[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12038-12040]
[FR Doc No: 2021-04088]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91189; File No. SR-CTA/CQ-2021-01]

Consolidated Tape Association; Notice of Filing of the Thirty-
Sixth Substantive Amendment to the Second Restatement of the CTA Plan
and Twenty-Seventh Substantive Amendment to the Restated CQ Plan

February 23, 2021.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on February 3, 2021,\3\ the Participants \4\ in the Second Restatement
of the Consolidated Tape Association (``CTA'') Plan and Restated
Consolidated Quotation (``CQ'') Plan (collectively ``CTA/CQ Plans'' or
``Plans'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') a proposal to amend the Plans.\5\ These amendment
represents the Thirty-Sixth Substantive Amendment to the CTA Plan and
Twenty-Seventh Substantive Amendment to the CQ Plan (``Amendments'').
Under the Amendments, the Participants propose revisions to the
provisions of the Plans governing regulatory and operational halts.\6\
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    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ See Letter from Robert Books, Chair, CTA/CQ Operating
Committee, to Vanessa Countryman, Secretary, Commission (Feb. 3,
2021).
    \4\ The Participants are: Cboe BYX Exchange, Inc., Cboe BZX
Exchange, Inc., Cboe EDGA Exchange, Inc., Cboe EDGX Exchange, Inc.,
Cboe Exchange, Inc., Financial Industry Regulatory Authority, Inc.,
The Investors' Exchange LLC, Long-Term Stock Exchange, Inc., MEMX
LLC, MIAX PEARL, LLC, Nasdaq BX, Inc., Nasdaq ISE, LLC, Nasdaq PHLX,
Inc., The Nasdaq Stock Market LLC, New York Stock Exchange LLC, NYSE
American LLC, NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE
National, Inc. (collectively, the ``Participants'').
    \5\ The Amendments were posted to the Plans' website on February
12, 2021. See Email from James P. Dombach, Counsel to the Plans, to
Michael E. Coe, Assistant Director, Commission, et al. (Feb. 12,
2021).
    \6\ The Participants previously, on December 5, 2016, filed
amendments to the provisions of the Plans governing regulatory and
operation halts. These amendments were not acted upon by the
Commission and were withdrawn by the Participants. See Letter from
Robert Books, UTP Chair, to Vanessa Countryman, Secretary,
Commission (Nov. 17, 2020).
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    The proposed Amendments have been filed by the Participants
pursuant to Rule 608(b)(2) under Regulation NMS.\7\ The Commission is
publishing this notice to solicit comments from interested persons on
the proposed Amendments. Set forth in Sections I and II is the
statement of the purpose and summary of the Amendments, along

with the information required by Rules 608(a) and 601(a) under the Act,
prepared and submitted by the Participants to the Commission.
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    \7\ 17 CFR 242.608(b)(2).
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I. Rule 608(a)

A. Purpose of the Amendments

    The purpose of the Amendments is to incorporate into the Plans the
same processes for Regulatory Halts that are proposed by the equity
exchanges. Consistent with the proposals from the equity exchanges, the
Primary Listing Market may declare a Regulatory Halt \8\ in trading for
any security for which it is the Primary Listing Market.\9\ The
Participants believe that it is appropriate for the Primary Listing
Market to declare a Regulatory Halt in order to vest the authority to
declare a Regulatory Halt in a single entity, and with respect to any
given security, the Primary Listing Market is best positioned to
determine when to initiate and end a Regulatory Halt.
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    \8\ Regulatory Halt is defined in Section XI(a)(i)(J) as ``a
halt declared by the Primary Listing Market in trading in one or
more securities on all Trading Centers for regulatory purposes,
including for the dissemination of material news, news pending,
suspensions, or where otherwise necessary to maintain a fair and
orderly market. A Regulatory Halt includes a trading pause triggered
by Limit Up Limit Down, a halt based on Extraordinary Market
Activity, a trading halt triggered by a Market-Wide Circuit Breaker,
and a SIP Halt.''
    \9\ The ``Primary Listing Market'' is defined in Section
XI(a)(i)(H) as ``the national securities exchange on which an
Eligible Security is listed. If an Eligible Security is listed on
more than one national securities exchange, Primary Listing Market
means the exchange on which the security has been listed the
longest.''
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    The Primary Listing Market may declare a Regulatory Halt as
provided for in the rules of the Primary Listing Market, if it
determines that there is a SIP Outage,\10\ Material SIP Latency,\11\
Extraordinary Market Activity,\12\ or in the event of national,
regional, or localized disruption that necessitates a Regulatory Halt
to maintain a fair and orderly market.\13\ In making such
determination, the Primary Listing Market will consider the totality of
information available concerning the severity of the disruption, its
likely duration, and potential impact on Member Firms and other market
participants, and will make a good-faith determination that the
criteria to declare a Regulatory Halt have been satisfied and that a
Regulatory Halt is appropriate. The Primary Listing Market will
consult, if feasible before declaring a Regulatory Halt, with the
affected Trading Center(s), other Participants, or the Processor, as
applicable, regarding the scope of the issue and what steps are being
taken to address the issue.
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    \10\ SIP Outage is defined in Section XI(a)(i)(M) as ``a
situation in which the Processor has ceased, or anticipates being
unable, to provide updated and/or accurate quotation or last sale
price information in one or more securities for a material period
that exceeds the time thresholds for an orderly failover to backup
facilities established by mutual agreement among the Processor, the
Primary Listing Market for the affected securities, and the
Operating Committee unless the Primary Listing Market, in
consultation with the Processor and the Operating Committee,
determines that resumption of accurate data is expected in the near
future.''
    \11\ Material SIP Latency is defined in Section XI(a)(i)(E) as
``a delay of quotation or last sale price information in one or more
securities between the time data is received by the Processor and
the time the Processor disseminates the data over the high speed
line or over the ``high speed line'' under the CQ Plan, which delay
the Primary Listing Market determines, in consultation with, and in
accordance with, publicly disclosed guidelines established by the
Operating Committee, to be (a) material and (b) unlikely to be
resolved in the near future.''
    \12\ Extraordinary Market Activity is defined in Section
XI(a)(i)(A) as ``a disruption or malfunction of any electronic
quotation, communication, reporting, or execution system operated
by, or linked to, the Processor or a Trading Center or a member of
such Trading Center that has a severe and continuing negative
impact, on a market-wide basis, on quoting, order, or trading
activity or on the availability of market information necessary to
maintain a fair and orderly market. For purposes of this definition,
a severe and continuing negative impact on quoting, order, or
trading activity includes (i) a series of quotes, orders, or
transactions at prices substantially unrelated to the current market
for the security or securities; (ii) duplicative or erroneous
quoting, order, trade reporting, or other related message traffic
between one or more Trading Centers or their members; or (iii) the
unavailability of quoting, order, transaction information, or
regulatory messages for a sustained period.'' In the originally
proposed amendments in 2016, Extraordinary Market Activity was
defined to include disruptions or malfunctions on a market. After
discussions with SEC Staff, the Participants revised this provision
to solely limit the definition to disruptions or malfunctions that
occur on a market-wide basis.
    \13\ See Section XI(a)(iii). In the originally proposed
amendments in 2016, the Primary Listing Market could have declared a
Regulatory Halt ``when otherwise necessary to maintain a fair and
orderly market or in the public interest.'' After discussions with
SEC Staff, the Participants revised this provision as part of the
current Amendments in order to provide greater detail as to when a
Regulatory Halt may be declared. The definitions of SIP Outage,
Material SIP Latency, and Extraordinary Market Activity appear in
Section XI(a)(i).
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    Should the Primary Listing Market declare a Regulatory Halt, the
Primary Listing Market will determine the SIP Halt Resume Time.\14\ The
Primary Listing Market will declare a resumption of trading when it
makes a good-faith determination and considers the totality of
information to determine that trading may resume in a fair and orderly
manner in accordance with its rules. The Primary Listing Market retains
discretion to delay the SIP Halt Resume Time if it believes trading
will not resume in a fair and orderly manner. The Primary Listing
Market has the responsibility to notify all other Participants of the
initiation of the halt as well as the lifting of the halt. The
notification process will be mutually agreed to by the Operating
Committee and the Primary Listing Market.\15\
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    \14\ SIP Halt Resume Time is defined in Section XI(a)(i)(L) as
``the time that the Primary Listing Market determines as the end of
a SIP Halt.''
    \15\ See Section XI(a)(viii).
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    During Regular Trading Hours, if the Primary Listing Market does
not open a security within the amount of time as specified by the rules
of the Primary Listing Market after the SIP Halt Resume Time, a
Participant may resume trading in that security. Outside of Regular
Trading Hours, a Participant may resume trading immediately after the
SIP Halt Resume Time.
    The Amendments provide that the Processor shall disseminate to the
Participants notice of the Regulatory Halt as well as notice of the
lifting of a Regulatory Halt through any means the Processor considers
appropriate.\16\
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    \16\ See id.
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B. Governing or Constituent Documents

    Not applicable.

C. Implementation of Amendment

    Each of the Participants has approved the Amendments in accordance
with Section IV(b) of the CTA Plan and Section IV(c) of the CQ Plan, as
applicable. The Participants also solicited the Advisory Committee for
its thoughts and any comments on the Amendments. The Amendments would
become operational upon approval by the Commission.

D. Development and Implementation Phases

    The Amendments proposed herein would be implemented to coincide
with amendments filed by the equity exchanges and approved by the
Commission.

E. Analysis of Impact on Competition

    The Amendments proposed herein do not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the amendments simply incorporate into the
Plans the processes for Regulatory Halts that will be proposed by the
equity exchanges. The Participants do not believe that the proposed
Amendments introduce terms that are unreasonably discriminatory for the
purposes of Section 11A(c)(1)(D) of the Act.

F. Written Understanding or Agreements Relating to Interpretation of,
or Participation in, Plans

    Not applicable.

G. Approval by Sponsors in Accordance With Plans

    Section IV(c)(i) of the CQ Plan and Section IV(b)(i) of the CTA
Plan require the Participants to unanimously approve the Amendments
proposed herein. They so approved it.

H. Description of Operation of Facility Contemplated by the Proposed
Amendments

    Not applicable.

I. Terms and Conditions of Access

    Not applicable.

J. Method of Determination and Imposition, and Amount of, Fees and
Charges

    Not applicable.

K. Method and Frequency of Processor Evaluation

    Not applicable.

L. Dispute Resolution

    Not applicable.

II. Regulation NMS Rule 601(a) (Solely in Its Application to the
Amendments to the CTA Plan)

A. Equity Securities for Which Transaction Reports Shall be Required by
the Plan

    Not applicable.

B. Reporting Requirements

    Not applicable.

C. Manner of Collecting, Processing, Sequencing, Making Available and
Disseminating Last Sale Information

    Not applicable.

D. Manner of Consolidation

    Not applicable.

E. Standards and Methods Ensuring Promptness, Accuracy and Completeness
of Transaction Reports

    Not applicable.

F. Rules and Procedures Addressed to Fraudulent or Manipulative
Dissemination

    Not applicable.

G. Terms of Access to Transaction Reports

    Not applicable.

H. Identification of Marketplace of Execution

    Not applicable.

III. Solicitation of Comments

    The Commission seeks comments on the Amendments. Interested persons
are invited to submit written data, views, and arguments concerning the
foregoing, including whether the proposed Amendments are consistent
with the Act and the rules and regulations thereunder applicable to
national market system plans. 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-CTA/CQ-2021-01 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-CTA/CQ-2021-01. 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 website (http://www.sec.gov/rules/sro.shtml). Copies
of the submission, all written statements with respect to the proposed
Amendments that are filed with the Commission, and all written
communications relating to the proposed Amendments 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 website viewing and printing at
the principal office of the Plans. 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-CTA/CQ-2021-01 and should be submitted on or before
March 22, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(85).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-04088 Filed 2-26-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 33005-33006]
[DOCID:fr09jy09-134]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60226; File No. SR-NYSEAmex-2009-33]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change
Amending the Linkage Fees Portion of the Schedule of Fees and Charges
for Exchange Services

July 1, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on June 26, 2009, the NYSE Amex LLC (``NYSE Amex'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons and grant
accelerated approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 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 [sic] the Linkage Fees portion of the
Schedule of Fees and Charges for Exchange Services (``Schedule''). The
Exchange intends for these changes to become operative on July 1, 2009
in conjunction with changes to the equivalent transaction fees. The
text of the proposed rule change is attached as Exhibit 5 to the 19b-4
form. A copy of this filing is available on the Exchange's Web site at
http://www.nyse.com, at the Exchange's principal office and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item III below, and the most significant
aspects of such statements are set forth in Sections A, B, and C below.

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

1. Purpose
    The purpose of this filing is to amend the existing Schedule in
order to revise the Linkage Fees portion of the Schedule, so as to
match the fee changes the Exchange has proposed in a separate filing
concerning certain Broker Dealer and Firm executions.
    Executions on NYSE Amex resulting from orders sent via the
InterMarket Linkage System (``Linkage Orders'') are presently subject
to the same billing treatment as other Broker Dealer and Firm orders.
In a separate filing, the Exchange proposed to charge $0.15 for
electronic Broker Dealer and Firm transactions. By this filing, the
Exchange proposes to match the Linkage Fees to the electronic Broker
Dealer and Firm charges and now charge $0.15 per contract for
electronically executed Linkage orders. The Exchange intends to
implement this new Linkage fee in conjunction with the implementation
of the new transaction fees on July 1, 2009.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act,\4\ in general, and Section 6(b)(5) [sic], in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its members and other
persons using its facilities for the purpose of executing Linkage
orders that are routed to the Exchange from other market centers.
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    \4\ 15 U.S.C. 78f.
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

III. 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 (www.sec.gov/
rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2009-33 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2009-33. 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 am and 3 pm. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAmex-2009-33 and should
be submitted on or before July 30, 2009.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to

a national securities exchange.\5\ In particular, the Commission finds
that the proposed rule change is consistent with Section 6(b)(4) of the
Act,\6\ which requires that the rules of an exchange to provide for the
equitable allocation of reasonable dues, fees and other charges among
its members and other persons using its facilities.
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    \5\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(5).
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    The Commission finds good cause for approving this proposal before
the 30th day after the publication of notice thereof in the Federal
Register. The proposal seeks to conform Linkage Fees with the fees
charged on other Broker Dealer and Firm executions. The Exchange plans
to implement this new Linkage Fee in conjunction with the
implementation of the new transactions fees on July 1, 2009.\7\ The
reduction of transactions fees charged on Linkage Orders to conform
with the fees charged on other Broker Dealer and Firm executions does
not appear to present any new or significant regulatory concerns.
Therefore, the Commission believes that accelerating approval of this
proposal would allow the Exchange to implement this new lower Linkage
Fee in conjunction with the implementation of the new transactions fees
on July 1, 2009.
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    \7\ See SR-NYSEAmex-2009-38
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-NYSEAmex-2009-33) be, and it
hereby is, approved on an accelerated basis.
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    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-16188 Filed 7-8-09; 8:45 am]

BILLING CODE 8010-01-P


                       INDEX OF PUBLIC DOCKET DOCUMENTS
            VIRGINIA RCRA I APPROVAL AND INCORPORATION BY REFERENCE

 Virginia State Program Approval (SPA) Application
 AG Certification  -  final.pdf
 Chapter580.pdf (VA UST technical standards)
 Chapter590.pdf (VA UST financial responsibility requirements)
 ENFORCEMENT PROCEDURES.final.pdf
 Governors signed SPA transmittal letter.pdf
 MOA signed final 11.26.18.pdf
 UST Certification  -  Delegation of Authority (1).pdf
 VA AG Statement APP A  -  List of Regs and Statutes.pdf
 VA AG statement APP B  -  USBC Inter 71-87 rev.pdf
 VA AG Statement APP C  -  Guthrie Terry letters rev.pdf
 VA AG Statement  - final.pdf
 VA Scanned Gov signed SPA letter 121318.pdf
 VA UST Program Description.final.pdf

 Virginia UST regulations to be incorporated by reference

 Virginia UST statutes to be incorporated by reference

 Forms (9VAC25-580)

 Folder of 19 PDF Documents Referenced in VA SPA Documents as Internet Links to preserve linked documents we may no longer be able to access after time has passed -- includes state guidance documents and screenshots of public websites

 PDF of Virginia UST Statutes, Articles 9 and 10 (Va. Code 62.1-44.34:8 to :13)

 June 15, 2020 e-mail from Lisa Dewey (Virginia DEQ) to Thomas UyBarreta (EPA) with responses to specific questions for clarification


[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11447-11449]
[FR Doc No: 2023-03714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0363]

Patient-Focused Drug Development for Long COVID; Public Meeting;
Request for Comments

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, the Agency, or we) is
announcing the following public meeting entitled ``Patient-Focused Drug
Development for Long COVID.'' The purpose of the public meeting is to
allow FDA to obtain patient perspectives on the impact of Long COVID on
daily life, patient views on treatment approaches, and decision factors
considered when selecting a treatment.

DATES: The public meeting will be held virtually on April 25, 2023,
from 10 a.m. to 4 p.m. Eastern Time. Submit either electronic or
written comments on this public meeting by June 26, 2023. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public meeting will be hosted via a live webcast.
    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 June
26, 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.

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-0363 for ``Patient-Focused Drug Development for Long COVID;
Public Meeting; 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., 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>.

FOR FURTHER INFORMATION CONTACT: Shannon Sparklin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-
796-9208, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This meeting will provide FDA with the opportunity to hear directly
from patients and patient representatives about their experiences with
Long COVID, including how Long COVID affects their daily life, the
symptoms that matter most to them, their current approaches to treating
Long COVID, and what they consider when determining whether or not to
participate in a clinical trial. Long COVID, also known as post-COVID
syndrome, post-acute sequalae of severe acute respiratory syndrome 2
coronavirus (SARS-CoV-2), long-haul COVID, or post-acute COVID-19
syndrome, is defined as persistence of COVID-19 symptoms 4 weeks beyond
SARS-CoV-2 infection. Literature has reported two categories of Long
COVID known as subacute or ongoing COVID-19 symptoms (4-12 weeks of
persistent symptoms post-infection), and chronic or post-COVID syndrome
(12 weeks or more of persistent symptoms post-infection). SARS-CoV-2
may cause cell damage to multiple organs in an infected person. The
most commonly reported symptoms include fatigue, brain fog, pain,
palpitations, shortness of breath, cough, insomnia, anxiety,
depression, constipation, and nausea. Since Long COVID was recently
recognized, there is currently no standardized framework for diagnosis
and treatment. While no medicines have been approved to treat Long
COVID, symptoms may be treated with medication, exercise, diet
modification, and meditation. FDA is interested in adult and pediatric
patients' perspectives on the following topics: (1) health effects and
daily impacts; (2) current approaches to treatment; and (3) clinical
trial participation.
    For each topic, a brief discussion by a patient panel will begin
the dialogue. This discussion will be followed by a facilitated
discussion where FDA will invite patients and patient representatives
from the viewing audience to provide comments by calling into the
meeting via phone, or by submitting through the meeting platform live
comments which may be read during the meeting by the meeting
facilitator.
    In addition to input generated through this public meeting, FDA is
interested in receiving patient and patient representative input
through written comments, which can be submitted to the public docket
(see ADDRESSES). FDA's questions will be available on the meeting
website and as part of the information provided in the public docket.
When submitting comments, if you are commenting on behalf of a patient,
please indicate that you are doing so, and answer the questions as much
as possible from the patient's perspective.
    FDA will post the agenda and other meeting materials approximately
5 days before the meeting at: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023.

II. Topics for Discussion at the Public Meeting

    On April 25, 2023, FDA is conducting a public meeting on Patient-
Focused Drug Development for Long COVID. FDA is interested in obtaining
patient perspectives on the impact of Long COVID on daily life and
patient views on treatment approaches, as well as clinical trial
participation.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://www.surveymonkey.com/r/LongCOVIDPFDD. Persons without access to the
internet can call<PHONE_NUMBER> to register.
    If you need special accommodations due to a disability, please
contact Shannon Sparklin (see FOR FURTHER INFORMATION CONTACT) no later
than April 18, 2023.
    Panelist Selection: Patients or patient representatives 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 or patient
representatives also will be asked to send [email protected] a
brief summary of responses to the topic questions by April 4, 2023.
Panelists will be notified of their selection approximately 7 days
before the public meeting. We 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.
    Streaming Webcast of the Public Meeting: This public meeting will
be streamed via a webcast in both English and Spanish languages. Please
register for the webcast by visiting https://www.surveymonkey.com/r/LongCOVIDPFDD.
    The English-language webcast can be accessed via: https://fda.yorkcast.com/webcast/Play/4eba453a2412474e98fff1fabcc63ac51d. The
Spanish-language webcast can be accessed via: https://fda.yorkcast.com/webcast/Play/0385884d5655420fabd3a55a237926691d. Simply click on the
link and hit the ``play'' button and it will start. A test signal will
be playing 30 minutes prior to the event, so you can click on the link
at any point during that time to start. You will hear music playing
during the test period and then the event will begin at 10 a.m. ET. If
you would like to check your system now, you can click on the link and
the page will open with a ``waiting'' statement showing.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible on the meeting
website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023.

    Dated: February 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03714 Filed 2-22-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Page 34283]
[FR Doc No: 2018-15603]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
(UCR Board) and Subcommittee Meetings.

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

TIME AND DATE: The meetings will occur on the following schedule and
will take place in the Mountain (Daylight) Time Zone:

Thursday, August 23, 2018

8:15 a.m.-9:00 a.m. Registration System Subcommittee
9:00 a.m.-12:00 Noon. UCR Board

PLACE: These meetings will be open to the public at the Radisson Hotel
Salt Lake City Downtown, 215 West South Temple, Salt Lake City, UT
84101, and via conference call. Those not attending the meetings in
person may call toll-free; 1-877-422-1931, passcode<PHONE_NUMBER>, to
listen and participate in the meetings.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board. An agenda for
these meetings will be available no later than 5:00 p.m. Eastern
Daylight Time, August 14, 2018 at: https://ucrplan.org.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: July 16, 2018.
Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2018-15603 Filed 7-17-18; 4:15 pm]
 BILLING CODE 4910-EX-P


Drinking Water Criteria Document for Cyanogen Chloride and Potential Metabolites EPA/ OW/ OST/ HECD i Final draft TABLE OF CONTENTS Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Chapter I. Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I 1 Chapter II. Physical and Chemical Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II 1 Chapter III. Toxicokinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 1 A. Absorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 1 B. Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 2 C. Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 5 D. Excretion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 26 E. Bioaccumulation, Retention and Body Burden . . . . . . . . . . . . . . . . III 31 F. Summary of Toxicokinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 34 Chapter IV. Human Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 1 A. Drinking Water Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 1 A. 1 National Occurrence Data for Cyanogen Chloride . . . . . . . . . IV 2 A. 1.1 Quarterly Finished Water and Distribution Maximum for Cyanogen Chloride . . . . . . . . . . . . . . . IV 3 A. 2 National Occurrence Data for Cyanide . . . . . . . . . . . . . . . . . IV 5 A. 2.1 National Drinking Water Contaminant Occurrence Database Data on Cyanide . . . . . . . . . . . . . . . . . . . . . IV 6 B. Exposure to Sources Other Than Drinking Water . . . . . . . . . . . . . . IV 12 B. 1 Dietary Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 15 B. 2 Air Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 19 B. 3 Dermal Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 20 C. Overall Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 20 D. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 26 Chapter V. Health Effects in Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 1 A. Short Term Exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 1 B. Long Term Exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 14 C. Reproductive/ Developmental Toxicity . . . . . . . . . . . . . . . . . . . . . . . . V 28 D. Mutagenicity and Genotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 36 E. Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V 39 Chapter VI. Health Effects in Humans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 1 A. Case Reports and Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 1 B. Epidemiological Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 13 C. Summary of Human Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 18 Chapter VII. Mechanism of Toxicity and Sensitive Populations . . . . . . . . . . . . . . . . . . . . VII 1 A. Biochemical Basis of Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 1 Drinking Water Criteria Document for Cyanogen Chloride and Potential Metabolites EPA/ OW/ OST/ HECD ii Final draft B. Mechanism of Carcinogenesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 15 C. Interactions and Suceptibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 18 D. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII 31 Chapter VIII. Quantification of Toxicological Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 1 A. Introduction to Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 1 A. 1 Quantification of Noncarcinogenic Effects . . . . . . . . . . . . . . VIII 1 A. 1.1 Drinking Water Equivalent Level . . . . . . . . . . . . . . . VIII 4 A. 1.2 Health Advisory Values . . . . . . . . . . . . . . . . . . . . . . VIII 4 A. 2 Quantification of Carcinogenic Effects . . . . . . . . . . . . . . . . . VIII 6 B. Noncarcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 9 B. 1 Cyanide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 9 B. 1.1 One day Health Advisory for Cyanide . . . . . . . . . . . VIII 9 B. 1.2 Ten day Health Advisory for Cyanide . . . . . . . . . . . VIII 10 B. 1.3 Longer term Health Advisory for Cyanide . . . . . . . VIII 13 B. 1.4 Reference Dose, Drinking Water Equivalant Level And Lifetime Health Advisory for Cyanide . . . . . . . VIII 17 B. 2 Thiocyanate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 23 B. 2.1 One day Health Advisory for Thiocyanate . . . . . . . VIII 23 B. 2.2 Ten day Health Advisory for Thiocyanate . . . . . . . VIII 23 B. 2.3 Longer term Health Advisory for Thiocyanate . . . . VIII 25 B. 2.4 Reference Dose, Drinking Water Equivalent Level, and Lifetime Health Advisory for Thiocyanate . . . . . . . VIII 29 B. 3 Cyanogen Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 31 B. 3.1 One day Health Advisory for Cyanogen Chloride . . VIII 37 B. 3.2 Ten day Health Advisory for Cyanogen Chloride . . VIII 37 B. 3.3 Longer term Health Advisory for Cyanogen Chloride . . . . . . . . . . . . . . . . . . . . . . . . VIII 38 B. 3.4 Reference Dose, Drinking Water Equivalent Level, and Lifetime Health Advisory for Cyanogen Chloride . VIII 40 C. Carcinogenic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 42 D. Characterization of Uncertainties and Data Gaps . . . . . . . . . . . . . VIII 44 Chapter IX. Risk Characterization Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX 1 A. Hazard Characterization and Mode of Action Implications . . . . . . . . IX 1 B. Dose Response Characterization and Implications in Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX 9 C. Weight of Evidence and Implications in Risk Conclusions . . . . . . . . IX 17 D. Exposure Characterization and Implication in Relative Source Contribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX 19 E. Risk Characterization for Drinking Water Exposure . . . . . . . . . . . . IX 26 F. Comparison With Other Standards . . . . . . . . . . . . . . . . . . . . . . . . . IX 30 Chapter X. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X 1 Drinking Water Criteria Document for Cyanogen Chloride and Potential Metabolites EPA/ OW/ OST/ HECD iii Final draft Appendix A. Benchmark Dose Modeling Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A 1 Appendix B. Benchmark Dose Modeling Output, Available electronically only . . . . . . . . B 1 Appendix C. CYANATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C 1 Appendix D. CYANAMIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D 1 Appendix E. HYDROGEN CHLORIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E 1 Drinking Water Criteria Document for Cyanogen Chloride and Potential Metabolites EPA/ OW/ OST/ HECD iv Final draft TABLES I 1 Summary of Health Advisory Values for Cyanogen Chloride . . . . . . . . . . . . . . . . . . . I 1 II 1 Physical and Chemical Properties of Cyanogen Chloride and its Potential Metabolites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II 1 III 1 HCN and HSCN Levels Following Inhalation of CNCl or HCN1 . . . . . . . . . . . . . . . III 8 IV 1 Cyanogen Chloride Quarterly Distribution System Finish and Maximum . . . . . . . . . . IV 4 IV 2. National Drinking Water Contaminant Occurrence Database Public Water Supply  National Drinking Water Data for Cyanide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV 8 V 1. Reproductive Effects in Rats and Mice Administered Sodium Cyanide in Drinking Water for 13 Week. . . . . . . . . . . . . . . . . V 16 VI 1 Serum Thiocyanate and Thyroid Hormone Levels in Women Exposed for > 5 Years to Thiocyanate in Milk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI 7 VIII 1 Summary of Toxicity Studies for Cyanogen Chloride . . . . . . . . . . . . . . . . . . . . . . VIII 45 VIII 2 Summary of Oral Toxicity Studies for Cyanide . . . . . . . . . . . . . . . . . . . . . . . . . . VIII 47 VIII 3 Summary of Inhalation Toxicity Studies for Cyanide . . . . . . . . . . . . . . . . . . . . . . VIII 56 VIII 4 Summary of Oral Toxicity Studies for Thiocyante . . . . . . . . . . . . . . . . . . . . . . . . VIII 69 VIII 5. Summary of Development of the Health Advisories for Cyanide . . . . . . . . . . . . . VIII 70 VIII 6 Summary of Development of the Health Advisories for Thiocyanate . . . . . . . . . . . . VIII 71 VIII 7 Summary of Development of the Health Advisories for Cyanogen Chloride . . . . . VIII 72 FIGURES III 1 Reactions of cyanogen chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 13 III 2 Cyanide Primary Metabolic Pathways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III 21 Drinking Water Criteria Document for Cyanogen Chloride and Potential Metabolites EPA/ OW/ OST/ HECD v Final draft Acknowledgements Acknowledgements This document is an update and expansion of the Rough Final Draft for the Drinking Water Criteria Document on Haloacetonitriles, Chloropicrin and Cyanogen Chloride ( U. S. EPA, 1987). The section on cyanide is an update and extension of Drinking Water Criteria Document for Cyanide ( U. S. EPA, 1992), and the section on thiocyanate is an update and extension of an Issue Paper prepared by U. S. EPA's Superfund Health Risk Technical Support Center ( U. S. EPA, 1997a). Full literature searches were conducted in December 1999 on the toxicity of cyanogen chloride, cyanide, thiocyanate, cyanate, cyanamide, and HCl, and on exposure to cyanogen chloride and cyanide. These searches were supplemented by selected key references identified after the search.

Contributor and Chemical Manager Nancy Chiu, Ph. D., U. S. EPA Office of Water Contractor Authors:

Lynne T. Haber, Ph. D. ( TERA) Joan S. Dollarhide, M. S., M. T. S. C., J. D. ( TERA) Claudine Kasunic, M. S. ( GRAM, Inc.) Bruce Allen, M. S. ( ENVIRON)

Peer Reviewers Patricia McGinnis, Ph. D., DABT, Syracuse Research Corporation John Reif, M. Sc. ( Med), D. V. M., Colorado State University Alan Stern, Dr. P. H., DABT, New Jersey Department of Environmental Protection