[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56683-56684]
[FR Doc No: 2022-19997]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1156]

Q3D(R2)--Guideline for Elemental Impurities; International
Council for Harmonisation; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Q3D(R2)
Guideline for Elemental Impurities.'' The guidance was prepared under
the auspices of the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH),
formerly the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use. The
guidance revises the guidance for industry ``Q3D(R1) Elemental
Impurities'' issued in March 2020 to provide Permissible Daily
Exposures (PDEs) for the cutaneous and transcutaneous routes of
administration. It also provides relevant risk assessment
considerations to supplement previous guidance for the oral,
parenteral, and inhalation routes of administration. The guidance is
intended to provide recommendations for acceptable amounts of the
listed elemental impurities for pharmaceutical products and for
conducting risk assessments.

DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1156 for ``Q3D(R2) Guideline for Elemental Impurities.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Timothy McGovern, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20993-0002, 240-
402-0477.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Q3D(R2) Guideline for Elemental Impurities.'' The guidance
was prepared under the auspices of ICH. ICH has the mission of
achieving greater regulatory harmonization worldwide to ensure that
safe, effective, high-quality medicines are developed, registered, and

maintained in the most resource-efficient manner. By harmonizing the
regulatory requirements in regions around the world, ICH guidelines
have substantially reduced duplicative clinical studies, prevented
unnecessary animal studies, standardized the reporting of important
safety information, standardized marketing application submissions, and
made many other improvements in the quality of global drug development
and manufacturing and the products available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In September 2020, the ICH Assembly endorsed the draft guideline
entitled ``Q3D(R2) Guideline for Elemental Impurities'' and agreed that
the guideline should be made available for public comment. The draft
guideline is the product of the Q3D(R2) Working Group of the ICH. In
the Federal Register of May 12, 2021 (85 FR 26052), FDA published a
notice announcing the availability of the draft guidance. The notice
gave interested persons an opportunity to submit comments by June 11,
2021. After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies on April 26, 2022.
    The guidance revises the guidance for industry ``Q3D(R1) Elemental
Impurities'' issued in March 2020 to provide PDEs for the cutaneous and
transcutaneous routes of administration. It also provides relevant risk
assessment considerations to supplement previous guidance for the oral,
parenteral, and inhalation routes of administration and corrects errors
to previously identified PDEs for gold (oral, parenteral, and
inhalation routes), silver (parenteral route), and nickel (inhalation
route). The final guidance is intended to provide recommendations for
acceptable amounts of the listed elemental impurities for
pharmaceutical products and for conducting risk assessments.
    This guidance represents the current thinking of FDA on ``Q3D(R2)
Guideline for Elemental Impurities.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information relating to good laboratory practice have been approved
under OMB control number 0910-0119. The collections of information
pertaining to current good manufacturing practice have been approved
under OMB control number 0910-0139. The collections of information for
new drug applications and biologics license applications have been
approved under OMB control numbers 0910-0001 and 0910-0338,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: September 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19997 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57981-57983]
[FR Doc No: 2016-20208]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78614; File No. SR-NYSEArca-2016-64]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove Proposed Rule
Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares
of the AdvisorShares KIM Korea Equity ETF

August 18, 2016.
    On May 2, 2016, NYSE Arca, Inc. (``Exchange'') 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\ a proposed rule change to list and trade
shares (``Shares'') of the AdvisorShares KIM Korea Equity ETF
(``Fund'') under NYSE Arca Equities Rule 8.600. On May 13, 2016, the
Exchange submitted Amendment No. 1 to the proposed rule change.\3\ The
Commission published notice of the proposed rule change, as modified by
Amendment No. 1, in the Federal Register on May 23, 2016.\4\ On May 23,
2016, the Exchange submitted Amendment No. 2 to the proposed rule
change.\5\ On July 7, 2016, pursuant to Section 19(b)(2) of the Act,\6\
the Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\7\ The Commission received no comments on the proposed rule
change. This order institutes proceedings under Section 19(b)(2)(B) of
the Act \8\ to determine whether to approve or disapprove the proposed
rule change, as modified by Amendment Nos. 1 and 2.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety. Amendment No. 1 is available at https://www.sec.gov/comments/sr-nysearca-2016-64/nysearca201664-1.pdf.
    \4\ See Securities Exchange Act Release No. 34-77847 (May 17,
2016), 81 FR 32364 (NYSEArca-2016-64) (``Notice'').
    \5\ In Amendment No. 2, which replaced and superseded the
original filing in its entirety, the Exchange clarified certain
statements relating to the Fund's investments in Depositary Receipts
and certain representations by the Exchange relating to
surveillance. Amendment No. 2 is available at https://www.sec.gov/comments/sr-nysearca-2016-64/nysearca201664-2.pdf. Because Amendment
No. 2 does not materially alter the substance of the proposed rule
change or raise unique or novel regulatory issues, Amendment No. 2
is not subject to notice and comment.
    \6\ 15 U.S.C. 78s(b)(2).
    \7\ See Securities Exchange Act Release No. 78240, 81 FR 45332
(July 13, 2016). The Commission designated August 21, 2016, as the
date by which the Commission would either approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \8\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

I. The Exchange's Description of the Proposal \9\
---------------------------------------------------------------------------

    \9\ Additional information regarding the Fund, the Shares, and
the Trust (as defined herein), including investment strategies,
risks, creation and redemption procedures, fees, portfolio holdings,
disclosure policies, calculation of net asset value, distributions,
and taxes, among other things, can be found in the Notice and the
Registration Statement, as applicable. See Notice, supra note 4, and
Registration Statement, infra note 10.
---------------------------------------------------------------------------

    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.600, which governs the listing and trading of Managed
Fund Shares on the Exchange. The Shares will be offered by
AdvisorShares Trust (``Trust''), an open-end management investment
company.\10\ The investment adviser to the Fund will be AdvisorShares
Investments LLC (``Adviser'') and Korea Investment Management Co., Ltd.
will be the Fund's sub-adviser (``Sub-Adviser''). Foreside Fund
Services, LLC will be the principal underwriter and distributor of the
Fund's Shares, and the Bank of New York Mellon will serve as the
administrator, custodian, and transfer agent for the Fund.
---------------------------------------------------------------------------

    \10\ The Exchange states that the Trust is registered under the
Investment Company Act of 1940 (``1940 Act'') and that on March 25,
2016, the Trust filed with the Commission amendments to its
registration statement on Form N-1A under the Securities Act of 1933
(``Securities Act'') and under the 1940 Act relating to the Fund
(File Nos. 333-157876 and 811-22110) (``Registration Statement'').
In addition, the Exchange states that the Commission has issued an
order granting certain exemptive relief to the Trust under the 1940
Act. See Investment Company Act Release No. 29291(May 28, 2010)
(File No. 812-13677).
---------------------------------------------------------------------------

The Fund's Principal Investments

    The Exchange states that the investment objective of the Fund will
be to seek to provide long-term capital appreciation above the capital
appreciation of its primary benchmark, the MSCI Korea Index, and other
Korea-focused indexes. The Fund will seek to achieve its investment
objective by investing primarily in growth-oriented stocks of any
capitalization range listed on the Korea Exchange. Under normal
circumstances,\11\ the Fund will invest at least 80% of its net assets
(plus any borrowings for investment purposes) in equity securities
listed on the Korea Exchange.\12\
---------------------------------------------------------------------------

    \11\ The Exchange states that the term ``under normal
circumstances'' means, without limitation, the absence of extreme
volatility or trading halts in the equity markets or the financial
markets generally; operational issues causing dissemination of
inaccurate market information; or force majeure type events such as
systems failure, natural or man-made disaster, act of God, armed
conflict, act of terrorism, riot or labor disruption or any similar
intervening circumstance.
    \12\ The Korea Exchange is a member of the Intermarket
Surveillance Group (``ISG'').
---------------------------------------------------------------------------

    The Exchange states that the Sub-Adviser will manage the Fund's
portfolio by buying and holding stocks of companies at attractive
valuation that it believes have growth potential. The Sub-Adviser will
focus on corporate fundamental research in its stock selection, often
called ``bottom up'' analysis. The Sub-Adviser will invest the Fund's
assets with a mid- to- long-term view, typically seeking to avoid
short-term trading. In selecting investments for the Fund's portfolio,
the Sub-Adviser will place emphasis on fundamentals rather than on
short-term momentum and continuously monitor market risks. In deciding
whether to sell

investments in the Fund's portfolio, the Sub-Adviser will consider the
following factors: A company's stock price reaches its target price; a
company in the portfolio experiences negative fundamental changes;
errors are found in the previous assumptions or forecasts of a company;
and more profitable alternatives are found.
    In addition to individual stock selection, the Exchange states that
the Sub-Adviser will engage in sector allocation based on analysis of
the macro economy and its effect on corporate competitiveness and
industry cycles. This is often called ``top down'' analysis. The Sub-
Adviser will strive to invest with large economic cycles as compared to
short-term market trends and short-term supply and demand.

The Fund's Non-Principal Investments

    The Exchange represents that while the Fund, under normal
circumstances, will invest at least 80% of its assets in the securities
described above in the ``Principal Investments of the Fund,'' the Fund
may invest its remaining assets in the securities and financial
instruments as described below.
    The Fund may invest in the following equity securities traded on a
U.S. or foreign exchange or over-the-counter, including equity
securities of foreign issuers in emerging countries: Common stocks,
preferred stocks, warrants, rights, securities convertible into common
stock, and investments in master limited partnerships.
    The Fund may invest in issuers located outside the United States
directly and may invest in exchange-traded funds (``ETFs''),\13\
exchange-traded notes (``ETNs''),\14\ and exchange-traded products
(``ETPs'') \15\ that are indirectly linked to the performance of
foreign issuers. The Fund may invest in ``Depositary Receipts,''
consisting of American Depositary Receipts (``ADRs''), Global
Depositary Receipts, European Depositary Receipts, International
Depositary Receipts, ``ordinary shares,'' and ``New York shares''
issued and traded in the U.S.\16\
---------------------------------------------------------------------------

    \13\ For purposes of the proposed rule change, ETFs are
Investment Company Units (as described in NYSE Arca Equities Rule
5.2(j)(3)); Portfolio Depositary Receipts (as described in NYSE Arca
Equities Rule 8.100); and Managed Fund Shares (as described in NYSE
Arca Equities Rule 8.600). The ETFs that the Fund invests in all
will be listed and traded in the U.S. on registered exchanges. The
Fund will invest in the securities of ETFs registered under the 1940
Act consistent with the requirements of Section 12(d)(1) of the 1940
Act, or any rule, regulation or order of the Commission or
interpretation thereof. The Fund will only make ETF investments in
conformity with the requirements of Regulation M of the Internal
Revenue Code of 1986, as amended. While the Fund may invest in
inverse ETFs, the Fund will not invest in leveraged or inverse
leveraged ETFs (e.g., 2X or 3X).
    \14\ For purposes of the proposed rule change, ETNs include
Index-Linked Securities (as described in NYSE Arca Equities
Rule5.2(j)(6)). While the Fund may invest in inverse ETNs, the Fund
will not invest in leveraged or inverse leveraged ETNs (e.g., 2X or
3X).
    \15\ For purposes of the proposed rule change, ETPs include
Trust Issued Receipts (as described in NYSE Arca Equities Rule
8.200) and Currency Trust Shares (as described in NYSE Arca Equities
Rule 8.202). While the Fund may invest in inverse ETPs, the Fund
will not invest in leveraged or inverse leveraged ETPs (e.g., 2X or
3X).
    \16\ The Exchange represents that not more than 10% of the
Fund's assets will be invested in non-exchange-traded ADRs. In
addition, the Exchange represents that other Depositary Receipts in
which the Fund invests will be exchange-traded.
---------------------------------------------------------------------------

    The Fund may invest in non-exchange-traded investment company
securities to the extent that such investments would be consistent with
the requirements of Section 12(d)(1) of the 1940 Act or any rule,
regulation, or order of the Commission or interpretation thereof.
Consistent with the restrictions discussed above, the Fund may invest
in U.S. and non-U.S. exchange-listed closed-end funds and business
development companies. Except with respect to inverse ETFs as described
above,\17\ the Fund will not invest in inverse, leveraged, or inverse
leveraged investment company securities.
---------------------------------------------------------------------------

    \17\ See note 13, supra.
---------------------------------------------------------------------------

    The Fund may invest in U.S. government securities and may invest in
certain U.S. government securities that are issued or guaranteed by
agencies or instrumentalities of the U.S. government.\18\ The Fund also
may invest in non-exchange-traded convertible securities that are
bonds, debentures, notes, or other securities that may be converted or
exchanged (by the holder or by the issuer) into shares of the
underlying common stock (or cash or securities of equivalent value) at
a stated exchange ratio. Finally, the Fund may invest in shares of U.S.
or non-U.S. exchange-traded real estate investment trusts and
repurchase agreements and reverse repurchase agreements.\19\
---------------------------------------------------------------------------

    \18\ According to the Exchange, securities issued or guaranteed
by the U.S. government or its agencies or instrumentalities include
the following: U.S. Treasury securities, which are backed by the
full faith and credit of the U.S. Treasury and which differ only in
their interest rates, maturities, and times of issuance; U.S.
Treasury bills, which have initial maturities of one year or less;
U.S. Treasury notes, which have initial maturities of one to ten
years; U.S. Treasury bonds, which generally have initial maturities
of greater than ten years; and U.S. Treasury zero-coupon bonds.
    \19\ The Fund may purchase securities on a when-issued, delayed-
delivery or forward commitment basis (i.e., delivery and payment can
take place between a month and 120 days after the date of the
transaction).
---------------------------------------------------------------------------

The Fund's Investment Restrictions

    The Exchange represents that the Fund may hold up to an aggregate
amount of 15% of its net assets in assets deemed illiquid by the
Adviser.\20\ The Fund will monitor its portfolio liquidity on an
ongoing basis to determine whether, in light of current circumstances,
an adequate level of liquidity is being maintained, and will consider
taking appropriate steps in order to maintain adequate liquidity if,
through a change in values, net assets, or other circumstances, more
than 15% of the Fund's net assets are held in illiquid assets.\21\
---------------------------------------------------------------------------

    \20\ The Exchange states that, under the supervision of the
Fund's Board of Trustees, the Adviser determines the liquidity of
the Fund's investments. In determining the liquidity of the Fund's
investments, the Adviser may consider various factors, including (1)
the frequency and volume of trades and quotations; (2) the number of
dealers and prospective purchasers in the marketplace; (3) dealer
undertakings to make a market; and (4) the nature of the security
and the market in which it trades (including any demand, put or
tender features, the mechanics and other requirements for transfer,
any letters of credit or other credit enhancement features, any
ratings, the number of holders, the method of soliciting offers, the
time required to dispose of the security, and the ability to assign
or offset the rights and obligations of the security).
    \21\ Illiquid assets include securities subject to contractual
or other restrictions on resale and other instruments that lack
readily available markets as determined in accordance with
Commission staff guidance.
---------------------------------------------------------------------------

    The Exchange also represents that the Fund will not invest in
options, futures, swaps, or forward contracts. Further, the Fund's
investments will be consistent with its investment objective and will
not be used to provide multiple returns of a benchmark or to produce
leveraged returns. Finally, the Exchange represents that not more than
10% of the net assets of the Fund in the aggregate invested in equity
securities (other than non-exchange-traded investment company
securities) shall consist of equity securities whose principal market
is not a member of the ISG or is a market with which the Exchange does
not have a comprehensive surveillance sharing agreement.

II. Proceedings To Determine Whether To Approve or Disapprove SR-
NYSEArca-2016-64 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \22\ to determine whether the proposed rule
change, as modified by Amendment Nos. 1 and 2, should be approved or
disapproved. Institution of such proceedings is appropriate at this
time in view of the

legal and policy issues raised by the proposed rule change, as modified
by Amendment Nos. 1 and 2. Institution of proceedings does not indicate
that the Commission has reached any conclusions with respect to any of
the issues involved. Rather, as described below, the Commission seeks
and encourages interested persons to provide comments on the proposed
rule change, as modified by Amendment Nos. 1 and 2.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\23\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for the submission
of additional analysis regarding the proposed rule change's consistency
with Section 6(b)(5) of the Act, which requires, among other things,
that the rules of a national securities exchange be ``designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade,'' and ``to protect investors and the
public interest.'' \24\
---------------------------------------------------------------------------

    \23\ Id.
    \24\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange provides that the Fund will invest at least 80% of its
net assets in equity securities listed on the Korea Exchange. The
Exchange, however, proposes no other quantitative standards with
respect to the types of equity securities listed on the Korea Exchange
in which the Fund, at the Sub-Adviser's discretion, may invest. The
Commission has recently noted that appropriate quantitative standards,
such as minimum market value and trading volume requirements, ``should
reduce the extent to which Managed Fund Shares holding Non-U.S.
Component Stocks may be susceptible to manipulation.'' \25\
Accordingly, the Commission seeks comment on whether the Exchange's
representations relating to the Korean equity securities held by the
Fund are sufficient to prevent the susceptibility of the Fund's
portfolio to manipulation and are thereby consistent with the
requirements of Section 6(b)(5) of the Act, which, among other things,
requires that the rules of an exchange be designed to prevent
fraudulent and manipulative acts and practices and to protect investors
and the public interest.
---------------------------------------------------------------------------

    \25\ See Securities Exchange Act Release No. 78397 (July 22,
2016), 81 FR 49320, at 49325 (July 27, 2016). The term ``Non-U.S.
Component Stocks'' is defined in NYSE Arca Equities Rule 5.2(j)(3)
as an equity security that is not registered under Sections 12(b) or
12(g) of the Act and that is issued by an entity that (a) is not
organized, domiciled, or incorporated in the United States, and (b)
is an operating company (including Real Estate Investment Trusts and
income trusts, but excluding investment trusts, unit trusts, mutual
funds, and derivatives). See NYSE Arca Equities Rule 5.2(j)(3).
---------------------------------------------------------------------------

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, or
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\26\
---------------------------------------------------------------------------

    \26\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by September 14, 2016. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
September 28, 2016. The Commission asks that commenters address the
sufficiency of the Exchange's statements in support of the proposal,
which are set forth in the Notice \27\ and in Amendment No. 2 to the
proposed rule change,\28\ in addition to any other comments they may
wish to submit about the proposed rule change, as modified by Amendment
Nos. 1 and 2.
---------------------------------------------------------------------------

    \27\ Supra note 4.
    \28\ Supra note 5.
---------------------------------------------------------------------------

    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-NYSEArca-2016-64 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 Numbers SR-NYSEArca-2016-64. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site 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 these filings also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2016-64 and should
be submitted on or before September 14, 2016. Rebuttal comments should
be submitted by September 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-20208 Filed 8-23-16; 8:45 am]
BILLING CODE 8011-01-P