[Federal Register Volume 87, Number 3 (Wednesday, January 5, 2022)]
[Notices]
[Pages 528-532]
[FR Doc No: 2021-28569]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93885; File No. SR-DTC-2021-018]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Reorganizations Guide and the Fee Guide

December 30, 2021.
    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 December 29, 2021, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. DTC filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rules 19b-
4(f)(2) and (f)(4) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2) and (f)(4).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change \5\ consists of amendments to the
Reorganizations Guide and the Fee Guide to (i) postpone the retirement
of DTC's legacy computer to computer facility (``CCF'') files for
corporate actions entitlements and allocations (``CCF Entitlements and
Allocations Files'') \6\ to January 1, 2023,

and (ii) amend the Fee Guide to apply the CCF File Fee to Participants
that consume CCF Entitlements and Allocations Files \7\ between January
1, 2022 and December 31, 2022, as more fully described below.
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    \5\ Each term not otherwise defined herein has its respective
meaning as set forth in the Rules, By-Laws and Organization
Certificate of DTC (the ``Rules''), the Guide to the DTC Fee
Schedule (``Fee Guide''), and the Reorganizations Service Guide
(``Reorganizations Guide''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
    \6\ Each of the CCF Entitlements and Allocations Files falls
into one of two categories (each, a ``File Category''): (i) Pre-
allocation (``Pre-Allocation CCF Files''), which includes files
containing a Participant's allocation projections and entitlements,
or (ii) allocation/post-allocation (``Allocation/Post-Allocation CCF
Files''), which includes files containing information on a
Participant's allocations and pending allocations. See Important
Notice 13851-20 (August 27, 2020), available at https://www.dtcc.com/legal/important-notices.
    \7\ There are three types of CCF files representing the
corporate actions lifecycle: Corporate actions announcements (``CCF
Announcements Files''); the CCF Entitlements and Allocations Files;
and corporate actions instructions from Participants through CCF
files (``CCF Corporate Actions Instructions Files''). All CCF
Announcement Files were retired as of December 31, 2018. See
Securities Exchange Act Release No. 79746 (January 5, 2017), 82 FR
3372 (January 11, 2017) (SR-DTC-2016-014). CCF Corporate Actions
Instructions Files have not yet been retired and are not subject to
this proposed rule change.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change would amend the Reorganizations Guide and
the Fee Guide to (i) postpone the retirement of CCF Entitlements and
Allocations Files to January 1, 2023, and (ii) amend the Fee Guide to
apply the CCF File Fee to Participants that consume CCF Entitlements
and Allocations Files between January 1, 2022 and December 31, 2022, as
more fully described below.
(i) Retirement of CCF Entitlements and Allocations Files and CCF File
Fee
A. Background
    On November 19, 2020, DTC filed a rule change (the ``CCF Retirement
Filing'') \8\ that amended the Reorganizations Guide and the Fee Guide
to (i) set a retirement date for CCF Entitlements and Allocations Files
of January 1, 2022, and (ii) apply a $50,000,000 CCF File Fee, per File
Category (Pre-Allocation or Allocation/Post-Allocation) of CCF
Entitlements and Allocations Files, to Participants that continued to
consume CCF Entitlements and Allocations Files between January 1, 2021
and December 31, 2021 (``Original Fee Period'').
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    \8\ See Securities Exchange Act Release No. 90490 (November 23,
2020), 85 FR 76645 (November 30, 2020) (SR-DTC-2020-016).
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    As discussed in the CCF Retirement Filing, DTC has been informing
Participants that corporate actions CCF files \9\ will be retired and
will be replaced by ISO 20022 messaging since 2011.\10\ ISO 20022
messaging offers enhanced efficiency and transparency in the corporate
action lifecycle because, in contrast to the proprietary function and
activity codes of CCF Files, ISO 20022 is a business-model-based
standard for the development of messages for the international
financial services industry.
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    \9\ There are three event groups for CCF files for corporate
actions. Participants subscribe to the CCF files for each event
group separately. The event groups are (i) distributions
(``Distributions''), such as cash and stock dividends, principal and
interest, and capital gain distributions; (ii) redemptions
(``Redemptions''), such as full and partial calls, final paydowns,
and maturities; and (iii) reorganizations (``Reorganizations''),
which include both mandatory and voluntary reorganizations such as
exchange offers, conversions, Dutch auctions, mergers, puts, reverse
stock splits, tender offers, and warrant exercises.
    \10\ See Securities Exchange Act Release No. 63886 (February 10,
2011), 76 FR 9070 (February 16, 2011) (SR-DTC-2011-02) (indicating
that DTC will continue to support its legacy proprietary CCF files
until 2015.)
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    DTC has been working with Participants to specifically support
their orderly transition from CCF Entitlements and Allocations Files to
ISO 20022 messaging since 2013. DTC began providing Participants with
parallel entitlements and allocations ISO 20022 messaging in 2013
(Distributions), 2015 (Redemptions) and 2017 (Reorganizations). In
addition, since 2016, DTC had been communicating with Participants
about the deadline for retirement of the CCF Entitlements and
Allocation Files and postponed the projected retirement date multiple
times.\11\ Finally, in 2020, DTC filed the CCF Retirement Filing and
continued to work with Participants to support their orderly migration
away from the CCF Entitlements and Allocations Files to ISO 20022
messaging before the January 1, 2022.
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    \11\ See Important Notice 2538-16 (January 21, 2016), supra note
6; Important Notice 4381-16 (November 4, 2016), supra note 6;
Important Notice 5099-17 (February 2017), supra note 6; Important
Notice 7488-18 (February 28, 2018), supra note 6; Important Notice
9861-18 (October 9, 2018), supra note 6.
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B. Proposed Rule Change
    Most Participants have successfully migrated from CCF Entitlements
and Allocations Files to ISO 20022 messaging. However, DTC understands
that a few Participants are still testing the ISO 20022 messages and
that not all will be ready to transition away from the CCF Entitlements
and Allocations Files before January 1, 2022.
    Therefore, pursuant to this proposed rule change, DTC would
postpone the retirement date of the CCF Entitlements and Allocation
Files to January 1, 2023, and would charge Participants the $50,000 CCF
File Fee for each File Category of CCF Entitlements and Allocations
Files that they consume between January 1, 2022 and December 31, 2022
(the ``New Fee Period''). The CCF File Fee would be charged to the
Account of the Participant, upon the Participant's first receipt of CCF
Entitlements and Allocations Files in a particular File Category during
the New Fee Period. The CCF File Fee would cover all CCF Entitlements
and Allocations Files within that File Category during the New Fee
Period.
    Pursuant to the proposed rule change, DTC would amend the
description of the CCF File Fee in the Fee Guide to conform with the
proposed rule change. DTC would also amend the Reorganizations Guide to
reflect the January 1, 2023 retirement date for CCF Entitlements and
Allocations Files. Specifically, in the ``Preparing to Use the
Services'' subsection of the ``How Reorganizations Work'' section of
the Reorganizations Guide, DTC is proposing to replace ``*CCF files
associated with entitlements and allocations will be retired as of
January 1, 2022'' with ``*CCF files associated with entitlements and
allocations will be retired as of January 1, 2023.''
Implementation Date
    DTC will implement the proposed changes on January 1, 2022. DTC
will announce the implementation date of the proposed rule change in an
Important Notice posted on its website.
    As proposed, a legend would be added to the Reorganizations Guide
and the Fee Guide stating there are changes that became effective upon
filing with the Commission but have not yet been implemented. The
proposed legend also would include that the implementation date will be
January 1, 2022. In addition, the proposed legend would state that the
legend would automatically be removed upon the implementation of the
proposed changes.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act requires, inter alia, that the
Rules be designed to promote the prompt and

accurate clearance and settlement of securities transactions.\12\
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    \12\ 15 U.S.C. 78q-1(b)(3)(F).
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    As described above, the proposed rule change would (i) postpone the
retirement of CCF Entitlements and Allocations Files to January 1,
2023, and (ii) apply the CCF File Fee to Participants that continue to
consume CCF Entitlements and Allocations Files during the New Fee
Period. By postponing the retirement of CCF Entitlements and
Allocations Files to January 1, 2023, the proposed rule change would
allow Participants to minimize potential business interruptions by
undertaking an orderly and organized migration from CCF files to the
more efficient ISO 20022 standard. Similarly, by charging a CCF File
Fee to those Participants that continue to receive CCF Entitlements and
Allocations Files after December 31, 2021, the proposed rule change
would encourage Participants to accelerate system development and the
adoption of the ISO 20022 standard. In this manner, the proposed rule
change would encourage and facilitate the transition to the ISO 20022
standard, which provides efficiencies and enhanced transparency in
processing corporate actions and the settlement activities related
thereto. Accordingly, DTC believes that the proposed rule change would
promote the prompt and accurate clearance and settlement of securities
transactions, consistent with the requirements of Section 17A(b)(3)(F)
of the Act, cited above.
    Section 17A(b)(3)(D) of the Act requires that the Rules provide for
the equitable allocation of reasonable dues, fees, and other charges
among its Participants.\13\ DTC believes that the proposed rule change
to apply the CCF File Fee to Participants that continue to consume CCF
Entitlements and Allocations Files during the New Fee Period would
provide for the equitable allocation of reasonable fees.
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    \13\ 15 U.S.C. 78q-1(b)(3)(D).
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    DTC believes that the proposed application of the CCF File Fee
would be equitably allocated because the CCF File Fee (i) would only be
charged to those Participants that have delayed their migration from
CCF Entitlements and Allocations Files beyond December 31, 2021 \14\
and (ii) would be applied in accordance with the Participant's use of a
particular File Category.
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    \14\ As discussed above, DTC has been communicating with
Participants about the migration from CCF files to the ISO 20022
standard for corporate actions events since 2011. Since 2013, DTC
has been communicating with Participants about targeted retirement
dates for CCF Entitlements and Allocations Files and has, at the
request of Participants, postponed the projected dates numerous
times. Before October 2018, DTC had always told Participants that
there would not be any charges for the continued consumption of CCF
Entitlements and Allocations Files. After the CCF Retirement Filing
most Participants did complete development and fully adopted the ISO
20022 standard for entitlements and allocations information,
illustrating the effectiveness of the CCF File Fee.
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    Further, DTC believes that the application of the $50,000 CCF File
Fee would be reasonable. As discussed above, Participants that did not
complete their migration to ISO 20022 by January 1, 2021 were charged
the $50,000 CCF File Fee for each File Category of CCF Entitlements and
Allocations Files that they consumed during the Original Fee Period.
Most Participants completed their migration during the Original Fee
Period, which DTC believes is due, in part, to the application of the
CCF Fee. Based on this prior experience with the CCF File Fee, DTC
believes that the CCF File Fee in the amount of $50,000 provides the
necessary encouragement for Participants to accelerate their system
development for their adoption of the ISO 20022 standard for
entitlements and allocations information.\15\ Further, during the
application of the CCF File Fee to CCF Entitlements and Allocations
Files during the Original Fee Period, DTC had not received any negative
feedback from Participants suggesting that the $50,000 fee was overly
burdensome.\16\
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    \15\ The CCF File Fee is not designed to cover costs incurred by
DTC as a result of continuing to service CCF files.
    \16\ DTC also had charged a similar $50,000 CCF File Fee to
Participants that continued to receive the CCF Announcements Files
between 2016-2018, in order to encourage Participants to migrate
from CCF Announcements Files to ISO 20022 messaging. DTC believes
that the CCF File Fee provided a strong incentive for Participants
to accelerate their migration from the CCF format to the ISO 2002
standard, thereby allowing DTC to retire all of the CCF
Announcements Files by December 31, 2018. See Securities Exchange
Act No. 76811 (December 31, 2015), 81 FR 826 (January 7, 2016) (SR-
DTC-2015-013) (postponing retirement of CCF Announcements Files and
implementation of a $50,000 CCF File Fee to encourage prompt
transition to the ISO 20022 standard); and see also Securities
Exchange Act Release No. 79746 (January 5, 2017), 82 FR 3372
(January 11, 2017) (SR-DTC-2016-014) (establishing the retirement
date for CCF Announcement Files).
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    Therefore, DTC believes that the proposed rule change regarding the
CCF File Fee provides for the equitable allocation of reasonable dues,
fees, and other charges among its Participants, consistent with Section
17A(b)(3)(D) of the Act, cited above.

(B) Clearing Agency's Statement on Burden on Competition

    DTC believes that the proposed rule change with respect to
postponing the retirement of CCF Entitlements and Allocations Files to
January 1, 2023 would not have any impact on competition. The proposed
rule change would provide any Participant that has not completed its
migration from CCF Entitlements and Allocation Files with additional
time to complete its testing and development of its systems, and
finalize the transition to ISO 20022 messaging. Therefore, DTC believes
that the proposed rule change with respect to postponing the retirement
of CCF Entitlements and Allocations Files to January 1, 2023 would not
have a burden on competition.\17\
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    \17\ 15 U.S.C. 78q-1(b)(3)(I).
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    DTC believes that the proposed rule change with respect to amending
the Fee Guide to apply the CCF File Fee to Participants that continue
to consume CCF Entitlements and Allocations Files during the New Fee
Period could have an impact on competition because it could create a
burden on competition.\18\ Although the proposed application of the CCF
File Fee is designed to incentivize Participants to accelerate their
adoption of the ISO 20022 standard, DTC recognizes and appreciates that
charging the fee could negatively affect such Participants' operating
costs. However, DTC believes that any burden on competition would not
be significant and would be necessary and appropriate in furtherance of
the purposes of the Act, as permitted by Section 17A(b)(3)(I) of the
Act.\19\
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    \18\ Id.
    \19\ Id.
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    DTC believes any burden on competition would not be significant
because (i) the fee would only be charged once per File Category, upon
the Participant's first receipt of CCF Entitlements and Allocations
Files for a File Category during the New Fee Period, and (ii) the
application of the CCF File Fee for a File Category would cover the
consumption of all CCF Entitlements and Allocations Files within that
File Category during the New Fee Period. In addition, based on DTC's
prior use of the CCF File Fee for CCF Announcements Files \20\ and CCF
Entitlements and Application Files, DTC has no indication that the
amount of the fee creates a significant burden on any Participant.
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    \20\ See supra note 16.
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    DTC believes that any burden on competition that may be created by
the proposed change to amend the Fee Guide to apply the CCF File Fee to
Participants that continue to consume CCF Entitlements and Allocations
Files during the New Fee Period would be

necessary and appropriate in furtherance of the purposes of the Act, as
permitted by Section 17A(b)(3)(I) of the Act.\21\ DTC believes that
this proposed change would be necessary because some Participants have
yet to adopt the ISO 20022 standard, despite at least seven years of
communication and prompting on the issue.\22\ As noted above, the ISO
20022 standard provides efficiencies and enhanced transparency in
processing corporate actions and the settlement activities related
thereto. Thus, DTC believes that the proposed rule change would promote
the prompt and accurate clearance and settlement of securities
transactions, consistent with Section 17A(b)(3)(F) of the Act.\23\
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    \21\ Id.
    \22\ See supra notes 10 and 11.
    \23\ 15 U.S.C. 78q-1(b)(3)(F).
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    DTC believes that the proposed rule change to apply the CCF File
Fee to Participants that continue to consume CCF Entitlements and
Allocations Files during the New Fee Period would be appropriate in
furtherance of the purposes of the Act, as permitted by Section
17A(b)(3)(I) of the Act.\24\ DTC's prior experience with the $50,000
CCF File Fee and the successful retirement of CCF Announcements Files
illustrates that a $50,000 CCF File Fee provides the necessary
encouragement for Participants to accelerate their system development
for the full adoption of the ISO 20022 standard. Further, during the
application of the CCF File Fee to CCF Announcements Files, DTC had not
received any negative feedback from Participants that suggested that
the $50,000 fee was overly burdensome; nor did DTC receive any
objections during the application of the CCF File Fee to CCF
Entitlements and Allocations Files during the Original Fee Period that
suggested that the $50,000 fee was overly burdensome. Accordingly, DTC
believes that application of the $50,000 CCF File Fee would be
appropriate here in order to incentivize Participants to accelerate
their migration to the ISO 20022 standard. In addition, as discussed
above, DTC believes that the proposed application of the CCF File Fee
would be equitably allocated because the CCF File Fee (i) would only be
charged to those Participants that have delayed their migration from
CCF Entitlements and Allocations beyond December 31, 2021 and (ii)
would be applied in accordance with the Participant's use of a
particular File Category.
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    \24\ 15 U.S.C. 78q-1(b)(3)(I).
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    Therefore, for these reasons, DTC believes that a perceived
competitive burden of the proposed rule change to apply the CCF File
Fee to Participants that continue to consume CCF Entitlements and
Allocations Files during the Fee Period would be necessary and
appropriate in furtherance of the purposes of the Act, as permitted by
Section 17A(b)(3)(I) of the Act.\25\
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    \25\ 15 U.S.C. 78q-1(b)(3)(I).
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(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    DTC has not received or solicited any written comments relating to
this proposal. If any written comments are received, DTC will amend
this filing to publicly file such comments as an Exhibit 2 to this
filing, as required by Form 19b-4 and the General Instructions thereto.
    Persons submitting written comments are cautioned that, according
to Section IV (Solicitation of Comments) of the Exhibit 1A in the
General Instructions to Form 19b-4, the Commission does not edit
personal identifying information from comment submissions. Commenters
should submit only information that they wish to make available
publicly, including their name, email address, and any other
identifying information.
    All prospective commenters should follow the Commission's
instructions on How to Submit Comments, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments. General
questions regarding the rule filing process or logistical questions
regarding this filing should be directed to the Main Office of the
Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    DTC reserves the right to not respond to any comments received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \26\ of the Act and paragraph (f) \27\ of Rule 19b-4
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \26\ 15 U.S.C 78s(b)(3)(A).
    \27\ 17 CFR 240.19b-4(f).
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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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-DTC-2021-018 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2021-018. 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 (https://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 DTC and on DTCC's
website (https://dtcc.com/legal/sec-rule-filings.aspx). All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2021-018 and should be submitted on
or before January 26, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
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    \28\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2021-28569 Filed 1-4-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45291-45293]
[FR Doc No: 2017-20798]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Fee for Using a Rare Pediatric Disease Priority Review Voucher in
Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare pediatric disease priority
review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Food and Drug
Administration Safety and Innovation Act (FDASIA), authorizes FDA to
determine and collect rare pediatric disease priority review user fees
for certain applications for review of human drug or biological
products when those applications use a rare pediatric disease priority
review voucher. These vouchers are awarded to the sponsors of rare
pediatric disease product applications that meet all of the
requirements of this program and that are submitted 90 days or more
after July 9, 2012, upon FDA approval of such applications. The amount
of the fee for using a rare pediatric disease priority review voucher
is determined each FY, based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous FY and the average cost incurred in the
review of an application that is not subject to priority review in the
previous FY. This notice establishes the rare pediatric disease
priority review fee rate for FY 2018 and outlines the payment
procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the sponsor of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party. The voucher may be transferred (including by sale)
repeatedly until it ultimately is used for a human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act. A priority review is a review
conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6
months after the receipt or filing date, depending on the type of
application. Information regarding PDUFA goals is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The applicant that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the rare pediatric disease priority
review voucher program is available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
    This notice establishes the rare pediatric disease priority review
fee rate for FY 2018 at $2,830,579 and outlines FDA's procedures for
payment of rare pediatric disease priority review user fees. This rate
is effective on October 1, 2017, and will remain in effect through
September 30, 2018.

II. Rare Pediatric Priority Review User Fee for FY 2018

    Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted

priority review status within this expedited timeframe. Normally, an
application for a human drug or biological product will qualify for
priority review if the product is intended to treat a serious condition
and, if approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation will receive a standard review. Under the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    FDA is setting a fee for FY 2018, which is to be based on standard
cost data from the previous fiscal year, FY 2017. However, the FY 2017
submission cohort has not been closed out yet, thus the cost data for
FY 2017 are not complete. The latest year for which FDA has complete
cost data is FY 2016. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. FDA uses data that the Agency estimates and
publishes on its Web site each year--standard costs for review. FDA
does not publish a standard cost for ``the review of a human drug
application subject to priority review in the previous fiscal year.''
However, we expect all such applications would contain clinical data.
The standard cost application categories with clinical data that FDA
publishes each year are: (1) New drug applications (NDAs) for a new
molecular entity (NME) with clinical data and (2) biologics license
applications (BLAs).
    The standard cost worksheets for FY 2016 show standard costs
(rounded to the nearest hundred dollars) of $5,929,100 for an NME NDA,
and $4,887,100 for a BLA. Based on these standard costs, the total cost
to review the 49 applications in these two categories in FY 2016 (27
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no
investigational new drug (IND) review costs are included in this
amount.) 23 of these applications (14 NDAs and 9 BLAs) received
priority review, which would mean that the remaining 26 received
standard reviews. Because a priority review compresses a review
schedule that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months divided by 6 months) should be
applied to non-priority review costs in estimating the effort and cost
of a priority review as compared to a standard review. This multiplier
is consistent with published research on this subject which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2016 figures, the costs of a priority and standard review are
estimated using the following formula:

(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$4,154,664 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $6,938,289
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,783,625, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2018 fee, FDA will need to adjust the FY 2016
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount
for cost increases in FY 2017. That adjustment, published in the
Federal Register on September 14, 2017 (82 FR 43244), setting the FY
2018 PDUFA fee, is 1.6868 percent for the most recent year, not
compounded. Increasing the FY 2016 incremental priority review cost of
$2,783,625 by 1.6868 percent (or 0.016868) results in an estimated cost
of $2,830,579 (rounded to the nearest dollar). This is the rare
pediatric disease priority review user fee amount for FY 2018 that must
be submitted with a priority review voucher for a human drug
application in FY 2018, in addition to any PDUFA fee that is required
for such an application.

III. Fee Schedule for FY 2018

    The fee rate for FY 2018 is set out in Table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2018
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2018
------------------------------------------------------------------------
Application submitted with a rare pediatric disease          $2,830,579
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Rare Pediatric Disease Priority Review User Fee

    Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e. the obligation to pay the fee is incurred) when a
sponsor notifies FDA of its intent to use the voucher. Section
529(c)(4)(B) of the FD&C Act specifies that the application will be
considered incomplete if the priority review user fee and all other
applicable user fees are not paid in accordance with FDA payment
procedures. In addition, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act. Beginning with FDA's
appropriation for FY 2015, the annual appropriation language states
specifically that ``priority review user fees authorized by 21 U.S.C.
360n [i.e., section 524 of the FD&C Act] and 360ff [i.e., section 529
of the FD&C Act] shall be credited to this account, to remain available
until expended.'' (Pub. L. 113-235, Section 5, Division A, Title VI).
    The rare pediatric disease priority review fee established in the
new fee schedule must be paid for any application that is received on
or after October 1, 2017. In order to comply with this requirement, the
sponsor must notify FDA 90 days prior to submission of the human drug
application that is the subject of a priority review voucher of an
intent to submit the human drug application, including the date on
which the sponsor intends to submit the application.
    Upon receipt of this notification, FDA will issue an invoice to the
sponsor who has incurred a rare pediatric disease priority review
voucher fee. The invoice will include instructions on how to pay the
fee via wire transfer or check.
    As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow

FDA's normal procedures for timely payment of the PDUFA fee for the
human drug application.
    Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial
payments can be made online). Once you search for your invoice, select
``Pay Now'' to be redirected to Pay.gov. Note that electronic payment
options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S bank accounts as well as U.S. credit cards.
    If paying with a paper check the invoice number should be included
on the check, followed by the words ``Rare Pediatric Disease Priority
Review.'' All paper checks must be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your invoice number
when completing your transfer. The originating financial institution
may charge a wire transfer fee. If the financial institution charges a
wire transfer fee it is required to add that amount to the payment to
ensure that the invoice is paid in full. The account information is as
follows: U.S. Dept. of Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Account Number: 75060099, Routing Number: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993-0002.

V. Reference

    The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20798 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53999-54000]
[FR Doc No: 2011-22110]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0162; Notice No. 11-7]

Safety Notice: Transportation of DOT Special Permit Packages in
Commerce

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice.

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SUMMARY: In this safety notice, PHMSA is alerting the regulated
community to the importance of adhering to Federal requirements when
offering and transporting hazardous materials in DOT Special Permit
(SP) packages. PHMSA is concerned that many persons who offer or
transport SP packages fail to recognize the additional requirements
applicable to filling, offering, and moving SP packages. By issuing
this safety notice, PHMSA is attempting to raise awareness within the
hazardous materials community of the inherent characteristics of DOT
SPs and underscore the possible consequences of failing to recognize an
SP package and react accordingly.

FOR FURTHER INFORMATION CONTACT: For questions regarding specifics on
the cryogenic gas incident, please contact: Mr. John Heneghan,
Director, Southern Region Office, Office of Hazardous Materials Safety,
(404) 832-1135. For general questions regarding Special Permits, please
contact: Mr. Ryan Paquet, Director, Approvals and Permits Division,
Office of Hazardous Materials Safety,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    DOT SPs (previously known as DOT Exemptions) allow the SP grantee
to perform some function contrary to, or in addition to, the Hazardous
Materials Regulations (HMR; 49 CFR parts 171-180). SPs may be used to
allow an exemption from provisions of the HMR. SPs can also grant
permission to third parties, i.e., persons who are not SP grantees or
otherwise party to an SP, to receive, use, retest, or reship an SP
package according to the requirements of the HMR and the additional
requirements or exceptions described in the SP. SPs are commonly used
to authorize: (i) Packaging construction standards that differ from a
UN Standard or DOT Specification, (ii) alternative means of testing or
closure, (iii) reuse of the packaging in general, (iv) alternative
hazard communication requirements, (v) alternative segregation
requirements, or (vi) transportation of forbidden materials.
    PHMSA's purpose in authorizing the use of SPs is to allow industry
to benefit from alternative technologies, materials, and/or processes
while maintaining a level of safety at least equal to the safety level
required under the HMR. However, PHMSA wishes to emphasize that failure
to comply with SP requirements can result in breakdowns in hazard
communication, packaging failures, property damage, injury, loss of
life and even catastrophic events.
    In many cases, maintaining an equivalent level of safety while
pursuing alternatives to the normal requirements of the HMR will
require additional safety measures. For example, consider the case of a
DOT 3HT cylinder that has been manufactured and re-qualified for
service under an SP to be used in a fire suppression system onboard an
aircraft. The SP may require the cylinder to be tested more frequently
and at a different test pressure than the HMR would otherwise require.
If a cylinder re-qualifier fails to recognize the cylinder's SP
markings and apply the more stringent SP requirements, it might wait
too long to retest the cylinder or apply the wrong test pressure. These
errors put lives and property at risk when defective cylinders are
improperly tested and allowed to function as part of an emergency
response system, such as a fire suppression system.
    Hazardous materials training is an important tool for ensuring
proper hazard communication and compliance with SP and HMR
requirements. Part of the training process involves learning to
identify SP packages. Pursuant to the HMR, each SP package is required
to be marked ``DOT-SP'' with a number identifying the SP associated
with that package, unless specifically excepted by the SP. PHMSA
expects trained employees to recognize SP packages and react
accordingly by following the requirements of the HMR and the applicable
SP. PHMSA recently concluded an investigation where a hazardous
material shipper's failure to recognize an SP package and comply with
the safety requirements of the applicable SP and HMR cost the lives of
three transportation workers.

II. Current Regulatory Requirements

    The HMR specifies that persons may offer or transport packages
authorized by DOT SPs under the terms specified therein and that if an
SP contains requirements applicable to a carrier of an SP package, the
offeror shall provide a copy of the SP to the respective carrier (see
Sec.  173.22a), unless excepted by the SP. In addition to specific
requirements contained in DOT SPs, the HMR includes requirements for
hazard communication and handling of SP packages. SP packages must be:
     Plainly and durably marked ``DOT-SP'' followed by the SP
number assigned (see Sec. Sec.  172.301(c) and 172.302(c)), unless
excepted by the SP; and
     Accompanied by shipping papers bearing the notation ``DOT-
SP'' followed by the SP number assigned and clearly associated with the
shipping description to which the SP applies (see Sec.  172.203(a)),
unless excepted by the SP.

    Furthermore, under the training requirements in Sec.
172.704(a)(2), each hazmat employee must be provided function-specific
training concerning requirements of the HMR, and exemptions or special
permits issued under subchapter A of Title 49 that are specifically
applicable to the functions the employee performs.
    Non-compliance with SP package requirements has serious safety
consequences. PHMSA seeks to encourage compliance by aggressively
enforcing SP safety standards and increasing its awareness and outreach
efforts.
    Accordingly, PHMSA is publishing this safety notice to further
promote awareness of the ongoing safety concern and ensure that
industry is aware of its responsibilities associated with the offering
and transportation of hazardous materials in SP packaging, the current
regulatory requirements applicable to such transportation, and that
regulatory violations will be prosecuted to the maximum extent
permitted under the law.
    Persons who violate the HMR may be subject to significant civil
penalties and/or criminal fines and imprisonment. Maximum civil
penalties may be imposed of up to $55,000 per violation or $110,000 per
violation if a death, serious illness, or severe injury occurs to a
person or substantial destruction of property. Potential criminal
penalties include fines of up to $500,000 and/or ten years in jail.
    More detailed information on the requirements in the HMR governing
the offering and transportation of SP packages is available on DOT's
Hazmat Safety Web site: http://www.phmsa.dot.gov/hazmat. The HMR are
also accessible through PHMSA's Web site, and answers to specific
questions may be obtained from the Hazardous Materials Information
Center at 1-800-467-4922 (in Washington, DC, call<PHONE_NUMBER>).

III. Recommended Action

    PHMSA recommends that industry institute quality control measures
to identify and properly handle DOT SP packages and packages containing
hazardous materials in general:
    (1) Shippers and carriers should stress the importance of
recognizing an SP package to their employees. The importance of
recognizing an SP package should be given the same level of attention
as when they determine whether a packaging specification meets a UN
standard or DOT specification. This is especially important to those
operations that re-ship packages.
    (2) Once a person has identified a DOT SP package, that person
should obtain a current copy of the SP and review it for applicable
requirements. Copies of SPs may be obtained from PHMSA's Web site at:
http://phmsa.dot.gov/hazmat/regs/sp-a/special-permits. The person
should also review the HMR requirements applicable to SP packages.
    (3) Shippers and carriers should evaluate hazardous materials
training programs and communication protocols in their operations with
respect to recognizing and handling SP packages to ensure that the
subject is discussed and included during knowledge testing. Any person
performing a function required by an SP or shipping an SP package is
required to receive ``function-specific'' training of the requirements
contained in each special permit.
    (4) Third-party hazardous materials or dangerous goods instructors,
consultants, and others, should review their training programs to
ensure that the subject of SP packages is discussed and included during
knowledge testing.
    (5) Shippers should implement or review existing pre-shipment
procedures to ensure that a particular packaging is prepared as
authorized by an SP and/or the HMR and that all communication
requirements have been met.
    These recommendations are not exclusive; we hope that industry
representatives will use the information provided herein, together with
any other available information, to consider other reasonable measures
they believe appropriate to increase awareness of DOT SPs and their
responsibility in the handling and transporting such packages.

    Issued in Washington, DC on August 24, 2011.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2011-22110 Filed 8-29-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15351-15352]
[FR Doc No: 2011-6513]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.
Extension:
    Rule 19b-4 and Form 19b-4, OMB Control No. 3235-0045, SEC File No.
270-38.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
     Rule 19b-4 (17 CFR 240.19b-4) and Form 19b-4--Filings with
respect to proposed rule changes by self-regulatory organizations.
    Section 19(b) of the Securities Exchange Act of 1934 (``Act'') (15
U.S.C. 78s(b)) requires each self-regulatory organization (``SRO'') to
file with the Commission copies of any proposed rule, or any proposed
change in, addition to, or deletion from the rules of such SRO. Rule
19b-4 (17 CFR 240.19b-4) implements the requirements of Section 19(b)
by requiring the SROs to file their proposed rule changes on Form 19b-4
and by clarifying which actions taken by SROs are deemed proposed rule
changes and so must be filed pursuant to Section 19(b).
    The collection of information is designed to provide the Commission
with the information necessary to determine, as required by the Act,
whether the proposed rule change is consistent with the Act and the
rules thereunder. The information is used to determine if the proposed
rule change should be approved, disapproved, or if proceedings should
be instituted to determine whether the proposed rule change should be
approved or disapproved.
    The respondents to the collection of information are self-
regulatory organizations (as defined by the Act), including national
securities exchanges, national securities associations, registered
clearing agencies and the Municipal Securities Rulemaking Board.
    Twenty-three respondents file an average total of 1,323 responses
per year. Each response takes approximately 23.51 hours to complete.
Thus, the estimated annual response burden is 31,105 hours. At an
average cost per response of $6,945.64, the resultant total related
cost of compliance for these respondents is $9,191,396.21 per year
(1,323 responses x $6,945.64/response = $9,191,396.21).

    Compliance with Rule 19b-4 is mandatory. Information received in
response to Rule 19b-4 shall not be kept confidential; the information
collected is public information.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Comments should be directed to: Thomas Bayer, Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, Virginia 22312 or send an e-mail
to<EMAIL_ADDRESS>Comments must be submitted within 60 days of
this notice.

    Dated: March 15, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-6513 Filed 3-18-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12777-12778]
[FR Doc No: 2016-05346]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-0030]

Petition for Exemption; Summary of Petition Received; AGERpoint,
Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before March 30, 2016.

ADDRESSES: Send comments identified by docket number FAA-2015-0323
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Joshua Parker<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 3, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-0323
    Petitioner: AGERpoint, Inc.
    Section(s) of 14 CFR Affected: Sec. Sec.  61.23 (a)(1); 61.101
(e)(4)(5); 61.113 (a); 61.315 (a); 91.7 (a); 91.119 (c); 91.121; 91.151
(a)(1); 91.405 (a); 91.407 (a)(1); 91.409 (a)(1)(2); 91.417 (a)(b).
    Description of Relief Sought: The petitioner is requesting relief
in order to operate UAS USA Tempest, UAS USA Tempest XL, Pulse
Aerospace Vapor PA-01, AeroScout Scout B1-100, and Guided Systems
Technologies, Inc. SICX-75 (one of which is over 55 pounds), to perform
aerial data collection.

[FR Doc. 2016-05346 Filed 3-9-16; 8:45 am]
BILLING CODE 4910-13-P


4. Q ACTIVITIES 4.1 Texas Portion of the Delaware Basin Data on drilling activities as related to hydrocarbon resources, sulfur boreholes, and water wells that occur within the Texas portion of the Delaware Basin will be speeificalIy collected and recorded by Long Term Regulatory Compliance on a monthly basis. The data will be collected from commercial databases and will be verified from state and federal records as necessary. This data (to the extent it is not proprietary) will be added to the existing visual database established for the CCA. The specific activities in the Texas area (see Figure 1) that will be tracked on a monthly basis are as follows:

New drilling activities (deep and shallow) Abandonment activities (when plugged) Type of well (oil, gas, sulfur, water, etc.)

4.2 New Mexico Portion of the Delaware Basin Data on drilling activities related to hydrocarbon resources, sulfur boreholes, and water wells that occur within the New Mexico portion of the Delaware Basin will be specifically collected and recorded by Long Term Regulatory Compliance on a monthly basis. The data will be collected from commercial databases and will be verified from state and federal records. This data (to the extent it is not proprietary) will be added to the existing visual database and a database of New Mexico wells established for the CCA.

3 Woiking Copy Delaware Basin Drilling Surveillance Plan WP 02 PC. 02, Rev. 0 The specific activities in the New Mexico area (see Figure 1) that will be tracked on a monthly basis are as follows:

New drilling activities (deep and shallow) Abandonment activities (when and how plugged) Type of weli (oil, gas, sulfur, water, etc.) Occurrences of pressurized brine within the Castile Formation Injection well operation (disposal and secondary recovery) Solution well mining (salt and potash) * *

0 0 *

4.3 Nine Township" Area Information Data on drilling activities related to hydrocarbon resources, potash boreholes, and water wells that occur within the Delaware Basin portion of the nine township area (see Figure) will be specifically collected and recorded by bong Term Regulatory Compliance on a monthly basis. The data will be collected from commercial databases and from state and federal records. This data (to the extent it is not proprietary) will be added to the existing visual and New Mexico wells databases established for the CCA. The specific activities in the nine township area that will be tracked on a monthly basis are as follows:

New drilling activities (of any kind, both deep and shallow)

e Abandonment activities (when and how plugged)

* Type of well (oil, gas, sulfur, water, ete.)

* Occurrences of pressurized brine within the Castile Formation Injection well operation (disposal and secondary recovery)

Solution well mining (salt and potash)

Maintenance of databases for incidences of non compliance with Bureau of Land Management (BLM) and State of New Mexico Oil Conservation Division (OC) rules as information is recw ied in the files maintained by the BLMIOCD e Identification of ownership (through BLMIOCD records monitoring) of all state and federal minerals and hydrocarbon leases within the area 4 Working Copy Delaware Basin Drilling Surveillance Plan WP 02 PC. 02, Rev. 0 4.4 General Database Maintenance Long Term Regulatory Compliance will maintain and update, on a monthly basis, the databases of the Delaware Basin established for the CCA, in an electronic format. The visual database (an electronic map of the defined area) will reflect the current status of ail known wells in the Delaware Basin. Maps of the Delaware Basin wiil be published as needed from this visual database. The New Mexico well database will be in a database format that will contain the same information as the visual database and will include much more detailed information on the wells in the New Mexico portion of the Delaware Basin.

5.0 REPORTS Data will be reviewed annually to ensure there are no substantial and detrimental deviations from the assumptions used in the perfdrrnance assessment documented in the CCA. An annual report will then be prepared and included with other environmental data and will be provided to the DOE and made available to the EPA. Every five years, information will be summarized for input into the recertification process as defined in 40 CFR 5 194.15 (EPA 1996).

6.0 QUALITY ASSURANCE Activities will be conducted in accordance with the appropriate sections of WP 13 1, WID QAPD. Specifically, an outside source (the Waste Isolation Division Quaiity and Regulatory Assurance Department) will randomly select a minimum of 20 wells from a map of the Delaware Basin. They will verify that the information contained in the two databases; the visual and New Mexico wek, matches the information prorided from the commercial databases and records $rom the state and federal agencies. When possible and practical, field verification will be conducted only within the nine township area and only to the extent to verify the actual condition of the well. Field verification recorded in permanent notebooks will be done in accordance with WP 13 1, WID QAPD.

REFERENCES EPA, 1993. 40 CFR § Part 191: Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High Level and transuranic Radioactive Wastes; Final Rule. Federal Register, Vol. 58, No. 242, p. 66398. December 20, 1993. Office of Radiation and Air, Washington, D. C.

€PA, 1996. 40 CFR Pa& 194: CritePia for the Certifi Waste Isolation Pilot Plant's Compliance with the 40 CFR Part 191 Disposal Regulations; Final Rule. Federal Register, Vol. 61 , pp. 5224 5245, February 9, 1996. Office of Radiation and Indoor Air, Washington, D. C. & M c a t i o n of the 5


[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Rules and Regulations]
[Pages 23595-23599]
[FR Doc No: 2021-08849]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0789; Project Identifier AD-2020-00849-T;
Amendment 39-21519; AD 2021-09-06]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2019-22-
10, which applied to all The Boeing Company Model 737-600, -700, -700C,
-800, -900, and -900ER series airplanes. AD 2019-22-10 required
repetitive inspections for cracking of the left- and right-hand side
outboard chords of frame fittings and failsafe straps at a certain
station around eight fasteners, and repair if any cracking is found.
For certain airplanes, this AD reduces the compliance time for the
initial inspection, and for all airplanes this AD reduces the
repetitive interval. This AD was prompted by a determination that the
initial inspection threshold and repetitive inspection interval are
inadequate to address the cracking in a timely manner. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective June 8, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 8,
2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
November 13, 2019 (84 FR 61533, November 13, 2019).
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
October 3, 2019 (84 FR 52754, October 3, 2019).

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information 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 on
the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0789.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.govby searching for and locating Docket No. FAA-2020-
0789; 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, 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: Greg Rutar, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2019-22-10, Amendment 39-19789 (84 FR
61533, November 13, 2019) (AD 2019-22-10). AD 2019-22-10 applied to all
The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes. The NPRM published in the Federal Register on
September 8, 2020 (85 FR 55391). The NPRM was prompted by an
engineering analysis of the inspection reporting results and
metallurgical evaluation of the submitted frame fitting assemblies,
which indicated that the initial inspection threshold for Model 737-
900ER series airplanes and the repetitive inspection interval for all
affected airplanes are inadequate to address the cracking in a timely
manner. For certain airplanes, the NPRM proposed to reduce the
compliance time for the initial inspection, and for all airplanes the
NPRM proposed to reduce the repetitive inspection interval.

Comments

    The FAA gave the public the opportunity to participate in
developing this AD. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Request To Extend the Compliance Time for the Reporting Requirement

    American Airlines (AA) asked that the compliance time for the
reporting requirements in paragraphs (h) and (k) of the proposed AD be
extended to 30 days after the date of inspection. AA stated that the
cracking of the station (STA) 663.75 fitting is now a known problem,
and Boeing has been receiving reports for almost a year. AA added that
extending the reporting requirement to 30 days would provide relief to
the operators while not decreasing safety. Hainan Airlines (HNA)
recommended that the compliance time for the reporting requirement in
paragraph (k) of the proposed AD be extended from 3 to 30 days after
the inspection or after the effective date of the proposed AD, or an
equivalent date, to alleviate the burden on operators. HNA believes
that Boeing already received a large number of inspection reporting
results for its root cause analysis over the past year.
    Southwest Airlines (SWA) asked that the compliance time for the
reporting requirement be extended to 10 days. SWA stated that the 3-day
reporting requirement was developed for AD 2019-20-02, Amendment 39-
19755 (84 FR 52754, October 3, 2019). SWA added that the inspection
program has matured within Boeing and the Model 737-600, -700, -700C, -
800, -900, and -900ER operators, and the reporting requirement of
initial inspections can be relaxed from 3 to 10 days to reduce the
burden on airline operations for reporting non-crack findings.
Additionally, SWA noted that Boeing's airworthiness limitation
(Document D626A001-9-01) has a requirement to report any crack found
during these inspections to Boeing within 10 days.
    AIRDO Airlines asked that the reporting requirement be changed from
3 to 7 days, since the statistical data of the inspection results for
most of the aging 737NG airplanes has been reported.
    Boeing stated that it has been receiving inspection reports over
the past year and has accumulated substantial data, and asked that the
reporting requirement be extended to 10 days.
    Because of the information available from the inspection findings
that have already been reported to Boeing, the FAA agrees to extend the
reporting requirements in paragraphs (h) and (k) of this AD to 10 days,
which would reduce the reporting burden on operators and would provide
an acceptable level of safety. However, Boeing and the FAA are still
relying on those inspection results both to provide repair instructions
when cracks are found and to better understand the nature, cause, and
extent of the cracking and ultimately develop a terminating action. The
FAA, therefore, does not agree to extend the reporting requirement to
30 days.

Request To Provide Credit for Previous Reporting Requirement

    Boeing and AIRDO Airlines asked that reporting as specified in
paragraph (k) of the proposed AD not be required if an inspection
report was previously submitted in accordance with AD 2019-20-02 or AD
2019-22-10.
    The FAA partially agrees with the commenters' request. Although
reporting per AD 2019-20-02 alone is not adequate for credit with the
reporting requirement specified in paragraph (k) of this AD, reporting
per AD 2019-22-10 meets the reporting requirement specified in
paragraph (k) of this AD. Therefore, the FAA has revised paragraph (k)
of this AD to specify that a report submitted as required in paragraph
(h) of this AD is acceptable for compliance with the requirements of
paragraph (k) of this AD.

Request To Clarify Reporting Requirement

    One commenter asked that the reporting requirement in paragraph (k)
of the proposed AD be clarified. The commenter stated that inspection
report example specified in Boeing Multi-Operator Message MOM-MOM-20-
0443-01B (R1), dated June 2, 2020, has columns for repetitive
inspections. The commenter noted that reporting findings only for the
initial inspection is required by the proposed AD, and would like
conformation that reporting findings for repetitive inspections
thereafter is not required if no cracks are found.
    The FAA acknowledges the commenter's concern and confirms that
paragraph (k) of this AD requires reporting findings for only the
initial inspection, and no reporting is required for any repetitive
inspection regardless of the findings.

Effects of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing, SWA, and HNA stated that the installation
of blended or split scimitar winglets per Supplemental Type Certificate
(STC) ST00830SE does not affect compliance with the proposed actions.
    The FAA agrees with the commenters that STC ST00830SE does not
affect the accomplishment of the manufacturer's service instructions.
Operators of airplanes with these winglets do not need to request a
``change in product'' alternative method of compliance (AMOC) approval
as specified in 14 CFR 39.17. The FAA has redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD, and added paragraph
(c)(2) to this AD accordingly.

Request To Use Figures To Accomplish the Refined Inspection

    AA asked that it be allowed to use the figures for the refined
inspection areas in FAA Letter 782-19-14004. AA stated that the global
AMOC provided in FAA Letter 782-19-14004 and Boeing Multi-Operator
Message MOM-MOM-19-0536-01B, dated September 30, 2019, is referenced in
Boeing Multi-Operator Message MOM-MOM-20-0443-01B (R1), dated June 2,
2020; however, it is not mentioned in the proposed AD.
    The FAA partially agrees with the commenter's request. Paragraph
(n)(5) of this AD states that AMOCs approved previously for AD 2019-22-
10, which

include the referenced global AMOC, are approved as AMOCs for the
corresponding provisions of this AD. Therefore, no change to this AD is
necessary regarding this issue.

Request for Correction of Typographical Error

    Boeing and HNA requested the FAA correct a typographical error for
the effective date of AD 2019-22-10, which is referenced in paragraph
(h)(1) of the proposed AD as October 3, 3019, when the correct date is
October 3, 2019.
    The FAA agrees with the commenters' request. The FAA has corrected
the effective date of AD 2019-22-10 in paragraph (h)(1) of this AD
accordingly.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this AD with the changes described previously, and
minor editorial changes. The FAA has determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    The FAA also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Multi-Operator Message MOM-MOM-20-0443-01B
(R1), dated June 2, 2020. This service information specifies procedures
for repetitive detailed inspections for cracking of the left- and
right-hand outboard chords of the STA 663.75 frame fittings and
failsafe straps around eight fasteners adjacent to the stringer S-18A
straps.
    This AD also requires Boeing Multi-Operator Message MOM-MOM-19-
0623-01B, dated November 5, 2019, which the Director of the Federal
Register approved for incorporation by reference as of November 13,
2019 (84 FR 61533, November 13, 2019).
    This AD also requires Boeing Multi-Operator Message MOM-MOM-19-
0536-01B, dated September 30, 2019, which the Director of the Federal
Register approved for incorporation by reference as of October 3, 2019
(84 FR 52754, October 3, 2019).
    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.

Interim Action

    The FAA considers this AD interim action. The inspection reports
that are required by this AD will enable the manufacturer to obtain
better insight into the nature, cause, and extent of the cracking, and
eventually to develop final action to address the unsafe condition.
Once final action has been identified, the FAA might consider further
rulemaking.

Costs of Compliance

    The FAA estimates that this AD affects 1,911 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection (retained action from   1 work-hour x $85                $0  $85 per inspection   $162,435 per
 AD 2019-22-10).                    per hour = $85 per                   cycle.               inspection cycle.
                                    inspection cycle.
Reporting (retained action from    1 work-hour x $85                 0  $85................  $162,435.
 AD 2019-22-10).                    per hour = $85.
Inspection (new action)..........  1 work-hour x $85                 0  $85 per inspection   $162,435 per
                                    per hour = $85 per                   cycle.               inspection cycle.
                                    inspection cycle.
Reporting (new action)...........  1 work-hour x $85                 0  $85................  $162,435.
                                    per hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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

    The FAA has determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 2019-22-10, Amendment 39-19789 (84
FR 61533, November 13, 2019); and
0
b. Adding the following new airworthiness directive:

2021-09-06 The Boeing Company: Amendment 39-21519; Docket No. FAA-
2020-0789; Project Identifier AD-2020-00849-T.

(a) Effective Date

    This airworthiness directive (AD) is effective June 8, 2021.

(b) Affected ADs

    This AD replaces AD 2019-22-10, Amendment 39-19789 (84 FR 61533,
November 13, 2019) (AD 2019-22-10).

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 737-600, -
700, -700C, -800, -900, and -900ER series airplanes, certificated in
any category.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST00830SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of cracking discovered in the
station (STA) 663.75 frame fitting outboard chords and failsafe
straps adjacent to the stringer S-18A straps and a determination
that the initial inspection threshold for certain airplanes and the
repetitive inspection interval specified in AD 2019-22-10 are
inadequate to address the cracking in a timely manner. The FAA is
issuing this AD to address cracking in the STA 663.75 frame fitting
outboard chords and failsafe straps adjacent to the stringer S-18A
straps, which could result in failure of a Principal Structural
Element (PSE) to sustain limit load. This condition could adversely
affect the structural integrity of the airplane and result in loss
of control of the airplane.

(f) Compliance

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

(g) Retained Inspection and Corrective Action, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2019-22-10, with no changes. At the earlier of the times specified
in paragraphs (g)(1) and (2) of this AD: Do a detailed inspection
for cracking of the left- and right-hand side outboard chords of the
STA 663.75 frame fittings and failsafe straps adjacent to the
stringer S 18A straps, in accordance with Boeing Multi-Operator
Message MOM-MOM-19-0536-01B, dated September 30, 2019. If any crack
is found, repair before further flight using a method approved in
accordance with the procedures specified in paragraph (n) of this
AD. Repeat the inspection thereafter at intervals not to exceed
3,500 flight cycles until the initial inspection required by
paragraph (i) of this AD is done.
    (1) Prior to the accumulation of 30,000 total flight cycles, or
within 7 days after October 3, 2019 (the effective date of AD 2019-
20-02, Amendment 39-19755 (84 FR 52754, October 3, 2019) (AD 2019-
20-02)), whichever occurs later.
    (2) Prior to the accumulation of 22,600 total flight cycles, or
within 1,000 flight cycles after October 3, 2019 (the effective date
of AD 2019-20-02), whichever occurs later.

(h) Retained Reporting Requirement, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2019-22-10, with no changes. At the applicable time specified in
paragraph (h)(1) or (2) of this AD, submit a report of all findings,
positive and negative, of the initial inspection required by
paragraph (g) of this AD. Submit the report in accordance with
Boeing Multi-Operator Message MOM-MOM-19-0536-01B, dated September
30, 2019.
    (1) If the inspection was done on or after October 3, 2019 (the
effective date of AD 2019-20-02): Submit the report within 10 days
after the inspection.
    (2) If the inspection was done before October 3, 2019 (the
effective date of AD 2019-20-02): Submit the report within 10 days
after October 3, 2019.

(i) Inspection and Corrective Action With Reduced Compliance Times

    Except as specified in paragraph (j) of this AD: At the
applicable initial compliance time specified in Tables 1 and 2 of
``Ref I'' of Boeing Multi-Operator Message MOM-MOM-20-0443-01B (R1),
dated June 2, 2020, do a detailed inspection of the left- and right-
hand side outboard chords of the STA 663.75 frame fittings and
failsafe straps around eight fasteners adjacent to the stringer S-
18A straps, in accordance with Boeing Multi-Operator Message MOM-
MOM-20-0443-01B (R1), dated June 2, 2020. If any crack is found,
repair before further flight using a method approved in accordance
with the procedures specified in paragraph (n) of this AD. Repeat
the inspection thereafter at the applicable intervals specified in
Tables 1 and 2 of ``Ref I'' of Boeing Multi-Operator Message MOM-
MOM-20-0443-01B (R1), dated June 2, 2020. Accomplishing the initial
inspection required by this paragraph or an initial inspection
specified in Boeing Multi-Operator Message MOM-MOM-19-0623-01B,
dated November 5, 2019, terminates the inspections required by
paragraph (g) of this AD.

(j) Exceptions to Service Information Specifications

    Where Boeing Multi-Operator Message MOM-MOM-20-0443-01B (R1),
dated June 2, 2020, uses the phrase ``the original issue date of
MOM-MOM-20-0443-01B(R1),'' this AD requires using ``the effective
date of this AD.''

(k) New Reporting Requirement

    At the applicable time specified in paragraph (k)(1) or (2) of
this AD, submit a report of all findings, positive and negative, of
the initial inspection required by paragraph (i) of this AD. Submit
the report in accordance with MOM-MOM-20-0443-01B (R1), dated June
2, 2020. A report submitted as specified in paragraph (h) of this AD
is acceptable for compliance with the requirements of this
paragraph.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 10 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 10 days after the effective date of
this AD.

(l) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the airplane to a location where the
airplane can be repaired if any crack is found, provided the
Manager, Seattle ACO Branch, FAA, concurs with issuance of the
special flight permit. Send requests for concurrence by email to<EMAIL_ADDRESS>
(m) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed,

and completing and reviewing the collection of information. All
responses to this collection of information are mandatory as
required by this AD. Send comments regarding this burden estimate or
any other aspect of this collection of information, including
suggestions for reducing this burden to Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

(n) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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
manager of the certification office, send it to the attention of the
person identified in paragraph (o) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously for AD 2019-20-02 are approved as
AMOCs for the corresponding provisions of this AD.
    (5) AMOCs approved previously for AD 2019-22-10 are approved as
AMOCs for the corresponding provisions of this AD.

(o) Related Information

    For more information about this AD, contact Greg Rutar,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
June 8, 2021.
    (i) Boeing Multi-Operator Message MOM-MOM-20-0443-01B (R1),
dated June 2, 2020.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
November 13, 2019 (84 FR 61533, November 13, 2019).
    (i) Boeing Multi-Operator Message MOM-MOM-19-0623-01B, dated
November 5, 2019.
    (ii) [Reserved]
    (5) The following service information was approved for IBR on
October 3, 2019 (84 FR 52754, October 3, 2019).
    (i) Boeing Multi-Operator Message MOM-MOM-19-0536-01B, dated
September 30, 2019.
    (ii) [Reserved]
    (6) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (7) You may view this service information 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>.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 15, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-08849 Filed 5-3-21; 8:45 am]
BILLING CODE 4910-13-P