[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46083-46084]
[FR Doc No: 2017-21218]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0502]

Range of Risk Evaluation and Mitigation Strategies Platform
Standards Initiative: Needs Assessment; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
seeking public input on the design of the REMS Platform Standards
Initiative, as well as methods and best practices for its construction.
To facilitate this, FDA is making available the ``REMS Platform
Standards Initiative: Needs Assessment'' (needs assessment), which
summarizes a range of risk evaluation and mitigation strategies (REMS)
activities that could be standardized and integrated into the health
care system through the use of electronic data standards.

DATES: The comment period will be open indefinitely.

ADDRESSES: You may submit comments 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-N-0502 for ``REMS Platform Standards Initiative: Needs
Assessment; Request for Comments.'' 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Adam Kroetsch, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993-0002, 301-
796-3842<EMAIL_ADDRESS>or Aaron Sherman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002,
240-402-0493<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On October 5, 2015, FDA launched the REMS Platform Standards
Initiative (previously referred to as the ``Common REMS Platform
Initiative''), with the goal of developing and leveraging electronic
health data standards, referred to as ``REMS platform standards,'' to
further standardize certain activities associated with REMS with
elements to assure safe use (ETASU), and integrate them into existing
health care systems. (Information about the initiative can be found at:
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM507451.pdf). Since then, FDA has been
working to determine the most effective methods for carrying out this
initiative, including how best to engage the public on the project and
advance the development of REMS platform standards. To achieve these
ends, FDA is publishing the ``REMS Platform Standards Initiative: Needs
Assessment,'' which seeks to provide REMS stakeholders, standards
developers, and health information technology (IT) systems developers
with specific, detailed information on the areas in which standards
development is needed and the information that the data standards would
need to communicate to effectively carry out REMS activities. FDA seeks
comment on the document as a whole, as well as on the specific
questions that follow.
    (1) Does this needs assessment cover all of the REMS activities for
which standards development would be beneficial?
    (2) Which REMS activities should be given highest priority for
standards development?
    (3) What standards already exist that could be used to address the
needs and facilitate the REMS activities described in the needs
assessment?
    (4) Where (if at all) do new standards need to be developed?
    (5) What other opportunities exist to leverage health IT to
facilitate the completion of REMS activities?
    FDA hopes that the needs assessment will help identify areas where
standards development projects to support REMS are already underway, as
well as areas that are ripe for standards development, enabling
interested stakeholders to engage further in this project.
What is the REMS Platform Standards Initiative?
    The goal of the REMS Platform Standards Initiative is to leverage
electronic health data standards to standardize certain activities in
REMS with ETASU and integrate them into health IT systems. Under the
initiative, FDA seeks to work with third-party standards development
organizations to encourage the development of electronic data standards
that may be used to facilitate communication between REMS and their
participants. Once the standards are developed, FDA would maintain a
list of REMS platform standards, encourage their use in REMS with
ETASU, and encourage the development of tools that use these standards
to integrate REMS into health care providers' existing systems.
Why is FDA launching the REMS Platform Standards Initiative?
    This initiative was launched for a number of reasons. Stakeholders
have requested a centralized method to enroll in and interact with REMS
with ETASU and more fundamental standardization of REMS architecture.
There is also a need for a comprehensive set of standards for REMS to
help minimize REMS burden on the health care delivery system and
integrate REMS into health IT systems.
    The goal of the REMS Platform Standards Initiative is to give all
stakeholders--including sponsors, data vendors, clinical decision
support system developers (such as those for hospitals, private
practices, etc.)--a ``fixed target'' for standardization and
integration. If successful, this will clarify how sponsors can develop
standardized REMS that are more easily integrated into the health care
system and what health care providers must do to comply with those
REMS. Ultimately, REMS that are more effectively standardized and
integrated into the health care system should facilitate enhanced
compliance and safer use of drugs that have REMS.

II. Electronic Access

    Persons with access to the Internet may obtain the needs assessment
at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM565594.pdf.

    Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21218 Filed 10-2-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4584-4589]
[FR Doc No: 2019-02394]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85099; File No. SR-CboeBZX-2019-001]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To List and Trade Under Rule
14.11(c)(3) Shares of the Global X Russell 2000 Covered Call ETF of
Global X Funds

February 11, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 28, 2019, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the 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 submits this proposal to list and trade under Rule
14.11(c)(3) shares of the Global X Russell 2000 Covered Call ETF (the
``Fund'') of Global X Funds (the ``Trust'').
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 shares (``Shares'') of the
Fund under BZX Rule 14.11(c)(3),\3\ which governs the listing and
trading of index fund shares based on an index composed of U.S.
Component Stocks.\4\ The Exchange notes that the Commission has
previously approved a fund that employs a very similar strategy.\5\
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    \3\ The Commission approved BZX Rule 14.11(c) in Securities
Exchange Act Release No. 65225 (August 30, 2011), 76 FR 55148
(September 6, 2011) (SR-BATS-2011-018).
    \4\ Rule 14.11(c)(1)(D) provides that the term ``U.S. Component
Stock'' shall mean an equity security that is registered under
Sections 12(b) or 12(g) of the Act.
    \5\ See Securities Exchange Act Release No. 68708 (January 23,
2013), 78 FR 6161 (January 29, 2013) (SR-NYSEArca-2012-131) (order
granting approval of proposed rule change relating to listing and
trading of shares of the Horizons S&P 500 Covered Call ETF).
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    The Shares are offered by Global X Funds, which is organized as a
Delaware statutory trust and is registered with the Commission as an
open-end management investment company.\6\ The investment adviser and
administrator to the Fund is Global X Management Company LLC (the
``Adviser'' or ``Administrator'').\7\
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    \6\ The Trust is registered under the Investment Company Act of
1940 (15 U.S.C. 80a-1) (``1940 Act''). On December 20, 2018, the
Trust filed with the Commission an amendment to its Form N-1A under
the Securities Act of 1933 (15 U.S.C. 77a), and under the 1940 Act
relating to the Funds (File Nos. 333-151713 and 811-22209)
(``Registration Statement''). The description of the operation of
the Trust and the Fund herein is based, in part, on the Registration
Statement. In addition, the Commission has issued an order granting
certain exemptive relief to the Trust under the 1940 Act. See
Investment Company Act Release No. 29852 (October 28, 2011) (File
No. 812-13830).
    \7\ The Adviser is not registered as a broker-dealer, but is
affiliated with broker-dealers and has implemented and will maintain
a fire wall with respect to its broker-dealer affiliates regarding
access to information concerning the portfolio holdings of the Fund.
In the event (a) the Adviser becomes newly affiliated with a broker-
dealer, or (b) any new adviser or sub-adviser becomes affiliated
with a broker-dealer, it will implement and maintain a fire wall
with respect to such broker-dealer regarding access to information
concerning the portfolio holdings of the Fund, and will be subject
to procedures designed to prevent the use and dissemination of
material non-public information regarding said portfolio.
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    SEI Investments Distribution Co. (the ``Distributor'') is the
principal underwriter and distributor of the Shares. Brown Brothers
Harriman & Co. (the ``Custodian'' or ``Transfer Agent'') will serve as
custodian and transfer agent for the Fund.
    As described below, the Fund will seek investment results that,
before fees and expenses, generally correspond to the performance of
the Cboe Russell 2000 BuyWrite V2 Index (the ``Underlying Index'')
provided by FTSE Russell (the ``Index Provider'').\8\ The Underlying
Index measures the performance of a theoretical portfolio that holds a
portfolio of the stocks included in the Russell 2000 Index \9\ (the
``Reference Index''), and ``writes'' (or sells) a succession of one-
month at-the-money covered call options on the Reference Index. The
written covered call options on the Reference Index are held until
expiration. The Reference Index is an equity benchmark which measures
the performance of the small-capitalization sector of the U.S. equity
market, as defined by FTSE Russell.\10\
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    \8\ The Underlying Index is provided by the Index Provider,
which is unaffiliated with the Fund or the Adviser. The Index
Provider maintains, calculates and publishes information regarding
the Underlying Index. The Index Provider is not a broker-dealer and
has implemented and will maintain procedures designed to prevent the
use and dissemination of material, non-public information regarding
the Underlying Index.
    \9\ The Exchange notes that the Russell 2000 Index has been
previously approved by the Commission under Section 19(b)(2) of the
Act in connection with the listing and trading of FLEX Options and
Quarterly Index Options, as well as other securities. See, e.g.,
Securities Exchange Act Release Nos. 32694 (July 29, 1993), 58 FR
41814 (July 5, 1993) (approving the listing and trading of FLEX
Options based on the Russell 2000 Index); 32693 (July 29, 1993), 58
FR 41817 (August 5, 1993) (approving the listing and trading of
Quarterly Index Option based on the Russell 2000 Index). Rule
14.11(c)(3)(A)(i)(e) provides that all securities in the applicable
index or portfolio shall be U.S. Component Stocks listed on a
national securities exchange and shall be NMS Stocks as defined in
Rule 600 under Regulation NMS of the Act. Each component stock of
the Russell 2000 Index is a U.S. Component Stock that is listed on a
national securities exchange and is an NMS Stock. Options are
excluded from the definition of NMS Stock. The Fund and the Index
[sic] meet all of the requirements of the listing standards for
Index Fund Shares in Rule 14.11(c)(3), except the requirements in
Rule 14.11(c)(3)(A)(i)(a)-(e), as the Index [sic] consists of
options on U.S. Component Stocks. The Russell 2000 Index consists of
U.S. Component Stocks and satisfies the requirements of Rule
14.11(c)(3)(A)(i)(a)-(e).
    \10\ The Underlying Index methodology is available at http://www.cboe.com/products/strategy-benchmark-indexes/buywrite-indexes/cboe-russell-2000-buywrite-index-bxr. The Index Provider may amend
the methodology from time to time. In such case, the methodology
would be updated accordingly on the website.
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    The Exchange is submitting this proposed rule change because the
Underlying Index for the Fund does not meet all of the ``generic''
listing requirements of Rule 14.11(c)(3)(A)(i) applicable to the
listing of Index Fund Shares based upon an index of U.S. Component
Stocks. Specifically, Rule 14.11(c)(3)(A)(i) sets forth the
requirements to be met by components of an index or portfolio of U.S.

Component Stocks. As further described below, the Underlying Index
consists of the constituent securities of the Russell 2000 Index and
options on the Russell 2000 Index. The Underlying Index meets all the
requirements of Rule 14.11(c)(3)(A)(i) except that the Underlying Index
includes call options, which are not NMS Stocks as defined in Rule 600
of Regulation NMS. As described below, the Underlying Index is
comprised solely of Russell 2000 companies and includes an exposure to
call options on the Reference Index. All securities in the Reference
Index are listed and traded on a U.S. national securities exchange. The
options on the Reference Index are traded on Cboe Exchange, Inc.
(``Cboe Options''). Notwithstanding that the Underlying Index does not
meet all of the generic listing requirements of Rule 14.11(c)(3)(A)(i),
the Exchange believes that the Underlying Index is sufficiently broad-
based enough to deter potential manipulation in that the Reference
Index stocks are among the most actively traded, highly capitalized
stocks traded in the U.S.
The Underlying Index
    According to the Registration Statement, the Global X Russell 2000
Covered Call ETF will seek investment results that, before fees and
expenses, generally correspond to the performance of the Fund's
Underlying Index, which is the Cboe Russell 2000 BuyWrite V2 Index. The
Underlying Index measures the performance of a theoretical portfolio
that holds a portfolio of the stocks included in the Reference Index,
and ``writes'' (or sells) a succession of one-month at-the-money
covered call options on the Reference Index. The written covered call
options on the Reference Index are held until the applicable expiration
date. The Reference Index is an equity benchmark which measures the
performance of the small-capitalization sector of the U.S. equity
market, as defined by FTSE Russell. The Underlying Index is comprised
of all the equity securities in the Reference Index and a succession of
short (written) one-month at-the-money covered call options on the
Reference Index. The written covered call options on the Reference
Index are held until the expiration date.
The Fund
    According to the Registration Statement, in seeking to track the
Underlying Index, the Fund follows a ``buy-write'' (also called a
covered call) investment strategy on the Reference Index in which the
Fund purchases the component securities of the Reference Index or
purchases other investments (including other ETFs) \11\ that have
economic characteristics that are substantially identical to the
economic characteristics of such component securities, and also writes
(or sells) call options that correspond to the Reference Index. The
Fund uses this strategy in an attempt to enhance its portfolio's risk-
adjusted returns, reduce its volatility, and generate monthly income
from the premiums received from writing the call options. According to
the Registration Statement, the Fund will invest at least 80% of its
total assets in securities that comprise its Underlying Index or in
investments that have economic characteristics that are substantially
identical to the economic characteristics of such component securities,
either individually or in the aggregate.
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    \11\ For purposes of this filing, ETFs include index fund shares
(as described in BZX Rule 14.11(c)); Portfolio Depositary Receipts
(as described in BZX Rule 14.11(b)); and Managed Fund Shares (as
described in BZX Rule 14.11(i)). The ETFs all will be listed and
traded in the U.S. on registered exchanges. The Fund may 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.
While the Fund may invest in inverse ETFs, the Fund will not invest
in leveraged (e.g., 2X, -2X, 3X or -3X) ETFs.
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    According to the Registration Statement, the Fund will be an index
fund that employs a ``passive management'' investment strategy in
seeking to achieve its objective. According to the Registration
Statement, the Adviser's strategy will consist of holding an equity
portfolio (including ETFs) indexed to the Reference Index and writing
(selling) covered call options on the Reference Index.\12\ The
Underlying Index provides a benchmark measure of the total return of
this hypothetical portfolio.
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    \12\ A covered call strategy is generally considered to be an
investment strategy in which an investor buys a security, and sells
a call option that corresponds to the security. In return for a
premium, the Fund will give the purchaser of the option written by
the Fund either the right to buy the security from the Fund at an
exercise price or the right to receive a cash payment equal to the
difference between the value of the security and the exercise (or
``strike'') price, if the value is above the exercise price on or
before the expiration date of the option. In addition, the covered
call options hedge against a decline in the price of the securities
on which they are written to the extent of the premium the Fund
receives. A covered call strategy is generally used in a neutral-to-
bullish market environment, where a slow and steady rise in market
prices is anticipated.
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    According to the Registration Statement, the Fund will generally
use a representative sampling methodology, meaning it will invest in a
representative sample of securities that collectively has an investment
profile similar to the Underlying Index in terms of key risk factors,
performance attributes and other characteristics.
    According to the Registration Statement, the Fund will concentrate
its investments (i.e., hold 25% or more of its total assets) in a
particular industry or group of industries to approximately the same
extent that the Underlying Index is so concentrated. The Fund will be
diversified under the 1940 Act.
Investment Guidelines
    According to the Registration Statement, the Fund will write (sell)
call options on the Reference Index to the same extent as such short
call options are included in its Underlying Index.
    The Trust, on behalf of the Fund, has filed a notice of eligibility
for exclusion from the definition of the term ``commodity pool
operator'' in accordance with Rule 4.5 so that the Fund is not subject
to registration or regulation as a commodity pool operator under the
Commodity Exchange Act (``CEA'').
Other Investments
    The Fund may also hold up to 20% of its net assets in cash and Cash
Equivalents,\13\ shares of non-exchange traded registered open-end
investment companies, subject to applicable limitations under Section
12(d)(1) of the 1940 Act (``Mutual Funds''),\14\ futures, listed
options, and U.S. listed equities that are not included in the
underyling [sic] index, but which the Adviser believes will help the
Fund track the Underlying Index.
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    \13\ As defined in Exchange Rule 14.11(i)(4)(C)(iii)(b), Cash
Equivalents are short-term instruments with maturities of less than
three months, which includes only the following: (i) U.S. Government
securities, including bills, notes, and bonds differing as to
maturity and rates of interest, which are either issued or
guaranteed by the U.S. Treasury or by U.S. Government agencies or
instrumentalities; (ii) certificates of deposit issued against funds
deposited in a bank or savings and loan association; (iii) bankers
acceptances, which are short-term credit instruments used to finance
commercial transactions; (iv) repurchase agreements and reverse
repurchase agreements; (v) bank time deposits, which are monies kept
on deposit with banks or savings and loan associations for a stated
period of time at a fixed rate of interest; (vi) commercial paper,
which are short-term unsecured promissory notes; and (vii) money
market funds.
    \14\ The Fund will not invest in leveraged (e.g. 2x, -2x, 3x, or
-3x) Mutual Funds.
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    The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid securities (calculated at the time of
investment).\15\ The Fund will monitor

its portfolio liquidity on an ongoing basis to determine whether, in
the 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 securities and other illiquid assets.
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    \15\ The Commission has stated that long-standing Commission
guidelines have required open-end funds to hold no more than 15% of
their net assets in illiquid securities and other illiquid assets.
See Investment Company Act Release No. 8901 (March 11, 2008), 73 FR
14618 (March 18, 2008), footnote 34. See also, Investment Company
Act Release No. 5847 (October 21, 1969), 35 FR 19989 (December 31,
1970) (Statement Regarding ``Restricted Securities''); Investment
Company Act Release No. 18612 (March 12, 1992), 57 FR 9828 (March
20, 1992) (Revisions of Guidelines to Form N-1A). A fund's portfolio
security is illiquid if it cannot be disposed of in the ordinary
course of business within seven days at approximately the value
ascribed to it by the exchange traded fund (``ETF''). See Investment
Company Act Release No. 14983 (March 12, 1986), 51 FR 9773 (March
21, 1986) (adopting amendments to Rule 2a-7 under the 1940 Act);
Investment Company Act Release No. 17452 (April 23, 1990), 55 FR
17933 (April 30, 1990) (adopting Rule 144A under the Securities Act
of 1933).
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    The Fund will seek to qualify for treatment as a regulated
investment company (``RIC'') under the Code.\16\
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    \16\ 26 U.S.C. 851.
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Availability of Information
    The Fund's website, which will be publicly available prior to the
public offering of Shares, will include a form of the prospectus for
the Fund that may be downloaded. The website will include additional
quantitative information updated on a daily basis, including, for the
Fund: (1) The prior business day's reported NAV and a calculation of
the premium and discount of the Bid/Ask Price against the NAV; and (2)
data in chart format displaying the frequency distribution of discounts
and premiums of the daily Bid/Ask Price against the NAV, within
appropriate ranges, for each of the four previous calendar quarters.
Daily trading volume information for the Shares will also be available
in the financial section of newspapers, through subscription services
such as Bloomberg, Thomson Reuters, and International Data Corporation,
which can be accessed by authorized participants and other investors,
as well as through other electronic services, including major public
websites. On each business day, the Fund will disclose on its website
the identities and quantities of the portfolio of securities and other
assets in the daily disclosed portfolio held by the Fund that formed
the basis for the Fund's calculation of NAV at the end of the previous
business day. The daily disclosed portfolio will include, as
applicable: The ticker symbol; CUSIP number or other identifier, if
any; a description of the holding (including the type of holding, such
as the type of swap); the identity of the security, index or other
asset or instrument underlying the holding, if any; for options, the
option strike price; quantity held (as measured by, for example, par
value, notional value or number of shares, contracts, or units);
maturity date, if any; coupon rate, if any; effective date, if any;
market value of the holding; and the percentage weighting of the
holding in the Fund's portfolio. The website and information will be
publicly available at no charge. The value, components, and percentage
weightings of the Underlying Index will be calculated and disseminated
at least once daily and will be available from major market data
vendors. Rules governing the Underlying Index are available on the
Exchange's website and in the Fund's prospectus.
    In addition, an estimated value, defined in BZX Rule 14.11(c)(6)(A)
as the ``Intraday Indicative Value'' (the ``IIV''), that reflects an
estimated intraday value of the Fund's portfolio, will be disseminated.
Moreover, the IIV will be based upon the current value for the
components of the daily disclosed portfolio and will be updated and
widely disseminated by one or more major market data vendors at least
every 15 seconds during the Exchange's Regular Trading Hours.\17\
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    \17\ Currently, it is the Exchange's understanding that several
major market data vendors display and/or make widely available IIVs
published via the Consolidated Tape Association (``CTA'') or other
data feeds.
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    The dissemination of the IIV, together with the daily disclosed
portfolio, will allow investors to determine the value of the
underlying portfolio of the Fund on a daily basis and provide a close
estimate of that value throughout the trading day.
    Quotation and last sale information for the Shares will be
available via the CTA high speed line and, for the securities held by
the Fund, will be available from the exchange on which they are listed.
Quotation and last sale information for options contracts held by the
Fund will be available via the Options Price Reporting Authority. The
intra-day, closing, and settlement prices of the portfolio instruments,
including equities, ETFs, futures, and options, will also be readily
available from the securities exchanges trading such securities,
automated quotation systems, published or other public sources, or
online information services such as Bloomberg or Reuters. Price
information for Cash Equivalents will be available from major market
data vendors. Mutual Funds are typically priced once each business day
and their prices will be available through the applicable fund's
website or from major market data vendors.
Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares. Trading also may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the shares the Fund inadvisable. If the IIV and index value
are not being disseminated for the Fund as required, the Exchange may
halt trading during the day in which the interruption to the
dissemination of the IIV or index value occurs. If the interruption to
the dissemination of an IIV or index value persists past the trading
day in which it occurred, the Exchange will halt trading. The Exchange
may consider all relevant factors in exercising its discretion to halt
or suspend trading in the Shares. The Exchange will halt trading in the
Shares under the conditions specified in BZX Rule 11.18. Trading may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Shares inadvisable. These may
include: (1) The extent to which trading is not occurring in the
securities and/or the financial instruments composing the daily
disclosed portfolio of the Fund; or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. Trading in the Shares also will be
subject to Rule 14.11(c)(1)(B)(iv), which sets forth circumstances
under which Shares of a Fund may be halted.
Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. The Exchange will
allow trading in the Shares from 8:00 a.m. until 8:00 p.m. Eastern Time
and has the appropriate rules to facilitate transactions in the Shares
during all trading sessions. As provided in Rule 11.11(a), the minimum
price variation for quoting and entry of orders in securities traded on
the Exchange is $0.01, with the exception of securities that are priced
less than $1.00, for which the minimum price variation for order entry
is $0.0001.

Surveillance
    The Exchange believes that its surveillance procedures are adequate
to properly monitor the trading of the Shares on the Exchange during
all trading sessions and to deter and detect violations of Exchange
rules and the applicable federal securities laws. Trading of the Shares
through the Exchange will be subject to the Exchange's surveillance
procedures for derivative products, including Index Fund Shares. The
issuer has represented to the Exchange that it will advise the Exchange
of any failure by the Fund to comply with the continued listing
requirements, and, pursuant to its obligations under Section 19(g)(1)
of the Exchange Act, the Exchange will surveil for compliance with the
continued listing requirements. FINRA conducts certain cross-market
surveillances on behalf of the Exchange pursuant to a regulatory
services agreement. The Exchange is responsible for FINRA's performance
under this regulatory services agreement. If the Fund is not in
compliance with the applicable listing requirements, the Exchange will
commence delisting procedures under Exchange Rule 14.12.
    The Exchange or FINRA, on behalf of the Exchange, will communicate
as needed regarding trading in the Shares, underlying equities
(including ETFs), futures, and options contracts with other markets and
other entities that are members of the Intermarket Surveillance Group
(``ISG'') \18\ and may obtain trading information regarding trading in
the Shares, underlying equities (including ETFs), futures, and options
contracts from such markets and other entities. In addition, the
Exchange may obtain information regarding trading in the Shares,
underyling [sic] equities (including ETFs), futures, and the options
contracts from markets and other entities that are members of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement. In addition, the Exchange is able to access, as
needed, trade information for certain fixed income securities held by
the Fund reported to FINRA's Trade Reporting and Compliance Engine
(``TRACE'').
---------------------------------------------------------------------------

    \18\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all of the components
of the portfolio for the Fund may trade on exchanges that are
members of the 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.
    The Exchange represents that, for initial and/or continued listing,
the Fund will be in compliance with Rule 10A-3 \19\ under the Exchange
Act, as provided by generic listing standards under Rule 14.11(c)(4)
and the continued listing standards under Rule 14.11(c). A minimum of
100,000 Shares for the Fund will be outstanding at the commencement of
trading on the Exchange. The Exchange represents that, except for the
exceptions to BZX Rule 14.11(c) described above, the Fund and Shares
will satisfy all applicable requirements for Index Fund Shares under
Rule 14.11(c), including the requirements related to the net asset
value (``NAV'') per Share being calculated daily and made available to
all market participants at the same time, intraday indicative value,
suspension of trading or removal, trading halts, disclosure, and
firewalls.
---------------------------------------------------------------------------

    \19\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

Information Circular
    Prior to the commencement of trading, the Exchange will inform its
members in an Information Circular of the special characteristics and
risks associated with trading the Shares. Specifically, the Information
Circular will discuss the following: (1) The procedures for purchases
and redemptions of Shares in Creation Units (and that Shares are not
individually redeemable); (2) BZX Rule 3.7, which imposes suitability
obligations on Exchange members with respect to recommending
transactions in the Shares to customers; (3) how information regarding
the Intraday Indicative Value and the portfolio holdings is
disseminated; (4) the risks involved in trading the Shares during the
Pre-Opening \20\ and After Hours Trading Sessions \21\ when an updated
Intraday Indicative Value will not be calculated or publicly
disseminated; (5) the requirement that members deliver a prospectus to
investors purchasing newly issued Shares prior to or concurrently with
the confirmation of a transaction; and (6) trading information.
---------------------------------------------------------------------------

    \20\ The Pre-Opening Session is from 8:00 a.m. to 9:30 a.m.
Eastern Time.
    \21\ The After Hours Trading Session is from 4:00 p.m. to 5:00
p.m. Eastern Time.
---------------------------------------------------------------------------

    In addition, the Information Circular will advise members, prior to
the commencement of trading, of the prospectus delivery requirements
applicable to the Fund. Members purchasing Shares from the Fund for
resale to investors will deliver a 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.
    In addition, the Information Circular will reference that the 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 of the Fund and the applicable NAV calculation time
for the Shares. The Information Circular will disclose that information
about the Shares of the Fund will be publicly available on the Fund's
website.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \22\ in general and Section 6(b)(5) of the Act \23\ 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, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78f.
    \23\ 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 will be listed and traded on the Exchange pursuant to the
initial and continued listing criteria for Index Fund Shares based on
an index composed of U.S. Component Stocks in Rule 14.11(c)(3). The
Exchange represents that trading in the Shares will be subject to the
existing trading surveillances administered by the Exchange as well as
cross-market surveillances administered by FINRA on behalf of the
Exchange, which are designed to detect violations of Exchange rules and
federal securities laws applicable to trading on the Exchange. The
Exchange represents that these procedures are adequate to properly
monitor Exchange trading of the Shares in all trading sessions and to
deter and detect violations of Exchange rules and federal securities
laws applicable to trading on the Exchange. Exchange or FINRA, on
behalf of the Exchange, will communicate as needed regarding trading in
the Shares, underlying equities (including ETFs), futures, and options
contracts with other markets and other entities that are members of the
ISG and may obtain trading information regarding trading in the Shares,
underlying equities

(including ETFs), futures, and options contracts from such markets and
other entities. In addition, the Exchange may obtain information
regarding trading in the Shares, underyling [sic] equities (including
ETFs), futures, and the options contracts from markets and other
entities that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement. In addition,
FINRA, on behalf of the Exchange, is able to access, as needed, trade
information for certain fixed income securities held by the Fund
reported to TRACE.
    The Adviser is affiliated with broker-dealers and has implemented
and will maintain a fire wall with respect to its broker-dealer
affiliates regarding access to information concerning the portfolio
holdings of the Fund. In the event (a) the Adviser becomes newly
affiliated with a broker-dealer, or (b) any new adviser or sub-adviser
becomes affiliated with a broker-dealer, it will implement and maintain
a fire wall with respect to such broker-dealer regarding access to
information concerning the portfolio holdings of the Fund, and will be
subject to procedures designed to prevent the use and dissemination of
material non-public information regarding such portfolios. The Index
Provider is not a broker-dealer and has implemented and will maintain
procedures designed to prevent the use and dissemination of material,
non-public information regarding the Underlying Index. All securities
in the Reference Index are listed and traded on a U.S. national
securities exchange. The options on the Reference Index are traded on
Cboe Options, a U.S. national options exchange and member of ISG.
    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Exchange will obtain a representation from the issuer of the
Shares that the NAV per Share will be calculated daily and that the NAV
will be made available to all market participants at the same time. In
addition, a large amount of information is publicly available regarding
the Fund and the Shares, thereby promoting market transparency.
Moreover, the IIV and the Underlying Index value will be widely
disseminated by one or more major market data vendors at least every 15
seconds during Regular Trading Hours. If the IIV or the Underlying
Index value of a Fund is not being disseminated as required, the
Exchange may halt trading during the day in which the interruption to
the dissemination of the applicable IIV or Underlying Index value
occurs. If the interruption to the dissemination of the applicable IIV
or Underlying Index value persists past the trading day in which it
occurred, the Exchange will halt trading. In addition, if the Exchange
becomes aware that the NAV of a Fund is not being disseminated to all
market participants at the same time, it will halt trading in the
relevant Shares on the Exchange until such time as the NAV is available
to all market participants. On each business day, before commencement
of trading in Shares during Regular Trading Hours on the Exchange, the
Fund will disclose on itswebsite [sic] the securities and other
financial instruments in the Fund's portfolio that will form the basis
for the Fund's calculation of NAV at the end of the business day.
Information regarding market price and trading volume of the Shares
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services, and
quotation and last sale information will be available via the CTA high-
speed line. The website for the Fund will include a form of the
prospectus for the Fund and additional data relating to NAV and other
applicable quantitative information. Moreover, prior to the
commencement of trading, the Exchange will inform its Members in an
Information Circular of the special characteristics and risks
associated with trading the Shares. The Exchange will halt trading in
the Shares under the conditions specified in Rule 11.18. Trading may be
halted because of market conditions or for reasons that, in the view of
the Exchange, make trading in the Shares inadvisable. These may
include: (1) The extent to which trading is not occurring in the
securities and/or the financial instruments composing the daily
disclosed portfolio of the Fund; or (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. In addition, the equity securities
(including ETFs), futures, and options in which the Fund will invest
will trade in markets that are ISG members. Additional information
regarding the Underlying and Reference Indices' components and their
percentage weights will be available from the Index Provider and major
market data vendors. In addition, quotation and last sale information
for the components of the Underlying and Reference Indices will be
available from the exchanges on which they trade. The intra-day,
closing and settlement prices of the portfolio instruments will also be
readily available from the exchanges trading such instruments,
automated quotation systems, published or other public sources, or on-
line information services such as Bloomberg or Reuters. In addition, as
noted above, investors will have ready access to information regarding
the Fund's holdings, the IIV, the Underlying Index's value, and
quotation and last sale information for the Shares.
    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
additional types of Index Fund Shares that will enhance competition
among market participants, to the benefit of investors and the
marketplace. As noted above, the Exchange has in place surveillance
procedures relating to trading in the Shares, the underlying equities
(including ETFs), futures, and options contracts and 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. In addition, as noted above, investors will have
ready access to information regarding the Fund's holdings, the IIV,
relevant Underlying Index value, and quotation and last sale
information for the Shares.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The Exchange notes that the
proposed rule change will facilitate the listing and trading of an
additional series of Index Fund Shares on the Exchange that will
enhance competition among market participants, to the benefit of
investors and the marketplace.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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 Exchange consents, the Commission will:

    A. By order approve or disapprove such proposed rule change, or
    B. institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2019-001 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2019-001. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2019-001, and should be
submitted on or before March 8, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02394 Filed 2-14-19; 8:45 am]
 BILLING CODE 8011-01-P


IMPORTANT NOTE TO USER: February 26, 1996 This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OAR/ OAQPS 2. OMB control number b. G None a_ 2 _ 0 _ 6 _ 0  _ 0 _ 2 _ 3 _ 4 __ __ __ __

3. Type of information collection ( check one) a. G New collection b.

Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one)

a.

Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes G No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.

Three years from approval date b. G Other Specify: / /___

7. Title Part 70 Operating Permits Regulations 8. Agency form number( s) ( If applicable) EPA ICR Number 1587.05 9. Keywords Reporting and Recordkeeping Requirements, Permits, Air Pollution Control 10. Abstract Sources monitor operations and submit to permitting authorities semi annual monitoring reports, annual compliance certifications, and applications for permit revisions. Permitting authorities review reports, prepare permits and permit revisions, and submit proposed permits and permit revisions to EPA.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c.

Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 21,036 b. Total annual responses 21,036 1. Percentage of these responses collected electronically 50 % c. Total annual hours requested 4,779,620 d. Current OMB inventory 5,160,333 e. Difference ( 380,713) f. Explanation of difference 1. Program Change 2. Adjustment ( 380,713) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. X _ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply)

a.

Recordkeeping b. Q Third party disclosure c.

Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5.

Semi annually 6.

Annually 7. Q Biennually 8.

Other ( describe) One time 17. Statistical methods Does this information collection employ statistical methods?

Q Yes

No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Roger Powell Phone: 919 541 5331 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Information ( OPPE) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

10/ 95


[Federal Register Volume 86, Number 115 (Thursday, June 17, 2021)]
[Rules and Regulations]
[Page 32215]
[FR Doc No: 2021-12840]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0390]

Safety Zones; Annual Event in the Captain of the Port Buffalo
Zone

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone located in Federal
regulations for a recurring marine event. This action is necessary and
intended for the safety of life and property on navigable waters during
these events. During each enforcement period, no person or vessel may
enter the respective safety zone without the permission of the Captain
of the Port Buffalo.

DATES: The regulations in 33 CFR 165.939, Table 165.939, entry (a)(1),
will be enforced from 9:45 p.m. to 11:15 p.m. on June 18, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email LCDR William Fitzgerald,
Chief of Waterways Management, U.S. Coast Guard Marine Safety Unit
Cleveland; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zones; Annual Events in the Captain of the Port Buffalo Zone listed in
33 CFR 165.939, Table 165.939, entry (a)(1), in Vermillion, OH, on all
U.S. waters within a 420 foot radius of the fireworks launch site
located at position 41[deg]25'45'' N and 082[deg]21'54'' W, (NAD 83)
for the Festival of the Fish.
    Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring
within the safety zone during an enforcement period is prohibited
unless authorized by the Captain of the Port Buffalo or a designated
representative. Those seeking permission to enter the safety zone may
request permission from the Captain of Port Buffalo via channel 16,
VHF-FM. Vessels and persons granted permission to enter the safety zone
shall obey the directions of the Captain of the Port Buffalo or a
designated representative. While within a safety zone, all vessels
shall operate at the minimum speed necessary to maintain a safe course.
    This notification of enforcement is issued under authority of 33
CFR 165.939 and 5 U.S.C. 552(a). In addition to this notification of
enforcement in the Federal Register, the Coast Guard will provide the
maritime community with advance notification of this enforcement period
via Broadcast Notice to Mariners or Local Notice to Mariners. If the
Captain of the Port Buffalo determines that the safety zone need not be
enforced for the full duration stated in this notification she may use
a Broadcast Notice to Mariners to grant general permission to enter the
respective safety zone.

Lexia M. Littlejohn,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2021-12840 Filed 6-16-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Rules and Regulations]
[Pages 5595-5598]
[FR Doc No: 2019-02938]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0907; Product Identifier 2018-NM-118-AD; Amendment
39-19562; AD 2019-03-10]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2017-07-05,
which applied to all Airbus SAS Model A300 series airplanes; and Model
A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-
605R Variant F airplanes (collectively called Model A300-600 series
airplanes). AD 2017-07-05 required repetitive detailed visual
inspections of the main landing gear (MLG) leg components and
replacement of the MLG leg if cracked components are found. This AD
retains the requirements of AD 2017-07-05 and removes the credit for
doing an MLG overhaul in lieu of the initial inspection of the MLG leg
components. This AD was prompted by further investigation after AD
2017-07-05 was issued, which revealed that overhaul of the MLG does not
alleviate the need for inspecting the MLG hinge arm/barrel pin for
cracking. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective March 29, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 29,
2019.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAW, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
internet http://www.airbus.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2018-0907.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0907; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2017-07-05, Amendment 39-18843 (82 FR 16101,
April 3, 2017) (``AD 2017-07-05''). AD 2017-07-05 applied to all Airbus
SAS Model A300 series airplanes; and Model A300-600 series airplanes.
The NPRM published in the Federal Register on November 6, 2018 (83 FR
55498). The NPRM was prompted by further investigation after AD 2017-
07-05 was issued, which revealed that overhaul of the MLG does not
alleviate the need for inspecting the MLG hinge arm/barrel pin for
cracking. The NPRM proposed to retain the requirements of AD 2017-07-05
and remove the credit for doing an MLG overhaul in lieu of the initial
inspection of the MLG leg components. We are issuing this AD to address
cracking of certain components in the MLG leg, which could result in an
MLG collapse, and consequent damage to the airplane and injury to the
airplane occupants.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0170, dated August 6, 2018 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus SAS Model A300 series
airplanes; and Model A300-600 series airplanes. The MCAI states:

    Two cases were reported of finding a cracked MLG hinge arm/
barrel pin, one was discovered in service during a maintenance

task and the other one was identified during MLG overhaul.
    This condition, if not detected and corrected, could lead to MLG
collapse, possibly resulting in damage to the aeroplane and injury
to occupants.
    To address this potential unsafe condition, Airbus issued [Alert
Operators Transmission] AOT A32W008-16 (original issue) to provide
instructions for detailed visual inspections (DET) to detect cracks
and EASA issued AD 2016-0058 accordingly [which corresponds to FAA
AD 2017-07-05], requiring repetitive DET of the affected parts and,
depending on findings, replacement of the affected MLG leg.
    Since that [EASA] AD was issued, further investigation results
highlighted that, the overhaul of the MLG cannot alleviate the
inspection need of the hinge arm/barrel pin.
    For the reasons described above, this [EASA] AD retains the
requirement of EASA AD 2016-0058, which is superseded, removing the
credit of MLG overhaul for the first inspection of the pin.

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0907.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comments received. Air Line
Pilots Association, International and Madeline Roach each indicated
support for the NPRM.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed, except for minor editorial changes. We
have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Alert Operators Transmission (AOT) A32W008-16,
Rev 01, dated July 30, 2018. This service information describes
procedures for inspecting the MLG hinge arm/barrel pin for cracking,
and replacement of the MLG leg if cracking is detected.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 128 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
          Labor cost              Parts cost    Cost per product              Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour =                $0  $85, per          $10,880, per inspection cycle.
 $85, per inspection cycle.                      inspection
                                                 cycle.
----------------------------------------------------------------------------------------------------------------

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
              Labor cost                         Parts cost                        Cost per product
----------------------------------------------------------------------------------------------------------------
20 work-hours x $85 per hour = $1,700  $3,400,000 per MLG...........  $3,401,700 per MLG.
 per MLG.
----------------------------------------------------------------------------------------------------------------

    We estimate that it will take about 1 work-hour per product to
comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, we estimate the cost of
reporting the inspection results on U.S. operators to be $85 per
product.
    The new requirements of this AD add no additional economic burden.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.

    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-07-05, Amendment 39-18843 (82 FR 16101, April 3, 2017), and adding
the following new AD:

2019-03-10 Airbus SAS: Amendment 39-19562; Docket No. FAA-2018-0907;
Product Identifier 2018-NM-118 AD.

(a) Effective Date

    This AD is effective March 29, 2019.

(b) Affected ADs

    This AD replaces AD 2017-07-05, Amendment 39-18843 (82 FR 16101,
April 3, 2017) (``AD 2017-07-05'').

(c) Applicability

    This AD applies to Airbus SAS airplanes, certificated in any
category, all manufacturer serial numbers, identified in paragraphs
(c)(1) through (c)(5) of this AD.
    (1) Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and
B4-203 airplanes.
    (2) Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
    (3) Model A300 B4-605R and B4-622R airplanes.
    (4) Model A300 F4-605R and F4-622R airplanes.
    (5) Model A300 C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by reports of cracks in main landing gear
(MLG) leg components. We are issuing this AD to address cracking of
certain components in the MLG leg, which could result in an MLG
collapse, and consequent damage to the airplane and injury to the
airplane occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definition

    For the purpose of this AD an affected part is an MLG hinge arm/
barrel pin having part number (P/N) C66441-(X) and P/N C65543-(X),
where the X is representing a variable number.

(h) Repetitive Inspections

    At the applicable compliance time specified in figure 1 to
paragraph (h) of this AD, and thereafter at intervals not to exceed
100 flight cycles, accomplish a detailed visual inspection of the
internal diameter of each affected MLG hinge arm/barrel pin for
cracking, in accordance with the instructions of Airbus Alert
Operators Transmission (AOT) A32W008-16, Rev 01, dated July 30, 2018
(``AOT A32W008-16, Rev 01'').
[GRAPHIC] [TIFF OMITTED] TR22FE19.016

(i) Corrective Action

    If any crack is found during any inspection required by
paragraph (h) of this AD: Before further flight, replace the MLG leg
in accordance with the instructions of Airbus AOT A32W008-16, Rev
01. Replacement of an MLG leg does not constitute terminating action
for the repetitive inspections required by paragraph (h) of this AD.

(j) Reporting

    At the applicable time specified in paragraph (j)(1) or (j)(2)
of this AD, report the inspection results required by paragraph (h)
of this AD to Airbus SAS. This can be accomplished using the
instructions of Airbus AOT A32W008-16, Rev 01.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after each inspection
required by paragraph (h) of this AD.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for the initial inspection
required by paragraph (h) of this AD and corrective actions required
by paragraph (i) of this AD, if those actions were performed before
the effective date of this AD using the instructions of Airbus AOT
A32W008-16, dated February 25, 2016.

(l) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (m)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or
Airbus SAS's EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 1
hour per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW, Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES 200.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0170, dated August 6, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0907.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (n)(3) and (n)(4) of this AD.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Alert Operators Transmission A32W008-16, Rev 01,
dated July 30, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>internet
http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on February 8, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-02938 Filed 2-21-19; 8:45 am]
 BILLING CODE 4910-13-P