[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68529-68532]
[FR Doc No: 2022-24761]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96260; File No. SR-NYSECHX-2022-24]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Extending
the Expiration Date of the Temporary Amendments to Rules 10.9261 and
10.9830.

November 8, 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 28, 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes extending the expiration date of the
temporary amendments to Rules 10.9261 and 10.9830 as set forth in SR-
NYSECHX-2022-19 from October 31, 2022 to January 31, 2023, in
conformity with recent changes by the Financial Industry Regulatory
Authority, Inc. (``FINRA''). The proposed rule change would not make
any changes to the text of Rules 10.9261 and 10.9830. 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 extending the expiration date of the
temporary amendments as set forth in NYSECHX-2022-19 \4\ to Rules
10.9261 (Evidence and Procedure in Hearing) and 10.9830 (Hearing) from
October 31, 2022 to January 31, 2023 to harmonize with recent changes
by FINRA to extend the expiration of temporary amendments to its Rules
9261 and 9830. NYSECHX-2022-19 temporarily granted to the Chief or
Deputy Chief Hearing Officer the authority to order that hearings be
conducted by video conference if warranted by the current COVID-19
public health risks posed by in-person hearings. The proposed rule
change would not make any changes to the text

of Exchange Rules 10.9261 and 10.9830.\5\
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    \4\ See Securities Exchange Act Release No. 95477 (August 11,
2022), 85 FR 50680 (August 17, 2022) (SR-NYSECHX-2022-19) (``SR-
NYSECHX-2022-19'').
    \5\ The Exchange may submit a separate rule filing to extend the
expiration date of the proposed temporary amendments if the Exchange
requires temporary relief from the rule requirements identified in
this proposal beyond January 31, 2023. The amended NYSE Chicago
rules will revert back to their original state at the conclusion of
the temporary relief period and any extension thereof.
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Background
    In 2022, NYSE Chicago adopted disciplinary rules that are, with
certain exceptions, substantially the same as the disciplinary rules of
its affiliate NYSE Arca, Inc., which are in turn substantially similar
to the FINRA Rule 8000 Series and Rule 9000 Series, and which set forth
rules for conducting investigations and enforcement actions.\6\
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    \6\ See Securities Exchange Act Release No. 95020 (June 1,
2022), 87 FR 35034, (June 8, 2022) (SR-NYSECHX-2022-10) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Adopt
Investigation, Disciplinary, Sanction, and Other Procedural Rules
Modeled on the Rules of the Exchange's Affiliates) (``2022 Notice of
Disciplinary Rules'').
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    In adopting disciplinary rules modeled on FINRA's rules, NYSE
Chicago adopted the hearing and evidentiary processes set forth in Rule
10.9261 and in Rule 10.9830 for hearings in matters involving temporary
and permanent cease and desist orders under the Rule 9800 Series. As
adopted, the text of Rule 10.9261 and Rule 10.9830 are substantially
the same as the FINRA rules with certain modifications.\7\
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    \7\ See id.
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    In 2020, in view of the ongoing spread of COVID-19 and its effect
on FINRA's adjudicatory functions nationwide, FINRA filed a temporary
rule change to grant FINRA's Office of Hearing Officers (``OHO'') and
the National Adjudicatory Council (``NAC'') the authority to conduct
certain hearings by video conference, if warranted by the current
COVID-19-related public health risks posed by in-person hearings. Among
the rules FINRA amended were Rules 9261 and 9830.\8\
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    \8\ See Securities Exchange Act Release Nos. 83289 (September 2,
2020), 85 FR 55712 (September 9, 2020) (SR-FINRA-2020-027)
(``Initial FINRA Filing''). FINRA also proposed to temporarily amend
FINRA Rules 1015 and 9524. FINRA Rule 1015 governs the process by
which an applicant for new or continuing membership can appeal a
decision rendered by FINRA's Department of Member Supervision under
FINRA Rule 1014 or 1017 and request a hearing which would be
conducted by a subcommittee of the NAC. See id. at 55714. The
Exchange has not adopted FINRA Rule 1015. FINRA Rule 9524 governs
the process by which a statutorily disqualified member firm or
associated person can appeal the Department's recommendation to deny
a firm or sponsoring firm's application to the NAC. See id. Under
the Exchange's version of Rule 10.9524, if the CRO rejects the
application, the ETP Holder or applicant may request a review by the
Exchange Board of Directors. This differs from FINRA's process,
which provides for a hearing before the NAC and further
consideration by the FINRA Board of Directors.
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    FINRA represented in its filing that its protocol for conducting
hearings by video conference would ensure that such hearings maintain
fair process for the parties by, among other things, FINRA's use of a
high quality, secure and user-friendly video conferencing service and
provide thorough instructions, training and technical support to all
hearing participants.\9\ According to FINRA, the proposed changes were
a reasonable interim solution to allow FINRA's critical adjudicatory
processes to continue to function while protecting the health and
safety of hearing participants as FINRA works towards resuming in-
person hearings in a manner that is compliant with the current guidance
of public health authorities.\10\
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    \9\ See Initial FINRA Filing, 85 FR at 55713.
    \10\ See id.
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    Since the Initial FINRA Filing (in 2020), FINRA periodically
extended the temporary relief as the COVID-19 pandemic and concerns
surrounding its spread persisted.\11\ Due to the continued presence and
uncertainty of COVID-19, FINRA believes that there is a continued need
for temporary relief beyond October 31, 2022.\12\ On date, 2022, the
Exchange filed to temporarily grants the Chief or Deputy Chief Hearing
Officer the authority to order that hearings be conducted by video
conference if warranted by public health risks posed by in-person
hearings during the ongoing COVID-19 pandemic.\13\
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    \11\ See, e.g., Securities Exchange Act Release No. 94430 (March
16, 2022), 87 FR 16262 (March 22, 2022) (SR-FINRA-2022-018) (earlier
extension of temporary relief from July 31, 2022 until October 31,
2022).
    \12\ See Securities Exchange Act Release No. 96107 (October 19,
2022), 87 FR 64526 (October 25, 2022) (SR-FINRA-2022-029) (``SR-
FINRA-2022-029'').
    \13\ See supra note 4, SR-NYSECHX-2022-19.
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    According to FINRA, although there has been a downward trend in the
number of COVID-19 cases since July 2022--when FINRA last filed to
extend the temporary relief, COVID-19 still remains a public health
concern.\14\ For example, according to the Centers for Disease Control
and Prevention (``CDC''), the 7-day moving average of new deaths from
COVID-19 in the United States during September 2022 ranged from
approximately 300 to 500 deaths per day,\15\ and approximately 23
percent of counties in the United States have a medium or high COVID-19
Community Level based on the CDC's most recent calculations.\16\ Much
uncertainty also remains as to whether there will be a significant
increase in the number of cases of COVID-19 in the future given the
emergence of new Omicron variants that the CDC currently is tracking
\17\ and the dissimilar vaccination rates (completed primary series and
a first booster dose) throughout the United States.\18\ Due to the
continued presence and uncertainty of COVID-19, FINRA believes that
there is a continued need for temporary relief beyond October 31,
2022.\19\ On October 17, 2022, FINRA accordingly filed to extend the
expiration date of the temporary rule amendments to, among other rules,
FINRA Rule 9261 and 9830 from October 31, 2022 to January 31, 2023.\20\
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    \14\ See id.
    \15\ See CDC, COVID Data Tracker--Trends in Number of COVID-19
Cases and Deaths in the U.S. Reported to CDC, by State/Territory,
https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths_select_00 (last visited Oct. 11, 2022).
    \16\ See CDC, COVID Data Tracker--COVID-19 Integrated County
View, https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=all_states&list_select_county=all_counties&data-type=CommunityLevels&null=CommunityLevels (last visited Oct. 11,
2022).
    \17\ These new Omicron variants include BA.4.6, BF.7, and
BA.2.75. See CDC, COVID Data Tracker--Variant Proportions, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last visited
Oct. 11, 2022).
    \18\ A state-by-state comparison of vaccination rates is
available at https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop.
    \19\ See SR-FINRA-2022-029, 87 FR at 64526-28.
    \20\ See generally SR-FINRA-2022-029.
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Proposed Rule Change
    Consistent with FINRA's recent proposal, the Exchange proposes to
extend the expiration date of the temporary rule amendments to NYSE
Chicago Rules 10.9261 and 10.9830 as set forth in SR-NYSECHX-2022-19
from October 31, 2022 to January 31, 2023.
    As set forth in SR-FINRA-2022-029, although there has been a
downward trend in the number of COVID-19 cases since July 2022--when
FINRA last filed to extend the temporary relief, that COVID-19 still
remains a public health concern. For example, according to the Centers
for Disease Control and Prevention (``CDC''), the 7-day moving average
of new deaths from COVID-19 in the United States during September 2022
ranged from approximately 300 to 500 deaths per day,\21\ and
approximately 23 percent of counties in the United States have a medium
or high COVID-19 Community Level based on the CDC's most recent
calculations.\22\ Much uncertainty also remains as to

whether there will be a significant increase in the number of cases of
COVID-19 in the future given the emergence of new Omicron variants that
the CDC currently is tracking \23\ and the dissimilar vaccination rates
(completed primary series and a first booster dose) throughout the
United States.\24\ Due to the continued presence and uncertainty of
COVID-19, FINRA believes that there is a continued need for temporary
relief beyond October 31, 2022.\25\ FINRA accordingly proposed to
extend the expiration date of the temporary rule amendments from
October 31, 2022 to January 31, 2023.
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    \21\ See supra note 15 (CDC, COVID Data Tracker--Trends in
Number of COVID-19 Cases and Deaths in the U.S. Reported to CDC, by
State/Territory).
    \22\ See supra note 16 (CDC, COVID Data Tracker--COVID-19
Integrated County View).
    \23\ See supra note 17 (regarding the new Omicron variants
include BA.4.6, BF.7, and BA.2.75 described in CDC, COVID Data
Tracker--Variant Proportions).
    \24\ See supra note 18 (regarding state-by-state comparison of
COVID-19 vaccination rates).
    \25\ See SR-FINRA-2022-029, 87 FR at 64526-28.
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    The Exchange proposes to similarly extend the expiration date of
the temporary rule amendments to NYSE Chicago Rules 10.9261 and 10.9830
as set forth in SR-NYSECHX-2022-19 from October 31, 2022 to January 31,
2023. The Exchange agrees with FINRA that, although there has been a
downward trend in the number of COVID-19 cases since July 2022--when
FINRA last filed to extend the temporary relief, that COVID-19 still
remains a public health concern. The Exchange also agrees that, due to
the continued presence and uncertainty of COVID-19, for the reasons set
forth in SR-FINRA-2022-029, there is a continued need for this
temporary relief beyond October 31, 2022. The proposed change would
permit OHO to continue to assess, based on critical COVID-19 data and
criteria and the guidance of health and security consultants, whether
an in-person hearing would compromise the health and safety of the
hearing participants such that the hearing should proceed by video
conference. As noted in SR-FINRA-2022-029, in deciding whether to
schedule a hearing by video conference, OHO may consider a variety of
other factors in addition to COVID-19 trends. Similarly, as noted in
SR-FINRA-2022-029, in SR-FINRA-2020-027, FINRA provided a non-
exhaustive list of other factors OHO may take into consideration,
including a hearing participant's individual health concerns and access
to the connectivity and technology necessary to participate in a video
conference hearing.\26\ The Exchange believes that this is a reasonable
procedure to continue to follow for hearings under Rules 10.9261 and
10.9830 chaired by a FINRA employee.
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    \26\ See SR-FINRA-2022-029, 87 FR at 64527, n. 15.
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    As noted below, the Exchange has filed the proposed rule change for
immediate effectiveness and has requested that the SEC waive the
requirement that the proposed rule change not become operative for 30
days after the date of the filing, so the Exchange can implement the
proposed rule change immediately.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\27\ in general, and furthers the objectives of Section
6(b)(5),\28\ 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. Additionally, the Exchange believes
the proposed rule change is designed to provide a fair procedure for
the disciplining of members and persons associated with members,
consistent with Sections 6(b)(7) and 6(d) of the Act.\29\
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    \27\ 15 U.S.C. 78f(b).
    \28\ 15 U.S.C. 78f(b)(5).
    \29\ 15 U.S.C. 78f(b)(7) and 78f(d).
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    The Exchange believes that the proposed rule change support the
objectives of the Act by providing greater harmonization between
Exchange rules and FINRA rules of similar purpose, resulting in less
burdensome and more efficient regulatory compliance. As such, the
proposed rule change will foster cooperation and coordination with
persons engaged in facilitating transactions in securities and will
remove impediments to and perfect the mechanism of a free and open
market and a national market system.
    The proposed rule change, which extends the expiration date of the
temporary amendments to Exchange rules consistent with FINRA's
extension to its Rules 9261 and 9830 as set forth in SR-FINRA-2022-029,
will permit the Exchange to continue to effectively conduct hearings
given the continued presence and uncertainty of COVID-19. Given that
COVID-19 remains a public health concern and the uncertainty around a
potential spike in cases of the disease, without this relief allowing
OHO to proceed by video conference, some or all hearings may have to be
postponed. The ability to conduct hearings by video conference will
permit the adjudicatory functions of the Exchange's disciplinary rules
to continue unabated, thereby avoiding protracted delays. The Exchange
believes that this is especially important in matters where temporary
and permanent cease and desist orders are sought because the proposed
rule change would enable those hearings to continue to proceed without
delay, thereby enabling the Exchange to continue to take immediate
action to stop significant, ongoing customer harm, to the benefit of
the investing public.
    As set forth in detail in NYSECHX-2022-19, the temporary relief to
permit hearings to be conducted via video conference maintains fair
process and will continue to provide fair process consistent with
Sections 6(b)(7) and 6(d) of the Act \30\ while striking an appropriate
balance between providing fair process and enabling the Exchange to
fulfill its statutory obligations to protect investors and maintain
fair and orderly markets while avoiding the COVID-19-related public
health risks for hearing participants. The Exchange notes that this
proposal, like NYSECHX-2022-19, provides only temporary relief. As
proposed, the changes would be in place through January 31, 2023. As
noted in NYSECHX-2022-19 and above, the amended rules will revert back
to their original state at the conclusion of the temporary relief
period and, if applicable, any extension thereof.
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    \30\ 15 U.S.C. 78f(b)(7) & 78f(d).
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    Accordingly, the proposed rule change extending this temporary
relief is in the public interest and consistent with the Act's purpose.

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

    The Exchange does not believe that the proposed temporary 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 is rather
intended to extend temporary relief necessitated by the continued
presence and uncertainty of COVID-19 and the related health and safety
risks of conducting in-person activities. The Exchange believes that
the proposed rule change will prevent unnecessary impediments to
critical adjudicatory processes and its ability to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets that would otherwise result if

the temporary amendments were to expire on October 31, 2022.

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 \31\ and Rule 19b-4(f)(6) thereunder.\32\
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.
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    \31\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \32\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \33\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\34\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange has
indicated that there is a continued need to extend the temporary relief
because the Exchange agrees with FINRA that the COVID-19 related health
concerns necessitating this relief will continue beyond October 31,
2022.\35\ The Exchange also states that the temporary relief provided
in this proposal immediately upon filing and without a 30-day operative
delay will allow the Exchange to continue critical adjudicatory and
review processes so that the Exchange may continue to operate
effectively and meet its critical investor protection goals, while also
protecting the health and safety of hearing participants.\36\ The
Commission also notes that this proposal extends without change the
temporary relief previously provided by SR-NYSECHX-2022-19.\37\ As
proposed, the temporary changes would be in place through January 31,
2023 and the amended rules will revert back to their original state at
the conclusion of the temporary relief period and, if applicable, any
extension thereof.\38\ For these reasons, the Commission believes that
waiver of the 30-day operative delay for this proposal is consistent
with the protection of investors and the public interest. Accordingly,
the Commission hereby waives the 30-day operative delay and designates
the proposal operative upon filing.\39\
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    \33\ 17 CFR 240.19b-4(f)(6).
    \34\ 17 CFR 240.19b-4(f)(6)(iii).
    \35\ See supra Item II; see also SR-FINRA-2022-029, 87 FR 64526,
at 64527.
    \36\ See 87 FR 64526, at 64528-29 (noting the same in granting
FINRA's request to waive the 30-day operative delay so that SR-
FINRA-2022-029 would become operative immediately upon filing).
    \37\ See supra note 4.
    \38\ See supra note 5. As noted above, the Exchange states that
if it requires temporary relief from the rule requirements
identified in this proposal beyond January 31, 2023, it may submit a
separate rule filing to extend the effectiveness of the temporary
relief under these rules.
    \39\ 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).
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    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) \40\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \40\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSECHX-2022-24 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-2022-24. 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-2022-24 and should be submitted
on or before December 6, 2022.
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    \41\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-24761 Filed 11-14-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Notices]
[Pages 15279-15280]
[FR Doc No: 2021-05825]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91333; File No. SR-CFE-2021-005]

Self-Regulatory Organizations; Cboe Futures Exchange, LLC; Notice
of a Filing of a Proposed Rule Change To Update Regulatory Independence
Policies

March 16, 2021.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on March 8, 2021 Cboe Futures
Exchange, LLC (``CFE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II, and III below, which Items have been prepared by CFE.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons. CFE also has filed this
proposed rule change with the Commodity Futures Trading Commission
(``CFTC''). CFE filed a written certification with the CFTC under
Section 5c(c) of the Commodity Exchange Act (``CEA'') \2\ on March 8,
2021.
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    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
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I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    CFE is proposing to update CFE Policy and Procedure XIII (Cboe
Global Markets, Inc. and Subsidiaries Regulatory Independence Policy
for Regulatory Group Personnel) (``P&P XIII'') and CFE Policy and
Procedure XIV (Cboe Global Markets, Inc. and Subsidiaries Regulatory
Independence Policy for Non-Regulatory Group Personnel) (``P&P XIV'')
(collectively, ``Regulatory Independence Policies'').
    The scope of this filing is limited solely to the application of
the proposed rule change to security futures that may be traded on CFE.
Although no security futures are currently listed for trading on CFE,
CFE may list security futures for trading in the future. The text of
the proposed rule change is attached as Exhibit 4 to the filing but is
not attached to the publication of this notice.

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

    In its filing with the Commission, CFE 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. CFE 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
    CFE is a subsidiary of Cboe Global Markets, Inc. (``CGM''). CGM and
its exchange subsidiaries previously adopted the Regulatory
Independence Policies and make updates to the Regulatory Independence
Policies from time to time. The Regulatory Independence Policies are
incorporated into the Policies and Procedures Section of the CFE
Rulebook in P&P XIII and P&P XIV.
    CFE previously had a regulatory services agreement (``RSA'') in
place with National Futures Association (``NFA'') under which NFA acted
as a

regulatory services provider to CFE. The Regulatory Independence
Policies provide, in relevant part, that they apply with respect to
employees of a regulatory services provider that provides regulatory
services to a Cboe Company (as defined in the Regulatory Independence
Policies) in the same manner that they apply with respect to regulatory
employees of a Cboe Company. The Regulatory Independence Policies also
make clear that notwithstanding that a Cboe Company has entered into an
RSA with a regulatory services provider, the Cboe Company retains
ultimate legal responsibility for, and control of, its self-regulatory
responsibilities. The current Regulatory Independence Policies
reference the RSA between CFE and NFA in relation to these provisions
of the Regulatory Independence Policies.
    The RSA between CFE and NFA expired at the end of 2020.
Accordingly, CGM and CFE are making updates to the Regulatory
Independence Policies to remove references to the RSA and to NFA's
previous status as a regulatory services provider to CFE. The proposed
rule change proposes to revise P&P XIII and P&P XIV to reflect these
updates that CGM and CFE are making to the Regulatory Independence
Policies.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\3\ in general, and furthers the
objectives of Sections 6(b)(1) \4\ and 6(b)(5) \5\ in particular, in
that it is designed:
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(1).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

     to enable the Exchange to enforce compliance by its
Trading Privilege Holders and persons associated with its Trading
Privilege Holders with the provisions of the rules of the Exchange,
     to prevent fraudulent and manipulative acts and practices,
     to promote just and equitable principles of trade,
     to remove impediments to and perfect the mechanism of a
free and open market and a national market system,
     and in general, to protect investors and the public
interest.
    The proposed rule change retains the current substantive provisions
of the Regulatory Independence Policies within CFE's rules while
updating the Regulatory Independence Policies to remove reference to a
regulatory service provider that no longer performs regulatory services
for CFE. By retaining the current substantive provisions of the
Regulatory Independence Policies within CFE's rules, the proposed rule
change contributes to minimizing conflicts of interest in the decision
making process of CFE and to the preservation of the independence of
the Exchange's regulatory group as it performs regulatory functions for
the Exchange. The Exchange believes that the proposed rule change is
equitable and not unfairly discriminatory in that the Regulatory
Independence Policies apply equally in relation to all CFE Trading
Privilege Holders.

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

    CFE 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, in that the proposed rule change contributes
to CFE's ability to carry out its responsibilities as a self-regulatory
organization. The Exchange believes that the proposed rule change will
not impose any undue burden on competition because the Regulatory
Independence Policies apply equally in relation to all CFE Trading
Privilege Holders.

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 proposed rule change will become operative on March 22, 2021.
At any time within 60 days of the date of effectiveness of the proposed
rule change, the Commission, after consultation with the CFTC, may
summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\6\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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-CFE-2021-005 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-CFE-2021-005. 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 10:00 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-CFE-2021-005, and should be submitted on
or before April 12, 2021.
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(73).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-05825 Filed 3-19-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 67069-67072]
[FR Doc No: 2020-23254]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90193; File No. SR-NYSEAMER-2020-76]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Change To Amend the NYSE
American Options Fee Schedule

October 15, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 9, 2020, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the 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 the NYSE American Options Fee
Schedule (``Fee Schedule'') regarding the Strategy Execution Fee Cap.
The Exchange proposes to implement the fee change effective October 9,
2020.\4\ The proposed 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.
---------------------------------------------------------------------------

    \4\ The Exchange originally filed to amend the Fee Schedule on
October 1, 2020. (SR-NYSEAMER-2020-72) and withdrew such filing on
October 9, 2020.
---------------------------------------------------------------------------

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 purpose of this filing is to amend the Fee Schedule to modify
the Strategy Execution Fee Cap (``Strategy Cap''), effective October 9,
2020.
    Currently, the Fee Schedule provides that transaction fees for ATP
Holders are limited or capped at $1,000 for certain options strategy
executions ``on the same trading day,'' meaning it is a daily fee
cap.\5\ Strategy executions that qualify for the Strategy Cap are (a)
reversals and conversions, (b) box spreads, (c) short stock interest
spreads, (d) merger spreads, and (e) jelly rolls, which are described
in detail in the Fee Schedule (the ``Strategy Executions'').\6\
---------------------------------------------------------------------------

    \5\ See Fee Schedule, Section I.J., Strategy Execution Fee Cap,
available here: https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf. Any
reversal and conversion strategy executed as a QCC order is eligible
for this cap; however, any other strategy executed as a QCC order is
excluded from this fee cap. See id.
    \6\ See id.
---------------------------------------------------------------------------

    The Exchange proposes to modify the Strategy Cap to offer a lower
cap of $200 for those ATP Holders that trade at least 25,000 monthly
billable contract sides in Strategy Executions.\7\ Thus, at the end of
the month, qualifying ATP Holders would have transaction fees for their
Strategy Executions for each day of the month capped at $200 (as
opposed to $1,000 for non-qualifying ATP Holders).\8\
---------------------------------------------------------------------------

    \7\ See proposed Fee Schedule, Section I.J., Strategy Execution
Fee Cap.
    \8\ See id.
---------------------------------------------------------------------------

    For example, assume an ATP Holder executes the following Strategy
Executions against interest in the Trading Crowd on the third business
day of the month on behalf of a non-Customer that is not a Specialist
or e-Specialist, which participants are subject to a $0.25 per Manual
transaction fee. Under the current Fee Schedule an ATP Holder would be
charged a total of $1,000 in options fees, per the daily fee cap:
     Trade 1: A Reversal Conversion in DEF comprised of 3,000
call options against 3,000 put options would be $1,500 (at $0.25 per
execution), absent the $1,000 Strategy Cap.
     Trade 2: A Reversal Conversion in ABC comprised of 1,000
call options against 1,000 put options would be $500 (at $0.25 per
execution), absent the Strategy Cap. However, because the ATP Holder
reached the daily cap (with Trade 1), the ATP Holder would not be
charged for these transactions.
    However, if, in addition to the two trades above, the ATP Holder
executes a ``jelly roll'' consisting of 5,000 October puts and 5,000
October calls against 5,000 November calls and 5,000 November puts on
the fifteenth business day of the month, the total fees for these
qualifying Strategy Executions under the proposed Fee Schedule would be
capped at $200 for this trading day, given that the total number of
contracts on day three and day fifteen is above minimum 25,000 billable
contract sides threshold. Similarly, having met this threshold, the
fees charged on Trades 1 and 2 that were executed on the third business
day would likewise be capped at $200. Thus, the fees for each of the
third and fifteenth trading day would be capped at $200 each, for a
monthly total of $400 for Strategy Executions.
    The Exchange's fees are constrained by intermarket competition, as
ATP Holders may direct their order flow to any of the 16 options
exchanges, including those with similar Strategy Fee Caps.\9\ Thus, ATP
Holders have a choice of where they direct their order flow. This
proposed change is designed to incent ATP Holders to increase their
Strategy Execution volumes by executing (often smaller) strategies that
are not necessarily economically viable on a per symbol basis, but
which may be profitable when fees on Strategy Executions--regardless of
symbol--are

capped for the trading day. The Exchange notes that all market
participants stand to benefit from increased volume, which promotes
market depth, facilitates tighter spreads and enhances price discovery,
and may lead to a corresponding increase in order flow from other
market participants.
---------------------------------------------------------------------------

    \9\ See e.g., Cboe fee schedule, footnote 13. Cboe caps fees for
each participant at $0.00 for the following strategies executed on
the same trading day: Short stock interest, reversal, conversion,
jelly roll, and merger strategies.
---------------------------------------------------------------------------

    The Exchange cannot predict with certainty whether any, or how
many, ATP Holders would avail themselves of this proposed fee change.
The Exchange believes that ATP Holders that execute Strategy Executions
on the Exchange can achieve the proposed 25,000 minimum contract sides
threshold to qualify for the proposed (reduced) Strategy Cap and this
proposal may encourage ATP Holders to execute (and aggregate) Strategy
Executions on the Exchange, which order flow would enhance price
discovery.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\11\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

The Proposed Rule Change Is Reasonable
    The Exchange operates in a highly competitive market. The
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. In Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \12\
---------------------------------------------------------------------------

    \12\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (S7-10-04) (``Reg NMS
Adopting Release'').
---------------------------------------------------------------------------

    The Exchange is only one of 16 options venues to which market
participants may direct their order flow. Based on publicly available
information, no single options exchange has more than 16% of the market
share of executed volume of multiply-listed equity and ETF options
trades.\13\ Therefore, no exchange possesses significant pricing power
in the execution of multiply-listed equity & ETF options order flow.
More specifically, since August 2019, the Exchange has had less than 9%
market share of executed volume of multiply-listed equity & ETF options
trades.\14\
---------------------------------------------------------------------------

    \13\ The OCC publishes options and futures volume in a variety
of formats, including daily and monthly volume by exchange,
available here: https://www.theocc.com/market-data/volume/default.jsp.
    \14\ Based on OCC data, see id., the Exchange's market share in
equity-based options increased from 7.73% for the month of August
2019 to 8.18% for the month of August 2020.
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees. Stated otherwise,
modifications to exchange transaction fees can have a direct effect on
the ability of an exchange to compete for order flow.
    The Exchange believes that the proposed modification to the
Strategy Cap is reasonable because it is designed to incent ATP Holders
to increase their Strategy Executions submitted to and executed on the
Exchange's Trading Floor. The Exchange offers a hybrid market system
and aims to balance incentives for its ATP Holders to continue to
contribute to deep liquid markets for investors on both its electronic
and open outcry platforms. The Exchange notes that all market
participants stand to benefit from any increase in volume transacted on
the Trading Floor, which promotes market depth, facilitates tighter
spreads and enhances price discovery, and may lead to a corresponding
increase in order flow from other market participants.
    To the extent that the proposed change attracts more Strategy
Executions to the Exchange, this increased (open outcry) order flow
would continue to make the Exchange a more competitive venue for order
execution, which, in turn, promotes just and equitable principles of
trade and removes impediments to and perfects the mechanism of a free
and open market and a national market system.
    Finally, to the extent the proposed change continues to attract
greater volume and liquidity, the Exchange believes the proposed change
would improve the Exchange's overall competitiveness and strengthen its
market quality for all market participants. In the backdrop of the
competitive environment in which the Exchange operates, the proposed
rule change is a reasonable attempt by the Exchange to increase the
depth of its market and improve its market share relative to its
competitors. The Exchange's fees are constrained by intermarket
competition, as ATP Holders may direct their order flow to any of the
16 options exchanges, including those with similar Strategy Fee
Caps.\15\ Thus, ATP Holders have a choice of where they direct their
order flow--including their Strategy Executions. The proposed rule
change is designed to incent ATP Holders to direct liquidity, and
specifically Strategy Executions, to the Exchange, thereby promoting
market depth, price discovery and improvement and enhancing order
execution opportunities for market participants.
---------------------------------------------------------------------------

    \15\ See supra note 9 (regarding Cboe Strategy Cap).
---------------------------------------------------------------------------

    The Exchange cannot predict with certainty whether any, or how
many, ATP Holders would avail themselves of this proposed fee change.
The Exchange cannot predict with certainty whether any, or how many,
ATP Holders would avail themselves of this proposed fee change. [sic]
The Exchange believes that ATP Holders that execute Strategy Executions
on the Exchange can achieve the proposed 25,000 minimum contract sides
threshold to qualify for the proposed (reduced) Strategy Cap and this
proposal may encourage ATP Holders to execute (and aggregate) Strategy
Executions on the Exchange, which order flow would enhance price
discovery.
The Proposed Rule Change Is an Equitable Allocation of Credits and Fees
    The Exchange believes the proposed rule change is an equitable
allocation of its fees and credits. The proposal is based on the amount
and type of business transacted on the Exchange and ATP Holders can opt
to avail themselves of the Strategy Cap or not. The proposed Strategy
Cap, as modified. [sic] applies to all qualifying Strategy Executions
transacted on the Trading Floor. The Exchange believes that the
proposed change would facilitate the execution of orders via open
outcry, thus enhancing price discovery as a result of increased
liquidity. Moreover, the proposal is designed to encourage ATP Holders
to aggregate all Strategy Executions at the Exchange as a primary
execution venue. To the extent that the proposed change attracts more
Strategy Executions to the Exchange, this increased order flow would
continue to make the Exchange a more competitive venue for order
execution. Thus, the

Exchange believes the proposed rule change would improve market quality
for all market participants on the Exchange and, as a consequence,
attract more order flow to the Exchange thereby improving market-wide
quality and price discovery.
The Proposed Rule Change Is Not Unfairly Discriminatory
    The Exchange believes it is not unfairly discriminatory to modify
the Strategy Cap because the proposed modification would be available
to all similarly-situated market participants on an equal and non-
discriminatory basis.
    The proposal is based on the amount and type of business transacted
on the Exchange and ATP Holders are not obligated to try to achieve the
modified Strategy Cap, nor are they obligated to execute any Strategy
Executions. Rather, the proposal is designed to encourage ATP Holders
to utilize the Exchange as a primary trading venue for Strategy
Executions (if they have not done so previously) or increase volume
sent to the Exchange. To the extent that the proposed change attracts
more Strategy Executions to the Exchange, this increased order flow
would continue to make the Exchange a more competitive venue for, among
other things, order execution. Thus, the Exchange believes the proposed
rule change would improve market quality for all market participants on
the Exchange and, as a consequence, attract more order flow to the
Exchange thereby improving market-wide quality and price discovery. The
resulting increased volume and liquidity would provide more trading
opportunities and tighter spreads to all market participants and thus
would promote just and equitable principles of trade, 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.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act, the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed changes would encourage the submission of additional
liquidity to a public exchange, thereby promoting market depth, price
discovery and transparency and enhancing order execution opportunities
for all market participants. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering integrated competition among orders, which
promotes ``more efficient pricing of individual stocks for all types of
orders, large and small.'' \16\
---------------------------------------------------------------------------

    \16\ See Reg NMS Adopting Release, supra note 12, at 37499.
---------------------------------------------------------------------------

    Intramarket Competition. The proposed change is designed to attract
additional order flow (particularly Strategy Executions) to the
Exchange. The Exchange believes that the proposed modification to the
Strategy Cap would incent market participants to direct their Strategy
Execution volume to the Exchange. Greater liquidity benefits all market
participants on the Exchange and increased Strategy Executions would
increase opportunities for execution of other trading interest. The
proposed reduced Strategy Cap would be available to all similarly-
situated market participants that incur transaction fees on Strategy
Executions, and, as such, the proposed change would not impose a
disparate burden on competition among market participants on the
Exchange.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily favor one
of the 16 competing option exchanges if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges and to attract order flow to the Exchange. Based on publicly-
available information, and excluding index-based options, no single
exchange has more than 16% of the market share of executed volume of
multiply-listed equity and ETF options trades.\17\ Therefore, no
exchange possesses significant pricing power in the execution of
multiply-listed equity & ETF options order flow. More specifically, in
the second quarter of 2020, the Exchange had less than 9% market share
of executed volume of multiply-listed equity & ETF options trades.\18\
---------------------------------------------------------------------------

    \17\ See supra note 13.
    \18\ Based on OCC data, see supra note 14, the Exchange's market
share increased from 7.73% for the month of August 2019 to 8.18% for
the month of August 2020.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change reflects this
competitive environment because it modifies the Exchange's fees in a
manner designed to encourage ATP Holders to direct trading interest
(particularly Strategy Executions) to the Exchange, to provide
liquidity and to attract order flow. To the extent that this purpose is
achieved, all the Exchange's market participants should benefit from
the improved market quality and increased opportunities for price
improvement.
    The Exchange believes that the proposed change could promote
competition between the Exchange and other execution venues, including
those that currently offer similar Strategy Caps, by encouraging
additional orders to be sent to the Exchange for execution.

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 foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \19\ of the Act and subparagraph (f)(2) of Rule
19b-4 \20\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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) \21\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMER-2020-76 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-NYSEAMER-2020-76. 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-NYSEAMER-2020-76, and should be
submitted on or before November 12, 2020.
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-23254 Filed 10-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Rules and Regulations]
[Pages 21027-21029]
[FR Doc No: 2022-07538]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2021-0885; FRL-9523-02-R5]

Air Plan Approval; Wisconsin; Redesignation of the Wisconsin
Portion of the Chicago-Naperville, Illinois-Indiana-Wisconsin Area to
Attainment of the 2008 Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) finds that the
Chicago-Naperville, IL-IN-WI area (Chicago area) is attaining the 2008
ozone National Ambient Air Quality Standard (NAAQS or standard) and, in
response to a request from the Wisconsin Department of Natural
Resources (Wisconsin or the State), is redesignating the Wisconsin
portion of the area to attainment for the 2008 ozone NAAQS, because the
State has met the statutory requirements for redesignation under the
Clean Air Act (CAA). EPA is approving, as a revision to the Wisconsin
State Implementation Plan (SIP), the State's plan for maintaining the
2008 ozone NAAQS through 2035 for the Wisconsin portion of the Chicago
area. EPA finds adequate and is approving Wisconsin's 2030 and 2035
volatile organic compound (VOC) and oxides of nitrogen (NOX)
Motor Vehicle Emission Budgets (Budgets) for the Wisconsin portion.
Finally, pursuant to section 110 and part D of the CAA, EPA is
approving the enhanced Inspection/Maintenance (I/M) program
certification included in Wisconsin's December 3, 2021 submittal,
because it satisfies the serious enhanced I/M requirements for the
Wisconsin portion. EPA proposed to approve this action on February 7,
2022, and received no comments.

DATES: This final rule is effective on April 11, 2022.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2021-0885. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Michael
Leslie, Environmental Engineer at<PHONE_NUMBER> before visiting the
Region 5 office.

FOR FURTHER INFORMATION CONTACT: Michael Leslie, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background Information

    On February 7, 2022 (87 FR 6006), EPA proposed to find that the
Chicago area is attaining the 2008 ozone NAAQS, in response to a
request from the Wisconsin, and is redesignating the Wisconsin portion
of the area to attainment for the 2008 ozone NAAQS, because the State
has met the statutory requirements for redesignation under the CAA. The
Wisconsin portion of the Chicago 2008 ozone area consists of the
portion of Kenosha County bounded by the I-94 corridor and the area
east to Lake Michigan (Wisconsin portion). Wisconsin submitted this
request on December 3, 2021. EPA proposed to approve, as a revision to
the Wisconsin SIP, the State's plan for maintaining the 2008 ozone
NAAQS through 2035 for the Wisconsin portion. EPA also proposed to
approve and find adequate Wisconsin's 2030 and 2035 VOC and
NOX Budgets for the Wisconsin portion. Finally, pursuant to
section 110 and part D of the CAA, EPA proposed to approve the enhanced
I/M certification, because it satisfies the serious enhanced I/M
requirements for the Wisconsin portion. The public comment period for
this proposed rule ended on March 9, 2022. EPA received no comments on
the proposal.

II. Final Action

    EPA is determining that the Chicago area is attaining the 2008
ozone NAAQS, based on quality-assured and certified monitoring data for
the 2019-2021 period. EPA is approving enhanced I/M revision included
in Wisconsin's December 3, 2021 submittal because Wisconsin
demonstrated that its current I/M program meets the applicable enhanced
I/M performance standard requirements in 40 CFR part 51, subpart S, for
the 2008 ozone NAAQS. EPA has determined that the Wisconsin portion of
the Chicago area has met the requirements for redesignation under
section 107(d)(3)(E) of the CAA. EPA is thus changing the legal
designation for the Wisconsin portion of the Chicago-Naperville, IL-IN-
WI area from nonattainment to attainment for the 2008 ozone NAAQS. EPA
is also approving, as a revision to the Wisconsin SIP, the State's
maintenance plan for the area. The maintenance plan is designed to keep
the Wisconsin portion of the Chicago area in attainment of the 2008
ozone NAAQS through 2035. Finally, EPA is finding adequate and
approving the newly established 2030 and 2035 Budgets for the Wisconsin
portion of the Chicago area.
    In accordance with 5 U.S.C. 553(d) of the Administrative Procedure
Act (APA), EPA finds there is good cause for this action to become
effective immediately upon publication. The immediate effective date
for this action is authorized under 5 U.S.C. 553(d)(1).
    Section 553(d)(1) of the APA provides that final rules shall not
become effective until 30 days after publication in the Federal
Register ``except . . . a substantive rule which grants or recognizes
an exemption or relieves a restriction.'' The purpose of this provision
is to ``give affected parties a reasonable time to adjust their
behavior before the final rule takes effect.'' Omnipoint Corp. v. Fed.
Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United
States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting
legislative history). However, when the agency grants or recognizes an
exemption or relieves a restriction, affected parties do not need a
reasonable time to adjust because the effect is not adverse. EPA has
determined that this rule relieves a restriction because this rule
relieves sources in the area of Nonattainment New Source Review (NNSR)
permitting requirements; instead, upon the effective date of this
action, sources will be subject to less restrictive Prevention of
Significant Deterioration (PSD) permitting requirements. For this
reason, EPA finds good cause under 5 U.S.C. 553(d)(1) for this action
to become effective on the date of publication of this action.

III. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 10, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: March 29, 2022.
Debra Shore,
Regional Administrator, Region 5.
    For the reasons stated in the preamble, 40 CFR parts 52 and 81 are
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

0
2. Section 52.2585 is amended by adding paragraph (ss) to read as
follows:

Sec.  52.2585   Control strategy: Ozone.

* * * * *
    (ss) Redesignation. Approval--On December 3, 2021, Wisconsin
submitted a request to redesignate the Wisconsin portion of the
Chicago-Naperville, IL-IN-WI area to attainment of the 2008 ozone
National Ambient Air Quality Standards (NAAQS). As part of the
redesignation request, the State submitted a maintenance plan as
required by section 175A of the Clean Air Act (CAA). Elements of the
section 175 maintenance plan include a contingency plan and an
obligation to submit a subsequent maintenance plan revision in eight
years as required by the CAA. The ozone maintenance plan also
establishes 2030 and 2035 Motor Vehicle Emission Budgets (Budgets) for
the area. The 2030 Budgets for the area are 0.54 tons/day for volatile
organic compounds (VOC) and 0.85 tons/day for oxides of nitrogen
(NOX). The 2035 Budgets for the area are 0.47 tons/day for
VOC and 0.75 tons/day for NOX. Wisconsin also submitted a
revision to its State Implementation Plan to satisfy the Enhanced
Inspection/Maintenance recertification for the 2008 ozone NAAQS
requirements of the CAA.

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

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

0
4. Section 81.350 is amended by revising the entry for ``Chicago-
Naperville, IL-IN-WI'' in the table entitled ``Wisconsin-2008 8-Hour
Ozone NAAQS [Primary and Secondary]'' to read as follows:

Sec.  81.350   Wisconsin.

* * * * *

                                       Wisconsin--2008 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \1\              Type
----------------------------------------------------------------------------------------------------------------
Chicago-Naperville, IL-IN-WI: \2\.       4/11/2022  Attainment...........  ..............  Serious.
    Kenosha County (part): The
     portion of Kenosha County
     bounded by the Lake Michigan
     shoreline on the East, the
     Kenosha County boundary on
     the North, the Kenosha County
     boundary on the South, and
     the I-94 corridor (including
     the entire corridor) on the
     West.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ This date is July 20, 2012, unless otherwise noted.
\2\ Excludes Indian country located in each area, unless otherwise noted.

* * * * *
[FR Doc. 2022-07538 Filed 4-8-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1159-1161]
[FR Doc No: 2019-00749]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4629]

Survey Methodologies To Assess Risk Evaluation and Mitigation
Strategies Goals That Relate to Knowledge; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Survey
Methodologies to Assess REMS Goals That Relate to Knowledge; Draft
Guidance For Industry.'' This draft guidance provides recommendations
to industry on conducting risk evaluation and mitigation strategies
(REMS) assessment surveys used to evaluate respondent knowledge of
REMS-related information. Most applicants use surveys to evaluate
patients' and healthcare providers' understanding of the serious risks
associated with, and safe use of, their drugs to assess REMS knowledge
goals. The draft guidance discusses general principles and
recommendations related to conducting REMS assessment knowledge
surveys, including study design, survey instrument development, survey
data collection and processing, and data analysis.

DATES: Submit either electronic or written comments on the draft
guidance by April 2, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4629 for the ``Survey Methodologies to Assess REMS Goals
That Relate to Knowledge.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Brian Gordon, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2486, Silver Spring, MD 20993-0002, 301-
796-3960<EMAIL_ADDRESS>Doris Auth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2480, Silver Spring, MD 20993-0002, 301-
796-0487<EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Survey Methodologies to Assess REMS Goals That Relate to
Knowledge.'' The Food and Drug Administration Amendments Act of 2007
(FDAAA) created section 505-1 (21 U.S.C. 355-1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), which authorizes FDA to require a
REMS for certain drugs if FDA determines that a REMS is necessary to
ensure that the benefits of a drug outweigh its risks.
    REMS elements may include a medication guide, a patient package
insert, and/or a communication plan. FDA may also require certain
elements to assure safe use (ETASU) as part of a REMS. The ETASU can
include, for example, requirements that health care providers who
prescribe the drug have particular training or experience, that
patients using the drug be monitored, or that the drug be dispensed to
patients with evidence or other documentation of safe use conditions.
Certain REMS with ETASU may also include an implementation system
through which the sponsor is able to monitor and evaluate
implementation of the ETASU and work to improve their implementation.
All REMS for drugs approved under a new drug application or a biologics
license application must include a timetable for submission of
assessments of the REMS. The timetable for submission of assessments
must be, at a minimum, an assessment by 18 months after the strategy is
initially approved, an assessment by 3 years after the strategy is
initially approved, and an assessment in the 7th year after the initial
approval of the REMS. For additional information about REMS, see the
draft guidance for industry ``Format and Content of a REMS Document,''
(82 FR 47529, October 12, 2017) available at<EMAIL_ADDRESS>    The FD&C Act requires applicants to conduct assessments to evaluate
the effectiveness of REMS. The statute specifies that the assessment
for REMS must include an assessment of the extent to which the approved
strategy,

including each element of the strategy, is meeting the goal or whether
one or more such goals or such elements should be modified (section
505-1(g)(3) of the FD&C Act). The statute does not specifically
describe how this assessment should be conducted. Many REMS include a
goal related to knowledge, such as to inform or educate patients and
healthcare providers about the serious risks associated with and safe
use of a drug. When knowledge goals are part of a REMS, the REMS
assessment plan generally includes, as appropriate, an evaluation of
patients' and healthcare providers' understanding of the serious
risk(s) associated with, and safe use of, the drug.
    The purpose of the REMS knowledge assessment is to evaluate the
target populations' knowledge about the serious risk(s) and safe use of
the drug. Most applicants use surveys to evaluate patients' and
healthcare providers' understanding of the serious risk(s) associated
with, and safe use of, their drugs to assess REMS knowledge goals.
    This draft guidance, which describes best practices for the design,
conduct, and data analyses of the results of REMS assessment knowledge
surveys to evaluate patients' and healthcare providers' understanding
of the serious risk(s) associated with, and safe use of, a drug,
incorporates input obtained from the June 7, 2012, public workshop on
``REMS Assessments: Social Science Methodologies to Assess Goals
Related to Knowledge,'' and the comments submitted to the docket opened
in association with the workshop (FDA-2012-N-0408).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on conducting
risk evaluation and mitigation strategy assessment surveys used to
assess respondent knowledge of REMS-related information. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to collections of information that 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). Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of the draft guidance ``REMS Assessment: Planning and Reporting.'' The
assessment of burden hours included in the NOA for the draft guidance
``REMS Assessment: Planning and Reporting'' includes the burden for
conducting knowledge surveys when conducted in support of a REMS
Assessment.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00749 Filed 1-31-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76021-76022]
[FR Doc No: 2012-30988]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2374-001; ER10-1533-002.
    Applicants: Puget Sound Energy, Macquarie Energy LLC.
    Description: Notice of Non-Material Change in Status of Puget Sound
Energy, Inc. et al.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5247.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER12-2207-001.
    Applicants: California Independent System Operator Corporation.
    Description: 12-12-17 Compliance with November 5 Order re Western
Antelope Dry Ranch SGIA to be effective 7/6/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5200.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER12-2209-001.
    Applicants: California Independent System Operator Corporation.
    Description: 2012-12-17 Compliance with November 5 Order on Western
Antelope Blue Sky SGIA to be effective 7/6/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5203.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER12-2227-001; ER10-1952-001; ER10-1971-007.
    Applicants: Ensign Wind, LLC.
    Description: NextEra Resources Entities' Notification of Non-
material Change in Status and Subsidiary Name Change.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5231.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER12-480-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: 12-17-12 Entergy Cost Allocation Compliance to be
effective 6/1/2013.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5199.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-565-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2503 The Central Nebraska Public Power & Irrigation
District GIA to be effective 11/26/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5133.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-566-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2504 The Central Nebraska Public Power & Irrigation
District GIA to be effective 11/26/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5141.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-567-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2505 The Central Nebraska Public Power & Irrigation
District GIA to be effective 11/26/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5145.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-568-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.13(a)(2)(iii:
Idaho RATFA Communications Agreements Concurrence to be effective 2/8/
2013.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5187.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-569-000.
    Applicants: Avista Corporation.
    Description: Avista Corp Rate Schedule No. 59 to be effective 12/
18/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5201.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-570-000.
    Applicants: PacifiCorp.
    Description: NWE 2nd Amnd and Rstd Interconnection Agmt (AMPS)
Concurrence to be effective 12/18/2012.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5202.
    Comments Due: 5 p.m. ET 1/7/13.

    Docket Numbers: ER13-572-000.
    Applicants: New York State Reliability Council, L.L.C.
    Description: New York State Reliability Council, L.L.C.'s
Submission of the Revised Installed Capacity Requirement for the New
York Control Area under ER13-572.
    Filed Date: 12/17/12.

    Accession Number: 20121217-5226.
    Comments Due: 5 p.m. ET 1/7/13.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH13-4-000.
    Applicants: ArcLight Capital Holdings, LLC.
    Description: Notice of Change in Facts of ArcLight Capital
Holdings, LLC.
    Filed Date: 12/17/12.
    Accession Number: 20121217-5248.
    Comments Due: 5 p.m. ET 1/7/13

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 18, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-30988 Filed 12-21-12; 4:15 pm]
BILLING CODE 6717-01-P