[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 44033]
[DOCID:fr27jy10-141]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold Closed Meetings on Wednesday, July
28, 2010 at 2:30 p.m. and on Thursday, July 29, 2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meetings.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meetings in closed session, and determined that
no earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Wednesday,
July 28, 2010 will be:
    Institution and settlement of an injunctive action; and
    Institution and settlement of administrative proceedings.
    The subject matter of the Closed Meeting scheduled for Thursday,
July 29, 2010 will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: July 22, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-18451 Filed 7-23-10; 11:15 am]
BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Notices]
[Pages 19938-19939]
[FR Doc No: 2020-07491]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP20-50-000; CP20-51-000]

Tennessee Gas Pipeline Company, LLC and Southern Natural Gas
Company, LLC; Notice of Schedule for Environmental Review of the
Evangeline Pass Expansion Project

    On February 7, 2020, Tennessee Gas Pipeline Company, LLC
(Tennessee) and Southern Natural Gas Company, LLC (SNG) filed
applications in Docket Nos. CP20-50-000 and CP20-51-000, respectively,
requesting a Certificate of Public Convenience and Necessity pursuant
to Section 7(c) of the Natural Gas Act to construct and operate certain
natural gas pipeline facilities in Louisiana and Mississippi. SNG is
also requesting authorization under Section 7(b) of the Natural Gas Act
to abandon by lease the new capacity to Tennessee. The proposed
projects, collectively known as the Evangeline Pass Expansion Project
(Project), would provide up to 1,100 million standard cubic feet of
natural gas per day to the recently approved Venture Global Gator
Express Pipeline interconnect for feed gas for the Plaquemines
Liquified Natural Gas Terminal in Plaquemines Parish, Louisiana.
    On February 21, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--July 27, 2020
90-day Federal Authorization Decision Deadline--October 26, 2020

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Tennessee proposes to construct and operate two 36-inch-diameter
looping \1\ pipeline segments, totaling 13 miles, in

St. Bernard and Plaquemines Parishes, Louisiana and a new 23,470
horsepower compressor station in St. Bernard Parish. In addition,
Tennessee would replace certain facilities including a like-for-like
replacement of two 10,410 horsepower units at its existing Compressor
Station 527 located in Plaquemines Parish. SNG proposes to construct a
new 22,220 horsepower compressor station in Clarke County, Mississippi,
and three new meter stations in Clarke and Smith Counties, Mississippi
and St. Bernard Parish, Louisiana. Additionally, Tennessee and SNG
propose to construct, modify, or replace certain system auxiliary and
appurtenant facilities under sections 2.55(a) and 2.55(b) of the
Commission's regulations.\2\
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    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
    \2\ SNG is proposing to construct or modify auxiliary facilities
pursuant to section 2.55(a) of the Commission's regulations in these
additional counties and parishes: Jasper, Simpson, Jefferson Davis,
Lawrence, and Walthall Counties, Mississippi and Washington, St.
Tammany, and Orleans Parishes, Louisiana.
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Background

    On March 20, 2020, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Evangeline Pass
Expansion Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the NOI, the Commission
received comments from the Teamsters National Pipeline Labor Management
Cooperation Trust in support of the Project. No additional comments
have been received to date. All substantive comments will be addressed
in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP20-50 or CP20-51), and
follow the instructions. For assistance with access to eLibrary, the
helpline can be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: April 3, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-07491 Filed 4-8-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41437-41439]
[FR Doc No: 2023-13458]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97772; File No. SR-BOX-2023-02]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend BOX Rule
4120 (Transactions of Certain Public Customers) and BOX Rule 100
(Definitions) and Adopt IM-4120-1

June 20, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 5, 2023, BOX Exchange LLC (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 primarily by the Exchange. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(6) thereunder,\4\ such that the proposed rule change was
immediately effective upon filing with the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend BOX Rule 4120 (Transactions of
Certain Public Customers) and BOX Rule 100 (Definitions) and adopt IM-
4120-1. The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room and also on the Exchange's internet website at https://rules.boxexchange.com/rulefilings.

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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend BOX Rule 4120 (Transactions of
Certain Public Customers) and BOX Rule 100 (Definitions) and adopt IM-
4120-1. The purpose of the proposed rule change is to amend the BOX
Rule that governs interested transactions to, among other things,
clarify that clearing firms are not intended to be included within the
scope of BOX Rule 4120. The Exchange notes that the proposed changes
are similar to the scope of activities covered by existing rules at
other options exchanges.\5\
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    \5\ See NYSE Rule 407 and NYSE American Rule 407. The Exchange
believes NYSE and NYSE American similarly do not include clearing
firms within the scope of their rules.
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Rule 4120 and Proposed IM-4120-1
    Presently, BOX Rule 4120 prohibits an OFP,\6\ without prior
consent, from executing any transaction in securities or carrying a
position in any security in which: (1) an officer or employee of the
Exchange or any national securities exchange that is a participant of
the Clearing Corporation,\7\ or an officer or employee of a corporation
in which the Exchange, or such other exchange owns the majority of the
capital stock, is directly or indirectly interested; or (2) a partner,
officer, director, principal shareholder or employee of another OFP is
directly or indirectly interested. In such circumstances, the OFP is
required to receive written consent from the Exchange or consent of the
other OFP prior to taking such action.
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    \6\ The terms ``Order Flow Provider'' or ``OFP'' mean those
Options Participants representing as agent Customer Orders on BOX
and those non-Market Maker Participants conducting proprietary
trading. See BOX Rule 100(a)(47). The term ``Customer Order'' means
an agency order for the account of either a Public Customer, as
defined herein, or a broker-dealer. See BOX Rule 100(a)(18). The
term ``Market Maker'' means an Options Participant registered with
the Exchange for the purpose of making markets in options contracts
traded on the Exchange and that is vested with the rights and
responsibilities specified in the Rule 8000 Series. All Market
Makers are designated as specialists on the Exchange for all
purposes under the Exchange Act or Rules thereunder. The term
``Public Customer'' means a person that is not a broker or dealer in
securities. See BOX Rule 100(a)(53).
    \7\ The term ``Clearing Corporation'' or ``OCC'' means The
Options Clearing Corporation.
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    This Rule 4120 is intended to govern conflicts of interest and
regulate interested transactions.\8\ The Rule prohibits OFPs from
engaging in specified interested actions without obtaining prior
written consent from the Exchange or consent of the other OFP prior to
taking such action. For example, under Rule 4120, an OFP may not
execute a transaction in a security in which an employee of the
Exchange is directly interested, without first obtaining written
consent from the Exchange. The Exchange is proposing to amend BOX Rule
4120 to clarify that clearing firms are not intended to be included
within the scope of BOX Rule 4120. Specifically, the Exchange is
proposing to add ``open a securities or commodities account'' and
remove ``in securities or carry a position in any security'' within BOX
Rule 4120(a) to amend the scope of this requirement, which is in line
with the scope and language of other exchanges.\9\ The Exchange
believes that this change removes unintended parties from the scope of
the rule and thus allows for more effective supervision of interested
transactions. At present, due to the broad language within Rule 4120(a)
stating that no OFP shall ``carry a position in any security'' clearing
firms are being captured within the scope of the Rule. The Exchange is
proposing to amend Rule 4120 to remove the language relating to
carrying a position in a security to clarify that clearing firms are
not included in the scope of this Rule due to only carrying a position,
which the Exchange believes is in line with the intent of the rule and
existing practices at other exchanges.\10\
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    \8\ BOX Rule 4120 governs direct or indirect conflicts of
interest involving officers or employees of the Exchange or any
national securities exchange that is a participant of the OCC, an
officer or employee of a corporation in which the Exchange, or such
other exchange owns the majority of the capital stock, and partners,
officers, directors, principal shareholders or employees of another
OFP. See BOX Rule 4120.
    \9\ See supra note 3.
    \10\ Id.

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

    The proposed amended language within BOX Rule 4120(a) would
provide, ``No OFP shall open a securities or commodities account or
execute any transaction in which: (1) an officer or employee of the
Exchange or any national securities exchange that is a participant of
the Clearing Corporation, or an officer or employee of a corporation in
which the Exchange, or such other exchange owns the majority of the
capital stock, is directly or indirectly interested, without the prior
written consent of the Exchange; or (2) a partner, officer, director,
principal shareholder or employee of another OFP is directly or
indirectly interested, without the consent of such other OFP.'' Rule
4120 also requires that where the required consent has been granted,
duplicate reports of the transaction and position shall promptly be
sent to the Exchange or OFP, as the case may be. Additionally, the
Exchange is proposing to adopt language to provide that the Exchange
may, upon written request, and where good cause is shown, waive any
requirements of Rule 4120. The Exchange notes that this proposed waiver
language is identical to language found within NYSE American Rule 407
and NYSE Rule 407.\11\ The Exchange believes that the adoption of this
provision will provide the Exchange with greater flexibility, to allow
for more effective and efficient supervision of the interested
transactions that are governed by Rule 4120.
---------------------------------------------------------------------------

    \11\ Id.
---------------------------------------------------------------------------

    The Exchange is also proposing to adopt IM-4120-1. Proposed IM-
4120-1 would provide that the term ``securities or commodities
accounts'' as used in Rule 4120 shall include, but not be limited to,
limited or general partnership interests in investment partnerships. As
part of the proposed changes detailed above, the Exchange is adopting
language within Rule 4120(a) to provide that no OFP shall ``open a
securities or commodities account.'' The Exchange believes that
adopting IM-4120-1, which provides that for the purposes of Rule 4120,
securities or commodities accounts also include limited or general
partnership interests in investment partnerships, will reduce the
potential for investor confusion regarding what is included within the
scope of the Rule. Additionally, proposed IM-4120-1 would require OFPs
to develop and maintain written procedures for reviewing such accounts
and transactions and assure that their associated persons are not
improperly recommending or marketing such securities or products to
others through Participants \12\ or Participant organizations. At
present, Rule 4120 is silent on the requirements for how an OFP must
ensure compliance with this Rule. The Exchange is now proposing to
adopt language codifying the requirement for OFPs to develop and
maintain written procedures for reviewing these transactions and
accounts. The Exchange believes that OFPs already maintain such written
procedures in practice and is looking to codify the requirement for
clarity. The Exchange is adopting IM-4120-1 to provide more clarity on
what is covered under the term ``securities or commodities accounts,''
and the obligation for OFPs to develop related written procedures.
---------------------------------------------------------------------------

    \12\ The term ``Participant'' means a firm, or organization that
is registered with the Exchange pursuant to the Rule 2000 Series for
purposes of participating in trading on a facility of the Exchange
and includes an ``Options Participant'' and ``BSTX Participant.''
---------------------------------------------------------------------------

    The Exchange believes that proposed IM-4120-1, which provides
greater clarity on the requirements of Rule 4120, will allow for more
effective regulatory compliance. The Exchange also notes that proposed
IM-4120-1 is substantively identical to an existing rule at NYSE
American and NYSE.\13\
---------------------------------------------------------------------------

    \13\ See NYSE American Rule 407, Supplementary Material .11 and
NYSE Rule 407, Supplementary Material .11.
---------------------------------------------------------------------------

Technical Amendments
    In addition to the proposed amendments, the Exchange is proposing
to amend Rule 100(a)(16) to update the cross references to the rules of
the OCC within the definition of the term ``covered short position.''
The OCC has amended their Rule 610 since BOX adopted Rule 100(a)(16),
so the Exchange is proposing to update the OCC cross references within
BOX Rule 100(a)(16). The Exchange is proposing to update the cross
reference to OCC Rule 610(f) to 610(A) and 610(B) and the cross
reference to OCC Rule 610(g) to 610(C).\14\ The Exchange is not
proposing to make any substantive changes to Rule 100(a)(16).
---------------------------------------------------------------------------

    \14\ See OCC Rules 610A (Member Specific Deposits), 610B (Third-
Party Specific Deposits), and 610C (Escrow Deposits).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Securities Exchange Act of 1934
(the ``Act''),\15\ in general, and 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 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.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Rule 4120 and Proposed IM-4120-1
    Together, the proposed amendment of Rule 4120 and the proposed
adoption of IM-4120-1 are intended to amend the BOX Rule governing
conflicts of interest by updating and adopting rules that regulate
interested transactions.\17\ Specifically, the proposed changes are
intended to clarify that clearing firms are not intended to be included
within the scope of BOX Rule 4120. The Exchange believes that the
proposed rule change may reduce potential investor or market
participant confusion over which BOX Participants are covered under
scope of BOX Rule 4120. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \17\ See supra notes 3 and 11.
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change may result
in more efficient regulatory compliance, as the proposed updates are
similar in relevant part to existing rules at NYSE American and
NYSE.\18\ As such, the Exchange believes that the proposed rule change
is in the public interest and therefore, is consistent with the Act.
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    \18\ Id.
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Technical Changes
    In addition, the Exchange believes that the proposed non-
substantive clarifying changes described above to update the OCC cross
references within BOX Rule 100(a)(16) would add clarity to the
Exchange's rules. The Exchange believes that adding such clarity would
also be consistent with the public interest and the protection of
investors because investors will not be harmed and in fact would
benefit from increased clarity, thereby reducing potential confusion.
In addition, the Exchange believes that amending the OCC cross
references to accurately reflect the updated section numbers within the
OCC Rulebook would promote fairness and consistency in the marketplace
by providing investors with access to the appropriate citations as
detailed within the Rules of the OCC. The proposed

change is not intended to make any substantive change to the definition
of ``covered short position'' within the BOX Rulebook.

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 not necessary or appropriate in
furtherance of the purposes of the Act. In this regard and as indicated
above, the Exchange notes that the rule change is being proposed to
clarify that clearing firms are not intended to be included within the
scope of BOX Rule 4120. The Exchange notes that, the proposed updates
are similar in relevant part to existing rules at NYSE American and
NYSE.\19\ The proposed rule change does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \19\ See supra notes 3 and 11.
---------------------------------------------------------------------------

    The proposed rule change is not designed to address any competitive
issues but rather to clarify that clearing firms are not intended to be
included within the scope of BOX Rule 4120. The Exchange's proposal to
amend BOX Rule 4120 does not impose an undue burden on competition as
all Participants that conduct business with the public would be subject
to the proposed rules.
    The proposed rule change is not designed to address any competitive
issues but rather seeks to clarify that clearing firms are not intended
to be included within the scope of BOX Rule 4120. The Exchange's
proposal to adopt proposed IM-4120-1 does not impose an undue burden on
competition as all Participants that conduct business with the public
would be subject to the proposed rules.
Technical Amendments
    The Exchange's proposal to amend BOX Rule 100(a)(16) to update the
cross references to the rules of the OCC within the definition of the
term ``covered short position'' is a non-substantive amendment.

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

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

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

    (a) This proposed rule change is filed pursuant to paragraph (A) of
section 19(b)(3) of the Exchange Act \20\ and Rule 19b-4(f)(6)
thereunder.\21\
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    (b) This proposed rule change does not significantly affect the
protection of investors or the public interest, does not impose any
significant burden on competition, and, by its terms, does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest.
    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 protected]. Please include
File Number SR-BOX-2023-02 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-BOX-2023-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method.
    The Commission will post all comments on the Commission's internet
website (http://www.sec.gov/rules/sro.shtml). Copies of the submission,
all subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, on official business days between the hours of 10:00
a.m. and 3:00 p.m., located at 100 F Street NE, Washington, DC 20549.
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. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly.
    All submissions should refer to File Number SR-BOX-2023-02 and
should be submitted on or before July 17, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-13458 Filed 6-23-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34082-34083]
[FR Doc No: 2011-14412]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0402]

Agency Information Collection Activities; Proposed Collection;
Comment Request; State Petitions for Exemption From Preemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements
contained in existing FDA regulations governing State petitions for
exemption from preemption.

DATES: Submit either electronic or written comments on the collection
of information by August 9, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use

of automated collection techniques, when appropriate, and other forms
of information technology.

State Petitions for Exemption From Preemption--21 CFR 100.1(d) (OMB
Control Number 0910-0277)--Extension

    Under Section 403A(b) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for
exemption from Federal preemption of State food labeling and standard
of identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth
the information a State is required to submit in such a petition. The
information required under section 100.1(d) enables FDA to determine
whether the State food labeling or standard of identity requirement
satisfies the criteria of section 403A(b) of the FD&C Act for granting
exemption from Federal preemption.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d).................................................                 1                  1                  1                 40                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  100.1(d) is minimal because
petitions for exemption from preemption are seldom submitted by States.
In the last 3 years, FDA has not received any new petitions for
exemption from preemption; therefore, the Agency estimates that one or
fewer petitions will be submitted annually. Although FDA has not
received any new petitions for exemption from preemption in the last 3
years, it believes these information collection provisions should be
extended to provide for the potential future need of a State or local
government to petition for an exemption from preemption under the
provisions of section 403(A) of the FD&C Act.

    Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14412 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Notices]
[Page 77665]
[FR Doc No: 2023-24974]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0036]

Southeastern Pennsylvania Transportation Authority's Request To
Amend Its Positive Train Control Safety Plan

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that, on
November 1, 2023, the Southeastern Pennsylvania Transportation
Authority (SEPTA) submitted a request for amendment (RFA) to its FRA-
approved Positive Train Control Safety Plan (PTCSP) in order to update
its positive train control (PTC) Onboard Computer (OBC) to Rev. 14.00
to correct two defects. As this RFA may involve a request for FRA's
approval of proposed material modifications to an FRA-certified PTC
system, FRA is publishing this notice and inviting public comment on
SEPTA's RFA to its PTCSP.

DATES: FRA will consider comments received by December 4, 2023. FRA may
consider comments received after that date to the extent practicable
and without delaying implementation of valuable or necessary
modifications to a PTC system.

ADDRESSES:
    Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for
submitting comments.
    Instructions: All submissions must include the agency name and the
applicable docket number. The relevant PTC docket number for this host
railroad is Docket No. FRA-2010-0036. For convenience, all active PTC
dockets are hyperlinked on FRA's website at https://railroads.dot.gov/research-development/program-areas/train-control/ptc/railroads-ptc-dockets. All comments received will be posted without change to https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In general, title 49 United States Code
(U.S.C.) section 20157(h) requires FRA to certify that a host
railroad's PTC system complies with title 49 Code of Federal
Regulations (CFR) part 236, subpart I, before the technology may be
operated in revenue service. Before making certain changes to an FRA-
certified PTC system or the associated FRA-approved PTCSP, a host
railroad must submit, and obtain FRA's approval of, an RFA to its PTCSP
under 49 CFR 236.1021.
    Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will
publish a notice in the Federal Register and invite public comment in
accordance with 49 CFR part 211, if an RFA includes a request for
approval of a material modification of a signal and train control
system. Accordingly, this notice informs the public that, on November
1, 2023, SEPTA submitted an RFA to its PTCSP for its Advanced Civil
Speed Enforcement System II (ACSES II), which seeks FRA's approval for
an update to software version Rev. 14.00 for its OBC to correct two
defects. That RFA is available in Docket No. FRA-2010-0036.
    Interested parties are invited to comment on SEPTA's RFA to its
PTCSP by submitting written comments or data. During FRA's review of
SEPTA's RFA, FRA will consider any comments or data submitted within
the timeline specified in this notice and to the extent practicable,
without delaying implementation of valuable or necessary modifications
to a PTC system. See 49 CFR 236.1021; see also 49 CFR 236.1011(e).
Under 49 CFR 236.1021, FRA maintains the authority to approve, approve
with conditions, or deny a railroad's RFA to its PTCSP at FRA's sole
discretion.

Privacy Act Notice

    In accordance with 49 CFR 211.3, FRA solicits comments from the
public to better inform its decisions. DOT posts these comments,
without edit, including any personal information the commenter
provides, to https://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate
comment tracking, we encourage commenters to provide their name, or the
name of their organization; however, submission of names is completely
optional. If you wish to provide comments containing proprietary or
confidential information, please contact FRA for alternate submission
instructions.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2023-24974 Filed 11-9-23; 8:45 am]
BILLING CODE 4910-06-P


5/27/04

Notes on call w/Cooper & Darney, ORD; Sheppard and Birgfeld, OAP

Overview—

OAP:  We are now looking at female reproductive issues.  We are looking at Yamada vs. WIL.  The purpose is to see if we should develop a new AEL for risk assessment.

	We will need:	UF for rats to humans

			UF for interhuman variability

Before—In June proposal, looking at male reproductive effects.  We calculated a BMDL of ~ 169 ppm.

For female reproductive effects, we were not able to benchmark—models didn’t fit well—

Issue:  ordinal scale (regularity) vs. continuous (cycle length)

How to do, when some of the animals were acyclic?

ORD:  Which parts of the ovarian cycle are you examining?

What are the lengths in estrous vs. diestrous portions of cycle?

			Diestrous(follicles not growing; prolonged

4 to 5 days is typical for the estrous cycle for ovary

Cycle may stop or be extended because:

An ovarian effect—withered away

or

“pseudo-pregnant”  -high levels of progesterone

The target site may be the central nervous system or the pituitary

In Yamada, there were no growing antral follicles, as would be expected in a pseudo-pregnant animal.

Based on Yamada, we would expect reduced litter size, prolonged diestrous—found in WIL.

Midcycle surges of LH and FSH (pituitary hormones) precede ovulation—measuring LH and FSH in diestrous may not mean much.

OAP:  Should impacts on the number of antral follicles be considered a LOAEL?

What is the relevance, esp. to humans:

ORD:  If no cycle at all—can’t get pregnant

But—there are also male effects

Not clear if male or female only

In women—population of women with different ages, different cycle types

High sensitivity—might interact with blood pressure medication

WIL( 250 ppm LOAEL for estrous cycle length   100 ppm NOEC for both genders

OAP: Could we do a benchmark for females?  If so, what health effect?

On estrous cycle length?

ORD:  Yes, or even better would be the number of cycles in 3 weeks of data collection

Will avoid the problem of how to address cycle length in acyclic animals

Dependency on progesterone does matter for humans, too

if mode of action is through the pituitary – may have effects in both men and women—an endocrine disruptor

if direct ovarian effect, definitely an impact

Yamada—thinks 1- and 2-BP have different modes of action

OAP:  Is it possible to do a BMD?  We will follow up w/Yamada to get raw data.


[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55599-55600]
[FR Doc No: 2017-25328]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-301-000]

Ormesa LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding
Ormesa LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 6, 2017.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected]. or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: November 16, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-25328 Filed 11-21-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69760-69761]
[FR Doc No: 2019-27303]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4468-DR; Docket ID FEMA-2019-0001]

Florida; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4468-DR), dated October 21, 2019, and
related determinations.

DATES: This amendment was issued December 9, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
areas among those

areas determined to have been adversely affected by the event declared
a major disaster by the President in his declaration of October 21,
2019.

    Broward and Volusia Counties for Public Assistance.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-27303 Filed 12-18-19; 8:45 am]
BILLING CODE 9111-23-P