[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31940-31944]
[FR Doc No: 2019-14164]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86224; File No. SR-CBOE-2019-030]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To Use Cboe Exchange's Affiliate, Cboe
Trading, as an Inbound and Outbound Router for Cboe Options

June 27, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 25, 2019, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to adopt rules related to the inbound and outbound router for Cboe
Options, as well as seek approval from the Securities and Exchange
Commission (``Commission'') for affiliate, [sic] Trading, Inc. (``Cboe
Trading''), to become a Trading Permit Holder of the Exchange. The text
of the proposed rule change is provided in Exhibit 5.
    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 (1) seek approval from the Commission
pursuant to current Rule 3.32(b) for affiliate, Cboe Trading, to become
a Trading Permit Holder of the Exchange; (2) relocate and amend Rule
3.32(b) related to exchange affiliations to Rule 3.11; (3) adopt Rule
3.12 to govern the Exchange's use of Cboe Trading as an outbound
router; (4) adopt Rule 3.13 to govern the Exchange's receipt of inbound
orders from Cboe Trading, on behalf of the Exchange's affiliate options
exchanges, Cboe EDGX Exchange, Inc. (``EDGX''), Cboe BZX Exchange, Inc.
(``BZX'') and Cboe C2 Exchange, Inc. (``C2''); and (5) make non-
substantive changes to Rule 6.14B regarding non-affiliated routing
brokers. The Exchange notes that proposed Rules 3.11, 3.12 and 3.13 and
current Rule 6.14B are substantively identical in all material respects
to EDGX Rules 2.10, 2.11, 2.12, and 21.9(e), as well as C2 Rules 3.16,
3.17, 3.18 and 6.15(e).
Commission Approval Under Current Rule 3.32(b)
    Current Rule 3.32(b) provides that without prior Commission
approval, no Trading Permit Holder may be or become affiliated with the
Exchange. The Exchange seeks Commission approval for Exchange affiliate
Cboe Trading to become a Trading Permit Holder of the Exchange pursuant
to Rule 3.32(b). The Exchange also seeks Commission approval to
transfer and amend current Rule 3.32(b) to proposed Rule 3.11, as
described below.
Relocation and Amendment of Rule 3.32(b)
    The Exchange seeks the Commission's approval to relocate Rule
3.32(b) \3\ to proposed new Rule 3.11 and add to proposed Rule 3.11
similar exclusions from the affiliation prohibition contained in its
affiliated options exchanges, EDGX Rule 2.10 and C2 Rule 3.16. Current
Rule 3.32(b) prohibits the Exchange from acquiring or maintaining an
ownership interest in a Trading Permit Holder, as well as prohibits
Trading Permit Holder affiliations with the Exchange or an affiliate of
the Exchange without prior Commission approval. Current exceptions
include equity interests in CBSX LLC and the Exchange's parent company,
Cboe Global Markets, Inc., and affiliations with OneChicago, LLC. EDGX
Rule 2.10 and C2 Rule 3.16 contain similar restrictions on Exchange
affiliations with EDGX Members and C2 Trading Permit Holders, but also
contains additional exceptions, including (a) affiliations solely by
reason of a Member (or any officer, director, manager, managing member,
partner, or affiliate of such Member) becoming a director of the
Exchange or Cboe Global Markets, Inc., or (b) affiliations with Cboe
Trading or of Cboe EDGA Exchange, Inc., Cboe EDGX Exchange, Inc., Cboe
BZX Exchange, Inc., Cboe BYX Exchange, Inc., Cboe C2 Exchange, Inc., or
Cboe Futures Exchange, LLC (each, a ``Cboe Exchange''). The Exchange
proposes to include these two additional exceptions in proposed Rule
3.11 as the same affiliate restrictions apply to all three exchanges
and are consistent with governing documents of Cboe Options and Cboe
Global Markets, Inc., previously filed with the Commission.
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    \3\ And, as a result, update the subsequent lettering under Rule
3.32.
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Proposed Rule 3.12 (Cboe Trading as Outbound Router)
    The proposed rule change also adopts Rule 3.12 to govern the
Exchange's use of Cboe Trading as an outbound router. Proposed Rule
3.12 is based on EDGX Rule 2.11 and C2 Rule 3.17. As long as Cboe
Trading is affiliated with Cboe Options and is providing outbound
routing of orders from Cboe Options to other securities exchanges,
facilities of securities exchanges, automated trading systems,
electronic communications networks or other brokers or dealers
(``Trading Centers'' and, such function of Cboe Trading is referred to
as the ``Outbound Router''), Cboe Trading's outbound routing services
would be subject to the following conditions and limitations:
     Cboe Options will regulate the Outbound Router function of
Cboe Trading as a facility (subject to Section 6 of the Act), and will,
among other things, be responsible for filing with the Commission rule
changes and fees relating to the Cboe Trading Outbound Router function
and Cboe Trading will be subject to exchange non-discrimination
requirements;
     FINRA, a self-regulatory organization unaffiliated with
the Exchange or any of its affiliates, will carry out oversight and
enforcement responsibilities as the designated examining authority
designated by the Commission pursuant to Rule 17d-1 of the Act with the
responsibility for examining Cboe Trading for compliance with
applicable financial responsibility rules.
     A Trading Permit Holder's use of Cboe Trading to route
orders to another Trading Center will be optional. Any Trading Permit
Holder that does not want to use Cboe Trading may use other routers to
route orders to other Trading Centers.
     Cboe Trading will not engage in any business other than
(i) its Outbound Router function, (ii) its Inbound Router function as
described in Rule 3.13, (iii) its usage of an error account in
compliance with proposed paragraph (a)(7) (regarding Cboe Trading
maintenance of an error account described below), and (iv) any other
activities it may engage in as approved by the Commission.
     The Exchange will establish and maintain procedures and
internal controls reasonably designed to adequately restrict the flow
of confidential and proprietary information between the Exchange and
its facilities (including Cboe Trading), and any other entity,
including any affiliate of Cboe Trading, and, if Cboe Trading or any of
its affiliates engages in any other business activities other than
providing routing services to the Exchange, between the segment of Cboe
Trading or its affiliate that provides the other business activities
and the routing services.
     The Exchange or Cboe Trading may cancel orders as either
deems to be necessary to maintain fair and orderly markets if a
technical or systems issue occurs at the Exchange, Cboe Trading, or a
routing destination. The Exchange or Cboe Trading will provide notice
of the cancellation to affected Trading Permit Holders as soon as
practicable.
     Proposed Rule 3.12(a)(7) provides that Cboe Trading will
maintain an error account for the purpose of addressing

positions that are the result of an execution or executions that are
not clearly erroneous under Rule 6.25 and result from a technical or
systems issue at Cboe Trading, the Exchange, a routing destination, or
a non-affiliate third-party Routing Broker that affects one or more
orders (``Error Positions'').
     For purposes of proposed Rule 3.12(a)(7), an Error
Position will not include any position that results from an order
submitted by a Trading Permit Holder to the Exchange that is executed
on the Exchange and automatically processed for clearance and
settlement on a locked-in basis.
     Except as provided in proposed subparagraph (7)(C)
(described in the next bullet), Cboe Trading does not accept any
positions in its error account of a Trading Permit Holder or permit any
Trading Permit Holder to transfer any positions from the Trading Permit
Holder's account to Cboe Trading's error account.
     If a technical or systems issue results in the Exchange
not having valid clearing instructions for a Trading Permit Holder to a
trade, Cboe Trading may assume the Trading Permit Holder's side of the
trade so that the trade can be automatically processed for clearance
and settlement on a locked-in basis.
     In connection with a particular technical or systems
issue, Cboe Trading or the Exchange will either assign all resulting
Error Positions to the Trading Permit Holders in accordance with
proposed subparagraph (D)(i),\4\ or have all resulting Error Positions
liquidated in accordance with proposed subparagraph (D)(ii).\5\ Any
determination to assign or liquidate Error Positions, as well as any
resulting assignments, will be made in a nondiscriminatory fashion.
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    \4\ Proposed subparagraph (a)(7)(D)(i) states Cboe Trading or
the Exchange will assign all Error Positions resulting from a
particular technical or systems issue to the Trading Permit Holders
affected by that technical or systems issue if Cboe Trading or the
Exchange (a) determines it has accurate and sufficient information
(including valid clearing information) to assign the positions to
all of the Trading Permit Holders affected by that technical or
systems issue; (b) determines it has sufficient time pursuant to
normal clearance and settlement deadlines to evaluate the
information necessary to assign the positions to all of the Trading
Permit Holders affected by that technical or systems issue; and (c)
has not determined to cancel all orders affected by that technical
or systems issue in accordance with proposed subparagraph (a)(6).
    \5\ Proposed subparagraph (a)(7)(D)(ii) states if Cboe Trading
or the Exchange is unable to assign all Error Positions resulting
from a particular technical or systems issue to all of the affected
Trading Permit Holders in accordance with proposed subparagraph (D),
or if Cboe Trading or the Exchange determines to cancel all orders
affected by the technical or systems issue in accordance with
proposed subparagraph (a)(6), then Cboe Trading will liquidate any
applicable Error Positions as soon as practicable. In liquidating
such Error Positions, Cboe Trading will (a) provide complete time
and price discretion for the trading to liquidate the Error
Positions to a third-party broker-dealer and not attempt to exercise
any influence or control over the timing or methods of such trading;
and (b) establish and enforce policies and procedures that are
reasonably designed to restrict the flow of confidential and
proprietary information between the third-party broker-dealer and
Cboe Trading/the Exchange associated with the liquidation of the
Error Positions.
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     Cboe Trading and the Exchange will make and keep records
to document all determinations to treat positions as Error Positions
and all determinations for the assignment of Error Positions to Trading
Permit Holders or the liquidation of Error Positions, as well as
records associated with the liquidation of Error Positions through the
third-party broker-dealer.
     The books, records, premises, officers, agents, directors,
and employees of Cboe Trading as a facility of the Exchange are deemed
to be the books, records, premises, officers, agents, directors, and
employees of the Exchange for purposes of, and subject to oversight
pursuant to, the Exchange Act. The books and records of Cboe Trading as
a facility of the Exchange are subject at all times to inspection and
copying by the Exchange and the Commission. Nothing in the Rules
precludes officers, agents, directors, or employees of the Exchange
from also serving as officers, agents, directors, and employees of Cboe
Trading.
    The Exchange will comply with the above-listed conditions prior to
offering outbound routing from Cboe Trading. In meeting the conditions,
the Exchange will have mechanisms in place to protect the independence
of the Exchange's regulatory responsibility with respect to Cboe
Trading, as well as demonstrate the Cboe Trading cannot use any
information that it may have because of its affiliation with the
Exchange to its advantage. Current Rule 3.32(b) and proposed Rule 3.11
provide that without prior Commission approval, no Trading Permit
Holder may be or become affiliated with the Exchange.
Proposed Rule 3.13 (Cboe Trading as Inbound Router)
    The Exchange also proposes to adopt Rule 3.13, which is based on
EDGX Rule 2.12 and C2 Rule 3.18. Pursuant to proposed Rule 3.13, Cboe
Trading's inbound routing services from EDGX Options, BZX Options and
C2 to the Exchange would be subject to the following conditions and
limitations:
     The Exchange must enter into a plan pursuant to Rule 17d-2
under the Exchange Act with a non-affiliated self-regulatory
organization and a regulatory services contract with a non-affiliated
SRO to perform regulatory responsibilities for Cboe Trading for unique
Exchange rules.
     The regulatory services contract must require the Exchange
to provide the non-affiliated self-regulatory organization with
information, in an easily accessible manner, regarding all exception
reports, alerts, complaints, trading errors, cancellations,
investigations, and enforcement matters (collectively, ``Exceptions'')
in which Cboe Trading is identified as a participant that has
potentially violated Exchange or Commission rules, and shall require
that the non-affiliated self-regulatory organization provide a report
to the Exchange quantifying all such exception reports, alerts,
complaints, trading errors, cancellations, investigations and
enforcement matters on not less than a quarterly basis.
     The Exchange, on behalf of its parent company, Cboe Global
Markets, must establish and maintain procedures and internal controls
reasonably designed to ensure that Cboe Trading does not develop or
implement changes to its systems on the basis of nonpublic information
obtained as a result of its affiliation with the Exchange until such
information is available generally to similarly situated Trading Permit
Holders of the Exchange.
    If the Exchange complies with the above-listed conditions and if
Cboe Trading operates as an Outbound Router on behalf of each Cboe
Exchange in accordance with the rules of each Cboe Exchange, Cboe
Trading may provide inbound routing services to the Exchange from each
Cboe Exchange.
Proposed Change to Rule 6.14B
    Additionally, the Exchange proposes to amend Rule 6.14B to account
for its use of affiliate Cboe Trading as an outbound router, as
proposed, by specifying that the rule applies to the Exchange's non-
affiliated routing brokers. Current Rule 6.14B describes the procedures
and requirements for routing brokers that automatically route
intermarket sweep orders to other Exchanges (``Routing Services''). The
introductory paragraph under Rule 6.14B states that the Exchange may
automatically route intermarket sweep orders to other exchanges under
certain circumstances, and that certain requirements (provided in
subparagraphs (a) through (h)) apply in connection with such services.
Current paragraph (a) states that Routing Services will be provided in
conjunction with one or more routing

brokers that are not affiliated with the Exchange. Therefore, this rule
is currently applicable to non-affiliated routing brokers and the
Exchange now proposes to merely provide additional clarity regarding
its application to non-affiliated routing brokers in light of proposed
use of affiliate Cboe Trading as an outbound router. The Exchange
proposes to move language in paragraph (a), stated above, to the
introductory provision under 6.14B and amend such language to provide
that Routing Services may be provided in conjunction with one or more
routing brokers that are not affiliated with the Exchange. This
proposed change accounts for proposed Rule 3.12 in which affiliate Cboe
Trading may also provide outbound routing. The Exchange also proposes
to specify in the introductory rule text under Rule 6.14B that the
conditions in the following subparagraphs apply to non-affiliated
routing brokers, as well as update the rule heading accordingly. The
Exchange notes that this proposed change does not substantively alter
any of the conditions listed which are already applicable to non-
affiliated routing brokers and that C2 Rule 6.15(e) and EDGX Options
Rule 21.9(e), provide the same conditions for their non-affiliated
routing brokers.\6\
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    \6\ The Exchange notes that the corresponding rules on EDGX
Options and C2 treat their non-affiliated routing brokers as ``back-
up'' routing brokers to their affiliate, Cboe Trading. The Exchange,
however, does not propose to add that its non-affiliated routing
brokers will function as back-up routing brokers, as the Exchange
currently has Routing Service agreements in place today with non-
affiliated and such non-affiliated routing brokers will continue to
function on the Exchange as they have prior to this proposed rule
change.
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    The Exchange also proposes to add the definition of ``Cboe
Trading'' to mean Cboe Trading, Inc. to Rule 1.1.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\7\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \8\ requirements that the rules of an exchange be
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 regulating, clearing,
settling, processing information with respect to, and 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \9\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ Id.
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    In particular, the Exchange believes proposed Rules 3.12 and 3.13
promote the maintenance of a fair and orderly market, the protection of
investors and the public interest, and is in the best interests of the
Exchange and its Trading Permit Holders as it will allow the routing of
orders to and from Trading Centers (including affiliated exchanges BZX
Options, EDGX Options and C2) and the Exchange in the same manner as
each Cboe Exchange currently routes orders. Moreover, in meeting the
requirements of Rule 3.13 (i.e., the 17d-2 plan, the regulatory
services contract, and procedures and internal controls) the Exchange
believes it will have mechanisms in place that protect the independence
of the Exchange's regulatory responsibility with respect to Cboe
Trading, as well as demonstrates that Cboe Trading cannot use any
information that it may have because of its affiliation with the
Exchange to its advantage. Similarly, in meeting the requirements of
Rule 3.12 (i.e., regulation as a facility, FINRA acting as the
designated examining authority, optional use of Cboe Trading as an
outbound router, restrictions on business of Cboe Trading, procedures
and internal controls, cancellation of orders, maintenance of error
account), the Exchange believes it will have mechanisms in place that
protect the independence of the Exchange's regulatory responsibility
with respect to Cboe Trading. It also serves to ensure that Cboe
Trading cannot use any information that it may have because of its
affiliation with the Exchange to its advantage, thus preventing an
unfair burden on competition and unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange also believes
that the proposed definition of Cboe Trading will provide additional
clarity of its Rules for investors.
    Additionally, proposed Rule 3.11 incorporates the provisions in
current Rule 3.32(b) related to restrictions on Exchange affiliations
with Trading Permit Holders. As noted above, the provisions related to
Exchange affiliations with Trading Permit Holders (including exceptions
to any restrictions in the Rules) are consistent with the governing
documents of Cboe Options and Cboe Global Markets, Inc. Proposed Rule
3.11 also mirrors EDGX Rule 2.10 and C2 Rule 3.16.
    Further, the Exchange believes that the proposed changes to Rule
6.14B provide additional clarity of its Rules for investors,
particularly in connection with the proposed use of affiliate Cboe
Trading as an outbound router. The Exchange notes that Rule 6.14B is
currently applicable to non-affiliated routing brokers and the proposed
change merely seeks to provide specificity regarding its application.
The Exchange also notes that it does not alter any of the conditions
already applicable to non-affiliated routing brokers under Rule 6.14B,
therefore the proposed change does not present any new obligations or
novel issues for non-affiliated routing brokers. The Exchange also
notes that proposed Rules 3.11, 3.12, 3.13, and 6.14B are substantially
similar to corresponding EDGX and C2 rules,\10\ previously approved or
filed with the Exchange. Therefore, the proposed rule will provide
consistent rules and functionality with that of its affiliated options
exchange, thereby benefiting participants across the affiliated
exchanges.
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    \10\ See supra note 6.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe the proposed rule change will impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of Act
as the proposed rules are based on the corresponding rules of its
affiliated exchanges which allow Cboe Trading to become a member of the
Exchange. Additionally, the proposed rule change is based on EDGX
Options Rule 2.12 and C2 Rule 3.18, which allow EDGX Options and C2 to
receive options orders from affiliate Cboe Trading on behalf of
affiliate exchanges. The Exchange notes that use of Cboe Trading as an
outbound router is voluntary and available to all participants and also
notes that the proposed changes to Rule 6.14B do not substantively
alter any requirements for non-affiliated routing brokers. Further, the
Exchange does not believe Cboe Trading as an inbound router will impose
any burden on intramarket competition as it does not affect

incoming orders which will continue to be prioritized and allocated
pursuant to Rule 6.45 (Order and Quote Priority Allocation). Moreover,
the requirements of Rule 3.13 (i.e., the 17d-2 plan, the regulatory
services contract, and procedures and internal controls) help to
prevent an unfair burden on competition and unfair discrimination
between customers, issuers, brokers, or dealers.
    The Exchange does not believe that the proposed change will impose
any burden on intermarket competition that is not necessary or
appropriate in furtherance of Act as the Exchange's affiliated options
exchanges have the same rules in place and already route orders using
their affiliate, Cboe Trading, to and from Trading Centers. As stated
above, the Exchange also notes that the proposed rule change ensures
that Cboe Trading cannot use any information that it may have because
of its affiliation with the Exchange to its advantage, thus preventing
an unfair burden on competition.

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

    The Exchange neither solicited nor received 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-CBOE-2019-030 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-CBOE-2019-030. 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-CBOE-2019-030 and should be submitted on
or before July 18, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-14164 Filed 7-2-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 36 (Wednesday, February 23, 2022)]
[Rules and Regulations]
[Pages 10064-10067]
[FR Doc No: 2022-03730]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0682; Project Identifier MCAI-2021-00474-T;
Amendment 39-21944; AD 2022-04-03]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -
113, -114, -115, -131, -132, -133, -151N, and -153N airplanes; and
Model A320 and A321 series airplanes. This AD was prompted by a
determination that new or more restrictive airworthiness limitations
are necessary. This AD requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective March 30, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 30,
2022.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; 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 material at the FAA,
Airworthiness Products Section, Operational Safety 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 at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0682.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0682; 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
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The address for Docket Operations 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: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0108, dated April 20, 2021
(EASA AD 2021-0108) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A318-111, -112, -121, and -
122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, -
133, -151N, and -153N airplanes; Model A320-211, -212, -214, -215, -
216, -231, -232, -233, -251N, -252N, -253N, -271N, -272N, and -273N
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, -
232, -251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX,
and -272NX airplanes. Model A320-215 airplanes are not certificated by
the FAA and are not included on the U.S. type certificate data sheet;
this AD therefore does not include those airplanes in the
applicability. Airplanes with an original airworthiness certificate or
original export certificate of airworthiness issued after December 9,
2020 must comply with the airworthiness limitations specified as part
of the approved type design and referenced on the type certificate data
sheet; this AD therefore does not include those airplanes in the
applicability.
    EASA AD 2021-0108 specifies that it requires a task (limitation)
already required by EASA AD 2020-0067 (which corresponds to FAA AD
2020-22-16, Amendment 39-21312 (85 FR 70439, November 5, 2020) (AD
2020-22-16)) and invalidates (terminates) prior instructions for that
task. This AD terminates the limitations of Task<PHONE_NUMBER>1-1-C, as
required by paragraph (i) of AD 2020-22-16, for airplanes with an
original airworthiness certificate or original export certificate of
airworthiness issued on or before January 17, 2020 only.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus SAS
Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -
131, -132, -133, -151N, and -153N airplanes; and Model A320 and A321
series airplanes. The NPRM published in the Federal Register on August
19, 2021 (86 FR 46626). The NPRM was prompted by a determination that
new or more restrictive airworthiness limitations are necessary. The
NPRM proposed to require revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, as specified in EASA AD 2021-
0108.
    The FAA is issuing this AD to address a safety-significant latent
failure (that is not annunciated), which, in combination with one or
more other specific failures or events, could result in a hazardous or
catastrophic failure condition. See the MCAI for additional background
information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Delta Airlines (DAL). The following
presents the comments received on the NPRM and the FAA's response to
each comment.

Request To Review the Code of Federal Regulations (CFRs)

    DAL requested that the FAA review the CFRs to possibly revise it in
order to make the airworthiness limitations section (ALS) and
airworthiness limitations (AWL) incorporations simpler (no ADs) for
commercial airplanes. DAL commented that the FAA and operators would
not have to produce as much paperwork for ADs and alternative methods
of compliance (AMOCs). DAL also commented that revising the CFR that
would mandate operators to incorporate the latest approved revision or
variation in a certain number of months after the revision or variation
is published regardless of taking on new airplanes.
    DAL stated that the initial compliance time for doing the tasks
specified in the ALS or AWL is at the applicable ``thresholds'' of the
ALS, or within a certain number of months after the revision or
variation is published, whichever occurs later (similar to the typical
language used in ALS ADs and paragraph (h)(4) of this proposed AD). DAL
also stated that this would reduce the amount of confusion for
operators to determine if an AMOC is needed, simplify and standardize
the incorporation of AWLs, and allow operators to address these safety
concerns faster (this ALS variation was published more than nine months
ago). DAL commented that AD 2021-16-01 was published one week after
this proposed AD and most operators would have preferred to see these
ADs combined into one in order to reduce the number of ALS ADs.
    While the FAA understands the commenter's concern, the current CFR
requires incorporating the latest ALS included in the type design of
the airplane, such as 14 CFR 91.403(c) and 91.409(e). ADs are the only
viable method to mitigate risk identified in a product when its type
design did not require incorporation of the latest ALS document, as
applicable, by mandating subsequent ALS revisions or variations at the
applicable thresholds. The FAA's regulatory requirements are
promulgated via notice-and-comment rulemaking as required by the
Administrative Procedure Act (APA), and the public can petition for
rulemaking pursuant to 14 CFR part 11.
    Also, the FAA determined that combining the requirements of AD
2021-16-01 with the requirements in this AD would have resulted in the
FAA issuing a supplemental NPRM in order to give notice and allow for
public comment on the additional requirements. In the interest of
safety to address the unsafe condition specified in AD 2021-16-01, the
FAA determined AD 2021-16-01 should not be delayed. The FAA has not
changed this AD in this regard.

Request for Clarification of Later Approved Revisions

    DAL requested clarification of paragraph (i) of the proposed AD,
which allows alternative actions and intervals if they are approved in
the ``Ref. Publications'' paragraph of EASA AD 2021-0108. DAL asked the
following questions.
     Are later approved revisions of Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 3, Certification
Maintenance Requirement (CMR), Variation 7.3, dated December 9, 2020,
referring to Variation 7.4 or Variation 7.5 (or Variation 7.3 Revision
02)?
     If the technical content of the tasks is modified at a
later approved variation or revision, does paragraph (i) of the

proposed AD give operators approval to incorporate these later approved
variations or revisions? Or is the statement regarding ``technical
content'' only, giving approval to incorporate a later approved
variation or revision if the technical content has not changed?
    The FAA agrees to clarify. Operators may not revise their existing
maintenance or inspection programs after incorporating Airbus A318/
A319/A320/A321 Airworthiness Limitations Section (ALS) Part 3,
Certification Maintenance Requirement (CMR), Variation 7.3, dated
December 9, 2020, unless they are incorporating a future variation or
revision of the ALS document that includes the tasks identified in the
variation specified in EASA AD 2021-0108. The future variation or
revision of the variation should incorporate the same technical content
as specified in EASA AD 2021-0108. The FAA has not changed this AD in
this regard.

Request To Delete the Terminating Action for Certain Requirements

    DAL requested that the FAA remove AD 2020-22-16 as an affected AD
in paragraph (b) of the proposed AD and as a terminating action in
paragraph (j) of the proposed AD. DAL stated that, technically, those
paragraphs are not needed because paragraph (k) of AD 2020-22-16 allows
alternative actions and intervals if they are approved in the ``Ref.
Publications'' paragraph of EASA AD 2020-0067. DAL commented that the
``Ref. Publications'' paragraph of EASA AD 2020-0067 specifies the use
of later approved variations or revisions of Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 3, Certification
Maintenance Requirement (CMR), Revision 07, dated October 11, 2019; and
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS) Part
3, Certification Maintenance Requirement (CMR), Revision 07, Issue 2,
dated January 17, 2020; as acceptable for compliance with the
requirements of EASA AD 2020-0067. DAL commented that Airbus A318/A319/
A320/A321 Airworthiness Limitations Section (ALS) Part 3, Certification
Maintenance Requirement (CMR), Variation 7.3, dated December 9, 2020,
is a later approved variation.
    The FAA disagrees with removing AD 2020-22-16 as an affected AD and
as a terminating action to this AD. Paragraph (j) of this AD is
necessary because it allows operators to not have conflicting
requirements for Task<PHONE_NUMBER>1-1-C from previous versions or
revisions of A318/A319/A320/A321 Airworthiness Limitations Section
(ALS) Part 3, Certification Maintenance Requirement (CMR) and its
corresponding replacement task in A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 3, Certification Maintenance Requirement
(CMR), Variation 7.3, dated December 9, 2020. Allowance for
incorporation of future revisions of an ALS document is not mandatory,
but an optional requirement under applicable conditions. The FAA has
not changed this AD in this regard.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator. Accordingly, the FAA is issuing this AD to
address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0108 describes new or more restrictive airworthiness
limitations for certification maintenance requirements. This material
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

    The FAA estimates that this AD affects 1,728 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate. Therefore, the agency estimates the average total cost per
operator to be $7,650 (90 work-hours x $85 per work-hour).

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.

Regulatory Findings

    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) 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 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 adding the following new airworthiness
directive:

2022-04-03 Airbus SAS: Amendment 39-21944; Docket No. FAA-2021-0682;
Project Identifier MCAI-2021-00474-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 30, 2022.

(b) Affected ADs

    This AD affects AD 2020-22-16, Amendment 39-21312 (85 FR 70439,
November 5, 2020) (AD 2020-22-16).

(c) Applicability

    This AD applies to the Airbus SAS airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category, with an original airworthiness certificate or original
export certificate of airworthiness issued on or before December 9,
2020.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, and -153N airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, -
252N, -253N, -271N, -272N, and -273N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address a safety-significant latent failure (that
is not annunciated), which, in combination with one or more other
specific failures or events, could result in a hazardous or
catastrophic failure condition.

(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
2021-0108, dated April 20, 2021 (EASA AD 2021-0108).

(h) Exceptions to EASA AD 2021-0108

    (1) Where EASA AD 2021-0108 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0108 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2021-0108 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2021-0108 is at the applicable ``thresholds''
as incorporated by the requirements of paragraph (3) of EASA AD
2021-0108, or within 90 days after the effective date of this AD,
whichever occurs later.
    (5) The provisions specified in paragraphs (4) of EASA AD 2021-
0108 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0108 does not apply
to this AD.

(i) Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2021-0108.

(j) Terminating Action for Certain Requirements in AD 2020-22-16

    Accomplishing the actions required by this AD terminates the
limitations of Task<PHONE_NUMBER>1-1-C, as required by paragraph (i)
of AD 2020-22-16, for airplanes with an original airworthiness
certificate or original export certificate of airworthiness issued
on or before January 17, 2020 only.

(k) Additional AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (l) of this AD. Information may be emailed to: [email protected]. 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, Large Aircraft
Section, International Validation 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): Except as required by
paragraph (k)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those 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 existing
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

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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) European Union Aviation Safety Agency (EASA) AD 2021-0108,
dated April 20, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0108, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 4, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-03730 Filed 2-22-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Proposed Rules]
[Page 85]
[DOCID:fr03ja06-30]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2005-MT-0002, FRL-8012-7]

Approval and Promulgation of Air Quality Implementation Plans;
Montana; Revisions to the Emergency Episode Avoidance Plan; Proposed
Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Montana on August 2, 2004. The
revision is to the State's Emergency Episode Avoidance Plan (EEAP). In
the ``Rules and Regulations'' section of this Federal Register, EPA is
approving the State's SIP revision as a direct final rule without prior
proposal because the Agency views this as a noncontroversial SIP
revision and anticipates no adverse comments. A detailed rationale for
the approval is set forth in the preamble to the direct final rule. If
EPA receives no adverse comments, EPA will not take further action on
this proposed rule. If EPA receives adverse comments, EPA will withdraw
the direct final rule and it will not take effect. EPA will address all
public comments in a subsequent final rule based on this proposed rule.
EPA will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time. Please note
that if EPA receives adverse comment on an amendment, paragraph, or
section of this rule and if that provision may be severed from the
remainder of the rule, EPA may adopt as final those provisions of the
rule that are not the subject of an adverse comment.

DATES: Written comments must be received on or before February 2, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2005-MT-0002, by one of the following methods:
     http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>and<EMAIL_ADDRESS>
     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Richard R. Long, Director, Air and Radiation
Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P-
AR, 999 18th Street, Suite 200, Denver, Colorado 80202-2466.
     Hand Delivery: Richard R. Long, Director, Air and
Radiation Program, Environmental Protection Agency (EPA), Region 8,
Mailcode 8P-AR, 999 18th Street, Suite 300, Denver, Colorado 80202-
2466. Such deliveries are only accepted Monday through Friday, 8 a.m.
to 4:55 p.m., excluding federal holidays. Special arrangements should
be made for deliveries of boxed information.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Laurie Ostrand, Air and Radiation
Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region
8, 999 18th Street, Suite 200, Denver, Colorado 80202-2466, (303) 312-
6437<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: See the information provided in the Direct
Final action of the same title which is located in the Rules and
Regulations section of this Federal Register.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: December 7, 2005.
Kerrigan G. Clough,
Acting Regional Administrator, Region 8.
[FR Doc. 05-24365 Filed 12-30-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55720-55722]
[FR Doc No: 2018-24320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tropical Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Tropical Disease Priority Review Vouchers.

DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2008-D-0530 for the ``Tropical Disease Priority Review Vouchers.''
Received comments, those filed in a timely manner (see ADDRESSES), 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: 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 protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Tropical Disease Priority Review Vouchers

OMB Control Number 0910-0822--Revision

    Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360n) is designed to encourage development of new drug or
biological products for prevention and treatment of certain tropical
diseases affecting millions of people throughout the world and makes
provisions for awarding priority review vouchers for future
applications to sponsors of tropical disease products. By enacting
section 524 of the FD&C Act, Congress intended to stimulate new drug
development for drugs to treat certain tropical diseases for which
there are no or few available treatments by offering additional
incentives for obtaining FDA approval for pharmaceutical treatments for
these diseases. Under section 524 of the FD&C Act, a sponsor of a human
drug application for a qualified tropical disease may be eligible for a
voucher that can be used to obtain a priority review for any
application submitted under section 505(b)(1) of the FD&C Act (21
U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (the
PHS Act).
    Accordingly, we have developed the guidance document entitled,
``Guidance for Industry (GFI): Tropical Disease Priority Review
Vouchers.'' The guidance explains how FDA will implement the provisions
of section 524 of the FD&C Act, how sponsors may use priority review
vouchers, and how priority review vouchers may be transferred to other
sponsors. The guidance also explains eligibility criteria for tropical
disease drug product applications submitted under section 505(b)(1) of
the FD&C Act and section 351 of the PHS Act, and provides instructions
to sponsors on how they may:
     Request a priority review voucher; and
     notify FDA of their intent to use a priority review
voucher, including the date on which the sponsor intends to submit the
application.
    The guidance also explains that transfer of a priority review
voucher from one sponsor to another is permitted and that each transfer
should be documented with a letter of transfer. Finally, the guidance
will be revised to include new information collection established by
section 611 of the FDA Reauthorization Act of 2017 (FDARA). As amended,
section 524 of the FD&C Act requires the sponsor of a tropical disease
product application to include an attestation regarding its eligibility
for a priority review voucher.
    Description of Respondents: Sponsors submitting applications under
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Information collection activity     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Priority Review Voucher Request.               5               1               5               8              40
Notifications of Intent to Use a               5               1               5               8              40
 Voucher........................
Letters Indicating the Transfer                2               1               2               8              16
 of a Voucher Letter............
Acknowledging the Receipt of a                 2               1               2               8              16
 Transferred Voucher............
Attestation of Eligibility......               5               1               5               2              10
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............             122
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have increased our burden estimate since last approval to
account for attestations added by FDARA; however, all other information
collection elements remain unchanged.

    Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24320 Filed 11-6-18; 8:45 am]
 BILLING CODE 4164-01-P