2008 (``CtW 2 Letter''); Tim Solso, Chairman and Chief Executive
Officer, Cummins Inc., dated March 25, 2009 (``Cummins Letter'');
David M. Dobkin, dated March 27, 2009 (``Dobkin Letter''); Patrick
B. Carey, Associate General Counsel & Assistant Corporate Secretary,
DTE Energy, dated March 27, 2009 (``DTE Letter''); Alexander M.
Cutler, Chairman and Chief Executive Officer, Eaton Corporation,
dated March 13, 2009 (``Eaton Letter''); Bronwen L Mantlo, Associate
General Counsel and Assistant Secretary, dated March 26, 2009 (``Eli
Lilly Letter''); Holly Roseberry, President, EV Innovations, Inc.,
dated March 25, 2009 (``EV Letter''); David S. Rosenthal, Vice
President, Investor Relations and Secretary, Exxon Mobil
Corporation, dated March 27, 2009 (``Exxon Mobil Letter'');
Christine P. Richards, Executive Vice President, General Counsel and
Secretary, FedEx Corporation, dated March 26, 2009 (``FedEx
Letter''); Kevin Kopaunik, President, Fidelity Transfer Company,
dated March 24, 2009 (``Fidelity Letter''); Salli Marinov, President
and Chief Executive Officer, First American Stock Transfer, Inc.,
dated March 24, 2009 (``First American Letter''); Dorothy B. Wright,
Vice President and Corporate Secretary, First Financial Holdings,
Inc., dated March 24, 2009 (``First Financial Letter''); Alissa E.
Ballot, Vice President and Corporate Secretary, FPL Group, Inc.,
dated March 23, 2009 (``FPL Letter''); Michael McCauley, Director,
Office of Corporate Governance, State Board of Administration of
Florida, dated June 13, 2007 (``FSBA Letter''); Ashbel C. Williams,
Executive Director and Chief Executive Officer, State Board of
Administration of Florida, dated March 27, 2009 (``FSBA 2 Letter'');
Jon D. Botsford, Senior Vice President, General Counsel and
Secretary, Furniture Brands International, dated March 23, 2009
(``Furniture Brands Letter''); Michael R. McAlevey, Vice President
and Chief Corporate, Securities and Finance Counsel, General
Electric Company, dated April 13, 2009 (``GE Letter''); Roderick A.
Palmore, Executive Vice President, General Counsel and Chief
Compliance and Risk Management Officer, General Mills, dated March
17, 2009 (``General Mills Letter''); Robert McCormick, Chief Policy
Officer, Glass Lewis & Co., dated March 13, 2009 (``Glass Lewis
Letter''); G. Richard Wagoner, Jr., Chairman and Chief Executive
Officer, General Motors Corporation, dated March 27, 2009 (``GM
Letter''); Brian Connolly, Director of Sales, GovernanceMetrics
International (``GovernanceMetrics Letter''); Neila B. Radin, Chair,
Securities Law Committee, The Society of Corporate Secretaries and
Governance Professionals, dated March 20, 2009 (``Governance
Professionals Letter''); Steven Gratzer, dated April 27, 2009
(``Gratzer Letter''); William A. Little III, President, Gulf
Registrar and Transfer Corporation, dated March 24, 2009 (``Gulf
Letter''); Carl T. Hagberg, Chairman and CEO, Carl T. Hagberg and
Associates, dated March 27, 2009 (``Hagberg Letter''); Dinesh C.
Paliwal, Chairman and Chief Executive Officer, Harman International,
dated March 26, 2009 (``Harman Letter''); Steven R. Mackey,
Executive Vice President, Secretary and General Counsel, Helmerich &
Payne, Inc., dated March 24, 2009 (``Helmerich Letter''); Bess
Joffe, Associate Director, Hermes Equity Ownership Services Limited,
dated March 20, 2009 (``Hermes Equity Letter''); Thomas F. Larkins,
Vice President, Corporate Secretary and General Counsel, Honeywell,
dated March 27, 2009 (``Honeywell Letter''); Paul Schott Stevens,
President, Investment Company Institute, dated November 20, 2006
(``ICI Letter''); Paul Schott Stevens, President, Investment Company
Institute, dated December 18, 2006 (``ICI 2 Letter''); Paul Schott
Stevens, President, Investment Company Institute, dated February 20,
2007 (``ICI 3 Letter''); Karrie McMillian, General Counsel,
Investment Company Institute, dated March 27, 2009 (``ICI 4
Letter'') (supporting the proposal, as amended to exempt investment
companies); Robert G. Pearson, President and Chief Executive
Officer, Illinois Stock Transfer Company, dated March 24, 2009
(``Illinois Stock Letter''); Maura Abelin Smith, Senior Vice
President, General Counsel and Corporate Secretary, International
Paper Company, dated March 24, 2009 (``International Paper
Letter''); Cary Klafter, Vice President, Legal and Corporate
Affairs, Intel Corporation, dated March 26, 2009 (``Intel Letter'');
Gilbert J. Pomar, III, President and Chief Executive Officer, and
Valerie A. Kendall, EVP and Chief Financial Officer, Jacksonville
Bancorp Inc., dated March 26, 2009 (``Jacksonville Letter'');
Stephen A. Roell, Chairman and Chief Executive Officer, Johnson
Controls, Inc., dated March 25, 2009 (``Johnson Letter''); Anthony
J. Horan, Corporate Secretary, J.P.Morgan Chase & Co., dated March
27, 2009 (``J.P. Morgan Letter''); Sarah Wilson, Chief Executive,
Manifest, dated March 27, 2009 (``Manifest Letter''); McKesson
Corporation, dated March 27, 2009 (``McKesson Letter''); Thomas M.
Moriaty, General Counsel, Secretary and SVP, Medco Health Solutions,
Inc., dated March 26, 2009 (``Medco Letter''); Kenneth G. Frassetto,
Director--Treasury Management and Shareholder Services, MGE Energy,
Inc., dated March 26, 2009 (``MGE Letter''); Michael C. Miller,
Executive Vice President, General Counsel and Secretary, Monster
Worldwide, Inc., dated March 24, 2009 (``Monster Letter''); Larry S.
Dohrs, Vice President, Newground Social Investment, dated March 27,
2009 (``Newground Letter''); Jeffrey D. Morgan, CAE, President &
CEO, National Investor Relations Institute, dated March 16, 2009
(``NIRI Letter''); C.W. Moorman, Chairman, President and Chief
Executive Officer, Norfolk Southern Corporation, dated March 23,
2009 (``NS Letter''); Daniel R. DiMicco, Chairman, President and
Chief Executive Officer, Nucor Corporation, dated March 25, 2009
(``Nucor Letter''); Jeffrey W. Rubin, Chair, Business Law Section,
Committee on Securities Regulation, New York State Bar Association,
dated March 27, 2009 (``NYSBA Sec. Reg. Letter''); Elisa D. Garcia,
Executive Vice President and General Counsel, Office Depot, Inc.,
dated March 24, 2009 (``Office Depot Letter''); Chris DeRose, Chief
Executive Officer, Ohio Public Employees Retirement System, dated
March 24, 2009 (``OPERS Letter''); Toni Zaks, President, OTC
Corporate Transfer Service, dated March 24, 2009 (``OTC Letter'');
Loren K. Hanson, Assistant Secretary, Otter Tail Corporation, dated
March 24, 2009 (``Otter Tail Letter''); E. J. Wunsch, Assistant
Secretary and Associate General Counsel, The Procter & Gamble
Company, dated March 27, 2009 (``P&G Letter''); Alexander C. Schoch,
Executive Vice President, Chief Legal Officer and Secretary, Peabody
Energy, dated March 17, 2009 (``Peabody Letter''); Matthew Lepore,
Vice President, Chief President-Corporate Governance, Pfizer, dated
March 27, 2009 (``Pfizer Letter''); Laura J. Cataldo, President and
Chief Executive Officer, Platinum Stock Transfer, dated March 24,
2009 (``Platinum Letter''); James T. Breedlove, Senior Vice
President, General Counsel and Secretary, Praxair, dated March 27,
2009 (``Praxair Letter''); Daniel Rothstein, Executive Vice
President, Provident Bank, dated March 27, 2009 (``Provident
Letter''); John F. Kuntz, General Counsel and Corporate Secretary,
Provident Financial Services, Inc. (``Provident Financial Letter'');
Larry W. Sonsini, Chairman, Proxy Working Group, dated March 25,
2009 (``PWG Letter''); William J. O'Shaughnessy, Jr., Assistant
General Counsel and Corporate Secretary, Quest Diagnostics
Incorporated, dated March 25, 2009 (``Quest Letter''); Frank
Curtiss, Head of Corporate Governance, Railways Pension Trustee
Company Limited, dated April 15, 2009 (``Railpen Letter''); Marilyn
Wasser, Executive Vice President and General Counsel, Realogy
Corporation, dated April 2, 2009 (``Realogy Letter''); Ralph V.
Whitworth, Principal, Relational Investors LLC, dated March 12, 2009
(``Relational Investors Letter''); Jason Freeman, President, Routh
Stock Transfer, Inc., dated March 24, 2009 (``Routh Letter''); Karen
Gross, Vice President and Secretary, Royal Gold, Inc., dated March
23, 2009 (``Royal Gold Letter''); Robert D. Fatovic, Executive Vice
President, Chief Legal Officer and Corporate Secretary, Ryder, dated
March 26, 2009 (``Ryder Letter''); Sullivan & Cromwell LLP, dated
March 27, 2009 (``S&C Letter''); Niels Holch, Executive Director,
Shareholder Communications Coalition, dated March 27, 2009 (``SCC
Letter''); Niels Holch, Executive Director, Shareholder
Communications Coalition, dated April 24, 2009 (``SCC 2 Letter'');
R. Scott McMillen, Vice President and Associate General Counsel, The
Charles Schwab Corporation, dated March 27, 2009 (``Schwab
Letter''); George Johnson, Vice President, Securities Transfer
Corporation, dated March 24, 2009 (``Securities Transfer Letter'');
Thomas F. Price, Managing Director, Securities Industry and
Financial Markets Association (``SIFMA Letter'') (noting that some
of the assertions made by other commenters were ``inaccurate and
promote confusion,'' and presenting its own observations on those
issues); John C. Wilcox, Chairman, Sod'ali, dated March 27, 2009
(``Sod'ali Letter''); Charles V. Rossi, President, The Securities
Transfer Association, Inc., dated March 27, 2009 (``STA Letter'');
Mary Cleo Fernandez,

Transfer Agent, Standard Registrar Transfer Agency, Inc., dated
March 24, 2009 (``Standard Letter''); Robert M. Stanton, dated March
25, 2009 (``Stanton Letter''); Jonathan Miller, President,
StockTrans, Inc., dated March 24, 2009 (``StockTrans Letter''); Paul
Abel, General Counsel and Secretary, Suburban Propane Partners,
L.P., dated November 16, 2006 (``Suburban Letter'') (resubmitted on
March 3, 2009); Douglas Ian Shaw, Senior Vice President and
Corporate Secretary, Suffolk County National Bank, Suffolk Bancorp,
dated March 13, 2009 (``Suffolk Letter''); Holly Roseberry,
Director, Superlattice Power, Inc., dated March 25, 2009
(``Superlattice Letter''); Steven B. Boehm and Cynthia M. Krus,
Sutherland Asbill and Brennan LLP, dated March 31, 2009
(``Sutherland Letter''); Cheryl C. Carter, Corporate Secretary,
Synalloy Corporation, dated March 25, 2009 (``Synalloy Letter'');
Lewis B. Campbell, Chairman and Chief Executive Officer, Textron
Inc., dated March 30, 2009 (``Textron Letter''); Cynthia H. Haynes,
Vice President, Assistant Secretary and Assistant General Counsel,
Texas Instruments Incorporated, dated March 26, 2009 (``TI
Letter''); Hye-Won Choi, Senior Vice President and Head of Corporate
Governance, TIAA-CREF, dated March 27, 2009 (``TIAA-CREF Letter'');
Jonas Kron, Senior Social Research Analyst, Trillium Asset
Management, dated March 17, 2009 (``Trillium Letter''); Scott
Renwick, Senior Vice President and General Counsel, Unitrin, dated
March 27, 2009 (``Unitrin Letter''); Donald A. French, Treasurer,
UQM Technologies, Inc., dated March 26, 2009 (``UQM Letter'');
Gregory A. Robbins, Senior Vice President and General Counsel, Veeco
Instruments Inc., dated March 26, 2009 (``Veeco Letter''); Marianne
Drost, Senior Vice President, Deputy General Counsel and Corporate
Secretary, Verizon Communications Inc., dated March 27, 2009
(``Verizon Letter''); David A. Katz, Wachtell, Lipton, Rosen & Katz,
dated March 26, 2009 (``Wachtell Letter''); Shelly L. Angus, Senior
Vice President, Investor Relations, Washington Banking Company,
dated March 23, 2009 (``Washington Banking Letter''); Robert J.
LaForest, Vice President and Associate General Counsel, Whirlpool
Corporation, dated March 26, 2009 (``Whirlpool Letter''); Michael C.
Connelly, Vice President and General Counsel, Xcel Energy, dated
March 27, 2009 (``Xcel Letter''); Anne M. Mulcahy, Chairman and
Chief Executive Officer, Xerox Corporation, dated March 25, 2009
(``Xerox Letter''); and William D. Zollars, Chairman of the Board,
President and Chief Executive Officer, and YRC Worldwide Inc., dated
March 25, 2009 (``YRC Letter'').

[FR Doc. E9-16318 Filed 7-9-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Pages 35256-35259]
[FR Doc No: 2017-15904]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81191; File No. SR-BatsBZX-2017-46]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing of a Proposed Rule Change to Rule 14.11(c), Index Fund Shares,
To List and Trade Shares of the Aptus Fortified Value ETF, a Series of
ETF Series Solutions

July 24, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 10, 2017, Bats BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \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 filed a proposal to list and trade shares of the Aptus
Fortified Value ETF (the ``Fund''), a series of ETF Series Solutions
(the ``Trust''), under Rule 14.11(c) (``Index Fund Shares'').
    The text of the proposed rule change is available at the Exchange's
Web site at www.bats.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to list and trade the Shares under Rule
14.11(c)(3), which governs the listing and trading of Index Fund Shares
on the Exchange.\3\ The Fund will be an index-based exchange traded
fund (``ETF''). The Exchange is submitting this proposed rule change
because the Index, as defined below, 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.'' \4\ 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. Because the

Index may purchase put options on a security that tracks the broader
U.S. equity market, as further described below, which are not included
in the definition of ``U.S. Component Stocks'' as defined in Rule
14.11(c)(1)(D), the Index does not satisfy the requirements of Rule
14.11(c)(3)(A)(i). The Index will otherwise conform to the initial and
continued listing criteria under Rule 14.11(c). Rule 14.11(i), which
covers the listing and trading of actively managed ETFs (``Managed Fund
Shares''), does however provide generic listing standards related to
funds holding listed derivatives in Rule 14.11(i)(4)(C)(iv), which
includes the kinds of options that may be held by the Index. The
Exchange believes that, while the Index wouldn't necessarily meet the
requirements of Rule 14.11(i)(4)(C)(iv), the listing and trading of the
Shares would not give rise to the policy concerns on which the
substance of Rule 14.11(i)(4)(C)(iv) is based, as further described
below.
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    \3\ The Commission originally 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\ As defined in Rule 14.11(c)(1)(D), the term ``U.S. Component
Stock'' shall mean an equity security that is registered under
Sections 12(b) or 12(g) of the Act, or an American Depositary
receipt, the underlying equity security of which is registered under
Sections 12(b) or 12(g) of the Act.
---------------------------------------------------------------------------

    The Shares will be offered by the Trust, which was established as a
Delaware statutory trust on February 9, 2012. The Trust is registered
with the Commission as an open-end investment company and has filed a
registration statement on behalf of the Fund on Form N-1A
(``Registration Statement'') with the Commission.\5\
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    \5\ See Registration Statement on Form N-1A for the Trust, dated
June 8, 2017 (File Nos. 333-179562 and 811-22668). The descriptions
of the Fund and the Shares contained herein are based, in part, on
information in the Registration Statement.
---------------------------------------------------------------------------

    The Fund intends to qualify each year as a regulated investment
company under Subchapter M of the Internal Revenue Code of 1986, as
amended.
Aptus Fortified Value ETF
    According to the Registration Statement, the Fund will seek to
track the performance, before fees and expenses, of the Aptus Fortified
Value Index (the ``Index''). The Index is a rules-based, equal-weighted
index that is designed to gain exposure to 50 of the most undervalued
U.S.-listed common stocks and real estate investment trusts
(``REITs''), while hedging against significant U.S. equity market
declines when the market is overvalued.
    The Index is composed of two components: An equity component of 50
common stocks and REITs and, when the Index determines that the U.S.
equity market is overvalued, a ``tail hedge'' of long put options on a
security that tracks the broader U.S. equity market.\6\ When the tail
hedge is not in effect, the Index will be composed 100% of the equity
component. At the time the tail hedge is implemented, the Index will be
composed 99.5% of the equity component and 0.50% of the tail hedge, as
described below.
---------------------------------------------------------------------------

    \6\ The Exchange notes that the equity component of the Index
meets the requirements of Rule 14.11(c)(3)(A)(i).
---------------------------------------------------------------------------

    When the tail hedge is implemented, the Index will reallocate 0.50%
of its weight to buy put options on a large, highly liquid ETF that
tracks the performance of the large-cap U.S. equity market (the
``Underlying ETF''). The Underlying ETF will be the ETF that tracks the
large-cap U.S. equity market and has the highest average daily options
volume as determined annually by the Index rules. A put option gives
the purchaser the right to sell shares of the underlying asset at a
specified price (``strike price'') prior to a specified date
(``expiration date''). The purchaser pays a cost (premium) to purchase
the put option. In the event the underlying asset declines in value,
the value of the put option will generally increase, and in the event
the underlying asset appreciates in value, the put option may end up
worthless and the premium may be lost.
    At the time the tail hedge is implemented, the put options on the
Underlying ETF will have an expiration date of approximately three
months from the date the tail hedge is implemented, and the strike
price will be approximately 30% less than the most recent closing price
of the Underlying ETF.
    On the last business day of each month, any options held by the
Index are sold. If the tail hedge will not be in effect for the
following month, the weight of such options, if any, will be
reallocated pro rata to the securities in the Index's equity component.
If the tail hedge will continue in effect for the following month, the
Index is rebalanced (i.e., no equity securities are added or deleted)
such that the tail hedge (with new options purchased) has a weight of
0.50% and the equity component securities are adjusted up or down pro
rata to have a weight of 99.5%.\7\
---------------------------------------------------------------------------

    \7\ This calculation is based on the cost to purchase the put
contracts. While the Index would not necessarily meet the
requirements of Rule 14.11(i)(4)(C)(iv)(b) applicable to options
holdings for Managed Fund Shares, which prevents the aggregate gross
notional value of listed derivatives based on any single underlying
reference asset from exceeding 30% of the weight of the portfolio
(including gross notional exposures) and the aggregate gross
notional value of listed derivatives based on any five or fewer
underlying reference assets from exceeding 65% of the weight of the
portfolio (including gross notional exposures), the actual potential
downside associated with purchased put contracts is limited to the
cost of the contract. The Exchange believes that this, combined with
the relatively small percentage of the Index's exposure to options
on the Underlying ETF and the liquidity in the options market for
the Underlying ETF mitigates the concerns that Rule
14.11(i)(4)(C)(iv)(b) is intended to address and would prevent the
Shares from being susceptible to manipulation.
---------------------------------------------------------------------------

    The Exchange represents that, except for the 0.50% options position
that the Index might hold, the Index will satisfy, on an initial and
continued listing basis, all of the generic listing standards under
Rule 14.11(c)(3)(A)(i) and all other applicable requirements for Index
Fund Shares under Rule 14.11(c), including, but not limited to,
requirements relating to the dissemination of key information such as
the Net Asset Value, the Intraday Indicative Value, rules governing the
trading of equity securities, trading hours, trading halts,
surveillance, and the information circular, as set forth in Exchange
rules applicable to Index Fund Shares and the orders approving such
rules. Moreover, all of the equity securities and options contracts
held by the Index trade on markets that are a member of Intermarket
Surveillance Group (``ISG'') or affiliated with a member of ISG or with
which the Exchange has in place a comprehensive surveillance sharing
agreement.\8\ All statements and representations made in this filing
regarding (a) the description of the portfolio, (b) limitations on
portfolio holdings or reference assets, or (c) the applicability of
Exchange rules shall constitute continued listing requirements for
listing the Shares on the Exchange. The issuer has represented to the
Exchange that it will advise the Exchange of any failure by the Fund or
the Shares to comply with the continued listing requirements, and,
pursuant to its obligations under Section 19(g)(1) of the Act, the
Exchange will surveil for compliance with the continued listing
requirements. If the Fund or the Shares are not in compliance with the
applicable listing requirements, the Exchange will commence delisting
procedures under Exchange Rule 14.12.
---------------------------------------------------------------------------

    \8\ For a list of the current members and affiliate members of
ISG, see www.isgportal.com. The Exchange notes that not all
components of the Disclosed Portfolio for the Fund may trade on
markets that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \9\ in general and Section 6(b)(5) of the Act \10\ 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.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 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, 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 in that the Shares will meet
each of the initial and continued listing criteria in BZX Rule 14.11(c)
with the exception of the possible 0.50% of assets used to purchase put
options.\11\ While the Index would not necessarily meet the
requirements of Rule 14.11(i)(4)(C)(iv)(b) applicable to options
holdings for Managed Fund Shares, which prevents the aggregate gross
notional value of listed derivatives based on any single underlying
reference asset from exceeding 30% of the weight of the portfolio
(including gross notional exposures) and the aggregate gross notional
value of listed derivatives based on any five or fewer underlying
reference assets from exceeding 65% of the weight of the portfolio
(including gross notional exposures), the actual potential downside
associated with purchased put contracts is limited to the cost of the
contract. The Exchange believes that this, combined with the relatively
small percentage of the Index's exposure to options on the Underlying
ETF and the liquidity in the options market for the Underlying ETF
mitigates the concerns that Rule 14.11(i)(4)(C)(iv)(b) is intended to
address and would prevent the Shares from being susceptible to
manipulation. 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. All of
the futures contracts held by the Fund will trade on markets that are a
member of ISG or affiliated with a member of ISG or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
The Exchange may obtain information regarding trading in the Shares and
the underlying equities and options contracts held by the Fund via the
ISG from other exchanges who are members or affiliates of the ISG or
with which the Exchange has entered into a comprehensive surveillance
sharing agreement.\12\ The Exchange further notes that the Fund will
meet and be subject to all other requirements of Rule 14.11(c) and
other applicable continued [sic] Net Asset Value, the Intraday
Indicative Value, rules governing the trading of equity securities,
trading hours, trading halts, surveillance, and the information
circular, as set forth in Exchange rules applicable to Index Fund
Shares and the orders approving such rules.
---------------------------------------------------------------------------

    \11\ As noted above, the Exchange is proposing that the Fund be
exempt from the requirement of Rule 14.11(i)(4)(C)(iv)(b) that
prevents the aggregate gross notional value of listed derivatives
based on any single underlying reference asset from exceeding 30% of
the weight of the portfolio (including gross notional exposures) and
the aggregate gross notional value of listed derivatives based on
any five or fewer underlying reference assets from exceeding 65% of
the weight of the portfolio (including gross notional exposures).
    \12\ See note 11, supra.
---------------------------------------------------------------------------

    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
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, rather will facilitate the listing and trading of
an additional exchange-traded product that will enhance competition
among both market participants and listing venues, 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 self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-BatsBZX-2017-46 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BatsBZX-2017-46. 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 such filing will also 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 No. SR-BatsBZX-2017-46 and should be
submitted on or before August 18, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-15904 Filed 7-27-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27131-27133]
[FR Doc No: 2019-12288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1425]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mitigation Strategies
To Protect Food Against Intentional Adulteration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
11, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0812.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration--21 CFR Part 121

OMB Control Number 0910-0812--Extension

    This information collection supports FDA regulations. Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA
Food Safety Modernization Act, certain provisions have been established
to protect against the intentional adulteration of food. Section 418 of
the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the
context of facilities that manufacture, process, pack, or hold food and
are required to register under section 415 of the FD&C Act (21 U.S.C.
350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses
intentional adulteration in the context of fruits and vegetables that
are raw agricultural commodities. Section 420 of the FD&C Act (21
U.S.C. 350i) addresses intentional adulteration in the context of high-
risk foods and exempts farms except for farms that produce milk. These
provisions are codified at part 121 (21 CFR part 121), and include
requirements that an owner, operator, or agent in charge of a facility
must:
     Prepare and implement a written food defense plan that
includes a vulnerability assessment to identify significant
vulnerabilities and actionable process steps, mitigation strategies,
and procedures for food defense monitoring, corrective actions, and
verification (Sec.  121.126);
     identify any significant vulnerabilities and actionable
process steps by conducting a vulnerability assessment for each type of
food manufactured, processed, packed, or held at the facility using
appropriate methods to evaluate each point, step, or procedure in a
food operation (Sec.  121.130);
     identify and implement mitigation strategies at each
actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by the facility
will not be adulterated. For each mitigation strategy implemented at
each actionable process step, include a written explanation of how the
mitigation strategy sufficiently minimizes or prevents the significant
vulnerability associated with the actionable process step (Sec.
121.135);
     establish and implement mitigation strategies management
components, as appropriate to ensure the proper implementation of each
such mitigation strategy, taking into account the nature of the
mitigation strategy and its role in the facility's food defense system
(Sec.  121.138);
     establish and implement food defense monitoring
procedures, for monitoring the mitigation strategies, as appropriate to
the nature of the mitigation strategy and its role in the facility's
food defense system (Sec.  121.140);
     establish and implement food defense corrective action
procedures that must be taken if mitigation strategies are not properly
implemented, as appropriate to the nature of the actionable process
step and the nature of the mitigation strategy (Sec.  121.145);
     establish and implement specified food defense
verification activities, as appropriate to the nature of the mitigation
strategy and its role in the facility's food defense system (Sec.
121.150);
     conduct a reanalysis of the food defense plan (Sec.
121.157);
     ensure that all individuals who perform required food
defense activities are qualified to perform their assigned duties
(Sec.  121.4); and
     establish and maintain certain records, including the
written food defense plan (vulnerability assessment, mitigation
strategies and procedures for food defense monitoring, corrective
actions, and verification) and documentation related to training of
personnel. All records are subject to certain general recordkeeping and
record retention requirements (Sec. Sec.  121.301 to 121.330).
    Description of Respondents: The respondents to this information
collection are manufacturers of retail food products marketed in the
United States.
    In the Federal Register of February 25, 2019 (84 FR 6009), we
published a 60-day notice soliciting public comment of the proposed
collections of information. Several comments were received in response
to the notice and are summarized here. Minor comments included general
support for efforts at protecting food against intentional
adulteration. Other comments, however, questioned the estimates we
ascribed to meeting the requirements found in subpart C of the
applicable regulations: Food defense measures (Sec. Sec.  121.126
through 121.157 (21 CFR 121.126 through 121.157)). The comments offered
alternative estimates ranging from few to several hours, and most
correlated this time to aspects of developing plans, conducting
vulnerability assessments, and documenting procedures, activities which
we attribute to the initial review and implementation of new
regulations. We also note that alternative compliance dates were
established for the covered entities and have yet to be realized. In
addition, to assist respondents in complying with the regulation,
including the information collection requirements, we offer both Agency
guidance as well as an FDA Food Defense Plan Builder, a user-friendly
tool designed to help owners and operators of food facilities develop a
personalized food defense plan, which is currently under development
with stakeholder input. These and other resources are available from
our website at https://www.fda.gov. Finally, none of the comments
appeared to question the applicability of the recordkeeping or the
associated retention requirements found in part 121, subpart D.
    While we continue to invite comment regarding our burden estimates,
we note that they reflect what we believe is representative of the
industry average. This information collection covers numerous
respondents with varying facility sizes and with differing product
inventories. As compliance with the regulatory requirements continues
to take effect, we will continue to evaluate the associated information
collection burden accordingly. Although we always appreciate feedback
regarding ways to improve efficiencies associated with our information
collection activities, we decline to adopt alternative burden estimates
for the information collection at this time. Rather, we retain the
current estimates, which are as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
           Activity; 21 CFR section               Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food from very small                     18,080               1          18,080  0.5 (30 minutes).........................           9,040
 businesses; Sec.   121.5.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Certain facilities may qualify for an exemption under the
regulations. Because these facilities must provide documentation upon
request to verify their exempt status, we have characterized this as a
reporting burden. We estimate 18,080 respondents will prepare and
update relevant files an average of 30 minutes annually, for a total
annual burden of 9,040 hours (30 minutes x 18,080 firms).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR section               Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Defense Plan; Sec.   121.126............           3,247               1           3,247  23.......................................          74,681
Actionable Process Steps; Sec.   121.130.....           9,759               1           9,759  20.......................................         195,180
Mitigation Strategies; Sec.   121.135(b).....           9,759               1           9,759  20.......................................         195,180
Monitoring Corrective Actions, Verification;            9,759               1           9,759  175......................................       1,707,825
 Sec.  Sec.   121.140(a) and 121.145(a)(1).
Training; Sec.   121.4.......................         367,203               1         367,203  0.67 (40 minutes)........................         246,026
Records; Sec.  Sec.   121.305 and 121.310....           9,759               1           9,759  10.......................................          97,590
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       2,516,482
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Under the regulations, an owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food
defense plan, including written identification of actionable process
steps, written mitigation strategies, written procedures for defense
monitoring, written food defense corrective actions, and written food
defense verification procedures. The estimated recordkeeping burden
associated with these activities totals 2,516,482 annual recordkeeping
burden hours and 409,486 annual recordkeeping responses.
    We estimate an average of 3,247 firms will continue to need to
create a food defense plan under Sec.  121.126, that a one-time burden
of 60 hours will be needed to create a plan, and that a burden of 10
hours will be required to update the plan. We annualize this estimate
by dividing the total number of burden hours (70) over a 3-year period
as reflected in table 2, row 1.
    Under Sec.  121.130, each of the estimated 9,759 food production
facilities will identify and specify actionable process steps for its
food defense plan. We estimate that an individual at the level of an
operations manager incurs a burden of 20 hours for this activity, as
reflected in table 2, row 2.
    Under Sec.  121.135(b), each of the estimated 9,759 food production
facilities must identify and implement mitigation strategies to provide
assurances that any significant vulnerability at each step is
significantly minimized or prevented, ensuring that the food
manufactured, processed, packed, or held by the facility will not be
adulterated. We do not specify a specific number or set of mitigation
strategies to be implemented. Some of the covered facilities are
already implementing mitigation strategies. We estimate that it
requires an average of 20 hours per facility to satisfy the
recordkeeping burden associated with these activities for a total of
195,180 hours, as reflected in table 2, row 3.
    We estimate that the recordkeeping activities associated with
monitoring, documenting mitigation strategies, and implementing
necessary corrective actions require first-line supervisors or others
responsible for quality control an average of 175 hours for each
recordkeeping, and that these provisions apply to each of the 9,759
facilities. This results in a total of 1,707,825 annual burden hours,
as reflected in table 2, row 4.
    We estimate that recordkeeping activities associated with training
under Sec.  121.4 total 244,802 annual burden hours, as reflected in
table 2, row 5. We estimate that there are 1.2 million employees
working at the regulated facilities and that 30 percent of them
(367,203) require training. We estimate that the average burden for the
associated recordkeeping activity is approximately 40 minutes (or 0.67
hours) per record.
    Finally, we estimate the 9,759 food production facilities will
fulfill the recordkeeping requirements under Sec. Sec.  121.305 and
121.310, and that it will require an average of 10 hours per record, as
reflected in table 2, row 6.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12288 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Proposed Rules]
[Pages 60003-60007]
[FR Doc No: 2019-21880]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0016; Product Identifier 2018-NM-168-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening
of comment period.

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SUMMARY: The FAA is revising an earlier proposal for all Airbus SAS
Model A350-941 and -1041 airplanes. This action revises the notice of
proposed rulemaking (NPRM) by including additional part numbers that
are affected by the unsafe condition. The FAA is proposing this
airworthiness directive (AD) to address the unsafe condition on these
products. Since these actions would impose an additional burden over
those in the NPRM, the

FAA is reopening the comment period to allow the public the chance to
comment on these changes.

DATES: The comment period for the NPRM published in the Federal
Register on February 22, 2019 (84 FR 5611), is reopened.
    The FAA must receive comments on this SNPRM by December 23, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For the material identified in this SNPRM that will be incorporated
by reference (IBR), contact the European Union Aviation Safety Agency
(EASA), Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 89990 1000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material 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 in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0016.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0016; 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 SNPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0016;
Product Identifier 2018-NM-168-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this SNPRM. The FAA will
consider all comments received by the closing date and may amend this
SNPRM based on those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact the agency receives about this SNPRM.

Discussion

    The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to all Airbus SAS Model A350-941 and -1041 airplanes. The
NPRM published in the Federal Register on February 22, 2019 (84 FR
5611). The NPRM was prompted by reports of loss of retention of the
regulator inlet filter retainer on certain crew oxygen cylinder
assemblies. The NPRM proposed to require an operational check of the
crew oxygen cylinder assembly, replacement of an affected assembly, and
eventual replacement of all affected assemblies with redesigned
serviceable assemblies.

Actions Since the NPRM Was Issued

    Since the FAA issued the NPRM, the agency has determined that loose
regulator inlet filter retainers also exist on redesigned oxygen
cylinders having part number (P/N) 4441227-058-001. In the NPRM, P/N
4441227-058-001 was specified as the replacement part to be installed
after an affected part was removed. This SNPRM expands the scope of the
NPRM by including oxygen cylinders having P/N 4441227-058-001 as
affected parts that need to be inspected and, depending on findings,
replaced.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0168, dated July 16, 2019
(``EASA AD 2019-0168'') (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes.
The FAA is issuing this AD to address loss of retention of the
regulator inlet filter retainer on certain crew oxygen cylinder
assemblies. This condition could lead to particle ingestion into the
regulator during ground handling, possibly resulting in ignition/fire
during system ground operational testing following crew oxygen cylinder
(re)installation on an airplane. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0168 describes procedures for an inspection of the
crew oxygen cylinder assembly for any discrepancy (a loose part making
a sound during agitation of the cylinder) and replacement of an
affected crew oxygen cylinder assembly with a serviceable part.
    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.

Comments

    The FAA gave the public the opportunity to participate in
developing this proposed AD. The FAA considered the comments received.
The Air Line Pilots Association, International (ALPA) expressed support
for the NPRM.

Request To Clarify Mandatory Actions

    Delta Air Lines (DAL) requested clarification regarding which
actions described in Airbus All Operators Transmission (AOT) A35P010-
17, Revision 00, dated December 20, 2017 (``Airbus AOT A35P010-17,
Revision 00''), and the associated vendor service bulletins, are
required for compliance with the requirements of the proposed AD (in
the NPRM). The commenter stated that Airbus AOT A35P010-17, Revision
00, is not written in the traditional service bulletin format, and
suggested that the intent of the proposed AD (in the NPRM) is for
operators to comply with only section 4.2.2, Inspection Requirements,
of Airbus AOT A35P010-17, Revision 00. The commenter reasoned that all
other aspects and parts of Airbus AOT A35P010-17, Revision 00, are
unrelated to the unsafe condition and are for operator reference and
logistics information. Specifically, the commenter requested that
paragraph (h) of the proposed AD (in the NPRM) be revised to include a
paragraph (h)(3) which would state that ``Where the

EASA AD states accomplishment of a task `in accordance with the
instructions of the AOT'', an operator may use alternative approved
procedures. The AOT and Vendor SB can be referred to for accepted
procedures to comply with the mandated tasks.'' The commenter advised
that the proposed AD (in the NPRM) would mandate procedures that are
not related to airworthiness, such as returning affected parts to
Rockwell Collins and reporting the inspection results to Airbus
Customer Service.
    The FAA agrees to clarify which actions described in the AOT would
be required by this proposed AD. Since the NPRM was published, EASA has
issued AD 2019-0168, and the FAA has revised this proposed AD to refer
to EASA AD 2019-0168. EASA AD 2019-0168 refers to Airbus AOT A35P010-
17, Revision 00; and Airbus AOT A35P010-17, Revision 01, dated April
11, 2019 (``AOT A35P010-17, Revision 01''). The FAA has revised
paragraph (h) of this proposed AD to include paragraph (h)(3) to state
that the language in paragraph (2) of EASA AD 2019-0168 that states
``the instructions of the AOT'' should be replaced with ``paragraph
4.2.2., Inspection Requirements, of the AOT.''
    In regard to the reporting requirement, paragraph (i) of the
proposed AD (in the NPRM) states that although EASA AD 2018-0245R1
specifies to submit certain information to the manufacturer that action
would not be required. Because EASA AD 2018-0245R1 was superseded by
EASA AD 2019-0168, the FAA has revised paragraph (i) of this proposed
AD to refer to EASA AD 2019-0168. In addition, the FAA has added
paragraph (j) to this proposed AD to clarify that returning affected
parts to the manufacturer is not required, and redesignated the
subsequent paragraphs accordingly.
    The FAA does not agree with the commenter's request to revise
paragraph (h) of this proposed AD to allow operators to use alternative
approved procedures to comply with the proposed requirements. Any
request for an Alternative Method of Compliance (AMOC) must be done in
accordance with paragraph (k)(1) of this proposed AD. The FAA has not
revised this proposed AD in regard to this issue.

Request To Refer to Vendor Service Bulletins

    DAL requested that the NPRM be revised to include a reference to
Rockwell Collins (formerly B/E Aerospace) Vendor Service Bulletin (VSB)
4441227-35-003, and to allow operators to use the applicable Rockwell
Collins VSB for inspection procedures. The commenter noted that there
is an error in Rockwell Collins VSB 4441227-35-003, because it refers
to a modification Rockwell Collins VSB for instructions on how to
replace an affected crew oxygen cylinder assembly, but that service
information does not contain replacement instructions.
    The FAA does not find it necessary to reference VSB 4441227-35-003
in this proposed AD because it is already referenced in Airbus AOT
A35P010-17, Revision 01, for the required inspection. The FAA notes
that EASA AD 2019-0168 refers to Airbus AOT A35P010-17, Revision 01, as
the primary source of service information for operators to use for
procedures to address the unsafe condition. AOT A35P010-17, Revision
01, includes updated inspection procedures that are acceptable for
compliance.
    The FAA acknowledges the commenter's observation that there is an
error in certain revisions of Rockwell Collins VSB 4441227-35-003
regarding certain other Rockwell Collins VSB numbers. Airbus AOT
A35P010-17, Revision 01, references Maintenance Planning (MP) Task
A350-A-35-11-56-00001-520A-A for removal of affected crew oxygen
cylinder assemblies and MP Task A350-A-35-11-56-00001-720A-A for
installation of crew oxygen cylinder assemblies. Therefore, the
Rockwell Collins VSBs are not required to accomplish actions involving
removal and installation of crew oxygen cylinder assemblies. If needed,
operators may request an AMOC for the required actions in this proposed
AD, using the procedures specified in paragraph (k)(1) of this proposed
AD. The FAA has not revised this proposed AD in regard to this issue.

Request To Allow Any Revision Level of Service Information

    DAL stated that Airbus AOT A35P010-17, Revision 00, did not refer
to specific revision levels for the Rockwell Collins VSBs. Therefore,
it assumed that any approved version was acceptable for operators to
use for inspection procedures.
    The FAA infers that the commenter is requesting clarification
regarding revision levels of the Rockwell Collins VSBs for inspection
procedures. Since AOT A35P010-17, Revision 01, does not specify a
revision level for the Rockwell Collins VSBs, any revision is
acceptable for compliance with the applicable requirements of this
proposed AD. The FAA has not revised this proposed AD in regard to this
issue.

Request for Clarification of Terminology

    DAL requested that the proposed AD (in the NPRM) be revised to
state that operators should do an inspection for loose retainer
assemblies in the affected crew oxygen cylinder assemblies instead of
an operational check. The commenter noted that ``operational check'' is
used in EASA AD 2018-0245R1 (which is the MCAI referred to in the NPRM)
but ``inspection'' is used in Airbus AOT A35P010-17, Revision 00, and
the associated Rockwell Collins VSBs.
    The FAA agrees to clarify. The referenced terminology has been
revised in EASA AD 2019-0168, which refers to an ``inspection'' instead
of an ``operational check.'' This terminology is now consistent among
EASA AD 2019-0168, this proposed AD, Airbus AOT A35P010-17, Revision
01, and the associated Rockwell Collins VSBs. The FAA has revised the
``Related Service Information under 1 CFR part 51'' section of this
proposed AD to clarify this information.

Request for Clarification of Airplane Groups

    DAL requested that the proposed AD (in the NPRM) be revised to
include instructions to operators stating that by removing an affected
crew oxygen cylinder assembly an airplane can move from Group 1 to
Group 2 for the purposes of compliance with the proposed AD (in the
NPRM). The commenter stated that EASA AD 2018-0245R1 (referred to as
the MCAI in the NPRM) identified a Group 1 airplane as an airplane that
has an affected crew oxygen cylinder assembly installed and that by
removing an affected crew oxygen cylinder assembly the airplane would
then be identified as a Group 2 airplane. The commenter stated that the
only compliance method would be to ensure an affected crew oxygen
cylinder assembly is not reinstalled on that airplane so it can remain
a Group 2 airplane. The commenter stated that this could create
confusion for operators regarding which proposed requirements specified
in the proposed AD (in the NPRM) would apply to a given airplane. The
commenter also stated that operators could become confused regarding
what is required to maintain compliance with the requirements in the
proposed AD (in the NPRM) and how to report compliance.
    The FAA agrees to clarify. As stated previously, the FAA has
revised this proposed AD to refer to EASA AD 2019-0168, which addresses
this issue by removing the definitions of the airplane

groups and allowing the installation of an affected crew oxygen
cylinder assembly on any airplane, provided it is a serviceable part as
defined in EASA AD 2019-0168. The FAA has not revised this proposed AD
in regard to this issue.

Proposed Requirements of This SNPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0168 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.
    Certain changes described above expand the scope of the NPRM. As a
result, the FAA has determined that it is necessary to reopen the
comment period to provide additional opportunity for the public to
comment on this SNPRM.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA worked with Airbus and EASA to develop a process to
use certain EASA ADs as the primary source of information for
compliance with requirements for corresponding FAA ADs. As a result,
EASA AD 2019-0168 will be incorporated by reference in the FAA final
rule. This proposed AD would, therefore, require compliance with the
provisions specified in EASA AD 2019-0168, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2019-0168 that is required for compliance with EASA AD 2019-
0168 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2019-0016 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 13 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
172 work-hours x $85 per hour = $14,620......................          $6,940          $21,560         $280,280
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition replacements
specified in this proposed AD.
    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is 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 proposed 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

    The FAA has determined that this proposed AD would not have
federalism implications under Executive Order 13132. This proposed AD
would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus SAS: Docket No. FAA-2019-0016; Product Identifier 2018-NM-
168-AD.

(a) Comments Due Date

    The FAA must receive comments by December 23, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by reports of loss of retention of the
regulator inlet filter retainer on certain crew oxygen cylinder
assemblies. The FAA is issuing this AD to address loss of retention
of the regulator inlet filter retainer on certain crew oxygen
cylinder assemblies. This condition could lead to particle ingestion
into the regulator during ground handling, possibly resulting in
ignition/fire during system ground operational testing following
crew oxygen cylinder (re)installation on an airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2019-0168, dated July 16, 2019 (``EASA AD 2019-0168'').

(h) Exceptions to EASA AD 2019-0168

    (1) Where EASA AD 2019-0168 refers to its effective date this AD
requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0168 does not apply
to this AD.
    (3) Replace the language in paragraph (2) of EASA AD 2019-0168
that states ``the instructions of the AOT'' with ``paragraph 4.2.2.,
Inspection Requirements, of the AOT.''

(i) No Reporting Required

    Although the service information referenced in EASA AD 2019-0168
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) No Return of Parts Required

    Although the service information referenced in EASA AD 2019-0168
specifies to return affected parts to the manufacturer, this AD does
not include that requirement.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (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 (l)(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: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0168 that contains RC procedures and
tests: Except as required by paragraph (k)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(l) Related Information

    (1) For information about EASA AD 2019-0168, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD 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. EASA AD 2019-0168 may be found in the AD docket on the
internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2019-0016.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on September 27, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-21880 Filed 11-6-19; 8:45 am]
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