-dealer,
and is not affiliated with a broker-dealer. Personnel who make
decisions on a Fund's portfolio composition must be subject to
procedures designed to prevent the use and dissemination of material,
non-public information regarding the open-end fund's portfolio.\8\
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    \8\ An investment adviser to an open-end fund is required to be
registered under the Advisers Act. As a result, the Adviser and its
related personnel are subject to the provisions of Rule 204A-1 under
the Advisers Act relating to codes of ethics. This Rule requires
investment advisers to adopt a code of ethics that reflects the
fiduciary nature of the relationship to clients as well as
compliance with other applicable securities laws. Accordingly,
procedures designed to prevent the communication and misuse of non-
public information by an investment adviser must be consistent with
Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under
the Advisers Act makes it unlawful for an investment adviser to
provide investment advice to clients unless such investment adviser
has (i) adopted and implemented written policies and procedures
reasonably designed to prevent violation, by the investment adviser
and its supervised persons, of the Advisers Act and the Commission
rules adopted thereunder; (ii) implemented, at a minimum, an annual
review regarding the adequacy of the policies and procedures
established pursuant to subparagraph (i) above and the effectiveness
of their implementation; and (iii) designated an individual (who is
a supervised person) responsible for administering the policies and
procedures adopted under subparagraph (i) above.
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    In the event that (a) the Adviser registers as a broker-dealer or
becomes newly affiliated with a broker-dealer, or (b) any new adviser
or sub-adviser to a Fund is a registered broker-dealer or is affiliated
with a broker-dealer, such adviser or sub-adviser will implement and
will maintain a fire wall with respect to its relevant personnel and/or
such broker-dealer affiliate, as applicable, regarding access to
information concerning the composition and/or changes to a Fund's
portfolio and will be subject to procedures designed to prevent the use
and dissemination of material non-public information regarding such
portfolio.
    SEI Investments Distribution Co. (``SIDCO'') will be the principal
underwriter and distributor of each Fund's Shares. SEI Investments
Global Funds Services, Inc. will act as the administrator and
accounting agent to each Fund; The Bank of New York Mellon will act as
transfer agent and custodian to the Funds; ICE Data Indices, LLC will
calculate intraday indicative values (``IIVs'') for each Fund.
    The Funds will be actively managed and will pursue the principal
investment strategies described below.\9\
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    \9\ Additional information regarding the Funds will be available
on a free public website for the Funds (www.causewayfunds.com, which
may contain links for certain information to www.nextshares.com) and
in the Registration Statement for the Funds.
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Causeway International Value NextShares (``International Value
NextShares'')
    The investment objective of the International Value NextShares is
to seek long-term growth of capital and income. Under normal market
conditions, the International Value NextShares will invest primarily in
equity securities of companies in developed countries outside the U.S.
Normally, the International Value NextShares will invest at least 80%
of its total assets in equity securities of companies in a number of
foreign countries and normally will invest the majority of its total
assets in equity securities of companies that pay dividends or
repurchase their shares. The International Value NextShares may invest
in emerging (less developed) markets. The International Value
NextShares considers a country to be an emerging market if the country
is included in the MSCI Emerging Markets Index. The International Value
NextShares may invest in equity securities of companies of any market
capitalization, and will not be required to invest a minimum amount and
will not be limited to investing a maximum amount in any particular
country.
Causeway Global Value NextShares (``Global Value NextShares'')
    The investment objective of the Global Value NextShares is to seek
long-term growth of capital and income. Under normal market conditions,
the Global Value NextShares will invest primarily in equity securities
of companies in developed and emerging countries outside the U.S. and
of companies in the U.S. Normally, the Global Value NextShares will
invest the

majority of its total assets in equity securities of companies that pay
dividends or repurchase their shares.
    Under normal circumstances, the Global Value NextShares will invest
at least 40% of its total assets in a number of countries outside the
U.S. The Global Value NextShares may invest in emerging (less
developed) markets. The Global Value NextShares considers a country to
be an emerging market if the country is included in the MSCI Emerging
Markets Index. The Global Value NextShares may also invest in frontier
markets. The Global Value NextShares considers a country to be a
frontier market if the country is classified by MSCI, based on a
country's economic development, size, liquidity and market
accessibility, as a frontier market.
    The Global Value NextShares may invest in equity securities of
companies of any market capitalization, and will not be required to
invest a minimum amount and will not be limited to investing a maximum
amount in any particular country.
Creations and Redemptions of Shares
    Shares will be issued and redeemed on a daily basis at a Fund's
next-determined net asset value (``NAV'') \10\ in specified blocks of
Shares called ``Creation Units.'' A Creation Unit will consist of at
least 25,000 Shares. Creation Units may be purchased and redeemed by or
through ``Authorized Participants.'' \11\ Purchases and sales of Shares
in amounts less than a Creation Unit may be effected only in the
secondary market, as described below, and not directly with a Fund.
---------------------------------------------------------------------------

    \10\ As with other registered open-end investment companies, NAV
generally will be calculated daily (on each day the New York Stock
Exchange is open for trading), as of 4:00 p.m. Eastern Time. NAV
will be calculated by dividing a Fund's net asset value by the
number of Shares outstanding. Information regarding the valuation of
investments in calculating a Fund's NAV will be contained in the
Registration Statement for its Shares.
    \11\ ``Authorized Participants'' will be either: (1)
``participating parties,'' i.e., brokers or other participants in
the Continuous Net Settlement System (``CNS System'') of the
National Securities Clearing Corporation (``NSCC''), a clearing
agency registered with the Commission and affiliated with the
Depository Trust Company (``DTC''), or (2) DTC participants, which
in either case have executed participant agreements with a Fund's
distributor, and which have been acknowledged by the transfer agent,
regarding the creation and redemption of Creation Units. Investors
will not have to be Authorized Participants in order to transact in
Creation Units, but must place an order through and make appropriate
arrangements with an Authorized Participant for such transactions.
---------------------------------------------------------------------------

    The creation and redemption process for a Fund may be effected ``in
kind,'' in cash, or in a combination of securities and cash. Creation
``in kind'' means that an Authorized Participant--usually a brokerage
house or large institutional investor--purchases the Creation Unit with
a basket of securities equal in value to the aggregate NAV of the
Shares in the Creation Unit. When an Authorized Participant redeems a
Creation Unit in kind, it receives a basket of securities equal in
value to the aggregate NAV of the Shares in the Creation Unit.\12\
---------------------------------------------------------------------------

    \12\ In compliance with Nasdaq Rule 5745(b)(5), which applies to
Shares based on an international or global portfolio, Causeway ETMF
Trust's application for exemptive relief under the Investment
Company Act states that Causeway ETMF Trust will comply with the
federal securities laws in accepting securities for deposits and
satisfying redemptions with securities, including that the
securities accepted for deposits and the securities used to satisfy
redemption requests are sold in transactions that would be exempt
from registration under the Securities Act of 1933, as amended (15
U.S.C. 77a).
---------------------------------------------------------------------------

Composition File
    As defined in Nasdaq Rule 5745(c)(3), the Composition File is the
specified portfolio of securities and/or cash that a Fund will accept
as a deposit in issuing a Creation Unit of Shares, and the specified
portfolio of securities and/or cash that a Fund will deliver in a
redemption of a Creation Unit of Shares. The Composition File will be
disseminated through the NSCC once each business day before the open of
trading in Shares on such day and also will be made available to the
public each day on a free public website.\13\ Because each Fund seeks
to preserve the confidentiality of its current portfolio trading
program, a Fund's Composition File generally will not be a pro rata
reflection of the Fund's investment positions. Each security included
in the Composition File will be a current holding of the relevant Fund,
but the Composition File generally will not include all of the
securities in that Fund's portfolio or match the weightings of the
included securities in the portfolio. Securities that the Adviser is in
the process of acquiring for a Fund generally will not be represented
in the Fund's Composition File until their purchase has been completed.
Similarly, securities that are held in a Fund's portfolio but in the
process of being sold may not be removed from its Composition File
until the sale program is substantially completed. To the extent that a
Fund creates or redeems Shares in kind, it will use cash amounts to
supplement the in-kind transactions to the extent necessary to ensure
that Creation Units are purchased and redeemed at NAV. The Composition
File also may consist entirely of cash, in which case it will not
include any of the securities in a Fund's portfolio.\14\
---------------------------------------------------------------------------

    \13\ The free public website containing the Composition File
will be www.nextshares.com.
    \14\ In determining whether a Fund will issue or redeem Creation
Units entirely on a cash basis, the key consideration will be the
benefit that would accrue to the Fund and its investors. For
instance, in bond transactions, the Adviser may be able to obtain
better execution for a Fund than Authorized Participants because of
the Adviser's size, experience and potentially stronger
relationships in the fixed- income markets.
---------------------------------------------------------------------------

Transaction Fees
    All persons purchasing or redeeming Creation Units are expected to
incur a transaction fee to cover the estimated cost to the relevant
Fund of processing the transaction, including the costs of clearance
and settlement charged to it by NSCC or DTC, and the estimated trading
costs (i.e., brokerage commissions, bid-ask spread and market impact)
to be incurred in converting the Composition File to or from the
desired portfolio holdings. The transaction fee is determined daily and
will be limited to amounts approved by the board of trustees of the
Funds and determined by the Adviser to be appropriate to defray the
expenses that a Fund incurs in connection with the purchase or
redemption of Creation Units.
    The purpose of transaction fees is to protect a Fund's existing
shareholders from the dilutive costs associated with the purchase and
redemption of Creation Units. Transaction fees may vary over time for a
Fund depending on the estimated trading costs for its portfolio
positions and Composition File, processing costs and other
considerations. To the extent that a Fund specifies greater amounts of
cash in its Composition File, it may impose higher transaction fees. In
addition, to the extent that a Fund includes in its Composition File
instruments that clear through DTC, the Fund may impose higher
transaction fees than when the Composition File consists solely of
instruments that clear through NSCC, because DTC may charge more than
NSCC in connection with Creation Unit transactions.\15\ The transaction
fees applicable to a Fund's purchases and redemptions on a given
business day will be disseminated through the NSCC prior to the open of
market trading on that day and also will be made available

to the public each day on a free public website.\16\ In all cases, the
transaction fees will be limited in accordance with the requirements of
the Commission applicable to open-end management investment companies
offering redeemable securities.
---------------------------------------------------------------------------

    \15\ Authorized Participants that participate in the CNS System
of the NSCC are expected to be able to use the enhanced NSCC/CNS
process for effecting in-kind purchases and redemptions of Shares
(the ``NSCC Process'') to purchase and redeem Creation Units of a
Fund that limits the composition of its basket to include only NSCC
Process-eligible instruments (generally domestic equity securities
and cash). Because the NSCC Process is generally more efficient than
the DTC clearing process, NSCC is likely to charge a Fund less than
DTC to settle purchases and redemptions of Creation Units.
    \16\ The free public website will be www.nextshares.com.
---------------------------------------------------------------------------

NAV-Based Trading
    Because Shares will be listed and traded on the Exchange, Shares
will be available for purchase and sale on an intraday basis. Shares
will be purchased and sold in the secondary market at prices directly
linked to the relevant Fund's next-determined NAV using a new trading
protocol called ``NAV-Based Trading.'' \17\ All bids, offers and
execution prices of Shares will be expressed as a premium/discount
(which may be zero) to a Fund's next-determined NAV (e.g., NAV-$0.01,
NAV+$0.01). A Fund's NAV will be determined daily (on each day the New
York Stock Exchange is open for trading), as of 4:00 p.m. Eastern Time.
Trade executions will be binding at the time orders are matched on
Nasdaq's facilities, with the transaction prices contingent upon the
determination of NAV.
---------------------------------------------------------------------------

    \17\ Aspects of NAV-Based Trading are protected intellectual
property subject to issued and pending U.S. patents held by
NextShares Solutions LLC (``NextShares Solutions''), a wholly owned
subsidiary of Eaton Vance Corp. Nasdaq has entered into a license
agreement with NextShares Solutions to allow for NAV- Based Trading
on the Exchange of exchange-traded managed funds that have
themselves entered into license agreements with NextShares
Solutions.
---------------------------------------------------------------------------

Trading Premiums and Discounts
    Bid and offer prices for Shares will be quoted throughout the day
relative to NAV. The premium or discount to NAV at which Share prices
are quoted and transactions are executed will vary depending on market
factors, including the balance of supply and demand for Shares among
investors, transaction fees and other costs in connection with creating
and redeeming Creation Units of Shares, the cost and availability of
borrowing Shares, competition among market makers, the Share inventory
positions and inventory strategies of market makers, the profitability
requirements and business objectives of market makers, and the volume
of Share trading. Reflecting such market factors, prices for Shares in
the secondary market may be above, at or below NAV. A Fund with higher
transaction fees may trade at wider premiums or discounts to NAV than
other funds with lower transaction fees, reflecting the added costs to
market makers of managing their Share inventory positions through
purchases and redemptions of Creation Units.
    Because making markets in Shares will be simple to manage and low
risk, competition among market makers seeking to earn reliable, low-
risk profits should enable the Shares to routinely trade at tight bid-
ask spreads and narrow premiums/discounts to NAV. As noted below, each
Fund will make available on a free public website that will be updated
on a daily basis current and historical trading spreads and premiums/
discounts of Shares trading in the secondary market.\18\
---------------------------------------------------------------------------

    \18\ The free public website containing this information will be
www.nextshares.com, which will be available directly and through a
link from www.causewayfunds.com.
---------------------------------------------------------------------------

    Transmitting and Processing Orders. Member firms will utilize
certain existing order types and interfaces to transmit Share bids and
offers to Nasdaq, which will process Share trades like trades in shares
of other listed securities.\19\ In the systems used to transmit and
process transactions in Shares, a Fund's next-determined NAV will be
represented by a proxy price (e.g., 100.00) and a premium/discount of a
stated amount to the next-determined NAV to be represented by the same
increment/decrement from the proxy price used to denote NAV (e.g., NAV-
$0.01 would be represented as 99.99; NAV+$0.01 as 100.01).
---------------------------------------------------------------------------

    \19\ As noted below, all orders to buy or sell Shares that are
not executed on the day the order is submitted will be automatically
cancelled as of the close of trading on such day. Prior to the
commencement of trading in a Fund, the Exchange will inform its
members in an Information Circular of the effect of this
characteristic on existing order types.
---------------------------------------------------------------------------

    To avoid potential investor confusion, Nasdaq will work with member
firms and providers of market data services to seek to ensure that
representations of intraday bids, offers and execution prices of Shares
that are made available to the investing public follow the ``NAV-$0.01/
NAV+$0.01'' (or similar) display format. All Shares listed on the
Exchange will have a unique identifier associated with their ticker
symbols, which would indicate that the Shares are traded using NAV-
Based Trading. Nasdaq makes available to member firms and market data
services certain proprietary data feeds that are designed to supplement
the market information disseminated through the consolidated tape
(``Consolidated Tape''). Specifically, the Exchange will use the Nasdaq
Basic and Nasdaq Last Sale data feeds to disseminate intraday price and
quote data for Shares in real time in the ``NAV-$0.01/NAV+$0.01'' (or
similar) display format. Member firms could use the Nasdaq Basic and
Nasdaq Last Sale data feeds to source intraday Share prices for
presentation to the investing public in the ``NAV-$0.01/NAV+$0.01'' (or
similar) display format. Alternatively, member firms could source
intraday Share prices in proxy price format from the Consolidated Tape
and other Nasdaq data feeds (e.g., Nasdaq TotalView and Nasdaq Level 2)
and use a simple algorithm to convert prices into the ``NAV-$0.01/
NAV+$0.01'' (or similar) display format. As noted below, prior to the
commencement of trading in a Fund, the Exchange will inform its members
in an Information Circular of the identities of the specific Nasdaq
data feeds from which intraday Share prices in proxy price format may
be obtained.
    Intraday Reporting of Quotes and Trades. All bids and offers for
Shares and all Share trade executions will be reported intraday in real
time by the Exchange to the Consolidated Tape \20\ and separately
disseminated to member firms and market data services through the
Exchange data feeds listed above. The Exchange will also provide the
member firms participating in each Share trade with a contemporaneous
notice of trade execution, indicating the number of Shares bought or
sold and the executed premium/discount to NAV.\21\
---------------------------------------------------------------------------

    \20\ Due to systems limitations, the Consolidated Tape will
report intraday execution prices and quotes for Shares using a proxy
price format. As noted, Nasdaq will separately report real-time
execution prices and quotes to member firms and providers of market
data services in the ``NAV-$0.01/NAV+$0.01'' (or similar) display
format, and otherwise seek to ensure that representations of
intraday bids, offers and execution prices for Shares that are made
available to the investing public follow the same display format.
    \21\ All orders to buy or sell Shares that are not executed on
the day the order is submitted will be automatically cancelled as of
the close of trading on such day.
---------------------------------------------------------------------------

    Final Trade Pricing, Reporting and Settlement. All executed Share
trades will be recorded and stored intraday by Nasdaq to await the
calculation of a Fund's end-of- day NAV and the determination of final
trade pricing. After a Fund's NAV is calculated and provided to the
Exchange, Nasdaq will price each Share trade entered into during the
day at that Fund's NAV plus/minus the trade's executed premium/
discount. Using the final trade price, each executed Share trade will
then be disseminated to member firms and market data services via an
FTP file to be created for exchange-traded managed funds and confirmed
to the member firms participating in the trade to supplement the
previously provided

information to include final pricing.\22\ After the pricing is
finalized, Nasdaq will deliver the Share trading data to NSCC for
clearance and settlement, following the same processes used for the
clearance and settlement of trades in other exchange-traded securities.
---------------------------------------------------------------------------

    \22\ File Transfer Protocol (``FTP'') is a standard network
protocol used to transfer computer files on the internet. Nasdaq
will arrange for the daily dissemination of an FTP file with
executed Share trades to member firms and market data services.
---------------------------------------------------------------------------

Availability of Information
    Prior to the commencement of market trading in Shares, a Fund will
be required to establish and maintain a free public website through
which its current prospectus may be downloaded.\23\ The free public
website will include directly or through a link additional Fund
information updated on a daily basis, including the prior business
day's NAV, and the following trading information for such business day
expressed as premiums/discounts to NAV: (a) Intraday high, low, average
and closing prices of Shares in Exchange trading; (b) the midpoint of
the highest bid and lowest offer prices as of the close of Exchange
trading, expressed as a premium/discount to NAV (the ``Closing Bid/Ask
Midpoint''); and (c) the spread between highest bid and lowest offer
prices as of the close of Exchange trading (the ``Closing Bid/Ask
Spread.'').\24\ The free public website will also contain charts
showing the frequency distribution and range of values of trading
prices, Closing Bid/Ask Midpoints and Closing Bid/Ask Spreads over
time.
---------------------------------------------------------------------------

    \23\ The free public website containing this information will be
www.causewayfunds.com.
    \24\ The free public website containing a Fund's NAV will be
www.causewayfunds.com. All other information listed will be made
available on www.nextshares.com, which can be accessed directly and
via a link on www.causewayfunds.com.
---------------------------------------------------------------------------

    The Composition File will be disseminated through the NSCC before
the open of trading in Shares on each business day and also will be
made available to the public each day on a free public website as noted
above.\25\ Consistent with the disclosure requirements that apply to
traditional open-end investment companies, a complete list of current
Fund portfolio positions will be made available at least once each
calendar quarter, with a reporting lag of not more than 60 days. A Fund
may provide more frequent disclosures of portfolio positions at its
discretion.
---------------------------------------------------------------------------

    \25\ The free public website containing this information will be
www.nextshares.com.
---------------------------------------------------------------------------

    Reports of Share transactions will be disseminated to the market
and delivered to the member firms participating in the trade
contemporaneous with execution. Once a Fund's daily NAV has been
calculated and disseminated, Nasdaq will price each Share trade entered
into during the day at the relevant Fund's NAV plus/minus the trade's
executed premium/discount. Using the final trade price, each executed
Share trade will then be disseminated to member firms and market data
services via an FTP file to be created for exchange-traded managed
funds and confirmed to the member firms participating in the trade to
supplement the previously provided information to include final
pricing.
    Information regarding NAV-based trading prices, best bids and
offers for Shares, and volume of Shares traded will be continuously
available on a real-time basis throughout each trading day on brokers'
computer screens and other electronic services.
Initial and Continued Listing
    Shares will conform to the initial and continued listing criteria
as set forth under Nasdaq Rule 5745. A minimum of 50,000 Shares and no
less than two Creation Units of each Fund will be outstanding at the
commencement of trading on the Exchange. The Exchange will obtain a
representation from the issuer of the Shares that the NAV per Share
will be calculated daily (on each day the New York Stock Exchange is
open for trading) and provided to Nasdaq via the Mutual Fund Quotation
Service (''MFQS'') by the fund accounting agent. As soon as the NAV is
entered into MFQS, Nasdaq will disseminate the NAV to market
participants and market data vendors via the Mutual Fund Dissemination
Service (``MFDS'') so all firms will receive the NAV per Share at the
same time. The Reporting Authority \26\ also will implement and
maintain, or will ensure that the Composition File will be subject to,
procedures designed to prevent the use and dissemination of material
non-public information regarding a Fund's portfolio positions and
changes in the positions.
---------------------------------------------------------------------------

    \26\ See Nasdaq Rule 5745(c)(4).
---------------------------------------------------------------------------

    An estimated value of an individual Share, defined in Nasdaq Rule
5745(c)(2) as the ``Intraday Indicative Value,'' will be calculated and
disseminated at intervals of not more than 15 minutes throughout the
Regular Market Session \27\ when Shares trade on the Exchange. The
Exchange will obtain a representation from the issuer of the Shares
that the IIV for each Fund will be calculated on an intraday basis and
provided to Nasdaq for dissemination via the Nasdaq Global Index
Service (``GIDS'').
---------------------------------------------------------------------------

    \27\ See Nasdaq Rule 4120(b)(4) (describing the three trading
sessions on the Exchange: (1) Pre-Market Session from 4 a.m. to 9:30
a.m. Eastern Time; (2) Regular Market Session from 9:30 a.m. to 4
p.m. or 4:15 p.m. Eastern Time; and (3) Post-Market Session from 4
p.m. or 4:15 p.m. to 8 p.m. Eastern Time).
---------------------------------------------------------------------------

    The IIV for each Fund will be based on current information
regarding the value of the securities and other assets held by a
Fund.\28\ The purpose of the IIV for each Fund is to enable investors
to estimate the next-determined NAV so they can determine the number of
Shares to buy or sell if they want to transact in an approximate dollar
amount (e.g., if an investor wants to acquire approximately $5,000 of a
Fund, how many Shares should the investor buy?).\29\
---------------------------------------------------------------------------

    \28\ IIVs for each Fund disseminated throughout each trading day
would be based on the same portfolio as used to calculate that day's
NAV. A Fund will reflect purchases and sales of portfolio positions
in its NAV the next business day after trades are executed.
    \29\ Because, in NAV-Based Trading, prices of executed trades
are not determined until the reference NAV is calculated, buyers and
sellers of Shares during the trading day will not know the final
value of their purchases and sales until the end of the trading day.
A Fund's Registration Statement, free public website and any
advertising or marketing materials will include prominent disclosure
of this fact. Although the IIV for a Fund may provide useful
estimates of the value of intraday trades, they cannot be used to
calculate with precision the dollar value of the Shares to be bought
or sold.
---------------------------------------------------------------------------

    The Adviser is not a registered broker-dealer, or affiliated with a
broker-dealer. Personnel who make decisions on a Fund's portfolio
composition must be subject to procedures designed to prevent the use
and dissemination of material, non-public information regarding the
open-end fund's portfolio.
    In the event that (a) the Adviser registers as a broker-dealer or
becomes newly affiliated with a broker-dealer, or (b) any new adviser
or sub-adviser to a Fund is a registered broker-dealer or becomes
affiliated with a broker-dealer, such adviser or sub-adviser will
implement and will maintain a fire wall with respect to its relevant
personnel and/or such broker-dealer affiliate, as applicable, regarding
access to information concerning the composition and/or changes to a
Fund's portfolio and will be subject to procedures designed to prevent
the use and dissemination of material non- public information regarding
such portfolio.
Trading Halts
    The Exchange may consider all relevant factors in exercising its
discretion to halt or suspend trading in Shares. Nasdaq will halt
trading in Shares under the conditions specified in

Nasdaq Rules 4120 and in Nasdaq Rule 5745(d)(2)(C). Additionally,
Nasdaq may cease trading Shares if other unusual conditions or
circumstances exist which, in the opinion of Nasdaq, make further
dealings on Nasdaq detrimental to the maintenance of a fair and orderly
market. To manage the risk of a non-regulatory Share trading halt,
Nasdaq has in place back-up processes and procedures to ensure orderly
trading.
    Because, in NAV-Based Trading, all trade execution prices are
linked to end-of-day NAV, buyers and sellers of Shares should be less
exposed to risk of loss due to intraday trading halts than buyers and
sellers of conventional exchange-traded funds (``ETFs'') and other
exchange-traded securities.
    Every order to trade Shares of a Fund is subject to the proxy price
protection threshold of plus/minus $1.00, which determines the lower
and upper threshold for the life of the order and whereby the order
will be cancelled at any point if it exceeds $101.00 or falls below
$99.00, the established thresholds.\30\ With certain exceptions, each
order also must contain the applicable order attributes, including
routing instructions and time-in-force information, as described in
Nasdaq Rule 4703.\31\
---------------------------------------------------------------------------

    \30\ See Nasdaq Rule 5745(h).
    \31\ See Nasdaq Rule 5745(b)(6).
---------------------------------------------------------------------------

Trading Rules
    Nasdaq deems Shares to be equity securities, thus rendering trading
in Shares subject to Nasdaq's existing rules governing the trading of
equity securities. Nasdaq will allow trading in Shares from 9:30 a.m.
until 4:00 p.m. Eastern Time.
Surveillance
    The Exchange represents that trading in Shares will be subject to
the existing trading surveillances, administered by both Nasdaq and the
Financial Industry Regulatory Authority, Inc. (``FINRA'') on behalf of
the Exchange, which are designed to detect violations of Exchange rules
and applicable federal securities laws.\32\ The Exchange represents
that these procedures are adequate to properly monitor trading of
Shares on the Exchange and to deter and detect violations of Exchange
rules and applicable federal securities laws.
---------------------------------------------------------------------------

    \32\ FINRA provides surveillance of trading on the Exchange
pursuant to a regulatory services agreement. The Exchange is
responsible for FINRA's performance under this regulatory services
agreement.
---------------------------------------------------------------------------

    The surveillances referred to above generally focus on detecting
securities trading outside their normal patterns, which could be
indicative of manipulative or other violative activity. When such
situations are detected, surveillance analysis follows and
investigations are opened, where appropriate, to review the behavior of
all relevant parties for all relevant trading violations.
    FINRA, on behalf of the Exchange, will communicate as needed with
other markets and other entities that are members of the Intermarket
Surveillance Group (``ISG'') \33\ regarding trading in Shares, and in
exchange-traded securities and instruments held by a Fund (to the
extent such exchange-traded securities and instruments are known
through the publication of the Composition File and periodic public
disclosures of a Fund's portfolio holdings), and FINRA may obtain
trading information regarding such trading from other markets and other
entities. In addition, the Exchange may obtain information regarding
trading in Shares, and in exchange-traded securities and instruments
held by a Fund (to the extent such exchange-traded securities and
instruments are known through the publication of the Composition File
and periodic public disclosures of a Fund's portfolio holdings), from
markets and other entities that are members of ISG, which includes
securities and futures exchanges, or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

    \33\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of a
Fund's portfolio may trade on markets that are members of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement.
---------------------------------------------------------------------------

    In addition, the Exchange also has a general policy prohibiting the
distribution of material non-public information by its employees.
Information Circular
    Prior to the commencement of trading in a Fund, the Exchange will
inform its members in an Information Circular of the special
characteristics and risks associated with trading the Shares of each
Fund. Specifically, the Information Circular will discuss the
following: (1) The procedures for purchases and redemptions of Shares
in Creation Units (and noting that Shares are not individually
redeemable); (2) Nasdaq Rule 2111A, which imposes suitability
obligations on Nasdaq members with respect to recommending transactions
in Shares to customers; (3) how information regarding the IIV and
Composition File is disseminated; (4) the requirement that members
deliver a prospectus to investors purchasing Shares prior to or
concurrently with the confirmation of a transaction; and (5)
information regarding NAV-Based Trading protocols.
    As noted above, all orders to buy or sell Shares that are not
executed on the day the order is submitted will be automatically
cancelled as of the close of trading on such day. The Information
Circular will discuss the effect of this characteristic on existing
order types. The Information Circular also will identify the specific
Nasdaq data feeds from which intraday Share prices in proxy price
format may be obtained.
    In addition, the Information Circular will advise members, prior to
the commencement of trading, of the prospectus delivery requirements
applicable to a Fund. Members purchasing Shares from a Fund for resale
to investors will deliver a summary prospectus to such investors. The
Information Circular will also discuss any exemptive, no-action and
interpretive relief granted by the Commission from any rules under the
Act.
    The Information Circular also will reference that a Fund is subject
to various fees and expenses described in the Registration Statement.
The Information Circular will also disclose the trading hours of the
Shares and the applicable NAV calculation time for the Shares. The
Information Circular will disclose that information about the Shares
will be publicly available on a Fund's free public website.\34\
---------------------------------------------------------------------------

    \34\ See supra footnote 24.
---------------------------------------------------------------------------

    Information regarding Fund trading protocols will be disseminated
to Nasdaq members in accordance with current processes for newly listed
products. Nasdaq intends to provide its members with a detailed
explanation of NAV-Based Trading through a Trader Alert issued prior to
the commencement of trading in Shares on the Exchange.
Continued Listing Representations
    All statements and representations made in this filing regarding
(a) the description of the portfolios or reference assets, (b)
limitations on portfolio holdings or reference assets, (c)
dissemination and availability of the reference asset or intraday
indicative values, or (d) the applicability of Exchange listing rules
shall constitute continued listing requirements for listing the Shares
on the Exchange. In addition, the issuer has represented to the
Exchange that it will advise the Exchange of any failure by a Fund to
comply with the continued listing requirements, and, pursuant to its
obligations under Section 19(g)(1) of the Act, the Exchange will
monitor for

compliance with the continued listing requirements. If a Fund is not in
compliance with the applicable listing requirements, the Exchange will
commence delisting procedures under the Nasdaq 5800 Series.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\35\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\36\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanism of a
free and open market and a national market system.
---------------------------------------------------------------------------

    \35\ 15 U.S.C. 78f(b).
    \36\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares would be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in Nasdaq Rule 5745. The
Exchange believes that its surveillance procedures are adequate to
properly monitor the trading of Shares on Nasdaq and to deter and
detect violations of Exchange rules and the applicable federal
securities laws. The Adviser is not a registered broker-dealer, and is
not affiliated with a broker-dealer. Personnel who make decisions on a
Fund's portfolio composition must be subject to procedures designed to
prevent the use and dissemination of material, non-public information
regarding the open-end fund's portfolio.
    In the event that (a) the Adviser registers as a broker-dealer or
becomes newly affiliated with a broker-dealer, or (b) any new adviser
or sub-adviser to a Fund is a registered broker-dealer or becomes
affiliated with a broker-dealer, such adviser or sub-adviser will
implement and will maintain a fire wall with respect to its relevant
personnel and/or such broker-dealer affiliate, as applicable, regarding
access to information concerning the composition and/or changes to a
Fund's portfolio and will be subject to procedures designed to prevent
the use and dissemination of material non-public information regarding
such portfolio.
    The Exchange may obtain information via ISG from other exchanges
that are members of ISG or with which the Exchange has entered into a
comprehensive surveillance sharing agreement.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest.
The Exchange will obtain a representation from the issuer of Shares
that the NAV per Share will be calculated daily (on each day the New
York Stock Exchange is open for trading) and provided to Nasdaq via the
MFQS by the fund accounting agent. As soon as the NAV is entered into
MFQS, Nasdaq will disseminate the NAV to market participants and market
data vendors via MFDS so all firms will receive the NAV per share at
the same time. In addition, a large amount of information would be
publicly available regarding a Fund and the Shares, thereby promoting
market transparency.
    Prior to the commencement of market trading in Shares, a Fund will
be required to establish and maintain a free public website through
which its current prospectus may be downloaded.\37\ The free public
website will include directly or through a link additional Fund
information updated on a daily basis, including the prior business
day's NAV, and the following trading information for such business day
expressed as premiums/discounts to NAV: (a) Intraday high, low, average
and closing prices of Shares in Exchange trading; (b) the Closing Bid/
Ask Midpoint; and (c) the Closing Bid/Ask Spread.\38\ The free public
website will also contain charts showing the frequency distribution and
range of values of trading prices, Closing Bid/Ask Midpoints and
Closing Bid/Ask Spreads over time.
---------------------------------------------------------------------------

    \37\ See supra footnote 23.
    \38\ See supra footnote 24.
---------------------------------------------------------------------------

    The Composition File will be disseminated through the NSCC before
the open of trading in Shares on each business day and also will be
made available to the public each day on a free public website.\39\ An
estimated value of an individual Share, defined in Nasdaq Rule
5745(c)(2) as the ``Intraday Indicative Value,'' will be calculated and
disseminated at intervals of not more than 15 minutes throughout the
Regular Market Session \40\ when Shares trade on the Exchange. The
Exchange will obtain a representation from the issuer of the Shares
that the IIV for each Fund will be calculated on an intraday basis and
provided to Nasdaq for dissemination via GIDS. A complete list of
current portfolio positions for a Fund will be made available at least
once each calendar quarter, with a reporting lag of not more than 60
days. A Fund may provide more frequent disclosures of portfolio
positions at its discretion.
---------------------------------------------------------------------------

    \39\ See supra footnote 13.
    \40\ See supra footnote 27.
---------------------------------------------------------------------------

    Transactions in Shares will be reported to the Consolidated Tape at
the time of execution in proxy price format and will be disseminated to
member firms and market data services through Nasdaq's trading service
and market data interfaces, as defined above. Once a Fund's daily NAV
has been calculated and the final price of its intraday Share trades
has been determined, Nasdaq will deliver a confirmation with final
pricing to the transacting parties. At the end of the day, Nasdaq will
also post a newly created FTP file with the final transaction data for
the trading and market data services. Information regarding NAV-based
trading prices, best bids and offers for Shares, and volume of Shares
traded will be continuously available on a real-time basis throughout
each trading day on brokers' computer screens and other electronic
services. Because Shares will trade at prices based on the next-
determined NAV, investors will be able to buy and sell individual
Shares at a known premium or discount to NAV that they can limit by
transacting using limit orders at the time of order entry. Trading in
Shares will be subject to Nasdaq Rules 5745(d)(2)(B) and (C), which
provide for the suspension of trading or trading halts under certain
circumstances, including if, in the view of the Exchange, trading in
Shares becomes inadvisable.
    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
the Funds, which seek to provide investors with access to actively
managed investment strategies in a structure that offers the cost and
tax efficiencies and shareholder protections of ETFs, while removing
the requirement for daily portfolio holdings disclosure, and is
designed to ensure a tight relationship between market trading prices
and NAV.
    For the above reasons, Nasdaq believes the proposed rule change is
consistent with the requirements of Section 6(b)(5) of the Act.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. In fact, the
Exchange believes that the introduction of the Funds would promote
competition by making available to investors actively managed
investment

strategies in structures that offer the cost and tax efficiencies and
shareholder protections of ETFs, while removing the requirement for
daily portfolio holdings disclosure, and is designed to ensure a tight
relationship between market trading prices and NAV. Moreover, the
Exchange believes that the proposed method of Share trading would
provide investors with transparency of trading costs, and the ability
to control trading costs using limit orders, that is not available for
conventionally traded ETFs.
    These developments could significantly enhance competition to the
benefit of the markets and investors.

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

    No written comments were either solicited or received.

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

    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 the 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 protected]. Please include
File No. SR-NASDAQ-2017-123 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 No. SR-NASDAQ-2017-123. 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 No. SR-NASDAQ-2017-123 and should be submitted on
or before January 5, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
---------------------------------------------------------------------------

    \41\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert Errett,
Deputy Secretary.
[FR Doc. 2017-27012 Filed 12-14-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Rules and Regulations]
[Pages 9083-9085]
[FR Doc No: 2014-03388]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2013-M-0042]

Medical Devices; Neurological Devices; Classification of the
Neuropsychiatric Interpretive Electroencephalograph Assessment Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
neuropsychiatric interpretive electroencephalograph (EEG) assessment
aid into class II (special controls). The Agency is classifying the
device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective March 20, 2014. The classification was
applicable beginning July 15, 2013.

FOR FURTHER INFORMATION CONTACT: Peter Como, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2463, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012, 126 Statute 1054), provides two procedures by which
a person may request that FDA classify a device under the criteria set
forth in section 513(a)(1). Under the first procedure, the person
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified and, within 30
days of receiving an order classifying the device into class III under
section 513(f)(1) of the FD&C Act, the person requests a classification
under section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. Within
30 days after the issuance of an order classifying the device, FDA must
publish a notice in the Federal Register announcing this
classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on November 18, 2011, classifying the Neuropsychiatric EEG-Based
Assessment Aid (NEBA) System for attention-deficit/hyperactivity
disorder into class III, because it was not substantially equivalent to
a device that was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
a device which was subsequently reclassified into class I or class II.
On December 8, 2011, Lexicor Medical Technology, LLC, submitted a
request for classification of the NEBA System under section 513(f)(2)
of the FD&C Act. The manufacturer recommended that the device be
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the de novo request, FDA determined that the
device can be classified into class II with the establishment of
special controls. FDA believes these special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on July 15, 2013, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 882.1140 (Sec.
882.1440).
    Following the effective date of this final classification
administrative order, any firm submitting a 510(k) premarket
notification for a neuropsychiatric interpretive EEG assessment aid
will need to comply with the special controls named in the final
administrative order.
    The device is assigned the generic name neuropsychiatric
interpretive electroencephalograph assessment aid,

and it is identified as a prescription device that uses a patient's EEG
to provide an interpretation of the patient's neuropsychiatric
condition. The neuropsychiatric interpretive EEG assessment aid is used
only as an assessment aid for a medical condition for which there
exists other valid methods of diagnosis.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

   Table 1--Neuropsychiatric Interpretive EEG Assessment Aid Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
Electromagnetic incompatibility........  Electromagnetic compatibility
                                          testing.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to user/patient (shock, burn, or         mechanical testing.
 mechanical failure).                    Labeling.
False result leading to delay in         Performance testing.
 treatment or unnecessary treatment due  Hardware and software
 to hardware failure.                     verification, validation, and
                                          hazard analysis.
                                         Technical parameters.
                                         Labeling.
False result due to incorrect artifact   Operator training.
 reduction.
                                         Software verification and
                                          validation.
                                         Labeling.
False result due to incorrect placement  Operator training.
 of electrodes.
                                         Clinical performance testing.
                                         Labeling.
False result when a neuropsychiatric     Clinical performance testing.
 interpretive EEG assessment aid is      Device design characteristics.
 used for confirmatory support or        Labeling.
 support for further testing.
Use error..............................  Clinical performance testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
    1. The technical parameters of the device, hardware and software,
must be fully characterized and must demonstrate a reasonable assurance
of safety and effectiveness.
    a. Hardware specifications must be provided. Appropriate
verification, validation, and hazard analysis must be performed.
    b. Software, including any proprietary algorithm(s) used by the
device to arrive at its interpretation of the patient's condition, must
be described in detail in the software requirements specification and
software design specification. Appropriate software verification,
validation, and hazard analysis must be performed.
    2. The device parts that contact the patient must be demonstrated
to be biocompatible.
    3. The device must be designed and tested for electrical safety,
electromagnetic compatibility, thermal, and mechanical safety.
    4. Clinical performance testing must demonstrate the accuracy,
precision, reproducibility, of determining the EEG-based
interpretation, including any specified equivocal zones (cutoffs).
    5. Clinical performance testing must demonstrate the ability of the
device to function as an assessment aid for the medical condition for
which the device is indicated. Performance measures must demonstrate
device performance characteristics per the intended use in the intended
use environment. Performance measurements must include sensitivity,
specificity, positive predictive value, and negative predictive value
per the device intended use. Repeatability of measurements must be
demonstrated using interclass correlation coefficients and illustrated
by qualitative scatter plot(s).
    6. The device design must include safeguards to prevent use of the
device as a stand-alone diagnostic.
    7. The labeling must include the following information:
    a. A warning that the device is not to be used as a stand-alone
diagnostic.
    b. A detailed summary of the clinical performance testing,
including any adverse events and complications.
    c. The qualifications and training requirements for device users
including technicians and clinicians.
    d. The intended use population and the intended use environment.
    e. Any instructions technicians should convey to patients regarding
the collection of EEG data.
    f. Information allowing clinicians to gauge clinical risk
associated with integrating the EEG interpretive assessment aid into
their diagnostic pathway.
    g. Where appropriate, validated methods and instructions for
reprocessing of any reusable components.
    Neuropsychiatric interpretive EEG assessment aids are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device. (Proposed
Sec.  882.1440(a); see section 520(e) of the FD&C Act (21 U.S.C.
360j(e)) and Sec.  801.109 (21 CFR 801.109) (Prescription devices).)
Prescription-use restrictions are a type of general controls as defined
in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification prior to marketing the device,
which contains information about the neuropsychiatric interpretive EEG
assessment aid they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore,

neither an environmental assessment nor an environmental impact
statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling,
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. K112711--De Novo Request per 513(f) pursuant to the Agency's NSE
Determination, dated November 18, 2011, From Lexicor Medical
Technology, LLC, dated December 7, 2011.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as
follows:

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

0
2. Add Sec.  882.1440 to subpart B to read as follows:

Sec.  882.1440  Neuropsychiatric interpretive electroencephalograph
assessment aid.

    (a) Identification. The neuropsychiatric interpretive
electroencephalograph assessment aid is a prescription device that uses
a patient's electroencephalograph (EEG) to provide an interpretation of
the patient's neuropsychiatric condition. The neuropsychiatric
interpretive EEG assessment aid is used only as an assessment aid for a
medical condition for which there exists other valid methods of
diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The technical parameters of the device, hardware and software,
must be fully characterized and must demonstrate a reasonable assurance
of safety and effectiveness.
    (i) Hardware specifications must be provided. Appropriate
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the
device to arrive at its interpretation of the patient's condition, must
be described in detail in the software requirements specification and
software design specification. Appropriate software verification,
validation, and hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated
to be biocompatible.
    (3) The device must be designed and tested for electrical safety,
electromagnetic compatibility, thermal, and mechanical safety.
    (4) Clinical performance testing must demonstrate the accuracy,
precision, reproducibility, of determining the EEG-based
interpretation, including any specified equivocal zones (cutoffs).
    (5) Clinical performance testing must demonstrate the ability of
the device to function as an assessment aid for the medical condition
for which the device is indicated. Performance measures must
demonstrate device performance characteristics per the intended use in
the intended use environment. Performance measurements must include
sensitivity, specificity, positive predictive value, and negative
predictive value per the device intended use. Repeatability of
measurements must be demonstrated using interclass correlation
coefficients and illustrated by qualitative scatter plot(s).
    (6) The device design must include safeguards to prevent use of the
device as a stand-alone diagnostic.
    (7) The labeling must include the following information:
    (i) A warning that the device is not to be used as a stand-alone
diagnostic.
    (ii) A detailed summary of the clinical performance testing,
including any adverse events and complications.
    (iii) The qualifications and training requirements for device users
including technicians and clinicians.
    (iv) The intended use population and the intended use environment.
    (v) Any instructions technicians should convey to patients
regarding the collection of EEG data.
    (vi) Information allowing clinicians to gauge clinical risk
associated with integrating the EEG interpretive assessment aid into
their diagnostic pathway.
    (vii) Where appropriate, validated methods and instructions for
reprocessing of any reusable components.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03388 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P