[Federal Register Volume 76, Number 111 (Thursday, June 9, 2011)]
[Notices]
[Pages 33795-33797]
[FR Doc No: 2011-14232]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64595; File No. SR-NYSEArca-2011-32]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Arca Equities Schedule of Fees and Charges for Exchange Services To
Establish a Gross FOCUS Revenue Fee

June 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on May 31, 2011, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange through its wholly-owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities'') proposes to amend the NYSE Arca
Equities Schedule of Fees and Charges for Exchange Services (the
``Schedule'') to establish a new regulatory fee. While changes to the
Schedule pursuant to this proposal will be effective on filing, the
changes will become operative on June 1, 2011. The text of the proposed
rule change is available at the Exchange, at the Commission's Public
Reference

Room, on the Commission's Web site at http://www.sec.gov, and at http://www.nyse.com.

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

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

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

1. Purpose
    Effective June 1, 2011, the Exchange proposes to amend the Schedule
to establish a regulatory fee (``Gross FOCUS Revenue Fee'') to be
charged to ETP Holders, the purpose of which is to recover the
regulatory expenses of the Exchange with respect to ETP Holders,
including expenses associated with the regulatory functions performed
both by NYSE Regulation, Inc. (``NYSE Regulation'') and by the
Financial Industry Regulatory Authority (``FINRA'') pursuant to a
regulatory services agreement, for which FINRA is paid by NYSE
Regulation. The Exchange is proposing to set this regulatory fee at a
rate of $0.07 per $1,000 of gross revenues as reported by each ETP
Holder in its FOCUS report.\3\ The fee would be similar to the gross
revenue FOCUS Report fee that the New York Stock Exchange (``NYSE'')
charges its member organizations to partially recover its expenses for
performance of regulatory functions.\4\ However, the rate will be lower
than the $0.105 per $1,000 of FOCUS gross revenues charged by the NYSE,
reflecting the fact that the costs of regulating the electronic NYSE
Arca market are less than the costs of regulating the NYSE with its
trading floor. Moving to a regulatory fee based on FOCUS gross revenues
would align the Exchange's equity regulatory fee structure more closely
with that of the NYSE. The Exchange believes that the revenue generated
from this new regulatory fee, when combined with the Exchange's other
regulatory fees with respect to ETP Holders, will be less than or equal
to the Exchange's related regulatory costs.
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    \3\ FOCUS (Securities Exchange Act Form X-17A-5) is an acronym
for Financial and Operational Combined Uniform Single Report. The
report is filed periodically with the Commission pursuant to
Securities Exchange Act Rule 17a-5.
    \4\ See NYSE Rule 129 (Oversight Services).
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    Prior to the initiation of the new Gross FOCUS Revenue Fee on June
1, the Exchange has eliminated, by means of a separate rule filing,\5\
the fees assessed on ETP Holders, OTP Holders and OTP Firms \6\ that
conduct equities and/or options business on the Exchange and that
register financial advisors (or registered representatives) (``RR
Fees''). Each RR Fee was a fixed amount of money that an ETP Holder,
OTP Holder or OTP Firm paid to the Exchange for each registered
representative that it registered, and it was based on the action
associated with the registration. The Exchange has eliminated the RR
Fees because it believes that such fees are no longer the most
equitable manner in which to assess regulatory fees. Among other
things, sales practice regulation has been allocated to FINRA pursuant
to a 17d-2 plan, so tying the Exchange's regulatory fees to the number
of registered representatives does not match regulatory revenues to
regulatory expenses. The Exchange's regulatory costs are primarily
driven by market regulation. Consequently, a fee based on trading
activity, such as the proposed Gross FOCUS Revenue Fee, will better
match such revenues and expenses.\7\ The Exchange believes that the
proposed Gross FOCUS Revenue Fee represents the best alternative for
replacing the revenue dedicated to covering the costs of the Exchange's
regulatory programs with respect to ETP Holders and the equities
business of the Exchange that was lost with the elimination of the RR
Fees.
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    \5\ See Securities Exchange Act Release No. 64399 (May 4, 2011),
76 FR 27114 (May 10, 2011) (File No. SR-NYSEArca-2011-20) (the
``Options Regulatory Fee Filing'').
    \6\ The term ``ETP Holder'' refers to a sole proprietorship,
partnership, corporation, limited liability company or other
organization in good standing that has been issued an Equity Trading
Permit (``ETP'') by NYSE Arca Equities for effecting approved
securities transactions on the trading facilities of NYSE Arca
Equities. See NYSE Arca Equities Rule 1.1(n).
    The term ``OTP Holder'' refers to a natural person, in good
standing, who has been issued an Options Trading Permit (``OTP'') by
the Exchange for effecting approved securities transactions on the
trading facilities of the Exchange, or has been named as a nominee.
See Exchange Rule 1.1(q).
    The term ``OTP Firm'' refers to a sole proprietorship,
partnership, corporation, limited liability company or other
organization in good standing that holds an OTP or upon whom an
individual OTP Holder has conferred trading privileges on the
Exchange's trading facilities pursuant to and in compliance with the
rules of the Exchange. See Exchange Rule 1.1(r).
    Each ETP Holder, OTP Holder and OTP Firm has status as a
``member'' of the Exchange as that term is defined in Section 3 of
the Act. An ETP Holder or an OTP Firm must be a registered broker or
dealer pursuant to Section 15 of the Securities Exchange Act of
1934, as amended (the ``Act''). An OTP Holder must be a registered
broker or dealer pursuant to Section 15 of the Act, or a nominee or
an associated person of a registered broker or dealer that has been
approved by the Exchange to conduct business on the trading
facilities of the Exchange.
    \7\ See the Options Regulatory Fee Filing for a more complete
analysis of the rationale for eliminating RR Fees.
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    The Exchange believes that the realigned regulatory fee structure
as proposed herein will allow the Exchange to continue to adequately
fund the expenses associated with the performance of its regulatory
functions with respect to ETP Holders and the equities business of the
Exchange. The Exchange will monitor the amount of revenue collected
from the Gross FOCUS Revenue Fee to ensure that it, in combination with
its other regulatory fees and fines, does not exceed regulatory costs.
The Exchange expects to monitor regulatory costs and revenues on an
annual basis, at a minimum. If the Exchange determines that regulatory
revenues exceed regulatory costs, the Exchange would adjust the Gross
FOCUS Revenue Fee downward by submitting a fee change filing to the
Commission.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\8\ in general, and Section
6(b)(4) of the Act,\9\ in particular, in that it is designed to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities. The
Exchange believes that the proposal does not constitute an inequitable
allocation of fees, as all similarly situated member organizations will
be subject to the same fee structure, and access to the Exchange's
market is offered on fair and non-discriminatory terms. More
specifically, the Exchange believes that the proposed Gross FOCUS
Revenue Fee represents a fairer and more equitable allocation of fees
than the current fee structure because it would be charged to all
members on revenues generated by their equity business instead of how
many registered persons a particular ETP Holder employs. The latter
standard has become increasingly irrelevant as a measure of regulatory
services required due, among other reasons, to the rise of Internet and
discount brokerage firms in comparison

to traditional brokerage firms. The Exchange believes the proposed
Gross FOCUS Revenue Fee is reasonable because it will raise revenue
related to the amount of equity business conducted, which correlates
more closely with the amount of Exchange regulatory services required.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange further believes that the initial level of the Gross
FOCUS Revenue Fee is reasonable because it is expected to generate
revenues that, when combined with the Exchange's other regulatory fees
with respect to ETP Holders, will be less than or equal to the
Exchange's costs related to the regulation of its equities business.
This is consistent with the Commission's previously stated view that
regulatory fees be used for regulatory purposes and not to support the
Exchange's business side.

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

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

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by NYSE Arca.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-32 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-32. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2011-32 and should be submitted on or before June 30, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-14232 Filed 6-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64574-64575]
[FR Doc No: 2012-25866]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68058; File No. SR-Phlx-2012-123]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Assess a
Monthly Fee for Subscription to the QView Service

October 16, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 9, 2012, NASDAQ OMX PHLX LLC (``PHLX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    PHLX proposes to modify its fee schedule concerning NASDAQ OMX PSX
fees to assess a monthly fee for subscription to the QView service. The
Exchange is proposing to implement the proposed fee beginning on
October 15, 2012. The text of the proposed rule change is available at
http://nasdaqomxphlx.cchwallstreet.com, at PHLX's principal office, 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 III [sic] below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange is proposing to adopt a fee of $100 per month, per
member firm for subscription to the new QView service. The Exchange
recently introduced the QView service, a web-based, front-end
application that provides a subscribing member firm with increased
transparency over its trading activity on the Exchange by allowing the
member firm to track its Exchange order flow.\3\ The Exchange is
proposing to implement the proposed fee on October 15, 2012.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 67951 (October 1,
2012), 77 FR 61039 (October 5, 2012) (SR-Phlx-2012-114) (adopting
the QView Service on PHLX).
---------------------------------------------------------------------------

    PHLX notes that QView is currently offered by its sister exchange,
The NASDAQ Stock Market LLC for a fee of $600 per month, per member
firm.\4\ PHLX's QView service is identical to that of NASDAQ, yet
offered at a lower monthly subscription fee of $100 per month, per
member firm. The Exchange determined to assess a lower fee than the
NASDAQ service based on the lower volume of trading on the Exchange's
equities market, NASDAQ OMX PSX (``PSX'') and, hence, less data
provided

by PHLX QView as compared to NASDAQ QView.\5\ As noted in adopting PHLX
QView, a subscriber must also subscribe to Tradeinfo PSX to subscribe
to PHLX QView.\6\
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    \4\ See NASDAQ Rule 7058.
    \5\ Member firms are assessed an initial monthly subscription
fee prorated for the remainder of the month subscribed.
    \6\ Supra note 3.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b)(4) of the Act \7\ in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system which the
Exchange operates or controls, and it does not unfairly discriminate
between customers, issuers, brokers or dealers. The Exchange believes
that the proposed fee is equitable and not unfairly discriminatory
because member firms that voluntarily elect to subscribe to this
service will be charged the same fee. QView provides subscribing member
firms with a top down view of their trading activity on the Exchange
and the proposed fee is assessed on a per member firm basis. The value
of QView to a subscribing member firm is the convenience of aggregating
and displaying the firm's data in a single interface regardless of the
amount of data (executions, open orders, etc.) or the number of MPIDs
that the firm has. In this regard, the Exchange notes that the number
of MPIDs that a subscribing member firm possesses is not indicative of
quantity and value of the data provided by QView. In many cases, a firm
with a single MPID may in fact have more data than a firm with multiple
MPIDs. As such, the Exchange believes that it is equitable to assess
the fee on a per firm basis, as opposed to a per MPID basis. The
Exchange also believes that the proposed fee does not unfairly
discriminate because it is available to all member firms on equal terms
and there is no differentiation among member firms in regard to the fee
assessed to subscribers. In addition, the Exchange believes that it is
not unfair discrimination to limit the service to broker-dealers that
are members of the Exchange because it provides information solely
concerning a subscribing member firm's trading activity on the
Exchange.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange determined that the proposed fee is reasonable based
on member firm interest in QView, costs associated with developing and
supporting QView, and the value that QView provides to subscribing
member firms. The information provided by QView relates to the
subscribing member firm's activity on the Exchange and the member firm
may access and aggregate this information by other means, including its
own internal systems. As such, the Exchange believes that if a member
firm determines that the fee is not cost-efficient for its needs, it
may decline to subscribe to QView and access such information from
other sources. Finally, the maximum fee for a member that elects to
subscribe to this service, regardless of the number of MPIDs held by
the firm, is $100 per month. Subscription to QView is per member firm,
therefore a firm must subscribe only once to QView to receive the
service for as many of its MPIDs as it wishes.

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

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

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act,\8\ the Exchange has
designated this proposal as establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization on any person,
whether or not the person is a member of the self-regulatory
organization, which renders the proposed rule change effective upon
filing.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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 should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2012-123 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549.
    All submissions should refer to File Number SR-Phlx-2012-123. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2012-123 and should be
submitted on or before November 13, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25866 Filed 10-19-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 18 (Friday, January 27, 2023)]
[Notices]
[Page 5367]
[FR Doc No: 2023-01736]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0882]

BNSF Railway Bridge Across the Missouri River Between Bismarck
and Mandan, North Dakota; Record of Decision

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability for a Record of Decision.

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SUMMARY: The Coast Guard announces the availability of a Record of
Decision (ROD) for the replacement of the BNSF Railway Bridge across
the Missouri River between Bismarck and Mandan, North Dakota. This was
prepared in compliance with the National Environmental Policy Act
(NEPA) of 1969, as amended, and Council on Environmental Quality
implementing regulations. The ROD, which concludes the Environmental
Impact Statement (EIS) process for the project, explains the Coast
Guard's decision, describes the alternatives considered, and discusses
the plans for mitigation and monitoring. The Coast Guard's decision is
to approve the location and plans for the replacement of the BNSF
Railway Bridge using the applicant's preferred alternative: Construct a
new bridge with 200-foot spans and piers, 20 feet upstream of the
existing bridge, and remove the existing bridge. The Coast Guard is
making the ROD available to the public in the docket for this notice.

DATES: Brian Dunn, Chief, Coast Guard Office of Bridge Programs, signed
the ROD on December 22, 2022.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Rob McCaskey, Coast Guard District 8 Project Officer;
telephone:<PHONE_NUMBER>, or email: [email protected].

SUPPLEMENTARY INFORMATION: On January 8, 2020, the Coast Guard
published a notice of intent to prepare an Environmental Impact
Statement (EIS) (85 FR 930). On June 7, 2021, we published a notice of
availability for a draft EIS seeking public comments and announcing a
virtual meeting (86 FR 30323) for the BNSF Railway Bridge across the
Missouri River between the cities of Bismarck and Mandan, ND. On June
14, 2021, we published a notice of extension to the public comment
period (86 FR 31509), which extended the comment period to July 26,
2021.
    The notice of availability solicited substantive and relevant
comments related to the draft EIS. On June 30, 2021, the Coast Guard
held a virtual public meeting to receive written and oral comments on
the draft EIS. Public comments yielded very few substantive changes.
The Coast Guard published a notice of availability for the final EIS on
October 28, 2022 (87 FR 65216).
    The Coast Guard is making the ROD available to the public at:
https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/Marine-Transportation-Systems-CG-5PW/Office-of-Bridge-Programs/PROJECTS/.
    This notice is issued under authority of NEPA, 42 U.S.C. 4321 et
seq., Council on Environmental Quality implementing regulations in 40
CFR parts 1500 through 1508, and 5 U.S.C. 552(a).

    Dated: January 24, 2023.
Brian L. Dunn,
Chief, U.S. Coast Guard, Office of Bridge Programs.
[FR Doc. 2023-01736 Filed 1-25-23; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Page 16589]
[FR Doc No: 2021-06510]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-639-000.
    Applicants: Northern Natural Gas Company.
    Description: Request for Limited Waiver of Northern Natural Gas
Company.
    Filed Date: 3/19/21.
    Accession Number: 20210319-5286.
    Comments Due: 5 p.m. ET 3/31/21.

    Docket Numbers: RP21-640-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 3.23.21 Negotiated Rates--
Citadel Energy Marketing LLC R-7705-04 to be effective 4/1/2021.
    Filed Date: 3/23/21.
    Accession Number: 20210323-5011.
    Comments Due: 5 p.m. ET 4/5/21.

    Docket Numbers: RP21-641-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 3.23.21 Negotiated Rates--
Sequent Energy Management, L.P. R-3075-14 to be effective 4/1/2021.
    Filed Date: 3/23/21.
    Accession Number: 20210323-5012.
    Comments Due: 5 p.m. ET 4/5/21.

    Docket Numbers: RP21-642-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Rate Schedule LSS Rates Clean
Up Filing to be effective 4/1/2021.
    Filed Date: 3/23/21.
    Accession Number: 20210323-5034.
    Comments Due: 5 p.m. ET 4/5/21.

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

    Dated: March 24, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-06510 Filed 3-29-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57939-57940]
[FR Doc No: 2014-22973]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1242]

Submissions for Early Growth Response 1 Gene Fluorescence In-Situ
Hybridization Test System for Specimen Characterization Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Content and Format for
Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene
Fluorescence In-Situ Hybridization (FISH) Test System for Specimen
Characterization Devices.'' This draft guidance provides industry and
Agency staff with recommendations for the suggested format and content
of an abbreviated 510(k) submission for early growth response 1 (EGR1)
gene fluorescence in-situ hybridization (FISH) test system for specimen
characterization devices. This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 26, 2014.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Content and Format for Abbreviated 510(k)s for Early Growth Response
1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for
Specimen Characterization Devices'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Shyam Kalavar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5568, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document was developed to provide industry and
Agency staff with recommendations for the suggested format and content
of an abbreviated 510(k) submission for early growth response 1 (EGR1)
gene fluorescence in-situ hybridization (FISH) test system for specimen
characterization devices and recommendations for addressing certain
labeling issues relevant to the review process specific to these
devices. An early growth response 1 (EGR1) gene fluorescence in-situ
hybridization (FISH) test system for specimen characterization is a
device intended to detect the EGR1 probe target on chromosome 5q in
bone marrow specimens from patients with acute myeloid leukemia or
myelodysplastic syndrome. The assay results are intended to be
interpreted only by a qualified pathologist or cytogeneticist. These
devices do not include automated systems that directly report results
without review and interpretation by a qualified pathologist or
cytogeneticist. These devices also do not include any device intended
for use to select patient therapy, predict patient response to therapy,
or to screen for disease as well as any device with a claim for a

particular diagnosis, prognosis, and monitoring or risk assessment.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on content and
format for abbreviated 510(k)s for early growth response 1 (EGR1) gene
fluorescence in-situ hybridization (FISH) test system for specimen
characterization devices. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Content and Format for
Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene
Fluorescence In-Situ Hybridization (FISH) Test System for Specimen
Characterization Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1400030 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, are currently
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 809.10 are currently approved under 0910-
0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22973 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4916-4917]
[FR Doc No: 2016-01683]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Bioequivalence Recommendations for Lamotrigine; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry on lamotrigine
extended-release tablets entitled ``Draft Guidance on Lamotrigine.''
The recommendations provide specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for lamotrigine extended-release tablets.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic submissions 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 submissions 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-2007-D-0369 for ``Draft Guidance on Lamotrigine.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' will be 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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific BE recommendations and to provide a
meaningful opportunity for the public to consider and comment on those
recommendations. This notice announces the availability of revised
draft BE recommendations for lamotrigine extended-release tablets.
    On May 29, 2009, FDA initially approved new drug application 022115
for LAMICTAL (lamotrigine) extended-release tablets. There are eight
approved ANDAs for this product. In April 2010, we issued a draft
guidance for industry on BE recommendations for lamotrigine extended-
release tablets, which we subsequently revised in May 2010; July 2010;
and August 2010. We are now issuing a further revised draft guidance
for industry on BE recommendations for generic lamotrigine extended-
release tablets (``Draft Guidance on Lamotrigine'').
    In October 2006, UCB, Inc., submitted a citizen petition requesting
that FDA

take several actions with respect to anti-epileptic drugs (AEDs),
including that FDA narrow the bioequivalence range for all such drugs
(Docket No. FDA-2006-P-0461). FDA is reviewing the issues raised in the
petition. Although lamotrigine is not the sole focus of the petition,
lamotrigine is discussed and it is indicated for use as an AED;
therefore, FDA will consider any comments on the draft guidance on
lamotrigine in responding to the petition.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the design
of BE studies to support ANDAs for lamotrigine extended-release
tablets. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01683 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P