[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32592-32593]
[FR Doc No: 2017-14755]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81108; File No. SR-ISE-2017-65]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Priority
Customer Taker Fees for Regular Orders in Select Symbols

July 10, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 30, 2017, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Schedule of Fees, as described
further below.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Schedule of
Fees to make changes to the Priority Customer \3\ taker fees for
regular orders in Select Symbols,\4\ as described in more detail below.
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    \3\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in Nasdaq ISE Rule
100(a)(37A).
    \4\ ``Select Symbols'' are options overlying all symbols listed
on the Nasdaq ISE that are in the Penny Pilot Program.
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    Currently, the Exchange charges a taker fee for regular orders in
Select Symbols that is $0.44 per contract for Market Maker \5\ orders,
$0.45 per contract for Non-Nasdaq ISE Market Maker,\6\ Firm
Proprietary,\7\ Broker-Dealer,\8\ and Professional Customer \9\ orders,
and $0.40 per contract for Priority Customer orders. In addition, the
Exchange charges a reduced Priority Customer taker fee of $0.35 per
contract for regular orders in SPY, which is the most actively traded
name on the Exchange.
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    \5\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \6\ A ``Non-Nasdaq ISE Market Maker'' is a market maker as
defined in Section 3(a)(38) of the Securities Exchange Act of 1934,
as amended, registered in the same options class on another options
exchange.
    \7\ A ``Firm Proprietary'' order is an order submitted by a
member for its own proprietary account.
    \8\ A ``Broker-Dealer'' order is an order submitted by a member
for a broker-dealer account that is not its own proprietary account.
    \9\ A ``Professional Customer'' is a person or entity that is
not a broker/dealer and is not a Priority Customer.
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    The Exchange now proposes to further reduce the Priority Customer
taker fee for regular orders in SPY from $0.35 per contract to $0.30
per contract. The Exchange also proposes to reduce the Priority
Customer taker fee for QQQ, IWM and VXX from $0.40 per contract to
$0.35 per contract. SPY, QQQ, IWM and VXX are some of the most actively
traded names on the Exchange. As such, the Exchange believes that this
reduction in fees will attract Priority Customer orders in those
symbols to ISE. Finally, the Exchange proposes to increase the Priority
Customer taker fee for regular orders in all other Select Symbols from
$0.40 per contract to $0.44 per contract.

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\10\ in general, and
Section 6(b)(4) of the Act,\11\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is reasonable and equitable to reduce
the Priority Customer taker fee for regular orders in SPY, QQQ, IWM and
VXX as the proposed fees are more favorable than those currently
offered on the Exchange. The Exchange is targeting SPY, QQQ, IWM and
VXX for this change as these are some of the most actively traded
symbols on ISE. With this change, the Exchange will charge lower taker
fees for Priority Customer orders in SPY, QQQ, IWM and VXX, thereby
attracting additional order flow in these symbols to the benefit of all
members that trade on the Exchange. Furthermore, the Exchange believes
that it is equitable and not unfairly discriminatory to only offer this
reduced taker fee to Priority Customer orders. A Priority Customer is
by definition not a broker or dealer in securities, and does not place
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s). This limitation does
not apply to participants on the Exchange whose behavior is
substantially similar to that of market professionals, including
Professional Customers, who will generally submit a higher number of
orders than Priority Customers.
    The Exchange believes that it is reasonable and equitable to
increase the Priority Customer taker fee for regular orders in all
other Select Symbols because the proposed fees will remain lower or be
equal to other market participants that remove liquidity on the
Exchange. In addition, the proposed increase will be offset by the
lower taker fees proposed for Priority Customer orders in SPY, QQQ, IWM
and VXX, which as noted above are some of the most actively traded
names on ISE. The Exchange also notes that the increased fees proposed
herein are still lower than the level of fees charged by one of the
Exchange's competitors.\12\ In addition, the Exchange believes that the
proposed fee changes are equitable and not unfairly discriminatory
because the increased Priority Customer taker fees will apply equally
to all similarly-situated market participants.
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    \12\ See C2 Options Exchange, Inc.'s Fee Schedule, Section 1:
http://www.cboe.com/publish/C2FeeSchedule/C2FeeSchedule.pdf.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\13\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
believes that the proposed fees remain competitive with those on other
options markets, and will continue to attract order flow to the
Exchange. The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.
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    \13\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\14\ and Rule 19b-4(f)(2) \15\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).
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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_ADDRESS>Please include
File Number SR-ISE-2017-65 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-ISE-2017-65. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2017-65 and should be
submitted on or before August 4, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-14755 Filed 7-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 125 (Monday, June 29, 2020)]
[Notices]
[Pages 39016-39018]
[FR Doc No: 2020-13868]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89123; File No. SR-NYSE-2020-51)

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change To Add the Consolidated Audit Trail Industry Member
Compliance Rules to the List of Minor Rule Violations

June 23, 2020.
    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 June 12, 2020, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons and
approving the proposal on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to add the Consolidated Audit Trail (``CAT'')
industry member compliance rules to the list of minor rule violations
in Rule 9217. The proposed rule change is available on the Exchange's
website at www.nyse.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to add NYSE's CAT industry member compliance
rules (the ``CAT Compliance Rules'') to the list of minor rule
violations in Rule 9217. This proposal is based upon the Financial
Industry Regulatory Authority, Inc. (``FINRA'') filing to amend FINRA
Rule 9217 in order to add FINRA's corresponding CAT Compliance Rules to
FINRA's list of rules that are eligible for minor rule violation plan
treatment.\4\
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    \4\ See Securities Exchange Act Release No. 88870 (May 14,
2020), 85 FR 30768 (May 20, 2020) (SR-FINRA-2020-013).
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Proposed Rule Change
    The Exchange recently adopted the CAT Compliance Rules in the Rule
6800 Series in order to implement the National Market System Plan
Governing the Consolidated Audit Trail (the ``CAT NMS Plan'' or
``Plan'').\5\ The CAT NMS Plan was filed by the Plan Participants to
comply with Rule 613 of Regulation NMS under the Exchange Act,\6\ and
each Plan Participant accordingly has adopted the same compliance rules
in the Exchange's Rule 6800 Series. The common compliance rules adopted
by each Plan Participant are designed to require industry members to
comply with the provisions of the CAT NMS Plan, which broadly calls for
industry members to record and report timely and accurately customer,
order, and trade information relating to activity in NMS Securities and
OTC Equity Securities.
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    \5\ See Securities Exchange Act Release No. 79907 (January 31,
2017), 82 FR 9413 (February 6, 2017) (SR-NYSE-2017-01).
    \6\ 17 CFR 242.613.
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    Rule 9217 sets forth the list of rules under which a member
organization or covered person may be subject to a fine under Rule
9216(b). Rule 9217 permits the Exchange to impose a fine of up to
$5,000 on any member or covered person for a minor violation of an
eligible rule. The Exchange proposes to amend Rule 9217 to add the CAT
Compliance Rules in the Rule 6800 Series to the list of rules in Rule
9217 eligible for disposition pursuant to a minor fine under Rule
9216(b).\7\
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    \7\ FINRA's maximum fine for minor rule violations under FINRA
Rule 9216(b) is $2,500. The Exchange will apply an identical maximum
fine amount for eligible violations of the Rule 6800 Series to
achieve consistency with FINRA and also to amend its minor rule
violation plan (``MRVP'') to include such fines. Like FINRA, the
Exchange would be able to pursue a fine greater than $2,500 for
violations of the Rule 6800 Series in a regular disciplinary
proceeding or an acceptance, waiver, and consent (``AWC'') under the
Rule 9000 Series as appropriate. Any fine imposed in excess of
$2,500 or not otherwise covered by Rule 19d-1(c)(2) of the Act would
be subject to prompt notice to the Commission pursuant to Rule 19d-1
under the Act. As noted below, in assessing the appropriateness of a
minor rule fine with respect to CAT Compliance Rules, the Exchange
will be guided by the same factors that FINRA utilizes. See text
accompanying notes 9-10, infra.
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    The Exchange is coordinating with FINRA and other Plan Participants
to promote harmonized and consistent enforcement of all the Plan
Participants' CAT Compliance Rules. The Commission recently approved a
Rule 17d-2 Plan under which the regulation of CAT Compliance Rules will
be allocated among Plan Participants to reduce regulatory duplication
for industry members that are members of more than one Participant
(``common members'').\8\ Under the Rule 17d-2 Plan, the regulation of
CAT Compliance Rules with respect to common members that are members of
FINRA is allocated to FINRA. Similarly, under the Rule 17d-2 Plan,
responsibility for common members of multiple other Plan Participants
and not a member of FINRA will be allocated among those other Plan
Participants, including to the Exchange. For those non-common members
who are allocated to NYSE pursuant to the Rule 17d-2 Plan, the Exchange
and FINRA entered into a Regulatory

Services Agreement (``RSA'') pursuant to which FINRA will conduct
surveillance, investigation, examination, and enforcement activity in
connection with the CAT Compliance Rules on the Exchange's behalf (with
the exception of such matters once a complaint is filed, which in such
instance is no longer administered through the MRVP). We expect that
the other exchanges would be entering into a similar RSA.
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    \8\ See Securities Exchange Act Release No. 88366 (March 12,
2020), 85 FR 15238 (March 17, 2020) (File No. 4-618).
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    In order to achieve consistency with FINRA and the other Plan
Participants, the Exchange proposes to adopt fines up to $2,500 in
connection with minor rule fines for violations of the CAT Compliance
Rules in the Rule 6800 Series under Rule 9217 and the Exchange's MRVP.
    FINRA, in connection with its proposed amendment to FINRA Rule 9217
to make FINRA's CAT Compliance Rules MRVP eligible, has represented
that it will apply the minor fines for CAT Compliance Rules in the same
manner that FINRA has for its similar existing audit trail-related
rules.\9\ Accordingly, in order to promote regulatory consistency, the
Exchange plans to do the same. Specifically, application of a minor
rule fine with respect to CAT Compliance Rules will be guided by the
same factors that FINRA referenced in its filing. However, more formal
disciplinary proceedings may be warranted instead of minor rule
dispositions in certain circumstances such as where violations prevent
regulatory users of the CAT from performing their regulatory functions.
Where minor rule dispositions are appropriate, the following factors
help guide the determination of fine amounts:
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    \9\ See SR-FINRA-2020-013; see also FINRA Notice to Members 04-
19 (March 2004) (providing specific factors used to inform
dispositions for violations of OATS reporting rules).
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     Total number of reports that are not submitted or
submitted late;
     The timeframe over which the violations occur;
     Whether violations are batched;
     Whether the violations are the result of the actions of
one individual or the result of faulty systems or procedures;
     Whether the firm has taken remedial measures to correct
the violations;
     Prior minor rule violations within the past 24 months;
     Collateral effects that the failure has on customers; and
     Collateral effects that the failure has on the Exchange's
ability to perform its regulatory function.\10\
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    \10\ See id.
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    Upon effectiveness of this rule change, the Exchange will publish a
regulatory bulletin notifying its member organizations of the rule
change and the specific factors that will be considered in connection
with assessing minor rule fines described above.
    For the foregoing reasons, the Exchange believes that the proposed
rule change will result in a coordinated, harmonized approach to CAT
compliance rule enforcement across Plan Participants that will be
consistent with the approach FINRA has taken with the CAT rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\11\ in general, and furthers the objectives of Section
6(b)(5),\12\ 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.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    Minor rule fines provide a meaningful sanction for minor or
technical violations of rules when the conduct at issue does not
warrant stronger, immediately reportable disciplinary sanctions. The
inclusion of a rule in the Exchange's MRVP does not minimize the
importance of compliance with the rule, nor does it preclude the
Exchange from choosing to pursue violations of eligible rules through
an AWC if the nature of the violations or prior disciplinary history
warrants more significant sanctions. Rather, the Exchange believes that
the proposed rule change will strengthen the Exchange's ability to
carry out its oversight and enforcement responsibilities in cases where
full disciplinary proceedings are unwarranted in view of the minor
nature of the particular violation. Rather, the option to impose a
minor rule sanction gives the Exchange additional flexibility to
administer its enforcement program in the most effective and efficient
manner while still fully meeting the Exchange's remedial objectives in
addressing violative conduct. Specifically, the proposed rule change is
designed to prevent fraudulent and manipulative acts and practices
because it will provide the Exchange the ability to issue a minor rule
fine for violations of the CAT Compliance Rules in the Rule 6800 Series
where a more formal disciplinary action may not be warranted or
appropriate consistent with the approach of other Plan Participants for
the same conduct.
    In connection with the fine level specified in the proposed rule
change, adding language that minor rule fines for violations of the CAT
Compliance Rules in the Rule 6800 Series shall not exceed $2,500 would
further the goal of transparency and add clarity to the Exchange's
rules. Adopting the same cap as FINRA for minor rule fines in
connection with the CAT Compliance Rules would also promote regulatory
consistency across self-regulatory organizations.
    The Exchange further believes that the proposed amendments to Rule
9217 are consistent with Section 6(b)(6) of the Act,\13\ which provides
that members and persons associated with members shall be appropriately
disciplined for violation of the provisions of the rules of the
exchange, by expulsion, suspension, limitation of activities,
functions, and operations, fine, censure, being suspended or barred
from being associated with a member, or any other fitting sanction. As
noted, the proposed rule change would provide the Exchange ability to
sanction minor or technical violations of the Rule 6800 Series pursuant
to the Exchange's rules.
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    \13\ 15 U.S.C. 78f(b)(6).
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    Finally, the Exchange also believes that the proposed changes are
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.\14\ Rule 9217 does not preclude a member
organization or covered person from contesting an alleged violation and
receiving a hearing on the matter with the same procedural rights
through a litigated disciplinary proceeding.
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    \14\ 15 U.S.C. 78f(b)(7) and 78f(d).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but rather is concerned
solely with making the CAT Compliance Rules in the Rule 6800 Series
eligible for a minor rule fine disposition, thereby strengthening the
Exchange's ability to carry out its

oversight and enforcement functions and deter potential violative
conduct.

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. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2020-51 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2020-51. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2020-51 and should be submitted on
or before July 20, 2020.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\15\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\16\ which requires that the
rules of an exchange be designed to promote just and equitable
principles of trade, to remove impediments and to 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 Commission
also believes that the proposal is consistent with Sections 6(b)(1) and
6(b)(6) of the Act \17\ which require that the rules of an exchange
enforce compliance with, and provide appropriate discipline for,
violations of Commission and Exchange rules. Finally, the Commission
finds that the proposal is consistent with the public interest, the
protection of investors, or otherwise in furtherance of the purposes of
the Act, as required by Rule 19d-1(c)(2) under the Act,\18\ which
governs minor rule violation plans.
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    \15\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \16\ 15 U.S.C. 78f(b)(5).
    \17\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
    \18\ 17 CFR 240.19d-1(c)(2).
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    As stated above, the Exchange proposes to add the CAT Compliance
Rules to the list of minor rule violations in Rule 9217 to be
consistent with the approach FINRA has taken for minor violations of
its corresponding CAT Compliance Rules.\19\ The Commission has already
approved FINRA's treatment of CAT Compliance Rules violations when it
approved the addition of CAT Compliance Rules to FINRA's MRVP.\20\ As
noted in that order, and similarly herein, the Commission believes that
Exchange's treatment of CAT Compliance Rules violations as part of its
MRVP provides a reasonable means of addressing violations that do not
rise to the level of requiring formal disciplinary proceedings, while
providing greater flexibility in handling certain violations. However,
the Commission expects that, as with FINRA, the Exchange will continue
to conduct surveillance with due diligence and make determinations
based on its findings, on a case-by-case basis, regarding whether a
sanction under the rule is appropriate, or whether a violation requires
formal disciplinary action. Accordingly, the Commission believes the
proposal raises no novel or significant issues.
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    \19\ As discussed above, the Exchange has entered into a Rule
17d-2 Plan and an RSA with FINRA with respect to the CAT Compliance
Rules. The Commission notes that, unless relieved by the Commission
of its responsibility, as may be the case under the Rule 17d-2 Plan,
the Exchange continues to bear the responsibility for self-
regulatory conduct and liability for self-regulatory failures, not
the self-regulatory organization retained to perform regulatory
functions on the Exchange's behalf pursuant to an RSA. See
Securities Exchange Release No. 61419 (January 26, 2010), 75 FR 5157
(February 1, 2010) (SR-BATS-2009-031), note 93 and accompanying
text.
    \20\ See supra note 4.
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    For the same reasons discussed above, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\21\ for approving the
proposed rule change prior to the thirtieth day after the date of
publication of the notice of the filing thereof in the Federal
Register. The proposal merely adds the CAT Compliance Rules to the
Exchange's MRVP and harmonizes its application with FINRA's application
of CAT Compliance Rules under its own MRVP. Accordingly, the Commission
believes that a full notice-and-comment period is not necessary before
approving the proposal.
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    \21\ 15 U.S.C. 78s(b)(2).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\22\ and Rule 19d-1(c)(2) thereunder,\23\ that the proposed rule change
(SR-NYSE-2020-51) be, and hereby is, approved on an accelerated basis.
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    \22\ 15 U.S.C. 78s(b)(2).
    \23\ 17 CFR 240.19d-1(c)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-13868 Filed 6-26-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35720-35721]
[DOCID:fr21jn06-156]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53982; File No. SR-NASD-2006-063]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change and Amendment No. 1 Thereto Relating to Fee for Extension
of Time Requests

June 14, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 15, 2006, the National Association of Securities Dealers, Inc.
(``NASD'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by NASD. On May 25,
2006, NASD filed Amendment No. 1 to the proposed rule change.\3\ NASD
has designated this proposal as one establishing or changing a due,
fee, or other charge under section 19(b)(3)(A)(ii) of the Act \4\ and
Rule 19b-4(f)(2) thereunder,\5\ which renders the proposal effective
upon filing with Commission. The Commission is publishing this notice
to solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, NASD made non-substantive changes to the
discussion of the purpose of the proposed rule filing.
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    NASD is proposing to amend Section 8 of Schedule A to NASD's By-
Laws to increase the service charge for processing extension requests
to $4.00 per request. Below is the text of the proposed rule change.
Proposed new language is in italics; proposed deletions are in
brackets.
* * * * *
SCHEDULE A TO NASD BY-LAWS
* * * * *
Section 8--Service Charge for Processing Extension of Time Requests
    (a) No Change.
    (b) The service charge for processing each initial extension of
time request and for all subsequent extension of time requests (1)
involving the same transaction under Regulation T and/or (2) involving
an extension of time previously granted pursuant to SEC Rule 15c3-3(n)
shall be [$2.00; provided, however, that the service charge shall be
$1.00 for extension of time requests filed electronically by members
using NASD's Automated Regulatory Reporting System]$4.00 per request.
* * * * *

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

    In its filing with the Commission, NASD 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. NASD 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
    Regulation T, issued by the Board of Governors of the Federal
Reserve System (``FRB'') pursuant to the Act, among other things,
governs the extension of credit to customers by broker-dealers for
purchasing securities.\6\ Rule 15c3-3 under the Act governs, among
other things, the time period in which broker-dealers must complete
sell orders on behalf of customers.\7\ Under SEC Rule 15c3-3(n), a
self-regulatory organization (``SRO'') may grant a broker-dealer an
extension of time for delivery on sales of securities

if: (1) It is satisfied that the broker-dealer is acting in good faith
in making the application; and (2) exceptional circumstances warrant
such action. Regulation T has a similar standard to allow an extension
of time for payment for purchases of securities.\8\
---------------------------------------------------------------------------

    \6\ 12 CFR 220.4(c) and 220.8(d). Regulation T generally
requires that customers with a cash account pay for securities
within five business days of purchase; for customers with a margin
account, there must be sufficient minimum margin (typically 50%) to
support the purchase.
    \7\ 17 CFR 240.15c3-3. In particular, Rule 15c3-3(m) requires a
broker-dealer that executes a customer sell order to obtain
possession of the securities within ten business days of the
settlement date or to close the transaction by purchasing the
securities.
    \8\ Under Regulation T, a firm's examining authority may grant
an extension unless the examining authority believes that the
broker-dealer is not acting in good faith or that the broker-dealer
has not sufficiently determined that exceptional circumstances
warrant such action. See supra note 6.
---------------------------------------------------------------------------

    NASD proposes to amend Section 8 of Schedule A to NASD's By-Laws to
increase the service charge for processing each extension of time
request pursuant to the provisions of Regulation T and Rule 15c3-3 from
$2 (or $1 in the case of electronically filed extension of time
requests) to $4 for all manually or electronically filed extension of
time requests. NASD believes that the proposed fees align with the
actual costs associated with reviewing, processing, recording and
responding to such requests. The NYSE similarly increased the fee it
charges for extension requests to $4.00 per extension.\9\
---------------------------------------------------------------------------

    \9\ See Exchange Act Release No. 53235 (February 6, 2006), 71 FR
7820 (February 14, 2006) (SR-NYSE-2005-92) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change and Amendment No.
1 Thereto Relating to Increasing Certain Fees Charged by the NYSE to
Its Members and Member Organizations).
---------------------------------------------------------------------------

    NASD has filed the proposed rule change for immediate
effectiveness. The new fee shall be implemented on July 1, 2006.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of section 15A(b)(5) of the Act,\10\ which requires, among
other things, that NASD's rules provide for the equitable allocation of
reasonable dues, fees and other charges among members and issuers and
other persons using any facility or system that NASD operates or
controls. NASD believes that the rule change reflects NASD's increased
costs in reviewing, processing and administering the extensions of time
requests.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

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

    NASD does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change is effective upon filing with the
Commission pursuant to section 19(b)(3)(A) of the Act \11\ and Rule
19b-4(f)(2) thereunder,\12\ because it establishes or changes a due,
fee, or other charge imposed by NASD. At any time within 60 days of the
filing of the proposed rule change, the Commission may summarily
abrogate 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.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
    \13\ The effective date of the original proposed rule change is
May 15, 2006, and the effective date for Amendment No. 1 is May 25,
2006. For purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposed rule change, as
amended, under section 19(b)(3)(C) of the Act, the Commission
considers the period to commence on May 25, 2006, the date on which
NASD submitted Amendment No. 1. See 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-063 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NASD-2006-063. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of NASD.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NASD-2006-063
and should be submitted on or before July 12, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-9691 Filed 6-20-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54461-54462]
[FR Doc No: 2013-21414]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-139-000.
    Applicants: Basin Creek Equity Partners L.L.C., Capitol District
Energy Center Cogeneration, Forked River Power LLC, Pawtucket Power
Associates Limited Partnership, Pittsfield Generating Company, L.P.

    Description: Joint Application for Authorization for Disposition of
Jurisdictional Facilities Pursuant to Section 203 of the FPA of Basin
Creek Equity Partners, LLC, et al.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5273.
    Comments Due: 5 p.m. ET 9/16/13.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-2238-000.
    Applicants: BE Ironwood LLC.
    Description: Tariff Cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5184.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2239-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 1883R2 Westar Energy, Inc. NITSA and NOA to be
effective 8/1/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5177.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2240-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 1884R2 Westar Energy, Inc. NITSA and NOA to be
effective 8/1/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5180.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2241-000.
    Applicants: Central Power & Lime LLC.
    Description: Tariff cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5185.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2242-000.
    Applicants: BE Louisiana LLC.
    Description: Tariff cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5194.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2243-000.
    Applicants: BE Rayle LLC.
    Description: Tariff cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5202.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2244-000.
    Applicants: Cedar Brakes II, L.L.C.
    Description: Tariff Cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5207.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2245-000.
    Applicants: Southern California Edison Company.
    Description: GIA and Distribution Service Agmt with Rhodia Inc to
be effective 10/26/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5217.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2246-000.
    Applicants: BE Allegheny LLC.
    Description: Tariff cancellation to be effective 10/25/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5218.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2247-000.
    Applicants: NorthWestern Corporation.
    Description: SA 689 and 690--Second Amended GIAs with PPL Montana
to be effective 8/23/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5220.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2248-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 1885R2 Westar Energy, Inc. NITSA and NOA to be
effective 8/1/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5221.
    Comments Due: 5 p.m. ET 9/16/13.

    Docket Numbers: ER13-2249-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 1887R2 Westar Energy, Inc. NITSA and NOA to be
effective 8/1/2013.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5243.
    Comments Due: 5 p.m. ET 9/16/13.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR13-10-000.
    Applicants: North American Electric Reliability Corporation.
    Description: North American Electric Reliability Corporation
Petition for Approval of the Further Amendments to the Amended and
Restated Delegation Agreement with Western Electricity Coordinating
Council.
    Filed Date: 8/26/13.
    Accession Number: 20130826-5266.
    Comments Due: 5 p.m. ET 9/16/13.

    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: August 27, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-21414 Filed 9-3-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73482-73483]
[FR Doc No: 2020-25412]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidance for Tiotropium Bromide; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry, entitled
``Draft Guidance for Tiotropium Bromide.'' The draft guidance, when
finalized, will provide product-specific recommendations on, among
other things, the information and data needed to demonstrate
bioequivalence (BE) to support abbreviated new drug applications
(ANDAs) for tiotropium bromide inhalation spray.

DATES: Submit either electronic or written comments on the draft
guidance by January 19, 2021 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 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-2007-D-0369 for ``Draft Guidance for Tiotropium Bromide.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' will be publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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. 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.

FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-
796-0683.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a draft guidance on a generic
tiotropium bromide inhalation spray.
    FDA initially approved new drug application 21936 for SPIRIVA
RESPIMAT (tiotropium bromide inhalation spray) in September 2015. We
are now issuing draft guidance for industry on BE recommendations for
generic tiotropium bromide inhalation spray (``Draft Guidance for
Tiotropium Bromide'').
    In October 2012, Boehringer Ingelheim, manufacturer of the
reference listed drug SPIRIVA HANDIHALER, new drug application 21395,
submitted a citizen petition requesting, among other things, that FDA
adopt and apply certain requirements in its review of any

proposed generic and follow-on versions of SPIRIVA HANDIHALER or any
other Boehringer Ingelheim oral inhalation product containing the
active ingredient tiotropium bromide under section 505(j) and (b)(2),
respectively, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j) and (b)(2)) (Docket No. FDA-2012-P-1072). FDA is reviewing the
issues raised in the petition and will consider any comments on the
draft guidance entitled ``Draft Guidance for Tiotropium Bromide''
before responding to Boehringer's citizen petition.
    The 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 current thinking of FDA on the
information and data to demonstrate BE to support ANDAs for tiotropium
bromide inhalation spray. 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.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25412 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Notices]
[Page 50232-50233]
[DOCID:fr30se09-85]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2009-0001]

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; new information
collection; OMB No. 1660-NEW; FEMA Form 089-8, IBSGP Investment
Justification Template.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed new information collection. In accordance with
the Paperwork Reduction Act of 1995, this Notice seeks comments
concerning the Intercity Bus Security Grant Program (IBSGP).

DATES: Comments must be submitted on or before November 30, 2009.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
docket ID FEMA-2009-0001. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Wash, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include docket
ID FEMA-2009-0001 in the subject line.
    All submissions received must include the agency name and docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available on the Privacy and Use Notice link on the
Administration Navigation Bar of www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Alexander Mrazik, Program
Analyst, Grant Programs Directorate,<PHONE_NUMBER> for additional
information. You may contact the Records Management Branch for copies
of the proposed collection of information at facsimile number (202)
646-3347 or e0mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Intercity Bus Security Grant Program
(IBSGP) is a DHS grant program that focuses on infrastructure
protection activities. IBSGP is one tool among a comprehensive set of
measures authorized by Congress and implemented by the Administration
to help strengthen the nation's critical infrastructure against risks
associated with potential terrorist attacks. Section 1532, Title XV of
the Implementing Recommendations of the 9/11 Commission Act of 2007 (6
U.S.C. 1182), mandates the Secretary to establish a grant program for
eligible private operators providing transportation by an over-the-road
bus for security improvements and that the Secretary shall determine
the requirements for grant recipients, including application
requirements.

Collection of Information

    Title: FEMA FY 2009 Preparedness Grants: Intercity Bus Security
Grant Program (IBSGP).
    Type of Information Collection: New information collection.
    OMB Number: 1660-NEW.
    Form Titles and Numbers: FEMA Form 089-8, IBSGP Investment
Justification Template.
    Abstract: The IBSGP Investment Justification Template is submitted
with the application which provides narrative details on proposed
investments. These Investment Justifications must demonstrate how
proposed projects address gaps and deficiencies in current programs and
capabilities and the ability to provide enhancements consistent with
the purpose of the program and guidance provided by FEMA. The data from
the IBSGP Investment Justification Template is collected to assist
decision-making at all levels, although it is primarily used by
individual application reviewers.
    Affected Public: Business or other for-profit.
    Estimated Total Annual Burden Hours: 280 hours.

                                                 Table A.12--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                Avg. burden     Total                     Total
                                                                Number of    responses      Total         per         annual    Avg. hourly     annual
         Type of respondent            Form name/form number   respondents      per       number of     response   burden  (in   wage rate*   respondent
                                                                             respondent   responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Business or other for-profit........  IBSGP Investment                  56            1           56            5          280       $25.97    $7,271.60
                                       Justification
                                       Template, FEMA Form
                                       089-8.
                                                              ------------------------------------------------------------------------------------------
    Total...........................  .......................           56  ...........  ...........  ...........          280  ...........    $7,271.60
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: There is no annual reporting recordkeeping cost
associated with this collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Larry Gray,
Director, Records Management Division, Office of Management, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. E9-23520 Filed 9-29-09; 8:45 am]

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[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19663-19664]
[FR Doc No: 2012-7895]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2011-0542; FRL-9654-9]

Notice of Data Availability Concerning Renewable Fuels Produced
from Palm Oil Under the RFS Program; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
an extension in the public comment period for the ``Notice of Data
Availability Concerning Renewable Fuels Produced from Palm Oil under
the RFS Program'' (the notice is herein referred to as the ``palm oil
NODA''). EPA published a NODA, which included a request for comment, in
the Federal Register on January 27, 2012 (77 FR 4300). The public
comment period was to end on February 27, 2012--30 days after
publication in the Federal Register. On February 14, 2012, EPA
published a notice extending the comment period by 30 days until March
28, 2012. The purpose of this document is to extend the comment period
an additional 30 days until April 27, 2012. This extension of the
comment period is provided to allow the public additional time to
provide comment on the NODA.

DATES: Comments must be received on or before April 27, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2011-0542, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: Air and Radiation Docket and Information
Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20004. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2011-0542. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or<EMAIL_ADDRESS>The www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC 20004. The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Air Docket is (202) 566-
1742.

FOR FURTHER INFORMATION CONTACT: Aaron Levy, Office of Transportation
and Air Quality, Transportation and Climate Division, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460
(MC: 6041A); telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In a separate notice of data availability, EPA provided an
opportunity to comment on EPA's analyses of palm oil used as a
feedstock to produce biodiesel and renewable diesel under the Renewable
Fuel Standard (RFS) program. EPA's analysis of palm oil-based biofuels
is a supplement to the final rule published on March 26, 2010, which
made changes to the RFS program (75 FR 14670). EPA's analysis of the
two types of biofuel shows that biodiesel and renewable diesel produced
from palm oil have estimated lifecycle greenhouse gas (GHG) emission
reductions of 17% and 11% respectively for these biofuels compared to
the statutory baseline petroleum-based diesel fuel used in the

RFS program. This analysis indicates that both palm oil-based biofuels
would not qualify as meeting the minimum 20% GHG performance threshold
for renewable fuel under the RFS program. On February 14, 2012, EPA
published a notice extending the comment period by 30 days until March
28, 2012 to provide the public additional time to comment on the NODA.

Extension of Comment Period

    EPA received requests for an additional extension of the palm oil
NODA comment period from various parties. After considering all of
these comments, EPA has determined that an extension of the comment
period would provide the public adequate time to provide meaningful
comment on the NODA. However, this need must be balanced against our
desire to finalize our analysis in a timely manner. EPA believes that
an additional 30 days is an appropriate amount of time to balance these
needs. Accordingly, the public comment period for the palm oil NODA is
extended until April 27, 2012. EPA does not anticipate any further
extension of the comment period at this time.

    Dated: March 27, 2012.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air Quality.
[FR Doc. 2012-7895 Filed 3-30-12; 8:45 am]
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