[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50414-50416]
[FR Doc No: 2018-21681]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84326; File No. SR-BX-2018-046]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Relocate the
Pricing Schedule Rules

October 1, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 17, 2018, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (a) relocate its current Rule 7000 Series
(``Equities Pricing'') and the rules at Chapter XV (``Options
Pricing''; together, ``Equities and Options Pricing'') to the
Exchange's rulebook's (``Rulebook'') shell structure; \3\ (b) make
conforming cross-reference changes throughout the Rulebook; and (c)
amend the Equity 4's title in the shell structure.
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    \3\ In 2017, the Exchange added a shell structure to its
Rulebook with the purpose of improving efficiency and readability
and to align its rules closer to those of its five sister exchanges,
The Nasdaq Stock Market LLC; Nasdaq PHLX LLC; Nasdaq ISE, LLC;
Nasdaq GEMX, LLC; and Nasdaq MRX, LLC (``Affiliated Exchanges'').
See Securities Exchange Act Release No. 82174 (November 29, 2017),
82 FR 57492 (December 5, 2017) (SR-BX-2017-054).
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    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to (a) relocate the Equities and Options
Pricing rules, currently under the Equities Rule 7000 Series and
Options Chapter XV, into the Rulebook's shell structure, respectively,
under Equity 7 and Options 7 (both named ``Pricing Schedule''); (b)
make conforming cross-reference changes throughout the Rulebook; and
(c) amend the Equity 4's title, ``Equity Listing Rules,'' in the shell
structure, as detailed below.
(a) Relocation of the Pricing Rules
    The Exchange, as part of its continued effort to promote efficiency
and the conformity of its processes with those of the Affiliated
Exchanges,\4\ and the goal of harmonizing and uniformizing its rules,
proposes to relocate the Equities Pricing rules, currently under the
Rule 7000 Series, into Equity 7, Pricing Schedule, of the shell
structure. Specifically, the Exchange will add the word ``Section'' and
renumber the Equities Pricing rules as detailed in the table below:
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    \4\ See footnote 3.

------------------------------------------------------------------------
            Rule 7000 Series                         Equity 7
------------------------------------------------------------------------
7000....................................  Section 1.
7001....................................  Section 10.
7002....................................  Section 20.
7003....................................  Section 30.
7010....................................  Section 100.
7011....................................  Section 111.
7012....................................  Section 112.
7013....................................  Section 113.
7014....................................  Section 114.
7015....................................  Section 115.
7016....................................  Section 116.
7017....................................  Section 117.
7018....................................  Section 118.
7019....................................  Section 119.
7020....................................  Section 120.
7021....................................  Section 121.
7022....................................  Section 122.
7023....................................  Section 123.
7024....................................  Section 124.
7025....................................  Section 125.
7026....................................  Section 126.
7027....................................  Section 127.
7028....................................  Section 128.
7029....................................  Section 129.
7030....................................  Section 130.
7031....................................  Section 131.
7032....................................  Section 132.
7033....................................  Section 133.
7034....................................  Section 134.
7035....................................  Section 135.
7039....................................  Section 139.
7047....................................  Section 147.
7051....................................  Section 151.
7055....................................  Section 155.
7058....................................  Section 158.
------------------------------------------------------------------------

    The Exchange will also relocate the Options Pricing rules,
currently under Chapter XV, into Options 7, Pricing Schedule, of the
shell structure. No renumbering of the Options Pricing Schedule will be
necessary other than replacing the abbreviated word ``Sec.'' with the
full word ``Section.''
    The Exchange believes that the relocation of the Equities and
Options Pricing rules will facilitate the use of the Rulebook by
Members \5\ of the Exchange, including those who are members of other
Affiliated Exchanges, and other market participants. Moreover, the
proposed changes are of a non-substantive nature and they will not
amend the relocated rules, other than to update their numbers as
detailed above.
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    \5\ Exchange Rule 0120(i).

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(b) Cross-Reference Updates
    In connection with the changes described above, the Exchange
proposes to update all cross-references in the Rulebook that direct the
reader to the current placement of the Equities and Options Pricing
rules and/or any of their subsections. Furthermore, the Exchange notes
that the proposed amendments include cross-reference updates to the
Connectivity rules under General 8, Section 1.\6\ Moreover, for
consistency with the current title of General 8, Section 2 (``Direct
Connectivity''), the Exchange proposes to update the description
provided under Rule 7011(a) (to be relocated under Equity 7, Section
111(a)) by removing the text ``to BX''.
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    \6\ See Securities Exchange Act Release No. 83535 (June 28,
2018), 83 FR 31241 (July 3, 2018) (SR-BX-2018-024).
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(c) Amendment of the Equity 4's Title
    Finally, the Exchange will amend Equity 4's title in the shell
structure, currently ``Equity Listing Rules,'' and replace it with the
word ``Reserved,'' since no rules will be placed in this section of the
shell structure.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ 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,
by promoting efficiency and structural conformity of the Exchange's
processes with those of the Affiliated Exchanges and to make the
Exchange's Rulebook easier to read and more accessible to its Members
and market participants. The Exchange believes that the relocation of
the Equities and Options Pricing rules, cross-reference updates, and
the amendment to the Equity 4's title are of a non-substantive nature.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes do not
impose a burden on competition because, as previously stated, they (i)
are of a non-substantive nature, (ii) are intended to harmonize the
structure of the Exchange's rules with those of its Affiliated
Exchanges, and (iii) are intended to organize the Rulebook in a way
that it will ease the Members' and market participants' navigation and
reading of the rules.

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

    No written comments were either solicited or received.

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

    Because the foregoing 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 for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of 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.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. Waiver
of the operative delay would allow the Exchange to promptly relocate
the Pricing Schedule rules and continue to reorganize its Rulebook to
promote efficiency and structural consistency between the Exchange's
rules and those of the Affiliated Exchanges. The Commission believes
that waiver of the 30-day operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\13\
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    \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 also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BX-2018-046 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-BX-2018-046. 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-BX-2018-046 and should be
submitted on or before October 26, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-21681 Filed 10-4-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 48 (Tuesday, March 12, 2019)]
[Notices]
[Pages 8937-8938]
[FR Doc No: 2019-04425]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85254; File No. SR-C2-2019-005]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Modify
its Provision Related to its Risk Monitor Mechanism

March 6, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 25, 2019, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') 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 Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'') is filing with
the Securities and Exchange Commission (``Commission'') a proposed rule
change to modify its provision related to its Risk Monitor Mechanism.
The text of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend its provision related to its Risk
Monitor Mechanism to correct an inadvertent oversight to use a defined
term per Rule 6.14(c)(5)(A). Specifically, on November 30, 2018, the
Exchange filed a rule filing, SR-C2-2018-024, which proposed to make
clarifying and miscellaneous non-substantive changes, provide the
ability for Trading Permit Holders (``TPHs'') \5\ to establish limits
for a group of executing firm IDs (``EFIDs''), and adopt a new risk
parameter.\6\ The Exchange notes that although it reflected the
definition of a TPH-established time period as an ``interval'' time
period in Rule 6.14(c)(5)(A), it mistakenly referred to such time
period as a ``specified'' time period, instead of an ``interval'' time
period, in then proposed Rule 6.14(c)(5)(D)(vi)(ii).\7\ The Exchange
now proposes to update the reference to ``specified time period'' to
``interval time period'' to maintain consistency throughout the rule
and alleviate potential confusion. No substantive changes are being
made by the proposed rule change.
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    \5\ See Securities and Exchange Act Release 34-84787 (December
11, 2018), 83 FR 64618 (December 17, 2018) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating To Amend
Its Provision Related to Its Risk Monitor Mechanism) (SR-C2-2018-
024), which proposed to replace references to ``User'' in Rule
6.14(c)(5) with ``TPH''.
    \6\ Id.
    \7\ Id.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\8\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \9\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in

securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5) \10\ requirement that the rules of an exchange not be designed
to permit unfair discrimination between customers, issuers, brokers, or
dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ Id.
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    The Exchange believes the proposed rule change to update an
inaccurate term under Rule 6.14(c)(5)(D)(vi)(ii) will alleviate
potential confusion, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system and
protecting investors and the public interest. As noted above, the
proposed filing does not substantively change any TPH abilities or risk
parameters under Rule 6.14, but merely corrects an inadvertent
oversight from a previous rule filing.

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
does not address competitive issues, but rather, as discussed above, is
merely intended to correct an inadvertent use of the wrong term
relating to TPH-established time period made in a previous rule filing,
which will alleviate potential confusion.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    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 for 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 \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) 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 Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \13\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \14\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
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    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
as it will allow the Exchange to update an inaccurate term in its
rulebook and thereby avoid investor confusion. The Exchange has
represented that no substantive changes are being made by the proposed
rule change. For this reason, the Commission designates the proposed
rule change to be operative upon filing.\15\
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    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also 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 the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-C2-2019-005 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-C2-2019-005. 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 a.m. and 3 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-C2-
2019-005 and should be submitted on or before April 2, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-04425 Filed 3-11-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Notices]
[Page 62613-62614]
[DOCID:fr12oc10-141]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on October 13, 2010
at 10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
    1. The Commission will consider whether to adopt an interim final
temporary rule under Section 766 of the Dodd-Frank Wall Street Reform
and Consumer Protection Act, Public Law 111-203, to provide for the
reporting of certain security-based swap transactions and including an
interpretive note regarding retention and recordkeeping requirements
for certain security-based swap transactions.
    2. The Commission will consider whether to propose Regulation MC
pursuant to Section 765 of the Dodd-Frank Act to mitigate conflicts of
interest at security-based swap clearing agencies, security-based swap
execution facilities, and national security exchanges that post or make
available for trading security-based swaps.
    3. The Commission will consider whether to propose rules that would
implement Section 945 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act, which requires an issuer of asset-backed securities
(ABS) to perform a review of the assets underlying the ABS and disclose
information relating to the review. The Commission will also consider
whether to propose rules that would implement Section 15E(s)(4)(A) of
the Exchange Act as added by Section 932 of the Act, which requires an
ABS issuer or underwriter to make publicly available the findings and
conclusions of any third-party due diligence report.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: October 6, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-25677 Filed 10-7-10; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40091]
[DOCID:fr14jy06-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 199-205]

South Carolina Public Service Authority; Notice of Intent To
Prepare an Environmental Impact Statement

July 7, 2006.
    On March 15, 2004, the South Carolina Public Service Authority
(Public Service) filed an application for a new license for the
continued operation of the 134.52-megawatt Santee Cooper Hydroelectric
Project (FERC No. 199-205). The project is located on the Santee and
Cooper Rivers in Berkeley, Calhoun, Clarendon, Orangeburg, and Sumter
Counties, South Carolina. The project does not occupy any Federal
lands.
    In accordance with the National Environmental Policy Act (NEPA) and
the Commission's regulations, Commission staff held public scoping
meetings for the Santee Cooper Hydroelectric Project on May 17, 2005,
in Moncks Corner, South Carolina, and on May 18, 2005, in Manning,
South Carolina. Additionally, Commission staff held an agency scoping
meeting on May 19, 2005, in Moncks Corner, South Carolina. Commission
staff, state, Federal, and local agencies, and the public participated
in the meetings. These scoping meetings were used to define the issues
and alternatives addressed in Public Service's application.
    Based on comments received, since the scoping meeting, Commission
staff has determined that licensing the Santee Cooper Hydroelectric
Project could constitute a major federal action significantly affecting
the quality of the human environment. Therefore, staff intends to
prepare an Environmental Impact Statement (EIS) for the project.
    The staff's EIS will objectively consider both site-specific and
cumulative environmental impacts of the project and reasonable
alternatives, and will include economic and engineering analyses.
    A draft EIS will be issued and circulated for review by all
interested parties. All comments filed on the draft EIS will be
analyzed by the staff and considered in the final EIS. The staff's
conclusions and recommendations will be available for the consideration
of the Commission in reaching its final licensing decision.
    This notice informs all interested individuals, organizations, and
agencies with environmental expertise and concerns, that: (1) The
Commission staff has decided to prepare an EIS; and (2) the scoping
conducted on the Santee Cooper Hydroelectric Project by Commission
staff and comments filed with the Commission on the application will be
taken into account in the EIS.
    Any questions regarding this notice may be directed to Monte
Terhaar at<PHONE_NUMBER>, or via e-mail at<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
[FR Doc. E6-11181 Filed 7-13-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Rules and Regulations]
[Pages 2532-2534]
[FR Doc No: 2022-00585]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0794; Project Identifier AD-2021-00400-T;
Amendment 39-21869; AD 2021-26-10]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 747-400, -400D, and -400F series
airplanes. This AD was prompted by reports of burned Boeing Material
Specification (BMS) 8-39 urethane foam, and a report from the airplane
manufacturer that airplanes were assembled with seals throughout
various areas of the airplane (including flight deck and cargo
compartments) made of BMS 8-39 urethane foam, a material with fire-
retardant properties that deteriorate with age. This AD requires
replacing the system tube/wire seals made of BMS 8-39 urethane foam in
certain areas of the airplane. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective February 22, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 22,
2022.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0794.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0794; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Julie Linn, Aerospace Engineer, Cabin
Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email: [email protected].

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 The Boeing
Company Model 747-400, -400D, and -400F series airplanes. The NPRM
published in the Federal Register on October 14, 2021 (86 FR 57081).
The NPRM was prompted by reports of burned BMS 8-39 urethane foam, and
a report from the airplane manufacturer that airplanes were assembled
with seals throughout various areas of the airplane (including flight
deck and cargo compartments) made of BMS 8-39 urethane foam, a material
with fire-retardant properties

that deteriorate with age. In the NPRM, the FAA proposed to require
replacing the system tube/wire seals made of BMS 8-39 urethane foam in
certain areas of the airplane. The FAA is issuing this AD to prevent
failure of the urethane seals to maintain sufficient Halon
concentrations in the cargo compartments to extinguish or contain fire
or smoke, and to prevent penetration of fire or smoke in areas of the
airplane that are difficult to access for fire and smoke detection or
suppression.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Boeing, the Air Line Pilots
Association, International (ALPA), and two individuals, who supported
the NPRM without change.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
requires adopting this AD as proposed. Except for minor editorial
changes, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Special Attention Service Bulletin 747-25-
3381, Revision 3, dated February 19, 2021. This service information
specifies procedures for replacing BMS 8-39 urethane foam seals with
BMS 1-68 silicone foam rubber seals (including doing a general visual
inspection of the foam for any tube or wire penetrations and sealing
any penetrations that go through the insulation blankets). This service
information adds the work instructions for Group 11, Configuration 2;
Group 13 and 14, Configuration 4; and Group 16, 17, and 19,
Configuration 5 airplanes.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 131 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                     Parts
            Action                  Labor cost        cost        Cost per product       Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Replacement (including GVI)...  Up to 32 work-           * $  Up to $2,720............  Up to $356,320.
                                 hours x $85 per
                                 hour = Up to
                                 $2,720.
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the parts cost estimates for this AD.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2021-26-10 The Boeing Company: Amendment 39-21869; Docket No. FAA-
2021-0794; Project Identifier AD-2021-00400-T.

(a) Effective Date

    This airworthiness directive (AD) is effective February 22,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 747-400, -400D, and
-400F series airplanes, certificated in any category, identified as
Group 11, Configuration 2; Group 13 and 14, Configuration 4; and
Group 16, 17, and 19, Configuration 5, in Boeing Special Attention
Service Bulletin 747-25-3381, Revision 3, dated February 19, 2021.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
Furnishings.

(e) Unsafe Condition

    This AD was prompted by reports of burned Boeing Material
Specification (BMS) 8-39 urethane foam, and a report from the
airplane manufacturer that airplanes were assembled with seals
throughout various areas of the airplane (including flight deck and
cargo compartments) made of BMS 8-39 urethane foam, a material with
fire-retardant properties that deteriorate with age. The FAA is
issuing this AD to prevent failure of the urethane seals to maintain
sufficient Halon concentrations in the cargo compartments to
extinguish or contain fire or smoke, and to prevent penetration of
fire or smoke in areas of the airplane that are difficult to access
for fire and smoke detection or suppression.

(f) Compliance

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

(g) BMS 8-39 Urethane Foam Seal Replacements

    Within 72 months after the effective date of this AD: Replace
the BMS 8-39 urethane foam seals in the forward cargo compartment
system tube/wire (including doing a general visual inspection of the
foam for any tube or wire penetrations and sealing any penetrations
that go through the insulation blankets) with BMS 1-68 silicone foam
rubber seals, as applicable, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 747-25-
3381, Revision 3, dated February 19, 2021.

(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 responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in Related Information. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards 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 Julie Linn,
Aerospace Engineer, Cabin Safety and Environmental Systems Section,
FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>; email: [email protected].

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 747-25-3381,
Revision 3, dated February 19, 2021.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 9, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-00585 Filed 1-14-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Pages 53515-53516]
[FR Doc No: 2011-21871]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65182; File No. SR-NYSEArca-2011-62]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change Amending NYSE Arca Options Rule 6.96(b)(2) To
Make Permanent the Pilot Program That Permits the Exchange To Accept
Inbound Orders Routed by Archipelago Securities LLC in its Capacity as
a Facility of Affiliated Exchanges and To Clarify the Text of NYSE Arca
Options Rule 6.96(b)(1)(B) To More Accurately Reflect the Regulatory
Services Agreement between the Exchange and the Financial Industry
Regulatory Authority

August 22, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 18, 2011, NYSE Arca, Inc. (``NYSE Arca'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend NYSE Arca Options Rule 6.96(b)(2) to
make permanent the pilot program that permits the Exchange to accept
inbound orders routed by Archipelago Securities LLC (``Arca
Securities'') in its capacity as a facility of an affiliated exchange
(with the attendant obligations and conditions) and to clarify the text
of NYSE Arca Options Rule 6.96(b)(1)(B) to more accurately reflect the
regulatory services agreement (``RSA'') between the Exchange and the
Financial Industry Regulatory Authority (``FINRA''). The text of the
proposed rule change is available at the Exchange, at the Exchange's
Web site at http://www.nyse.com, at the Commission's Public Reference
Room, and at the Commission's Web site at http://www.sec.gov.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Arca Options Rule 6.96(b)(2) to
make permanent the pilot program that permits the Exchange to accept
inbound orders routed by Arca Securities in its capacity as a facility
of an affiliated exchange (with the attendant obligations and
conditions) and to clarify the text of NYSE Arca Options Rule
6.96(b)(1)(B) to more accurately reflect the RSA between the Exchange
and FINRA.\3\
---------------------------------------------------------------------------

    \3\ The change to the rule text to more accurately reflect the
RSA between the Exchange and FINRA is similar to language that
NASDAQ OMX BX, Inc. uses to describe its relationship with FINRA.
See Securities Exchange Act Release No. 64896 (July 15, 2011), 76 FR
43740 (July 21, 2011) (SR-BX-2011-045).
---------------------------------------------------------------------------

    Currently, Arca Securities is an approved outbound routing facility
of the Exchange, providing outbound routing from the Exchange to other
market centers.\4\ The Exchange also has been previously approved to
receive inbound routes of orders by Arca Securities in its capacity as
an order routing facility of an affiliated exchange on a pilot basis
until September 30, 2011.\5\ On June 16, 2011, the Exchange filed an
immediate effective proposal that codified the inbound routing
authority in NYSE Arca Options Rule 6.96(b).\6\ The Exchange hereby
seeks permanent approval to permit the Exchange to accept inbound
orders that Arca Securities routes in its capacity as a facility of an
affiliated exchange.
---------------------------------------------------------------------------

    \4\ See NYSE Arca Options Rules 6.1A(15) and 6.96(a).
    \5\ See NYSE Arca Options Rule 6.96(b); see also Securities
Exchange Act Release No. 64731 (June 23, 2011) 76 FR 38237 (June 29,
2011) (SR-NYSEArca-2011-39).
    \6\ See SR-NYSEArca-2011-39, supra note 5.
---------------------------------------------------------------------------

    Under the pilot, the Exchange is committed to the following
obligations and conditions:
     The Exchange will maintain an agreement pursuant to Rule
17d-2 under the Exchange Act with FINRA to relieve the Exchange of
regulatory responsibilities for Arca Securities with respect to rules
that are common rules between the Exchange and FINRA, and maintain an
RSA with FINRA to perform regulatory responsibilities for Arca
Securities for unique Exchange rules.
     The RSA will require the Exchange to provide FINRA with
information, in an easily accessible manner, regarding all exception
reports, alerts, complaints, trading errors, cancellations,
investigations, and enforcement matters (collectively ``Exceptions'')
in which Arca Securities is identified as a participant that has
potentially violated Exchange or SEC Rules and of which the Exchange
becomes aware, and shall require that FINRA provide a report, at least
quarterly, to the Exchange quantifying all Exceptions in which Arca
Securities is identified as a participant that has potentially violated
Exchange or SEC Rules.\7\
---------------------------------------------------------------------------

    \7\ As noted below, the Exchange proposes to change this
provision to more accurately reflect the RSA with FINRA.
---------------------------------------------------------------------------

     The Exchange, on behalf of its parent, NYSE Euronext, will
establish and maintain procedures and internal controls reasonably
designed to prevent Arca Securities from receiving any benefit, taking
any action or engaging in any activity based on non-public information
regarding planned changes to Exchange systems, obtained as a result of
its affiliation with the Exchange, until such information is available
generally to similarly situated OTP Holders of the Exchange in
connection with the provision of inbound order routing to the Exchange.
     The Exchange may furnish to Arca Securities the same
information on the same terms that the Exchange makes available in the
normal course of business to any other OTP Holder.\8\
---------------------------------------------------------------------------

    \8\ See SR-NYSEArca-2011-39, supra note 5, and NYSE Arca Options
Rule 6.96(b)(1)(D).
---------------------------------------------------------------------------

    The Exchange is in compliance with the above-listed obligations and
conditions. In meeting them, the Exchange has set up mechanisms that
protect the independence of the Exchange's regulatory responsibility
with respect to Arca Securities, as well as demonstrate that Arca
Securities cannot use any information it may have because of its
affiliation with the Exchange to its advantage. Since the Exchange has
met all the above-listed obligations and conditions, it now seeks
permanent approval of the Exchange and Arca Securities' inbound routing

relationship. The Exchange also proposes to clarify the text of NYSE
Arca Options Rule 6.96(b)(1)(B) to more accurately reflect the RSA
between the Exchange and FINRA and specify that the quarterly report of
Exceptions shall be provided to the Exchange's Chief Regulatory
Officer. Upon approval of the proposed rule change, the Exchange will
continue to comply with the obligations and conditions as set forth in
proposed NYSE Arca Options Rule 6.96(b).
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \9\ of the
Act, in general, and furthers the objectives of Section 6(b)(5),\10\ in
particular, in that the proposal 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 regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Specifically, the proposed
rule change will allow the Exchange to continue receiving inbound
routes of orders from Arca Securities, acting in its capacity as a
facility of an affiliated exchange, in a manner consistent with prior
approvals and established protections. The Exchange believes that
meeting the commitments established during the pilot program
demonstrates that the Exchange has mechanisms that protect the
independence of the Exchange's regulatory responsibility with respect
to Arca Securities, as well as demonstrate that Arca Securities cannot
use any information it may have because of its affiliation with the
Exchange to its advantage.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-62 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-62. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
publicly available. All submissions should refer to File Number SR-
NYSEArca-2011-62 and should be submitted on or before September 16,
2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-21871 Filed 8-25-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Rules and Regulations]
[Pages 7215-7218]
[FR Doc No: 2020-01725]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2019-N-5325]

Medical Devices; Immunology and Microbiology Devices;
Classification of Human Immunodeficiency Virus Drug Resistance
Genotyping Assay Using Next Generation Sequencing Technology

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the human immunodeficiency virus (HIV) drug resistance
genotyping assay using next generation sequencing (NGS) technology into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the HIV drug resistance genotyping assay using
NGS technology's classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective on February 7, 2020. The classification
was applicable on November 5, 2019.

FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the HIV drug resistance genotyping
assay using NGS technology as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976 (Pub. L. 94-295),
which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order \1\ finding a new device to be substantially equivalent under
section 513(i) of the FD&C Act to a predicate device that does not
require premarket approval (see 21 U.S.C. 360c(i)). We determine
whether a new device is substantially equivalent to a predicate by
means of the procedures for premarket notification under section 510(k)
of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
---------------------------------------------------------------------------

    \1\ In December 2019, FDA began adding the term ``Final
amendment'' to the ``ACTION'' caption for these documents, typically
styled ``Final order'', to indicate that they ``amend'' the Code of
Federal Regulations. This editorial change was made in accordance
with the Office of Federal Register's (OFR) interpretations of the
Federal Register Act (44 U.S.C. chapter 15), its implementing
regulations (1 CFR 5.9 and parts 21 and 22), and the Document
Drafting Handbook.
---------------------------------------------------------------------------

    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval in order to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the 510(k) process, when necessary, to market
their device.

II. De Novo Classification

    On March 19, 2019, Vela Diagnostics USA Inc. submitted a request
for De Novo classification of the SENTOSA SQ HIV Genotyping Assay. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on November 5, 2019, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3955. We have named
the generic type of device ``Human immunodeficiency virus drug
resistance genotyping assay using next generation sequencing
technology,'' and it is identified as a prescription in vitro
diagnostic device intended for use in detecting HIV genomic mutations
that confer resistance to specific antiretroviral drugs. The device is
intended to be used as an aid in monitoring and treating HIV infection.
    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--In Vitro HIV Drug Resistance Genotype Assay Using NGS
                Technology Risks and Mitigation Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
Inaccurate detection of resistance  Device description information,
 mutation(s).                        including performance
                                     characteristics, and performance
                                     studies in labeling.
                                    Device description validation
                                     procedures and performance studies
                                     meeting acceptance criteria.
                                    Device limitations in labeling for
                                     genetic mutation detection.
Incorrect interpretation of test    Device description information,
 results.                            performance characteristics, and
                                     performance studies in labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, HIV drug resistance genotyping
assays using NGS technology are for prescription use only. Prescription
devices are exempt from the requirement for adequate directions for use
for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met (referring
to 21 U.S.C. 352(f)(1)).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k) if, after notice of our intent to exempt and
consideration of comments, we determine by order that premarket
notification is not necessary to provide reasonable assurance of safety
and effectiveness of the device. We are not announcing intent to exempt
at this time.

III. Analysis of Environmental Impact

    The Agency has 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved FDA collections of information. 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-
3521). The collections of information in the guidance document ``De
Novo Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 820, regarding quality
system regulation, have been approved under OMB control number 0910-
0073; 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 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, 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
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  [thinsp]866.3955 to subpart D to read as follows:

Sec.  866.3955   Human immunodeficiency virus (HIV) drug resistance
genotyping assay using next generation sequencing technology.

    (a) Identification. The HIV drug resistance genotyping assay using
next generation sequencing (NGS) technology is a prescription in vitro
diagnostic device intended for use in detecting HIV genomic mutations
that confer resistance to specific antiretroviral drugs. The device is
intended to be used as an aid in monitoring and treating HIV infection.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The intended use of the device must:
    (i) Specify the analyte (RNA or DNA), the genes in which mutations
are detected, the clinical indications appropriate for test use, the
sample type, and the specific population(s) for which the device in
intended.
    (ii) State that the device in not intended for use as an aid in the
diagnosis of infection with HIV or to confirm the presence of HIV
infection, or for screening donors of blood, plasma, or human cells,
tissues, and cellular and tissue-based products.
    (2) The labeling must include:
    (i) A detailed device description, including but not limited to,
all procedures from collection of the patient sample to reporting the
final result, all device components, the control elements incorporated
into the test procedure, instrument requirements, and reagents required
for use but not provided as part of the device.
    (ii) Performance characteristics from analytical studies and all
intended specimen types.
    (iii) A list of specific mutations detected.
    (iv) The name and version of the standardized database used for
sequence comparison and results derivation.
    (v) A detailed explanation of the interpretation of test results,
including acceptance criteria for evaluating the validity of a test
run.
    (vi) A limitation statement that the device is intended to be used
in conjunction with clinical history and other laboratory findings.
Results of this test are intended to be interpreted by a physician or
equivalent.
    (vii) A limitation statement that lack of detection of drug
resistance mutations does not preclude the possibility of genetic
mutation.
    (viii) A limitation statement indicating the relevant genetic
mutations that are included in the standardized database of HIV genomic
sequences used for comparison and results derivation but that are not
detected by the test.

    (ix) A limitation statement that detection of a genomic drug
resistance mutation may not correlate with phenotypic gene expression.
    (x) A limitation statement that the test does not detect all
genetic mutations associated with antiviral drugs.
    (xi) A limitation statement listing the HIV types for which the
test is not intended, if any.
    (3) Device verification and validation must include:
    (i) Design of primer sequences and rationale for sequence
selection.
    (ii) Computational path from collected raw data to reported result.
    (iii) Detailed documentation of analytical studies including, but
not limited to, characterization of the cutoff, analytical sensitivity,
inclusivity, reproducibility, interference, cross reactivity,
instrument and method carryover/cross contamination, sample stability,
and handling for all genomic mutations claimed in the intended use.
    (iv) Precision studies that include all genomic mutations claimed
in the intended use.
    (v) Detailed documentation of a multisite clinical study evaluating
the sensitivity and specificity of the device. Clinical study subjects
must represent the intended use population and device results for all
targets claimed in the intended use must be compared to Sanger
sequencing or other methods found acceptable by FDA. Drug resistance-
associated mutations at or above the 20 percent frequency level must
detect the mutations in greater than 90 percent of at least 10
replicates, for each of drug class evaluated.
    (vi) Documentation that variant calling is performed at a level of
coverage that supports positive detection of all genomic mutations
claimed in the intended use.
    (vii) Detailed documentation of limit of detection (LoD) studies in
which device performance is evaluated by testing a minimum of 100 HIV-
positive clinical samples including samples with analyte concentrations
near the clinical decision points and near the LoD.
    (A) The LoD for the device must be determined using a minimum of 10
HIV-1 group M genotypes if applicable. A detection rate at 1 x LoD
greater than or equal to 95 percent must be demonstrated for mutations
with a frequency greater than 20 percent.
    (B) The LoD of genetic mutations at frequency levels less than 20
percent must be established.
    (viii) A predefined HIV genotyping bioinformatics analysis pipeline
(BAP). The BAP must adequately describe the bioinformatic analysis of
the sequencing data, including but not limited to read alignment,
variant calling, assembly, genotyping, quality control, and final
result reporting.
    (ix) A clear description of the selection and use of the
standardized database that is used for sequence comparison and results
derivation.
    (4) Premarket notification submissions must include the information
in paragraphs (b)(3)(i) through (ix) of this section.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01725 Filed 2-6-20; 8:45 am]
 BILLING CODE 4164-01-P