[Federal Register: June 22, 2006 (Volume 71, Number 120)]
[Notices]
[Page 35884-35886]
[DOCID:fr22jn06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

June 14, 2006.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC06-99-000.
    Applicants: Tor Power, LLC; Tyr Energy, LLC; Lincoln Generating
Facility, LLC; Green Country Energy, LLC.
    Description: Tyr Energy, LLC, Green Country Energy, LLC et al.
submit an amendment to their application to provide a description of
their reorganization.
    Filed Date: June 6, 2006.
    Accession Number: 20060609-0045.
    Comment Date: 5 p.m. Eastern Time on Friday, June 23, 2006.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER02-298-003; EL05-111-000.
    Applicants: Thompson River Co-Gen, LLC.
    Description: Thompson River Co-Gen, LLC submits its revised updated
market power analysis to include the generation power market screens.
    Filed Date: May 30, 2006.
    Accession Number: 20060606-0453.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 20, 2006.

    Docket Numbers: ER03-534-002.
    Applicants: Ingenco Wholesale Power, L.L.C.
    Description: Ingenco Wholesale Power, L.L.C. submits its triennial
market power update analysis pursuant to Commission order issued March
24, 2003.
    Filed Date: April 27, 2006.
    Accession Number: 20060427-5031.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 21, 2006.

    Docket Numbers: ER03-774-003.
    Applicants: Eagle Energy Partners I, L.P.
    Description: Eagle Energy Partners I, L.P. submits its updated
power market analysis pursuant to the Commission's order issued June
11, 2003.
    Filed Date: June 12, 2006.
    Accession Number: 20060614-0110.
    Comment Date: 5 p.m. Eastern Time on Monday, July 3, 2006.

    Docket Numbers: ER03-796-004.
    Applicants: Katahdin Paper Company LLC.
    Description: Katahdin Paper Co. LLC submits its triennial market
power

analysis in compliance with Commission's order.
    Filed Date: June 12, 2006.
    Accession Number: 20060614-0109.
    Comment Date: 5 p.m. Eastern Time on Monday, July 3, 2006.

    Docket Numbers: ER04-805-005.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc. submits its
notice of non-material change in status in compliance with the
requirements adopted by FERC in Order 652.
    Filed Date: May 30, 2006.
    Accession Number: 20060602-0332.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 20, 2006.

    Docket Numbers: ER05-1502-003.
    Applicants: California Independent System Operator Corporation
    Description: California Independent System Operator Corp. submits
its compliance filing pursuant to FERC's May 12, 2006 Order.
    Filed Date: June 12, 2006.
    Accession Number: 20060614-0112.
    Comment Date: 5 p.m. Eastern Time on Monday, July 3, 2006.

    Docket Numbers: ER06-436-001.
    Applicants: Avista Corporation.
    Description: Avista Corporation submits Non-Conforming Agreements
under its OATT, Volume 8 consisting of twelve Network Integration
Transmission Service Agreements with Bonneville Power Administration.
    Filed Date: June 9, 2006.
    Accession Number: 20060614-0080.
    Comment Date: 5 p.m. Eastern Time on Friday, June 30, 2006.

    Docket Numbers: ER06-723-002.
    Applicants: California Independent System Operator Corporation
    Description: California Independent System Operator Corp. submits
its revised Interim Reliability Requirements Program pursuant to FERC's
May 12, 2006 Order.
    Filed Date: June 12, 2006.
    Accession Number: 20060614-0111.
    Comment Date: 5 p.m. Eastern Time on Monday, July 3, 2006.

    Docket Numbers: ER06-731-002.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits revisions to Module D of its OAT&EM Tariff.
    Filed Date: June 8, 2006.
    Accession Number: 20060612-0215.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 29, 2006.

    Docket Numbers: ER06-959-001.
    Applicants: Vermont Electric Cooperative, Inc.
    Description: Vermont Electric Cooperative, Inc. submits a letter
clarifying its May 24, 2006 letter and a list of the tariffs that
should be withdrawn, pursuant to Commission's amendment to section
201(f) of the Federal Power Act.
    Filed Date: May 26, 2006.
    Accession Number: 20060526-5008.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 21, 2006.

    Docket Numbers: ER06-1118-000.
    Applicants: ECP Energy, LLC.
    Description: ECP Energy, LLC submits an application for order
accepting initial tariff, waiving regulations and granting blanket
approvals.
    Filed Date: June 8, 2006.
    Accession Number: 20060612-0216.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 29, 2006.

    Docket Numbers: ER06-1119-000.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Co. submits First Revised
Sheet 130 et al. to Rate Schedule FERC 14, Reliability Must Run Service
Agreement with California Independent System Operator Corp.
    Filed Date: June 8, 2006.
    Accession Number: 20060614-0071.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 29, 2006.

    Docket Numbers: ER06-1120-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
supplements its March 10, 2006 filing with signature pages, Original
Sheet Number 39.
    Filed Date: June 8, 2006.
    Accession Number: 20060614-0072.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 29, 2006.

    Docket Numbers: ER06-1121-000.
    Applicants: American Electric Power Service Corporation; Ohio Power
Company.
    Description: Ohio Power Co. submits its notice of cancellation of
its Amended Interconnection Agreement and Operation Agreement, Second
Revised Service Agreement 433, Electric Tariff Third Revised Volume 6,
with Lawrence Energy Center, LLC.
    Filed Date: June 9, 2006.
    Accession Number: 20060614-0073.
    Comment Date: 5 p.m. Eastern Time on Friday, June 30, 2006.

    Docket Numbers: ER06-1122-000.
    Applicants: High Trail Wind Farm, LLC.
    Description: High Trail Wind Farm, LLC submits a petition for order
accepting market-based rate schedule for filing and granting waivers
and blanket approvals.
    Filed Date: June 9, 2006.
    Accession Number: 20060614-0074.
    Comment Date: 5 p.m. Eastern Time on Friday, June 30, 2006.

    Docket Numbers: ER06-1123-000.
    Applicants: American Electric Power System; Ohio Power Company.
    Description: Ohio Power Co. submits its notice of cancellation of
its Amended Interconnection Agreement and Operation Agreement, Second
Revised Service Agreement 516, Electric Tariff Third Revised Volume 6,
with Lawrence Energy Center, LLC.
    Filed Date: June 9, 2006.
    Accession Number: 20060614-0075.
    Comment Date: 5 p.m. Eastern Time on Friday, June 30, 2006.

    Docket Numbers: ER06-1124-000.
    Applicants: Kentucky Utilities Company.
    Description: Kentucky Utilities Co. submits a request for an
extension of its contract term for an Interconnection Agreement with
Eastern Kentucky Power Cooperative.
    Filed Date: June 9, 2006.
    Accession Number: 20060614-0090.
    Comment Date: 5 p.m. Eastern Time on Friday, June 30, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies

of the intervention or protest to the Federal Energy Regulatory
Commission, 888 First St.,NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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. E6-9796 Filed 6-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62115-62118]
[FR Doc No: 2023-19357]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98279; File No. SR-NYSEARCA-2023-57]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Modify Rule
6.62P-O(g)(1)

September 1, 2023.
    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 August 18, 2023, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify Rule 6.62P-O(g)(1) regarding
Complex Qualified Contingent Cross Orders. 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 modify Rule 6.62P-O(g)(1) regarding
Complex Qualified Contingent Cross (``QCC'') Orders to allow Complex
QCC Orders in non-standard ratios (as defined below) to be processed
electronically.
    Rule 6.62P-O(f) provides that a Complex Order is any order
involving the simultaneous purchase and/or sale of two or more option
series in the same underlying security (the ``legs'' or ``components''
of the Complex Order), for the same account, in a ratio that is equal
to or greater than one-to-three (.333) and less than or equal to three-
to-one (3.00) (referred to herein as the ``standard ratio'' or
``standard ratio requirement'').The Exchange currently permits certain
Complex Orders with ratios greater than three-to-one or less than one-
to-three (``non-standard ratios'') for execution on the Exchange's
trading floor.\4\ This proposed change is competitive as at least one
other options exchange permits Complex QCC Orders in non-standard
ratios to be processed electronically.\5\ As such, the Exchange
proposes to add new Rule 6.62P-O(g)(1)(G) to specify that Complex QCC
Orders may be processed electronically in non-standard ratios.\6\
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    \4\ See, e.g., Rule 6.62P-O(h)(6)(B) (regarding Stock/Complex
Orders, which are a subset of Complex Orders (per Rule 6.62P-O(f)),
that are only available for trading in Open Outcry and are not
subject to the standard ratio requirement).
    \5\ In June 2022, Cboe Exchange, Inc. (``Cboe'') began
supporting the electronic processing of certain stock-option orders
in non-standard ratios, including Complex QCC Orders. See Cboe
Exchange Alert, ``Schedule Update--Cboe Options Introduces New Net,
Leg Price Increments and Enhanced Electronic, Open Outcry Handling
for Complex Orders with Non-Conforming Ratios, Reference ID:
C2022060301 available online at https://cdn.cboe.com/resources/release_notes/2022/Schedule-Update-Cboe-Options-Introduces-New-Net-Leg-Price-Increments-and-Enhanced-Electronic-Open-Outcry-Handling-for-Complex-Orders-with-Non-Conforming-Ratios.pdf (providing, in
relevant part, that beginning June 12, 2022, ``automated handling
via COA, COB, AIM, and QCC will be available for applicable non-
conforming orders, except in SPX/SPXW). See also Securities Exchange
Act Release Nos. 94204 (February 9, 2022), 87 FR 8625 (February 15,
2022) (SR-CBOE-2021-046) (order approving Cboe's proposal, as
amended, to permit complex orders with ratios less than one-to-three
and greater than three-to-one to be eligible for electronic
processing and to trade in penny increments); 95006 (May 31, 2022),
87 FR 34334 (June 6, 2022) (SR-CBOE-2022-024) (allowing Cboe to
retain discretion to determine on class-by-class basis eligibility
for electronic processing of complex orders with ratios less than
one-to-three and greater than three-to-one (i.e., ratios other than
the standard ratio requirement). The current proposal is limited to
allowing Complex QCC Orders regardless of ratio to be traded
electronically. If the Exchange opts to allow other (non-QCC)
Complex Orders in any ratio to be traded electronically, the
Exchange will submit a separate rule filing.
    \6\ See proposed Rule 6.62P-O(g)(1)(G) (``Complex QCC Orders are
eligible for electronic processing regardless of the ratio in the
component legs.''). The Exchange notes that other options exchanges
offer Complex QCC Orders, however, the rules of these options
exchanges are silent as to whether they permit Complex QCC Orders in
non-standard ratios to be processed electronically. See, e.g.,
Nasdaq ISE, LLC (``ISE'') Options 3, Section 12(d) (describing
Complex Qualified Cross Orders).
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    Rule 6.62P-O(g)(1) provides that a QCC Order must be comprised of
an originating order to buy or sell at least 1,000 contracts that is
identified as being part of a qualified contingent trade coupled with a
contra-side order or orders totaling an equal number of contracts.\7\ A
Complex QCC Order is a QCC Order that has more than one option leg and
each option leg must have at least 1,000 contracts.\8\ Like QCC Orders,
each Complex QCC Order must be a part of a ``qualified contingent
trade'' (``QCT''), which is a transaction consisting of two or more
component orders, one of which must be a stock leg.\9\ The Exchange
notes that there may be instances when an order sender must submit a
Complex QCC in a non-standard ratio to meet the QCT criteria (e.g., to
be fully hedged).\10\
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    \7\ See Rule 6.62P-O(g)(1)(B) for the definition of a Qualified
Contingent Trade.
    \8\ See Rule 6.62P-O(g)(1) (defining Complex QCC Orders). See
also Rule 6.62P-O(g)(1)(D) regarding pricing requirements for
Complex QCCs. This proposal does not alter the pricing requirements
for Complex QCC Orders and such requirements apply regardless of
whether a Complex QCC Order has a standard (or non-standard) ratio.
    \9\ See Rule 6.62P-O(g)(1)(B)(i). See generally Rule 6.62P-
O(g)(1)(B) (setting forth criteria for a Qualified Contingent
Trade).
    \10\ See Rule 6.62P-O(g)(1)(B)(vi) (providing that the QCT
transaction must be ``fully hedged (without regard to any prior
existing position) as a result of other components of the contingent
trade.'').
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    The proposed rule change would have no impact on the pricing of
Complex QCCs because the same (existing) pricing requirements apply to
all Complex QCC Orders that are electronically processed by the
Exchange. Specifically, no option leg of a Complex QCC Order will trade
at a price worse than the Exchange BBO \11\ and a Complex QCC Order
will be rejected based on its price if:
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    \11\ See Rule 6.62P-O(g)(1)(D) (providing that ``no option leg
[of a Complex QCC Order] will trade at a price worse than the
Exchange BBO'').
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     ``any option leg cannot execute in compliance with
paragraph (g)(1)(C) of this Rule'', i.e., cannot meet the pricing
requirements for single-leg QCC Orders''; \12\
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    \12\ See Rule 6.62P-O(g)(1)(D)(i). See also Rule 6.62P-
O(g)(1)(C) (Execution of QCC Orders) (``A QCC Order with one option
leg will be rejected if received when the NBBO is crossed or if it
will trade at a price that (i) is at the same price as a displayed
Customer order on the Consolidated Book and (ii) is not at or
between the NBB'' and requiring that ``[a] QCC Order with one option
leg will never trade at a price worse than the Exchange BBO.'').
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     ``the best-priced Complex Order(s) on the Exchange
contain(s) displayed Customer interest and the Complex QCC Order price
does not improve such displayed Customer interest by 0.01;'' \13\ or
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    \13\ See Rule 6.62P-O(g)(1)(D)(ii). The Exchange proposes to
amend current Rule 6.62P-O(g)(1)(D)(ii) to clarify that the Complex
QCC Order must price improve any displayed Customer interest by ``at
least'' one penny ($0.01), which would make the Rule more accurate.
See proposed Rule 6.62P-O(g)(1)(D)(ii).
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     ``the price of the QCC Order is worse than the best-priced
Complex Orders in the Consolidated Book.'' \14\
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    \14\ See Rule 6.62P-O(g)(1)(D)(iii). The Exchange proposes to
amend current Rule 6.62P-O(g)(1)(D)(iii) to clarify that this
provision refers to the price of the ``Complex'' QCC Order, which
would make the Rule more accurate. See proposed Rule 6.62P-
O(g)(1)(D)(iii). The Exchange would continue to reject Complex QCC
Orders (regardless of ratio) if ``the prices of the best-priced
Complex Orders in the Consolidated Book are crossed''; or ``for any
option leg there is no NBO.'' See Rule 6.62P-O(g)(1)(D)(iii), (iv),
respectively.
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    Thus, under this proposal, the Exchange would ensure that every
component leg of a Complex QCC Order (regardless of ratio) would trade
at a price that is equal to or better than the Exchange BBO and better
than displayed Customer interest on the Exchange in the same manner as
it does today. In other words, the proposed rule change continues to
protect interest in the leg markets as well as displayed Customer
interest on the Exchange.
Implementation
    The Exchange will announce by Trader Update the implementation date
of the proposed rule change, which implementation will be no later than
90 days after the effectiveness of this rule change.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\15\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\16\
in particular, in that 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 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.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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    In particular, the proposed rule change will remove impediments to
and perfect the mechanism of a free and open market and a national
market system because it will enable the Exchange to compete on equal
footing with other exchanges that permit trading of Complex QCCs with
non-standard ratios.\17\ The proposed rule change would continue to
protect investors and the public interest because the (approved)
pricing requirements for Complex QCC Orders would continue to apply to
Complex QCC Orders with non-standard ratios. As such, the proposal
would ensure that the Complex QCC Order is priced equal to or better
than the best-priced Complex Order(s) and, if there is displayed
Customer interest on such order(s), that the execution price of the
Complex QCC Order improves the price of the displayed Customer interest
and improves the price of displayed Customer interest on each component
leg of the Complex QCC Order.
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    \17\ See supra note 5.
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    In addition, the proposed change would promote just and equitable
principles of trade, remove impediments to and perfect the mechanism of
a free and open market and a national market system, and, in general to
protect investors and the public interest because it would provide
another venue for electronically executing Complex QCC Orders with non-
standard ratios. The proposed change would also increase opportunities
for execution of Complex QCC Orders with non-standard ratios, which
benefits all investors. The Exchange also believes that the proposed
rule change would not permit unfair discrimination among market
participants, as all market participants may opt to trade Complex QCC
Orders with non-standard ratios.
    The Exchange believes that the proposed clarifying changes would
ensure accuracy of the proposed rule, which benefits all investors.\18\
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    \18\ See supra notes 13-14.
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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 Exchange does not
believe that its proposed rule change will impose any burden on intra-
market competition as it would apply equally to all market participants
that opt to submit Complex QCC Orders with non-standard ratios for
electronic processing, which orders the Exchange will process in a
uniform manner.
    The Exchange does not believe that its proposed rule change will
impose any burden on inter-market competition that is not necessary or
appropriate in furtherance of the purposes of the Act, rather the
Exchange believes that its proposal will promote inter-market
competition. As noted here, the proposed change is competitive as
another options exchange currently permits Complex QCC Orders with non-
standard ratios to be traded electronically. The Exchange's proposal
will enhance inter-market competition by providing an additional venue
where investors may electronically execute Complex QCC Orders with non-
standard ratios, giving investors greater flexibility and a choice of
where to send their orders. Market participants may find it more
convenient to access one exchange over another or may choose to
concentrate volume at a particular exchange to maximize the impact of
volume-based incentive programs or may prefer the trade execution
services of one exchange over another.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-
4(f)(6) thereunder.\20\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule change should be
approved or disapproved.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NYSEARCA-2023-57 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-NYSEARCA-2023-57. 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 (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number

SR-NYSEARCA-2023-57 and should be submitted on or before September 29,
2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12), (59).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19357 Filed 9-7-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19066-19069]
[FR Doc No: 2016-07524]

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

Food and Drug Administration

21 CFR Part 56

[Docket No. FDA-2015-N-5052]

Administrative Actions for Noncompliance; Lesser Administrative
Actions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulation describing lesser administrative actions that may be
imposed on an Institutional Review Board (IRB) that has failed to
comply with FDA's IRB regulations. We are clarifying that FDA may
require the IRB to withhold approval of new FDA-regulated studies, stop
the enrollment of new subjects in ongoing studies, and terminate
ongoing studies, or any combination of these actions, until the
noncompliance with FDA's IRB regulations is corrected. We are taking
this action to ensure clarity and improve the accuracy of the
regulations.

DATES: Submit electronic or written comments on this proposed rule or
its companion direct final rule by June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 comments as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-5052 for ``Subpart E--Administrative Actions for
Noncompliance; Lesser Administrative Actions.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Office of Good Clinical
Practice, Office of Special Medical Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is proposing to amend the text of Sec.  56.120(b) (21 CFR
56.120(b)), which describes lesser administrative actions that the
Agency may impose on an IRB until the IRB takes appropriate action to
correct the IRB's noncompliance. FDA is proposing this revision to
clarify the language and improve the accuracy of the regulations.
Specifically, this proposed rule would propose to amend Sec.  56.120(b)
by clarifying that FDA has authority to require the IRB to withhold
approval of new FDA-regulated studies conducted at the institution or
reviewed by the IRB, direct that no new subjects be added to ongoing
studies, and terminate ongoing studies provided that doing so would not
endanger study subjects.
    This amendment also proposes to renumber current paragraphs (b)(4)
and (c) as paragraphs (c) and (d), respectively, and inserts ``FDA
may'' into newly designated paragraph (c) so that it is a complete
sentence.
    FDA first proposed requirements for the composition and operations
of institutional review committees in the ``Proposed Investigational
Device Exemptions,'' published in the Federal Register of August 20,
1976 (41 FR 35282; ``Proposed IDE Rule''). In that document, FDA
proposed disqualification procedures for institutional review
committees and requested comments on the proposed procedures and other
possible administrative actions that FDA might take against a committee
that is not in compliance with the regulations (41 FR 35282 at 35293).
FDA also stated its intention to publish uniform, Agency-wide
regulations governing clinical investigations at a later date,
including requirements governing institutional review committees (41 FR
35282 at 35283).
    Subsequently, FDA published ``Standards for Institutional Review
Boards for Clinical Investigations'' on August 8, 1978 (43 FR 35186;
``Proposed IRB Standards''). Comments on implementing institutional
review requirements received in response to the Proposed IDE Rule were
reviewed and utilized in preparing the Proposed IRB Standards (43 FR
35186 at 35187). In the Proposed IRB Standards, FDA proposed that
disqualification would be used only if the Commissioner of Food and
Drugs finds that: (1) The IRB failed to comply with one or more of the
standards for IRBs in part 56 or other supplemental requirements in the
investigational new drugs or investigational device exemptions (IDE)
regulations; (2) the noncompliance adversely affects the validity of
the data or the rights or safety of the human subjects; and (3) other
lesser regulatory actions (e.g., warnings or rejection of data from
individual clinical investigations) have not been or probably will not
be adequate in achieving compliance (43 FR 35186 at 35195).
    FDA received numerous comments to the Proposed IRB Standards, and
addressed those comments in the Federal Register of January 27, 1981
(46 FR 8958), ``Protection of Human Subjects: Standards for
Institutional Review Boards for Clinical Investigations, Final Rule.''
Specifically, several comments suggested that any lesser regulatory
actions should be listed (46 FR 8958 at 8973). FDA accepted these
comments and revised Sec.  56.120(b) to set forth the lesser
administrative actions that the Agency may take if FDA finds
deficiencies in the operation of an IRB and to describe the
circumstances in which these lesser administrative actions may be used
by the Agency. FDA's longstanding interpretation of Sec.  56.120(b) is
that FDA may impose these restrictions on a noncompliant IRB until the
IRB takes appropriate corrective action. The text of the regulation,
however, suggests that it is the Agency that would withhold approval of
studies that have been reviewed by a noncompliant IRB, rather than
authorizing FDA to direct the IRB to stop approving new studies until
the IRB comes back into compliance.
    This proposed rule would amend Sec.  56.120(b) to read that, in
addition, until the IRB or the parent institution takes appropriate
corrective action, the Agency may require the IRB to withhold approval
of new studies, direct that no new subjects be added to ongoing
studies, or terminate ongoing studies. This will ensure that those
activities are suspended until the IRB takes appropriate corrective
action to address

its noncompliance. We believe revising Sec.  56.120(b) will improve the
clarity and accuracy of the regulations. We are also proposing to
redesignate Sec.  56.120(b)(4) as Sec.  56.120(c), and Sec.  56.120(c)
as Sec.  56.120(d).
    FDA may notify relevant State and Federal regulatory Agencies when
warranted to assure that organizations with a need to know about the
IRB's apparent noncompliance are appropriately informed. The revision
would eliminate confusion by stating clearly that FDA is authorized to
notify others about the IRB's noncompliance. We believe these changes
will ensure clarity and improve the accuracy of the regulations.

II. Why is FDA publishing this proposed rule?

    This proposed rule is a companion to a direct final rule affirming
FDA's longstanding interpretation of Sec.  56.120(b), i.e., that FDA
may impose these restrictions on a noncompliant IRB until the IRB takes
appropriate corrective action. The direct final rule is published in
the final rules section of this issue of the Federal Register. The
direct final rule and this companion proposed rule are substantively
identical. This companion proposed rule will serve the purpose of
issuing a proposed rule under usual notice-and-comment procedures in
the event we withdraw the direct final rule because we receive
significant adverse comment. We are publishing the direct final rule
because we believe it is noncontroversial, and we do not anticipate any
significant adverse comments. If we do not receive any significant
adverse comments in response to the direct final rule, we will not take
any further action on this proposed rule. Instead, within 30 days after
the comment period ends, we intend to publish a notice that confirms
the effective date of the direct final rule.
    If FDA receives any significant adverse comment regarding the
direct final rule, we will publish a notice of significant adverse
comment and withdraw the direct final rule within 30 days after the
comment period ends. We will then proceed to final rulemaking using our
usual notice-and-comment rulemaking procedures under the Administrative
Procedure Act (APA). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. We
will consider any comments that we receive in response to this
companion proposed rule to be comments also regarding the direct final
rule and vice versa. We do not intend to provide additional opportunity
for comment.
    A significant adverse comment is one that explains why the rule
would be inappropriate (including challenges to the rule's underlying
premise or approach), or would be ineffective or unacceptable without a
change. In determining whether an adverse comment is significant and
warrants withdrawing a direct final rule, we consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the APA (5 U.S.C. 553). Comments that are frivolous, insubstantial,
or outside the scope of the rule will not be considered adverse. A
comment recommending a rule change in addition to the rule would not be
considered a significant adverse comment, unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to part of a rule
and that part can be severed from the remainder of the rule, we may
adopt as final those parts of the rule that are not the subject of a
significant adverse comment.
    You can find additional information about FDA's direct final
rulemaking procedures in the guidance document entitled ``Guidance for
FDA and Industry: Direct Final Rule Procedures,'' \1\ announced in the
Federal Register of November 21, 1997 (62 FR 62466).
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.
---------------------------------------------------------------------------

III. Legal Authority

    This proposed rule, if finalized, would amend Sec.  56.120(b).
FDA's authority to modify Sec.  56.120(b) arises from the same
authority under which FDA initially issued this regulation, the IRB
regulations, and general administrative provisions of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b,
351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262).

IV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

V. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule would not add any additional
regulatory burdens, we propose to certify that this proposed rule will
not have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    The purpose of this proposed rule is to affirm FDA's longstanding
interpretation of Sec.  56.120(b), that FDA may impose these
restrictions on a noncompliant IRB until the IRB takes appropriate
corrective action. The amendment will improve the clarity and accuracy
of the regulations. Because this proposed rule is a clarification and
would impose no additional regulatory burdens, this regulation is not
anticipated to result in any compliance costs and the economic impact
is expected to be minimal.

VI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, we conclude that the
rule does not contain policies that have federalism implications as
defined in the Executive Order and, consequently, a federalism summary
impact statement is not required.

List of Subjects in 21 CFR Part 56

    Human research subjects, Reporting and recordkeeping requirements,
Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 56 is amended as follows:

PART 56--INSTITUTIONAL REVIEW BOARDS

0
1. The authority citation for 21 CFR part 56 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351,
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262.

0
2. In Sec.  56.120, redesignate paragraphs (b)(4) and (c) as paragraphs
(c) and (d), respectively, and revise paragraph (b) and newly
designated paragraph (c) to read as follows:

Sec.  56.120  Lesser administrative actions.

* * * * *
    (b) On the basis of the IRB's or the institution's response, FDA
may schedule a reinspection to confirm the adequacy of corrective
actions. In addition, until the IRB or the parent institution takes
appropriate corrective action, the Agency may require the IRB to:
    (1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
    (2) Direct that no new subjects be added to ongoing studies subject
to this part; or
    (3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects.
    (c) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, FDA may notify relevant State
and Federal regulatory agencies and other parties with a direct
interest in the Agency's action of the deficiencies in the operation of
the IRB.
* * * * *

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07524 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 4, 2010 (Volume 75, Number 191)]
[Rules and Regulations]
[Page 61094-61096]
[DOCID:fr04oc10-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-1075]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway,
Beaufort, SC

AGENCY: Coast Guard, DHS.

ACTION: Temporary rule.

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

SUMMARY: The Coast Guard is revising the operating schedule for the
U.S. Highway 21, Sea Island Parkway Bridge at mile marker 536 over the
Beaufort River (Atlantic Intracoastal Waterway). This bridge is also
known as the Lady's Island Bridge. Due to ongoing construction on the
McTeer Bridge, which is across the Atlantic Intracoastal Waterway at
mile 539.0 in Port Royal, South Carolina, vehicle traffic is currently
being rerouted from the McTeer Bridge to the Lady's Island Bridge. This
rerouting has resulted in increased vehicle traffic congestion on the
Lady's Island Bridge. As a result of the increased vehicle traffic
congestion, Beaufort County has requested a revision to the federal
regulation setting forth the Lady's Island Bridge operating schedule.
Such a revision will alleviate excessive vehicle congestion on the
Lady's Island Bridge while permitting sufficient access for maritime
passage underneath the bridge.

DATES: This temporary final rule is effective from October 4, 2010 to
October 4, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2009-1075 and are available by
going to http://www.regulations.gov, inserting USCG-2009-1075 in the
``Keyword'' box, and then clicking ``Search.'' This material is 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 Mr. Gene Stratton, Coast Guard;
telephone<PHONE_NUMBER>, 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 of increased vehicle congestion on
the Lady's Island Bridge due to the rerouting of traffic from the
McTeer Bridge, which is currently undergoing construction. Beaufort
County Emergency Management has requested an immediate schedule change
to alleviate this excessive vehicle congestion. The revised schedule
for the Lady's Island Bridge does not unduly affect access to the
waterway by the maritime public.
    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. As described above, Beaufort
County Emergency Management has requested an immediate schedule change
to alleviate the excessive vehicle congestion on the Lady's Island
Bridge.

Basis and Purpose

    Two bridges serve Lady's Island, GA. Ongoing construction on the
McTeer Bridge has resulted in the rerouting of vehicle traffic from the
McTeer Bridge to the Lady's Island Bridge. Beaufort County Emergency
Management has requested an immediate revision to the opening schedule
for the Lady's Island Bridge at mile marker 536 over the Beaufort River
(Atlantic Intracoastal Waterway). This operating schedule revision is
necessary to accommodate increased vehicle traffic on the Lady's Island
Bridge. The revised schedule will alleviate the excessive vehicle
traffic

that has resulted from the McTeer Bridge construction.

Discussion of Rule

    The current schedule, as described in the Code of Federal
Regulations, is as follows:
    33 CFR 117.911(f) Lady's Island Bridge, across the Beaufort River,
Mile 536.0 at Beaufort. The draw shall operate as follows:
    (1) On Monday through Friday, except Federal holidays:
    (i) From 7 a.m. to 9 a.m. and 4 p.m. to 6 p.m., the draw need not
open; and,
    (ii) Between 9 a.m. to 4 p.m., the draw need open only on the hour
and half-hour.
    (2) At all other times the draw shall open on signal.
    This temporary rule changes the scheduled closing times for the
Lady's Island Bridge to enable more closures during peak vehicle
traffic times between 7:15 a.m. and 8:59 a.m., 11:15 a.m. and 12:59
p.m., and 4:15 p.m. to 5:59 p.m. This schedule revision also allows
draw openings only on the hour between 9 a.m. and 4 p.m., rather than
on both the hour and half-hour.

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.

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: The owners or operators of vessels intending to transit
underneath the Lady's Island Bridge from 7:15 a.m. to 5:59 p.m. Monday
through Friday, and who require that the draw be open in order to do
so. These small entities will have a slightly decreased number of draw
openings.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons: (1) The
Lady's Island Bridge will continue to operate on demand outside the
restricted hours of 7:15 a.m. to 5:59 p.m.; (2) the majority of vessels
that transit underneath the bridge can safely do so without the draw
being open; and (3) despite the decreased number of draw openings,
there will still be several openings during the restricted hours.

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 would 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
that 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 (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. Suspend Sec.  117.911(f) from October 4, 2010 until October 4, 2011.
0
3. From October 4, 2010 until October 4, 2011 add Sec.  117.911(g) to
read as follows:

Sec.  117.911  Atlantic Intracoastal Waterway, Little River to Savannah
River.

* * * * *
    (g) Lady's Island Bridge, across the Beaufort River, Mile 536.0 at
Beaufort. The draw shall operate as follows:
    (1) On Monday through Friday, except federal holidays:
    (i) From 7:15 a.m. to 8:59 a.m., 11:15 a.m. to 12:59 p.m., and 4:15
p.m. to 5:59 p.m. the draw need not open; and
    (ii) Between 9 a.m. to 11 a.m. and 1 p.m. to 4 p.m., the draw need
open only on the hour.
    (2) At all times other than those specified in (1) above, the draw
shall open on signal.

    Dated: September 21, 2010.
W.D. Baumgartner,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2010-24645 Filed 10-1-10; 8:45 am]
BILLING CODE 9110-04-P