[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35340-35341]
[FR Doc No: 2020-12398]

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SECURITIES AND EXCHANGE COMMISSION

SEC File No. 270-598, OMB Control No. 3235-0655

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Regulation 14N and Schedule 14N

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Schedule 14N (17 CFR 240.14n-101) requires the filing of certain
information with the Commission by shareholders who submit a nominee or
nominees for director pursuant to applicable state law, or a company's
governing documents. Schedule 14N provides notice to the company of the
shareholder's or shareholder group's intent to have the company include
the shareholder's or shareholder group's nominee or nominees for
director in the company's proxy materials. This information is intended
to assist shareholders in making an informed voting decision with
regards to any nominee or nominees put forth by a nominating
shareholder or group, by allowing shareholders to gauge the nominating
shareholder's interest in the company, longevity of ownership, and
intent with regard to continued ownership in the company. We estimate
that Schedule 14N takes approximately 40 hours per response and will be
filed by approximately 10 issuers annually. In addition, we estimate
that 75% of the 40 hours per response (30 hours per response) is
prepared by the issuer for an annual reporting burden of 300 hours (30
hours per response x 10 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>

    Dated: June 3, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-12398 Filed 6-8-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Notices]
[Page 66635]
[DOCID:fr16de09-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-396-000]

Tres Amigas LLC; Notice of Filing

December 9, 2009.
    Take notice that on December 8, 2009, Tres Amigas LLC filed an
application requesting authorization to sell transmission services at
negotiated rates through the Tres Amigas Superstation, pursuant to
section 205 of the Federal Power Act, 16 USC 824d (2006), and Part 35
of the Commission's Rules and Regulations, 18 CFR Part 35 (2009).
    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. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    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 December 29, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-29913 Filed 12-15-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 8, 2009 (Volume 74, Number 194)]
[Notices]
[Page 51943-51944]
[DOCID:fr08oc09-108]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0161]

Notice 1 Receipt of Petition for Decision That Nonconforming 2009
Harley Davidson FX, FL, XL and VR Series Motorcycles Are Eligible for
Importation

AGENCY: National Highway Traffic Safety Administration, DOT

ACTION: Notice of receipt of petition for decision that nonconforming
2009 Harley Davidson FX, FL, XL and VR Series Motorcycles are eligible
for importation.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2009 Harley Davidson FX, FL, XL and VR Series Motorcycles that were not
originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS) are eligible for importation into the
United States because (1) they are substantially similar to vehicles
that were originally manufactured for sale in the United States and
that were certified by their manufacturer as complying with the safety
standards, and (2) they are capable of being readily altered to conform
to the standards.

DATES: The closing date for comments on the petition is November 9,
2009.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.

     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments Submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (J.K.)(Registered
Importer 90-006) has petitioned NHTSA to decide whether non-U.S.
certified 2009 Harley Davidson FX, FL, XL and VR series motorcycles are
eligible for importation into the United States. The vehicles that J.K.
believes are substantially similar are 2009 Harley Davidson FX, FL, XL
and VR series motorcycles that were manufactured for sale in the United
States and certified by their manufacturer as conforming to all
applicable FMVSS.
    The petitioner claims that it carefully compared non-U.S. certified
2009 Harley Davidson FX, FL, XL and VR series motorcycles to their U.S.
certified counterparts, and found the vehicles to be substantially
similar with respect to compliance with most FMVSS.
    J.K. submitted information with its petition intended to
demonstrate that non-U.S. certified 2009 Harley Davidson FX, FL, XL and
VR series motorcycles, as originally manufactured, conform to many
FMVSS in the same manner as their U.S. certified counterparts, or are
capable of being readily altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2009
Harley Davidson FX, FL, XL and VR series motorcycles are identical to
their U.S. certified counterparts with respect to compliance with
Standard Nos. 106 Brake Hoses, 111 Rearview Mirrors, 116 Brake Fluid,
119 New Pneumatic Tires for Vehicles other than Passenger Cars, 123
Motorcycle Controls and Displays, and 122 Motorcycle Brake Systems.
    The petitioner further contends that the vehicles are capable of
being readily altered to meet the following standards, in the manner
indicated below:
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: installation of the following U.S.-certified components on
vehicles not already so equipped: (a) Headlamp; (b) front and rear
side-mounted reflex reflectors; (c) rear-mounted reflex reflector; (d)
rear turn signal lamps; (e) stoplamp; (f) taillamp; and (g) license
plate lamp.
    Standard No. 120 Tire Selection and Rims for Vehicles other than
Passenger Cars: installation of a tire information placard.
    Standard No. 205 Glazing Materials: inspection of all vehicles, and
removal of noncompliant glazing or replacement of the glazing with
U.S.-certified components on vehicles that are not already so equipped.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: October 5, 2009.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. E9-24330 Filed 10-7-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 3 (Monday, January 6, 2014)]
[Notices]
[Page 677]
[FR Doc No: 2014-00018]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    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 a Closed Meeting on Wednesday,
January 8, 2014 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her 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 matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting 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: January 2, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-00018 Filed 1-2-14; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Notices]
[Pages 36832-36834]
[FR Doc No: 2014-15234]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0064]

Forging Machines; Extension of the Office of Management and
Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirements
contained in its standard on Forging Machines (29 CFR 1910.218). The
paperwork provisions of the Forging Machines Standard specify
requirements for developing and maintaining inspection records and for
identifying manually operated valves and switches.

DATES: Comments must be submitted (postmarked, sent, or received) by
August 29, 2014.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2011-0064, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2011-0064) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change and may be made
available online at http://www.regulations.gov. For further information
on submitting comments, see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA-95)(44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the Act or for developing information
regarding the causes and prevention of occupational injuries,
illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires
that OSHA obtain such information with minimum burden upon employers,
especially those operating small businesses, and to reduce to the
maximum extent feasible unnecessary duplication of efforts in obtaining
information (29 U.S.C. 657).
    The following sections describe who uses the information collected
under each requirement, as well as how they use it. The purpose of
these requirements is to reduce workers' risk of death or serious
injury by ensuring that forging machines used by them are in safe
operating condition, and that workers are able to clearly and properly
identify manually operated valves and switches.
    Inspection of Forging Machines, Guards, and Point-of-Operation
Protection Devices (paragraphs (a)(2)(i) and (a)(2)(ii)). Paragraph
(a)(2)(i) requires employers to establish periodic and regular
maintenance safety checks and to develop and maintain a certification
record of each inspection. The certification record must include the
date of the inspection, the signature of the person who performed the
inspection, and the serial number (or other identifier) of the forging
machine inspected. Under paragraph (a)(2)(ii), employers are to
schedule regular and frequent inspections of guards and point-of-
operation protection devices and to prepare a certification record of
each inspection that contains the date of the inspection, the signature
of the person who performed the inspection, and the serial number (or
other identifier) of the equipment inspected. These inspection
certification records provide assurance to employers, workers, and OSHA
compliance officers that forging machines, guards, and point-of-
operation protection devices have been inspected, and that they will
operate properly and safely, thereby preventing impact injuries or
death to workers during forging operations. These records also provide
the most efficient means for OSHA compliance officers to determine that
an employer is complying with the Forging Machines Standard.
    Identification of Manually Controlled Valves and Switches
(paragraphs (c), (h)(3), (i)(1) and (i)(2)). These paragraphs require
proper and clear identification of manually operated valves and
switches on presses, upsetters, boltheading equipment, and rivet-making
machines, respectively. Marking valves and switches provide information
to workers to help ensure that they operate the forging machines
correctly and safely.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Forging Machines
(29 CFR 1910.218). The Agency is requesting to retain its current
burden hour estimate of 187,264 hours associated with this

Standard. The Agency will summarize the comments submitted in response
to this notice and will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Forging Machines (29 CFR 1910.218).
    OMB Control Number: 1218-0228.
    Affected Public: Business or other for-profits.
    Number of Respondents: 27,700.
    Number of Responses: 1,440,788.
    Frequency of Responses: Bi-weekly.
    Average Time per Response: Varies from 2 minutes (.03 hour) for an
employer to disclose certification records to 8 minutes (.13 hour) for
a manufacturing employee to conduct a biweekly inspection of each
forging machine and guard or point-of-operation protection device.
    Estimated Total Burden Hours: 187,264.
    Estimated Cost Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number (Docket No. OSHA-2011-0064) for the ICR. You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the Web site and for assistance in using the Internet to
locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on June 25, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-15234 Filed 6-27-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57960-57961]
[FR Doc No: 2023-18243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3300]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

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 Vaccines and Related
Biological Products Advisory Committee (the Committee). The general
function of the Committee is to provide advice and recommendations to
FDA on regulatory issues. This meeting will be held to discuss the
Strain Selection for the Influenza Virus Vaccines for the 2024 Southern
Hemisphere Influenza Season. 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 virtually on October 5, 2023, from 8:30
a.m. to 1:30 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. The online web
conference meeting will be available at the following link on the day
of the meeting: https://youtube.com/live/3MRqhXOB3lQ.
    Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-3300. The docket will close on October
4, 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 4, 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 September 27, 2023, will be provided
to the Committee. Comments received on or after September 28, 2023, and
by October 4, 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-3300 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' 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. Eastern Time, Monday through Friday, 240-402-
7500.
     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 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: Sussan Paydar or Valerie Vashio,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002,<PHONE_NUMBER>, [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 5, 2023, the Committee will meet in
open session to discuss the Strain Selection for the Influenza Virus
Vaccines for the 2024 Southern Hemisphere Influenza Season.
    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 to the Docket (see ADDRESSES) on
or before September 27, 2023, will be provided to the Committee.
Comments received on or after September 28, 2023, and by October 4,
2023, will be taken into consideration by FDA. Oral presentations from
the public will be scheduled between approximately 11:20 a.m. and 12:20
p.m. Eastern Time. 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 their names, email addresses, and direct contact
phone numbers of proposed participants, on or before 12 p.m. Eastern
Time on September 20, 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, September 22, 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 Sussan Paydar or Valerie Vashio (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: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18243 Filed 8-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16057-16059]
[FR Doc No: 2019-07631]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85632; File No. SR-Phlx-2019-14]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Current Pilot Program Related to Clearly Erroneous Transactions

April 11, 2019.
    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 April 10, 2019, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the current pilot program related
to Phlx Rule 3312, Clearly Erroneous Transactions, to the close of
business on October 18, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to extend the current
pilot program related to Rule 3312, Clearly Erroneous Transactions, to
the close of business on October 18, 2019. This change is being
proposed in connection with proposed amendments to the Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan'') that would allow the Plan to continue to operate on a
permanent basis.\3\
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    \3\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (File No. 4-631)
(``Eighteenth Amendment'').
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    On September 10, 2010, the Commission approved, on a pilot basis,
changes to corresponding rules of The Nasdaq Stock Market LLC
(``Nasdaq''), Nasdaq BX, Inc. (``BX''), and other exchanges that, among
other things: (i) Provided for uniform treatment of clearly
erroneous[thinsp]execution reviews in multi-stock events involving
twenty or more securities; and (ii) reduced the ability of the
exchanges to deviate from the objective standards set forth in the
rule.\4\ Following this, on September 30, 2010, the Exchange adopted
changes to conform its Rule 3312 to Nasdaq's and BX's rules 11890.\5\
In 2013, the Exchange adopted a provision designed to address the
operation of the Plan.\6\ Finally, in 2014, the Exchange adopted two
additional provisions providing that: (i) A series of transactions in a
particular security on one or more trading days may be viewed as one
event if all such transactions were effected based on the same
fundamentally incorrect or grossly misinterpreted issuance information
resulting in a severe valuation error for all such transactions; and
(ii) in the event of any disruption or malfunction in the operation of
the electronic communications and trading facilities of an Exchange,
another SRO, or responsible single plan processor in connection with
the transmittal or receipt of a trading halt, an Officer, acting on his
or her own motion, shall nullify any transaction that occurs after a
trading halt has been declared by the primary listing market for a
security and before such trading halt has officially ended according to
the primary listing market.\7\ These changes are currently scheduled to
operate for a pilot period that coincides with the pilot period for the
Limit Up-Limit Down Plan,\8\ including any extensions to the pilot
period for the Plan.\9\
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    \4\ See Securities Exchange Act Release No. 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010) (File Nos. SR-BATS-2010-016;
SR-BX-2010-040; SR-CBOE-2010-056; SR-CHX-2010-13; SR-EDGA-2010-03;
SR-EDGX-2010-03; SR-ISE-2010-62; SR-NASDAQ-2010-076; SR-NSX-2010-07;
SR-NYSE-2010-47; SR-NYSEAmex-2010-60; SR-NYSEArca-2010-58).
    \5\ See Securities Exchange Act Release No. 63023 (September 30,
2010), 75 FR 61802 (October 6, 2010) (SR-Phlx-2010-125).
    \6\ See Securities Exchange Act Release No. 68820 (February 1,
2013), 78 FR 9436 (February 8, 2013) (SR-Phlx-2013-12).
    \7\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-Phlx-2014-27).
    \8\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \9\ See Securities Exchange Act Release No. 71783 (March 24,
2014), 79 FR 17617 (March 28, 2014) (SR-Phlx-2014-18).
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    The Commission recently published the proposed Eighteenth Amendment
to the Plan to allow the Plan to operate on a permanent, rather than
pilot, basis. The Exchange proposes to amend Rule 3312 to untie the
pilot program's effectiveness from that of the Plan and to extend the
pilot's effectiveness to the close of business on October 18, 2019--
i.e., six months after the expiration of the current pilot period for
the Plan. If the pilot period is not either extended, replaced or
approved as permanent, the prior versions of paragraphs (a)(2)(C), (b),
and (c)(1) shall be in effect, and the provisions of paragraphs (g)
through (i) shall be null and void.\10\ In such an event, the remaining
sections of Rule 3312 would continue to apply to all transactions
executed on the Exchange. The Exchange understands that the other
national securities exchanges and Financial Industry Regulatory
Authority (``FINRA'') will also file similar proposals to extend their
respective clearly erroneous execution pilot programs, the substance of
which are identical to Rule 3312.
---------------------------------------------------------------------------

    \10\ See supra notes 4-7. The prior versions of paragraphs
(a)(2)(C), (b), and (c)(1) generally provided greater discretion to
the Exchange with respect to breaking erroneous trades.
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to Rule 3312.
The Exchange believes the benefits to market participants from the more
objective clearly erroneous executions rule should continue on a
limited six month pilot basis after Commission approves

the Plan to operate on a permanent basis. Assuming the Plan is approved
by the Commission to operate on a permanent, rather than pilot, basis
the Exchange intends to assess whether additional changes should also
be made to the operation of the clearly erroneous execution rules.
Extending the effectiveness of Rule 3312 for an additional six months
should provide the Exchange and other national securities exchanges
additional time to consider further amendments to the clearly erroneous
execution rules in light of the proposed Eighteenth Amendment to the
Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\11\ in general, and
Section 6(b)(5) of the Act,\12\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning review of transactions as clearly
erroneous. The Exchange believes that extending the clearly erroneous
execution pilot under Rule 3312 for an additional six months would help
assure that the determination of whether a clearly erroneous trade has
occurred will be based on clear and objective criteria, and that the
resolution of the incident will occur promptly through a transparent
process. The proposed rule change would also help assure consistent
results in handling erroneous trades across the U.S. equities markets,
thus furthering fair and orderly markets, the protection of investors
and the public interest. Based on the foregoing, the Exchange believes
the amended Clearly Erroneous Transactions rule should continue to be
in effect on a pilot basis while the Exchange and the other national
securities exchanges consider and develop a permanent proposal for
clearly erroneous execution reviews.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of harmonized clearly erroneous
execution rules across the U.S. equities markets while the Exchange and
other national securities exchanges consider further amendments to
these rules in light of the proposed Eighteenth Amendment to the Plan.
The Exchange understands that the other national securities exchanges
and FINRA will also file similar proposals to extend their respective
clearly erroneous execution pilot programs. Thus, the proposed rule
change will help to ensure consistency across market centers without
implicating any competitive issues.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \16\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current clearly erroneous execution pilot program to
continue uninterrupted, without any changes, while the Exchange and the
other national securities exchanges consider and develop a permanent
proposal for clearly erroneous execution reviews. For this reason, the
Commission hereby waives the 30-day operative delay requirement and
designates the proposed rule change as operative upon filing.\17\
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    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

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-Phlx-2019-14 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-Phlx-2019-14. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2019-14 and should be submitted on or before May 8, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-07631 Filed 4-16-19; 8:45 am]
 BILLING CODE 8011-01-P