[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58313-58314]
[FR Doc No: 2013-23019]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1041]

Fibromyalgia Public Meeting on Patient-Focused Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for fibromyalgia. Patient-Focused Drug Development is part
of FDA's performance commitments in the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patients' perspectives on the impact of
fibromyalgia on daily life as well as the available therapies for
fibromyalgia.

DATES: The public meeting will be held on December 10, 2013, from 1
p.m. to 5 p.m. Registration to attend the meeting must be received by
November 27, 2013. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting. Submit electronic or
written comments by February 10, 2013.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, in Section A of the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants is through Building 1, where routine security
check procedures will be performed. For more information on parking and
security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected fibromyalgia as the focus of a meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patients' perspectives on the severity of the
disease and the available therapies for the condition. Patient-Focused
Drug Development is being conducted to fulfill FDA's performance
commitments made as part of the authorization of PDUFA V under Title I
of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-
144). The full set of performance commitments is available on the FDA
Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA has committed to obtain the patient perspective in twenty
disease areas during the course of PDUFA V. For each disease area, the
Agency will conduct a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient community, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice (78 FR 08441) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. To develop the list of disease areas, the Agency used
several criteria that were outlined in the April 11 notice. The Agency
obtained public comment on these criteria and potential disease areas
through a notice for public comment published in the Federal Register
on September 24, 2012 (77 FR 23454, and through a public meeting held
on October 25, 2012. In selecting the disease areas, FDA carefully
considered the public comments received and the perspectives of its
review divisions. By the end of FY 2015, FDA will initiate another
public process for determining the disease areas for FY 2016-2017. More
information, including the list of disease areas and a general schedule
of meetings, is posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on symptoms of fibromyalgia that
matter most to patients and on current approaches to treating
fibromyalgia. Fibromyalgia is a chronic disorder characterized by
widespread musculoskeletal pain and tenderness in multiple tender
points and may be accompanied by fatigue, sleep disturbances, irritable
bowel syndrome, headache, and mood disorders. While there is currently
no definitive cure, treatments for fibromyalgia include medications and
lifestyle changes with emphasis on minimizing symptoms and improving
general health and daily function. FDA is interested in obtaining a
better understanding of fibromyalgia patients' perspectives on the
severity of the disease and the available therapies used to treat
fibromyalgia and its symptoms.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief patient panel discussion will begin the
dialogue, followed by a facilitated discussion inviting comments from

other patient and patient stakeholder participants. In addition to
input generated through this public meeting, FDA is interested in
receiving patient input addressing these questions through written
comments that can be submitted to the public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    (1) Of all the symptoms that you experience because of your
condition, which 1-3 symptoms have the most significant impact on your
life? (Examples may include chronic pain, fatigue, difficulty
concentrating, sleep disorders, etc.)
    (2) Are there specific activities that are important to you but
that you cannot do at all or as fully as you would like because of your
condition? (Examples of activities may include sleeping through the
night, daily hygiene, driving, household chores, etc.)
    (a) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
    (3) How have your condition and its symptoms changed over time?
    (a) Do your symptoms come and go? If so, do you know of anything
that makes your symptoms better? Worse?
    (4) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treating
Fibromyalgia
    (1) What are you currently doing to help treat your condition or
its symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as exercise or acupuncture)
    (a) What specific symptoms do your treatments address?
    (b) How has your treatment regimen changed over time, and why?
    (2) How well does your current treatment regimen treat the most
significant symptoms of your disease?
    (a) How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
    (b) How well have these treatments worked for you as your condition
has changed over time?
    (3) What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, going to the hospital
for treatment, restrictions on driving, etc.)
    (4) What specific things would you look for in an ideal treatment
for your condition?

B. Meeting Attendance and/or Participation

    If you wish to attend this meeting, visit https://patientfocusedfibromyalgia.eventbrite.com. Please register by November
27, 2013. Those who are unable to attend the meeting in person can
register to view a live webcast of the meeting. You will be asked to
indicate in your registration whether you plan to attend in person or
via the webcast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
    Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients will
also be asked to send a brief summary of responses to the topic
questions to<EMAIL_ADDRESS>Panelists will be notified of
their selection soon after the close of registration on November 27,
2013. FDA will try to accommodate all patients and patient stakeholders
who wish to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
    Interested members of the public, including those who attend the
meeting in person or through the webcast, are invited to provide
electronic or written responses to the questions pertaining to Topics 1
and 2 to the public docket (see ADDRESSES). Comments may be submitted
until February 10, 2013.

    Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23019 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 19, 2005 (Volume 70, Number 201)]
[Notices]
[Page 60865-60866]
[DOCID:fr19oc05-110]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

    Extension: Rule 15c1-5, SEC File No. 270-422 OMB, OMB Control
No. 3235-0471.

    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 requests for extension on the previously approved collection
of information discussed below.
    Rule 15c1-5 states that any broker-dealer controlled by,
controlling, or under common control with the issuer of a security that
the broker-dealer is trying to sell to or buy from a customer must give
the customer written notification disclosing the control relationship
at or before completion of the transaction. The Commission estimates
that 360 respondents collect information annually under Rule 15c1-5 and
that approximately 3,600 hours would be required annually for these
collections.
    There is no retention period requirement under Rule 15c1-5. This
Rule does not involve the collection of confidential information.
Please note that 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.
    Written comments regarding the information above should be directed
to the following persons: (i) the Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Building,
Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Office of Information Technology, Securities and
Exchange Commission, Station Place, 100 F Street, NE., Washington, DC
20549. Comments must be submitted to OMB within 30 days of this notice.

    Dated: October 11, 2005.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E5-5745 Filed 10-18-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Rules and Regulations]
[Page 75636]
[FR Doc No: 2015-30587]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-1019]

Drawbridge Operation Regulation; English Kills, New York City, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Metropolitan Avenue Bridge across
the English Kills, mile 3.4, at New York City, New York. This deviation
is necessary to perform operating machinery installation. This
deviation allows the bridge to remain in the closed position for
approximately 3 days.

DATES: This deviation is effective from 6 a.m. on December 7, 2015 to 5
p.m. on December 10, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-1019] is available
at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy K. Leung-Yee, Project
Officer, First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: New York City DOT requested this temporary
deviation from the normal operating schedule to perform operating
machinery installation.
    The Metropolitan Avenue Bridge, mile 3.4, across the English Kills
has a vertical clearance in the closed position of 10 feet at mean high
water and 15 feet at mean low water. The existing bridge operating
regulations are found at 33 CFR 117.801(e).
    The waterway has one commercial facility located upstream of the
bridge.
    Under this temporary deviation, the Metropolitan Avenue Bridge may
remain in the closed position from 6 a.m. on December 7, 2015 through 5
p.m. on December 10, 2015.
    Vessels able to pass through the bridge in the closed positions may
do so at any time. The bridge will not be able to open for emergencies
and there is no immediate alternate route for vessel to pass.
    The Coast Guard will also inform the users of the waterways through
our Local and Broadcast Notice to Mariners of the change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 18, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2015-30587 Filed 12-2-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Notices]
[Page 50271]
[DOCID:fr30se09-115]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixth Meeting, Special Committee 213/EUROCAE WG 79: Enhanced
Flight Vision Systems/Synthetic Vision Systems (EFVS/SVS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 213/EUROCAE WG 79: Enhanced
Flight Vision Systems/Synthetic Vision Systems (EFVS/SVS).

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 213/EUROCAE WG 79: Enhanced Flight
Vision Systems/Synthetic Vision Systems (EFVS/SVS).

DATES: The meeting will be held November 3-5, 2009. Sign-in: 8:30 a.m.
on November 3, 2009. Meeting: 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at Dassault Aviation, 78 quai
Marcel Dassault, 92214 Saint-Cloud, France, http://www.dassault-
aviation.com.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 213/EUROCAE WG 79: Enhanced
Flight Vision Systems/Synthetic Vision Systems (EFVS/SVS) meeting. The
agenda will include:

Tuesday, November

 Sign-in at 8:30 a.m.
 9 a.m.-11:30 a.m.--Plenary (including break)
     Welcome, introductions, review agenda, minutes approval,
and objectives
     Plenary work group updates, action item review
     Plenary briefings
 1 p.m.-5 p.m.--Separate work group 1 and 2 discussions
(including break)

Wednesday, November 4

 9 a.m.-5 p.m.--Separate work group 1 and 2 discussions
(including break)

Thursday, November 5

 9 a.m.-5 p.m.--Plenary (including break)
     Agree on draft MASPS
     Review action items
     Review administrative items
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 23, 2009.
James H. Williams,
RTCA Advisory Committee.
[FR Doc. E9-23529 Filed 9-29-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: July 16, 2007 (Volume 72, Number 135)]
[Notices]
[Page 38850-38851]
[DOCID:fr16jy07-60]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56036; File No. SR-CBOE-2007-41]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change as Modified by
Amendment No. 1 Thereto To Codify Pre-Existing Practices and To Amend
and Supplement Rule 24.9

July 10, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 1, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II and III below, which Items have been substantially prepared
by the Exchange. The Exchange submitted Amendment No. 1 to the proposed
rule change on June 7, 2007.\3\ The Commission is publishing this
notice and order to solicit comments on the proposal, as amended, from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to codify in its rulebook its pre-existing
methodology used for determining the day on which the exercise
settlement value of CBOE Volatility Index options and CBOE Increased-
Value Volatility Index options (collectively, ``Volatility Index
options'') is calculated. The Exchange also proposes to set forth in
its rulebook the manner in which the expiration date and last trading
day for a Volatility Index option are determined and to supplement the
manner in which the day on which the exercise settlement value of a
Volatility Index option is calculated is determined. The text of the
rule proposal is available on the Exchange's Web site (http://www.cboe.org/legal
), at the Exchange's Office of the Secretary and at

the Commission.

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. 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 parts of such
statements.

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

1. Purpose
    The purpose of this rule filing is to amend Rule 24.9, Terms of
Index Options, to codify the pre-existing methodology used for
determining the day on which the exercise settlement value of
Volatility Index options is calculated.\4\ This day is also the
expiration date for Volatility Index options and the business day
immediately before the expiration date is the last trading day for
Volatility Index options. The Exchange also proposes to supplement the
manner for determining the day on which the exercise settlement value
of Volatility Index options is calculated in the event of an Exchange
holiday.
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    \4\ See Securities Exchange Act Release No. 53342 (February 21,
2006), 71 FR 10086 (February 28, 2006) (SR-CBOE-2006-008). This
filing set forth the current methodology for determining the date on
which the exercise settlement value of a Volatility Index option is
calculated and the expiration date of a Volatility Index option,
replacing prior methodology under which options would not expire
exactly thirty days prior to the expiration of the options on the
index on which the Volatility Index is based in four of the months
in any rolling twelve-month period. See also CBOE Regulatory
Circular 2006-23 (describing methodology for determining date of
calculation of exercise settlement value and expiration date).
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    In general, each Volatility Index is calculated using the quotes of
certain index option series (e.g., S&P 500 Index (``SPX'') options) to
derive a measure of volatility of the U.S. equity market. Under CBOE's
current methodology, the day on which the exercise settlement value of
a Volatility Index option is calculated and the expiration date of a
Volatility Index option is the Wednesday that is thirty days prior to
the third Friday of the calendar month immediately following the
expiring month of the Volatility Index option.\5\ Additionally, the
Tuesday immediately before that Wednesday is the last trading day for
Volatility Index options.
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    \5\ The options used to calculate the Volatility Indexes are
traded on CBOE and generally expire on the third Friday of any given
calendar month.
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    This methodology was chosen because it provides consistency by
ensuring that Volatility Index options expire exactly thirty days
before the expiration date of the options that are used to calculate
the Volatility Indexes.\6\ Additionally, the Exchange believes that the
settlement process works best if underlying option series with a single
expiration month are used to calculate a Volatility Index. If
underlying options series in two expiration months are used, the number
of options series used in the settlement process is markedly increased
and the settlement process becomes more complex and cumbersome. The
above methodology and the proposed revision to that methodology
described below with respect to Exchange holidays ensures that
underlying option series in a single expiration month will always be
used to calculate the underlying Volatility Index at settlement.
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    \6\ See supra note 4.
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    The Exchange also represents that this methodology is consistent
with the way in which the final settlement dates for futures contracts
on Volatility Indexes are calculated. The Exchange is proposing to
amend the existing text of Rule 24.9, relating to the current
methodology, to codify its pre-existing practice.
    In order to maintain the desired consistency described above, the
Exchange also proposes to supplement the current methodology by
providing a framework for determining the day on which the exercise
settlement value for Volatility Index options will be calculated and
the expiration date for Volatility Index options when the Exchange is
closed on the third Friday of any given calendar month. Specifically,
the Exchange proposes to amend Rule 24.9 to provide that if the third
Friday of the month subsequent to the expiration of a Volatility Index
option is an Exchange holiday, the exercise settlement value of the
Volatility Index option will be calculated on the business day that is
thirty days prior to the Exchange business day immediately preceding
that Friday.\7\ This would also be the expiration date for that
Volatility Index option.
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    \7\ The Exchange represents that it is also proposing a similar
change relating to the final settlement date for futures contracts
on volatility indexes.
---------------------------------------------------------------------------

    The following example is meant to illustrate how this revised
methodology will work. February 2008 CBOE Volatility Index (``VIX'')
options would generally expire on the Wednesday (February 20, 2008)
that is thirty days prior to the third Friday in the succeeding month
(March 21, 2008) (This would be the expiration date of the SPX options
used to calculate the VIX). However, the Exchange will be

closed on Friday, March 21, 2008 in observance of Good Friday;
therefore, the SPX options will expire on the immediately preceding
business day, which is Thursday, March 20, 2008. Accordingly, to ensure
that a thirty-day volatility measurement period is used for February
2008 VIX options, the exercise settlement value of those options would
be calculated on Tuesday, February 19, 2008 and the expiration date of
February 2008 VIX options would also be Tuesday, February 19, 2008.
Further, the last trading day for February 2008 VIX options would be
Monday, February 18, 2008.
    Because February 2008 VIX options are currently traded, the
Exchange proposes that this rule change apply to those contracts, as
well as to any Volatility Index options that are subsequently traded by
the Exchange. The Exchange represents that it will provide public
disclosure and notifications to its members and the investing public of
this change.
2. Statutory Basis
    Because this rule proposal will codify the Exchange's pre-existing
practices and improve the settlement procedures for Volatility Index
options, the Exchange believes the rule proposal is consistent with the
Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to a national securities exchange.
Specifically, the Exchange believes that the proposed rule change is
consistent with the Section 6(b)(5) Act \8\ requirements that the rules
of an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts and, in general, to
protect investors and the public interest.
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    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve the proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be 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, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-41 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2007-41. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying 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 filing also will be available for
inspection and copying at the principal offices of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-41 and should be
submitted on or before August 6, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-13694 Filed 7-13-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60210-60213]
[FR Doc No: 2015-25177]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76015; File No. SR-BATS-2015-76]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To
Restructure and Amend Rule 11.17, Clearly Erroneous Executions

September 29, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 21, 2015, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which items have been prepared by the Exchange. 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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to restructure and amend Rule 11.17,
Clearly Erroneous Executions, in order to conform to the rules of EDGA
Exchange, Inc. (``EDGA'') and EDGX Exchange, Inc. (``EDGX'').\3\
---------------------------------------------------------------------------

    \3\ See EDGA and EDGX Rule 11.15.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
    In early 2014, the Exchange and its affiliate, BATS Y-Exchange,
Inc. (``BYX''), received approval to effect a merger (the ``Merger'')
of the Exchange's parent company, BATS Global Markets, Inc., with
Direct Edge Holdings LLC, the indirect parent of EDGX and EDGA
(together with BZX, BYX and EDGX, the ``BGM Affiliated Exchanges'').\4\
In the context of the Merger, the BGM Affiliated Exchanges are working
to align their rules, retaining only intended differences between the
BGM Affiliated Exchanges. Thus, the Exchange proposes to restructure
and amend Rule 11.17, Clearly Erroneous Executions, in order to conform
to the corresponding rules of EDGA and EDGX and provide a consistent
rule set across each of the BGM Affiliated Exchanges.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 71375 (January 23,
2014), 79 FR 4771 (January 29, 2014) (SR-BATS-2013-059; SR-BYX-2013-
039).
    \5\ The Exchange notes that BYX intends to file an identical
proposal with the Commission to restructure and amend its Rule
11.17, Clearly Erroneous Executions, to conform to EDGA and EDGX
Rules 11.15.
---------------------------------------------------------------------------

Background
    On September 10, 2010, the Commission approved, on a pilot basis,
changes to BATS Rule 11.17 to provide for uniform treatment: (1) Of
clearly erroneous \6\ execution reviews in multi-stock events involving
twenty or more securities; and (2) in the event transactions occur that
result in the issuance of an individual stock trading pause by the
primary listing market and subsequent transactions that occur before
the trading pause is in effect on the Exchange.\7\ The Exchange also
adopted additional changes to Rule 11.17 that reduced the ability of
the Exchange to deviate from the objective standards set forth in Rule
11.17,\8\ and in 2013, adopted a provision designed to address the
operation of the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS under the Act (the ``Limit Up-
Limit Down Plan'' or the ``Plan'').\9\ 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 (the
``Multi-Day Event''); 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.\10\
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    \6\ The terms of a transaction executed on the Exchange are
``clearly erroneous'' when there is an obvious error in any term,
such as price, number of shares or other unit of trading, or
identification of the security. A transaction made in clearly
erroneous error and cancelled by both parties or determined by the
Exchange to be clearly erroneous will be removed from the
Consolidated Tape. See Exchange Rule 11.17(a).
    \7\ Securities Exchange Act Release No. 62886 (Sept. 10, 2010),
75 FR 56613 (Sept. 16, 2010) (SR-BATS-2010-016).
    \8\ Id.
    \9\ See Securities Exchange Act Release No. 68797 (Jan. 31,
2013), 78 FR 8635 (Feb. 6, 2013) (SR-BATS-2013-008); see also
current BATS Rule 11.17(h).
    \10\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-BATS-2014-014).
---------------------------------------------------------------------------

Proposed Amendments to Rule 11.17
    First, the Exchange proposes to add new subparagraph (h) to Rule
11.17 which would describe the process for nullifying trades in UTP
Securities that are the subject of an initial public offering
(``IPOs''). The provisions of proposed paragraph (h) are substantially
similar to EDGA and EDGX Rules 11.15(h) and differs only to the extent
to conform to existing phrasing and terminology within other provisions
of Rule 11.17.\11\
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    \11\ The Exchange notes that EDGA and EDGX are to file rule
changes with the Commission to proposes a series of ministerial
changes to their Rules 11.15, Clearly Erroneous Executions, to
conform with other provisions of BZX and BYX Rule 11.17 to ensure
each of the BGM Affiliated Exchange have identical rule text with
regard to the review and handling of clearly erroneous executions.
This filing would include changes to EDGA and EDGX Rules 11.15(h) to
mirror Exchange Rule 11.17(h) as proposed herein.
---------------------------------------------------------------------------

    Pursuant to Rule 12f-2 of the Securities Exchange Act of 1934,\12\
the Exchange may extend unlisted trading privileges to a security that
is the subject of an IPO when at least one transaction in the subject
security has been effected on the national securities exchange or
association upon which the security is listed and the transaction has
been reported pursuant to an effective transaction reporting plan.
Under proposed paragraph (h), a clearly erroneous error may be deemed
to have occurred in the opening transaction of the subject security if
the execution price of the opening transaction on the Exchange is the
lesser of $1.00 or 10% away from the opening price on the listing
exchange or association. In such circumstances, the Officer of the
Exchange or other senior level employee designee shall declare the
opening transaction null and void or shall decline to take action in
connection with the completed trade(s). Clearly erroneous executions of
subsequent transactions of the subject security will be reviewed in the
same manner as the procedure set forth in Exchange Rule 11.17(e)(1).
Absent extraordinary circumstances, any such action of the Officer of
the Exchange or other senior level employee designee pursuant to
proposed subparagraph (h) shall be taken in a timely fashion, generally
within thirty (30) minutes of the detection of the erroneous
transaction. When extraordinary circumstances exist, any such action of
the Officer of the Exchange or other senior level employee designee
must be taken by no later than the start of Regular Trading Hours on
the trading day following the date of execution(s) under review. Each
party involved in the transaction shall be notified as soon as
practicable by the Exchange, and the party aggrieved by the action may
appeal such action in accordance with the provisions of Exchange Rule
11.17(e)(2). As stated above, proposed paragraph (h) is substantially
similar to EDGA and EDGX Rules 11.15(h) and differs only to the extent
to conform to existing phrasing and terminology within other provisions
of Rule 11.17.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.12f-2.
---------------------------------------------------------------------------

    The Exchange also proposes the following ministerial amendments to
Rule 11.17 as a result of proposing new paragraph (h). First, the
Exchange proposes to renumber current paragraph

(h) as (i), current paragraph (i) as (j), and current paragraph (j) as
(k). In addition, the Exchange proposes to update the references to
these paragraph in the introductory section of Rule 11.17 to reflect
these changes and the addition of proposed paragraph (h).
    Lastly, the Exchange proposes the following changes to further
conform Rule 11.17 to EDGA and EDGX Rules 11.15:
     Amend paragraph (e)(1) to clarify that a determination
made pursuant to this paragraph shall be made generally within thirty
(30) minutes of receipt of the complaint, but in no case later than the
start of Regular Trading Hours on the following trading day, rather
than simply stating the following day. This proposed change would make
paragraph (e)(1) identical to EDGA and EDGX Rule 11.15(e)(1).
     Amend paragraph (e)(2)(A) to define CRO as the
``Exchange's Chief Regulatory Officer''. This proposed change would
make paragraph (e)(2)(A) identical to EDGA and EDGX Rule
11.15(e)(2)(A).
    Amend paragraph (e)(2)(F) to replace the term ``Officer'' with
``Official'' in order to use consistent terminology throughout Rule
11.17.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\13\
Specifically, the proposed change is consistent with Section 6(b)(5) of
the Act,\14\ because it is designed to promote just and equitable
principles of trade, to remove impediments to, and perfect the
mechanism of, a free and open market and a national market system, and,
in general, to protect investors and the public interest. As mentioned
above, the proposed rule changes, combined with the planned filing for
the BYX, EDGA, and EDGX, would allow the BGM Affiliated Exchanges to
provide a consistent set of rules as it relates to clearly erroneous
executions. Consistent rules, in turn, will simplify the regulatory
requirements for Members of the Exchange that are also participants on
EDGA, EDGX and/or BYX. The proposed rule change would provide greater
harmonization between rules of similar purpose on the BGM Affiliated
Exchanges, resulting in greater uniformity and less burdensome and more
efficient regulatory compliance and understanding of Exchange Rules. As
such, the proposed rule change would foster cooperation and
coordination with persons engaged in facilitating transactions in
securities and would remove impediments to and perfect the mechanism of
a free and open market and a national market system. Similarly, the
Exchange also believes that, by harmonizing the rules across each BGM
Affiliated Exchange, the proposal will enhance the Exchange's ability
to fairly and efficiently regulate its Members, meaning that the
proposed rule change is equitable and will promote fairness in the
market place.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Finally, the Exchange believes that the non-substantive,
ministerial changes discussed above will contribute to the protection
of investors and the public interest by helping to avoid confusion with
respect to Exchange Rules.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the act. To the contrary, allowing the
Exchange to implement substantively identical rules across each of the
BGM Affiliated Exchanges regarding clearly erroneous executions does
not present any competitive issues, but rather is designed to provide
greater harmonization among Exchange, BYX, EDGX, and EDGA rules of
similar purpose. The proposed rule change should, therefore, result in
less burdensome and more efficient regulatory compliance and
understanding of Exchange Rules for common members of the BGM
Affiliated Exchanges and an enhanced ability of the BGM Affiliated
Exchanges to fairly and efficiently regulate Members.

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

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

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

    The Exchange has designated this rule filing as non-controversial
under Section 19(b)(3)(A) of the Act \15\ and paragraph (f)(6) of Rule
19b-4 thereunder.\16\ The proposed rule change effects a change that
(A) does not significantly affect the protection of investors or the
public interest; (B) does not impose any significant burden on
competition; and (C) by its terms, does not become operative for 30
days after the date of the filing, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest; provided that the self-regulatory organization
has given the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date of
filing of the proposed rule change, or such shorter time as designated
by the Commission.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily temporarily suspend such rule
change if it appears to the Commission that such action is: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2015-76 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BATS-2015-76. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the

Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2015-76, and should be
submitted on or before October 26, 2015.
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-25177 Filed 10-2-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 7, 2007 (Volume 72, Number 109)]
[Notices]
[Page 31571]
[DOCID:fr07jn07-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket Nos. CP05-130-000, CP05-132-000; Docket No. CP05-131-000]

Dominion Cove Point LNG, LP; Dominion Transmission, Inc.; Notice
of Availability of the Final Conformity Determination for Pennsylvania,
Maryland, Virginia, West Virginia and New York--Cove Point Expansion
Project

June 1, 2007.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a Final General Conformity Determination to
assess the potential air quality impacts associated with the
construction and operation of a liquefied natural gas (LNG) import
terminal and natural gas pipeline facilities proposed by Dominion Cove
Point LNG, LP and Dominion Transmission, Incorporated (Dominion),
referred to as the Cove Point Expansion Project, in the above-
referenced docket.
    This Final General Conformity Determination was prepared to satisfy
the requirements of the Clean Air Act.
    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.

Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,

contact<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-11000 Filed 6-6-07; 8:45 am]

BILLING CODE 6717-01-P


Conversation Notes between William Creed, Engineered Systems, Woburn, MA, and John Eyraud and Karen Capwell, ERG regarding the most common characteristics of industrial ventilation systems for reducing silica exposures.

		MEMORANDUM

To:	Robert Burt, Robert Stone, Bob Blicksilver OSHA
From:	John Eyraud and Chet Fenton, ERG
Date:	May 28, 2014
--------------------------------------------------------------------------------
Subject:	Conversation Notes Regarding Average Ventilation Operating Costs

Discussion with Bill Creed, Engineered Systems, Inc., Woburn, MA and John Eyraud and Karen Capwell, May 23, 2014.

The determination of whether air would be recirculated is based on the interplay of the International Mechanical Code (IMC) and the International Energy Conservation Code. The IMC, however, would generally not be recommending recirculation of air in dusty or other hazardous environments. The International Energy Conservation Code would tend to encourage more recycling of air but that would probably not dominate the design considerations. The IMC generally requires the exhaust of dust.

Axial fans should be used in the design, not centrifugal fans. An average fan efficiency estimate should be built into the number.

For cost estimation purposes, he has not seen facilities with 30 inches of static pressure. For most installations he is familiar with, 4 to 10 inches of static pressure is sufficient. In the supply calculations, it is appropriate to use 1 inch to 3 or 4 inches of static pressure.

In his industrial work, he does not normally design cooling systems. Unless the product characteristics require cooling air inputs, cooling is not normally being provided. He has not worked outside New England, however. He could not suggest an average range for ventilation operating costs.


[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Page 48463]
[FR Doc No: 2023-15953]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2456-000]

Platteview Solar, 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
Platteview Solar, 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 August 10, 2023.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 21, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15953 Filed 7-26-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Page 62613]
[FR Doc No: 2013-24614]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP14-33-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Cleanup of NegRate Agreements--Oct2013 to be effective
11/10/2013.
    Filed Date: 10/10/13.
    Accession Number: 20131010-5047.
    Comments Due: 5 p.m. ET 10/22/13.

    Docket Numbers: RP14-34-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.204: KeySpan Nov2013 release to Brooklyn Union to be effective
11/1/2013.
    Filed Date: 10/10/13.
    Accession Number: 20131010-5123.
    Comments Due: 5 p.m. ET 10/22/13.

    Docket Numbers: RP14-35-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits tariff
filing per 154.204: 2013 Miscellaneous to be effective 11/11/2013.
    Filed Date: 10/11/13.
    Accession Number: 20131011-5000.
    Comments Due: 5 p.m. ET 10/23/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP13-1105-004.
    Applicants: Energy West Development, Inc.
    Description: Energy West Development, Inc. submits tariff filing
per 154.203: Compliance Filing to 153 to be effective 12/1/2012.
    Filed Date: 10/10/13.
    Accession Number: 20131010-5083.
    Comments Due: 5 p.m. ET 10/22/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 15, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24614 Filed 10-21-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55620-55623]
[FR Doc No: 2021-21798]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1138]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices. FDA is also announcing the withdrawal of two FDA guidance
documents related to the COVID-19 PHE.

DATES: The announcement of the guidances is published in the Federal
Register on October 6, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) 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.'' 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.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>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
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    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists Nationwide as the Result of the
2019 Novel Coronavirus'' (originally issued on January 31, 2020, and
subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
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    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and ``Search for FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
        Docket No.                  Center                Title of guidance            request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136...........  CDER..................  Development of Abbreviated<EMAIL_ADDRESS>Please
                                                     New Drug Applications During   include the docket number
                                                     the COVID-19 Pandemic--        FDA-2020-D-1136 and complete
                                                     Questions and Answers;         title of the guidance in the
                                                     Guidance for Industry          request.
                                                     (Updated September 2021).
FDA-2020-D-1138...........  CDRH..................  Enforcement Policy for Face<EMAIL_ADDRESS>                                                     Masks, Barrier Face            Please include the document
                                                     Coverings, Face Shields,       number 20018 and complete
                                                     Surgical Masks, and            title of the guidance in the
                                                     Respirators During the         request.
                                                     Coronavirus Disease (COVID-
                                                     19) Public Health Emergency
                                                     (Updated September 2021).
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CDER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                Another guidance title
      COVID-19 guidance title        CFR cite referenced in     referenced in COVID-19      OMB control No(s).
                                        COVID-19 guidance              guidance
----------------------------------------------------------------------------------------------------------------
Development of Abbreviated New Drug  21 CFR 211.170, 21 CFR  (1) ANDAs: Stability         0910-0001, 0910-0014,
 Applications During the COVID-19     314.3, 21 CFR 314.50,   Testing of Drug Substances   0910-0119, 0910-0139,
 Pandemic--Questions and Answers;     21 CFR 314.94, 21 CFR   and Products, Questions      0910-0338, 0910-0581,
 Guidance for Industry (Updated       314.101, 21 CFR         and Answers.                 0910-0672, 0910-0733,
 September 2021).                     314.105, 21 CFR        (2) Referencing Approved      0910-0797.
                                      314.107, 21 CFR         Drug Products in ANDA
                                      320.25, 21 CFR          Submissions.
                                      320.31, 21 CFR         (3) Protecting Participants
                                      320.38, 21 CFR 320.63.  in Bioequivalence Studies
                                                              for Abbreviated New Drug
                                                              Applications During the
                                                              COVID-19 Public Health
                                                              Emergency.
                                                             (4) Safety Reporting
                                                              Requirements for INDs and
                                                              BA/BE Studies.
                                                             (5) Controlled
                                                              Correspondence Related to
                                                              Generic Drug Development.
                                                             (6) Formal Meetings Between
                                                              FDA and ANDA Applicants of
                                                              Complex Products Under
                                                              GDUFA.
                                                             (5) Controlled
                                                              Correspondence Related to
                                                              Generic Drug Development.
                                                             (7) Conduct of Clinical
                                                              Trials of Medical Products
                                                              during the COVID-19
                                                              Pandemic.
                                                             (8) ANDAs: Stability
                                                              Testing of Drug Substances
                                                              and Products, Questions
                                                              and Answers.
                                                             (9) Manufacturing, Supply
                                                              Chain, and Drug and
                                                              Biological Product
                                                              Inspections During COVID-
                                                              19 Public Health Emergency
                                                              Questions and Answers.
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                               COVID-19 guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Face Masks and     800, 801, and 809.........                                   0910-0485
 Respirators During the Coronavirus       803.......................                                   0910-0437
 Disease (COVID-19) Public Health         806.......................                                   0910-0359
 Emergency (Revised); Guidance for        807, subpart E............                                   0910-0120
 Industry and Food and Drug
 Administration Staff.
                                          807, subparts A through D.                                   0910-0625
                                          820.......................                                   0910-0073
                                          830 and 801.20............                                   0910-0720
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities; Guidance for
                                                                       Industry and Other
                                                                       Stakeholders.
----------------------------------------------------------------------------------------------------------------

IV. Withdrawn COVID-19-Related Guidance Documents

    On June 30, 2021, FDA announced the revocation of the Emergency Use
Authorizations (EUAs) for Decontamination and Bioburden Reduction
Systems for Personal Protective Equipment. The full text of the
revocations are available electronically at https://www.regulations.gov
(Docket No. FDA-2021-N-0762) and https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations. With the revocation of these
EUAs, on June 30, 2021, FDA also withdrew two related decontamination
and bioburden reduction guidance documents (listed in table 4), as the
documents no longer represent the Agency's current thinking.

                  Table 4--Withdrawn Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
             Docket No.                    Center          Title of withdrawn guidance         Withdrawal date
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1138.....................  CDRH             Recommendations for Sponsors         June 30, 2021.
                                                        Requesting EUAs for
                                                        Decontamination and Bioburden
                                                        Reduction Systems for Face Masks
                                                        and Respirators During the
                                                        Coronavirus Disease 2019 (COVID-
                                                        19) Public Health Emergency;
                                                        Guidance for Industry and Food and
                                                        Drug Administration Staff.
FDA-2020-D-1138.....................  CDRH             Enforcement Policy for Bioburden     June 30, 2021.
                                                        Reduction Systems Using Dry Heat
                                                        to Support Single-User Reuse of
                                                        Certain Filtering Facepiece
                                                        Respirators During the Coronavirus
                                                        Disease (2019) Public Health
                                                        Emergency.
----------------------------------------------------------------------------------------------------------------

    These withdrawn guidance documents are presented on FDA's website,
for historical purposes only, at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance.

V. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21798 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Page 60833]
[FR Doc No: 2018-25758]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-358-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization: DG Whitefield
LLC

    This is a supplemental notice in the above-referenced proceeding of
DG Whitefield LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 10, 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: November 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-25758 Filed 11-26-18; 8:45 am]
 BILLING CODE 6717-01-P