[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67461-67463]
[FR Doc No: 2011-28238]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0770]

Cosmetic Microbiological Safety Issues; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments and opening of a
docket.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Cosmetic Microbiological Safety Issues.'' The
purpose of the public meeting is to provide stakeholders an opportunity
to present information regarding cosmetic microbiological safety and to
suggest areas for the possible development of FDA guidance documents.
FDA is seeking information regarding microbiological testing of
cosmetics; types of preservative systems and how to test their
efficacy; the identity and prevalence of microorganisms, including
antibiotic-resistant strains, that pose specific health risks in
finished products; routes of exposure to microorganisms and the
corresponding infective doses; product and packaging characteristics
that affect microbial growth and risk of infection; particular
subpopulations that may be at greater risk of infection when using
different cosmetic products; the occurrence of adverse events
associated with microbial contamination of cosmetics; and any other
issues relevant to the microbiological safety of cosmetics.

DATES: Submit either electronic or written comments to FDA's Division
of Dockets Management by January 30, 2012. See also ``How to
Participate in the Meeting'' in the SUPPLEMENTARY INFORMATION section
of this document for important meeting registration deadlines.

ADDRESSES: See Table 1 of this document for meeting location and other
information regarding registration for this meeting.

FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register orally, or to submit a notice of participation
by mail, fax, or email: Courtney Treece, Planning Professionals, Ltd.,
1210 W. McDermott, suite 111, Allen, TX 75013,<PHONE_NUMBER>. Fax:
(469) 854-6992<EMAIL_ADDRESS>
    For questions about the meeting, to request an opportunity to make
public comments, to submit the full text, comprehensive outline, or
summary of an oral presentation, or to request special accommodations
due to a disability: Juanita Yates, Center for Food Safety and Applied
Nutrition, Food and Drug Administration,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Background

    FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et seq.) and, for products marketed
on a retail basis to consumers, under the Fair Packaging and Labeling
Act (FPLA) (15 U.S.C. 1451 et seq.). The law requires that cosmetics be
neither adulterated under section 601 of the FD&C Act (21 U.S.C. 361)
nor misbranded under section 602 of the FD&C Act (21 U.S.C. 362). That
is, they must be safe for consumers under labeled or customary
conditions of use and they must be properly labeled. FDA has issued
regulations addressing certain aspects of cosmetic safety and labeling
(see 21 CFR parts 700, 701, and 740). FDA has also issued guidance
regarding certain aspects of cosmetic safety and labeling, including
the ``Good Manufacturing Practice (GMP) Guidelines/Inspection
Checklist'' (available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm),
the ``Cosmetic Labeling Manual'' (available at http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm), and other cosmetic guidance documents (available at
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm).
    FDA has not yet issued specific guidance regarding cosmetic
microbiological safety. FDA has presented its preferred laboratory
procedures for microbiological analyses of foods and cosmetics in its
Bacteriological Analytical Manual (BAM). Chapter 23 of the BAM concerns
microbiological methods for cosmetics (available at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm).

    Microbial contamination of cosmetic products is of concern to FDA
because of the potential for serious adverse events. Cosmetics intended
to be used in the area of the eye are of particular concern. Eye-area
cosmetics that contain pathogenic microorganisms have the potential to
cause serious eye infections which can, in some cases, result in
partial or total loss of vision. In addition, contaminated alcohol-free
mouthwash has caused outbreaks of serious bacterial illness among
hospitalized patients. Other microbially contaminated cosmetic product
types, such as skin lotions, also have the potential to cause
significant irritation or infection.
    A variety of factors can affect the microbiological safety of
cosmetic products. Microbial contaminants can be introduced during
manufacturing, packaging, or repacking. Microbial growth can be
supported by certain product characteristics, such as high water
content. Microorganisms can also be introduced by consumers during use.
Certain forms of cosmetic product packaging may serve to limit or
prevent the introduction of microorganisms. Preservative systems are
intended to protect consumers from microorganisms introduced during
manufacturing and while using a product, but inadequate preservative
systems may fail to do so. Some microorganisms are known to be
pathogenic, that is, they are capable of causing injury or illness,
while others are not. Certain microorganisms may pose little risk to
most consumers, but may pose significant risks to vulnerable consumers,
such as those with compromised immune systems.
    FDA believes that guidance on factors and practices to promote the
microbiological safety of cosmetics would benefit consumers and
industry. FDA is contemplating developing such guidance and is seeking
information about microbiological safety of cosmetics. This public
meeting is intended to provide stakeholders the opportunity to present
information regarding microbiological testing of cosmetics; types of
preservative systems and how to test their efficacy; the identity and
prevalence of microorganisms, including antibiotic-resistant strains,
that pose specific health risks in finished products; routes of
exposure to microorganisms and the corresponding infective doses;
product and packaging characteristics that affect microbial growth and
risk of infection; particular subpopulations that may be at greater
risk of infection when using different cosmetic products; the
occurrence of adverse events associated with microbial contamination of
cosmetics; and any other issues relevant to the microbiological safety
of cosmetics.

II. Purpose and Format of the Meeting

    If you wish to present at the meeting scheduled for November 30,
2011, please register at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 10, 2011. If you
wish to attend the meeting but not give a presentation, please register
at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 21, 2011. FDA is holding the public meeting on
cosmetic microbiological safety issues to receive input from the public
to support the development of guidance. The meeting format will include
introductory presentations by FDA, followed by the opportunity for
stakeholders to make presentations or offer remarks. Listening to our
stakeholders is the primary purpose of this meeting. In order to meet
this goal, FDA will provide multiple opportunities for individuals to
actively express their views by making presentations at the meeting and
submitting written comments to FDA's Division of Dockets Management
within 60 days of this meeting.

III. How To Participate in the Meeting

    Stakeholders will have an opportunity to provide oral comments. Due
to limited space and time, FDA encourages all persons who wish to
attend the meeting to register in advance. Interested persons and
organizations who desire an opportunity to make an oral presentation
during the time allotted for public comment at the meeting, are
encouraged to register in advance and to provide the specific topic or
issue to be addressed and the approximate desired length of their
presentation. Depending on the number of requests for such oral
presentations, there may be a need to limit the time of each oral
presentation (e.g., 3 minutes each). If time permits, individuals or
organizations that did not register in advance may be granted the
opportunity for such an oral presentation. FDA would like to maximize
the number of stakeholders who make a presentation at the meeting and
will do our best to accommodate all persons who wish to make a
presentation or express their views at the meeting. FDA encourages
persons and groups who have similar interests to consolidate their
information for presentation through a single representative. After
reviewing the presentation requests, FDA will notify each participant
before the meeting of the amount of time available and the approximate
time their presentation is scheduled to begin. Stakeholders will also
have an opportunity to submit electronic or written comments to the
docket following the meeting, but no later than January 30, 2012.
    There is no fee to register for the public meeting and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited.
    Table 1 of this document provides information on participating in
the meeting and on submitting comments to the docket.

                 Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                        Electronic       Address  (non-
                                        Date             address          electronic)        Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting.........  November 30,       Individuals who    L'Enfant Plaza     Registration begins at
                                  2011, from 9       wish to            Hotel, 480         8 a.m.
                                  a.m. to 5:30       participate in     L'Enfant Plaza
                                  p.m. EST.          person are asked   Southwest,
                                                     to pre-register    Washington, DC,
                                                     at http://         20024-2253.
                                                     www.fda.gov/Food/
                                                     NewsEvents/
                                                     WorkshopsMeeting
                                                     sConferences/
                                                     default.htm.
Advance Registration...........  Register by        http://            FDA encourages     Registration to attend
                                  November 21,       www.fda.gov/Food/  the use of         the meeting will also
                                  2011.              NewsEvents/        electronic         be accepted onsite on
                                                     WorkshopsMeeting   registration if    the day of the
                                                     sConferences/      possible.          meeting, as space
                                                     default.htm.                          permits. Registration
                                                                                information may be
                                                                                posted without change
                                                                                to http://www.regulations.gov
                                                                                including any
                                                                                personal information
                                                                                provided.
Request special accommodations   Register by        Juanita Yates, e-  Juanita Yates,     ......................
 due to disability.               November 21,       mail:<PHONE_NUMBER>.
                                  2011<EMAIL_ADDRESS>

Make a request for oral          Submit a request   http://            .................  Requests made on the
 presentation.                    by November 10,    www.fda.gov/Food/                     day of the meeting to
                                  2011.              NewsEvents/                           make an oral
                                                     WorkshopsMeeting                      presentation will be
                                                     sConferences/                         granted as time
                                                     default.htm.                          permits. Information
                                                                                on requests to make
                                                                                an oral presentation
                                                                                may be posted without
                                                                                change to http://www.regulations.gov,
                                                                                including any
                                                                                personal information
                                                                                provided.
Provide a brief description of   By November 21,    http://            .................  Written material
 the oral presentation and any    2011.              www.fda.gov/Food/                     associated with an
 written material for the                            NewsEvents/                           oral presentation
 presentation.                                       WorkshopsMeeting                      should be submitted
                                                     sConferences/                         in Microsoft
                                                     default.htm.                          PowerPoint, Microsoft
                                                                                Word, or Adobe
                                                                                Portable Document
                                                                                Format (PDF) and may
                                                                                be posted without
                                                                                change to http://www.regulations.gov,
                                                                                including any
                                                                                personal information
                                                                                provided.
Submit electronic or written     Submit comments    Federal            Fax: 301-827-      All comments must
 comments.                        by January 30,     eRulemaking        6870, Mail/Hand    include the Agency
                                  2012.              Portal: http://    delivery/Courier   name and the docket
                                                     www.regulations.   (for paper,        number corresponding
                                                     gov. Follow the    disk, or CD-ROM    to the Cosmetic
                                                     instructions for   submissions):      Microbiological
                                                     submitting         Division of        Safety Issues; Public
                                                     comments.          Dockets            Meeting. All received
                                                                        Management (HFA-   comments may be
                                                                        305), Food and     posted without change
                                                                        Drug               to http://
                                                                        Administration,    www.regulations.gov,
                                                                        5630 Fishers       including any
                                                                        Lane, rm. 1061,    personal information
                                                                        Rockville, MD      provided. FDA
                                                                        20852.             encourages the
                                                                                submission of
                                                                                electronic comments
                                                                                by using the Federal
                                                                                eRulemaking Portal.
                                                                                For additional
                                                                                information on
                                                                                submitting comments,
                                                                                see the ``Comments''
                                                                                heading of the
                                                                                SUPPLEMENTARY
                                                                                INFORMATION section
                                                                                of this document.
----------------------------------------------------------------------------------------------------------------

IV. Comments

    Regardless of attendance at the public meeting, interested persons
may submit to the Division of Dockets management (see Table 1 of this
document) either electronic or written comments for consideration at or
after the meeting in addition to, or in place of, a request for an
opportunity to make an oral presentation. It is only necessary to send
one set of comments. It is no longer necessary to send two copies of
mailed comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be
viewed in the Division of Dockets Management at the address provided in
Table 1 of this document between 9 a.m. and 4 p.m., Monday through
Friday.

V. References

    We have placed hard copies of the following references on display
in the Division of Dockets Management (see ADDRESSES). You may view
them between 9 a.m. and 4 p.m., Monday through Friday. (FDA has
verified the Web site addresses, but FDA is not responsible for any
subsequent changes to Web sites after this document publishes in the
Federal Register.)
    1. FDA, ``Good Manufacturing Practice (GMP) Guidelines/Inspection
Checklist,'' available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.
    2. FDA, ``Cosmetic Labeling Manual,'' available at http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm.
    3. FDA, ``Guidance Documents,'' available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm.
    4. FDA, Bacteriological Analytical Manual, chapter 23,
``Microbiological Methods for Cosmetics,'' available at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov and at FDA's Web site
under ``Cosmetics.'' It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after the submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28238 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48369-48371]
[FR Doc No: 2015-19757]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75624; File No. SR-ICEEU-2015-013]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change Relating to CDS End-of-Day Price
Discovery Policy

August 6, 2015.
    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 24, 2015, ICE Clear Europe Limited (``ICE Clear Europe'' or
``Clearing House'') 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 primarily prepared by ICE Clear
Europe. 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

    ICE Clear Europe proposes to amend its end-of-day price discovery
policies and procedures for credit default swap (``CDS'') contracts to
incorporate certain enhancements.

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

1. Purpose
    ICE Clear Europe proposes to amend its CDS End-of-Day Price
Discovery Policy (the ``EOD Price Discovery Policy'') to make certain
enhancements to the end-of-day submission and firm trade process for
CDS contracts. ICE Clear Europe also proposes to adopt a new Price
Submission Disciplinary Framework (the ``Disciplinary Framework'') that
addresses missed price submissions by Clearing Members for CDS
contracts. ICE Clear Europe does not otherwise propose to change its
Clearing Rules or Procedures in connection with these amendments.
    Under the EOD Price Discovery Policy, ICE Clear Europe currently
utilizes a ``cross and lock'' algorithm as part of its CDS price
discovery process. Under this algorithm, standardized bids and offers
derived from Clearing Member submissions are matched by sorting them
from highest to lowest and lowest to highest levels, respectively. This
sorting process pairs the Clearing Member submitting the highest bid
price with the Clearing Member submitting the lowest offer price, the
Clearing Member submitting the second highest bid price with the
Clearing Member submitting the second-lowest offer price, and so on.
The algorithm then identifies crossed and/or locked markets. Crossed
markets are the Clearing Member pairs generated by the sorting and
ranking process for which the bid price of one Clearing Member is above
the offer price of the matched Clearing Member. The algorithm
identifies locked markets, where the bid and the offer are equal, in a
similar fashion.
    Whenever there are crossed and/or locked matched markets, the
algorithm applies a set of rules designed to identify standardized
submissions that are ``obvious errors.'' The algorithm sets a high bid
threshold equal to the preliminary end-of-day (``EOD'') level plus one
bid-offer width (``BOW''), and a low offer threshold equal to the
preliminary EOD level minus one BOW. The algorithm considers a Clearing
Member's standardized submission to be an ``obvious error'' if the bid
is higher than the high bid threshold, or the offer is lower than the
low offer threshold.
    Clearing Member pairs identified by the algorithm as crossed or
locked markets may be required from time to

time, under the EOD Price Discovery Policy, to enter into cleared CDS
trades with each other (``Firm Trades''). Currently, ICE Clear Europe
excludes standardized submissions it identifies as obvious errors from
potential Firm Trades and does not use these submissions in its
determination of published EOD levels.
    ICE Clear Europe proposes to impose certain consequences under the
Firm Trade methodology for Clearing Members providing price discovery
submissions deemed to be obvious errors. As revised, the process for
determining potential Firm Trades will now include all standardized
submissions, including those classified as obvious errors (and as a
result submissions that are obvious errors may result in Firm Trades).
However, obvious errors will not be used in the calculation of the
final EOD level, as under the current framework. Thus, ICE Clear Europe
will effectively execute its current EOD algorithm twice: initially in
the same way it does today (eliminating obvious errors) to generate the
final EOD levels, and again, without excluding obvious errors, to
generate Firm Trades and related reversing transactions.\3\
---------------------------------------------------------------------------

    \3\ A reversing transaction is a second cleared transaction with
identical attributes to the initial Firm Trade, but with the buyer
and seller counterparties reversed, and at that day's EOD price
rather than the initial Firm Trade price.
---------------------------------------------------------------------------

    To limit the potential exposure created through Firm Trades that
include a bid or offer from an obvious error submission, ICE Clear
Europe will adjust Firm Trade prices, where appropriate, to fall within
a predefined band on either side of the EOD price such that the
potential profit or loss (``P/L'') realized by unwinding the trade at
the EOD level is capped.
    To prevent Clearing Members from receiving Firm Trades with large
P/L impact in certain index instruments that are less actively traded,
and for which it is therefore more difficult and/or more expensive to
manage the associated risk, ICE Clear Europe will automatically
generate reversing transactions at the end-of-day price level for
specific index CDS instruments (i.e., for specific combinations of
index/sub-index and series determined by the ICE Clear Europe risk
department in consultation with the trading advisory committee).
Currently, reversing transactions are only available for eligible
single name CDS instruments.
    ICE Clear Europe is also revising the EOD Price Discovery Policy to
remove the option for Clearing Members to provide end-of-day price
submissions for single name CDS instruments in terms of spread and
associated recovery rate. Under the revised approach, Clearing Members
will be required to provide price submissions (or equivalent ``points
upfront'' submissions) for all single name CDS instruments. Clearing
Members may provide a recovery rate, which the Clearing House will use
for purposes of its own analysis. Accordingly, the Clearing House will
no longer need to convert spread submissions for single name
instruments into a price level for purposes of the EOD price
determination process. Various conforming changes have been made
throughout the policy as a result.
    ICE Clear Europe also proposes to implement a new Disciplinary
Framework, which addresses failures by a Clearing Member to provide
required EOD price submissions for CDS Contracts in which they hold
cleared open interest with the Clearing House (``Missed Submissions'').
For purposes of the Disciplinary Framework, obvious errors (as
described above) with respect to CDX index CDS contracts will also be
treated as Missed Submissions (since such instruments are not subject
to Firm Trade requirements). ICE Clear Europe will impose a cash
assessment on Clearing Members for each Missed Submission, generally
ranging from $1,000 to $4,000, depending on whether the Missed
Submission related to an index or single-name, whether it occurred on
an announced firm trade date and whether the related contract is
actively traded. For single name CDS contracts, the framework also
specifies an aggregate daily maximum assessment per Clearing Member for
multiple Missed Submissions and a daily maximum assessment per Clearing
Member per risk sub-factor.
    As part of a new summary assessment process, ICE Clear Europe will
determine on a monthly basis whether a Clearing Member has any Missed
Submissions and provide the Clearing Member a notice of assessment with
details of such Missed Submissions. The notice of assessment will
include information about the date, type, quantity and assessment
amount for the relevant Missed Submission(s). The Disciplinary
Framework also provides a procedure for a Clearing Member to dispute a
notice of assessment. A Clearing Member will have fifteen days from the
notice of assessment to dispute the notice or seek to have it waived or
rescinded. The Clearing House may grant a waiver of an assessment for
certain specified reasons. A conditional waiver may be granted for the
first instance of a Missed Submission for a particular instrument,
provided that the Clearing Member does not have another Missed
Submission in that instrument within 90 days. The Clearing House may
grant an unconditional waiver where Missed Submissions result from
extraordinary circumstances outside of the Clearing Member's control,
such as market-wide disruptions. The imposition of a cash assessment on
a Clearing Member does not preclude ICE Clear Europe from taking any
other disciplinary action against a Clearing Member under the Rules and
Procedures, including for persistent failures to meet the requirements
of the EOD Price Discovery Policy.
2. Statutory Basis
    ICE Clear Europe believes that the proposed amendments are
consistent with the requirements of Section 17A of the Act \4\ and the
regulations thereunder applicable to it. Section 17A(b)(3)(F) of the
Act \5\ 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,
and the protection of investors and the public interest. The proposed
amendments are designed to enhance the Clearing House's EOD Price
Discovery Policy, which is a key aspect of the risk management and
daily settlement procedures of the Clearing House. In ICE Clear
Europe's view, the changes will strengthen the incentive of Clearing
Members to provide accurate end-of-day price submissions, by imposing
new consequences under the Firm Trade Methodology for submissions that
are obviously erroneous. The amendments will further incentivize
accurate price submissions by imposing financial consequences on
Clearing Members for Missed Submissions, through cash assessments under
the new Disciplinary Framework. The amendments thus ensure Clearing
Members are accountable for all price submissions and any failures to
make submissions. This will promote the accuracy and integrity of the
overall end-of-day pricing and settlement process. The amendments also
contain certain other enhancements and clarifications to the end-of-day
price submission process, as discussed above. Accordingly, ICE Clear
Europe believes that the proposed rule change will promote the prompt
and accurate clearance and settlement of securities transactions and
derivative agreements,

contracts and transactions, within the meaning of Section
17(A)(b)(3)(F).\6\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1.
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    In addition, in ICE Clear Europe's view, the new Disciplinary
Framework provides an appropriately tailored set of cash assessments
for Missed Submissions by Clearing Members, in light of the importance
of end-of-day price submissions to the Clearing House risk management
and settlement procedures. The framework is thus consistent with the
requirements of Section 17A(b)(3)(G) of the Act.\7\ The framework also
provides a procedure for notifying Clearing Members of the details of
any such assessments for Missed Submissions, and for Clearing Members
to dispute and/or seek a waiver of such assessments. In ICE Clear
Europe's view, this aspect of the framework is consistent with the
requirements of Section 17A(b)(3)(H) of the Act.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1(b)(3)(G).
    \8\ 15 U.S.C. 78q-1(b)(3)(H).
---------------------------------------------------------------------------

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

    ICE Clear Europe does not believe the proposed rule change would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The enhancements
to ICE Clear Europe's price discovery process apply uniformly to all
Clearing Members. As a result, ICE Clear Europe does not believe that
the adoption of the policy amendments will adversely affect competition
among Clearing Members, or the ability of market participants to clear
contracts generally. The Clearing House also does not believe that the
amendments will reduce access to clearing CDS contracts generally or
limit market participants' choices for clearing CDS.
    The amendments may result in certain additional costs for Clearing
Members that are required to enter into Firm Trades as a result of
obvious errors in their submissions, or are subject to cash assessments
as a result of Missed Submissions. ICE Clear Europe believes that these
additional costs are warranted to enhance the integrity of the price
submission process, and are in any event generally within the control
of the Clearing Member. As a result, ICE Clear Europe does not believe
the proposed amendments impose any burden on competition that is
inappropriate 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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate 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 or disapprove 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 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-ICEEU-2015-013 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-2015-013. 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 filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/clear-europe/regulation#rule-filings. 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-ICEEU-2015-013 and
should be submitted on or before September 2, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-19757 Filed 8-11-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: November 24, 2010 (Volume 75, Number 226)]
[Notices]
[Page 71792]
[DOCID:fr24no10-159]

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

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.

TIME AND DATE:  December 2, 2010, 12 noon to 3 p.m., Eastern Daylight
Time.

PLACE:  This meeting will take place telephonically. Any interested
person may call<PHONE_NUMBER>, passcode 4856462, to participate in this
meeting.

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.

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

    Issued on: November 19, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-29786 Filed 11-22-10; 4:15 pm]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 13 (Thursday, January 20, 2022)]
[Notices]
[Pages 3137-3138]
[FR Doc No: 2022-00978]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93972; File No. SR-MIAX-2021-58]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Designation of a Longer Period for Commission
Action on a Proposed Rule Change To Adopt Exchange Rule 532, Order and
Quote Price Protection Mechanisms and Risk Controls

January 13, 2022.
    On November 16, 2021, Miami International Securities Exchange, LLC
(``MIAX Options'' or the ``Exchange'') filed with the Securities and
Exchange Commission (the ``Commission''), pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt a new Managed Protection
Override feature, a new Max Put Price Protection feature, and a new
MIAX Strategy Price Protection, which will be included in new Exchange
Rule 532, ``Order and Quote Price Protection Mechanisms and Risk
Controls.'' The proposed rule change was published for comment in the
Federal Register on December 3, 2021.\3\ The Commission has received no
comment letters regarding the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 93676 (November 29,
2021), 86 FR 68695.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the proposed rule change
is January 17, 2022.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day period for Commission action
on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
act on the proposed rule change. Accordingly, pursuant to

Section 19(b)(2) of the Act,\5\ the Commission designates March 3,
2022, as the date by which the Commission shall either approve,
disapprove, or institute proceedings to determine whether to disapprove
the proposed rule change (File No. SR-MIAX-2021-58).
---------------------------------------------------------------------------

    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-00978 Filed 1-19-22; 8:45 am]
BILLING CODE 8011-01-P