[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11146-11148]
[FR Doc No: 2019-05572]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85357; File No. SR-ICC-2019-001]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change Relating to the ICE CDS Clearing: Back-
Testing Framework

March 19, 2019.

I. Introduction

    On January 28, 2019, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``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 (SR-ICC-2019-001)
to update and formalize the ICE CDS Clearing: Back-Testing Framework
(``Back-Testing Framework'').\3\ The proposed rule change was published
in the Federal Register on February 8, 2019.\4\ The Commission did not
receive comments on the proposed rule change. For the reasons discussed
below, the Commission is approving the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Capitalized terms used herein but not otherwise defined have
the meaning set forth in the ICC Rules or the Back-Testing
Framework. Available at https://www.theice.com/publicdocs/clear_credit/ICE_Clear_Credit_Rules.pdf.
    \4\ Securities Exchange Act Release No. 34-85047 (Feb. 4, 2019),
84 FR 2938 (Feb. 8, 2019) (SR-ICC-2019-001) (``Notice'').
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II. Description of the Proposed Rule Change

    The proposed rule change would update and formalize the Back-
Testing Framework. The Back-Testing Framework would describe ICC's
back-testing process, reporting of back-testing results, and procedures
for remediating poor back-testing results.

A. Back-Testing Process

    Generally, ICC's back-testing process would count the number of
occurrences, also referred to as exceedances, when the observed loss
for a Clearing Participant's (``CP'') portfolio over a given time
horizon is greater than the risk measure projected by ICC's Risk
Management Model (the ``Model'').\5\ ICC would then evaluate the total
number of exceedances against the number of exceedances acceptable at
the 99.5% risk quantile.\6\ Under the Framework, the ICC Risk
Management Department (``ICC Risk'') would perform daily, weekly,
monthly, and quarterly portfolio-level back-testing analyses.\7\
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    \5\ Notice, 84 FR at 2938.
    \6\ Notice, 84 FR at 2939.
    \7\ Notice, 84 FR at 2938.
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    The Back-Testing Framework would calculate the observed loss for a
CP's portfolio as the worst unrealized profit/loss (``P/L'') over the
Margin Period of Risk (``MPOR''), using the changes in net asset values
(``NAVs'').\8\ The Back-Testing Framework would use the greatest MPOR
for all of the instruments in the considered portfolio, rounded up to
the nearest integer.\9\ For example, if an instrument is subject to
5.5-day MPOR estimations and no other instrument in the portfolio has a
longer MPOR, then ICC would perform the back-testing analysis by
comparing the N-day worst unrealized P/L against the model projected
risk measure with N=6.\10\
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    \8\ Id.
    \9\ Id.
    \10\ Id.
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    The Back-Testing Framework would define the model projected risk
measure as the sum of the following selected initial margin components:
Integrated spread response, basis risk, and interest rate sensitivity
(collectively, the ``Back-Tested Components'').\11\ The Back-Testing
Framework would not test the other components of initial margin (Jump-
To-Default, Wrong-Way-Risk, Concentration Charge, and Liquidity Charge)
because those components are not always market observed and
statistically modeled.\12\
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    \11\ Notice, 84 FR at 2938.
    \12\ Notice, 84 FR at 2939.
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    For multi-currency portfolios, the Back-Testing Framework would
require that the back-testing analysis be performed in the
clearinghouse base currency (U.S. Dollar) and would account for the
foreign exchange risk exposure.\13\
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    \13\ Notice, 84 FR at 2938.
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    Under the Back-Testing Framework, ICC would utilize the Basel
Traffic Light System (``BTLS'') to assess the soundness of the
Model.\14\ The BTLS would be based on three zones: Green, yellow, and
red, with each zone defined by the maximum number of acceptable
exceedances.\15\ Under the Back-Testing Framework, ICC would consider
the model well calibrated if the number of exceedances across all CP-
related portfolios is consistent with the 99.5% risk quantile.\16\
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    \14\ Id.
    \15\ Id.
    \16\ Id.
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    In addition to analyzing all CP-related portfolios, the Back-
Testing Framework would also analyze a range of hypothetical
portfolios. The Back-Testing Framework would refer to these portfolios
as special strategy portfolios.\17\ ICC would use the back-testing
results for the special strategy portfolios to identify and assess
potential weaknesses in the Model's assumptions.\18\
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    \17\ Notice, 84 FR at 2939.
    \18\ Id.
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    Finally, in addition to assessing the Model's performance by back-
testing, the Back-Testing Framework would direct ICC Risk to assess the
Model by conducting monthly parameter reviews and parameter sensitivity
analyses.

B. Reporting of Results

    The Back-Testing Framework would require a number of reports
regarding the back-testing analysis of CP portfolios. First, daily
portfolio back-testing results would be reported for each CP based on
the appropriate MPOR.\19\ For each day in the back-testing period, the
report would provide all components of initial margin and

identify the back-tested components and non-back-tested components.\20\
The report would also provide the sum of the back-tested components
alongside the unrealized P/L and the associated shortfall.\21\ Second,
the Back-Testing Framework would require a report of the back-testing
results for the full period of the MPOR.\22\ Third and finally, with
each set of back-testing results (daily and full period), the Back-
Testing Framework would require an exceedance summary showing the total
number of exceedances in the back-testing period and the maximum number
of exceedances that satisfy each zone in the BTLS.\23\ This report
would show the back-tested components and the N-day P/L results for
every back-tested day for each portfolio associated with a given
CP.\24\
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    \19\ Id.
    \20\ Id.
    \21\ Id.
    \22\ Id.
    \23\ Notice, 84 FR at 2939.
    \24\ Id.
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    In addition to reporting results per a given CP, the Back-Testing
Framework would also require that ICC Risk report, periodically and as
appropriate depending on market conditions, instrument and Risk Factor
(``RF'') \25\ level results.\26\ Specifically, with this report, ICC
Risk would compute the unrealized worst P/Ls over the appropriate time
period, projected risk measures and exceedances for each RF and present
the results as an average over all SN RFs for five groups of benchmark
tenors.
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    \25\ ICC deems each index, sub-index, or underlying single name
(``SN'') reference entity a separate RF.
    \26\ Id.
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C. Remediation of Poor Results

    The Back-Testing Framework would provide guidelines for remediating
poor back-testing results. The Back-Testing Framework would identify
back-testing results as poor if the number of observed exceedances
falls in the red zone of the BTLS.\27\ The Back-Testing Framework would
also note that red-zone results coming from overlapping back-testing
periods should not be automatically classified as poor back-testing
results if the effects of one adverse observation are responsible for a
cluster of exceedances.\28\ In that case, the Back-Testing Framework
would make the Chief Risk Officer and Risk Oversight Officer
responsible for determining whether the number of exceedances is
indicative of poor back-testing results, basing their determination in
part on an additional back-testing analysis without overlapping
periods.\29\
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    \27\ Notice, 84 FR at 2939.
    \28\ Id.
    \29\ Notice, 84 FR at 2939.
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    The Back-Testing Framework would describe various actions to be
taken upon the identification of poor back-testing results, including
seeking feedback from the Risk Working Group and consulting with the
Risk Committee on any necessary remedial action.\30\ Moreover, if poor
back-testing results are identified and confirmed at the portfolio
level, the Back-Testing Framework would require an analysis of
individual RF back-testing results.\31\ Finally, the Back-Testing
Framework would empower ICC Risk to recommend enhancements to the Risk
Committee and the Board.\32\
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    \30\ Id.
    \31\ Id.
    \32\ Id.
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    The Back-Testing Framework would also describe the actions to take
if the number of exceedances falls in the yellow zone, including a
review by ICC Risk to determine the cause of the Model's performance
and, if necessary, a complimentary back-testing analysis without
overlapping back-testing periods.\33\
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    \33\ Id.
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III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\34\ For the reasons given below, the Commission finds
that the proposal is consistent with Section 17A(b)(3)(F) of the Act
\35\ and Rules 17Ad-22(b)(2), 17Ad-22(b)(3), and 17Ad-22(d)(8)
thereunder.\36\
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    \34\ 15 U.S.C. 78s(b)(2)(C).
    \35\ 15 U.S.C. 78q-1(b)(3)(F).
    \36\ 17 CFR 240.17Ad-22(b)(2), (b)(3), and (d)(8).
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A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICC be designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions, as well
as to assure the safeguarding of securities and funds which are in the
custody or control of ICC or for which it is responsible, and, in
general, to protect investors and the public interest.\37\
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    \37\ 15 U.S.C. 78q-1(b)(3)(F).
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    As discussed above, the proposed rule change would update and
formalize ICC's Back-Testing Framework. The Commission believes that,
in general, the Back-Testing Framework would help ensure the sound
operation of ICC's Model. Specifically, the Commission believes that
the Back-Testing Framework, in describing in detail ICC's process for
conducting back-testing of the Model, would help assure the soundness
of the Model by ensuring that ICC has a means for determining whether
the Model's margin requirements cover possible losses under CP
portfolios at the 99.5% risk quantile. The Commission further believes
that the Back-Testing Framework, in setting out the requirements for
reporting the results of the back-testing process, would help assure
that ICC personnel are informed of the results and therefore able to
take action to correct the Model if necessary. Finally, the Commission
believes that the Back-Testing Framework, in mandating action to
remediate poor back-testing results, would assure that ICC corrects
deficiencies in the Model.
    By helping to assure the sound operation of the Model and ICC's
margin requirements, which ICC uses to manage the credit exposures
associated with clearing security based swap transactions, the
Commission believes that the proposed rule change would help improve
ICC's ability to avoid the losses that could result from the
miscalculation of ICC's credit exposures. Because such losses could
disrupt ICC's ability to operate and thus clear and settle security
based swap transactions, the Commission finds the proposed rule change
would promote the prompt and accurate clearance and settlement of
securities transactions. Because such losses could also threaten access
to securities and funds in ICC's control, the Commission finds the
proposed rule change would help assure the safeguarding of securities
and funds that are in the custody or control of ICC or for which it is
responsible. Likewise, for both of these reasons, the Commission finds
the proposed rule change would, in general, help protect investors and
the public interest.
    Therefore, the Commission finds that the proposed rule change would
promote the prompt and accurate clearance and settlement of securities
transactions, assure the safeguarding of securities and funds in ICC's
custody and control, and, in general, protect investors and the public
interest,

consistent with the Section 17A(b)(3)(F) of the Act.\38\
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    \38\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Consistency With Rules 17Ad-22(b)(2) and 17Ad-22(b)(3)

    Rule 17Ad-22(b)(2) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to use
margin requirements to limit its credit exposures to participants under
normal market conditions and use risk-based models and parameters to
set margin requirements and review such margin requirements and the
related risk-based models and parameters at least monthly.\39\ Rule
17Ad-22(b)(3) requires that ICC establish, implement, maintain and
enforce written policies and procedures reasonably designed to maintain
sufficient financial resources to withstand, at a minimum, a default by
the two participant families to which it has the largest exposures in
extreme but plausible market conditions.\40\
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    \39\ 17 CFR 240.17Ad-22(b)(2).
    \40\ 17 CFR 240.17Ad-22(b)(3).
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    As discussed above, the Commission believes that the proposed rule
change would help ensure the soundness of the Model by formalizing
ICC's process for conducting back-testing, reporting the results of
back-testing, and remediating poor results. The Commission believes
that the proposed rule change would therefore help ICC to maintain
margin requirements to limit its credit exposures to participants under
normal market conditions. Moreover, as discussed above, the Back-
Testing Framework would also require that ICC Risk conduct monthly
parameter reviews and parameter sensitivity analyses. The Commission
believes that this aspect of the Back-Testing Framework would help ICC
to review margin requirements and the related risk-based models and
parameters at least monthly. Finally, as discussed above, the Back-
Testing Framework would also require reporting the results of the back-
testing process. The Commission believes that this aspect of the
proposed rule change would help ICC to use risk-based models and
parameters to set margin requirements by helping assure that ICC
personnel are informed of the results of back-testing and therefore
able to take action to improve the Model if necessary. The Commission
therefore finds that the proposed rule is consistent with is consistent
with Rule 17Ad-22(b)(2).\41\
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    \41\ 17 CFR 240.17Ad-22(b)(2).
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    Moreover, the amount a CP must contribute to ICC's Guaranty Fund is
equal to the expected losses to ICC associated with the default of that
CP, calculated using ICC's stress test methodology, and taking into
account, among other things, the loss after application of initial
margin.\42\ Thus, ICC's guaranty fund is based on the initial margin
requirements. The Commission therefore believes that, in helping to
maintain the soundness of ICC's Model and therefore margin
requirements, the proposed rule change would also help ICC to maintain
sufficient financial resources to withstand, at a minimum, a default by
the two participant families to which it has the largest exposures in
extreme but plausible market conditions. The Commission therefore finds
that the proposed rule is consistent with is consistent with Rule 17Ad-
22(b)(3).\43\
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    \42\ See ICC Rule 801(a).
    \43\ 17 CFR 240.17Ad-22(b)(3).
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    Therefore, for these reasons, the Commission finds that the
proposed rule change is consistent with Rules 17Ad-22(b)(2) and 17Ad-
22(b)(3).\44\
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    \44\ 17 CFR 240.17Ad-22(b)(2), (b)(3).
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C. Consistency with Rule 17Ad-22(d)(8)

    Rule 17Ad-22(d)(8) requires that ICC establish, implement, maintain
and enforce written policies and procedures reasonably designed to have
governance arrangements that are clear and transparent to fulfill the
public interest requirements in Section 17A of the Act and to promote
the effectiveness of ICC's risk management procedures.\45\
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    \45\ 17 CFR 240.17Ad-22(d)(8).
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    As described above, the proposed rule change would make a number of
ICC personnel responsible for reporting and remediating back-testing
results. Specifically, the Back-Testing Framework would require that
ICC Risk periodically report results in terms of each CDS instrument,
depending on market conditions. If red-zone results appear from
overlapping back-testing periods, the Back-Testing Framework would make
the Chief Risk Officer and Risk Oversight Officer responsible for
determining whether the number of exceedances is indicative of poor
back-testing results. Moreover, if the number of exceedances falls in
the yellow zone, the Back-Testing Framework would require ICC Risk to
determine the cause of the Model's performance. Finally, as discussed
above, the Back-Testing Framework would also require that ICC Risk
conduct monthly parameter reviews and parameter sensitivity analyses.
    The Commission believes that in assigning these responsibilities,
the proposed rule change would establish governance arrangements
relating to the Back-Testing Framework that are clear and transparent
to fulfill the public interest requirements in Section 17A of the Act
by clearly assigning and documenting responsibilities for reporting and
acting on the results of back-testing. Moreover, the Commission
believes that in setting out specific actions to remediate poor back-
testing results the proposed rule change would promote the
effectiveness of ICC's risk management procedures by requiring specific
actions to correct deficiencies in the Model.
    Therefore, for this reason, the Commission finds that the proposed
rule change is consistent with Rule 17Ad-22(d)(8).\46\
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    \46\ 17 CFR 240.17Ad-22(d)(8).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, and in
particular, with the requirements of Section 17A(b)(3)(F) of the Act
\47\ and Rules 17Ad-22(b)(2), 17Ad-22(b)(3), and 17Ad-22(d)(8)
thereunder.\48\
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    \47\ 15 U.S.C. 78q-1(b)(3)(F).
    \48\ 17 CFR 240.17Ad-22(b)(2), (b)(3), and (d)(8).
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    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\49\ that the proposed rule change (SR-ICC-2019-001) be, and hereby is,
approved.\50\
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    \49\ 15 U.S.C. 78s(b)(2).
    \50\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\51\
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    \51\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-05572 Filed 3-22-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Proposed Rules]
[Pages 56759-56763]
[FR Doc No: 2017-25671]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2017-N-6529]

The Food and Drug Administration's Approach To Evaluating
Nicotine Replacement Therapies; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing on FDA's approach to evaluating the safety
and efficacy of nicotine replacement therapy (NRT) products, including
how they should be used and labeled.

DATES: The public hearing will be held on Friday, January 26, 2018,
from 9 a.m. to 5 p.m. The public hearing may be extended or may end
early depending on the level of public participation. Persons seeking
to attend or to present at the public hearing must register by Tuesday,
January 2, 2018. Section II provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until Thursday, February 15, 2018.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room A,
Silver Spring, MD 20993-0002. Entrance for public hearing participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before February 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 15, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6529 for ``FDA's Approach to Evaluating Nicotine Replacement
Therapies''; Public Hearing; Request for Comments. Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     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.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, 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.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    A majority (roughly 70%) of adult smokers in the United States
report that they want to quit, and nearly half of them make a quit
attempt each year. Many of those quit attempts involve the use of NRT
products, which are designed to help people quit smoking by supplying
controlled amounts of nicotine to ease their withdrawal symptoms. FDA
has approved two types of prescription \1\ NRT products--a nicotine
nasal spray and nicotine inhaler--and three types of over-the-counter
(OTC) NRT products--a nicotine gum, transdermal nicotine patch, and
nicotine lozenge (see Appendix A). Most of these products have been
approved for over 20 years.\2\ The use of approved prescription and OTC
NRT products is generally considered to double the likelihood of a
successful quit attempt, although there is variation in efficacy among
the types of products.
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    \1\ Non-nicotine prescription medications are also available to
aid in smoking cessation, but are beyond the scope of this document.
    \2\ Only the lozenge formulation has been approved for less than
20 years; it was approved in 2002.
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    Although the formulations and routes of administration of currently
approved NRT products have remained relatively unchanged for decades,
there have been developments in research regarding NRT products and
corresponding changes in the regulatory landscape. For example, in
2013, FDA recommended changing the statements on concomitant use and
duration of use in the labeling for OTC NRT products because evidence
gathered since 1984--the year the first NRT product was approved--
suggested that the statements were no longer necessary to ensure the
safe use of OTC NRT products for smoking cessation.\3\ Specifically,
the Agency recommended that the statement in the labeling for OTC NRT
products warning consumers that they should not use an NRT product if
they are still smoking, or using any other product that contains
nicotine--including another NRT--be removed. FDA also recommended that
the directions in the labeling for OTC NRT products be modified to
remove the statement advising consumers to stop using the product at
the end of the labeled duration of use. Instead of this statement, FDA
recommended that consumers be advised to talk to their health care
provider if they feel the need to use the product for longer than the
labeled duration of use to keep from smoking. To facilitate these
labeling changes, FDA invited the submission of supplemental new drug
applications (labeling supplements).
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    \3\ See the Federal Register, available at https://www.federalregister.gov/documents/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use. Recommendations also included other
language revisions that were not related to dosing or duration.
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    On July 28, 2017, the FDA announced a new comprehensive plan that
places nicotine, and the issue of addiction, at the center of the
Agency's tobacco regulation efforts. This plan will serve as a multi-
year roadmap to better protect children and significantly reduce
tobacco-related disease and death in the United States. One of the
first actions of this comprehensive approach will be an advanced notice
of proposed rulemaking (ANPRM) to seek input on the potential impacts
of reducing nicotine levels in cigarettes to minimally or non-addictive
levels. A key piece of the FDA's comprehensive plan is a recognition
that nicotine--while highly addictive--is delivered through products
that represent a continuum of risk and is most harmful when delivered
through combustible tobacco products. Accordingly, the Agency is
committed to increasing access to and use of nicotine replacement
therapy, which could help more smokers quit. Therefore, the Agency is
seeking public input on its approach to evaluating the safety and
efficacy of NRT products.
    As a part of its mission to protect and promote public health, FDA
is responsible for ensuring that approved drugs, including NRT
products, are safe and effective.\4\ For FDA to approve a new drug, it
must find that the applicant has submitted ``substantial evidence'' of
effectiveness based on adequate and well-controlled studies \5\ and
that the drug is safe for use under the conditions set forth in the
labeling.\6\ Generally, the safety of a product is assessed by
determining whether its benefits outweigh its risks. The benefit-risk
assessment takes into account the extensive evidence of safety and
effectiveness submitted by a sponsor in a marketing application as well
as many other factors.\7\
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    \4\ Section 1003(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), 21 U.S.C. 393(b).
    \5\ Section 505(d) of the FD&C Act; 21 U.S.C. 355(d).
    \6\ 21 U.S.C. 355(d). FDA also noted in the preamble to the
final rule on new drug approvals (NDA final rule) that the new drug
approval process and the supplemental application requirements ``are
intended to ensure that the drug is safe, that its benefits outweigh
its risks, and that it is effective.'' See 50 FR 7452, 7469
(February. 22, 1985).
    \7\ See FDA's Structured Approach to Benefit-Risk Assessment in
Drug Regulatory Decision-Making, Draft PDUFA V Implementation Plan--
February 2013, Fiscal Years 2013-2017, available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.
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II. Purpose and Scope of the Public Hearing

    To enable a thorough assessment of its approach for evaluating the
safety and efficacy NRT products and how they should be used and
labeled, FDA is holding a public hearing to receive information and
comments from a broad group of stakeholders, including the public
health community, researchers, health care professionals,
manufacturers, interested industry and professional organizations, and
the public, on the appropriate study designs and methods for evaluating
the safety and efficacy of OTC NRT drug products. FDA is also seeking
input on the warnings and directions sections of the Drug Facts
labeling (among other

aspects) for approved OTC NRT products, specifically regarding the
possible impact of current warnings on likelihood of use. The Agency
has determined that a public hearing is the most appropriate way to
ensure public engagement on these important public health issues. FDA
believes it is critical to obtain input across the research and medical
fields, the tobacco and pharmaceutical industries, and among public
health stakeholders regarding how evolving science could influence
FDA's approach to evaluating the safety and effectiveness of NRT
products.

Questions for Commenters To Address

    Although FDA welcomes all feedback on any public health,
scientific, regulatory or legal considerations relating to NRT products
and their use in tobacco use cessation, we encourage commenters to
consider the following questions as they prepare their comments or
statements. Responses to questions should include supporting scientific
justification.
    1. Might there be ways to improve upon the currently available
delivery systems to yield new OTC NRT products that might be more
effective? If so, what evidence would be needed to support such
changes, and how should they be evaluated?
    2. Are there additional indications or regimens for OTC NRT
products that could be explored? Concepts to consider could include
relapse prevention, craving reduction, maintenance, reduce to quit, use
of short- and long-acting products in combination, or cessation of non-
cigarette tobacco products. What evidence would be needed to support
each indication or regimen?
    3. What data would be required to demonstrate health benefits of
reduction in consumption of combustible tobacco products?
    4. Are there OTC NRT products that could be studied for use in
combination that might result in reduced tobacco-related health
impacts? What evidence would be needed to support the safety and
efficacy of these products when used in combination?
    5. Is there other information that could be added to labeling for
currently approved or new dosage forms of OTC NRT products that would
maximize their ability to be used to support smoking cessation? Please
consider the various sections of the Drug Facts labeling, including the
Uses, Warnings, and Directions sections.
    6. Generally, the labeling of OTC NRT products contains a dosing
schedule based on duration of use, and FDA has recommended the labeling
on OTC NRT products be modified to include the following: ``If you feel
you need to use [the NRT product] for a longer period to keep from
smoking, talk to your health care provider.'' What is the impact of
longer term NRT treatment? What is the impact on likelihood of
cessation or relapse prevention? What data would support an affirmative
recommendation to use approved OTC NRT products for durations that
exceed those currently included in the Drug Facts labeling of approved
OTC NRT products, or would support a chronic or maintenance drug
treatment indication for such products?
    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and/or
make a request for oral presentations or comments by email to
[email protected] by Tuesday, January 2, 2018. The email should
contain complete contact information for each attendee (i.e., name,
title, affiliation, address, email address, and telephone number). For
those wishing to present at the hearing, the email should also include
a presentation title. Those without email access can register by
contacting Allison Hoffman at<PHONE_NUMBER> by Tuesday, January 2, 2018
(see FOR FURTHER INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the specific question, or questions, they wish to address. This will
help FDA organize the presentations. Individuals and organizations with
common interests should consolidate or coordinate their presentations
and request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Presenters are encouraged to submit an electronic copy of their
presentation to [email protected] on or before Friday, January
19, 2018. Persons registered to make an oral presentation are
encouraged to arrive at the hearing room early and check in at the
onsite registration table to confirm their designated presentation
time. An agenda for the hearing and any other background materials will
be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm580561.htm.
    If you need special accommodations because of a disability, please
contact [email protected] (see FOR FURTHER INFORMATION CONTACT)
no later than Tuesday, January 2, 2018, at 12 noon Eastern Time.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/part15nicotine.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES).

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, and the Center for Tobacco Products.
Under Sec.  15.30(f), the hearing is informal and the rules of evidence
do not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notice, conflict with any provisions set
out in part 15, this notice acts as a waiver of those provisions as
specified in Sec.  15.30(h).

IV. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal

Register, but Web sites are subject to change over time.

1. Babb S, Malarcher A, Schauer G, Asman K, and Jamal A. 2017.
Quitting Smoking Among Adults--United States, 2000-2015. Morbidity
and Mortality Weekly Report 65:1457-1464.
2. Etter J-F and Stapleton JA. 2006. Nicotine Replacement Therapy
for Long-Term Smoking Cessation: A Meta-Analysis. Tobacco Control
15:280-285.
3. Silagy C, Mant D, Fowler G, and Lodge M. 1994. Meta-Analysis on
Efficacy of Nicotine Replacement Therapies in Smoking Cessation.
Lancet 343:139-142.

Appendix A: Summary of FDA-Approved Active New Drug Applications (NDAs)
of Nicotine Replacement Therapies (September 18, 2017)

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       OTC or Rx (date approved;                                                              Labeled treatment duration
    Product name (NDA #; holder)           date Rx[rarr]OTC)              Route (doses)                  Indication                  and schedule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nicorette gum (nicotine polacrilex)   Approved as prescription on  Oral (2, 4 mg gum).........  Reduces withdrawal           12 weeks:
 (NDA 018612 for 2 mg, NDA 020066      1/13/84 for 2 mg; 6/8/92                                  symptoms, including          Wk 1-6: 1 per 1-2
 for 4 mg; GSK).                       for 4 mg; Rx[rarr]OTC for                                 nicotine craving,            hr.
                                       both on 2/9/16.                                           associated with quitting     Wk 7-9: 1 per 2-4
                                                                                smoking (under Directions:   hr.
                                                                                If you are under 18 years    Wk 10-12: 1 per 4-
                                                                                of age ask a doctor before   8 hr.
                                                                                use).                       If smoke 1st cigarette
                                                                                within 30 min of waking
                                                                                up, use 4 mg; if more than
                                                                                30 min, use 2 mg.
NicoDerm CQ (nicotine) (NDA 020165;   Approved as prescription on  Patch (7, 14, 21 mg).......  Same use as above..........  10 weeks and 8 weeks:
 GSK, Sanofi Aventis).                 11/7/91; Rx[rarr]OTC on 8/                                                            If >10 cigarettes/day:
                                       2/96.                                                                                Wk 1-6: one 21 mg/
                                                                                day.
                                                                                Wk 7-8: one 14 mg/
                                                                                day.
                                                                                Wk 9-10: one 7 mg/
                                                                                day.
                                                                                If <=10 cigarettes/day:
                                                                                Wk 1-6: one 14 mg/
                                                                                day.
                                                                                Wk 7-8: one 7 mg/
                                                                                day.
Habitrol (nicotine) (NDA 020076;      Approved as prescription on  Patch (7, 14, 21 mg).......  Same use as above..........  8 weeks:
 Ciba-Geigy, Novartis, Dr. Reddy's).   11/27/91; Rx[rarr]OTC on                                                              If >10 cigarettes/day:
                                       11/12/99.                                                                              Wk 1-4: one 21 mg/
                                                                                day.
                                                                                Wk 5-6: one 14 mg/
                                                                                day.
                                                                                Wk 7-8: one 7 mg/
                                                                                day.
                                                                                If <=10 cigarettes/day:
                                                                                Wk 1-6: one 14 mg/
                                                                                day.
                                                                                Wk 7-8: one 7 mg/
                                                                                day.
Nicotrol NS (nicotine) (NDA 020385;   Prescription (3/22/96; N/A)  Nasal spray................   Indicated as an     The label does not specify
 Pfizer).                                                                                aid to smoking cessation     the recommended duration
                                                                                for the relief of nicotine   of treatment, but notes
                                                                                withdrawal symptoms.         the following in the
                                                                                Should be used as    Indications and Usage
                                                                                a part of a comprehensive    section:
                                                                                behavioral smoking          The safety and efficacy of
                                                                                cessation program.           the continued use of
                                                                                Nicotrol NS for periods
                                                                                longer than 6 months have
                                                                                not been adequately
                                                                                studied and such use is
                                                                                not recommended.
Nicotrol Inhaler (nicotine) (NDA      Prescription (5/2/97; N/A).  Inhalant...................   Indicated as an     The recommended duration of
 020714; Pharmacia and Upjohn).                                                                  aid to smoking cessation     treatment is 3 months,
                                                                                for the relief of nicotine   after which patients may
                                                                                withdrawal symptoms.         be weaned from the inhaler
                                                                                Recommended for      by gradual reduction of
                                                                                use as part of a             the daily dose over the
                                                                                comprehensive behavioral     following 6 to 12 weeks.
                                                                                smoking cessation program.  The safety and efficacy of
                                                                                the continued use of
                                                                                Nicotrol Inhaler for
                                                                                periods longer than 6
                                                                                months have not been
                                                                                studied and such use is
                                                                                not recommended.

Commit lozenge (nicotine polacrilex)  OTC (10/3/02; N/A).........  Oral (2, 4 mg).............  Reduces withdrawal           12 weeks:
 (NDA 021330; GSK).                                                                              symptoms, including          Wk 1-6: 1 per 1-2
                                                                                nicotine craving,            hr.
                                                                                associated with quitting     Wk 7-9: 1 per 2-4
                                                                                smoking (under Directions:   hr.
                                                                                If you are under 18 years    Wk 10-12: 1 per 4-
                                                                                of age ask a doctor before   8 hr.
                                                                                use).                       If smoke 1st cigarette
                                                                                within 30 min of waking
                                                                                up, use 4 mg; if more than
                                                                                30 min, use 2 mg.
Nicorette mini lozenge (nicotine      OTC (5/18/09; N/A).........  Oral (2, 4 mg).............  Same use as above..........  12 weeks; same schedule as
 polacrilex) (NDA 022366; GSK).                                                                                Commit lozenge.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25671 Filed 11-29-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60996-60999]
[FR Doc No: 2023-19122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98249; File No. SR-MIAX-2023-32]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 402 (Criteria for
Underlying Securities) To Accelerate the Listing of Options on Certain
IPOs

August 30, 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 August 23, 2023, Miami International Securities Exchange LLC
(``MIAX'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange is filing a proposal to amend Exchange Rule 402. The
text of the proposed rule change is available on the Exchange's website
at https://www.miaxglobal.com/markets/us-options/miax-options/rule-filings, at MIAX'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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 402, Criteria for
Underlying Securities, to permit an underlying security having a market
capitalization of at least $3 billion based upon the offering price of
its initial public offering, to be listed and traded starting on or
after the second business day following the initial public offering
day. The Exchange is proposing a listing rule change that is
substantially similar in all material respects to the proposal approved
for NYSE American LLC (``NYSE American'').\3\ Following discussions
with other exchanges and a cross-section of industry participants and
in coordination with the Listed Options Market Structure Working Group
(``LOMSWG'') (collectively, the ``Industry Working Group''), NYSE
American filed a proposed rule change,\4\ which was recently approved,
to modify the standard for the listing and trading of options on
``covered securities'' to reduce the time to market. At this time, the
Exchange proposes to adopt an identical rule.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 98013 (July 27,
2023) 88 FR 50927 (August 2, 2023)(SR-NYSEAMER-2023-27)(Order
Granting Approval of a Proposed Rule Change to Amend Rule 915
(Criteria for Underlying Securities) to Accelerate the Listing of
Options on Certain IPOs).
    \4\ Id.
---------------------------------------------------------------------------

    Rule 402 sets forth the guidelines to be considered in evaluating
for option transactions underlying securities that are ``covered
securities,'' as defined in section 18(b)(1)(A) of the Securities Act
of 1933 (hereinafter ``covered security'' or ``covered
securities'').\5\ Currently, the Exchange permits the listing of an
option on an underlying covered security that, amongst other things,
has a market price of at least $3.00 per share for the previous three
consecutive business days preceding the date on which the Exchange
submits a certificate to The Options Clearing Corporation (``OCC'') to
list and trade options on the underlying security (the ``three-day
lookback period'').\6\ Under the current rule, if an initial public
offering (``IPO'') occurs on a Monday, the earliest date the Exchange
could submit its listing certificate to OCC would be on Thursday, with
the market price determined by the closing price over the three-day
lookback period from Monday through Wednesday. The option on the IPO'd
security would then be eligible for trading on the Exchange on Friday
(i.e., within four business days of the IPO inclusive of the day the
listing certificate is submitted to OCC).\7\
---------------------------------------------------------------------------

    \5\ Rule 402(a) requires that, for underlying securities to be
eligible for option transactions, such securities must be duly
registered and be an ``NMS stock'' as defined in Rule 600 of
Regulation NMS under the Act and will be characterized by a
substantial number of outstanding shares which are widely held and
actively traded. See Rule 402(a)(1) and (2).
    \6\ See Rule 402(b)(5)(i). The Exchange is not proposing to make
any changes to the guidelines for listing securities that are not a
``covered security.'' See Rule 402(b)(5)(ii).
    \7\ See proposed Rule 402(b)(5)(i). The Exchange proposes a non-
substantive change to number the existing and proposed criteria for
covered securities as (A) and (B) of paragraph (5)(i). See proposed
Rule 402(b)(5)(i).
---------------------------------------------------------------------------

    The Exchange notes that the three-day look back period helps ensure
that options on underlying securities may be listed and traded in a
timely manner while also allowing time for OCC to accommodate the
certification request. However, there are certain large IPOs that issue
high-priced securities--well above the $3.00 per share threshold--that
would obviate the need for the three-day lookback period. In this
regard, the Industry Working Group has recently identified proposed
changes to Rule 402(b)(5)(i) that would help options on covered
securities that have a market capitalization of at least $3 billion
based upon the offering price of its IPO come to market earlier. The
proposed change, which is intended to be harmonized across options
exchanges, is designed to provide investors the opportunity to hedge
their interest in IPO investments in a shorter amount of time than what
is currently permitted.\8\ The Exchange believes that

options serve a valuable tool to the trading community and help markets
function efficiently by mitigating risk. To that end, the Exchange
believes that the absence of options in the early days after an IPO may
heighten volatility in the trading of IPO'd securities.
---------------------------------------------------------------------------

    \8\ While the Exchange acknowledges that market participants may
utilize options for speculative purposes (in addition to as a
hedging tool), the Exchange believes (as set forth below) that its
existing surveillance technologies and procedures adequately address
potential violations of exchange rules and federal securities laws
applicable to trading on the Exchange.
---------------------------------------------------------------------------

    Accordingly, the Exchange proposes to modify Rule 402 to waive the
three-day lookback period for covered securities that have a market
capitalization of at least $3 billion based upon the offering price of
the IPO of such securities and to allow options on such securities to
be listed and traded starting on or after the second business day
following the initial public offering day (i.e., not inclusive of the
day of the IPO).\9\ NYSE American has stated that it has reviewed
trading data for IPO'd securities dating back to 2017 and is unaware of
any such security that achieved a market capitalization of $3 billion
based upon the offering price of its IPO that would not have also
qualified for listing options based on the three-day lookback
requirement. Specifically, NYSE American has determined that 202 of the
1,179 IPOs that took place between January 1, 2017, and October 21,
2022, met the $3 billion market capitalization/IPO offering price
threshold. Options on all 202 of those IPO shares subsequently
satisfied the three-day lookback requirement for listing and trading,
i.e., none of these large IPOs closed below the $3.00/share threshold
during its first three days of its trading. As such, the Exchange
believes the proposed capitalization threshold of $3 billion based upon
the offering price of its IPO is appropriate.
---------------------------------------------------------------------------

    \9\ The Exchange acknowledges that the Options Listing
Procedures Plan (``OLPP'') requires that the listing certificate be
provided to OCC no earlier than 12:01 a.m. and no later than 11:00
a.m. (Chicago time) on the trading day prior to the day on which
trading is to begin. See the OLPP, at p. 3., available here: https://ncuoccblobdev.blob.core.windows.net/media/theocc/media/clearing-services/services/options_listing_procedures_plan.pdf. The OLPP is a
national market system plan that, among other things, sets forth
procedures governing the listing of new options series.
---------------------------------------------------------------------------

    Under the proposed rule, if an IPO for a company with a market
capitalization of $3 billion based upon the offering price of its IPO
occurs on a Monday, the Exchange could submit its listing certificate
to OCC (to list and trade options on the IPO'd security) as soon as all
the other requirements for listing are satisfied. If, on Tuesday, all
requirements are deemed satisfied, the IPO'd security could then be
eligible for trading on the Exchange on Wednesday (i.e., starting on or
after the second business day following the IPO day). Thus, the
proposal could potentially accelerate the listing of options on IPO'd
securities by two days.
    The Exchange believes the proposed change would allow options on
IPO'd securities to come to market sooner without sacrificing investor
protection. The Exchange represents that trading in IPO'd securities--
like all other securities traded on the Exchange--is subject to
surveillances administered by the Exchange and to cross-market
surveillances administered by FINRA on behalf of the Exchange. Those
surveillances are designed to detect violations of Exchange rules and
applicable federal securities laws.\10\ The Exchange represents that
those surveillances are adequate to reasonably monitor Exchange trading
of IPO'd securities in all trading sessions and to reasonably deter and
detect violations of Exchange rules and federal securities laws
applicable to trading on the Exchange.\11\ As such, the Exchange
believes that its existing surveillance technologies and procedures,
coupled with NYSE American's findings related to the IPOs reviewed as
described herein, adequately address potential concerns regarding
possible manipulation or price stability.
---------------------------------------------------------------------------

    \10\ FINRA conducts cross-market surveillances on behalf of the
Exchange pursuant to a regulatory services agreement. The Exchange
is responsible for FINRA's performance under this regulatory
services agreement.
    \11\ See supra note 8.
---------------------------------------------------------------------------

Implementation Date
    The Exchange will announce the effective date of the proposed
change by Notice distributed to all Members.\12\ The Exchange will
coordinate the effective date to coincide with the implementation of
the proposed change on the other options exchanges.
---------------------------------------------------------------------------

    \12\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of section 6(b) of the
Act.\13\ Specifically, the Exchange believes the proposed rule change
is consistent with the section 6(b)(5) \14\ requirements that the rules
of an exchange be designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

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

    In particular, the Exchange believes the proposed change would
facilitate options transactions and would remove impediments to and
perfect the mechanism of a free and open market and a national market
system, which would, in turn, protect investors and the public interest
by providing an avenue for options on IPO'd securities to come to
market earlier. The Exchange notes that the three-day look back period
helps ensure that options on underlying securities may be listed and
traded in a timely manner while also allowing time for OCC to
accommodate the certification request. However, there are certain large
IPOs that issue high-priced securities--well above the $3.00 per share
threshold--that would obviate the need for the three-day lookback
period. As noted above, NYSE American has reviewed trading data for
IPO'd securities dating back to 2017 and is unaware of an IPO'd
security with a market capitalization of $3 billion or more (based upon
the offering price of its IPO) that subsequently would have failed to
qualify for listing and trading as options under the three-day lookback
requirement. The Exchange believes that the proposed amendment, which
would be harmonized across options exchanges, would remove impediments
to and perfect the mechanism of a free and open market and a national
market system by providing an avenue for investors to hedge their
interest in IPO investments in a shorter amount of time than what is
currently permitted. The Exchange believes that options serve a
valuable tool to the trading community and help markets function
efficiently by mitigating risk. To that end, the Exchange believes that
the absence of options in the early days after an IPO may heighten
volatility to IPO'd securities.\15\
---------------------------------------------------------------------------

    \15\ See supra note 8.
---------------------------------------------------------------------------

    Further, as noted herein, the Exchange believes the proposed change
would allow options on IPO'd securities to come to market sooner (i.e.,
at least two business days post-IPO not inclusive of the day of the
IPO) without sacrificing investor protection. The Exchange represents
that trading in IPO'd securities--like all other securities traded on
the Exchange--is

subject to surveillances administered by the Exchange and to cross-
market surveillances administered by FINRA on behalf of the Exchange.
Those surveillances are designed to detect violations of Exchange rules
and applicable federal securities laws.\16\ The Exchange represents
that those surveillances are adequate to reasonably monitor Exchange
trading of IPO'd securities in all trading sessions and to reasonably
deter and detect violations of Exchange rules and federal securities
laws applicable to trading on the Exchange, including wrongful efforts
to manipulate the prices of those securities in order to bring them in
compliance with the $3.00/share threshold for the listing of options.
As such, the Exchange believes that its existing surveillance
technologies and procedures, coupled with NYSE American's findings
related to the IPOs reviewed as described herein, would adequately
address potential concerns regarding possible manipulation or price
stability.
---------------------------------------------------------------------------

    \16\ See supra note 10.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In this regard and as indicated
above, the Exchange notes that the rule change is being proposed as a
competitive response to a filing submitted by NYSE American that was
recently approved by the Commission.\17\ The Exchange anticipates that
the other options exchanges will adopt substantively similar proposals,
such that there would be no burden on intermarket competition from the
Exchange's proposal.
---------------------------------------------------------------------------

    \17\ See supra note 3.
---------------------------------------------------------------------------

    Accordingly, the proposed change is not meant to affect competition
among the options exchanges. For these reasons, the Exchange believes
that the proposed rule change reflects this competitive environment and
does not impose any undue burden on intermarket competition.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest, it has become
effective pursuant to section 19(b)(3)(A) of the Act \18\ and Rule 19b-
4(f)(6) \19\ thereunder.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \20\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
a waiver of the operative delay is consistent with the protection of
investors and the public interest because it will ensure fair
competition among the exchanges by allowing the Exchange to allow
options on IPO'd securities to come to market sooner (i.e., at least
two business days post-IPO not inclusive of the day of the IPO) without
sacrificing investor protection. The Commission believes that waiver of
the 30-day operative delay is consistent with the protection of
investors and the public interest because the proposed rule change does
not raise any new or novel issues. Accordingly, the Commission hereby
waives the 30-day operative delay and designates the proposed rule
change as operative upon filing.\22\
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    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-MIAX-2023-32 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-MIAX-2023-32. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. 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-MIAX-2023-32 and should be submitted on or before September 27,
2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19122 Filed 9-5-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7857-7858]
[FR Doc No: 2013-02375]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2013-0002-N-3]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Requirements (ICRs)
abstracted below have been forwarded to the Office of Management and
Budget (OMB) for review and comment. The ICRs describes the nature of
the information collection and their expected burden. The Federal
Register notice with a 60-day comment period soliciting comments on the
following collection of information was published on November 15, 2012.

DATES: Comments must be submitted on or before March 6, 2013.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave. SE., Mail Stop 17, Washington, DC
20590 (telephone:<PHONE_NUMBER>), or Ms. Kimberly Toone, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, Section 2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR Part
1320, require Federal agencies to issue two notices seeking public
comment on information collection activities before OMB may approve
paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1),
1320.12. On November 15, 2012, FRA published a 60-day notice in the
Federal Register soliciting comment on ICRs for which the agency was
seeking OMB approval. 77 FR 68203. FRA received one comment in response
to this notice.
    On January 9, 2013, the Association of American Railroads (AAR)
submitted a comment on behalf of itself and its member railroads. AAR
stated its opposition to the proposed renewal of OMB's approval of
FRA's requirement that rolling stock with glazing materials be
stenciled and noted that 49 CFR 223.17 and 49 CFR 223, Appendix A, set
forth FRA's glazing requirements. Section 223.17 requires the
stenciling of the walls of rolling stock as follows:

    Each locomotive, passenger car and caboose that is fully
equipped with glazing materials that meets the requirements of this
part shall be stenciled on an interior wall as follows:
    ``Fully Equipped FRA Part 223 glazing'' or similar words
conveying that meaning in letters at least \3/8\ inch high.

Appendix A requires more detailed information than section 223.17. It
provides the following:

c. Material Identification

    (1) Each individual unit of glazing material shall be
permanently marked, prior to installation, to indicate that this
type of material has been successfully tested as set forth in this
appendix and that marking shall be done in such a manner that it is
clearly visible after the material has been installed.
    (2) Each individual unit of a glazing material that has
successfully passed the Type I testing regimen shall be marked to
indicate:
    (i) ``FRA Type I'' material;
    (ii) the manufacturer of the material;
    (iii) the type or brand identification of the material.
    (3) Each individual unit of a glazing material that has
successfully passed the Type II testing regimen shall be marked to
indicate:
    (i) ``FRA Type II'' material;
    (ii) the manufacturer of the material;
    (iii) the type or brand identification of the material.

    AAR believes that, ``with glazing materials required to have
detailed information set forth in Appendix A, there is no reason to
require the information on the walls of rolling stock required by
section 223.17. Section 223.17 is simply superfluous.'' In its letter,
AAR pointed out that it filed a petition with FRA in 2004 to eliminate
the stenciling requirement under 49 CFR 223.17 and remarked:

    With more than eight years having elapsed since AAR filed its
petition, it is past the point in time when FRA should have acted to
eliminate the requirement to stencil rolling stock. OMB should deny
the request to approve this useless information collection
requirement.

    FRA fully acknowledges the issue that AAR raises in its January 9th
letter and in its earlier petition to FRA. For some time, FRA has
planned to address this issue through an agency rulemaking. However,
FRA cannot always proceed with a rulemaking as quickly as it or the
regulated community would like, even when the agency knows that a
current rule needs to be revised. The AAR well knows that the
rulemaking process is neither a fast nor a simple process. Myriad
points of view must be considered before the agency changes an existing
rule. To achieve its mission to promote and enforce all areas of rail
safety, FRA must prioritize its rulemaking agenda to address those
areas that will most greatly and directly impact rail safety. In that
regard, the current state of rail safety throughout the nation is a
prime consideration. Rail accidents and incidents that occur at any
given time and result in numerous injuries, fatalities, significant
property damage, or harm to nearby communities will demand urgent
agency action. Items on the agency regulatory agenda then will be moved
up or down depending on current rail events. Having said all the above,
FRA plans on revising its Safety Glazing Standards Rule (49 CFR Part
223) later this year. FRA will carefully review section 223.17 and
other requirements in this rule that are deemed unnecessary or
superfluous with the object of eliminating them. FRA asks AAR's
patience and asks OMB to approve this latest renewal information
collection submission with its current requirements for the maximum
time period while FRA works on completing its intended rulemaking
action.
    Before OMB decides whether to approve a proposed collection of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30 day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30 day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summary below describes the nature of the information
collection requirements (ICRs) and the expected burden, and are being
submitted for clearance by OMB as required by the PRA.

    Title: Certification of Glazing Materials.
    OMB Control Number: 2130-0525.
    Type of Request: Extension without change of a previously approved
information collection.
    Affected Public: 5 Manufacturers.
    Abstract: The collection of information is set forth under 49 CFR
Part 223, which requires the certification and permanent marking of
glazing materials by the manufacturer. The manufacturer is also
responsible for making available test verification data to railroads
and FRA upon request.
    Form Number(s): N/A
    Annual Estimated Burden Hours: 119 hours
    Title: Use of Locomotive Horns at Highway-Rail Grade Crossings
    Title: Disqualification Proceedings
    OMB Control Number: 2130-0529
    Type of Request: Extension without change of a previously approved
information collection
    Affected Public: 40,000 Locomotive Engineers
    Abstract: Under 49 U.S.C. 20111(c), FRA is authorized to issue
orders disqualifying railroad employees, including supervisors,
managers, and other agents, from performing safety-sensitive service in
the rail industry for violations of safety rules, regulations,
standards, orders, or laws evidencing unfitness. FRA's regulations, 49
CFR Part 209, Subpart D, implement the statutory provision by requiring
(i) a railroad employing or formerly employing a disqualified
individual to disclose the terms and conditions of a disqualification
order to the individual's new or prospective employing railroad; (ii) a
railroad considering employing an individual in a safety-sensitive
position to ask the individual's previous employing railroad whether
the individual is currently serving under a disqualification order; and
(iii) a disqualified individual to inform his new or prospective
employer of the disqualification order and provide a copy of the same.
Additionally, the regulations prohibit a railroad from employing a
person serving under a disqualification order to work in a safety-
sensitive position. This information serves to inform a railroad
whether an employee or prospective employee is currently disqualified
from performing safety-sensitive service based on the issuance of a
disqualification order by FRA. Furthermore, it prevents an individual
currently serving under a disqualification order from retaining and
obtaining employment in a safety-sensitive position in the rail
industry.
    Annual Estimated Burden Hours: 5 hours
    Addressee: Send comments regarding this information collection to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 Seventeenth Street, NW., Washington, DC, 20503,
Attention: FRA Desk Officer. Comments may also be sent electronically
via email to the Office of Information and Regulatory Affairs (OIRA) at
the following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; the accuracy of the Department's estimate of
the burden of the proposed information collection; ways to enhance the
quality, utility, and clarity of the information to be collected; and
ways to minimize the burden of the collection of information on
respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on January 29, 2013.
Rebecca Pennington,
Chief Financial Officer, Federal Railroad Administration.
[FR Doc. 2013-02375 Filed 2-1-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8665-8666]
[FR Doc No: 2015-03209]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2245]

Immediately in Effect Guidance Document: Classification and
Requirements for Laser Illuminated Projectors; Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Immediately in Effect Guidance
Document: Classification and Requirements for Laser Illuminated
Projectors (LIPs).'' This guidance describes FDA's policy with respect
to certain LIPs that comply with International Electrotechnical
Commission (IEC) standards during laser product classification under
the Electronic Product Radiation Control provisions of the Federal
Food, Drug and Cosmetic Act (the FD&C Act) that apply to electronic
products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment, submit
either electronic or written comments on the guidance by April 20,
2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Immediately in Effect Guidance Document: Classification and
Requirements for Laser Illuminated Projectors'' to the Office of the
Center Director, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Patrick Hintz, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4248, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Immediately in Effect Guidance Document:
Classification and Requirements for Laser Illuminated Projectors.''
This guidance is being issued consistent with FDA's good guidance
practices (GGPs) regulation (21 CFR 10.115). The guidance is being
implemented without prior public comment because the Agency has
determined that prior public participation is not feasible or
appropriate (21 CFR 10.115(g)(2)). The Agency made this determination
because the guidance presents a less burdensome policy consistent with
the public health. Although this guidance is immediately in effect, it
remains subject to comment in accordance with the Agency's GGPs
regulation. This guidance describes FDA's policy with respect to
certain LIPs that comply with IEC standards during laser product
classification under the Electronic Product Radiation Control
provisions of the FD&C Act that apply to electronic products. The
regulations for classifying laser products are set forth in part 1040
(21 CFR part 1040).
    For purposes of this guidance, the term ``laser illuminated
projector'' refers to a type of demonstration laser product regulated
under Sec.  1040.10(b)(13) that is designed to project full-frame
digital images. The term ``demonstration laser product'' is defined
under Sec.  1040.10(b)(13) to mean, ``Any laser product manufactured,
designed, intended, or promoted for purposes of demonstration,
entertainment, advertising display, or artistic composition.'' LIPs may
be used in locations such as indoor or outdoor cinema theaters, laser
shows, presentations at conventions, as image/data projectors in an
office setting, or in a home.
    Lasers are being used in LIPs as an alternative to conventional
lamps in

projectors. Although these LIPs emit laser light from extended sources
and their uncollimated beams do not present the same hazards as other
lasers, they are laser products that present risks and must undergo
classification in accordance with Sec.  1040.10(c).
    Under Sec.  1040.10(c), FDA recognizes four major hazard classes (I
to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb).
Under this classification procedure, higher laser classes correspond to
more powerful lasers and the potential to pose serious danger if used
improperly.
    As demonstration laser products, LIPs cannot exceed class IIIa
(which is comparable to IEC class 3R) emissions limits as specified in
Sec.  1040.11(c) unless granted a variance by FDA under Sec.  1010.4.
Many LIPs and applications for LIPs will exceed the class IIIa limits
and therefore require a variance to exceed those emission limits.
    This guidance document describes FDA's intent with regard to the
application of certain aspects of the performance standard requirements
in Sec.  1040.11(c) for LIPs. The IEC standards used to evaluate lamps
are applicable to characterizing ocular hazards in LIPs, because a
laser retinal hazard is related to the radiance of the laser source and
the radiant emission levels produced by LIPs are comparable to
conventional lamps. Because the radiant emission levels produced by
LIPs can scientifically be characterized by an alternative IEC
standard, FDA does not intend to consider whether LIP manufacturers
that conform to these standards under the situations described in this
guidance also comply with Sec. Sec.  1040.10(c) and 1040.11(c).

II. Significance of Guidance

    The guidance represents the Agency's current thinking on the
classifications and requirements for LIPs. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Immediately in Effect
Guidance Document: Classification and Requirements for Laser
Illuminated Projectors'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1400056 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 1002, 1010, and
1040 are approved under OMB control number 0910-0025.
    The labeling referenced in section (IV)(c)(ii) of the guidance does
not constitute a ``collection of information'' under the PRA because
the labeling is a ``public disclosure of information supplied by the
Federal Government to the recipient for the purpose of disclosure to
the public'' (5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03209 Filed 2-17-15; 8:45 am]
BILLING CODE 4164-01-P