[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16436-16439]
[FR Doc No: 2020-06004]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88402; File No. SR-NYSE-2020-20]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Rule 7.12 Concerning the Resumption of Trading Following a
Level 3 Market-Wide Circuit Breaker Halt

March 17, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on March 16, 2020, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 7.12 concerning the resumption
of trading following a Level 3 market-wide circuit breaker halt. The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose

    The Exchange proposes to amend Rule 7.12 \4\ concerning the
resumption of trading following a Level 3 market-wide circuit breaker
halt. The Exchange is proposing this rule change in conjunction with
other national securities exchanges and the Financial Industry
Regulatory Authority (``FINRA'').
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    \4\ Rule 80B is no longer operative. To reduce potential
confusion regarding which rule governs market-wide circuit breakers,
the Exchange proposes to delete the text associated with Rule 80B
and to direct market participants to Rule 7.12.
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    Rule 7.12 provides a methodology for determining when to halt
trading in all stocks due to extraordinary market volatility (i.e.,
market-wide circuit breakers). The market-wide circuit breaker
mechanism (``MWCB'') under Rule 7.12 was approved by the Commission to
operate on a pilot basis,\5\ the term of which was to coincide with the
pilot period for the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS (the ``LULD Plan''),\6\
including any extensions to the pilot period for the LULD Plan.\7\ In
April 2019, the Commission approved an amendment to the LULD Plan for
it to operate on a permanent, rather than pilot, basis.\8\ In light of
the proposal to make the LULD Plan permanent, the Exchange amended Rule
7.12 to untie the pilot's effectiveness from that of the LULD Plan and
to extend the pilot's effectiveness to the close of business on October
18, 2019.\9\ The Exchange then filed to extend the pilot for an
additional year to the close of business on October 18, 2020.\10\
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    \5\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-NYSE-2011-48).
    \6\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a
mechanism to address extraordinary market volatility in individual
securities.
    \7\ See Securities Exchange Act Release Nos. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-NYSE-2011-48) (Approval
Order); and 68784 (January 31, 2013), 78 FR 8662 (February 6, 2013)
(SR-NYSE-2013-10) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change to Delay the Operative Date of a Rule Change to
NYSE Rule 80B).
    \8\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019).
    \9\ See Securities Exchange Act Release No. 85560 (April 9,
2019), 84 FR 15247 (April 15, 2019) (SR-NYSE-2019-19) (``Rule 80B
pilot extension filing''). At the time of the Rule 80B pilot
extension filing, Rule 7.12 existed but was not operative with
respect to Exchange-listed securities and was not amended to extend
its effectiveness through October 18, 2019. Now that all Exchange-
listed securities have transitioned to the Pillar trading platform,
Rule 7.12 is operative with respect to all securities trading on the
Exchange. See Securities Exchange Act Release No. 85962 (May 29,
2019), 84 FR 26188 (June 5, 2019) (SR-NYSE-2019-05). Although Rule
80B is not applicable to trading of any securities on the Exchange,
the Exchange believes that amending Rule 80B in this filing would
reduce the potential for confusion.
    \10\ See Securities Exchange Act Release No. 87016 (September
19, 2019), 84 FR 50502 (September 25, 2019) (SR-NYSE-2019-51).
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    The market-wide circuit breaker under Rule 7.12 provides an
important, automatic mechanism that is invoked to promote stability and
investor confidence during a period of significant stress when
securities markets experience extreme broad-based declines. All U.S.
equity exchanges and FINRA adopted uniform rules on a pilot basis
relating to market-wide circuit breakers in 2012 (``MWCB Rules''),
which are designed to slow the effects of extreme price movement
through coordinated trading halts across securities markets when severe
price declines reach levels that may exhaust

market liquidity.\11\ Market-wide circuit breakers provide for trading
halts in all equities and options markets during a severe market
decline as measured by a single-day decline in the S&P 500 Index.
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    \11\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-
025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-
30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-
2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SR-
NYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (``MWCB
Approval Order'').
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    Pursuant to Rule 7.12, a market-wide trading halt will be triggered
if the S&P 500 Index declines in price by specified percentages from
the prior day's closing price of that index. Currently, the triggers
are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level
2), and 20% (Level 3). A market decline that triggers a Level 1 or
Level 2 halt after 9:30 a.m. ET and before 3:25 p.m. ET would halt
market-wide trading for 15 minutes, while a similar market decline at
or after 3:25 p.m. ET would not halt market-wide trading. A market
decline that triggers a Level 3 halt at any time during the trading day
would halt market-wide trading until the primary listing market opens
the next trading day.
    Today, in the event that a Level 3 market decline occurs, the
Exchange would halt trading for the remainder of the trading day, and
would not resume until the primary listing market opens the next
trading day. On the next trading day, all NYSE Group exchanges (i.e.,
the Exchange, NYSE American, Inc. (``NYSE American''), NYSE Arca, Inc.
(``NYSE Arca''), NYSE National, Inc., and NYSE Chicago, Inc.) would
remain closed for all symbols until 9:30 a.m. ET, at which time the
Exchange, NYSE American, and NYSE Arca would begin their Core Open
Auction processes for their primary-listed securities.
    Upon feedback from industry participants, the Exchange has been
working with other national securities exchanges and FINRA to establish
a standardized approach for resuming trading in all NMS Stocks
following a Level 3 halt. The proposed approach would allow for the
opening of all securities the next trading day after a Level 3 halt as
a regular trading day, and is designed to ensure that Level 3 MWCB
events are handled in a more consistent manner that is transparent for
market participants.\12\
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    \12\ Of note, the U.S. futures markets, which have similar rules
for coordinated MWCB halts, normally begin their ``next day''
trading session at 6:00 p.m. ET (for CFE and CME) or at 8:00 p.m. ET
(for ICE). If the U.S. futures markets amend their MWCB rules, as
needed, to allow for normal course trading following a Level 3 halt,
the futures markets would resume trading in their normal course at
6:00 p.m. ET (CFE and CME) or 8:00 p.m. ET (ICE) the same day as the
Level 3 halt.
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    As proposed, a Level 3 halt would end at the end of the trading day
on which it is declared. This proposed change would allow for next-day
trading to resume in all NMS Stocks no differently from any other
trading day. In other words, an exchange could resume trading in any
security when it first begins trading under its rules and would not
need to wait for the primary listing market to re-open trading in a
security before it could start trading such security.\13\ Accordingly,
under the proposal, the Exchange could begin trading all UTP Securities
at the beginning of the Exchange's Early Trading Session at 7:00 a.m.
ET, regardless of whether the primary listing markets for those
securities have actually opened.\14\
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    \13\ The Exchange anticipates that the other national securities
exchanges and FINRA will also file similar proposals to amend their
MWCB rules on the resumption of trading following Level 3 halts, and
amend their rules, where required, to have their Level 3 next-day
openings happen normally.
    \14\ Only UTP Securities are eligible to trade in the Exchange's
Early Trading Session, which begins at 7:00 a.m. and continues until
9:30 a.m. See Rule 7.34(a)(1). The Exchange would not resume trading
Tape A securities until the Core Trading Session begins at 9:30 a.m.
ET. See Rule 7.34(a).
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    To effect this change, the Exchange proposes to delete the language
in Rule 7.12(b)(ii) requiring the Exchange to wait until the primary
listing exchange opens the next trading day following a Level 3 market
decline, and specify that the Exchange will halt trading for the
remainder of the trading day. The proposed rule change would therefore
allow each exchange to resume trading in all securities the next
trading day following a Level 3 halt at whatever time such exchange
normally begins trading under its rules, which for the Exchange would
be the beginning of the Early Trading Session at 7:00 a.m. ET for UTP
Securities and the beginning of the Core Trading Session at 9:30 a.m.
for Tape A securities. The Exchange also expects that the primary
listing exchanges will facilitate this change by sending resume
messages to the applicable securities information processor (``SIP'')
to lift the Level 3 trading halt message in all securities. The
resumption messages will be disseminated after the SIP has started on
the next trading day and before the start of the earliest pre-market
trading session of all exchanges. If a security is separately subject
to a regulatory halt that has not ended, the primary listing exchange
would replace the Level 3 halt message with the applicable regulatory
halt message.
    Having a consistent approach for all securities will make the
opening process the day after a Level 3 halt more uniform and reduce
complexity, which the Exchange believes is important after a
significant market event. Based on industry feedback, the Exchange
believes that resuming trading in the normal course in all equity
securities will be more beneficial to the marketplace. By allowing
trading to resume after a Level 3 halt in all securities no differently
from any normal trading day under the respective rules of each
exchange, the proposed rule change would provide greater certainty to
the marketplace by ensuring a familiar experience for all market
participants that trade NMS Stocks and balances out potential concerns
around volatility. While the Exchange recognizes that the impact of
this proposal is to permit all securities to be traded in the various
exchanges' early trading sessions,\15\ which do not have certain price
protections for volatility such as LULD Bands or MWCB protections, the
Exchange nonetheless believes that this outcome is outweighed by the
benefits provided by resuming trading in the early trading sessions in
a manner that is more familiar to the marketplace. Moreover, allowing
the resumption of trading to occur on the various exchanges at the
beginning of their early trading sessions in all NMS Stocks will allow
for price formation to occur earlier in the trading day, which in turn
allows market participants to react to news that has developed. As
such, trading at the beginning of regular hours may be more orderly.
---------------------------------------------------------------------------

    \15\ Note that because Tape A securities are not eligible to be
traded in the Exchange's Early Trading Session, the Exchange will
not resume trading Tape A securities until the Core Trading Session
begins at 9:30 a.m. ET, but any other exchange with an early trading
session could resume trading in Tape A securities at the beginning
of its early trading session.
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    The Exchange will announce the implementation date of the amendment
to Rule 7.12(b)(ii) by Trader Update.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market

system, and, in general to protect investors and the public interest.
The market-wide circuit breaker mechanism under Rule 7.12 is an
important, automatic mechanism that is invoked to promote stability and
investor confidence during a period of significant stress when
securities markets experience extreme broad-based declines. The
Exchange believes that the proposed rule change promotes just and
equitable principles of trade in that it promotes transparency and
uniformity across markets concerning when and how to halt trading in
all stocks as a result of extraordinary market volatility, and how the
markets will resume trading following a Level 3 market decline. As
described above, the Exchange, together with other national securities
exchanges and FINRA, is seeking to adopt a standardized approach
related to resuming trading in NMS Stocks after a Level 3 MWCB halt. In
this regard, the Exchange believes that the proposal to resume trading
in all securities following a Level 3 halt in the same manner that
securities would open trading on a regular trading day will benefit
investors, the national market system, Exchange members, and the
Exchange market by promoting a fair and orderly market and reducing
confusion during a significant cross-market event. By allowing trading
to resume after a Level 3 halt in all securities no differently from
any normal trading day under the respective rules of each exchange, the
proposed rule change would provide greater certainty to the marketplace
by ensuring a familiar experience for all market participants that
trade NMS Stocks.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Based on the foregoing, the Exchange believes the benefits to
market participants from the MWCB under Rule 7.12 with the proposed
standardized process for resuming trading in all securities following a
Level 3 halt will promote fair and orderly markets, and protect
investors and the public interest.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act because the proposed Level 3
rule change described above would standardize the opening process for
all securities on the Exchange, which would make the opening process
the day after a Level 3 halt more uniform and reduce complexity.
Further, the Exchange understands that FINRA and other national
securities exchanges will file similar proposals to adopt the proposed
Level 3 rule change.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \18\ and Rule 19b-4(f)(6) thereunder.\19\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\20\
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    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Commission has waived the pre-filing requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \21\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\22\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. The Commission notes
that it approved a substantively similarly proposed rule change
submitted by The Nasdaq Stock Market LLC.\23\ Waiver of the operative
delay will ensure consistency across the market centers and the timely
implementation of the proposed rule change. Accordingly, the Commission
waives the 30-day operative delay and designates the proposed rule
change operative upon filing.\24\
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    \21\ 17 CFR 240.19b-4(f)(6).
    \22\ 17 CFR 240.19b-4(f)(6)(iii).
    \23\ See Securities Exchange Act Release No. 88360 (March 11,
2020) (SR-NASDAQ-2020-03).
    \24\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \25\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \25\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2020-20 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2020-20. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public

Reference Room, 100 F Street NE, Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2020-20 and should be submitted on or before April 13, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06004 Filed 3-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22477-22478]
[FR Doc No: 2018-10396]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

AGENCY HOLDING MEETING: Federal Energy Regulatory Commission.

DATE AND TIME: May 17, 2018, 10:00 a.m.

PLACE: Room 2C, 888 First Street NE, Washington, DC 20426.

STATUS: Open.

MATTERS TO BE CONSIDERED: Agenda: * Note--Items listed on the agenda
may be deleted without further notice.

CONTACT PERSON FOR MORE INFORMATION: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>.
    For a recorded message listing items struck from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's website at http://ferc.capitolconnection.org/ sing the
eLibrary link, or may be examined in the Commission's Public Reference
Room.

1043rd--Meeting, Regular Meeting, May 17, 2018, 10:00 a.m.

----------------------------------------------------------------------------------------------------------------
          Item No.                       Docket No.                                  Company
----------------------------------------------------------------------------------------------------------------
                                                 ADMINISTRATIVE
----------------------------------------------------------------------------------------------------------------
A-1........................  AD18-1-000.......................  Agency Administrative Matters.
A-2........................  AD18-2-000.......................  Customer Matters, Reliability, Security and
                                                                 Market Operations.
A-3........................  AD06-3-000.......................  2018 Summer Market and Reliability Assessment.
----------------------------------------------------------------------------------------------------------------
                                                    ELECTRIC
----------------------------------------------------------------------------------------------------------------
E-1........................  RM18-8-000.......................  Geomagnetic Disturbance Reliability Standard.
E-2........................  RM16-15-001......................  Regulations Implementing FAST Act Section 61003--
                                                                 Critical Electric Infrastructure Security and
                                                                 Amending Critical Energy Infrastructure
                                                                 Information.
E-3........................  ER16-204-001.....................  Southwest Power Pool, Inc.
E-4........................  ER17-1575-002....................  Southwest Power Pool, Inc.
E-5........................  EL16-110-002, EL17-69-001 (not     Southwest Power Pool, Inc., Buffalo Dunes Wind
                              consolidated).                     Project, LLC, Enel Green Power North America,
                                                                 Inc., Alabama Power Company, and Southern
                                                                 Company Services, Inc. v. Southwest Power Pool,
                                                                 Inc.
E-6........................  EL17-59-001......................  Joint California Complainants v. Pacific Gas and
                                                                 Electric Company.
E-7........................  EL17-95-000......................  California Public Utilities Commission,
                                                                 Transmission Agency of Northern California,
                                                                 Sacramento Municipal Utility District, M-S-R
                                                                 Public Power Agency, City of Santa Clara,
                                                                 California, State Water Contractors, Modesto
                                                                 Irrigation District, and Northern California
                                                                 Power Agency v. Pacific Gas and Electric
                                                                 Company.
                             ER17-2154-000 (consolidated).....  Pacific Gas and Electric Company.
E-8........................  EL18-58-000......................  Oklahoma Municipal Power Authority v. Oklahoma
                                                                 Gas and Electric Company.
E-9........................  EL17-70-000, QF17-935-001, QF17-   Zeeland Farm Services, Inc.
                              936-001.
E-10                         EL15-3-002.......................  City and County of San Francisco v. Pacific Gas
                                                                 and Electric Company.
                             ER15-702-002, ER15-703-002, ER15-  Pacific Gas and Electric Company.
                              704-005, ER15-705-002, ER15-735-
                              002 (consolidated).
E-11.......................  EL01-88-015......................  Louisiana Public Service Commission v. Entergy
                                                                 Services, Inc.
E-12.......................  EL01-88-017......................  Louisiana Public Service Commission v. Entergy
                                                                 Services, Inc.
----------------------------------------------------------------------------------------------------------------
                                                  MISCELLANEOUS
----------------------------------------------------------------------------------------------------------------
M-1........................  OMITTED.
M-2........................  RM18-7-000.......................  Withdrawal of Pleadings.
----------------------------------------------------------------------------------------------------------------
                                                       GAS
----------------------------------------------------------------------------------------------------------------
G-1........................  RP16-1299-003, RP17-977-000        Kinetica Energy Express, LLC.
                              (consolidated).
G-2........................  OR18-9-000.......................  White Cliffs Pipeline, L.L.C.
G-3........................  OMITTED.
G-4........................  OR15-6-000.......................  Seaway Crude Pipeline Company LLC.
G-5........................  RP17-811-001.....................  Peregrine Oil & Gas II, LLC v. Texas Eastern
                                                                 Transmission, LP.
----------------------------------------------------------------------------------------------------------------
                                                      HYDRO
----------------------------------------------------------------------------------------------------------------
H-1........................  RM18-14-000......................  Elimination of Form 80 and Revision of
                                                                 Regulations on Recreational Opportunities and
                                                                 Development at Licensed Hydropower Projects.
----------------------------------------------------------------------------------------------------------------
                                                  CERTIFICATES
----------------------------------------------------------------------------------------------------------------
C-1........................  CP17-476-000.....................  Gulf South Pipeline Company, LP.

C-2........................  CP18-48-000......................  Tennessee Gas Pipeline Company, L.L.C., Kinder
                                                                 Morgan Border Pipeline LLC, Kinder Morgan Tejas
                                                                 Pipeline LLC.
----------------------------------------------------------------------------------------------------------------

    Issued: May 10, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
    A free webcast of this event is available through http://ferc.capitolconnection.org/. Anyone with internet access who desires to
view this event can do so by navigating to www.ferc.gov's Calendar of
Events and locating this event in the Calendar. The event will contain
a link to its webcast. The Capitol Connection provides technical
support for the free webcasts. It also offers access to this event via
television in the DC area and via phone bridge for a fee. If you have
any questions, visit http://ferc.capitolconnection.org/ or contact
Danelle Springer or David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. 2018-10396 Filed 5-11-18; 11:15 am]
 BILLING CODE 6717-01-P


[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Rules and Regulations]
[Page 35934-35937]
[DOCID:fr25jn08-20]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0269]
RIN 1625-AA00

Safety Zone; Mission Bay Yacht Club 4th of July Display; Mission
Bay, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of Mission Bay in support of the Mission Bay Yacht
Club 4th of July Display near the navigation channel in the vicinity of
Santa Clara Point. The safety zone is necessary to provide for the
safety of the crew, spectators, and participants of the event,
participating vessels and other vessels and users of the waterway.
Persons and vessels are prohibited from entering

into, transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

DATES: This rule is effective from 8:30 p.m. until 10 p.m. on July 4,
2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0269 and are available online
at www.regulations.gov. They are also available for inspection or
copying two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and at Coast
Guard Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101-1064
between 8 a.m. and 3 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Petty Officer Kristen Beer, Waterways
Management, U.S. Coast Guard Sector San Diego, CA at telephone (619)
278-7233.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. Final approval and permitting
of this event were not issued in time to engage in full notice and
comment rulemaking. Publishing an NPRM and delaying the effective date
would be contrary to the public interest since the event would occur
before the rulemaking process was complete.
    Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good
cause exists for making this rule effective less than 30 days after
publication in the Federal Register. In addition, it would be contrary
to the public interest not to publish this rule because the event has
been permitted and participants and the public require protection.

Background and Purpose

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of Mission Bay in support of the Mission Bay Yacht
Club 4th of July Display. The safety zone is comprised of an 800-foot
radius located around an anchored firing barge. This temporary safety
zone is necessary to provide for the safety of the show's crew,
spectators, and participants of the event, participating vessels and
other vessels and users of the waterway. Persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative.

Discussion of Rule

    The Coast Guard establishes this temporary rule, pursuant to 33
U.S.C. 1225, to provide for the safety of the participants, spectators
and other users of the waterways. This safety zone will be effective
from 8 p.m. to 10 p.m. on July 4, 2008. This temporary safety zone is
necessary to ensure the safety of participants and spectators of the
Mission Bay Yacht Club 4th of July Display. The duration of the show is
expected to be approximately 20-25 minutes. The event involves one
anchored barge, which will be used as a platform for launching of
fireworks. The limits of the temporary safety zones include all areas
within an 800-foot radius around an anchored barge. The barge will be
anchored at a location approximately 600 feet east of the Santa Clara
Point. This temporary safety zone is necessary to provide for the
safety of the crews, spectators, participants of the event,
participating vessels and other vessels and users of the waterway.
Persons and vessels are prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port, or his designated representative.
    U.S. Coast Guard personnel will enforce this safety zone. Other
Federal, State, or local agencies may assist the Coast Guard, including
the Coast Guard Auxiliary. Sec.  165.23 of Title 33, Code of Federal
Regulations, prohibits any unauthorized person or vessel from entering
or remaining in a safety zone. Vessels or persons violating this
section will be subject to the penalties set forth in 33 U.S.C. 1232.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Due to the temporary safety zone's short duration of one and a half
hours, its limited scope of implementation, and because vessels will
have an opportunity to request authorization to transit through the
zone or the vessels may safely travel around the zone, the Coast Guard
expects the economic impact of this rule to be so minimal that full
regulatory evaluation under paragraph 10(e) of the regulatory policies
and procedures of the DHS is unnecessary.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of Mission Bay from 8:30 p.m. to 10 p.m. on July
4, 2008. This safety zone will not have a significant economic impact
on a substantial number of small entities for the following reasons:
The safety zone only encompasses a small portion of the waterway, it is
short in duration at a late hour when commercial traffic is low,
vessels may safely travel around the safety zone, and the Captain of
the Port may authorize entry into the zone, if necessary.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. If your
small business or organization is affected by this rule and you have
questions concerning its provisions or options for compliance, please
contact Petty Officer Kristen Beer, U.S. Coast Guard Sector San Diego
at<PHONE_NUMBER>.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against

small entities that question or complain about this rule or any policy
or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards. This rule does not
use technical standards. Therefore, we did not consider the use of
voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
and Department of Homeland Security Management Directive 5100.1, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded,
under the Instruction, that there are no factors in this case that
would limit the use of a categorical exclusion under section 2.B.2 of
the Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because it establishes a safety zone. A
final ``Environmental Analysis Check List'' and a final ``Categorical
Exclusion Determination'' are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1225, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T11-045 to read as follows:

Sec.  165.T11-045  Safety Zone: Mission Bay Yacht Club 4th of July
Display; Mission Bay, San Diego, CA.

    (a) Location. The limits of the temporary safety zones include all
areas within an 800-foot radius around an anchored barge. The barge
will be anchored at a location approximately 600 feet east of the Santa
Clara Point.
    (b) Effective Period. This safety zone will be in effect from 8:30
p.m. until 10 p.m. on July 4, 2008. If the display concludes prior to
the scheduled termination time, the Captain of the Port or his
designated representative will cease enforcement of this safety zone
and will announce that fact via Broadcast Notice to Mariners.
    (c) Regulations. In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transit through, or anchoring
within this zone by all vessels is prohibited, unless authorized by the
Captain of the Port or his designated representative. Mariners
requesting permission to transit through the safety zone may request
authorization to do so from the U.S. Coast Guard Patrol Commander. The
U.S. Coast Guard Patrol Commander may be contacted via VHF-FM Channel
16.
    (d) Enforcement. All persons and vessels shall comply with the
instructions of the Coast Guard Captain of the Port or the designated
on-scene patrol personnel. Patrol personnel can be comprised of
commissioned, warrant, and petty officers of the Coast Guard onboard
Coast Guard, Coast Guard Auxiliary, local, state, and federal law

enforcement vessels. Upon being hailed by U.S. Coast Guard patrol
personnel by siren, radio, flashing light, or other means, the operator
of a vessel shall proceed as directed. The Coast Guard may be assisted
by other federal, state, or local agencies.

    Dated: June 10, 2008.
C.V. Strangfeld,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E8-14370 Filed 6-24-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Rules and Regulations]
[Pages 56277-56279]
[FR Doc No: 2011-22278]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 76, No. 177 / Tuesday, September 13, 2011 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0381; Directorate Identifier 2010-NM-203-AD;
Amendment 39-16799; AD 2011-18-17]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model DHC-8-400 Series
Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Several reports have been received on failures of the main
landing gear (MLG) stabilizer extension springs. A landing gear
audit has confirmed that the MLG may not lock in the down-lock
position with the absence of both MLG stabilizer extension springs.
The loss of the locking mechanism could result in the collapse of
the main landing gear.
* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective October 18, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 18,
2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Fabio Buttitta, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on April 19, 2011 (76
FR 21820). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Several reports have been received on failures of the main
landing gear (MLG) stabilizer extension springs. A landing gear
audit has confirmed that the MLG may not lock in the down-lock
position with the absence of both MLG stabilizer extension springs.
The loss of the locking mechanism could result in the collapse of
the main landing gear.
    This [TCCA] directive is to mandate the incorporation of a new
maintenance task for the MLG stabilizer extension springs.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request to Reference Latest Revision of the Maintenance Review Board
Report

    Merle Mattson requested that we revise paragraph (g) of the NPRM
(76 FR 21820, April 19, 2011), to reference the latest permanent
revision of the Bombardier Q400 Dash 8 Maintenance Requirements Manual,
PSM 1-84-7, rather than Bombardier Temporary Revision (TR) MRB-45,
dated October 6, 2009, to Section 1-32, Systems/Powerplant Maintenance
Program, of Part 1 of the Maintenance Review Board Report of the
Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7, for
Task 320100-213. The commenter suggested an option of adding a note
allowing the removal of Bombardier TR MRB-45, dated October 6, 2009,
when it is incorporated into Section 1-32, Systems/Powerplant
Maintenance Program, of Part 1 of the Maintenance Review Board Report
of the Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-
84-7, through a general revision. The commenter stated that the
proposed NPRM would force operators to go back to the manufacturer for
a copy of Bombardier TR MRB-45, dated October 6, 2009, because that TR
was discarded at the incorporation of permanent Revision 7, dated June
2010, of the Bombardier Q400 Dash 8 Maintenance Requirements Manual,
PSM 1-84-7.
    We agree with the request to add a note to allow the removal of
Bombardier TR MRB-45, dated October 6, 2009, when the information in
that TR is included in the general revision of Part 1 of the
Maintenance Review Board Report of the Bombardier Q400 Dash 8
Maintenance Requirements Manual, PSM 1-84-7. We have added Note 1 to
this AD to specify that the general revisions may be inserted into
Section 1-32, Systems/Powerplant Maintenance Program, of Part 1 of
Maintenance Review Board Report of the Bombardier Q400 Dash 8
Maintenance Requirements Manual, PSM 1-84-7, provided the relevant
information in the general revisions is identical to that in Bombardier
TR MRB-45, dated October 6, 2009.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously. We determined that this change
will not increase the economic burden on any operator or increase the
scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.

    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 65 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $5,525, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ''significant regulatory action'' under Executive Order
12866;
    2. Is not a ''significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 21820, April 19,
2011), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

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 adding the following new AD:

2011-18-17 Bombardier, Inc.: Amendment 39-16799. Docket No. FAA-
2011-0381; Directorate Identifier 2010-NM-203-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective October
18, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model DHC-8-400, -401,
and -402 airplanes, certificated in any category, serial numbers
4001, 4003 and subsequent.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Several reports have been received on failures of the main
landing gear (MLG) stabilizer extension springs. A landing gear
audit has confirmed that the MLG may not lock in the down-lock
position with the absence of both MLG stabilizer extension springs.
The loss of the locking mechanism could result in the collapse of
the main landing gear.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 30 days after the effective date of this AD, revise
the maintenance program by incorporating Task 320100-213 as
specified in Bombardier Temporary Revision (TR) MRB-45, dated
October 6, 2009, to Section 1-32, Systems/Powerplant Maintenance
Program, of Part 1 of the Maintenance Review Board Report of the
Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7.
The initial compliance time for Task 320100-213 is within 600 flight
hours after the effective date of this AD.

    Note 1: The actions required by paragraph (g) of this AD may be
done by inserting a copy of Bombardier TR MRB-45, dated October 6,
2009, into Section 1-32, Systems/Powerplant Maintenance Program, of
Part 1 of the Maintenance Review Board Report of the Bombardier Q400
Dash 8 Maintenance Requirements Manual, PSM 1-84-7. When this TR has
been included in the general revisions of Part 1 of the Maintenance
Review Board Report of the Bombardier Q400 Dash 8 Maintenance
Requirements Manual, PSM 1-84-7, the general revisions may be
inserted in Part 1 of the Maintenance Review Board Report of the
Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7,
provided the relevant information in the general revisions is
identical to that in Bombardier TR MRB-45, dated October 6, 2009.

No Alternative Actions or Intervals

    (h) After accomplishing the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections) or intervals
may be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO, ANE-170, FAA, 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 ACO, send it to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. 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. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (j) Refer to MCAI Transport Canada Civil Aviation (TCCA)
Airworthiness Directive CF-2010-22, dated July 20, 2010; and
Bombardier Temporary Revision MRB-45, dated October 6, 2009, to
Section 1-32, Systems/Powerplant Maintenance Program, of Part 1 of
the Maintenance Review Board Report of the Bombardier Q400 Dash 8
Maintenance Requirements Manual, PSM 1-84-7; for related
information.

Material Incorporated by Reference

    (k) You must use Bombardier Temporary Revision MRB-45, dated
October 6, 2009, to Section 1-32, Systems/Powerplant Maintenance
Program, of Part 1 of the Maintenance Review Board Report of the
Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7,
to do the actions required by this AD, unless the AD specifies
otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on August 23, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-22278 Filed 9-12-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Pages 13295-13299]
[FR Doc No: 2022-04972]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0075]

Food and Drug Administration Quality Metrics Reporting Program;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a docket to solicit comments on changes to FDA's
previously proposed quality metrics reporting program (QM Reporting
Program). This notice describes considerations for refining the QM
Reporting Program based on lessons learned from two pilot programs with
industry that were announced in the Federal Register in June 2018, a
Site Visit Program and a Quality Metrics Feedback Program, as well as
stakeholder feedback on FDA's 2016 revised draft guidance for industry
entitled ``Submission of Quality Metrics Data.'' FDA is interested in
responses to the questions listed in section III of this document, in
addition to any general comments on the proposed direction for the
program. This notice is not intended to communicate our regulatory
expectations for reporting quality metrics data to FDA but is instead
intended to seek input from industry to inform the future regulatory
approach.

DATES: Submit either electronic or written comments by June 7, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 7, 2022. The https://www.regulations.gov electronic filing system will accept comments until
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    Submit written/paper submissions as follows:
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SUPPLEMENTARY INFORMATION:

I. Background

A. Quality Metrics

    For pharmaceutical manufacturing, quality metrics are objective
means of measuring, evaluating, and monitoring the product and process
life cycle to proactively identify and mitigate quality risks; thereby
managing operations at higher levels of safety, efficacy, delivery, and
performance. Quality metrics are used throughout the drug and
biological product industry to monitor quality control systems and
processes and drive continuous improvement efforts in manufacturing.
Quality metrics are important because failure to update and innovate
manufacturing practices and lack of operational reliability (i.e.,
state of control) can lead to quality problems that have a negative
impact on public health.
    The minimum standard for ensuring that a manufacturer's products
are safe and effective is compliance with current good manufacturing
practice (CGMP) requirements as outlined in current regulations and as
recommended in current policies (21 CFR parts 210 and 211 for drug
products and the International Conference on Harmonisation guidance for
industry entitled ``Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients'' (September 2016); available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients-guidance-industry). However, compliance with CGMP does not necessarily
indicate whether a manufacturer is investing in improvements and
striving for sustainable compliance, which is the state of having
consistent control over manufacturing performance and quality.
Sustainable CGMP compliance is difficult to achieve without a focus on
continual improvement.
    An effective Pharmaceutical Quality System (PQS) ensures both
sustainable CGMP compliance and supply chain robustness. Quality
metrics data can contribute to a manufacturer's ability to develop an
effective PQS because metrics provide insight into manufacturing
performance and enable the identification of opportunities for updates
and innovation to manufacturing practices. Quality metrics also play an
important role in supplier oversight and can be used to inform the
oversight of outsourced activities and material suppliers as well as
appropriate monitoring activities to minimize supply chain disruptions.
    Quality metrics data provided by establishments can also be useful
to FDA. These data can assist the Agency in developing compliance and
inspection policies and practices to improve the Agency's ability to
predict, and therefore possibly mitigate, future drug shortages, and to
encourage the pharmaceutical industry to implement innovative quality
management systems for pharmaceutical manufacturing. For example,
quality metrics data can be applied to FDA's risk-based inspection
scheduling, reducing the frequency and/or length of routine
surveillance inspections for establishments with metrics data that
suggest sustainable compliance. Additionally, the submission of quality
metrics data can provide ongoing insight into an establishment's
operations between inspections.
    As part of FDA's shift towards a risk-based approach to regulation,
the Agency proposed to develop and implement a QM Reporting Program to
support its quality surveillance activities, as described in section
I.B of this notice. Under this program, FDA

intends to analyze the quality metrics data submitted by establishments
to: (1) Obtain a more quantitative and objective measure of
manufacturing quality and reliability at an establishment; (2)
integrate the metrics and resulting analysis into FDA's comprehensive
quality surveillance program; and (3) apply the results of the analysis
to assist in identifying products at risk for quality problems (e.g.,
quality-related shortages and recalls).

B. FDA Guidance for Industry on the Submission of Quality Metrics Data

    In July 2015, FDA issued the draft guidance entitled ``Request for
Quality Metrics'' (80 FR 44973), which described a potential mandatory
program for product-based reporting of quality metrics. Under this
proposed program, manufacturers would have submitted four primary
metrics (lot acceptance rate (LAR), product quality complaint rate
(PQCR), invalidated/overturned out-of-specification rate (IOOSR), and
annual product review (APR) or product quality review on-time rate) and
three optional metrics (senior management engagement, corrective and
preventative action (CAPA) effectiveness, and process capability/
performance). Stakeholder comments on the guidance included concerns
regarding the burden associated with collecting, formatting, and
submitting data at a product level across multiple establishments;
technical comments on the proposed metrics and definitions; and legal
concerns regarding the proposed mandatory program. Stakeholder
commenters also suggested a phased-in approach to allow learning by
both industry and FDA.
    In response to this feedback, FDA published a revised draft
guidance in November 2016 entitled ``Submission of Quality Metrics
Data'' (81 FR 85226). The 2016 guidance described an initial voluntary
phase of the QM Reporting Program, with participants reporting data
either by product or establishment, through an FDA submission portal.
FDA removed one of the four metrics from the 2015 draft guidance and
requested submission of the remaining three key metrics: (1) LAR to
measure manufacturing process performance; (2) IOOSR to measure
laboratory robustness; and (3) PQCR to measure patient or customer
feedback and proposed incentives for participation. This guidance also
described how FDA intended to utilize the submitted data. Stakeholder
comments on the guidance indicated that the FDA-standardized
definitions remained a challenge and incentives to participate in a
voluntary program needed to be strengthened (e.g., direct collaboration
with FDA to develop the program was an example of a strong incentive).
Commenters requested a better understanding of the value and utility of
the data to be submitted to FDA and how FDA would measure success of
the program. Commenters also expressed a preference for a pilot program
to gather industry input before implementing a widespread QM Reporting
Program.

C. Lessons Learned From FDA's Quality Metrics Pilot Programs

    In Federal Register notices issued on June 29, 2018, FDA announced
the availability of two pilot programs, a Quality Metrics Site Visit
Program (83 FR 30751) and a Quality Metrics Feedback Program (83 FR
30748) for any establishment that has a quality metrics program
developed and implemented by the quality unit and used to support
product and process quality improvement.
    The Quality Metrics Site Visit Program offered experiential
learning for FDA staff and provided participating establishments an
opportunity to explain the advantages and challenges associated with
implementing and managing a Quality Metrics program. For example,
participants provided feedback in the form of case studies to
demonstrate the differences between the metric definitions proposed in
the FDA draft guidances and definitions commonly used by industry for
the same metrics. They proposed changes to the definitions, justifying
why those changes (if any) would be needed. FDA toured the operations
of 14 establishments worldwide and engaged with establishments on
topics such as: How quality metrics data are collected, analyzed,
communicated (e.g., dashboards, business intelligence platforms), and
reported throughout the organization in a structured and centralized
manner; how management utilizes quality metrics data to monitor the
performance of their supply network; how management leverages metrics
to promote data-driven decisions; how an establishment implements and
monitors continuous improvements based on metrics; how various quality
metrics are defined; how actions were taken from observations resulting
from quality metrics data reviews; and how efforts to proactively
mitigate and prevent shortages are coordinated.
    In the Quality Metrics Feedback Program, participating
establishments presented their quality metrics programs to FDA staff.
The presentations were followed by discussions and knowledge sharing
that focused on analytical strategies, exploratory data analyses, data
preparation and structure, and visualizations for communication, as
well as demonstrations on how FDA plans to analyze the data using
advanced analytical techniques (e.g., data/text mining, interactive
visualizations), sophisticated statistical methods (e.g., control
charts, time series analysis), and machine learning (e.g., predictive
analytics, natural language processing). In these discussions, FDA also
obtained feedback on industry's anticipated challenges in applying the
approach described in FDA's revised draft guidance. Participants had
the opportunity to submit their quality metrics data through an FDA
submission portal and provide feedback on their user experience. The
industry participants represented different sectors of the
pharmaceutical industry including innovator drug products, generic drug
products, nonprescription (also known as over-the-counter (OTC)) drug
products, and biological products.
    The dedicated meetings with industry during the two pilot programs
that focused on data analytics resulted in the following key lessons
learned for FDA, which will inform the direction of the QM Reporting
Program:
    1. Different industry sectors prefer different metrics due to their
individual operations and business dynamics needs. Therefore, it is
necessary to implement a program with sufficient flexibility when
choosing metrics. Identifying critical practice areas (e.g.,
manufacturing process performance) and allowing establishments to
select appropriate metrics from several options is a more feasible
approach.
    2. Any metric chosen to be reported should be meaningful to the
practice area being measured, and the data collected on that metric
should be able to influence decision making about process improvements
and capital investments.
    3. In some instances, a combination of metrics rather than a single
metric is preferred to assess a particular practice area.
    4. The majority of participants prefer to report data at an
establishment level and have the capability to segment by product, but
some participants prefer product-level reporting due to their business
structure (e.g., a vertically integrated company).
    5. Calculating LAR and PQCR based on the definitions in the 2016
revised draft guidance can result in mathematical discrepancies such as
rates over 100 percent or invalid calculations (i.e., dividing by
zero)). These discrepancies are caused by inherent variabilities from
real-time

operations (e.g., lots may not be dispositioned in the same quarter in
which they were started) or how denominators are defined for a
specified period of time.
    6. While LAR and IOOSR are quality metrics that are routinely
monitored by establishments, they are not discerning metrics due to
limited variability over time or limited scope and can result in false
positives by highlighting nonexistent performance issues. Other metrics
should be identified as surrogates for manufacturing process
performance and laboratory robustness. Examples include, but are not
limited to, right-first-time rate, process capability, and adherence to
lead time.
    7. The effectiveness of the quality system is a critical component
of a QM Reporting Program as evidenced by numerous establishments
collecting data around their PQS. Examples include metrics related to
the effectiveness of CAPA programs, repeat deviations, maintenance
programs, and timeliness.
    8. Metrics related to quality culture are important indicators of
performance and reliability, but unlike other quality metrics, it is
difficult to capture quality culture at an establishment based on
numerical metrics alone. Both numerical key performance indicators
(KPIs) (e.g., APR timeliness and near misses) and qualitative summaries
(e.g., descriptions of management commitment or quality planning) can
be used to further understand quality culture.
    9. FDA's analysis of the data submitted during the Quality Metrics
Feedback Program indicates that the use of statistical quality control
applications (e.g., statistical process control and process capability)
and machine learning/natural language processing are appropriate and
meaningful analytical strategies to assess quality metrics data
submitted by establishments.

II. Proposed Direction for an FDA QM Reporting Program

    FDA has applied the lessons learned from the pilot programs and
other stakeholder feedback toward refining the QM Reporting Program
that was presented in the 2016 revised draft guidance. In this section,
we summarize a potential direction for the program, and in section III
we request input on specific aspects of this approach.
    FDA believes that a change in the entities responsible for
collecting and submitting quality metrics data is not needed. ``Covered
establishments,'' as defined in the 2016 revised draft guidance, are
establishments engaged in the manufacture, preparation, propagation,
compounding or processing of a ``covered drug product'' (products
subject to an approved application under section 505 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) or section 351
of the Public Health Service Act; legally marketed pursuant to section
505G of the FD&C Act (21 U.S.C. 355h) (nonprescription drugs marketed
without an approved drug application); or marketed as unapproved
finished drug products) or an active pharmaceutical ingredient used in
the manufacture of a covered drug product. ``Covered establishments''
include contract laboratories, contract sterilizers, and contract
packagers.
    FDA is considering changes to other aspects of the QM Reporting
Program. Stakeholders have indicated that different industry sectors
may prefer different quality metrics. To provide flexibility to
manufacturers, FDA would focus less on standardization of quality
metrics and definitions. Instead, FDA would identify practice areas
that are critical to ensure sustainable product quality and
availability and would permit manufacturers to select a metric(s) from
each practice area that are meaningful and enable establishments to
identify continual improvement opportunities. The metric definitions
would not specify how establishments calculate particular metrics.
Rather, the reporting establishment would select the most appropriate
metric(s) from each practice area and inform FDA how it was calculated.
Through the collective feedback gathered from pilot participants, FDA
has identified the following four general practice areas as appropriate
at this time for the QM Reporting Program: (1) Manufacturing Process
Performance, (2) PQS Effectiveness, (3) Laboratory Performance, (4)
Supply Chain Robustness. Examples of quality metrics associated with
each practice include the following:

1. Manufacturing Process Performance

     Process Capability/Performance Indices (Cpk/Ppk): A
measure that compares the output of a process to the specification
limits and can be calculated as a proportion (e.g., total number of
attributes with Ppk greater than 1.33 divided by total number of
attributes where Ppk is used). It is important to consider standard
deviation measurements using a reasonable sample size.
     LAR: A measure of the proportion of lots that were
accepted in a given time period. Examples of inputs that can be used to
calculate LAR include lots completed, lots dispositioned, lots
attempted, lots rejected, lots released, lots approved, abandoned lots,
and parallel/backup lots.
     Right-First-Time Rate: A measure of the proportion of lots
manufactured without the occurrence of a non-conformance. Examples of
inputs that can be used to calculate a right-first-time rate include
number of deviations, lots dispositioned, lots attempted, number of
nonconformances, and lots approved in the first pass.
     Lot Release Cycle Time: A measure of the amount of time it
takes for the lot disposition process. Lot release cycle time can be
calculated with an appropriate unit of measurement such as number of
hours or days.

2. PQS Effectiveness

     CAPA Effectiveness: A measure of the proportion of CAPA
plan implemented and deemed effective (i.e., effectiveness
verifications closed as effective). Examples of inputs that can be used
to calculate CAPA effectiveness include number of CAPAs initiated,
CAPAs closed on time, CAPAs closed as ``effective,'' overdue CAPAs, and
CAPAs resulting in retraining.
     Repeat Deviation Rate: A measure of the proportion of
recurring deviation measures. Examples of inputs that can be used to
calculate repeat deviation rate include total number of deviations and
number of deviations with the same assignable root cause.
     Change Control Effectiveness: A measure of timeliness and
effectiveness of implemented changes to GMP facilities, systems,
equipment, or processes. Examples of inputs that can be used to
calculate this metric include on-time closure of the change, total
number of late effectiveness checks, total number of changes initiated,
number of changes that are initiated reactively versus proactively, and
total number of changes deemed effective.
     Overall Equipment Effectiveness: A measure of operating
productivity, utilizing planned production time. Overall equipment
effectiveness can be calculated using inputs related to availability
(e.g., planned production time, operating time), performance (e.g.,
production capacity), and quality (e.g., production output that does
not result in acceptable product).
     Unplanned Maintenance: A measure of the proportion of
maintenance time that was not planned or scheduled. Examples of inputs
that can be used to calculate this metric include total maintenance
hours and planned maintenance hours.

3. Laboratory Performance

     Adherence to Lead Time: A measure of the proportion of
tests in the laboratory that are completed on time according to
schedule requirements. Adherence to lead time can be calculated, for
example, by tracking initiation and testing turnover time in release
and stability tests (i.e., the number of days between the start date
and completion date for quality control (QC)); tracking data review and
documentation; tracking final result reporting prior to batch
disposition; or comparing QC testing completion date against the target
date.
     Right-First-Time Rate: A measure of the proportion of
tests conducted without the occurrence of a deviation. Right-first-time
rate as a metric for laboratory performance can be calculated, for
example, by tracking the invalid assay rate, the number of assays
invalidated due to human errors, or CGMP documentation errors during
review.
     IOOSR: A measure that indicates a laboratory's ability to
accurately perform tests. Examples of inputs that can be used to
calculate this metric include total number of tests conducted and total
number of out-of-specification results invalidated due to an aberration
of the measurement process.
     Calibration Timeliness: A measure of a laboratory's
adherence to inspecting, calibrating, and testing equipment for its
intended purposes as planned. This metric can be measured by tracking
calibration criteria and schedules.

4. Supply Chain Robustness

     On-Time In-Full (OTIF): A measure of the extent to which
shipments are delivered to their destination containing the correct
quantity and according to the schedule specified in the order. This
metric can be calculated using inputs such as the number of orders
shipped, number of past due orders, or number of orders shipped within
tolerance.
     Fill Rate: A measure that quantifies orders shipped as a
percentage of the total demand for a given period. Examples of inputs
that can be used to calculate this metric include total number of
orders shipped, the number of orders placed, and the number of orders
received.
     Disposition On-Time: A measure of the proportion of lots
in which the disposition was carried out on time. Examples of inputs
that can be used to calculate this metric include the total number of
lots dispositioned and the total number of lots dispositioned on time.
     Days of Inventory On-Hand: A measure of how a company
utilizes the average inventory available. It is the number of days that
inventory remains in stock.
    Given that the majority of participants in the pilot programs
prefer to report data at an establishment level, FDA is considering an
approach for aggregating and reporting quality metrics data at the
establishment level, with the option to segment by manufacturing train,
product type, or product level (e.g., application number or product
family).
    Once the data are submitted, FDA intends to analyze the information
with statistical and machine learning methods to provide useful
insights for inspection resource allocation. Examples include
examination of product trends and clusters; exploratory and time-series
analyses for signal identification, thereby monitoring the health of
the establishment over time; and utilizing quality metrics data as an
input into machine learning models to assist in determining an
establishment's overall PQS effectiveness.

III. Request for Comments

    We are seeking comment on the following aspects of FDA's proposed
direction for its QM Reporting Program. We note that the questions
posed in this section are not meant to be exhaustive. We are also
interested in any other pertinent information that stakeholders and any
other interested parties would like to provide on FDA's QM Reporting
Program. FDA encourages stakeholders to provide the rationale for their
comments, including available examples and supporting information.

A. Reporting Levels

    1. Do you agree that reporting should be aggregated at an
establishment level?
    2. Would reporting at an establishment level facilitate submission
of quality metrics data by contract manufacturing organizations?
    3. If you normally assess metrics by product family at an
establishment, what are useful definitions of ``product family'' from
your industry sector?

B. Practice Areas and Quality Metrics

    1. If you think the general practice areas listed in section II of
this notice would not meet the objectives of FDA QM Reporting Program,
what other practice areas should FDA consider?
    2. If FDA were to consider Quality Culture as one of the general
practice areas, what are the critical components of a robust quality
culture and can any of these components be measured quantitatively? If
so, how do you recommend quality culture information be captured as a
quantitative metric (e.g., near misses, APR on-time, binary response to
Quality Culture survey, or other numerical metrics/KPIs)?
    3. Do you think that any of the examples of quality metrics
proposed by FDA would not be an appropriate measure for the designated
practice area?
    4. What other metrics should FDA consider for a designated practice
area?
    5. FDA is interested in an establishment's experience with
implementing process capability and performance metrics. For example,
how would you report Cpk and/or Ppk to FDA as part of the QM Reporting
Program (e.g., reporting Cpk and/or Ppk for certain products,
aggregated at the establishment level)?
    6. A metric may need to be changed or adjusted by an establishment
to better monitor PQS effectiveness, inform appropriate business
strategy, or capture insightful trends, thereby driving continual
improvement behaviors. What criteria should be applied to justify
changing or modifying a quality metric (by either the establishment or
by FDA)? How frequently would you expect changes or modifications to be
needed?
    7. When would you rely on multiple metrics versus a single metric
as an indicator when assessing a particular practice area (e.g., two
metrics are considered in combination because one metric influences the
other)? What combination of metrics have been meaningful and useful?

C. Other Considerations

    1. Are there considerations unique to specific product categories
(e.g., generic drug products, OTC drug products, or biological
products) that should be addressed in the QM Reporting Program?
    2. What would be the optimal reporting frequency for quality
metrics data submissions (e.g., monthly, quarterly, or yearly, and
segmented by quarter or month)?
    3. In instances where a manufacturer is not able to extract
domestic data and its submission to FDA contains both U.S. and foreign
data, how can these data be submitted to FDA in a manner that would
still be informative?
    4. Are there any other aspects of FDA's proposed direction for the
program that FDA should address in future policy documents?

    Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04972 Filed 3-8-22; 8:45 am]
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