[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54685-54687]
[FR Doc No: 2023-17211]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98072; File No. SR-ICEEU-2023-017]

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

August 7, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 26, 2023, ICE Clear Europe Limited (``ICE Clear Europe'' or the
``Clearing House'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes described in Items I, II and
III below, which Items have been prepared primarily by ICE Clear
Europe. ICE Clear Europe filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(4)(ii)
thereunder,\4\ such that the proposed rule change was immediately
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') proposes to amend Part O of its Delivery Procedures \5\ (for
Financials and Softs Cocoa Contracts) to provide for use of a new Softs
Delivery Platform, make certain changes to the delivery timetable and
delivery documentation, and address certain matters relating to
allocation and the conversion of lots.
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    \5\ Capitalized terms used but not defined herein have the
meanings specified in the Delivery Procedures or, if not defined
therein, the ICE Clear Europe Clearing Rules.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

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

(a) Purpose
    ICE Clear Europe is proposing to amend Part O of its Delivery
Procedures to amend certain delivery specifications for ICE Futures
Europe Financials and Softs Cocoa Futures Contracts (``Cocoa
Contracts'') to reflect the implementation of a new Softs Deliveries
Platform to be used for deliveries under the Contract. A conforming
change would also be made in the introductory section of the Delivery
Procedures. Certain other provisions in Part O relating to the delivery
timetable and allocation and conversion of lots would also be amended,
as described herein, in connection with the implementation of the Softs
Delivery Platform.
    In the General Provisions section of the Delivery Procedures, in
paragraph 21, references to the new Softs Delivery Platform as the
electronic system used for making and taking delivery under cocoa
contracts would be added (alongside the existing Guardian system, which
will continue to be used for deliveries under coffee contracts). The
amendments would also remove an incorrect reference to bonds (for which
neither Guardian nor the new Softs Delivery Platform is used).
    The proposed amendments in Part O of the Delivery Procedures would
replace relevant references to the Guardian delivery system throughout
Part O with the new Softs Delivery Platform and otherwise remove
references to the Guardian delivery system, such that transfers of
warrants would be made through the Softs Delivery Platform and
applicable delivery notices and other specified delivery documentation
relevant to Sellers and Buyers would be provided or made available
through the Softs Delivery Platform.
    Procedures for allocations of cocoa, including notifications and
reports relating to allocations would be reorganized and consolidated
into a single provision for simplicity and clarity. As proposed to be
revised, reports relating to allocation details would be made available
to both Sellers and Buyers through the Clearing House MFT system.
    The amendments also update the content of reports made available to
Seller and Buyer to remove general references to ``delivery details''
throughout Part O, as the relevant information is provided in the
specific referenced reports provided through the Softs Delivery
Platform. The names of certain reports would also be updated throughout
Part O, specifically with references to final account sale reports
changed to account sale reports and references to final invoice reports
changed to Buyers invoice reports.
    The timing for certain notifications related to the conversion of
lots would be moved from by 16:00 LPT (in the case of certain
directions by the Clearing House) and after 16:00 LPT (in the case of
the availability of conversion details for Sellers), to after 10:00 LPT
in both scenarios. The amendments would also remove an incorrect
reference about

converting bulk delivery units into large delivery units. The
amendments would change the system used to send Sellers and Buyers
information relating to LDU Conversion Notices from Guardian to MFT.
With respect to certain notices to be provided by Sellers in response
to a direction by the Clearing House to convert bulk or large delivery
units, references to the use of Guardian (or a successor system) would
be removed as unnecessary in light of the introduction of the Softs
Delivery Platform. In the provisions relating to BDU conversion
notices, the reference in the left column to ``Extension to
Conversion'' would be deleted, as it is not necessary and does not
relate to the 16:00 deadline.
    The amendments also update the summary of required delivery
documentation. Specifically, amendments would clarify that invoices and
account sales statements would be provided through MFT. References to
provisional invoices in the case of conversion would be removed as
unnecessary in light of other reports made available to Buyer and
Sellers. A reference to warrant delivery instructions report would be
removed as outdated in light of the manner in which delivery is made
under the contract.
(b) Statutory Basis
    ICE Clear Europe believes that the proposed amendments to the
Delivery Procedures are consistent with the requirements of Section 17A
of the Act \6\ and the regulations thereunder applicable to it. In
particular, Section 17A(b)(3)(F) of the Act \7\ requires, among other
things, that the rules of a clearing agency be designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivative agreements, contracts, and
transactions, the safeguarding of securities and funds in the custody
or control of the clearing agency or for which it is responsible, and
the protection of investors and the public interest. The proposed
changes to the Delivery Procedures are designed to revise ICE Clear
Europe's delivery arrangements relating to Cocoa Contracts to reflect
the implementation and use of the new Softs Delivery Platform for
delivery under such contracts. As part of the implementation of the
Softs Delivery Platform, the delivery timetable and provisions relating
to allocation and conversion of lots would be amended for clarity, to
update the systems used for notice and to remove unnecessary
provisions. Notably, the amendments would replace references to use of
existing Guardian system with references to use of the Softs Delivery
Platform or MFT system, as appropriate. In connection with the
implementation of the Softs Delivery Platform, the amendments revise
and simplify the process for allocations and conversion of lots by the
Clearing House and certain related delivery notification and delivery
documentation requirements. The contracts will otherwise continue to be
cleared by ICE Clear Europe in the same manner as they are currently.
In ICE Clear Europe's view, the amendments are thus consistent with the
prompt and accurate clearance and settlement of cleared contracts and
the protection of investors and the public interest. (ICE Clear Europe
would not expect the amendments to affect the safeguarding of
securities and funds in ICE Clear Europe's custody or control or for
which it is responsible). Accordingly, the amendments satisfy the
requirements of Section 17A(b)(3)(F).\8\
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    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
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    In addition, Rule 17Ad-22(e)(10) \9\ requires that each covered
clearing agency ``establish and maintain transparent written standards
that state its obligations with respect to the delivery of physical
instruments, and establish and maintain operational practices that
identify, monitor and manage the risks associated with such physical
deliveries.'' As discussed above, the amendments would clarify the
delivery specifications for Cocoa Contracts to reference the new Softs
Delivery Platform. The amendments would also make consistent with the
new Softs Delivery Platform certain obligations of the Clearing House
and Buyers and Sellers in the delivery process, including with respect
to allocations and conversions and related notifications. The
amendments would not otherwise change the manner in which the contracts
are cleared or in which delivery is made, as supported by ICE Clear
Europe's existing financial resources, risk management, systems and
operational arrangements. The amendments thus clarify the role and
responsibilities of the Clearing House and Clearing Members with
respect to delivery. As a result, ICE Clear Europe believes the
amendments are consistent with the requirements of Rule 17Ad-
22(e)(10).\10\
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    \9\ 17 CFR 240.17Ad-22(e)(10).
    \10\ 17 CFR 240.17Ad-22(e)(10).
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(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed amendments would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The amendments
are being adopted to update and clarify the delivery specifications in
the Delivery Procedures in connection with Cocoa Contracts, principally
with respect to the use of the Softs Delivery Platform. ICE Clear
Europe does not expect that the proposed changes will adversely affect
access to clearing or the ability of Clearing Members, their customers
or other market participants to continue to clear contracts. ICE Clear
Europe also does not believe the amendments would materially affect the
cost of clearing or otherwise impact competition among Clearing Members
or other market participants or limit market participants' choices for
selecting clearing services. Accordingly, ICE Clear Europe does not
believe the amendments would impose any burden on competition not
necessary or appropriate in furtherance of the purpose of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any written comments received with respect to the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2023-017 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICEEU-2023-017. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Europe and on ICE
Clear Europe's website at https://www.theice.com/clear-europe/regulation.
    Do not include personal identifiable information in submissions;
you should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-ICEEU-2023-017 and
should be submitted on or before September 1, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-17211 Filed 8-10-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Page 10601]
[FR Doc No: 2014-03982]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-15]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before March 17, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0889 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Keira Jones<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on February 20, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2013-0889.
    Petitioner: Aero-Flite, Inc.
    Section of 14 CFR Affected: 14 CFR 60.7(a)(1) and (b)(1).
    Description of Relief Sought: Aero-Flite requests relief from
Sec. Sec.  60.7(a)(1) and (b)(1) to allow it to sponsor the Swiss
Aviation Training simulator and have it recertified with the FAA. The
simulator would be used for crew training, perform certification check
rides, and annual currency check rides per 14 CFR 61.58.

[FR Doc. 2014-03982 Filed 2-24-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48712-48736]
[FR Doc No: 2021-18777]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0762]

Revocation of Authorization of Emergency Use of Certain Medical
Devices During COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of 15 Emergency Use Authorizations (EUAs) (the
Authorizations), including 12 Authorizations for decontamination
systems for personal protective equipment, 1 Authorization for a
bioburden reduction system for personal protective equipment, and 2
umbrella Authorizations for certain imported, non-NIOSH (National
Institute of Occupational Safety and Health)-approved disposable
respirators. FDA revoked the Authorizations for the decontamination and
bioburden reduction systems for personal protective equipment on June
30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as
requested by each Authorization holder. FDA revoked the umbrella
Authorizations issued to manufacturers and other stakeholders of
imported non-NIOSH approved filtering facepiece respirators
manufactured in China (China FFR Authorization), and to manufacturers
and other stakeholders of imported non-NIOSH approved filtering
facepiece respirators (Imports FFR Authorization) on June 30, 2021,
under the FD&C Act. The revocations, which each include an explanation
of the reasons for the revocation, are reprinted in this document.

DATES: The Authorizations for the decontamination and bioburden
reduction systems are revoked as of June 30, 2021. The Authorizations
for the China FFR Authorization and Imports FFR Authorization are
revoked as of July 6, 2021.

ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave, Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. Notice of the issuance of the Authorizations was published
in the Federal Register as follows, as required by section 564(h)(1) of
the FD&C Act: (1) Published June 5, 2020 (85 FR 34638) for Imports FFR
Authorization (Certain Imported, Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators) issued March 24, 2020; China FFR
Authorization (Certain Non-NIOSH-Approved Disposable Filtering
Facepiece Respirators Manufactured in China) issued April 3, 2020; and
STERIS Corporation for the STERIS Sterilization Systems (STERIS V-PRO 1
Plus, maX, and maX2 Low Temperature Sterilization Systems) issued April
9, 2020; (2) published July 14, 2020 (85 FR 42407) for Advanced
Sterilization Products, Inc. for the ASP STERRAD Decontamination
Systems issued April 11, 2020; Stryker

Instruments for the STERIZONE VP4 Sterilizer issued April 14, 2020;
Sterilucent, Inc. for the Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer issued April 20, 2020; Duke University Health System for the
Duke Decontamination System issued May 7, 2020; (3) published November
20, 2020, (85 FR 74346) for STERIS Corporation for the AMSCO Medium
Steam Sterilizers + the STERIS STEAM Decon Cycle issued May 21, 2020;
Stryker Sustainability Solutions (SSS) for the SSS VHP N95 Respirator
Decontamination System issued May 27, 2020; Technical Safety Services
LLC for the 20-CS Decontamination System issued June 13, 2020; MSU for
the MSU Decontamination System issued July 24, 2020; (4) published
April 23, 2021, (86 FR 21749) for Roxby Development, LLC for the Zoe-
Ann Decontamination System issued October 20, 2020; 3B Medical, Inc.
for the Lumin LM3000 Bioburden Reduction UV System issued December 3,
2020; Ecolab Inc. for the Bioquell Technology System issued December 4,
2020; and Yale New Haven Health System for the Yale New Haven Health
FILTERING FACEPIECE RESPIRATOR Decontamination System issued January
15, 2021.
    Any subsequent reissuances of the Authorizations are listed in the
revocation letters reprinted at the end of this document.
    The authorization of a device for emergency use under section 564
of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Criteria Met

    On June 30, 2021, FDA revoked the China FFR Authorization and
Imports FFR Authorization. FDA reviewed the totality of scientific
evidence available, including data provided by device manufacturers,
distributors, Group Purchasing Organizations, FDA Imports database,
healthcare organizations, and Federal/State stockpiles. Based on the
change in the Centers for Disease Control and Prevention (CDC)
recommendations, the increase in availability of NIOSH-approved
respirators, the Occupational Safety and Health Administration (OSHA)
Emergency Temporary Standard (ETS) requirements, and information
provided by healthcare organizations and others,\1\ FDA has concluded
that the known and potential benefits of these respirators, when used
for such use, no longer outweigh the known and potential risks of
continued use, and pursuant to section 564(g)(2)(B), the criteria under
section 564(c) of the FD&C Act for issuance of the Authorizations are
no longer met. In addition, based on the same information, revocation
of the Authorizations is appropriate to protect the public health and
safety pursuant to section 564(g)(2)(C) of the FD&C Act.
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    \1\ Non-NIOSH approved FFRs were previously recommended by CDC
as a crisis capacity strategy when there was a severe shortage of
NIOSH-approved FFRs available for healthcare personnel (HCP).
Available information now shows an increase in the current and
projected U.S. supply of NIOSH-approved respirators, including N95s
(https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1.html). As such, on April 9 and May 27, 2021, CDC updated
their recommendations to reflect that healthcare facilities should
return to conventional capacity strategies and thus CDC no longer
recommends the use of non-NIOSH-approved FFRs. On May 27, 2021, FDA
also recommended that healthcare facilities and HCP ``transition
away from crisis capacity conservation strategies, such as using
non-NIOSH-approved disposable respirators, including imported
respirators such as KN95s'' (https://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-recommends-transition-use-non-niosh-approved-and-decontaminated-disposable-respirators). In
addition, on June 21, 2021 (86 FR 32376), OSHA issued an Emergency
Temporary Standard (ETS) to adequately address the hazard of COVID-
19 for HCP. The ETS requires, among other things, healthcare
employers to provide NIOSH-approved or FDA-authorized respirators
for healthcare workers potentially exposed to COVID-19.
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    On June 30, 2021, FDA revoked the Authorizations for
decontamination and bioburden reductions systems pursuant to requests
from the following entities on the following dates:
     April 9, 2021, from Duke for the Duke Decontamination
System;
     April 15, 2021, from Sterilucent, Inc. for the Sterilucent
HC 80TT Hydrogen PeroxideSterilizer;
     April 16, 2021, from Yale for the Yale New Haven Health
FFR Decontamination System;
     May 13, 2021, from STERIS Corporation for the STERIS
Sterilization Systems, as well as the AMSCO Medium Steam Sterilizers +
the STERIS STEAM Decon Cycle;
     May 25, 2021, from Stryker Sustainability Solutions (SSS)
for the SSS VHP N95 Respirator Decontamination System;
     May 27, 2021 from MSU for the MSU Decontamination System;
     June 4, 2021, from Advanced Sterilization Products, Inc.
for the ASP STERRAD Decontamination Systems;
     June 7, 2021, from Technical Safety Services LLC for the
20-CS Decontamination System;
     June 7, 2021, from Roxby Development, LLC for the Zoe-Ann
Decontamination System;
     June 7, 2021, from 3B Medical, Inc. for the Lumin LM3000
Bioburden Reduction UV System;
     June 7, 2021, from Ecolab Inc. for the Bioquell Technology
System; and
     June 8, 2021, from Stryker Instruments for the STERIZONE
VP4 Sterilizer.
    Because these entities notified FDA that they have ceased
operations and associated activities and request withdrawal of their
respective Authorizations, and consistent with FDA's belief that the
known and potential benefits of these systems, when used for their
emergency use, no longer outweigh the known and potential risks of such
use, FDA has determined that it is appropriate to revoke the
Authorizations because the criteria for issuance of an EUA under
section 564(c)(2)(B) of the Act are no longer met. Moreover, based on
the same information, FDA has concluded under section 564(g)(2)(C) of
the FD&C Act that other circumstances make revocation appropriate to
protect the public health or safety.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/ and https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(B) and 564(g)(2)(C) of the FD&C
Act are met, FDA has revoked the following Authorizations:
     China FFR Authorization;
     Imports FFR Authorization;
     Duke's Duke Decontamination System;
     Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer;
     Yale's Yale New Haven Health FFR Decontamination System;
     STERIS Corporation's STERIS Sterilization Systems, as well
as the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle;
     Stryker Sustainability Solutions's SSS VHP N95 Respirator
Decontamination System;
     MSU's MSU Decontamination System;
     Advanced Sterilization Products, Inc.'s ASP STERRAD
Decontamination Systems;

     Technical Safety Services LLC's 20-CS Decontamination
System;
     Roxby Development, LLC's Zoe-Ann Decontamination System;
     3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV
System;
     Ecolab Inc.'s Bioquell Technology System; and
     Stryker Instruments's STERIZONE VP4 Sterilizer.
    The revocations in their entirety follow and provide an explanation
of the reasons for revocation, as required by section 564(h)(1) of the
FD&C Act.
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BILLING CODE 4164-01-C

    Dated: August 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18777 Filed 8-30-21; 8:45 am]
BILLING CODE 4164-01-P