[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Notices]
[Page 37700]
[DOCID:fr29jy09-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-65-000]

Californians for Renewable Energy, Inc. (CARE), Complainant v.
California Public Utilities Commission, Southern California Edison, and
the California Independent System Operator Corporation, Respondent;
Notice of Complaint

July 22, 2009.
    Take notice that on July 16, 2009, Californians for Renewable
Energy, Inc. (CARE) submitted a complaint against the California Public
Utilities Commission (CPUC), Southern California Edison Company (SCE),
and the California Independent System Operator Corporation (CASIO)
regarding the SCE Application for a Certificate of Public Convenience
and Necessity Concerning the Tehachapi Renewable Transmission Project
and SCE's Tehachapi amendment to its open access transmission tariff
under Docket No. ER08-375-000.
    CARE states that copies of this filing were served upon Respondents
and other interested parties.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 11, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-17987 Filed 7-28-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61598-61600]
[FR Doc No: 2023-19284]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1190]

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments--
Sickle Cell Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Cellular, Tissue, and Gene
Therapies Advisory Committee (the Committee). The general function of
the Committee is to provide advice and recommendations to FDA on
regulatory issues. On October 31, 2023, the Committee will discuss and
make recommendations on biologics license application (BLA) 125787 from
Vertex Pharmaceuticals, Inc. for exagamglogene autotemcel (exa-cel).
The applicant has requested an indication for the treatment of sickle
cell disease in patients 12 years and older with recurrent vaso-
occlusive crises. The meeting will be open to the public. FDA is
establishing a docket for public comment on this document.

DATES: The meeting will be held on October 31, 2023, from 9 a.m. to 5
p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    The online web conference meeting will be available at the
following link on the day of the meeting at https://youtube.com/live/M90IjjxOdQg.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-1190. The docket will close on October
30, 2023. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
October 30, 2023. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
    Comments received on or before October 24, 2023, will be provided
to the Committee. Comments received after that date and on October 30,
2023, will be taken into consideration by FDA. In the event that the
meeting is cancelled, FDA will continue to evaluate any relevant
applications or information, and consider any comments submitted to the
docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-1190 for ``Cellular, Tissue, and Gene Therapies Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments--Sickle Cell Disease, Meeting Date: October 31, 2023.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Cicely Reese or Marie DeGregorio,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1246, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email: [email protected], or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area). A notice in the Federal Register about
last-minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. On October 31, 2023, the Committee will discuss
and make recommendations on BLA 125787 from Vertex Pharmaceuticals,
Inc. for exagamglogene autotemcel (exa-cel). The applicant has
requested an indication for the treatment of sickle cell disease in
patients 12 years and older with recurrent vaso-occlusive crises.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 24, 2023, will be provided to the
Committee. Oral presentations from the public will be scheduled between
approximately 12:35 p.m. and 1:35 p.m. Eastern Time on October 31,
2023. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, along
with the names, email addresses, and direct contact phone numbers of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before 12 p.m. Eastern Time
on October 16, 2023. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by 6 p.m.
Eastern Time on October 18, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cicely Reece or Marie DeGregorio at [email protected] (see
FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this

meeting to take place using an online meeting platform. This waiver is
in the interest of allowing greater transparency and opportunities for
public participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and that the ends of justice will be served
by allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19284 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 111-112]
[FR Doc No: 2017-28279]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER18-534-000]

Montpelier Generating Station, 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 of
Montpelier Generating Station, 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 January 15, 2018.
    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 website 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: December 26, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-28279 Filed 12-29-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47329-47330]
[FR Doc No: 2013-18791]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0033; OMB No. 1660-0123]

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on an extension, without change, of a currently approved
information collection. In accordance with the Paperwork Reduction Act
of 1995, this notice seeks comments concerning the Regional
Catastrophic Preparedness Grant Program (RCPGP).

DATES: Comments must be submitted on or before October 4, 2013.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-0033. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 840, Washington, DC
20472-3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Nicholas Sleptzoff, Program
Specialist, FEMA, National Preparedness Directorate,<PHONE_NUMBER> for
additional information. You may contact the Records Management Division
for copies of the proposed collection of information at facsimile
number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The purpose of the Regional Catastrophic
Preparedness Grant Program (RCPGP) is to enhance catastrophic incident
preparedness in Tier 1 and selected Tier 2 Urban Areas. RCPGP is
intended to support coordination of regional all-hazard planning for
catastrophic events, including the development of integrated planning
communities, plans, protocols, and procedures to manage a catastrophic
event. The RCPGP is authorized by Title III of the Department of
Homeland Security Appropriations Act, 2013 (Pub. L. 113-6).
    The RCPGP information is to be used to produce improved
catastrophic plans and planning processes by the states and local
jurisdictions involved. Specifically, the plans and planning must
address shortcomings in existing plans to address regional catastrophic
planning issues, including the establishment of a regional network of
plans to address catastrophic events. Plans will include a process for
establishing an incident command structure and will also identify roles
and responsibilities for each organization. Additionally, plans will
identify detailed resource, personnel, and asset allocations in order
to execute strategic objectives and translate strategic priorities into
operational execution. These plans should apply existing capabilities
and assist in assessing gaps in needed capabilities.

Collection of Information

    Title: FEMA Preparedness Grants: Regional Catastrophic Preparedness
Grant Program (RCPGP).
    OMB Number: 1660-0123.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    FEMA Forms: FEMA Form 089-19, RCPGP Investment Justification
Template; FEMA Form 089-26, RCGCP (Sample) Detailed Project Plan
Template; FEMA Form 089-17, RCPT Membership List.
    Abstract: The RCPGP is an important tool among a comprehensive set
of measures to help strengthen the Nation against risks associated with
potential terrorist attacks. DHS/FEMA uses the information to evaluate
applicants' familiarity with the national preparedness architecture and
identify how elements of this architecture have been incorporated into
regional/state/local planning, operations, and investments.
    Affected Public: State, local or Tribal Government.
    Number of Respondents: 10.
    Number of Responses: 40.
    Estimated Total Annual Burden Hours: 1,762 hours.

                                                       Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                  Average       Total       Average       Total
                                                                Number of    responses      Total      burden per     annual       hourly       annual
         Type of respondent            Form name/form number   respondents      per       number of     response   burden  (in   wage rate    respondent
                                                                             respondent   responses    (in hours)     hours)        ($)       cost  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local or Tribal Government...  RCPGP Investment                  10            1           10          120        1,200       $50.08   $60,096.00
                                       Justification Template/
                                       FEMA Form 089-19.
State, Local or Tribal Government...  RCPGP (Sample) Detailed           10            1           10           40          400        50.08    20,032.00
                                       Project Plan Template/
                                       FEMA Form 089-26.
State, Local or Tribal Government...  Regional Catastrophic             10            1           10           16          160        50.08     8,012.80
                                       Planning Team (RCPT)
                                       Charter Guidelines.

State, Local or Tribal Government...  RCPT Membership List/             10            1           10          0.2            2        50.08       100.16
                                       FEMA Form 089-17.
                                                              ------------------------------------------------------------------------------------------
    Total...........................  .......................           10  ...........           40  ...........        1,762  ...........    88,240.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $88,240.96. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$33,963.52.

Comments

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

    Dated: July 29, 2013.
Loretta Cassatt,
Chief, Records Branch, Records Management Division, Mission Support
Bureau, Federal Emergency Management Agency, Department of Homeland
Security.
[FR Doc. 2013-18791 Filed 8-2-13; 8:45 am]
BILLING CODE 9111-46-P


[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Rules and Regulations]
[Pages 43180-43183]
[FR Doc No: 2011-17738]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2011-0338; FRL-9435-7]

Finding of Failure To Submit Section 110 State Implementation
Plans for Interstate Transport for the 2006 National Ambient Air
Quality Standards for Fine Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In this action, EPA is finding that Tennessee has failed to
submit a State Implementation Plan (SIP) to satisfy the requirements of
the Clean Air Act (CAA) with respect to the 2006 24-hour National
Ambient Air Quality Standards (NAAQS) for fine particulate matter (24-
hour PM2.5). Although Tennessee has submitted a SIP to
address the requirements, the state subsequently withdrew that portion
of its SIP submittal because it relied on the Clean Air Interstate Rule
to address transport. This finding creates a 2-year deadline for the
promulgation of a Federal Implementation Plan (FIP) by EPA. In a
separate action, commonly referred to as the Transport Rule, EPA is
finalizing a FIP for Tennessee to address these requirements.

DATES: The effective date of this rule is August 19, 2011.

FOR FURTHER INFORMATION CONTACT: General questions concerning this
final rule should be addressed to Edgar Mercado, Office of Atmospheric
Programs, Clean Air Markets Division, 2400 Pennsylvania Avenue, Mail
Code 6204J, Washington, DC 20460; telephone<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For questions related to Tennessee, please
contact Richard A. Schutt, Chief, Regulatory Development Section, EPA
Region IV, Sam Nun Atlanta Federal Center, 61 Forsyth Street, SW., 12th
Floor, Atlanta, GA 30303.

Table of Contents

I. Background
II. This Action
III. Statutory and Executive Order Reviews
    A. Notice and Comment Under the Administrative Procedures Act
(APA)
    B. Executive Order 12866: Regulatory Planning and Review
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 13132 (Federalism)
    G. Executive Order 13175
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    L. Congressional Review Act
    M. Judicial Review

I. Background

    On October 17, 2006, EPA published a final rule revising the 24-
hour standard for fine particulate matter (PM2.5) from 65
micrograms per cubic meter ([mu]g/m3) to 35[mu]g/m3. Section 110(a)(1)
of the CAA requires states to submit revised SIPs that provide for the
implementation, maintenance, and enforcement of a new or revised
standard within 3 years after promulgation of such standard, or within
such shorter period as EPA may prescribe. Section 110(a)(2)(D)(i)
contains four elements that revised SIPs must address. This findings
notice addresses the first two elements which require each state to
submit SIPs which contain adequate provisions to prohibit air pollution
within the state that (1) contributes significantly to another state's
nonattainment of the NAAQS; or (2) interferes with another state's
maintenance of the NAAQS. Section 110(a)(1) imposes the obligation upon
states to make a SIP submission for a new or revised NAAQS, but the
contents of that submission may vary depending upon the facts and
circumstances. In particular, the data and analytical tools available
at the time the state develops and submits the SIP for a new or revised
NAAQS necessarily affects the content of the submission.
    States were required to have submitted complete SIPs that addressed
the section 110(a)(2)(D)(i)(I) requirement related to interstate
transport for the 2006 24-hour PM2.5 NAAQS by September 21,
2009. On June 9, 2010, in a separate final rulemaking (75 FR 32763),
EPA found that 29 states and territories had not made a SIP submittal
that addressed this requirement. Although Tennessee has submitted a SIP
intended to address the Section 110(a)(2)(D)(i) requirements, the state
subsequently withdrew the Section 110(a)(2)(D)(i) of its infrastructure
SIP with respect to the 2006 24-hour PM2.5 NAAQS on December
2, 2010, because it relied on the Clean Air Interstate Rule. Although
deficient to address the transport of pollution as highlighted in
recent EPA air quality modeling to support the final Transport Rule,
EPA acknowledges the State's efforts in making this SIP submittal. In
response to Tennessee's withdrawal of the 110(a)(2)(D)(i)(I) portions
of its SIP because it relied on the Clean Air Interstate Rule, EPA is
making a finding that Tennessee has failed to submit the required
infrastructure SIP elements with respect to nonattainment or
interference with maintenance of the 2006 24-hour PM2.5
NAAQS. In accordance with Section 110(c)(1), this finding creates a 2-
year deadline for the promulgation of a Federal Implementation Plan
(FIP) by EPA unless, prior to promulgation of a FIP, the state makes a
submission to meet and EPA approves such submission as meeting the
attainment and

maintenance requirements of section 110(a)(2)(D)(i)(I) for the 2006 24-
hour PM2.5 NAAQS. The State's SIP submittal to address other
portions of Section 110(a)(2)(D)(i) will be addressed in a separate
rulemaking.
    This action does not result in sanctions pursuant to CAA section
179 because this finding of failure to submit does not pertain to a
part D plan for nonattainment areas, or to a SIP Call pursuant to
section 110(k)(5).

II. This Action

    By this action, EPA is making the finding that Tennessee has failed
to submit a SIP that addresses the requirements of section
110(a)(2)(D)(i)(I) of the CAA for the revised 2006 24-hour
PM2.5 NAAQS. This finding creates a 2-year deadline for the
promulgation of a FIP by EPA for Tennessee unless the State submits a
SIP to satisfy these section 110(a)(2)(D)(i)(I) requirements, and EPA
approves such submission prior to promulgation of a FIP.

III. Statutory and Executive Order Reviews

A. Notice and Comment Under the Administrative Procedures Act (APA)

    This is a final EPA action, which is subject to notice-and-comment
requirements of the Administrative Procedures Act (APA), 5 U.S.C.
553(b). However, EPA invokes, consistent with past practice (for
example, 61 FR 36294), the good cause exception pursuant to APA, 5
U.S.C. 553(b)(3)(B). Notice and comment are unnecessary because no
significant EPA judgment is involved in making a finding of failure to
submit SIPs or elements of SIPs required by the CAA, where states have
made no submissions to meet the requirement by the statutory deadline.

B. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review by the Office of Management and
Budget under the EO.

C. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). This action relates to the
requirement in the CAA for states to submit SIPs under section
110(a)(1) that implements the CAA requirements for the revised 24-hour
PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS which satisfies the requirements of section 110(a)(2)
within 3 years of promulgation of such standard, or shorter period as
EPA may provide. The present final action does not establish any new
information collection requirement apart from that required by law.

D. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the APA or any other
statute unless the EPA certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
    For the purpose of assessing the impacts of this final action on
small entities, small entity is defined as: (1) A small business that
is a small industry entity as defined in the U.S. Small Business
Administration (SBA) size standards. (See 13 CFR, part 121); (2) a
small governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less
than 50,000; and (3) a small organization that is any not-for profit
enterprise which independently owned and operated is not dominate in
its field.
    Courts have interpreted the RFA to require a regulatory flexibility
analysis only when small entities will be subject to the requirements
of the rule. See, Michigan v. EPA, 213 F.3d 663, 668-69 (DC Cir.,
2000), cert. den., 532 U.S. 903 (2001). This rule would not establish
requirements applicable to small entities. Instead, it would require
states to develop, adopt, and submit SIPs to meet the requirements of
section 110(a)(2)(D)(i), and would leave to the states the task of
determining how to meet those requirements, including which entities to
regulate. Moreover, because affected states would have discretion to
choose the sources to regulate and how much emissions reductions each
selected source would have to achieve, EPA could not predict the effect
of the rule on small entities. After considering the economic impacts
of this final rule on small entities, I certify that this action will
not have a significant economic impact on a substantial number of small
entities. In addition, although the action is subject to the
Administrative Procedures Act, the Agency has invoked the ``good
cause'' exemption under 5 U.S.C. 553(b); therefore, it is not subject
to the notice and comment requirement.

E. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. The action implements mandate(s) specifically and explicitly
set forth by the Congress in CAA section 110(a)(2)(D)(i)(I) without the
exercise of any policy discretion by EPA.
    This action does not create any additional requirements beyond
those of the 2006 24-hour PM2.5 NAAQS (71 FR 61144, October
17, 2006). Therefore, no UMRA analysis is needed. This rule responds to
the requirement in the CAA for states to submit SIPs to satisfy the
requirements of section 110(a)(2) of the CAA for the 2006 24-hour
PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS within 3 years of promulgation of such standard, or
shorter period as EPA may provide. This action does not impose any
requirements beyond those specified in the Act.
    Therefore, this action is not subject to the requirements of
sections 202 or 205 of the UMRA. This action is also not subject to the
requirements of section 203 of UMRA because it contains no regulatory
requirements that might significantly or uniquely affect small
governments.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in EO 13132. The CAA establishes the scheme whereby states
take the lead in developing plans to meet the NAAQS. This action will
not modify the relationship of the states and EPA for purposes of
developing programs to implement the NAAQS. Thus, Executive Order 13132
does not apply to this action.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action
responds to the requirement in the CAA for states to submit SIPs to
satisfy the requirements of section 110(a)(2) of the CAA for the

2006 24-hour PM2.5 NAAQS. Section 110(a)(1) of the CAA
requires that states submit SIPs that implement, maintain, and enforce
a new or revised NAAQS which satisfies the requirements of section
110(a)(2) within 3 years of promulgation of such standard, or shorter
period as EPA may provide. The CAA provides for states and tribes to
develop plans to regulate emissions of air pollutants within their
jurisdictions. The regulations clarify the statutory obligations of
states and tribes that develop plans to implement this rule. The Tribal
Authority Rule (TAR) gives tribes the opportunity to develop and
implement CAA programs, but it leaves to the discretion of the tribe
whether to develop these programs and which programs, or appropriate
elements of a program, the tribe will adopt.
    This action does not have tribal implications as defined by
Executive Order 13175. It does not have a substantial direct effect on
one or more Indian tribes, because no tribe has implemented an air
quality management program related to the 2006 24-hour PM2.5
NAAQS at this time. Furthermore, this action does not affect the
relationship or distribution of power and responsibilities between the
federal government and Indian tribes. The CAA and the TAR establish the
relationship of the federal government and Tribes in developing plans
to attain the NAAQS, and this action does nothing to modify that
relationship. Because this action does not have tribal implications,
Executive Order 13175 does not apply.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. Nonetheless, we have evaluated the environmental
health or safety effects of the 2006 24-hour PM2.5 NAAQS on
children. The results of this risk assessment are contained in the
final rule for 24-hour PM2.5 NAAQS (71 FR 61144, October 17,
2006).

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this final action. This action responds to the requirement
in the CAA for states to submit SIPs to satisfy the requirements of
section 110(a)(2)(D)(i)(I) of the CAA for the 2006 24-hour
PM2.5 NAAQS. Section 110(a)(1) of the CAA requires that
states submit SIPs that implement, maintain, and enforce a new or
revised NAAQS which satisfies the requirements of section 110(a)(2)
within 3 years of promulgation of such standard, or shorter period as
EPA may provide. EPA is merely determining whether Tennessee has
complied with this statutory requirement.

L. Congressional Review Act

    The Congressional Review Act (CRA), 5 U.S.C. 801 et seq., as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA has made such a good cause finding, including
the reasons therefore, and established an effective date of August 19,
2011. EPA will submit a report containing this action and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the action in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 808(2).

M. Judicial Review

    Section 307(b)(1) of the CAA indicates which Federal Courts of
Appeal have venue for petitions of review of final actions by EPA. This
section provides, in part, that petitions for review must be filed in
the Court of Appeals for the District of Columbia Circuit: (i) When the
EPA action consists of ''nationally applicable regulations promulgated,
or final actions taken, by the Administrator,'' or (ii) when such
action is locally or regionally applicable, if ``such action is based
on a determination of nationwide scope or effect and if in taking such
action the Administrator finds and publishes that such action is based
on such a determination.''
    The Administrator is determining that this action making a finding
of failure to submit SIPs related to the section 110(a)(2)(D)(i)(I)
requirements for the 2006 24-hour PM2.5 NAAQS is of
nationwide scope and effect for the purposes of section 307(b)(1). This
is particularly appropriate because in the report on the 1977
Amendments that revised section 307(b)(1) of the CAA, Congress noted
that the Administrator's determination that an action is of
``nationwide scope or effect'' would be appropriate for any action that
has ``scope or effect beyond a single judicial circuit.'' H.R. Rep. No.
95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the
scope and effect of this rulemaking extends to numerous judicial
circuits since the finding of failure to submit a SIP applies to a
rulemaking of national scope and effect. In these circumstances,
section 307(b)(1)

and its legislative history call for the Administrator to find the rule
to be of ``nationwide scope or effect'' and for venue to be in the
District of Columbia Circuit.
    Thus, any petitions for review of this action related to a finding
of failure to submit SIPs related to the requirements of section
110(a)(2)(D)(i)(I) of the CAA must be filed in the Court of Appeals for
the District of Columbia Circuit within 60 days from the date final
action is published in the Federal Register.

List of Subjects in 40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: July 1, 2011.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2011-17738 Filed 7-19-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64529-64531]
[FR Doc No: 2019-25328]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0129]

Agency Information Collection Activities; Proposed Additional
Collection; Comment Request; General Licensing Provisions; Section
351(k) Biosimilar Applications; Formal Meetings Between the Food and
Drug Administration and Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension/revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on ``General Licensing
Provisions; Section 351(k) Biosimilar Applications; Formal Meetings
Between the FDA and Sponsors or Applicants.''

DATES: Submit either electronic or written comments on the collection
of information by January 21, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 21, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0129 for ``General Licensing Provisions; Section 351(k)
Biosimilar Applications; Formal Meetings Between the FDA and Sponsors
or Applicants.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 additional 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.

General Licensing Provisions; Section 351(k) Biosimilar Applications;
Formal Meetings Between the FDA and Sponsors or Applicants

OMB Control Number 0910-0719--Revision

    The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) amended the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with an FDA-licensed
reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, sets forth the requirements for an application
for a proposed biosimilar product and an application or a supplement
for a proposed interchangeable product. In addition to the submission
requirements associated with a 351(k) application for a proposed
biosimilar or interchangeable biological product, FDA is committed to
meeting certain performance goals in connection with the FDA
Reauthorization Act of 2017 (FDARA) and its Biosimilar User Fee (BsUFA)
program. These performance goals are found in the commitment letter
entitled, ``Biosimilar Biological Product Reauthorization Performance
Goals and Procedures Fiscal Years 2018 Through 2022'' available from
our website at: https://www.fda.gov/media/100573/download. Included in
the performance goals is information collection associated with
meetings and other communications with FDA, and we are therefore
revising the information collection to cover these provisions. Also
consistent with the commitment letter, we have developed the associated
guidance document entitled ``Formal Meetings Between the FDA and
Sponsors or Applicants of BsUFA Products.'' The guidance document
discusses the BsUFA meeting management goal provisions set forth in the
commitment letter and provides instruction and recommendations to
respondents on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar biological
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER). The
guidance is intended to assist sponsors or applicants in generating and
submitting meeting requests and associated meeting packages to FDA for
biosimilar biological products. A formal meeting includes any meeting
that is requested by a sponsor or applicant following the procedures
provided in the guidance and includes meetings conducted in any format
(i.e., face to face, teleconference/videoconference, written response
only (WRO)). The guidance, available from our website at https://www.fda.gov/media/113913/download, includes the following
recommendations pertaining to BsUFA meeting requests and information
packages:

A. Request for a Meeting

    We recommend that a sponsor or applicant interested in meeting with
CDER or CBER submit a meeting request electronically to the sponsor's
or applicant's application (i.e., investigational new drug application,
biologics license application). If there is no application, a sponsor
or applicant should submit the request to either the appropriate CDER
division director, with a copy sent to the division's chief

of project management staff, or to the division director of the
appropriate product office within CBER, but only after first contacting
the appropriate review division or the Biosimilars Program staff, CDER,
Office of New Drugs to determine to whom the request should be
directed, how it should be submitted, and the appropriate format for
the request and to arrange for confirmation of receipt of the request.
We recommend the following information be included in the meeting
request:
    1. Application number (if previously assigned),
    2. development-phase code name of the product (if prelicensure),
    3. proper name (if post licensure),
    4. structure (if applicable),
    5. proper and proprietary names of the reference product,
    6. proposed indication(s) or context of product development,
    7. pediatric study plans, if applicable,
    8. human factors engineering plan, if applicable,
    9. combination product information (e.g., constituent parts,
including details of the device constituent part, intended packaging,
planned human factors studies), if applicable,
    10. meeting type being requested (the rationale for requesting the
meeting type should be included),
    11. proposed format of the meeting (face to face, tele-conference/
video-conference/WRO),
    12. a brief statement of the purpose of the meeting, including a
brief background of the issues underlying the agenda. It can also
include a brief summary of completed or planned studies and clinical
trials or data the sponsor or applicant intends to discuss at the
meeting, the general nature of the critical questions to be asked, and
where the meeting fits in the overall development plans.
    13. a list of specific objectives/outcomes expected from the
meeting,
    14. a proposed agenda, including times required for each agenda
item,
    15. a list of questions grouped by discipline and a brief
explanation of the context and purpose of each question,
    16. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and any consultants and interpreters,
    17. a list of FDA staff, if known, or disciplines asked to
participate in the requested meeting, and
    18. suggested dates and times for the meeting.

We use the information to determine the utility of the meeting, to
identify FDA staff necessary to discuss proposed agenda items, and to
schedule the meeting.

B. Information Package

    We recommend that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request and that
the following information be included in the package:
    1. Application number (if previously assigned),
    2. development-phase code name of product (if pre-licensure) or
proper name (if post-licensure),
    3. structure (if applicable),
    4. proprietary and proper names of the reference product,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency
and duration), and presentation(s),
    7. pediatric study plans, if applicable,
    8. human factors engineering plan, if applicable,
    9. combination product information, if applicable,
    10. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and any consultants and interpreters,
    11. background that includes a brief history of the development
program and the status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable),
    12. a brief statement summarizing the purpose of the meeting,
    13. the proposed agenda, and
    14. a list of questions for discussion grouped by discipline and
with a brief summary for each question to explain the need or context
for the question, and data to support discussion organized by
discipline and question.

The purpose of the meeting package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
  BsUFA information collection       Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CDER Information Packages.......              29             2.2              64              30           1,920
CBER Meeting Requests...........               2               1               2              15              30
CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since last OMB review of the information collection we have
increased our burden estimate by 95 annual responses and 1,965 annual
hours. This adjustment corresponds with an increase in submissions
received by the Agency over the past 3 years.

    Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25328 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55386-55387]
[FR Doc No: 2017-25155]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0125]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0121

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0121,
United States Coast Guard Academy Introduction Mission Program
Application and Supplemental Forms; without change. Our ICR describes
the information we seek to collect from the public. Before submitting
this ICR to OIRA, the Coast Guard is inviting comments as described
below.

DATES: Comments must reach the Coast Guard on or before January 22,
2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0125] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for

further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION:  Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2017-0125], and
must be received by January 22, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: United States Coast Guard Academy Introduction Mission
Program Application and Supplemental Forms.
    OMB Control Number: 1625-0121.
    Summary: This collection contains the application and all
supplemental forms required to be considered as an applicant to the
U.S. Coast Guard Academy Introduction Mission (AIM) Program.
    Need: The information is needed to select applicants for
participation in a one-week summer recruiting and training program for
prospective Cadets interested in attending the U.S. Coast Guard
Academy.
    Forms: USCGA-AIM1, Travel Update Form; USCGA-AIM2, Scholarship
Request Form; USCGA-AIM3, Medical Release Form.
    Respondents: Approximately 2,000 applicants apply annually to
attend the AIM Program. Approximately 3,000 individuals will submit
letters of recommendation for these applicants.
    Frequency: Applicants must apply only once per year.
    Hour Burden Estimate: The annual burden is estimated at 9,000
hours.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: November 15, 2017.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2017-25155 Filed 11-20-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15774-15775]
[FR Doc No: 2020-05735]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP20-68-000; CP20-70-000; CP20-70-000]

Enable Gas Transmission, LLC, Enable Gulf Run Transmission, LLC;
Notice of Application

    Take notice that on February 28, 2020, Enable Gas Transmission, LLC
(EGT), 910 Louisiana Street, Suite 4840, Houston, Texas 77002, filed an
application pursuant to sections 7(b) and 7(c) of the Natural Gas Act
(NGA), and Parts 157 and 284 of the Commission's regulations,
requesting authorization to (1) construct, install, own, operate, and
maintain various facilities along EGT's existing Line CP (Line CP
Modifications), including modifications to two existing compressor
stations, modification of three existing meter stations, and
construction of two new meter stations; (2) abandon by sale certain
assets related to EGT's Line CP, including the new and modified
facilities described above, with the exception of Line CP-3 (located in
Panola County, Texas) to Enable Gulf Run Transmission, LLC (Gulf Run);
and (3) lease a portion of the capacity on Line CP from Gulf Run.
    In combination with this filing, Enable Gulf Run Transmission, LLC
(Gulf Run), 910 Louisiana Street, Suite 4840, Houston, Texas 77002,
filed an application under sections 7(b) and 7(c) of the NGA, and Part
157 of the Commission's regulations requesting authorization to (1)
construct, install, own, operate, and maintain approximately 134 miles
of new natural gas transmission pipeline (Gulf Run Pipeline), and
ancillary facilities to transport up to approximately 1.65 million
dekatherms per day of natural gas from EGT's existing Westdale
Compressor Station to a delivery point near Starks, Louisiana; (2)
acquire certain assets related to EGT's Line CP from EGT; and (3) lease
a portion of the capacity on Line CP back to EGT and to re-acquire a
portion of such capacity following the term of the lease. Gulf Run also
requests a blanket certificate, pursuant to Part 157, Subpart F of the
Commission's regulations, authorizing Gulf Run to construct, operate,
acquire, and abandon certain facilities, and a blanket certificate
pursuant to Part 284, Subpart G of the Commission's regulations
authorizing Gulf Run to provide open-access firm and interruptible
interstate natural gas transportation services on a self-implementing
basis with pre-granted abandonment for such services, all as more fully
set forth in the application which is on file with the Commission and
open for public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
(202) 502-8659.
    Any questions regarding the proposed project should be directed to
Lisa Yoho, Senior Director, Regulatory & FERC Compliance, Enable Gulf
Run Transmission, LLC, Enable Gas Transmission, LLC, 910 Louisiana
Street, Suite 48040, Houston, Texas 77002, or by calling<PHONE_NUMBER>
(telephone) or email at<EMAIL_ADDRESS>    On April 12, 2019, the Commission staff granted the EGT and Gulf
Run request to utilize the FERC's Pre-Filing Process and assigned
Docket No. PF19-3-000 to staff activities involving the project. Please
note that on June 12, 2019, the FERC issued a Notice of Intent to
Prepare an Environmental Impact Statement for the Planned Gulf Run and
Line CP Modifications Project, Request for Comments on Environmental
Issues, and Notice of Public Scoping Sessions. Based on EGT's
subsequent decision not to propose certain segments of originally
planned pipeline and new compression as part of the filed project
application, FERC staff has determined that an environmental assessment
(EA) is the appropriate means to evaluate the project's environmental
impacts, rather than an environmental impact statement. Now, as of the
filing of the applications on February 28, 2020, the Pre-Filing Process
for this project has ended. From this time forward, this proceeding
will be conducted in Docket No. CP20-68-000 and CP20-70-000, as noted
in the caption of this Notice.
    Because the environmental review of the submitted projects includes
both the Line CP Modifications and the Gulf Run Pipeline, preparation
of the EA to comply with the National Environmental Policy Act of 1969
will combine both applications. Within 90 days after the issuance of
this Notice of Application, the Commission staff will issue a Notice of
Schedule for Environmental Review that will indicate the anticipated
date for the Commission's staff issuance of the EA analyzing both
proposals. The issuance of a Notice of Schedule for Environmental
Review will also serve to notify federal and state agencies of the
timing for the completion of all necessary reviews, and the subsequent
need to complete all federal authorizations within 90 days of the date
of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the

Commission) and will not have the right to seek court review of the
Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new Natural Gas Act
section 3 or section 7 proceeding.\1\ Persons desiring to become a
party to a certificate proceeding are to intervene in a timely manner.
If seeking to intervene out-of-time, the movant is required to ``show
good cause why the time limitation should be waived,'' and should
provide justification by reference to factors set forth in Rule
214(d)(1) of the Commission's Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC ] 61,167 at
] 50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on April 3, 2020.

    Dated: March 13, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-05735 Filed 3-18-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41171-41173]
[FR Doc No: 2023-13348]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97746; File No. SR-ICEEU-2023-015]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Amendments Part HH of Its Delivery Procedures

June 16, 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 6, 2023, ICE Clear Europe Limited filed with the Securities and
Exchange Commission (``Commission'') the proposed rule changes
described in Items I, II and III below, which Items have been prepared
primarily by ICE Clear Europe Limited. ICE Clear Europe Limited filed
the proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\
and Rule 19b-4(f)(4) 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 change from interested persons.
---------------------------------------------------------------------------

    \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)(4).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') proposes to amend Part HH of its Delivery Procedures
(``Delivery Procedures'' or ``Procedures'') \5\ to make certain
corrections and clarifications with respect to the ICE Endex French PEG
Natural Gas Contracts to be consistent with relevant exchange contract
specifications.
---------------------------------------------------------------------------

    \5\ Capitalized terms used but not defined herein have the
meanings specified in the Delivery Procedures or, if not defined
therein, the ICE Clear Europe Clearing Rules.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C)

below, of the most significant aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe is proposing to amend Part HH of the Delivery
Procedures which applies to ICE Endex French PEG Natural Gas Contracts
to make certain corrections and clarifications to be consistent with
exchange contract specifications. In paragraph 3.2, the amendments
would clarify that the contract trades in megawatt hours (MWh) per day
and would correctly reflect that the contract is delivered in kilowatt
hours (kWh) rather than MWh. The delivery documentation summary in
paragraph 9.1 would also be amended to reflect the correction from MWh
to kWh for deliveries under the contract. In paragraph 9.2, a
correction would be made for invoice report and account sale report
requirements to reflect that ICE Endex French PEG Daily Futures are
priced in Euros per MWh (rather than pence per Therm). The amendments
do not otherwise change the terms and conditions of deliveries under
the relevant contract.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed amendments to the
Delivery Procedures are consistent with the requirements of Section 17A
of the Act \6\ and the regulations thereunder applicable to it. In
particular, Section 17A(b)(3)(F) of the Act \7\ requires, among other
things, that the rules of a clearing agency be designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivative agreements, contracts, and
transactions, the safeguarding of securities and funds in the custody
or control of the clearing agency or for which it is responsible, and
the protection of investors and the public interest. The proposed
changes to the Delivery Procedures are designed to make certain
clarifications and corrections in Part HH relating to settlement for
ICE Endex French PEG Natural Gas Contracts, for consistency with
relevant exchange contract specifications. The amendments do not
otherwise change the manner in which the contracts are cleared or
settled. Accordingly, ICE Clear Europe believes that the Delivery
Procedures, as amended, would be consistent with the prompt and
accurate clearance and settlement of the contracts, and the protection
of investors and the public interest consistent with the requirements
of Section 17A(b)(3)(F) of the Act.\8\ (In ICE Clear Europe's view, the
amendments would not affect the safeguarding of funds or securities in
the custody or control of the clearing agency or for which it is
responsible, within the meaning of Section 17A(b)(3)(F).\9\)
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    In addition, Rule 17Ad-22(e)(10) \10\ provides that ``[e]ach
covered clearing agency shall establish, implement, maintain and
enforce written policies and procedures reasonably designed to, as
applicable [. . .] establish and maintain transparent written standards
that state its obligations with respect to the delivery of physical
instruments, and establish and maintain operational practices that
identify, monitor and manage the risks associated with such physical
deliveries.'' As discussed above, the amendments would make certain
corrections and clarifications relating to settlement under ICE Endex
French PEG Natural Gas Contracts, including with respect to deliveries
being made in kWh. The amendments thus appropriately clarify the role
and responsibilities of the Clearing House and Clearing Members with
respect to the contracts. As a result, ICE Clear Europe believes the
amendments are consistent with the requirements of Rule 17Ad-
22(e)(10).\11\
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    \10\ 17 CFR 240.17Ad-22(e)(10).
    \11\ 17 CFR 240.17Ad-22(e)(10).
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(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
amendments to the Delivery Procedures are intended to make certain
corrections and clarifications relating to ICE Endex French PEG Natural
Gas Contracts. The amendments would not change the obligations of
market participants under those contracts. ICE Clear Europe does not
believe the amendments would adversely affect competition among
Clearing Members, materially affect the cost of clearing, adversely
affect access to clearing in the new contracts for Clearing Members or
their customers, or otherwise adversely affect competition in clearing
services. Accordingly, ICE Clear Europe does not believe that the
amendments would impose any impact or burden on competition that is not
appropriate in furtherance of the purpose of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change

    Written comments relating to the proposed amendment has not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments 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 has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4 \13\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
file number SR-ICEEU-2023-015 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-ICEEU-2023-015. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule

change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filings will also be available for inspection and copying at the
principal office of ICE Clear Europe and on ICE Clear Europe's website
at https://www.theice.com/clear-europe/regulation.
    Do not include personal identifiable information in submissions;
you should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-ICEEU-2023-015 and
should be submitted on or before July 14, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-13348 Filed 6-22-23; 8:45 am]
BILLING CODE 8011-01-P