[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16794-16800]
[FR Doc No: 2022-06193]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94474; File No. SR-CboeBZX-2021-083]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing of Amendment No. 2 and Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Amendment No. 2, To Amend Rule
25.3, Which Governs the Exchange's Minor Rule Violation Plan, in
Connection With Certain Minor Rule Violations and Applicable Fines

March 18, 2022.

I. Introduction

    On December 6, 2021, Cboe BZX Exchange, Inc. (``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) \1\ of the Securities
Exchange Act of 1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ a
proposed rule change to amend Rule 25.3, which governs the Exchange's
Minor Rule Violation Plan (``MRVP''), in connection with certain minor
rule violations and applicable fines. The proposed rule change was
published for comment in the Federal Register on December 23, 2021.\4\
On February 3, 2022, the Commission extended the time period within
which to approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to approve or
disapprove the proposed rule change.\5\ On March 8, 2022, the Exchange
filed Amendment No. 1 to the proposed rule change, which replaced and
superseded the proposed rule change as originally filed. On March 11,
2022, the Exchange filed Amendment No. 2 to the proposed rule change,
which replaced and superseded the proposed rule change as modified by
Amendment No. 1.\6\ The Commission received no comments on the proposed
rule change. The Commission is publishing this notice to

solicit comments on Amendment No. 2 from interested persons and is
approving the proposed rule change, as modified by Amendment No. 2, 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.
    \4\ See Securities Exchange Act Release No. 93834 (December 20,
2021), 86 FR 73072.
    \5\ See Securities Exchange Act Release No. 94142, 87 FR 7518
(February 9, 2022) (extending the time period to March 23, 2022).
    \6\ In Amendment No. 2, the Exchange revised the proposal to:
(1) Provide additional detail and clarification regarding the
Exchange's current and proposed treatment of violations of a Market
Maker's quoting obligations, (2) correct an inadvertent error in the
Exhibit 5, and (3) remove a superfluous provision in the Exhibit 5
to provide for additional clarity. Amendment No. 2 to the proposed
rule change is available at: https://www.sec.gov/comments/sr-cboebzx-2021-083/srcboebzx2021083.htm.
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II. The Exchange's Description of the Proposed Rule Change, as Modified
by Amendment No. 2

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

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

1. Purpose
    The Exchange proposes to amend its MRVP in Rule 25.3 in connection
with certain minor rule violations and applicable fines. Rule 25.3
provides for disposition of specific violations through assessment of
fines in lieu of conducting a formal disciplinary proceeding.\7\
Current Rule 25.3(a)-(g) sets forth a list of specific Exchange Rules
under which an Options Member, associated person of an Options Member,
or registered or non-registered employee of an Options Member may be
subject to a fine for violations of such Rules and the applicable fines
that may be imposed by the Exchange.
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    \7\ The Exchange may, with respect to any such violation,
proceed under Rule 8.15 (Imposition of Fines for Minor Violation(s)
of Rules) and impose the fine set forth in Rule 25.3(a)-(g).
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    Specifically, the proposed rule change amends Rule 25.3 by: (1)
Eliminating violations of Rule 22.6(a) (regarding Market Maker firm
quotes) in Rule 25.3(c), which currently imposes fines for violations
of Rules 22.6(a) through (c) (Market Maker Quotations); (2) relocating
violations of Rule 22.6(b) (regarding Market Maker initial quote volume
requirements) and Rule 22.6(c) (regarding Market Maker two-sided quote
requirements) to Rule 25.3(d),\8\ which currently imposes fines for
violations of Rule 22.6(d) (regarding Market Maker continuous quoting
obligations) so that a single MRVP provision governs violations of a
Market Maker's quoting obligations; and (3) updating the fine schedule
applicable to minor rule violations related to Market Maker quoting
obligations (i.e., Rules 22.6(b)-(d), as proposed) in Rule 25.3(d).
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    \8\ As a result of the proposed elimination or relocation of the
rule violations listed under Rule 25.3(c), the proposed rule change
ultimately eliminates Rule 25.3(c) from the MRVP and subsequently
renumbers current Rules 25.3(d), 25.3(e), 25.3(f) and 25.3(g) to
Rules 25.3(c), 25.3(d), 25.3(e) and 25.3(f), respectively. In
addition to this, the proposed rule change makes a nonsubstantive
formatting change to Rule 25.3(e) (25.3(d), as amended) to denote
with a ``(2)'' where subparagraph (2) begins, which is titled
``American-Style, Cash-Settled Index Options''.
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    First, the proposed rule change eliminates the violation of 22.6(a)
currently in Rule 25.3(c) of the MRVP. Specifically, Rule 22.6(a)
requires a Market Maker to submit bids and offers that are firm for all
orders. The Exchange no longer believes violations of Rule 22.6(a) to
be minor in nature and therefore proposes to remove it from the list of
rules in Rule 25.3 eligible for a minor rule fine disposition.
Particularly, the Exchange believes that violations of Rule 22.6(a), to
the extent they would occur,\9\ may directly impact trading on the
Exchange, the maintenance of a fair and orderly market and customer
protections because honoring firm quotations is vital in promoting
efficient functioning of intermarket price priority and trading in
general. Pursuant to Rule 25.3, the Exchange is not required to proceed
under said Rules as to any rule violation and may, whenever such action
is deemed appropriate, commence a disciplinary proceeding under Chapter
VIII (Discipline) rules as to any such violation. The Exchange notes
that the proposed rule change is consistent with the MRVP of its
affiliated options exchange, Cboe Exchange, Inc. (``Cboe Options''),
which recently filed a proposal, approved by the Commission,\10\ to no
longer include such violations as eligible for a minor rule disposition
on Cboe Options for the same reason--it no longer believed violations
of the firm quote requirement to be minor in nature.
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    \9\ The Exchange notes that Market Maker bids and offers entered
on the Exchange's all-electronic trading platform are firm for all
orders for the number of contracts specified in the bid and offer,
subject to the exceptions noted in Rule 22.6(a) and in Rule 602 of
Regulation NMS under the Exchange Act of 1934 (the ``Act''), and
that the electronic execution of marketable orders against resting
bids and offers is system-enforced by the Exchange as provided in
the Exchange Rules.
    \10\ See Securities Exchange Act Release No. 92702 (August 18,
2021), 86 FR 47346 (August 24, 2021) (SR-CBOE-2021-045) (Notice of
Filing and Order Granting Accelerated Approval of a Proposed Rule
Change To Amend Rule 13.15, Which Governs the Exchange's Minor Rule
Violation Plan).
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    The proposed rule change next relocates violations of Rules 22.6(b)
and (c), currently in Rule 25.3(c) of the MRVP, to Rule 25.3(d) (Rule
25.3(c), as amended) \11\ of the MRVP. The Exchange notes that Rule
22.6 governs Market Maker quoting obligations on the Exchange and, more
specifically, Rule 22.6(b) requires a Market Maker to submit initial
quotes that contain a minimum size (currently, at least one contract)
and Rule 22.6(c) requires a Market Maker to submit two-sided quotes. As
stated above, Rule 25.3(d) currently imposes certain fines for a Market
Maker's failure to meet the continuous quoting obligations in Rule
22.6(d). By relocating violations of Rules 22.6(b) and (c) to join
violations of Rule 22.6(d) in Rule 25.3(d) of the MRVP, the proposed
rule change amends the MRVP to impose the same fine schedule for
violations of a Market Maker's quoting obligations. As a result of
combining these into Rule 25.3(d), the proposed rule change
subsequently renames Rule 25.3(d) as ``Market Maker Quoting
Obligations''. The Exchange notes that the proposed rule change is
consistent, and intended to harmonize to the extent possible, with the
MRVP of the Exchange's affiliated options exchange, Cboe Options, which
imposes one fine schedule for a market maker's failure to meet its
quoting obligations on Cboe Options, including failure to meet
continuous quoting requirements and failure to meet initial quote
volume requirements.\12\ The Exchange's other affiliated options
exchanges, Cboe EDGX Exchange, Inc. (``EDGX Options'') and Cboe C2
Exchange, Inc. (``C2 Options''), have also filed proposals to update
their MRVPs in connection with the violations of market maker quoting
requirements on EDGX Options and C2 Options, to the extent possible, in
an identical manner.\13\
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    \11\ See supra note 9.
    \12\ See Cboe Options Rule 13.15(g)(9).
    \13\ The Exchange notes that C2 Option's proposal has been
approved by the Commission and EDGX Option's proposal is currently
pending approval by the Commission. See Securities Exchange Act
Release Nos. 93887 (December 30, 2021), 87 FR 504 (January 5, 2022)
(SR-C2-2021-019) (Notice of Filing and Order Granting Accelerated
Approval of a Proposed Rule Change Relating to Certain Fine Amounts
in Rule 13.15, Which Governs the Exchange's Minor Rule Violation
Plan, and Non-Substantive Clarifying Changes); and 93815 (December
17, 2021), 86 FR 73029 (December 23, 2021) (SR-CboeEDGX-2021-052)
(Notice of Filing of a Proposed Rule Change To Amend Rule 25.3,
Which Governs the Exchange's Minor Rule Violation Plan, in
Connection With Certain Minor Rule Violations and Applicable Fines).
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    The Exchange notes that, under current Rule 25.3(c), violations of
the Market Maker initial quote volume requirement (Rule 22.6(b)) and
violations of the Market Maker two-sided quote requirement (Rule
22.6(c)) are to be treated separately for purposes of determining the
number of cumulative violations under the applicable fine schedule. For
example,

if during the same period, a Market Maker violates the initial quote
volume requirement five times and also violates the two-sided quote
requirement four times, the current provision would provide for two
separate Letters of Caution (one for the initial quote size violations
and one for the two-sided quote violations).\14\ The Cboe Options MRVP
applicable to violations of market maker quoting obligations does not
contain this language and, as proposed, the amended MRVP language would
not include this ``separate treatment'' provision for Market-Maker
quoting obligations to be consistent with corresponding Cboe Options
MRVP provision. Additionally, while current Rule 25.3(c) provides that
Rules 22.6(b) and (c) shall be treated separately for purposes of
determining the number of cumulative violations, pursuant to Rule
8.15(a), the Exchange, like Cboe Options, is permitted to ``aggregate
similar violations generally if the conduct was unintentional, there
was no injury to public investors, or the violations resulted from a
single systemic problem or cause that has been corrected.'' \15\ The
Exchange, like Cboe Options, considers violations of a Market Maker's
quoting obligations Rule 22.6(b), (c) and (d)) to be similar in
nature.\16\ The Exchange believes moving violations of Rule 22.6(b) and
(c) from Rule 25.3(c) to Rule 25.3(d) and removing the language to
treat each paragraph separately for purposes of determining the
cumulative violations aligns with how the Exchange generally surveils
for and sanctions violations across market maker quoting obligations
while still allowing the flexibility to treat the violations
separately, if necessary. By aligning the fine schedule across each of
the Market Maker quoting obligations the proposed rule change will
allow for consistent application of the MRVP for the various Market
Maker quoting obligations whether the violations are sanctioned
separately or aggregation is warranted pursuant to Rule 8.15(a).
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    \14\ The Exchange notes that Rule 22.6(b) requires the best bid
and best offer entered by a Market Maker to have a size of at least
one contract. The System requires a bid or offer to include a size
of at least one contract, as a bid or offer with a size of zero
results in any existing bid/offer quote for that series to be
cancelled. As a result, the Exchange does not observe violations of
Rule 22.6(b), but retains the provision in MRVP should the minimum
size requirement be greater than one in the future.
    \15\ Cboe Options Rule 13.15(a) contains the same language. The
Exchange, like Cboe Options, may consider violations of a Market
Maker's quoting obligations under Rule 22.6(b), (c), and (d) to be
similar in nature.
    \16\ The Exchange notes that Rule 22.6(d) requires a Market
Maker to provide continuous bids and offers in accordance with,
among other things, the Rule 22.6(c) requirement to provide two-
sided quotes. Because two-sided quotes are an element of the
continuous electronic quote obligation, and violations of continuous
quoting requirements can be the direct result of failure to provide
two-sided quotes, the Exchange commonly cites Rule 22.6(d) in
connection with two-sided quote violations. However, depending on
the particular facts and circumstances, a Market Maker may be cited
for a violation of continuous electronic quotes under Rule 22.6(d)
or two-sided quotes under Rule 22.6(c) or both.
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    Further, the Exchange notes that Rule 25.3(d) currently provides
that violations occurring during a calendar month are aggregated and
sanctioned as a single offense. In line with the proposed change to
allow the Exchange the flexibility to choose to aggregate violations
across different sections governing market maker quoting obligations
(upon the proposed relocation of the Market Maker two-sided quote and
initial quote volume requirements to Rule 25.3(d)), the proposed rule
change removes this language.\17\ Without the explicit requirement that
the Exchange must aggregate and sanction violations as a single
offense, the Exchange is free to determine whether or not violations of
a Market Maker's quoting obligations across different sections, and
across different review periods (e.g., calendar months),\18\ should be
aggregated and sanctioned as a single offense pursuant to Rule 8.15(a);
\19\ just as the Exchange may choose to aggregate violations, pursuant
to Rule 8.15(a), across different sections without time constraints
(e.g., in a calendar month) under other MRVP provisions that otherwise
do not contain any explicit aggregation requirement.\20\ Moreover, the
Exchange believes that, notwithstanding the relocation of the two-sided
quote and initial quote volume requirements to Rule 25.3(d), the
aggregation requirement in Rule 25.3(d) currently conflicts with Rule
22.6(d) and a Market Maker's continuous quoting obligations.
Specifically, Rule 22.6(d)(1) provides that the Exchange determines
compliance by a Market Maker with the continuous quoting obligation in
Rule 22.6(d) on a monthly basis. Rule 22.6(d)(1) goes on to provide
that determining compliance with the continuous quoting obligations on
a monthly basis does not relieve a Market Maker from meeting this
obligation on a daily basis, nor does it prohibit the Exchange from
taking disciplinary action against a Market Maker for failing to meet
this obligation each trading day. Therefore, the Exchange believes that
it should have the flexibility to be able to separately charge for
violations of a Market Maker's continuous quoting obligations on a
monthly basis and a daily basis.
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    \17\ Amendment No. 2 corrects an inadvertent error made to the
rule text in the Exhibit 5. Amendment No. 1 inadvertently did not
delete the proposed rule text changes to the Exhibit 5 made by the
Initial Rule Filing to the sentence that provides that ``Violations
occurring during a calendar month are aggregated and sanctioned as a
single offense'' before making proposed rule text changes to remove
this entire sentence. As such, Amendment No. 2 corrects this
inadvertent error by removing the rule text changes to the Exhibit 5
made by the Initial Rule Filing to this sentence and updating the
Exhibit 5 to correctly reflect the deletion of the entire sentence,
as made pursuant to Amendment No. 1.
    \18\ See infra note 22.
    \19\ See supra note 16.
    \20\ If the current provision were to be maintained in Rule
25.3(d) upon the relocation of the initial quote volume requirement
and the two-sided quote requirement to Rule 25.3(d), then violations
of a Market Maker's quoting obligations would never amount to more
than one offense if they occurred in the same month. For example, if
a Market Maker were to violate Rule 22.6(d) in February 2022 and
violate Rule 22.6(b) and/or Rule 22.6(c) during the same month,
then, pursuant to the current provision, such violations would have
to be treated as a single offense and could not constitute more than
one offense.
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    The proposed rule change also updates the fine schedule heading in
Rule 25.3(d) to reflect that fines may be imposed per the number of
offenses, rather than violations, within one period (i.e., any rolling
24-month period), which more accurately reflects the manner in which
the Exchange aggregates violations as a single offense under Rule
25.3(d), currently and as proposed, and further harmonizes Rule 25.3(d)
with that of Cboe Options corresponding MRVP provision, which also
counts the number of offenses in connection with market maker
violations of quoting obligations in any rolling 24-month period.
    Ultimately, the Exchange believes that the proposed flexibility to
choose whether to aggregate violations of a Market Maker's quoting
obligations across sections will allow it to administer discipline in a
manner it deems most appropriate. For example, if a Market Maker
violates its continuous quoting obligation pursuant to Rule 22.6(d) on
multiple trading days, January 27, 28 and 31, 2022, due to a systemic
error, and also violates the initial quote volume requirement pursuant
to Rule 22.6(b) multiple times during the next trading day, February 1,
2022,\21\ due to the same systemic error that has since been corrected,
the

Exchange may deem it appropriate to treat such violations as a single
offense \22\ and issue a Letter of Caution, which is applicable to a
first offense pursuant to Rule 25.3(d). This would be in lieu of
treating such violations as two separate offenses--the violation of the
Market Maker's continuous quoting obligations (22.6(d)) as a first
offense, for which the Exchange would issue a Letter of Caution, and
the violations of its initial quote volume requirement aggregated into
a separate, second offense, for which the Exchange would then issue a
fine applicable to a second offense pursuant to Rule 25.3(d) (as
proposed and described in detail below). If, in June 2022 (i.e., within
the same 24-month period as the above referenced violations),\23\ the
Market Maker violates the initial quote volume requirement multiple
times throughout the month due to another systemic error, and also
violates the continuous quote requirement pursuant to Rule 22.6(d) on
multiple days throughout June 2022 due to the same systemic error, the
Exchange may again deem it appropriate to treat these violations as a
single offense, constituting the Market Maker's second offense within
the previous rolling 24-month period for which the Exchange would then
issue a fine applicable to a second offense pursuant to Rule 25.3(d)
(as proposed). The Exchange could, alternatively, choose to aggregate
the June 2022 violations of the initial quote volume requirement as one
offense and the June 2022 violations of the continuous quote
requirement as another offense, which would result in the issuance of
two offenses stemming from the same review period (i.e., a review of
June 2022) \24\ to which the Exchange would then issue a fine
applicable to a second and third offense within the previous rolling
24-month period pursuant to Rule 25.3(d) (as proposed).
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    \21\ The Exchange is not required to treat violations occurring
in separate review periods (e.g., a monthly review, a weekly review,
etc.) as separate offenses and the Exchange is not required to treat
violations occurring in the same review period as a single offense
(including as proposed--in connection with removing the provision in
Rule 25.3(d) that requires the Exchange to aggregate and sanction
violations occurring in a month as a single offense).
    \22\ See supra note 16.
    \23\ See Rule 25.3, which states that a subsequent violation is
calculated on the basis of a rolling 24-month period (``Period'').
    \24\ See supra note 22.
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    The proposed rule change next amends the fine schedule in Rule
25.3(d) (Rule 25.3(c), as amended) \25\ applicable to Market Makers for
violations of their quoting obligations (Rules 22.6(b)-(d), as
proposed) in order to harmonize, to the extent possible, this MRVP
provision with the corresponding Cboe Options MRVP provision applicable
to violations of a market maker's quoting obligations on Cboe Options.
The current fine schedule in Rule 25.3(d), currently applicable to
violations of a Market Maker's continuous quoting obligations, sets
forth the following:
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    \25\ See supra note 9.
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    For the first violation during any rolling 24-month period (i.e.,
one period),\26\ the fine schedule imposed by Rule 25.3(d) currently
permits the Exchange to give a Letter of Caution. For a second
violation during the same period, the fine schedule currently permits
the Exchange to apply a fine of $1,000. For a third violation in the
same period, the fine schedule currently permits the Exchange to apply
a fine of $2,500. For a fourth violation in the same period, the fine
schedule currently permits the Exchange to apply a fine of $5,000.
Finally, for five or more violations in the same period, the fine
schedule currently permits the Exchange to proceed with formal
disciplinary action.
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    \26\ See supra note 24.
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    The proposed rule change updates the fine schedule to provide that,
during any rolling 24-month period, the Exchange may continue to give a
Letter of Caution for a first offense,\27\ may apply a fine of $1,500
for a second offense,\28\ may apply a fine of $3,000 for a third
offense, and may proceed with formal disciplinary action for subsequent
offenses. As described above, and as is the case for all rule
violations covered under Rule 25.3, the Exchange may determine that it
is appropriate to commence a formal disciplinary proceeding for a
violation of Market Maker quoting obligations and may choose to proceed
under the Exchange's formal disciplinary rules rather than its MRVP.
The Exchange may continue to aggregate similar violations generally if
the conduct was unintentional, there was no injury to public investors,
or the violations resulted from a single systemic problem or cause that
has been corrected, and treat such violations as a single offense.\29\
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    \27\ As stated herein, the proposed rule change also updates the
fine schedule heading to reflect that fines may be imposed per the
number of offenses, rather than violations, which more accurately
reflects the manner in which the Exchange aggregates violations as a
single offense under Rule 25.3(d), currently and as proposed.
    \28\ Any fine imposed pursuant to the Exchange's MRVP that does
not exceed $2,500 and is not contested shall not be publicly
reported, except as may be required by Rule 19d-1 under the Act or
as may be required by any other regulatory authority. See Rule
8.15(a).
    \29\ See Rule 8.15(a).
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    The Exchange believes it is appropriate to increase the fine
amounts for a second and third offense and to remove the fine imposed
for a fourth offense and proceed with formal disciplinary proceedings
for subsequent offenses following a third offense. Particularly, the
Exchange believes that applying a higher fine per second and third
offenses in connection with a Market Maker's quoting obligations \30\
and, ultimately, formal disciplinary proceedings for any subsequent
offenses during a rolling 24-month period, will allow the Exchange to
levy progressively larger fines and greater penalties (i.e., formal
disciplinary proceedings following a third offense) against repeat-
offenders. The Exchange believes this fine structure may serve to more
effectively deter repeat-offenders while continuing to provide
reasonable warning for a first offense during a rolling 24-month
period. The Exchange notes that the proposed fine schedule for
violations of a Market Maker's quoting obligations is identical to the
fine schedule under the MRVP of Cboe Options for market maker
violations of quoting obligations on Cboe Options, including a
continuous quoting requirement and initial volume requirement. The
Exchange further notes that the proposed change is intended to provide
for consistency across the Exchange's MRVP and the MRVPs of its
affiliated options exchanges, Cboe Options, EDGX Options and C2
Options, as EDGX Options and C2 Options also intend to file proposals
to update their minor rule violation fines for violations of market
maker quoting requirements on their exchanges in an identical manner.
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    \30\ The proposed fine amounts are also an increase from the
fines in Rule 25.3(c) currently imposed for violations of Market
Maker initial quote volume and two-sided requirements. The Exchange
notes, however, that Rule 25.3(c) currently imposes fines per
violation whereas Rule 25.3(d) imposes fines per offense, which may
be cumulative violations of Market Maker quoting obligations, as
proposed.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\31\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \32\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to

and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Exchange believes the proposed rule change is consistent
with the Section 6(b)(5) \33\ requirement that the rules of an exchange
not be designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \31\ 15 U.S.C. 78f(b).
    \32\ 15 U.S.C. 78f(b)(5).
    \33\ Id.
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    The Exchange believes that the proposed rule change to remove the
firm quote requirement, which it no longer considers violations of
which to be minor in nature, as eligible for a minor rule fine
disposition under its MRVP, will assist the Exchange in preventing
fraudulent and manipulative acts and practices and promoting just and
equitable principles of trade, and will serve to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, protect investors and the public
interest. Particularly, the Exchange believes that violations of the
firm quote requirement may directly impact trading on the Exchange,
maintenance of a fair and orderly market, and customer protection. As
such, the Exchange does not believe violations of this rule to be minor
in nature and, instead, should be handled under its formal disciplinary
rules, rather than imposing fines pursuant to its MRVP. Also, and as
stated above, the proposed rule change is consistent with the MRVP of
its affiliated options exchange, Cboe Options, which, for the same
reasons provided herein, no longer includes violations of the firm
quote requirement as eligible for a minor rule disposition on Cboe
Options.\34\
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    \34\ See supra note 11.
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    The Exchange believes that the proposed rule change to apply the
same MRVP fine schedule for violations of a Market Makers quoting
obligations pursuant to Rule 22.6 (i.e., Rules 22.6(b)-(d)) and the
same process for imposing such fines--that is, permitting the Exchange
to aggregate violations of such Market Maker obligations into a single
offense--will assist the Exchange in preventing fraudulent and
manipulative acts and practices and promoting just and equitable
principles of trade by uniformly imposing penalties and procedures for
failure to satisfy obligations governed by the same Rule. By allowing
for the consistent application of the MRVP for the various Market Maker
quoting obligations and the administration of discipline in a manner
the Exchange deems most appropriate (i.e., whether the violations are
sanctioned separately or aggregation is warranted pursuant to Rule
8.15(a)), the Exchange believes the proposed rule change provides the
Exchange with the flexibility to administer its enforcement program in
a more uniform, effective and efficient manner, and, as described
above, in a manner that aligns with how the Exchange generally surveils
for and sanctions violations across market maker quoting obligations,
thereby removing impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general, protecting
investors and the public interest.
    Additionally, the Exchange believes the proposed rule change will
serve to remove impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general, protect
investors and the public interest because it is intended to harmonize
the Exchange's MRVP in connection with Market Maker quoting obligations
with that of Cboe Options, as well as EDGX Options and C2 Options (to
the extent possible),\35\ thereby providing consistent structures and
procedures across MRVP provisions applicable to market maker
obligations on the affiliated options exchanges. The proposed rule
change contributes to the protection of investors and the public
interest by promoting regulatory consistency by increasing
understanding of the Exchange's MRVP provisions for Trading Permit
Holders (``TPHs'') that are also market participants on the Exchange's
affiliated options exchanges, making it easier for participants across
the affiliated options exchanges to adhere to the disciplinary rules.
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    \35\ See supra notes 13 and 14.
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    The Exchange also believes that the proposed rule change, in
connection with the fine schedule for violations of a Market Maker's
quoting obligations in Rule 25.3(d), as proposed, to increase the fine
amounts for a second and third offense \36\ and to remove the fine
imposed for a fourth offense and proceed with formal disciplinary
proceedings for subsequent offenses following a third offense will
assist the Exchange in preventing fraudulent and manipulative acts and
practices and promoting just and equitable principles of trade, and
will serve to remove impediments to and perfect the mechanism of a free
and open market and a national market system, and, in general, protect
investors and the public interest. Particularly, the Exchange believes
that applying a higher fine per second and third offenses and,
ultimately, formal disciplinary proceedings for any subsequent offenses
during a rolling 24-month period, will allow the Exchange to levy
progressively larger fines and greater penalties (i.e., formal
disciplinary proceedings following a third offense) against repeat-
offenders which may serve to more effectively deter repeat-offenders
while providing reasonable warning for a first offense during a rolling
24-month period. The Exchange believes that more effectively deterring
repeat-offenders, while continuing to make first instance offenders
aware of their quoting obligation violations and the subsequent
consequences for continued failure, will, in turn, further motivate
Market Makers to continue to uphold their quoting obligations,
providing liquid markets to the benefit of all investors. The Exchange
again notes that the proposed fine schedule is consistent with the fine
schedule under Cboe Options' MRVP applicable to violations of Market
Maker quoting requirements on Cboe Options, including a continuous
quoting requirement and initial quote volume requirement. As described
above, EDGX Options and C2 Options intend to file proposals to update
their minor rule violation fines applicable to violations of market
maker quoting obligations in the same manner as Cboe Options and as
proposed herein. As such, the proposed rule change is also designed to
benefit investors by providing from consistent penalties across the
MRVPs of the Exchange and its affiliated options exchanges.
---------------------------------------------------------------------------

    \36\ See supra note 31.
---------------------------------------------------------------------------

    The Exchange further believes that the proposed rule changes to
Rule 25.3 are consistent with Section 6(b)(6) of the Act,\37\ 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 removes a Rule listed as eligible for a
minor rule fine disposition under the Exchange's MRVP that the Exchange
no longer believes violations of which are minor in nature and is more
appropriately disciplined through the Exchange's formal disciplinary
procedures, amends the MRVP provisions so that the same fine schedule,
and process to impose such fines, uniformly applies to violations of a
Market Maker's quoting obligations in Rule 22.6, and amends the fine
schedule

applicable to Market Maker failures to meet their quoting obligations
in a manner that appropriately sanctions such failures.
---------------------------------------------------------------------------

    \37\ 15 U.S.C. 78f(b)(6).
---------------------------------------------------------------------------

    The Exchange also believes that the proposed 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.\38\ Rule 25.3, currently and as amended, does not preclude an
Options Member, associated person of an Options Member, or registered
or non-registered employee of an Options Member from contesting an
alleged violation and receiving a hearing on the matter with the same
procedural rights through a litigated disciplinary proceeding.
---------------------------------------------------------------------------

    \38\ 15 U.S.C. 78f(b)(7) and 78f(d).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but rather is concerned
solely with amending its MRVP in connection with rules eligible for a
minor rule fine disposition and with the fine schedule for Market Maker
failures to meet their quoting obligations. The Exchange believes the
proposed rule changes, overall, will strengthen 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

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

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change, as modified by
Amendment No. 2, is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\39\ In particular, the Commission finds that the proposed
rule change, as modified by Amendment No. 2, is consistent with Section
6(b)(5) of the Act,\40\ 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, as
modified by Amendment No. 2, is consistent with Sections 6(b)(1) and
6(b)(6) of the Act \41\ 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, as modified by Amendment No. 2, 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,\42\ which governs minor rule violation plans.
---------------------------------------------------------------------------

    \39\ 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).
    \40\ 15 U.S.C. 78f(b)(5).
    \41\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
    \42\ 17 CFR 240.19d-1(c)(2).
---------------------------------------------------------------------------

    As stated above, the Exchange proposes to amend Rule 25.3 by
eliminating violations of Rule 22.6(a) from Rule 25.3(c) and the
Exchange's MRVP; relocating violations of Rule 22.6(b) and Rule 22.6(c)
to proposed Rule 25.3(c) so that a single MRVP provision governs
violations of a Market Maker's quoting obligations; amending the
current manner of calculating violations of Market Marker rules,
including deleting a provision that requires violations of Market Maker
obligations occurring during a calendar month be aggregated and
sanctioned as a single offense; and updating the fine schedule
applicable to minor rule violations related to Market Maker quoting
obligations.
    The Commission believes that Rule 25.3 is an effective way to
discipline a member for a minor violation of a rule. More specifically,
the Commission finds that the Exchange's proposal, as modified by
Amendment No. 2, to eliminate Rule 22.6(a), a Market Maker quoting
obligation rule, from the MRVP is consistent with the Act because it
should help the Exchange enforce compliance with, and provide
appropriate discipline for, violation of a rule that the Exchange no
longer believes is minor in nature. Combining all the Market Maker
quoting obligation rules together in one provision of Rule 25.3 will
also bring clarity to the Rule. The Commission also finds that amending
the current manner of calculating violations of Market Maker rules is
appropriate because the Exchange can already aggregate violations under
Rule 8.15 under certain circumstances. Finally, the Commission finds
that amending the associated fee schedule is consistent with the Act
because it may help the Exchange's ability to better carry out its
oversight and enforcement responsibilities by levying appropriate fines
on Market Makers for violations of the Market Marker rules.
    In approving the propose rule change, as modified by Amendment No.
2, the Commission in no way minimizes the importance of compliance with
the Exchange's rules and all other rules subject to fines under Rule
25.3. The Commission believes that a violation of any self-regulatory
organization's rules, as well as Commission rules, is a serious matter.
However, Rule 25.3 provides a reasonable means of addressing rule
violations that may not rise to the level of requiring formal
disciplinary proceedings, while providing greater flexibility in
handling certain violations. The Commission expects that the Exchange
will continue to conduct surveillance with due diligence and make a
determination based on its findings, on a case-by-case basis, whether a
fine of more or less than the recommended amount is appropriate for a
violation under Rule 25.3 or whether a violation requires formal
disciplinary action.

IV. Solicitation of Comments on Amendment No. 2 to the Proposed Rule
Change

    Interested persons are invited to submit written views, data, and
arguments concerning whether Amendment No. 2 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-CboeBZX-2021-083 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-CboeBZX-2021-083. 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-
CboeBZX-2021-083 and should be submitted on or before April 14, 2022.

V. Accelerated Approval of Proposed Rule Change, as Modified by
Amendment No. 2

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment No. 2, prior to the thirtieth day
after the date of publication of notice of the filing of Amendment No.
2 in the Federal Register. According to the Exchange, Amendment No. 2
supplements the proposal by, among other things: (1) Providing
additional detail and clarification regarding the Exchange's current
and proposed treatment of a Market Maker's quoting obligations, (2)
correcting an inadvertent error in the Exhibit 5, and (3) removing a
superfluous provision in the Exhibit 5 to provide for additional
clarity. The Commission believes that Amendment No. 2 provides
additional accuracy and clarity to the proposal and does not raise any
novel regulatory issues. Accordingly, the Commission finds good cause,
pursuant to Section 19(b)(2) of the Act,\43\ to approve the proposed
rule change, as modified by Amendment No. 2, on an accelerated basis.
---------------------------------------------------------------------------

    \43\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\44\ that the proposed rule change (SR-CboeBZX-2021-083), as
modified by Amendment No. 2 thereto, be, and it hereby is, approved on
an accelerated basis.
---------------------------------------------------------------------------

    \44\ Id.
    \45\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\45\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-06193 Filed 3-23-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73344]
[DOCID:fr27de07-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RP07-443-000; RP07-443-001]

Iroquois Gas Transmission Systems, L.P.; Notice of Informal
Settlement Conference

December 17, 2007.
    Take notice that an informal settlement conference will be convened
in this proceeding commencing at 10 a.m. (EST), on Friday, January 11,
2008, at the offices of the Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426, for the purpose of exploring
the possible settlement of the above-referenced docket.
    Any party, as defined by 18 CFR 385.102(c), or any participant as
defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to
become a party must move to intervene and receive intervenor status
pursuant to the Commission's regulations (18 CFR 385.214).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For additional information, please contact Arnold Meltz at (202)
502-8649 or Marc Denkinger at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-25002 Filed 12-26-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 30, 2006 (Volume 71, Number 209)]
[Notices]
[Page 63289]
[DOCID:fr30oc06-44]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-433-002]

Columbia Gas Transmission Corporation; Notice of Tariff Filing

October 20, 2006.
    Take notice that on October 17, 2006, Columbia Gas Transmission
Corporation (Columbia) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, Sixth Revised Sheet No. 354, with
a proposed effective date of November 16, 2006.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-18119 Filed 10-27-06; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Joint Application of

Alitalia-Linee Aeree Italiane-S.p.A.,

Czech Airlines, Delta Air Lines, Inc.,

KLM Royal Dutch Airlines,

Northwest Airlines, Inc, and

Société Air France

for Approval of and Antitrust Immunity for Alliance Agreements under 49
U.S.C. §§ 41308 and 41309

Docket OST-2004-19214

Joint Application of

Delta Air Lines, Inc.,

KLM Royal Dutch Airlines,

Northwest Airlines, Inc., Society Air France,

Alitalia-Linee Aeree Italiane-S.p.A., and

Czech Airlines

for Statements of Authorization under 14 C.F.R. Part 212 (blanket
codesharing)

Docket OST-2004-19215

NOTICE PROVIDING ACCESS TO DOCUMENTS

ORDER CONSOLIDATING PROCEEDINGS

Summary

By this order, we consolidate into Docket OST-2004-19214 the joint
application for blanket codesharing (Docket OST-2004-19215) filed by the
Joint Applicants.  We also suspend the answer date in Docket
OST-2004-19215, pending our determination that the record is complete.
By this notice, we grant immediate interim access to all documents filed
in Docket OST-2004-19214 covered by the Rule 12 Motion to counsel and
outside experts for interested parties who file appropriate affidavits
with the Department in advance.  When we have determined that the record
of this case is complete, we will announce an appropriate procedural
schedule.  We shall serve this notice on all persons on the service list
for this docket.

Docket OST-2004-19214

On September 24, 2004, Alitalia-Linee Aeree Italiane-S.p.A.
(“Alitalia”), Czech Airlines (“CSA”), Delta Air Lines, Inc.
(“Delta”), KLM Royal Dutch Airlines (“KLM”), Northwest Airlines,
Inc. (“Northwest”), and Société Air France (“Air France”), and
their majority-owned corporate affiliates, filed a joint application
requesting approval of and antitrust immunity for (1) bilateral alliance
cooperation agreements between KLM and Delta, and between Northwest and
each of the Sky Team ATI Carriers; (2) a multilateral alliance
coordination agreement among the Joint Applicants; and (3) existing and
future agreements between and among the Joint Applicants concerning the
activities contemplated by or in furtherance of the cooperation and
coordination agreements, such as implementing agreements and other
transactions undertaken by the Joint Applicants pursuant to the
cooperation and coordination agreements (collectively, the “Alliance
Agreements”).

To date, five of the six Joint Applicants filed individual Motions under
14 C.F.R. 302.12 (Rule 12) of our regulations seeking confidential
treatment for supporting documents and information filed by them in
Docket OST-2004-19214.  Alitalia, Delta, KLM, and Northwest filed
Motions on September 27, 2004.  Air France filed a Motion on September
28, 2004.

In sum, five of the Joint Applicants (Alitalia, Delta, KLM, Northwest,
and Air France) state that the material filed in Docket OST-2004-19214
under the Motion is proprietary, commercially sensitive, and
confidential in nature which qualifies for being withheld from public
disclosure.  In their Motions, these five Joint Applicants specified the
submitted materials that they state should receive confidential
treatment.  KLM stated that its request for confidential treatment
extended to various agreements (to which KLM is a party) that will be
submitted by Air France and Northwest.  Each of these five Joint
Applicants has asked that access to this material be limited to counsel
and outside experts for interested parties.

In order to afford interested parties prompt access to the documents
under conditions agreed to by the applicants and imposed by the
Department under similar recent circumstances, we will grant immediate
interim access to all documents filed in Docket OST-2004-19214 covered
by the Rule 12 Motions filed by the five Joint Applicants to counsel and
outside experts for interested parties who file appropriate affidavits
with the Department in advance.  Moreover, consistent with earlier
determinations, at the Dockets facility, parties will be permitted to
make copies of the exhibits for use by persons who have filed
confidentiality affidavits.  We also find it appropriate to grant
interim access to any subsequent materials that may be filed in this
case under a Rule 12 Motion to counsel and outside experts for
interested parties who file appropriate affidavits with the Department
in advance, unless the party filing the Motion objects.

We expect all affidavits to state, at a minimum, that (1) the affiant is
counsel for an interested party or an outside independent expert
providing services to such a party; (2) the affiant will use the
information only for the purpose of participating in this proceeding;
and (3) the affiant will disclose such information only to other persons
who have filed a valid affidavit in the Docket OST-2004-19214.  Affiants
and interested parties must understand and agree that any pleading or
other filing that includes or discusses information contained in the
covered documents must itself be accompanied by a Rule 12 Motion
requesting confidential treatment.  Affidavits must be filed in Docket
OST-2004-19214 with the Department of Transportation, Dockets, Room
PL-401, 400 Seventh Street SW, Washington, DC, 20590.

Affiants having filed affidavits may examine the documents at the
Department of Transportation at the Dockets location.  Affiants must
present a stamped copy of the affidavit filed with the Department of
Transportation before examination of the documents.  Immediately after
the completion of any judicial review of our final decision in this
docket or the expiration of the 60-day period within which a person may
petition for judicial review, all persons who have filed confidentiality
affidavits in this proceeding are hereby directed to file a further
affidavit stating that all copies of the applicants’ confidential
materials have been destroyed or returned to the applicants.

Finally, when we have determined that the record of this case is
complete, we will announce an appropriate procedural schedule.

Docket OST-2004-19215

On September 24, 2004, Delta Air Lines, Inc. (“Delta”), KLM Royal
Dutch Airlines (“KLM”), Northwest Airlines, Inc. (“Northwest”),
Société Air France (“Air France”), Alitalia-Linee Aeree
Italiane-S.p.A. (“Alitalia”) and Czech Airlines (“CSA”) filed a
joint application requesting blanket statements of authorization to
engage in the reciprocal codeshare activities described within the
application.

Consolidation of Dockets OST-2004-19214 and OST-2004-19215

On September 30, 2004, American Airlines, Inc. (American) filed a motion
requesting that the Joint Applicants’ request for approval of and
antitrust immunity for the Alliance Agreements (Docket OST-2004-19214)
be consolidated with the Joint Applicants’ request for statements of
authorization under 14 CFR Part 212 (blanket codeshare) (Docket
OST-2004-19215).  American asserts that the Joint Applicants themselves
indicate that the applications for antitrust immunity and blanket
codesharing are closely interrelated.  Furthermore, American notes that
the Department consolidated the separate requests for antitrust immunity
and for codeshare authorizations filed by American and Lan Chile.
American also states that consolidation of these two dockets will enable
interested parties, in responding to the codeshare application, to
review and take into account the relevant confidential documents
accompanying the antitrust immunity application.

On October 1, 2004, the Joint Applicants filed an answer to American’s
motion stating that the Joint Applicants do not oppose American’s
motion.  We agree that, as stated by American, consolidation of these
two dockets will allow interested parties and the Department to consider
the possible interrelationships among various alliances as they relate
to the issues in both dockets.  By this order, we consolidate into
Docket OST-2004-19214 the joint application for blanket codesharing
(Docket OST-2004-19215) filed by the Joint Applicants.  We also suspend
the answer date in Docket OST-2004-19215, pending our determination that
the record is complete.

By:

KARAN K. BHATIA

Assistant Secretary for Aviation

and International Affairs

Date:

(SEAL)

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/search

 	The Joint Applicants requested that any Order granting immunity make
clear that the immunity extends to such corporate affiliates where a
Joint Applicant holds 50% or more of the ownership interest.  See
Application at 2.

 	Instant Coordination and Cooperation Agreements were submitted with
the Application.  See Appendix A.  The Joint Applicants state that
copies of all other existing agreements encompassed by this request for
antitrust immunity have, or are being, filed with Department in
conjunction with Dockets 48342, OST-01-10429, OST-02-11842, and/or the
Northwest/Continental/Delta domestic codeshare alliance review.

 	The Joint Applicants state that copies of any future agreements will
be submitted to the Department for review and prior approval in
accordance with the Department’s standard procedures.

	Answers to these Motions were due on October 6, 2004.  The Motions were
unopposed.

	Answers to the Motion were due on October 7, 2004.  The Motion is
unopposed.

 	See:  (1) Alitalia’s Motion at 2; (2) Delta’s Motion at
“Confidential Production Index”; (3) KLM’s Motion at “Index of
Documents Submitted to Department of Transportation”; (4)
Northwest’s Motion at “Index of Confidential Documents”; and (5)
Air France’s Motion at “Index of Confidential Documents.”

 	See KLM’s Motion at 1.

	See: (1) Alitalia’s Motion at 4; (2) Delta’s Motion at 5; (3)
KLM’s Motion at 4; (4) Northwest’s Motion at 4; and (5) Air
France’s Motion at 6.

 	See Notices in Dockets OST-2003-14202 dated January 21, 2003 and
Docket OST-2002-12688 dated July 10, 2002.

 	See Notice dated January 1, 2003, p. 1, Docket OST-2003-14202
(Asiana-United request for approval and antitrust immunity for Alliance
Agreements) and See Notice dated March 21, 2002, p. 1, Docket
OST-2002-11842 (Delta-KAL-Air France-Alitalia-CSA request for approval
of and antitrust immunity for Alliance Agreements).

 	See American’s motion at 2.

 	See Order 98-2-21, dated February 20, 1998 (Dockets OST-97-3285 and
OST-97-2982).

 PAGE

 PAGE   5

		Served:  October 18, 2004


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18559-18561]
[FR Doc No: 2014-07332]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0267]

Determination That NIMOTOP (Nimodipine) Capsules, 30 Milligrams,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that NIMOTOP (Nimodipine) Capsules, 30 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of the abbreviated new drug applications (ANDAs) that refer to
nimodipine capsules, 30 mg, and it will allow FDA to approve ANDAs that
refer to this drug as long as they meet relevant legal and regulatory
requirements.

FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends

approval of the drug's NDA or ANDA for reasons of safety or
effectiveness or if FDA determines that the listed drug was withdrawn
from sale for reasons of safety or effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under Sec. Sec.  10.25(a) and 10.30 (21 CFR 10.25(a) and 10.30).
Section 314.161(d) provides that if FDA determines that a listed drug
was withdrawn from sale for reasons of safety or effectiveness, the
Agency will initiate proceedings that could result in the withdrawal of
approval of the ANDAs that refer to the listed drug. FDA may not
approve an ANDA that does not refer to a listed drug.
    NIMOTOP (Nimodipine) Capsules, 30 mg, the subject of NDA 18-869,
held by Bayer HealthCare Pharmaceuticals Inc., was initially approved
on December 28, 1988. The most recent labeling for NIMOTOP states that
the product is indicated for the improvement of neurological outcome by
reducing the incidence and severity of ischemic deficits in patients
with subarachnoid hemorrhage (ruptured blood vessels in the brain) from
ruptured intracranial berry aneurysms regardless of their post-ictus
neurological condition (i.e., Hunt and Hess Grades I-V).
    In a letter dated July 30, 2010, Bayer HealthCare Pharmaceuticals
Inc. notified FDA that NIMOTOP (Nimodipine) Capsules, 30 mg, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. Currently, there are three
approved ANDAs for nimodipine capsules, 30 mg. The following table
lists the approved ANDAs for nimodipine capsules that are listed in the
``Active Drug Product List'' of the Orange Book and their sponsors.

----------------------------------------------------------------------------------------------------------------
             Applicant                   Application No.       Dosage form; route              Strength
----------------------------------------------------------------------------------------------------------------
Banner Pharmacaps..................  ANDA 076740...........  Capsule; Oral.........  30 mg.
Barr Labs, Inc.....................  ANDA 077811...........  Capsule; Oral.........  30 mg.
Sun Pharmaceuticals Inds., Inc.      ANDA 077067...........  Capsule; Oral.........  30 mg.
----------------------------------------------------------------------------------------------------------------

    Lachman Consultant Services, Inc., submitted a citizen petition
dated April 11, 2011 (Docket No. FDA-2011-P-0267) (Petition), under
Sec.  10.30, requesting that the Agency determine whether NIMOTOP
(Nimodipine) Capsules, 30 mg, was withdrawn from sale for reasons of
safety or effectiveness. In the Petition, the petitioner identified no
data or other information suggesting that NIMOTOP (Nimodipine)
Capsules, 30 mg, was withdrawn for reasons of safety or effectiveness.
    In responding to the Petition, we have carefully reviewed our files
for records concerning the withdrawal of NIMOTOP (Nimodipine) Capsules,
30 mg. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. The adverse event
reports included 36 reports of medication errors associated with the
administration or prescribing of nimodipine capsules, 30 mg, which were
received between 1989 (the initial marketing of NIMOTOP) and November
2013.\1\ Of these 36 reports, 27 involved the erroneous intravenous
administration of nimodipine.\2\ The intravenous injection of
nimodipine can result in cardiac arrest, severe drop in blood pressure,
other cardiac-related complications, and death. In almost all of the
cases involving erroneous intravenous administration, there were
serious or potentially serious outcomes, with 5 of the 27 cases
resulting in the death of the patient. FDA has attributed these
medication errors to the use of an intravenous needle and syringe at
bedside to extract the capsule contents for administration to patients
that are unconscious or cannot swallow the capsules. In such cases, the
professional labeling instructions call for using an 18-gauge needle to
make a hole on both ends of the capsule to extract the capsule's liquid
contents into a syringe, and then administering the extracted liquid to
the patient orally or via a nasogastric tube (feeding tube). Because a
needle will not fit on an oral syringe, the health care provider must
use a parenteral syringe to extract the liquid from the capsule. Once
the drug is prepared in a parenteral syringe, rather than administering
it orally or through a nasogastric tube as further directed in the
drug's labeling, a conditioned response can occur where the drug is
erroneously administered intravenously. Most patients receiving
nimodipine capsules require complex care, are hospitalized in critical
care units, and are receiving other intravenous medications, which may
further contribute to the occurrence of such errors.
---------------------------------------------------------------------------

    \1\ FDA became aware of these reports through a search of the
FDA Adverse Event Reporting System (FAERS), the Pennsylvania Patient
Safety Reporting System (PA-PSRS), the Institute for Safe Medication
Practices' (ISMP) Quantros MEDMARX database, the Council for
International Organizations of Medical Sciences (CIOMS) II database,
or through their publication in the medical literature. Thirty-one
of the 36 cases occurred between 1989 and 2009. (See FDA Drug Safety
Communication: Serious medication errors from intravenous
administration of nimodipine oral capsules, available at http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm220386.htm.) FDA identified five additional cases through
searches of the Agency's FAERS database conducted in 2012 and 2013.
    \2\ The remaining reports of medication errors involved
prescribing errors (i.e., physician erroneously prescribed that the
drug be administered intravenously), sublingual administration, or
drug name confusion.
---------------------------------------------------------------------------

    Each year, between 20,000 and 30,000 patients in the United States
\3\ are administered nimodipine for the emergency treatment of
subarachnoid hemorrhage. Since NIMOTOP was approved in 1988, FDA has
taken several actions to reduce these medication errors. These include
labeling changes, a Dear Healthcare Professional Letter, two FDA
Patient Safety News Webcasts, and a Drug Safety Communication.\4\ As
recently as August 2010, FDA issued a safety alert, again emphasizing
to health care professionals that nimodipine capsules should be given
only by mouth or through a nasogastric tube and that they should never
be given by intravenous administration.\5\ In addition, in

February 2012, Barr Pharmaceuticals added the following statement to
the labeling directing health care professionals to transfer the
capsule contents to a syringe that cannot accept a needle: ``A
parenteral syringe can be used to extract the liquid inside the
capsule, but the liquid should always be transferred to a syringe that
cannot accept a needle and that is designed for administration orally
or via a nasogastric tube or PEG.'' \6\
---------------------------------------------------------------------------

    \3\ American Heart Association Guidelines for the Management of
Aneurysmal Subarachnoid Hemorrhage, 2009, Stroke, 40:994-1025; see
also, National Institute of Neurological Disorders and Stroke--
Cerebral Aneurysms Fact Sheet, available at
http:[sol][sol]www.ninds.nih.gov/disorders/cerebral_aneurysm/
detail_cerebral_aneurysms.htm#228933098.
    \4\ Nimodipine (marketed as Nimotop)--Healthcare Professional
Sheet, text version, available at http:[sol][sol]www.fda.gov/Drugs/
DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
ucm129297.htm; NIMOTOP Safety alert, available at
http:[sol][sol]www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm150728.htm.
    \5\ FDA Drug Safety Communication: Serious Medication Errors
from Intravenous Administration of Nimodipine oral Capsules (August
2010), available at http:[sol][sol]www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/
ucm220386.htm.
    \6\ As used here, PEG refers to a percutaneous endoscopic
gastrostomy tube.
---------------------------------------------------------------------------

    Despite these efforts by FDA and the drug's sponsor, a small number
of adverse events due to erroneous intravenous administration continue
to be reported to the Agency. Nevertheless, FDA believes that it is in
the best interest of the public health for patients to continue to have
access to this lifesaving drug for a number of reasons. First, only a
portion of the patients treated with nimodipine capsules are
unconscious and unable to swallow--these are the patients who are most
vulnerable to the medication errors identified. Of those patients that
begin their course of treatment (two capsules every 4 hours for 21
days) while unable to swallow, many improve to the point where they are
awake and able to swallow a capsule soon after treatment begins. Hence,
for many patients, the risk of erroneous intravenous administration is
only present during a small percentage of their overall duration of
treatment.
    Second, we believe the approval of a nimodipine oral solution \7\
that is administered via an oral syringe only will further prevent
erroneous intravenous administration because it can be used for those
patients who are unconscious or unable to swallow and eliminates the
need for use of a parenteral syringe, which is the source of the
medication errors. And third, we believe the capsules play an important
role in treating patients with subarachnoid hemorrhage because many are
discharged from the hospital while taking capsules, and capsules
provide a more convenient route of administration that increases
patient compliance.
---------------------------------------------------------------------------

    \7\ Nymalize was approved on May 10, 2013. See FDA's News
Release, ``FDA Approves Nymalize--First Nimodipine Oral Solution for
Use in Certain Brain Hemorrhage Patients,'' available at
http:[sol][sol]www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm352280.htm.
---------------------------------------------------------------------------

    As a result, we believe that the benefits of having nimodipine
capsules on the market to treat these extremely sick patients, who
could die or have serious permanent injury without treatment, outweigh
the risks of medication errors.
    Therefore, after considering the Petition and reviewing Agency
records, and based on the information we have at this time, FDA has
determined under Sec.  314.161 that NIMOTOP (nimodipine) Capsules, 30
mg, was not withdrawn for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list NIMOTOP (Nimodipine)
Capsules, 30 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. FDA will not
begin procedures to withdraw approval of the approved ANDAs that refer
to NIMOTOP (Nimodipine) Capsules, 30 mg. Additional ANDAs that refer to
NIMOTOP (Nimodipine) Capsules, 30 mg, may also be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07332 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Rules and Regulations]
[Page 24402-24404]
[DOCID:fr05my10-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0124]
RIN 1625-AA00

Safety Zone; St. Louis River, Tallas Island, Duluth, MN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone around
the Tallas Island area of the St. Louis River, Duluth, Minnesota. All
vessels are prohibited from transiting the zone unless specifically
authorized by the Captain of the Port or a designated representative.
This temporary safety zone is necessary in order to ensure the safety
of the general public from hazards associated with the dredging
project.

DATES: Effective Date: this rule is effective in the CFR from May 5,
2010 until 11:59 p.m. November 30, 2010. This rule is effective with
actual notice for purposes of enforcement beginning 12:01 a.m. May 1,
2010 through 11:59 p.m. November 30, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0124 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0124 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LT Aaron Gross, Chief of Port
Operations, MSU Duluth, Coast Guard; telephone<PHONE_NUMBER> Ext. 111,
e-mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the publishing of an NPRM would be
impracticable and contrary to public interest as immediate action is
necessary to provide for the safety of life and property on navigable
waters. The Coast Guard will issue broadcast notice to mariners to
advise vessel operators of navigational restrictions. On-scene Coast
Guard and local law enforcement vessels will also provide actual notice
to mariners.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to public interest because the hazards associated with
dredging projects could lead to severe injury, fatalities, and/or
destruction of public property. Therefore, immediate action is needed
to ensure the public's safety.

Basis and Purpose

    This temporary safety zone is necessary to ensure the safety of the
general public from the potential threat associated with the dredging
project beginning at Tallas Island, St. Louis River. The Captain of the
Port Duluth has determined this activity could pose significant risk to
public safety and property. Establishing a safety zone to control
vessel movement around the location of the work site will help prevent
damage and injury to workers on the site, any recreational vessels, the
public and help minimize the associated risks.

Discussion of Rule

    The following area will be a temporary safety zone: Near Tallas
Island on the St. Louis River to include all waters contained within
the zone located at 46[deg]42.30 N 092[deg]11.56 W and then run
northeast to position; 46[deg]42.53 N 092[deg]11.30 W and then run
northwest to position; 46[deg]43.5 N 092[deg]11.41 W and then run
southwest to position; 46[deg]42.37 N 092[deg]12.11 W and then running
southeast back to the starting point (NAD 83). The safety zone's
boundary is approximately 3500 ft. by 1500 ft. on the long end,
extending behind Tallas Island, and 3000 ft by 1500 ft on the short
end, extending into open waters. The safety zone will be effective from
May 1, 2010 through November 30, 2010.
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the designated on-scene
representative. Entry into, transiting, or anchoring within the safety
zone will be prohibited unless authorized by the Captain of the Port
Duluth or his designated on-scene representative. The Captain of the
Port or his designated on-scene representative may be contacted via VHF
Channel 16.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this regulation will restrict access to the area, the
effect of this rule will not be significant because: (i) The safety
zone is a limited size; (ii) vessels may be granted permission to
transit the area by the Captain of the Port or a designated
representative .

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: Owners or operators of vessels operating in the
St. Louis River intending to transit through or anchor in the waters
near Tallas Island during the effective period of the safety zone. This
rule will not have a significant economic impact on the owners or
operators of affected vessels because the rule is temporary in nature,
lasting for only a few months. Also, it affects a relatively small area
of water along the St. Louis River. Therefore, vessels can easily
transit around the zone. In addition, the safety zone will not limit
any residential or public access areas. Finally, small entities needing
entry into the temporary safety zone might gain access via
communications with the Captain of the Port or designated
representative.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not

likely to have a significant adverse effect on the supply,
distribution, or use of energy. The Administrator of the Office of
Information and Regulatory Affairs has not designated it as a
significant energy action. Therefore, it does not require a Statement
of Energy Effects under Executive Order 13211.

Technical Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a safety zone
established to protect the public from the dangers associated with
dredging operations and therefore, is categorically excluded.
    An environmental analysis checklist and a categorical exclusion
determination will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165-REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T09-0124 to read as follows:

Sec.  165.T09-0124  Safety Zone; St. Louis River, Tallas Island,
Duluth, MN

    (a) Location. The following area is a temporary safety zone: near
Tallas Island on the St. Louis River to include all waters contained
within the zone located at 46[deg]42.30 N 092[deg]11.56 W and then run
northeast to position; 46[deg]42.53 N 092[deg]11.30 W and then run
northwest to position; 46[deg]43.5 N 092[deg]11.41 W and then run
southwest to position; 46[deg]42.37 N 092[deg]12.11 W and then running
southeast back to the starting point (NAD 83). The safety zone's
boundary is approximately 3500 ft. by 1500 ft. on the long end,
extending behind Tallas Island, and 3000 ft by 1500 ft on the short
end, extending into open waters.
    (b) Effective Dates. This rule is effective from 12:01 a.m. May 1,
2010 until 11:59 p.m. November 30, 2010.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into this zone is prohibited unless
authorized by the Coast Guard Captain of the Port Duluth, or his
designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Duluth or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port is
any Coast Guard commissioned, warrant, or petty officer who has been
designated by the Captain of the Port to act on his behalf. The on-
scene representative of the Captain of the Port will be aboard either a
Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or
his designated on-scene representative may be contacted via VHF Channel
16.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Duluth or his on-scene
representative to obtain permission to do so. Vessel operators
permitted to enter or operate in the safety zone must comply with the
instructions given to them by the Captain of the Port Duluth or his on-
scene representative.

    Dated: April 5, 2010.
M.P. Lebsack,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2010-10498 Filed 5-4-10; 8:45 am]
BILLING CODE 9110-04-P