[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Page 42343]
[FR Doc No: 2016-15390]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR16-19-000]

BridgeTex Pipeline Company, LLC; Notice of Petition for
Declaratory Order

    Take notice that on June 22, 2016, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2015), BridgeTex Pipeline
Company, LLC (BridgeTex), filed a petition for a declaratory order (1)
approving the proposed tariff and overall rate structure and terms of
service for a proposed expansion of the existing BridgeTex pipeline
system to offer service to shippers from the Eaglebine production area
in Texas (Eaglebine Expansion Project), and (2) ruling that the
regulatory assurances provided by the Commission in its declaratory
order issued on October 12, 2012 in Docket No. OR12-25-000, which
approved the proposed tariff and rate structure of the existing
BridgeTex Pipeline system, are not affected by the Eaglebine Expansion
Project, all as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on July 22, 2016.

    Dated: June 23, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-15390 Filed 6-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35071-35073]
[FR Doc No: 2017-15892]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-1914]

Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Closed Loop Hysteroscopic Insufflator With
Cutter-Coagulator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the closed loop hysteroscopic insufflator with cutter-
coagulator into class II (special controls). The special controls that
will apply to the device are identified in this order, and will be part
of the codified language for the closed loop hysteroscopic insufflator
with cutter-coagulator classification. The Agency is classifying the
device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective July 28, 2017. The classification was
applicable on March 28, 2014.

FOR FURTHER INFORMATION CONTACT: Veronica Price, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification

under section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) of the FD&C
Act and then a request for classification under the first procedure,
the person determines that there is no legally marketed device upon
which to base a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On September 5, 2013, IOGYN, Inc., submitted a request for
classification of the IOGYN System, Models FG-0200, FG-0201, and FG-
0202 under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on March 28, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 884.1710.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a closed loop
hysteroscopic insufflator with cutter-coagulator will need to comply
with the special controls named in the final order. A De Novo
classification decreases regulatory burdens. When FDA classifies a
device type as class I or II via the De Novo pathway, other
manufacturers do not have to submit a De Novo request or premarket
approval application in order to market the same type of device, unless
the device has a new intended use or technological characteristics that
raise different questions of safety or effectiveness. Instead,
manufacturers can use the less burdensome pathway of 510(k), when
necessary, to market their device, and the device that was the subject
of the original De Novo classification can serve as a predicate device
for additional 510(k)s from other manufacturers.
    The device is assigned the generic name closed loop hysteroscopic
insufflator with cutter-coagulator, and it is identified as a
prescription device configured for hysteroscopic insufflation,
resection, and coagulation. It is used to perform diagnostic and
surgical procedures (i.e., resection and coagulation). This device type
contains a closed loop recirculating fluid management system for the
controlled delivery of filtered distension fluid. This device type also
contains a bipolar radiofrequency device used in conjunction with a
hysteroscope for resection and coagulation of intrauterine tissues.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in Table 1:

  Table 1--Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Equipment malfunction leading to injury  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazards
                                          Analysis.
                                         Labeling.
                                         Training.
Recirculated fluid causes adverse        Biocompatibility.
 tissue reaction.                        Non-clinical Performance
                                          Testing.
Fluid overload, embolism, perforation    Non-clinical Performance
 or other adverse events.                 Testing.
                                         Software Verification,
                                          Validation, and Hazards
                                          Analysis.
                                         Labeling.
                                         Training.
Infection..............................  Sterility.
                                         Shelf Life Testing.
                                         Non-clinical Performance
                                          Testing.
Electromagnetic interference/electrical  Electromagnetic Compatibility
 safety issues.                           Testing.
                                         Electrical Safety Testing.
                                         Labeling.
Operator error leading to patient        Labeling.
 injury.                                 Training.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    Closed loop hysteroscopic insufflators with cutter-coagulator are
not safe for use except under the supervision of a practitioner
licensed by law to direct use of the device. As such, the device is a
prescription device and must satisfy prescription labeling requirements
(see 21 CFR 801.109 Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if

FDA determines that premarket notification is not necessary to provide
reasonable assurance of the safety and effectiveness of the device. For
this type of device, FDA has determined that premarket notification is
necessary to provide reasonable assurance of the safety and
effectiveness of the device. Therefore, this device type is not exempt
from premarket notification requirements. Persons who intend to market
this type of device must submit to FDA a premarket notification
(510(k)), prior to marketing the device, which contains information on
the closed loop hysteroscopic insufflator with cutter-coagulator they
intend to market.

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in part 801 regarding labeling have been approved under
OMB control number 0910-0485.

List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 is revised to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  884.1710 to subpart B to read as follows:

Sec.  884.1710  Closed loop hysteroscopic insufflator with cutter-
coagulator.

    (a) Identification. A closed loop hysteroscopic insufflator with
cutter-coagulator is a prescription device configured for hysteroscopic
insufflation, resection, and coagulation. It is used to perform
diagnostic and surgical procedures (i.e., resection and coagulation).
This device type contains a closed-loop recirculating fluid management
system for the controlled delivery of filtered distension fluid. This
device type also contains a bipolar radiofrequency device used in
conjunction with a hysteroscope for resection and coagulation of
intrauterine tissues.
    (b) Classification. Class II (special controls). The special
control(s) for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Software validation, verification, and hazard analysis must be
provided.
    (3) Electrical equipment safety, including appropriate thermal and
mechanical safety and electromagnetic compatibility (EMC) testing must
be performed.
    (4) Device components that are labeled sterile must be validated to
a sterility assurance level of 10-\6\.
    (5) Shelf-life testing that demonstrates the device packaging
maintains sterility and the functionality of the device is maintained
following simulated shipping and handling must be provided to support
the proposed shelf life.
    (6) Non-clinical testing data must demonstrate the performance
characteristics of the device. Detailed protocols and the test reports
must be provided for each test.
    (i) The following tests must be performed for the resection portion
of the device:
    (A) Mechanical testing to assess critical joint strength.
    (B) Device electrode temperature testing.
    (C) Coagulation depth testing.
    (D) Simulated use testing.
    (E) Device durability testing.
    (ii) The following tests must be performed for the fluid management
portion of the device:
    (A) Mechanical testing to assess tensile strength of connections.
    (B) Pressure testing that demonstrates the following parameters,
including accuracy of the pressure displayed; appropriate detection and
response to overpressure conditions; activation of a secondary
overpressure relief valve at the maximum safe level; and all
accessories within the fluid path meet the pressure requirements.
    (C) Fluid delivery volume testing that demonstrates that the
maximum fluid volume delivered is below a predefined level.
    (D) Flow rate testing.
    (E) Simulated use testing.
    (F) Filtration testing.
    (G) Blood filtration capacity testing.
    (H) Tissue collection capacity testing.
    (I) Filtrate characterization and testing that demonstrates that
the continuous reintroduction of filtrate into the uterus does not pose
a safety risk.
    (7) Clinician labeling must include:
    (i) Specific instructions and the clinical training needed for the
safe use of the device.
    (ii) Appropriate warnings, precautions, and information related to
overpressurization.
    (iii) Appropriate EMC information.
    (iv) An expiration date/shelf life.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15892 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65626-65628]
[FR Doc No: 2022-23580]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96150; File No. SR-NYSECHX-2022-23]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Commentary .01 of Article 6, Rule 13

October 25, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on October 11, 2022, the NYSE Chicago, Inc. (``NYSE Chicago'' 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Commentary .01 of Article 6, Rule 13
to add text inadvertently omitted when the rule was adopted. 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 Commentary .01 of Article 6, Rule 13

(Registration Requirements) to add text inadvertently omitted when the
rule was adopted.
Proposed Rule Change
    In 2018, the Exchange adopted Article 6, Rule 13 regarding
registration requirements and related Commentary.\4\ Article 6, Rule 13
provides that each person engaged in the investment banking or
securities business of a Participant must register with the Exchange as
a representative or principal in each category of registration
appropriate to his or her functions and responsibilities as specified
in Article 6, Rule 14 (Registration Categories), unless exempt from
registration pursuant to Article 6, Rule 15 (Associated Persons Exempt
from Registration). Article 6, Rule 13 also provides that such person
is not qualified to function in any registered capacity other than that
for which the person is registered, unless otherwise stated in the
rules.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 84896 (December 20,
2018), 83 FR 67376 (December 28, 2018) (SR-CHX-2018-07) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Regarding
Qualification, Registration and Continuing Education Requirements
Applicable to Participants).
---------------------------------------------------------------------------

    Commentary .01 to Article 6, Rule 13 provides for permissive
registrations, and was adopted in order for the Exchange to harmonize
its rules with the rules of the Financial Regulatory Authority, Inc.
(``FINRA'').\5\ The rule permits any associated person to obtain and
maintain any registration permitted by a Participant. As adopted, the
first sentence of Commentary .01 provides as follows:
---------------------------------------------------------------------------

    \5\ See id., 83 FR at 67377.

    A Participant may make application for or maintain the
registration as a representative or principal of any associated
person of a Participant and any individual engaged in the securities
business of a foreign securities affiliate or subsidiary of the
---------------------------------------------------------------------------
Participant.

    The Exchange inadvertently omitted the words ``investment banking
or'' immediately before ``securities business''. The omitted text
mirrors the language of FINRA Rule 1210.02 and Commentary .01 of Rule
2.1210 adopted by the Exchange's affiliates New York Stock Exchange,
Inc., and NYSE American LLC.\6\ As proposed, the first sentence of
Commentary .01 of Article 6, Rule 13 would read as follows (new text
italicized):
---------------------------------------------------------------------------

    \6\ See FINRA Rule 1210.02; NYSE Rule 1210, Commentary .01; NYSE
American Rule 1210, Commentary .01.

    A Participant may make application for or maintain the
registration as a representative or principal of any associated
person of a Participant and any individual engaged in the investment
banking or securities business of a foreign securities affiliate or
---------------------------------------------------------------------------
subsidiary of the Participant.

    The Exchange does not propose any additional changes to the text of
Article 6, Rule 13.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\7\ in general, and
furthers the objectives of Section 6(b)(5),\8\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to, and perfect the
mechanism of, a free and open market and a national market system and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, protect investors and the
public interest because the proposed conforming change would add
clarity, transparency and consistency to the Exchange's registration
rules. The Exchange believes that market participants would benefit
from the increased clarity, thereby reducing potential confusion.
Similarly, the Exchange believes that the proposed changes would also
make the Exchange's registration rules more consistent with the rules
of its affiliates, thereby ensuring that persons subject to the
Exchange's jurisdiction, regulators, and the investing public can more
easily navigate and understand the Exchange's rules.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but rather is concerned
solely with amending the registration rules to make a conforming change
to add text inadvertently omitted when the rules were adopted.

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 \9\ and Rule 19b-4(f)(6) thereunder.\10\
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.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\12\ 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 proposed
rule change may become operative immediately upon filing. The
Commission believes that because this rule change better harmonizes the
exchange's rules with those of FINRA, waiver of the 30-day operative
delay for this proposed rule change is consistent with the protection
of investors and the public interest. Accordingly, the Commission
hereby waives the 30-day operative delay and designates the proposed
rule change operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change'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) \14\
of the Act to determine whether the proposed rule change should be
approved or disapproved.
---------------------------------------------------------------------------

    \14\ 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 protected]. Please include
File Number SR-NYSECHX-2022-23 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-NYSECHX-2022-23. 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-NYSECHX-2022-23 and should be submitted
on or before November 21, 2022.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23580 Filed 10-28-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Rules and Regulations]
[Pages 72227-72230]
[FR Doc No: 2019-27885]

========================================================================
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.

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

Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9072; Product Identifier 2015-NM-110-AD; Amendment
39-19797; AD 2019-23-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 727 airplanes. This AD was prompted by
the FAA's analysis of the Model 727 fuel system review conducted by the
manufacturer. This AD requires modifying the fuel quantity indicating
system (FQIS) to prevent development of an ignition source inside the
body-mounted auxiliary fuel tanks due to electrical fault conditions.
As an alternative to the modification, this AD allows deactivating the
body-mounted auxiliary fuel tanks. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective February 4, 2020.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9072; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jon Regimbal, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Boeing Model
727 airplanes equipped with Boeing body-mounted auxiliary fuel tanks.
The NPRM published in the Federal Register on September 23, 2016 (81 FR
65579). The NPRM was prompted by the FAA's analysis of the Model 727
fuel system review conducted by the manufacturer. The NPRM proposed to
require modifying the FQIS to prevent development of an ignition source
inside the body-mounted auxiliary fuel tanks due to electrical fault
conditions. As an alternative to the modification, the NPRM proposed to
allow deactivating the body-mounted auxiliary fuel tanks.
    The FAA is issuing this AD to address ignition sources inside the
body-mounted auxiliary fuel tanks, which, in combination with flammable
fuel vapors, could result in a fuel tank explosion and consequent loss
of the airplane.

Comments

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

Request To Withdraw NPRM: No Unsafe Condition

    Boeing requested that the FAA withdraw the NPRM. Boeing reported
that its system safety assessment determined that the FQIS on the Model
727 airplane does not have an unsafe condition.
    The FAA disagrees with the request. Boeing did not provide specific
details about the type of assessment that was performed (total fleet
risk, average risk per flight hour, peak individual flight risk, etc.).
Based on Boeing's fuel system safety assessment submitted in response
to Special Federal Aviation Regulation No. 88 (``SFAR 88'') of 14 CFR
part 21, the FAA has determined that there is an unsafe condition due
to the potential for a fuel tank ignition source to occur from the FQIS
due to its design architecture, component design details, and
installation design details. The FAA's determination was made in
accordance with the guidance contained in FAA Policy Memorandum ANM100-
2003-112-15, ``SFAR 88--Mandatory Action Decision Criteria,'' dated
February 25, 2003.\1\ Under that policy, an ignition source that can
occur in a high-flammability fuel tank, due to a combination of a
preexisting failure that can exist undetected for multiple flights and
one additional failure, is an unsafe condition requiring corrective
action. High-flammability fuel tanks are defined in the policy as fuel
tanks with a fleet average flammability greater than 7 percent as
calculated in accordance with 14 CFR Appendix N of part 25. At the time
of the unsafe condition determination in April 2003, Boeing
acknowledged that the Model 727 body-mounted auxiliary fuel tanks are
high-flammability fuel tanks. The Boeing SFAR 88 report for the Model
727 showed that a combination of an in-tank wire fault or contamination
condition (which can remain latent for multiple flights) and a hot
short outside of the tank between the affected FQIS tank circuit and
other aircraft power wiring cobundled with FQIS tank circuit wiring
could result in an ignition source in the fuel tank. That combination
of failures was classified by the FAA as a ``known combination of
failures'' under the criteria in the policy memo due to the similarity
of the Model 727 FQIS system architecture and design details to those
of the Boeing Model 747 airplane involved in the TWA Flight 800
catastrophic fuel tank explosion accident in 1996. The National
Transportation Safety Board (NTSB) concluded that an FQIS failure
combination as described above was the most likely cause of that
accident.\2\ The FAA has therefore determined that it is necessary to
issue this final rule.
---------------------------------------------------------------------------

    \1\ http://rgl.faa.gov/Regulatory_and_Guidance_Library/
rgPolicy.nsf/0/dc94c3a46396950386256d5e006aed11/$FILE/Feb2503.pdf.
    \2\ NTSB Aviation Accident Report AAR-00-03 https://www.ntsb.gov/investigations/AccidentReports/Reports/AAR0003.pdf.

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

Request To Withdraw NPRM: Limited Vulnerability to Unsafe Condition

    Boeing requested that the FAA withdraw the NPRM. Boeing stated that
272 airplanes were manufactured with body-mounted auxiliary fuel tanks,
but only six were operated under FAA jurisdiction when the comment was
submitted, and that the fleet exposure continues to decrease due to
airplane aging and retirements. Boeing stated that its safety
assessment, using methodologies ``recognized by the FAA,'' shows that
the vulnerability of the Model 727 FQIS latent failure plus single
failure does not present an unsafe condition. Boeing concluded that
requiring the proposed actions will not promote air safety and instead
will add unnecessary cost to operators.
    The FAA disagrees with the request. The FAA has determined that an
unsafe condition exists. The FAA assumes that, in citing assessment
methodologies recognized by the FAA, Boeing is referring to having
performed its assessment of the total fleet risk for the Model 727
fleet that showed a very low likelihood of a fuel tank ignition event
in the remaining life of that fleet. Boeing mentioned the number of
airplanes operated under U.S. jurisdiction. The FAA, as the civil
aviation authority of the state of design, is obligated, under the
Convention on International Civil Aviation (the Treaty), to inform all
affected aircraft of continuing safety issues regardless of where they
are operated. Issuance of airworthiness directives is the accepted
method by which the FAA notifies aviation authorities of other
countries of an unsafe condition as required by Annex 8 of the Treaty.
    The FAA's unsafe condition determination was made using the
decision criteria in FAA Policy Memorandum ANM100-2003-112-15. This
determination was not driven by a fleet risk assessment. A latent in-
tank failure that provides a conductive path or reduces dielectric
strength of the tank wiring or components, combined with an external
wiring system failure that conducts power onto the tank wiring, could
create an ignition source in the fuel tank of the Boeing Model 727
airplane. That combination of failures was classified as a ``known
combination of failures'' under the criteria in the policy memorandum
due to the similarity of the Model 727 FQIS system architecture and
design details to those of the Model 747 airplane involved in the
catastrophic fuel tank explosion. The NTSB concluded that an FQIS
failure combination as described above was the most likely cause of
that accident. The FAA therefore considers it necessary to address this
unsafe condition. The per-airplane cost for modification is expected to
be approximately the same as the cost of the similar actions required
for Model 737 and 747 airplanes specified in AD 99-03-04, Amendment 39-
11018 (64 FR 4959, February 2, 1999) (``AD 99-03-04''); and AD 98-20-
40, Amendment 39-10808 (63 FR 52147, September 30, 1998) (``AD 98-20-
40''). If an operator chooses to deactivate or remove the auxiliary
tanks as allowed by the AD, the cost would be significantly lower.
Therefore, the FAA made no changes in this final rule as a result of
this comment.

Request To Withdraw NPRM: Extremely Remote Likelihood of Unsafe
Condition

    Boeing requested that the FAA withdraw the NPRM. Boeing considered
the likelihood of an undetected latent electrical fault condition of
the FQIS to be extremely remote, due to the FQIS architecture. Boeing
added that the existing Model 727 FQIS design uses a three-wire system
that goes directly from the fuel tank to the flight deck indication.
Boeing stated that an electrical fault of an in-tank component causes
the FQIS to provide a fault indication to the flight crew, so the
failure is not latent.
    The FAA disagrees with the request. The agency contacted Boeing to
resolve the apparent conflict between this comment and the company's
previously submitted SFAR 88 reports. In the SFAR 88 reports for Model
727 airplanes, Boeing stated that a latent in-tank failure condition
could not be claimed to be extremely remote, and acknowledged that the
system does not comply with the requirements of 14 CFR 25.981(a)(3)
related to a latent failure plus a single failure. (Extremely remote
qualitatively means that the condition would occur no more than a few
times in the total fleet life. In numerical probability analysis, a
condition that has a probability on the order of 1 in 10 million flight
hours or less is considered extremely remote.) However, the comment
that Boeing submitted to the NPRM stated that a latent in-tank failure
was extremely remote.
    A meeting with representatives from the FAA and Boeing was held
February 15, 2019, to clarify Boeing's position. (A record of that
meeting has been posted to the AD docket.) Boeing explained that it had
intended to convey in its comment that the estimated probability for
the initial failure that creates a latent in-tank loss of dielectric
strength, resistive current path, or short condition is extremely
remote. Boeing acknowledged that when the estimated probability of that
failure initiation is multiplied by the average latency period, the
probability of a latent in-tank failure existing in any given flight
hour is not extremely remote.
    Given this clarification, Boeing's comment was consistent with the
conclusions of its SFAR 88 reviews. The FQIS does not provide a fault
indication to the flight crew other than unusual readings or a zero
reading provided by a tank gage if a hard short to ground or power
occurs. In addition, even if such a fault is noted by the flight crew,
the approved Master Minimum Equipment List for the Model 727 airplane
allows operators to fly for up to ten days in that condition, without
disconnecting the FQIS for the affected tank, with provisions for
extending beyond the ten days. The FAA therefore does not agree that a
latent failure of in-tank wiring or components, such that an ignition
source could occur if an external hot short occurs, is extremely
remote. No changes were made to this final rule as a result of this
comment.

Request To Extend Compliance Time

    Boeing requested that the FAA revise the proposed 12-month
compliance time, which it asserts will require Model 727 operators to
``develop the solution on their own (under 14 CFR part 121).'' Boeing
stated that it had no plans to create service action to modify the FQIS
or deactivate the auxiliary tank(s), as no operators have contacted
Boeing requesting this support.
    The FAA disagrees with the request. Boeing did not propose a
specific compliance time, and after consideration, the agency still
considers 12 months to be adequate to allow operators to deactivate
their auxiliary tanks using existing information in the airplane
maintenance manual to develop alteration data and obtain FAA approval
of an alternative method of compliance (AMOC). A compliance time of 12
months or less is required for the deactivation of other after-market
body-mounted auxiliary fuel tanks on Model 727 airplanes in other ADs:
AD 2008-07-07, Amendment 39-15448 (73 FR 15880, March 26, 2008); AD
2008-07-09, Amendment 39-15450 (73 FR 16515, March 28, 2008); AD 2008-
12-03, Amendment 39-15546 (73 FR 31749, June 4, 2008); and AD 2009-20-
01, Amendment 39-16024 (74 FR 48007, September 21, 2009). The FAA has
not changed this AD regarding this issue. Under the provisions of
paragraph (h) of this AD, however, the FAA will consider requests for
approval of an extension to the compliance time if

sufficient data are submitted to substantiate that the new compliance
time would provide an acceptable level of safety.

Request To Revise Cost Estimate

    Boeing requested that if the NPRM is not withdrawn, the FAA revise
the cost estimate to reflect the cost of developing an FQIS design
solution for the body-mounted auxiliary tanks. Boeing expected that
only six airplanes would actually be modified, so the cost of
developing a design solution would be spread over a small number of
airplanes, resulting in a significant per-airplane cost. Boeing did not
provide any specific cost information or describe the modifications for
which they provided cost comments.
    The FAA disagrees with the request to revise the cost estimate
based on this comment. The agency based its cost estimate for Model 727
passenger airplanes on the inflation-adjusted estimated costs for
installation of transient suppression devices on the Model 747 airplane
as required by AD 98-20-40. The FAA considers that the transient
suppression design solutions, if not the actual parts, developed for
Model 737 and 747 airplanes in response to AD 99-03-04 and AD 98-20-40
will be applicable to the Model 727 airplane due to the similarity of
those models' FQIS designs. The FAA agrees that the nonrecurring design
development costs associated with any necessary model-specific design
activity will be spread over fewer airplanes, resulting in higher per-
airplane costs if the operator decides not to deactivate the subject
tanks. However, the FAA increased the cost estimate in the NPRM to
reflect that increased cost to the existing fleet. Boeing did not
propose any specific alternative cost figures to be substituted for the
FAA estimate. The FAA did not change this final rule as a result of
this comment.

Conclusion

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

Costs of Compliance

    The FAA estimates that this AD affects 6 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                        Estimated Costs: Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Modification........................  300 work-hours x $85           $100,000         $125,500         $753,000
                                       per hour = $25,500.
----------------------------------------------------------------------------------------------------------------

                                      Estimated Costs: Alternative Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Tank deactivation............................  10 work-hours x $85 per hour =               $0             $850
                                                $850.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-23-04 The Boeing Company: Amendment 39-19797; Docket No.

FAA-2016-9072; Product Identifier 2015-NM-110-AD.

(a) Effective Date

    This AD is effective February 4, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 727, 727-100, 727C,
727-100C, 727-200, and 727-200F series airplanes; certificated in
any category; equipped with Boeing body-mounted auxiliary fuel
tanks.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by the FAA's analysis of the Model 727 fuel
system review conducted by the manufacturer. The FAA is issuing this
AD to address ignition sources inside the body-mounted auxiliary
fuel tanks, which, in combination with flammable fuel vapors, could
result in a fuel tank explosion and consequent loss of the airplane.

(f) Compliance

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

(g) Modification

    Within 12 months after the effective date of this AD, do the
actions specified in either paragraph (g)(1) or (2) of this AD,
using a method approved in accordance with the procedures specified
in paragraph (h) of this AD.
    (1) Modify the fuel quantity indicating system (FQIS) to prevent
development of an ignition source inside the body-mounted auxiliary
fuel tanks due to electrical fault conditions.
    (2) Deactivate the body-mounted auxiliary fuel tanks.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (i) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane and the approval must
specifically refer to this AD.

(i) Related Information

    For more information about this AD, contact Jon Regimbal,
Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3557; email<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    None.

    Issued in Des Moines, Washington, on November 27, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-27885 Filed 12-30-19; 8:45 am]
BILLING CODE 4910-13-P