[Federal Register Volume 86, Number 232 (Tuesday, December 7, 2021)]
[Notices]
[Pages 69308-69311]
[FR Doc No: 2021-26448]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93690; File No. SR-ICC-2021-023]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Proposed Rule Change Relating to the ICC Clearing Rules and
ICC Exercise Procedures

December 1, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934,\1\ and Rule 19b-4,\2\ notice is hereby given that on November 19,
2021, ICE Clear Credit LLC (``ICC'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I, II and III below, which Items have been prepared
primarily by ICC. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The principal purpose of the proposed rule change is to revise the
ICC Clearing Rules (``Rules'') and Exercise Procedures \3\ in
connection with the clearing of credit default index Swaptions (``Index
Swaptions'').\4\
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    \3\ Capitalized terms used but not defined herein have the
meanings specified in the Rules and Exercise Procedures.
    \4\ Index Swaptions are also referred to in ICC's policies and
procedures as ``index options'' or ``index CDS options'', or in
similar terms.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

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

(a) Purpose
    ICC proposes revising the ICC Rules and Exercise Procedures related
to the clearing of Index Swaptions.\5\ The proposed changes to the ICC
Rules and Exercise Procedures enhance the restructuring component of
iTraxx Index Swaptions and include other clarifications or updates,
including with respect to fallback measures in the Exercise Procedures.
ICC proposes to make the changes effective following Commission
approval of the proposed rule change. The proposed revisions are
described in detail as follows.
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    \5\ Pursuant to an Index Swaption, one party (the ``Swaption
Buyer'') has the right (but not the obligation) to cause the other
party (the ``Swaption Seller'') to enter into an index credit
default swap transaction at a pre-determined strike price on a
specified expiration date on specified terms. In the case of Index
Swaptions cleared by ICC, the underlying index credit default swap
is limited to certain CDX and iTraxx index credit default swaps that
are accepted for clearing by ICC, and which would be automatically
cleared by ICC upon exercise of the Index Swaption by the Swaption
Buyer in accordance with its terms.
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I. Rule Amendments
    The proposed amendments revise Rule 26R-319, which addresses
procedures for settlement of an exercised Index Swaption. ICC proposes
clarifications to Rule 26R-319(b), under which additional settlements
may be required. The proposed changes add a parenthetical with an
exception and specify that clause (i) regarding the settlement of
amounts owed is subject to

any modification with respect to fixed rate payments or accrual rebates
as specified by ICC Circular.
    ICC proposes to revise Rule 26R-319(c) to amend the restructuring
component of iTraxx Index Swaptions. Currently, the iTraxx Index
Swaption delivers a single name position in addition to the re-
versioned underlying index. For bilateral iTraxx Index Swaptions,
counterparties to Index Swaption contracts on the restructured single
name decide what the Index Swaption will deliver in the future if
exercised/assigned: Single name physical position, buyer triggered
auction cash payment, or seller triggered auction cash payment.
Following the changes, the cleared iTraxx Index Swaption would deliver
a blend of all three outcomes such that the cleared instrument would
more closely replicate the payout of the bilateral instrument.
    Namely, under the amendments, the blended deliverables apply for
iTraxx Index Swaption expiries on or after the auction settlement date,
such that the Index Swaption delivers a re-versioned underlying index
plus a blend of cash payment and single name. In subsection (c), ICC
proposes minor updates in introducing Existing Restructuring as a
defined term. Clause (ii) continues to discuss the Underlying New Trade
that comes into effect \6\ and includes a reference to new clause (v).
Clause (iii) would be amended and divided into two clauses. Amended
clause (iii) discusses the treatment of the Underlying New Trade
described in clause (ii) if the expiration date occurs prior to
commencement of the CEN Triggering Period (as defined in the
Restructuring Procedures) \7\ for the Existing Restructuring. New
clause (iv) discusses the treatment of the Underlying New Trade
described in clause (ii) if the expiration date occurs on or following
the commencement of such period but prior to the auction settlement
date.
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    \6\ An Underlying New Trade remains defined in Rule 26R-102 as a
new single name CDS trade that would arise upon exercise of an Index
Swaption where a relevant Restructuring Credit Event, if applicable,
has occurred with respect to a reference entity in the relevant
index.
    \7\ ICC Restructuring Procedures available at: https://www.theice.com/publicdocs/clear_credit/ICE_Clear_Credit_Restructuring_Procedures.pdf.
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    Proposed clause (v) sets out the framework for the blended
deliverables and would be applicable if the expiration date occurs on
or following the auction settlement date. The proposed language
requires ICC to (1) determine the extent to which positions in relevant
single name contracts of the relevant tenor referencing the reference
entity subject to the Existing Restructuring are settled; (2)
determine, if applicable, a cash settlement amount with respect to the
corresponding portion of the notional amount of the Index Swaption
applicable to such reference entity; and (3) with respect to the
remaining portion of such notional amount, an Underlying New Trade to
come into effect. Additional specifications with respect to the
Underlying New Trade and a reference to the Exercise Procedures or
other applicable procedures are included.

II. Exercise Procedures Amendments

    The Exercise Procedures supplement the provisions of Subchapter 26R
of the Rules with respect to Index Swaptions. The proposed amendments
define Minimum Intrinsic Value in paragraph 1 as a minimum intrinsic
value below which an Index Swaption position would not be identified as
``in the money'' for paragraph 2.2(e)(ii) or 2.8. ICC may establish a
Minimum Intrinsic Value and/or permit an exercising party to specify a
Minimum Intrinsic Value for its Index Swaptions for a relevant pre-
exercise notification period or exercise period. ICC would incorporate
this term in respect of fallback provisions described in paragraphs
2.2(e)(ii) and 2.8. Specifically, ICC would take into account any
applicable Minimum Intrinsic Value as part of its procedures for the
pre-exercise notification period (during which preliminary exercise
notices can be submitted, modified, and/or withdrawn) in paragraph
2.2(e)(ii) and for automatic exercise in paragraph 2.8. The proposed
changes further specify that an ``in the money'' determination will be
based on intrinsic value. In general, if intrinsic value is greater
than the Minimum Intrinsic Value, the position will be exercised.
    ICC proposes paragraph 3, which would apply in connection with Rule
26R-319(c)(v) where an Existing Restructuring has occurred with respect
to a reference entity underlying an exercised Index Swaption and the
Index Swaption expiration date occurs on or following the auction
settlement date. Paragraph 3 provisions may be modified or supplemented
pursuant to ICC Circular, as specified in paragraph 3.1.
    Paragraph 3.2 would set out the determination of settled portions.
The proposed changes define Relevant CDS Transactions as single name
contracts in the relevant reference entity cleared at ICC and such
others as ICC may specify by Circular. ICC would determine the portion
of the aggregate notional amount of Relevant CDS Transactions for which
an eligible party timely delivered a credit event notice (``Triggered
Portion'') and the portion as to which no such notice was timely
delivered (``Untriggered Portion''). With respect to the Triggered
Portion, paragraph 3.2 defines the Buyer and Seller Triggered Portions
as the portions for which the protection buyer or seller delivered
certain notices (i.e., prevailing credit event notice, prevailing
notice to exercise movement option). The portion for which a movement
option was applicable but for which neither protection buyer nor seller
delivered a notice to exercise would be the Unmoved Portion, and
together with the Untriggered Portion, the Untriggered/Unmoved Portion.
ICC may establish by Circular a threshold pertaining to the
Untriggered/Unmoved Portion under paragraph 3.2. This paragraph also
sets out how the Buyer Triggered, Seller Triggered and Untriggered/
Unmoved Portions are defined as percentages, namely the Buyer
Triggered, Seller Triggered, and Untriggered/Unmoved Percentages.
    Paragraph 3.3 would discuss settlement in respect of an exercised
Index Swaption to which Rule 26R-319(c)(v) applies. Subsection (a) sets
forth ICC's determination of the cash settlement amount owed pursuant
to Rule 26R-319(c)(v)(2). ICC would sum the settlement amounts in cash
applicable to the Buyer and Seller Triggered Portions, which would be
calculated based on the Relevant Notional Amount (i.e., the notional
amount under the Index Swaption applicable to such reference entity)
multiplied by the Buyer and Seller Triggered Percentages. The cash
settlement amount may be adjusted to take into account applicable fixed
payments and accrual rebates as specified by ICC Circular. Under
subsection (b), the notional amount of the Underlying New Trade
established under Rule 26R-319(c)(ii) and (v)(3) would be the Relevant
Notional Amount multiplied by the Untriggered/Unmoved Percentage.
(b) Statutory Basis
    ICC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act \8\ and the regulations
thereunder applicable to it, including the applicable standards under
Rule 17Ad-22.\9\ In particular, Section 17A(b)(3)(F) of the Act \10\
requires that the rule change be consistent with the prompt and
accurate clearance and settlement of securities

transactions and derivative agreements, contracts and transactions
cleared by ICC, the safeguarding of securities and funds in the custody
or control of ICC or for which it is responsible, and the protection of
investors and the public interest. ICC proposes changes to the Rules
and Exercise Procedures to support the clearing of Index Swaptions,
including to amend the restructuring component of iTraxx Index
Swaptions. Currently, the iTraxx Index Swaption delivers a single name
position in addition to the re-versioned underlying index. Under the
amendments, the blended deliverables apply for iTraxx Index Swaption
expiries on or after the auction settlement date, such that the Index
Swaption delivers a re-versioned underlying index plus a blend of cash
payment and single name. These changes enhance the restructuring
component such that the cleared instrument more closely replicates the
payout of bilateral instruments, which would provide additional
consistency to market participants. The additional clarifications or
updates ensure that the Rules and Exercise Procedures remain effective,
clear, and up-to-date. The changes clearly identify where ICC may
modify or supplement procedures by Circular. The amended Exercise
Procedures incorporate Minimum Intrinsic Value in respect of fallback
provisions in paragraphs 2.2(e)(ii) and 2.8. ICC believes that defining
this value would enhance the procedures to ensure that ICC's cleared
Index Swaptions are appropriately exercised. Moreover, the changes
continue to specify ICC's role in identifying ``in the money''
positions, taking into account Minimum Intrinsic Value, to ensure that
the processes associated with the pre-exercise notification period and
automatic exercise operate reliably. In ICC's view, the proposed rule
change will ensure that ICC's Rules and policies and procedures clearly
reflect the terms and conditions applicable to Index Swaptions and is
thus consistent with the prompt and accurate clearing and settlement of
the contracts cleared by ICC, including Index Swaptions, the
safeguarding of securities and funds in the custody or control of ICC
or for which it is responsible, and the protection of investors and the
public interest, within the meaning of Section 17A(b)(3)(F) of the
Act.\11\
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    \8\ 15 U.S.C. 78q-1.
    \9\ 17 CFR 240.17Ad-22.
    \10\ 15 U.S.C. 78q-1(b)(3)(F).
    \11\ Id.
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    The amendments would also satisfy relevant requirements of Rule
17Ad-22.\12\ Rule 17Ad-22(e)(1) \13\ requires each covered clearing
agency to establish, implement, maintain, and enforce written policies
and procedures reasonably designed to provide for a well-founded,
clear, transparent, and enforceable legal basis for each aspect of its
activities in all relevant jurisdictions. The proposed changes support
the clearing of Index Swaptions by ICC, including by enhancing the
restructuring component of iTraxx Index Swaptions and making other
clarifications or updates, to ensure that the Rules and Exercise
Procedures clearly and accurately reflect the requirements and
procedures applicable to iTraxx Index Swaptions and Index Swaptions
more generally. Moreover, the changes to the Rules and Exercise
Procedures clearly identify where ICC may modify or supplement
procedures by Circular. The proposed rule change would thus continue to
support the legal basis for ICC's clearance of Index Swaptions and
operation of the exercise and assignment process. As such, the proposed
rule change would satisfy the requirements of the Rule 17Ad-
22(e)(1).\14\
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    \12\ 17 CFR 240.17Ad-22.
    \13\ 17 CFR 240.17Ad-22(e)(1).
    \14\ Id.
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    Rule 17Ad-22(e)(10) \15\ requires each covered clearing agency to
establish, implement, maintain, and enforce written policies and
procedures reasonably designed to establish and maintain transparent
written standards that state its obligations with respect to the
delivery of physical instruments, and establish and maintain
operational practices that identify, monitor, and manage the risks
associated with such physical deliveries. The Rules continue to clearly
set out the procedures for settlement of Index Swaptions on exercise.
Under the amendments, the blended deliverables apply for iTraxx Index
Swaption expiries on or after the auction settlement date, such that
the Index Swaption delivers a re-versioned underlying index plus a
blend of cash payment and single name. Moreover, the amended Exercise
Procedures clearly set out procedures associated with the determination
of the cash settlement amount owed pursuant to Rule 26R-319(c)(v)(2)
and the notional amount of the Underlying New Trade established under
Rule 26R-319(c)(ii) and (v)(3). In ICC's view, the Rules and Exercise
Procedures continue to enable ICC to identify and manage the risks of
settlement of Index Swaptions on exercise. As such, the amendments
would satisfy the requirements of Rule 17Ad-22(e)(10).\16\
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    \15\ 17 CFR 240.17Ad-22(e)(10).
    \16\ Id.
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    Rule 17Ad-22(e)(17) \17\ requires, in relevant part, each covered
clearing agency to establish, implement, maintain, and enforce written
policies and procedures reasonably designed to manage its operational
risks by (i) identifying the plausible sources of operational risk,
both internal and external, and mitigating their impact through the use
of appropriate systems, policies, procedures, and controls; and (ii)
ensuring that systems have a high degree of security, resiliency,
operational reliability, and adequate, scalable capacity. The enhanced
restructuring component in Rule 26R-319 would avoid introducing
unnecessary complexity or operational risk, as the iTraxx Index
Swaption would deliver a re-versioned underlying index plus a blend of
cash payment and single name, and proposed paragraph 3 of the Exercise
Procedures would further set out associated procedures. Moreover, the
Exercise Procedures allow ICC to manage the operational risks
associated with the exercise and assignment process by establishing
procedures for the exercise and assignment of Index Swaptions and
including fallback measures, which help mitigate the impact from
operational or technical issues and ensure that the system has a high
degree of security, resiliency, operational reliability, and adequate,
scalable capacity. The amendments to the Exercise Procedures add
clarity by specifying a minimum intrinsic value below which an Index
Swaption position would not be identified as ``in the money'' in
respect the pre-exercise notification period and automatic exercise and
would further ensure that the processes associated with these fallback
measures operate reliably. ICC's procedures continue to be designed to
help mitigate the impact from technical issues to ensure that the
system has a high degree of security, resiliency, operational
reliability, and adequate, scalable capacity. The proposed rule change
is therefore reasonably designed to meet the requirements of Rule 17Ad-
22(e)(17).\18\
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    \17\ 17 CFR 240.17Ad-22(e)(17)(i) and(ii).
    \18\ Id.
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(B) Clearing Agency's Statement on Burden on Competition

    ICC does not believe the proposed amendments would have any impact,
or impose any burden, on competition not necessary or appropriate in
furtherance of the purpose of the Act. The proposed changes to the ICC
Rules and Exercise Procedures will apply uniformly across all market
participants. Therefore, ICC does not believe the proposed rule

change imposes any burden on competition not necessary or appropriate
in furtherance of the purpose of the Act.

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ICC-2021-023 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICC-2021-023. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filings will also be available for inspection
and copying at the principal office of ICE Clear Credit and on ICE
Clear Credit's website at https://www.theice.com/clear-credit/regulation. All comments received will be posted without change.
Persons submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICC-2021-023 and should be
submitted on or before December 28, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-26448 Filed 12-6-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Proposed Rules]
[Pages 48033-48034]
[FR Doc No: 2017-22255]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0413; FRL-9969-47-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; 2015 Ozone National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the state implementation plan (SIP) revision submitted by the State of
West Virginia for the purpose of updating the effective date by which
the State regulations incorporate by reference the national ambient air
quality standards (NAAQS), additional monitoring methods, and
additional equivalent monitoring methods. This update will effectively
add the following to the West Virginia SIP: The 2015 ozone NAAQS,
monitoring reference and equivalent methods pertaining to fine
particulate matter (PM2.5), carbon monoxide (CO), and course
particulate matter (PM10), and it will revise the ozone
monitoring season to March 1st through October 31st, the Federal
Reference Method (FRM), the Federal Equivalent Method (FEM), and the
Photochemical Assessment Monitoring Stations

(PAMS) network. The SIP revision will also change a reference from the
``West Virginia Department of Environmental Protection,'' to the
``Division of Air Quality.'' In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action,
no further activity is contemplated. If EPA receives adverse comments,
the direct final rule will be withdrawn and all public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time.

DATES: Comments must be received in writing by November 15, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2017-0413 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Schulingkamp,<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information on this rulemaking
action to approve West Virginia's SIP revisions to update of the
effective date by which the State regulations incorporate by reference
the Federal NAAQS, additional monitoring methods, and additional
equivalent monitoring methods, effectively adding the 2015 ozone NAAQS
and ambient air monitoring reference and equivalent methods pertaining
to PM2.5, PM10, and CO, and changing the
reference to the state air agency, please see the information provided
in the direct final action, with the same title, that is located in the
``Rules and Regulations'' section of this Federal Register publication.

    Dated: September 27, 2017.
Cecil Rodrigues,
Acting Regional Administrator, Region III.
[FR Doc. 2017-22255 Filed 10-13-17; 8:45 am]
BILLING CODE 6560-50-P


September 18, 2000

Mr. Michael Trutna

Senior Technical Advisor

Information Transfer and Program Integration Division

U.S. Environmental Protection Agency

Research Triangle Park, NC 27711

Re: EPA’s Operating Permits Program, White Paper Number 3, “Design
of Flexible Air Permits”

Dear Mr. Trutna:

The Electronic Industries AlIiance (EIA) greatly appreciates this
opportunity to provide the its comments on EPA’s draft Title V White
Paper Number 3, entitled "Design of Flexible Air Permits."  These
comments were prepared by EIA's Clean Air Working Group ("CAWG"), which
has the active participation of major U.S. electronics manufacturers.
EIA is the oldest and largest trade association representing the U.S.
electronics industry.  It is comprised of more than 2,100 member
companies that design, manufacture, distribute and sell electronic
parts, components and systems for consumer, commercial, industrial,
military and aerospace use.

	EIA’s CAWG  has been involved in a broad range of implementation and
flexibility issues under the Clean Air Act (“CAA”).  Our focus has
primarily been on ensuring the compatibility of CAA requirements with
the hundreds of routine process upgrades, advancements and innovations
that an electronics or other high technology manufacturer must undertake
each year to control costs, maintain quality, meet corporate pollution
prevention goals, and satisfy new regulatory requirements.  In
particular, regulatory flexibility -- as defined as the ability of our
industry to undertake these routine operational changes without
significant delay -- is critical to the industry’s global
competitiveness.

EIA’s CAWG has been working cooperatively with EPA in various
capacities to explore flexible permitting approaches, including through
the Agency-sponsored Pollution Prevention In Permits (“P4”) Pilot --
which has resulted in the first cap-type permit for an electronics
facility -- as well as by participating Title V operational flexibility
workshops. The draft White Paper goes a long way toward incorporating
the lessons learned in those and other EPA pilot projects into Agency
guidance.

EIA’s CAWG reiterates its support for EPA's publication of this White
Paper. Together with issuing a final New Source Review rule that
includes a workable Plantwide Applicability Limits (PAL) program,
publishing this White Paper will be a significant step toward converting
the lessons learned in many different reinvention pilot projects into
programmatic reality.

Publishing the White Paper also would be an important step in
implementing a commitment articulated in EPA's July 1999 "Aiming for
Excellence" report.  In that report, the Agency pledged to learn from
its various permitting pilots to "…increase permitting flexibility
while providing equal or better levels of environmental and public
health protection, provide incentives for pollution prevention, and
ensure public participation in permitting decisions."

EIA’s line-specific comments are included as our “Attachment 1.”
Although they are very similar to Intel’s line-specific comments, they
do vary in some instances.  CAWG’s general comments are as follows:

The white paper is well grounded in practical, real-world examples that
should help permitting authorities and sources follow the EPA's
guidance.  However, additional examples would be helpful.

The White Paper could be strengthened by including an introductory
section that outlines the benefits that flexible permitting approaches
can provide to the environment, stakeholders, and regulators.
Articulation of these benefits can and should be strengthened in the
body of the paper; however, a summary of these benefits in the
introduction would underscore EPA’s commitment to the flexible
permitting concept.  EIA’s CAWG concurs with the principal benefits of
these permitting approaches, as Intel articulated in its comments.

EIA’s CAWG appreciates the significant changes EPA has made to section
V.B

concerning Plantwide Applicability Limits (PALs). That section contains
a good discussion of pending Agency decisions regarding New Source
Review reform that may significantly affect how PALs will be treated in
the future.  However, on balance, EIA believes that this section should
be deleted pending issuance of the regulations governing PAL permits.
EIA members have extensive experience with PAL and Cap permitting and
believe that the policies expressed in the paper are inconsistent with
prior Agency policies and current law.  Moreover, the draft states that
any future PAL rule will ultimately govern these permits in any case so
the effectiveness of the guidance would be short-lived.  We believe that
the guidance will either be too short-lived to be useful or it will
pre-determine the outcome of critical issues in the rulemaking, neither
of which is a workable result.  We understand that EPA intends that the
White Paper not pre-judge these issues but cannot see, as a practical
matter, how that result could be achieved.  Accordingly, we request that
this section of the paper be deleted.

In summary, EIA supports the provisions contained in the White Paper,
which will go a long way toward making flexible permitting approaches a
reality for electronic manufacturing facilities that need operational
flexibility to meet market demands.  We are happy to provide any
additional input, or answer any further questions, as necessary or
appropriate.  Please feel free to contact me about these comments
(703-907-7576).

Sincerely,

Holly Evans

Director of Environmental Affairs

Deputy General Counsel

 PAGE   5

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[Federal Register: July 10, 2007 (Volume 72, Number 131)]
[Notices]
[Page 37551-37554]
[DOCID:fr10jy07-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55976; File No. SR-CBOE-2003-41]

Self-Regulatory Organizations; Chicago Board Options Exchange
Incorporated; Order Granting Approval of Proposed Rule Change as
Modified by Amendment No. 4 To List and Trade Options on Corporate Debt
Securities

June 28, 2007.

I. Introduction

    On September 22, 2003, the Chicago Board Options Exchange
Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'' or ``SEC''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to list and trade options
on corporate debt securities (``CDSOs''). On March 1, 2003, CBOE filed
Amendment No. 1 to the proposed rule change. CBOE filed Amendment No. 2
to the proposed rule change on August 24, 2005. CBOE filed Amendment
No. 3 to the proposed rule change on May 26, 2006. On June 13, 2006,
the proposed rule change, as amended by Amendment Nos. 1, 2, and 3, was
published in the Federal Register.\3\ CBOE filed Amendment No. 4 on
July 14, 2006.\4\ The Commission received one comment letter on the
proposal.\5\ On October 31, 2006, CBOE filed a response to the
comment.\6\ This order approves the proposed rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 53935 (June 2,
2006), 71 FR 34174.
    \4\ In Amendment No. 4, CBOE made minor technical changes to the
proposed rule text.
    \5\ See Letter from Mary C.M. Kuan, Vice President and Assistant
General Counsel, The Bond Market Association (``TBMA''), to Nancy M.
Morris, Secretary, Commission, dated August 25, 2006 (``TBMA
Letter'').
    \6 \ See Letter from Angelo Evangelou, Assistant Secretary,
CBOE, to Ronesha Butler, Special Counsel, Commission, dated October
25, 2006 (``Response'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

(a) Background

    Over-the-counter (``OTC'') transactions in corporate debt
securities are publicly reported through the NASD's Trade Reporting and
Compliance Engine (``TRACE'') system. CBOE believes that the enhanced
transparency created by TRACE has given rise to an OTC market in CDSOs,
and that an exchange-traded alternative for such products may provide a
useful risk management and trading vehicle for member firms and their
customers.
    CBOE believes that exchange-listed CDSOs would have three important
advantages over similar options traded in the OTC market. First, as a
result of greater standardization of contract terms, exchange-listed
contracts should develop more liquidity. Second, counterparty credit
risk would be mitigated because the contracts would be issued and
guaranteed by The Options Clearing Corporation (``OCC''). Finally, the
quotation and last-sale data provided by CBOE and its members would
lead to more transparent markets. CBOE believes that offering CDSOs
would create competition with the OTC market and expand the universe of
listed products available to interested market participants.

(b) Listing Standards

    The Exchange has proposed CBOE Rules 5.3.10 and 5.4.14 for the
initial listing and continued maintenance standards, respectively, for
CDSOs. The Exchange proposes that for initial listing, a CDSO must
satisfy the following criteria:
     The original public sale of a corporate debt security on
which options transactions will be effected on the Exchange shall be at
least a $250,000,000 principal amount.
     Trading volume (in all markets in which the underlying
corporate debt security is traded) has been at least $100,000,000 in
notional value over the preceding six months.
     The corporate debt security has a minimum aggregate par
value or ``float'' of $200,000,000.

     The corporate debt security has at least 320 holders.
     The issuer of the corporate debt security or the issuer's
parent, if the issuer is a wholly-owned subsidiary, has at least one
class of common or preferred equity securities registered under Section
12(b) of the Act.
     The equity securities issued by the corporate debt
security issuer are ``covered securities'' as defined under Section
18(b)(1)(A) of the Securities Act of 1933 (``1933 Act'').
     The corporate debt security on which options transactions
will be effected on the Exchange has a credit rating issued by Moody's
Investors Service that is Caa or higher and a credit rating issued by
Standard and Poor's that is CC or higher.
     The issuer of the corporate debt security has registered
the offer and sale of such securities under the 1933 Act.
     The transfer agent of the corporate debt security is
registered under Section 17A of the Act.
     The trust indenture for the corporate debt security is
qualified under the Trust Indenture Act of 1939.

(c) Settlement

    CDSOs will be physically settled, European-style options that may
be exercised only on the last day of expiration. Trading in CDSOs
ordinarily will cease on the business day (usually a Friday) preceding
the expiration date and the trading hours will be 8:30 a.m. to 3:02
p.m. Chicago time. The expiration date will be the Saturday immediately
following the third Friday of the expiration month. CBOE Rule 28.7
provides that there will be up to five expiration months, none further
out than 15 months, but the Exchange can list additional options
expiration further out than 15 months where a reasonably active
secondary market exists.
    The settlement process for CDSOs will be the same as the settlement
process for equity options under CBOE rules, with the exception of the
delivery process.\7\ Payment of a CDSO's exercise price will be
accompanied by payment of accrued interest on the underlying corporate
debt security from, but not including, the last interest payment date
to, and including, the exercise settlement date, as specified in OCC
rules. The Exchange will notify OCC of the accrued interest calculation
methodology that applies to each corporate debt security prior to the
listing of the particular CDSO.
---------------------------------------------------------------------------

    \7\ If the outstanding debt issuance amount of an underlying
corporate debt security is insufficient to satisfy the delivery
requirements under CBOE Rule 11.3, OCC rules provide for special
settlement exercise procedures.
---------------------------------------------------------------------------

(d) Minimum Price Variation and Strike Price Intervals

    The option premium will be quoted in points where each point equals
$1,000. The minimum tick will be 0.05 ($50.00). Series with strike
prices in, at, and out of the money initially will be listed (up to ten
per month initially). In addition, CBOE proposes to limit the strike
price intervals that can be used for CDSOs, which will be fixed at a
percentage of principal amounts (based on a par quote basis of $100) as
follows:
     0.5% ($0.50) or greater, provided that the series to be
listed is no more than 5% above or below the current market price of a
corporate debt security reported on TRACE during TRACE system hours or
effected on or through the facilities of a national securities
exchange, as applicable, on the day prior to the day the series is
first listed for trading;
     1.0% ($1.00) or greater, provided that the series to be
listed is no more than 10% above or below the current market price of a
corporate debt security reported on TRACE during TRACE system hours or
effected on or through the facilities of a national securities
exchange, as applicable, on the day prior to the day the series is
first listed for trading; and
     2.5% ($2.50) or greater, provided that the series to be
listed is greater than 10% above or below the current market price of a
corporate debt security reported on TRACE during TRACE system hours or
effected on or through facilities of a national securities exchange, as
applicable, on the day prior to the day the series is first listed for
trading.
    These increments are designed to allow the Exchange flexibility to
list options with strike increments at appropriate levels, while
diminishing any potential adverse effect on the Exchange's quote
capacity thresholds. CBOE believes that the operational capacity used
to accommodate the trading of CDSOs on the Exchange will have a
negligible effect on the total capacity used by the Exchange to trade
its products on a daily basis. The Exchange has represented that it
will delist a CDSO series for which there is no open interest.

(e) Position Limits

    CBOE proposes to establish tiered position limits for CDSOs based
on a policy to limit positions in such options to a quantity that, if
exercised, would not exceed 10% of the total float of the underlying
bond. CBOE believes the 10% level is sufficient to inhibit market
manipulation or to mitigate other possible disruptions in the market.
CBOE's lowest position limit for equity options is 13,500 contracts,
which, if exercised, would represent approximately 19.28% of the
minimum float of an equity security eligible to underlie a CBOE equity
option (seven million shares).\8\ Moreover, CBOE's 13,500 equity option
contract limit applies to those options having an underlying security
that does not meet the requirements for a higher option contract limit.
CBOE believes the 10% position limit for CDSOs, which is significantly
less than that for equity options, is sufficiently high to account for
the differences in liquidity between the equity and debt markets and
would consist of the following tiers:
---------------------------------------------------------------------------

    \8\ See CBOE Rule 4.11 (Position Limits).

------------------------------------------------------------------------
                                                               Position
                                                              limit for
               Float of underlying debt issue                    CDSO
                                                             (contracts)
------------------------------------------------------------------------
$200,000,000-$499,999,000..................................          200
500,000,000-749,999,000....................................          500
750,000,000-999,999,000....................................          750
1,000,000,000-2,499,999,000................................        1,000
2,500,000,000 and greater..................................        2,500
------------------------------------------------------------------------

    If a person holds more than 10% of a particular corporate debt
security, the amount held by such person would not be included in the
``total float'' for purposes of determining the applicable position
(and exercise) limits.\9\
---------------------------------------------------------------------------

    \9\ For example, if a person holds 14% of the total outstanding
issuance of a corporate debt security, the applicable position (and
exercise) limits would be based only on the remaining 86% of the
issuance that is not held by such person.
---------------------------------------------------------------------------

(f) Margin

    The margin (both initial and maintenance) for writing uncovered
puts or calls will be as follows:
     An option writer will be required to deposit and maintain
100% of the current market value of the option plus 10% of the
aggregate contract value minus the amount, if any, by which the option
is out of the money, subject to a minimum for calls equal to 100% of
the current market value of the option plus 5% of the aggregate
contract value for any options on corporate debt securities that are
rated investment-grade.\10\
---------------------------------------------------------------------------

    \10\ The definition of an investment-grade corporate debt
security is set forth in CBOE Rule 12.3(a)(15). The definition
mirrors the definition set forth in NASD rules pertaining to TRACE.
---------------------------------------------------------------------------

     For options on non-investment-grade \11\ corporate debt
securities, the margin requirement will be 100% of the

current market value of the option plus 15% of the aggregate contract
value minus the amount, if any, by which the option is out of the
money, subject to a minimum for calls equal to 100% of the current
market value of the option plus 10% of the aggregate contract value.
---------------------------------------------------------------------------

    \11\ The definition of a non-investment-grade corporate debt
security is set forth in CBOE Rule 12.3(a)(16). The definition
mirrors the definition set forth in the NASD rules pertaining to
TRACE.
---------------------------------------------------------------------------

     Writers of options on convertible corporate debt
securities will be required to deposit and maintain 100% of the current
market value of the option plus 20% of the aggregate contract value
minus the amount, if any, by which the option is out of the money,
subject to a minimum for calls equal to 100% of the current market
value of the option plus 10% of the aggregate contract value.
     In the case of puts for each of investment-grade, non-
investment-grade, and convertible corporate debt securities, the
minimum margin required will be 100% of the current market value of the
option plus 5%, 10%, and 10%, respectively, of the put exercise price.
    This methodology incorporates the same formula that the Exchange
applies to all other option classes in Chapter 12 of CBOE rules, but
with percentages that consider the specific market factors pertaining
to the debt rating and type of corporate debt security. For example,
the Exchange requires a deposit of 100% of the current market value of
the option plus a 20% initial/maintenance margin and a 10% minimum
margin. The Exchange would apply these initial/maintenance margin and
minimum margin requirements if a convertible debt security underlies a
CDSO. If an investment-grade corporate debt security underlies an
option, the Exchange would impose a 10% initial/maintenance margin and
a 5% minimum margin on the CDSO position because an investment-grade
corporate debt security generally experiences lower price movements and
lower volatility levels than stocks. CBOE proposes a 15% initial/
maintenance margin and a 5% minimum margin for CDSOs based on non-
investment-grade corporate debt securities because these securities
exhibit more price movements than investment-grade corporate debt
securities. The Exchange believes that these margin levels are
consistent with the Commission's Net Capital Rule \12\ for the
underlying corporate debt securities.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.15c3-1.
---------------------------------------------------------------------------

(g) Surveillance

    CBOE will implement a surveillance plan to monitor trading in
CDSOs. The surveillance plan will include, but not be limited to,
monitoring for insider trading, mini-manipulation, manipulation,
frontrunning, and capping and pegging. The Exchange will also monitor
the media for rating downgrades and other corporate actions to ensure
the Exchange's maintenance standards are fulfilled, and monitor for any
corporate actions that may influence the pricing of corporate debt
securities and options thereon.

(h) Information Bulletin

    CBOE will issue a circular to its members before the initiation of
trading in CDSOs that will describe the special characteristics of
CDSOs. This circular will highlight the exercise methodology of the
series, explain the cash adjustment procedures, identify the new
symbols for the CDSO series, and identify the initial expiration months
and strike prices available for trading.

(i) Trading Halts

    The Exchange proposes CBOE Rule 28.10 which would allow floor
officials to consider the following factors, in addition to those set
forth in CBOE Rule 6.3, in determining whether to halt trading in a
CDSO:
     Whether TRACE is inoperative; and
     whether the issuer or trustee, as applicable under the
agreements governing the underlying corporate debt security, provides
notification to holders of the corporate debt security that the
corporate debt security is to be redeemed in whole or part.

III. Summary of Comments and CBOE Response

    The Commission received one comment on the proposal. The commenter,
TBMA, generally supported the proposed rule change, but suggested
modifying it in certain respects. TBMA noted that the initial principal
amount for bonds underlying an option is typically $500 million in the
OTC market, and suggested that CBOE raise its threshold. CBOE responded
that the $250 million issue threshold gave the Exchange the flexibility
to list options on smaller issues that CBOE believed were actively
traded.
    Furthermore, TBMA believed that the float and trading volume
requirements may not be sufficiently high. TBMA also requested
additional information on how the initial and ongoing trading volume
and float would be determined by the Exchange. CBOE responded that the
float and trading volume requirements for its CDSOs should not be
significantly higher than for equities. Setting the listing criteria
too high for CDSOs could prevent the listing of options on corporate
debt securities where options could be listed on equities of the same
issuer. CBOE also stated that it will determine the initial $200
million float by looking at public information submitted by investors
who are required to report their holdings.
    TBMA claimed that differences exist between CBOE's proposed margin
requirements and other self-regulatory organizations (``SROs'').
Specifically, TBMA notes the differences in the definition of
``investment grade'' and the range of products eligible for portfolio
margining. CBOE, however, believed that its proposed margin levels are
appropriate. CBOE asserted that the definition of investment grade is
consistent with the definition of that term as used by other SROs, and
that CBOE's definition is more comprehensive. With respect to the range
of equity products available for portfolio margining, CBOE stated that
it supports the inclusion of fixed income products within the portfolio
margining regime and expects that CDSOs will be incorporated at a later
stage. CBOE noted that it would consider amending its margin rules at
that time.
    TBMA requested information on how CBOE would exclude 10% holders in
determining the total float amount. CBOE stated that the Exchange
anticipates using Bloomberg's ``HDS'' function to obtain this
information in a timely manner. CBOE added that the Exchange intends to
implement monitoring procedures to identify corporate actions on an
ongoing basis.
    TBMA claimed that the expiration date of CBOE's CDSOs differed from
the general practice of OTC options on corporate bonds, which typically
expire on the 20th of the relevant month. TBMA believed that this
difference could affect how CBOE's options were used to hedge OTC
options. CBOE stated that final trading on third Fridays allows
settlement on Saturdays and allows dovetailing of processing of equity
and bond options. CBOE noted that, while the 20th of the month may be
the standard settlement date for credit index derivatives, it is not
clear that this settlement date has been adopted for the less active
market for CDSOs. CBOE added that it would nevertheless consider
amending its rule to adopt this standard at a later time.
    TBMA suggested that CBOE work with the OCC to revise the Options
Disclosure Document (``ODD'') to accommodate CDSOs, and that the ODD be
made available for review and comment before approval of the proposal.
In order to accommodate the listing and trading of CDSOs, CBOE expects
that the OCC would amend its By-Laws and Rules to reflect CDSOs, which
would be subject to public

comment.\13\ In addition, the Exchange believes that the OCC would seek
to revise the ODD to incorporate CDSOs.\14\ Further, CBOE clarified
that the Exchange is working with OCC to develop procedures to address
actions including full and partial redemptions, conversions to
equities, bankruptcies, conversion to new series, and other actions.
According to CBOE, the OCC intends to use a major data vendor to
determine the market value of the underlying corporate debt securities
of CDSOs. The data vendor will view TRACE and several other price
reporting services to derive a composite price for each underlying
security on a daily basis.
---------------------------------------------------------------------------

    \13\ Telephone conversation between Jennifer L. Klebes, Senior
Attorney, CBOE and Marc McKayle, Special Counsel, Division of Market
Regulation, Commission, on June 28, 2007.
    \14\ See also Exchange Act Rule 9b-1(b)(2)(i) which requires the
relevant option market to file material changes to the ODD with the
Commission, if the ODD without such changes would become inaccurate,
incomplete, or misleading.
---------------------------------------------------------------------------

IV. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\15\ In particular, the Commission believes that
the proposed rule change is consistent with Section 6(b)(5) of the
Act,\16\ which requires 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 remove impediments to and perfect
the mechanism for a free and open market and a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \15\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \16\ 15 U.S.C. 78s(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the listing rules proposed by CBOE for
CDSOs are reasonable and consistent with the Act. The Commission notes
that, for a CDSO to be listed, the underlying corporate debt security
must, among other things, have substantial trading volume, initial
principal amount, and outstanding float; the issuer of the corporate
debt security must have at least one class of equity security
registered under Section 12(b) of the Act; and such equity securities
must satisfy the requirements for options trading on CBOE. These
requirements are reasonably designed to facilitate investors' access to
information that may be necessary to price a CDSO appropriately.
    The Commission believes that the proposed position limits and
margin rules for CDSOs are reasonable and consistent with the Act. The
proposed position limits reasonably balance the promotion of a free and
open market for these securities with minimization of incentives for
market manipulation and insider trading. The proposed margin rules are
reasonably designed to deter a member or its customer from assuming an
imprudent position in CDSOs.
    In support of the proposed rule change, the Exchange has made the
following representations:
    1. The Exchange has sufficient operational capacity to accommodate
the listing and trading of CDSOs.
    2. The Exchange's surveillance procedures are adequate to properly
monitor the trading of the CDSOs.
    3. The Exchange will inform its members in an Information Circular
of the special characteristics and risks associated with trading the
CDSOs.
    4. The Exchange will delist CDSO series for which there is no open
interest.
    This approval order is conditioned on the Exchange's adherence to
these representations.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\17\ that the proposed rule change (SR-CBOE-2003-41), as modified
by Amendment No. 4, be, and hereby is, approved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-13275 Filed 7-9-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44974-44976]
[FR Doc No: 2011-18925]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64940; File No. SR-BX-2011-036]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Increase
the Application and Annual Fees for the BX Venture Market

July 21, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 14, 2011, NASDAQ OMX BX, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been 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 proposes to modify the application and annual fees
payable by a company listing on the BX Venture Market. The Exchange
will implement the proposed rule immediately.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\3\
---------------------------------------------------------------------------

    \3\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://nasdaqomxbx.cchwallstreet.com.
---------------------------------------------------------------------------

5910. Listing Fees
(a) Application Fee
    A Company that submits an application to list any class of its
securities on the Exchange, shall pay to the Exchange a non-refundable
application fee of [$7,500] $10,000, which must be submitted with the
Company's application. However, if a Company is listed on another
national securities exchange and has received notice that it is subject
to being delisted from that exchange for failure to comply with a
quantitative listing requirement, the application fee does not have to
be paid to the Exchange until the other exchange issues a final
decision to delist the Company's securities or the Company is listed on
the Exchange, whichever occurs first.
(b) Annual Fee
    (1) Each issuer shall pay an annual fee of [$15,000] $20,000 for
the first class of securities listed on the Exchange and $5,000 for
each additional class of securities listed on the Exchange.
    (2)-(4) No change.
    (c)-(d) No change.
* * * * *

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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange recently received approval for the BX Venture Market,
a new listing venue for the Exchange. Under the approved rules, a
company that submits an application to list any class of its securities
on the BX Venture Market must pay a non-refundable application fee of
$7,500 \4\ and a listed company must pay an annual fee of $15,000 for
the first class of securities listed on the BX Venture Market and
$5,000 for each additional listed class of securities.\5\
---------------------------------------------------------------------------

    \4\ Exchange Rule 5910(a).
    \5\ Exchange Rule 5910(b).
---------------------------------------------------------------------------

    The listing fees for the BX Venture Market were originally proposed
in August 2010.\6\ Following that original proposal, and in connection
with seeking approval for the BX Venture Market, the Exchange committed
to substantial enhancements to its regulatory process.\7\ Among these
enhancements are rules requiring the Exchange to engage independent
qualified third party investigative firms to assist in its public
interest review process in specified situations and on a random
basis.\8\ The Exchange may also

engage independent qualified third party investigative firms in
reviewing listed companies in certain situations, including where there
may be potential public interest concerns.\9\ The Exchange has also
committed to enhanced surveillance of the trading of listed securities,
including by FINRA and through the use of technology by the SMARTS
Group.
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 62818 (September 1,
2010), 75 FR 54665 (September 8, 2010) (proposing SR-BX-2010-059).
    \7\ Securities Exchange Act Release No. 64437 (May 6, 2011), 76
FR 27710 (May 12, 2011) (approving SR-BX-2010-059 as amended).
    \8\ Exchange Rule 5205(d).
    \9\ Exchange Rule 5205(e).
---------------------------------------------------------------------------

    These enhancements were not envisioned when the Exchange originally
proposed the fees for the BX Venture Market and the fees were not
previously adjusted in response to these changes. As such, the Exchange
now proposes to increase the application fee for the BX Venture Market
from $7,500 to $10,000 and the annual fees for the first class of
securities from $15,000 to $20,000.
    The Exchange notes that the proposed fees remain substantially
lower than the fees for other markets. For example, the initial listing
fees for listing common stock on the NASDAQ Capital Market range from
$50,000 to $75,000 and the annual fees are $27,500; \10\ the initial
listing fees for listing common stock on NYSE Amex range from $50,000
to $70,000 and the annual fees range from $27,500 to $40,000; \11\ and
the initial listing fees for listing common stock on the New York Stock
Exchange range from $125,000 to $250,000 and the annual fees range from
$38,000 to $500,000.\12\
---------------------------------------------------------------------------

    \10\ Nasdaq Rule 5920(a)(1) and (c)(1)(A).
    \11\ NYSE Amex Listed Company Guide Sections 140 and 141.
    \12\ NYSE Listed Company Manual 902.03
---------------------------------------------------------------------------

    In addition, the fees remain comparable to those charged by OTC
Markets Group for companies to appear on its OTCQX tier. While OTC
Markets Group does not operate a national securities exchange, and does
not undertake a regulatory review similar to that required by the
Exchange's rules, it claims to have ``listings'' \13\ and charges a
$5,000 application fee and $15,000 annual fee for marketplace services
that it describes as ``formerly available only on a U.S. exchange.''
\14\
---------------------------------------------------------------------------

    \13\ http://www.otcqx.com/qx/otcqx/listing (June 15, 2011).
    \14\ http://www.otcqx.com/qx/otcqx/overview (June 15, 2011).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6 of the Act,\15\ in general, and with Section 6(b)(4) of the
Act,\16\ in particular, in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system which the
Exchange operates or controls. The proposed rule change, which
increases the application and annual fees to listed companies, proposes
a reasonable allocation of the Exchange's costs, as it will allow the
Exchange to recoup the costs of the additional regulatory steps the
Exchange has agreed to in connection with the BX Venture Market.
Moreover, the fees remain substantially lower than fees on other
national securities exchanges, and comparable to the fees for
OTCQX.\17\ In addition, the Exchange believes that the fees are
equitable, insomuch as they are charged to all companies that chose to
apply and list on the BX Venture Market; and reasonable, insomuch as
these companies will receive the benefits commensurate with a listing
on a national securities exchange, including heightened regulatory
oversight.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f.
    \16\ 15 U.S.C. 78f(b)(4).
    \17\ The Exchange notes that the fees charged by OTCQX have not
been filed with the Commission.
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change is
consistent with the provisions of Section 6(b)(5) of the Act \18\
because it is 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 facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
As noted above, the Exchange believes the proposed fee increases will
help allow it to recoup the costs of performing its regulatory
responsibilities. As such, the Exchange believes that the proposed rule
change promotes just and equitable principles of trade and removes
impediments to the mechanism of a free and open market and a national
market system.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\19\ 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.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2011-036 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2011-036. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and

printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
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. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2011-036 and should be
submitted on or before August 17, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-18925 Filed 7-26-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Page 19190]
[FR Doc No: 2016-07610]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1076]

Determination That PRONESTYL (Procainamide Hydrochloride)
Injectable and Other Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
    Application No.                   Drug name               Active  ingredient(s)       Strength(s)         Dosage form/route          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 007335.............  PRONESTYL..........................  Procainamide           100 milligrams (mg)/   Injectable; Injection  Apothecon
                                                               Hydrochloride.         milliliter (mL); 500                          Pharmaceuticals Pvt.
                                                                                mg/mL.                                        Ltd.
                                                                                250 mg; 375 mg; 500    Capsule; Oral........
                                                                                mg.
NDA 016020.............  SYMMETREL..........................  Amantadine             100 mg...............  Capsule; Oral........  Endo Pharmaceuticals
                                                               Hydrochloride.                                                       Inc.
NDA 018127.............  OVCON-35...........................  Ethinyl Estradiol;     0.035 mg; 0.4 mg.....  Tablet; Oral-21......  Warner Chilcott LLC.
                                                               Norethindrone.
NDA 018309.............  TOPICORT LP........................  Desoximetasone.......  0.05%................  Cream; Topical.......  Taro Pharmaceutical
                                                                                Industries Ltd.
NDA 021431.............  CAMPRAL............................  Acamprosate Calcium..  333 mg...............  Delayed-release        Forest Laboratories,
                                                                                Tablets; Oral.         Inc.
NDA 050195.............  OXACILLIN SODIUM...................  Oxacillin Sodium.....  Equivalent to (EQ)     Injectable; Injection  Apothecon
                                                                                250 mg base/vial; EQ                          Pharmaceuticals Pvt.
                                                                                500 mg base/vial; EQ                          Ltd.
                                                                                1 gram (g) base/
                                                                                vial; EQ 2 g base/
                                                                                vial; EQ 4 g base/
                                                                                vial.
ANDA 061334............  BACTOCILL..........................  Oxacillin Sodium.....  EQ 500 mg base/vial;   Injectable; Injection  GlaxoSmithKline
                                                                                EQ 1 g base/vial; EQ
                                                                                2 g base/vial; EQ 4
                                                                                g base/vial; EQ 10 g
                                                                                base/vial.
ANDA 075730............  THIOTEPA...........................  Thiotepa.............  15 mg/vial; 30 mg/     Injectable; Injection  Teva Parenteral
                                                                                vial.
ANDA 077612............  SULFAMETHOXAZOLE AND TRIMETHOPRIM..  Sulfamethoxazole;      200 mg/5 mL; 40 mg/5   Suspension; Oral.....  ANI Pharmaceuticals,
                                                               Trimethoprim.          mL.                                           Inc.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07610 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61388-61390]
[FR Doc No: 2018-25950]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA

announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website. The guidances identified in
this notice were developed using the process described in that
guidance.

DATES: Submit either electronic or written comments on the draft
guidance by January 28, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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 Dockets
Management Staff 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidances to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on October 10, 2018. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Amphetamine.
Atropine sulfate; Diphenoxylate hydrochloride.
Dichlorphenamide.
Doxepin hydrochloride.
Ertugliflozin.
Ertugliflozin; Metformin hydrochloride.
Ertugliflozin; sitagliptin phosphate.
Estradiol.
Latanoprostene bunod.
Letermovir (multiple Reference Listed Drugs).
Levothyroxine sodium.
Lifitegrast.
Macimorelin acetate.
Metoprolol succinate.
Netarsudil dimesylate.
Nitazoxanide.
Penicillamine.
Plecanatide.
Reserpine.
Ribociclib succinate.
Thiothixene.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acetaminophen; Butalbital; Caffeine (multiple Reference Listed Drugs).
Acetaminophen; Oxycodone HCl.
Adapalene (multiple Reference Listed Drugs).
Adapalene; Benzoyl peroxide (multiple Reference Listed Drugs).
Asenapine maleate.
Benzoyl peroxide; Clindamycin phosphate (multiple Reference Listed
 Drugs).
Benzoyl peroxide; Erythromycin (multiple Reference Listed Drugs).
Clindamycin phosphate (multiple Reference Listed Drugs).
Clindamycin phosphate; Tretinoin.
Dapsone (multiple Reference Listed Drugs).
Everolimus.
Isosorbide dinitrate.
Metaxalone.
Mycophenolic acid.
Nitazoxanide.
Sulfacetamide Sodium.
Sulfamethoxazole; Trimethoprim.
Sumatriptan.
Tazarotene (multiple Reference Listed Drugs).
Tretinoin (multiple Reference Listed Drugs and multiple .strengths).
Triamterene.
Zolmitriptan.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25950 Filed 11-28-18; 8:45 am]
BILLING CODE 4164-01-P