[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28860-28864]
[FR Doc No: 2019-13070]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86109; File No. SR-MIAX-2019-28]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

June 14, 2019.
    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 May 31, 2019, Miami International Securities Exchange LLC (``MIAX''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'') to waive certain non-transaction fees
applicable to Market Makers \3\ that trade solely in Proprietary
Products \4\ until September 30, 2019.
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    \3\ The term ``Market Makers'' refers to ``Lead Market Makers'',
``Primary Lead Market Makers'' and ``Registered Market Makers''
collectively. See Exchange Rule 100.
    \4\ The term ``Proprietary Product'' means a class of options
that is listed exclusively on the Exchange. See Exchange Rule 100.
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    While changes to the Fee Schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative on June 1, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/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
Background
    On October 12, 2018, the Exchange received approval from the
Commission to list and trade on the Exchange, options on the
SPIKES[supreg] Index, a new index that measures expected 30-day
volatility of the SPDR S&P 500 ETF Trust (commonly known and referred
to by its ticker symbol, ``SPY'').\5\ The Exchange adopted its initial
SPIKES transaction fees on February 15, 2019.\6\
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    \5\ See Securities Exchange Act Release No. 84417 (October 12,
2018), 83 FR 52865 (October 18, 2018) (SR-MIAX-2018-14) (Order
Granting Approval of a Proposed Rule Change by Miami International
Securities Exchange, LLC to List and Trade on the Exchange Options
on the SPIKES\TM\ Index).
    \6\ See Securities Exchange Release No. 85283 (March 11, 2019),
84 FR 9567 (March 15, 2019) (SR-MIAX-2019-11). (The Exchange
initially filed the proposal on February 15, 2019 (SR-MIAX-2019-04).
That filing was withdrawn and replaced with (SR-MIAX-2019-11)).
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Proposal
    The Exchange now proposes to amend its Fee Schedule to waive
certain non-transaction fees applicable to Market Makers that trade
solely in Proprietary Products (including options on the SPIKES Index)
until September 30, 2019. In particular, the Exchange proposes to amend
Section (1)(a)(xi) of the Fee Schedule to add a definition for
Proprietary Product. The Exchange also proposes to amend Sections
(3)(a), (3)(b), (4)(a), and (5)(d)(ii) of the Fee Schedule to adopt
language that the Exchange will waive Membership Application Fees,
monthly Market Maker Trading Permit Fees, Member Application
Programming Interface (``API'') Testing and Certification Fees, and
monthly MEI Port Fees (as defined below) that are assessed to Market
Makers that trade solely in Proprietary Products (including options on
SPIKES) until September 30, 2019.
Definition for Proprietary Product
    Exchange Rule 100 currently provides a definition for Proprietary
Product.\7\ The Exchange now proposes to amend Section (1)(a)(xi) of
the Fee Schedule to insert the symbol ``[xutri]'' immediately following
the SPIKES Simple and Complex Fees table, followed by the definition
for Proprietary Product. The Exchange also proposes to adopt text for
the symbol ``[xutri]'' explicitly stating that SPIKES is a Proprietary
Product. The purpose of this proposal is to clarify that SPIKES is a
Proprietary Product of MIAX and, together with the other proposed
changes, that the Exchange will waive certain non-transaction fees
applicable to Market Makers that trade solely in Proprietary Products
(including options on SPIKES), until September 30, 2019.
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    \7\ See supra note 4.
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Membership Application Fees
    MIAX currently assesses Membership fees for applications of
potential Members. MIAX assesses a one-time Membership Application Fee
on the earlier of (i) the date the applicant is certified in the
membership system, or (ii) once an application for MIAX membership is
finally denied. The one-time application fee is based upon the
applicant's status as either a Market Maker or an Electronic Exchange

Member (``EEM''). A Market Maker is assessed a one-time Membership
Application Fee of $3,000.00.
    MIAX proposes that the one-time Membership Application Fee of
$3,000.00 for Market Makers that trade solely in Proprietary Products
(including options on SPIKES) will be waived until September 30, 2019,
which the Exchange proposes to state in the Fee Schedule. The purpose
of this proposed change is provide an incentive for potential Market
Makers to submit membership applications, which should result in
increasing potential liquidity in MIAX Proprietary Products, including
options on SPIKES. Even though the Exchange is proposing to waive this
particular fee for Market Makers who will trade solely in Proprietary
Products until September 30, 2019, the overall structure of the fee is
outlined in the Fee Schedule so that there is general awareness that
the Exchange intends to assess such a fee after September 30, 2019.
Trading Permit Fees
    MIAX issues Trading Permits that confer the ability to transact on
the Exchange. MIAX Trading Permits are issued to Market Makers and
EEMs. Members receiving Trading Permits during a particular calendar
month are assessed monthly Trading Permit Fees as set forth in the Fee
Schedule. As it relates to Market Makers, MIAX currently assesses a
monthly Trading Permit Fee in any month the Market Maker is certified
in the membership system, is credentialed to use one or more MEI Ports
in the production environment and is assigned to quote in one or more
classes. MIAX assesses its Market Makers the monthly Market Maker
Trading Permit Fee based on the greatest number of classes listed on
MIAX that the MIAX Market Maker was assigned to quote in on any given
day within a calendar month and the applicable fee rate this is the
lesser of either the per class basis or percentage of total national
average daily volume measurements. A MIAX Market Maker is assessed a
monthly Trading Permit Fee according to the following table:

----------------------------------------------------------------------------------------------------------------
                                                          Market maker assignments (the lesser of the applicable
                                           Monthly MIAX                     measurements below)
         Type of trading permit           trading permit -------------------------------------------------------
                                                fee                                      % of national average
                                                                   Per class                 daily volume
----------------------------------------------------------------------------------------------------------------
Market Maker (includes RMM, LMM, PLMM)..       $7,000.00  Up to 10 Classes..........  Up to 20% of Classes by
                                               12,000.00  Up to 40 Classes..........   volume.
                                             * 17,000.00  Up to 100 Classes.........  Up to 35% of Classes by
                                             * 22,000.00  Over 100 Classes..........   volume.
                                                                                Up to 50% of Classes by
                                                                                volume.
                                                                                Over 50% of Classes by
                                                                                volume up to all Classes
                                                                                listed on MIAX.
----------------------------------------------------------------------------------------------------------------
* For these Monthly MIAX Trading Permit Fee levels, if the Market Maker's total monthly executed volume during
  the relevant month is less than 0.060% of the total monthly executed volume reported by OCC in the market
  maker account type for MIAX-listed option classes for that month, then the fee will be $15,500 instead of the
  fee otherwise applicable to such level.

    MIAX proposes that the monthly Trading Permit Fee for Market Makers
that trade solely in Proprietary Products (including options on SPIKES)
will be waived until September 30, 2019, which the Exchange proposes to
state in the Fee Schedule. The purpose of this proposed change is to
provide an incentive for Market Makers to provide liquidity in
Proprietary Products on the Exchange, which should result in increasing
potential order flow and volume in MIAX Proprietary Products, including
options on SPIKES. Even though the Exchange is proposing to waive this
particular fee for Market Makers trading solely in Proprietary Products
until September 30, 2019, the overall structure of the fee is outlined
in the Fee Schedule so that there is general awareness by potential
Members seeking a Trading Permit on the Exchange that the Exchange
intends to assess such a fee after September 30, 2019.
    The Exchange also proposes that Market Makers who trade MIAX
Proprietary Products (including options on SPIKES) along with multi-
listed classes will not have Proprietary Products (including SPIKES)
counted toward those Market Makers' class assignment count or
percentage of total national average daily volume. The Exchange
proposes to note this exclusion by inserting the new symbol ``[Omega]''
following the table that shows the monthly Trading Permit Fees
currently assessed for Market Makers in Section (3)(b) of the Fee
Schedule.
API Testing and Certification Fee
    MIAX assesses an Application Programming Interface (``API'')
Testing and Certification Fee on all Members depending upon the type of
Member. An API makes it possible for Members' software to communicate
with MIAX software applications, and is subject to Members testing
with, and certification by, MIAX. The Exchange offers four types of
interfaces: (i) The Financial Information Exchange (``FIX'') Port,
which enables the FIX Port user (typically an EEM or a Market Maker) to
submit simple and complex orders electronically to MIAX; (ii) the MIAX
Express Interface (``MEI'') Port, which enables Market Makers to submit
simple and complex electronic quotes to MIAX; (iii) the Clearing Trade
Drop (``CTD'') Port, which provides real-time trade clearing
information to the participants to a trade on MIAX and to the
participants' respective clearing firms; and (iv) the FIX Drop Copy
(``FXD'') Port, which provides a copy of real-time trade execution,
correction and cancellation information through a FIX Port to any
number of FIX Ports designated by an EEM to receive such messages.
    API Testing and Certification Fees for Market Makers are assessed
(i) initially per API for CTD and MEI in the month the Market Maker has
been credentialed to use one or more ports in the production
environment for the tested API and the Market Maker has been assigned
to quote in one or more classes, and (ii) each time a Market Maker
initiates a change to its system that requires testing and
certification. API Testing and Certification Fees will not be assessed
in situations where the Exchange initiates a mandatory change to the
Exchange's system that requires testing and certification. A Market
Maker is assessed an API Testing and Certification Fee of $2,500.00.
The fees represent costs incurred by the Exchange as it works with each
Member for testing and certifying that the Member's software systems
communicate properly with MIAX's interfaces.
    MIAX proposes that the API Testing and Certification Fee for Market
Makers that trade solely in Proprietary Products (including options on
SPIKES) will be waived until September 30, 2019, which the Exchange
proposes to state in the Fee Schedule. The purpose of this proposed
change is provide an incentive for potential Market Makers to develop

software applications to trade in MIAX Proprietary Products, including
options on SPIKES. Even though the Exchange is proposing to waive this
particular fee for Market Makers who will trade solely in Proprietary
Products until September 30, 2019, the overall structure of the fee is
outlined in the Fee Schedule so that there is general awareness that
the Exchange intends to assess such a fee after September 30, 2019.
MEI Port Fees
    MIAX provides four (4) Port types, including (i) the FIX Port,
which enables the FIX Port user (typically an EEM or a Market Maker) to
submit simple and complex orders electronically to MIAX; (ii) the MEI
Port, which enables Market Makers to submit simple and complex
electronic quotes to MIAX;; [sic] (iii) the CTD Port, which provides
real-time trade clearing information to the participants to a trade on
MIAX and to the participants' respective clearing firms; and (iv) the
FXD Port, which provides a copy of real-time trade execution,
correction and cancellation information through a FIX Port to any
number of FIX Ports designated by an EEM to receive such messages.
    MIAX assesses monthly MEI Port Fees on Market Makers in each month
the Member has been credentialed to use the MEI Port in the production
environment and has been assigned to quote in at least one class. The
amount of the monthly MEI Port Fee is based upon the number of classes
in which the Market Maker was assigned to quote on any given day within
the calendar month, and upon the class volume percentages set forth in
the above table. The class volume percentage is based on the total
national average daily volume in classes listed on MIAX in the prior
calendar quarter. Newly listed option classes are excluded from the
calculation of the monthly MEI Port Fee until the calendar quarter
following their listing, at which time the newly listed option classes
will be included in both the per class count and the percentage of
total national average daily volume. The Exchange assesses MIAX Market
Makers the monthly MEI Port Fee based on the greatest number of classes
listed on MIAX that the MIAX Market Maker was assigned to quote in on
any given day within a calendar month and the applicable fee rate that
is the lesser of either the per class basis or percentage of total
national average daily volume measurement. MIAX assesses MEI Port Fees
on Market Makers according to the following table:

------------------------------------------------------------------------
                                 Market maker assignments (the lesser of
                                   the applicable measurements below)
     Monthly MIAX MEI fees     -----------------------------------------
                                                   % of national average
                                    Per class           daily volume
------------------------------------------------------------------------
$5,000.00.....................  Up to 5 Classes..  Up to 10% of Classes
                                                    by volume.
$10,000.00....................  Up to 10 Classes.  Up to 20% of Classes
                                                    by volume.
$14,000.00....................  Up to 40 Classes.  Up to 35% of Classes
                                                    by volume.
$17,500.00 *..................  Up to 100 Classes  Up to 50% of Classes
                                                    by volume.
$20,500.00 *..................  Over 100 Classes.  Over 50% of Classes
                                                    by volume up to all
                                                    Classes listed on
                                                    MIAX.
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* For these Monthly MIAX MEI Fees levels, if the Market Maker's total
  monthly executed volume during the relevant month is less than 0.060%
  of the total monthly executed volume reported by OCC in the market
  maker account type for MIAX-listed option classes for that month, then
  the fee will be $14,500 instead of the fee otherwise applicable to
  such level.

    MIAX proposes that the monthly MEI Port Fee for Market Makers that
trade solely in Proprietary Products (including options on SPIKES) will
be waived until September 30, 2019, which the Exchange proposes to
state in the Fee Schedule. The purpose of this proposal is to provide
an incentive to Market Makers to connect to MIAX through the MEI Port
such that they will be able to trade in MIAX Proprietary Products. Even
though the Exchange is proposing to waive this particular fee for
Market Makers trading solely in Proprietary Products until September
30, 2019, the overall structure of the fee is outlined in the Fee
Schedule so that there is general awareness that the Exchange intends
to assess such a fee after September 30, 2019.
    The Exchange notes that for the purposes of this proposed change,
other Market Makers who trade MIAX Proprietary Products (including
options on SPIKES) along with multi-listed classes will not have
Proprietary Products (including SPIKES) counted toward those Market
Makers' class assignment count or percentage of total national average
daily volume. The Exchange proposes to note this exclusion by inserting
the new symbol ``[Omega]'' following the table that shows the monthly
MEI Port Fees currently assessed for Market Makers in Section
(5)(d)(ii) of the Fee Schedule.
    The proposed fee waivers are targeted at market participants,
particularly market makers, who are not currently members of MIAX, who
may be interested in being a Market Maker in Proprietary Products on
the Exchange. The Exchange estimates that there are fewer than ten (10)
such market participants that could benefit from these fee waivers. The
proposed fee waivers do not apply differently to different sizes of
market participants, however they do only apply to Market Makers (and
not EEMs). The Exchange believes it is reasonable to only offer fee
waivers to market makers because the Exchange is seeking additional
liquidity providers for Proprietary Products, in order to enhance
liquidity and spreads in Proprietary Products, which is traditionally
provided by Market Makers, as opposed to EEMs.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \8\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \9\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among its members and issuers and other persons using its facilities.
The Exchange also believes the proposal furthers the objectives of
Section 6(b)(5) of the Act in that it is designed to promote just and
equitable principles of trade, 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 and is not
designed to permit unfair discrimination between customers, issuers,
brokers and dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes the proposed fee waivers are reasonable and
equitable because they waive non-transaction fees for a limited period
of time in order to enable the Exchange to improve its overall
competitiveness and strengthen its market quality for all market
participants in MIAX's Proprietary Products, including options on
SPIKES.

The proposed fee waivers are fair and equitable and not unreasonably
discriminatory because they will apply equally to the market
participants not currently registered as Market Makers at the Exchange.
Any market participant may choose to satisfy the additional
requirements and obligations of being a Market Maker and trade solely
in Proprietary Products in order to qualify for the fee waivers.
    The Exchange believes that it is equitable and not unfairly
discriminatory to waive certain non-transaction fees for Market Makers
as compared to EEMs because Market Makers, unlike other market
participants, take on a number of obligations, including quoting
obligations that other market participants do not have. Further, Market
Makers have added market making and regulatory requirements, which
normally do not apply to other market participants. For example, Market
Makers have obligations to maintain continuous markets, engage in a
course of dealings reasonably calculated to contribute to the
maintenance of a fair and orderly market, and to not make bids or
offers or enter into transactions that are inconsistent with a course
of dealing.
    The Exchange believes it is reasonable and equitable to waive the
one-time Membership Application Fee, monthly Trading Permit Fee, API
Testing and Certification Fee, and monthly MEI Port Fee for Market
Makers that trade solely in Proprietary Products (including options on
SPIKES) until September 30, 2019, since the waiver of such fees
provides incentives to interested market participants to trade in
Proprietary Products. This should result in increasing potential order
flow and liquidity in MIAX Proprietary Products, including options on
SPIKES.
    MIAX believes it is reasonable and equitable to waive the API
Testing and Certification fee assessable to Market Makers that trade
solely in Proprietary Products (including options on SPIKES) since the
waiver of such fees provides incentives to interested Members to
develop and test their APIs sooner. Determining system operability with
the Exchange's system will in turn provide MIAX with potential order
flow and liquidity providers in Proprietary Products.
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory that Market Makers who trade in Proprietary Products
along with multi-listed classes will not have Proprietary Products
counted toward those Market Makers' class assignment count or
percentage of total national average daily volume for monthly Trading
Permit Fees and monthly MEI Port Fees in order to incentivize existing
Market Makers who currently trade in multi-listed classes to also trade
in Proprietary Products, without incurring certain additional fees.
    The Exchange believes that the proposed fee waivers constitute an
equitable allocation of reasonable fees and other charges among its
members and issuers and other persons using its facilities. The
proposed fee waivers are available to all prospective market makers
that wish to become Market Maker Members of the Exchange and quote
solely in Proprietary Products. The proposed fee waivers do not apply
to potential EEMs, because the Exchange is seeking to enhance the
quality of its markets in Proprietary Products through introducing more
competition among market makers in Proprietary Products. In order to
increase the competition, the Exchange believes that it must waive
entry type fees for such market makers. EEMs do not provide the benefit
of enhanced liquidity which is provided by market makers, therefore the
Exchange believes it is reasonable and not unfairly discriminatory to
only offer the proposed fee waivers to market makers (and not EEMs).
Further, the Exchange believes it is reasonable and not unfairly
discriminatory to exclude Proprietary Products from an existing Market
Maker's permit fees and port fees, in order to incentive such Market
Makers to quote in Proprietary Products. The amount of a Market Maker's
permit and port fee is determined by the number of classes quoted and
volume of the Market Maker. By excluding Proprietary Products from such
fees, the Exchange is able to incentivize Market Makers to quote in
Proprietary Products. EEMs do not pay permit and port fees based on the
classes traded or volume, so the Exchange believes it is reasonable,
equitable, and not unfairly discriminatory to only offer the exclusion
to market makers (and not EEMs).

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. The Exchange believes that the
proposed changes would increase intramarket competition by
incentivizing new potential market makers to quote in Proprietary
Products, which will enhance the quality of quoting and increase the
volume of contracts in Proprietary Products traded on MIAX. To the
extent that this purpose is achieved, all the Exchange's market
participants should benefit from the improved market liquidity for the
Exchange's Proprietary Products. Enhanced market quality and increased
transaction volume in Proprietary Products that results from the
anticipated increase in Market Maker activity on the Exchange will
benefit all market participants and improve competition on the
Exchange.
    The Exchange does not believe that the proposed rule change will
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed changes for each separate type of market participant (new
market makers and existing market makers) will be assessed equally to
all such market participants. While different fees are assessed to
different market participants in some circumstances, these different
market participants have different obligations and different
circumstances as discussed above. For example, Market Makers have
quoting obligations that other market participants (such as EEMs) do
not have.
    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
propose fee waivers relate solely to Proprietary Products, which are
traded exclusively on the Exchange.

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,\10\ and Rule 19b-4(f)(2) \11\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine

whether the proposed rule should be approved or disapproved.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2019-28 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-2019-28. 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 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. 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-MIAX-2019-28 and should be submitted on
or before July 11, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Vanessa A. Countryman,
Acting Secretary.
[FR Doc. 2019-13070 Filed 6-19-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 18, 2006 (Volume 71, Number 160)]
[Notices]
[Page 47854-47856]
[DOCID:fr18au06-137]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54305; File No. SR-OCC-2006-11]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Quarterly Options

 August 11, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on June 23, 2006, The Options
Clearing Corporation (``OCC'') 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 primarily by
OCC. OCC filed the proposed rule change pursuant to Section 19(b)(3)(A)
of the Act \2\ whereby the proposal was effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(ii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change would amend OCC's By-Laws and Rules to
accommodate ``quarterly options'' (i.e., a series of options or index
options that expires on the last business day of the calendar quarter)
which have been proposed for trading by the International Securities
Exchange (``ISE'').

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\3\
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    \3\ The Commission has modified parts of these statements.
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 (A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    Quarterly options in general have the same terms as conventional
options

except that (a) quarterly options expire on the last business day of a
calendar quarter and (b) all quarterly index options would be settled
based on the level of the underlying index at the close on the day of
exercise (``P.M. Settled'') rather than the level of the index at the
opening on that day (``A.M. Settled''). In addition, certain
modifications in exercise procedures are necessary to accommodate the
business day expiration of quarterly options.
    Because of concerns with quoting capacity, ISE filed and the
Commission has approved a proposed rule change that allows ISE to list
quarterly options under a pilot program that is limited both in
duration and in the number of classes of quarterly options that may
trade.\4\ Specifically, for an initial one-year period following the
first trade date (``Pilot Period'') ISE would list series of quarterly
options in (a) up to five options classes already listed on ISE that
are either (i) index options or (ii) options on exchange traded funds
and (b) options classes that are selected by any other exchanges that
list quarterly options under a similar pilot program. If ISE decides to
continue to list quarterly options at the end of the Pilot Period, ISE
would have to file an additional rule filing with the Commission as
well as a pilot program report analyzing a variety of data, including
the impact of the pilot program on the capacity of ISE, the Options
Price Reporting Authority, and market data vendors. If ISE decides to
cease listing quarterly options at the end of the Pilot Period or if
the Commission were to refuse to approve a rule change permitting
quarterly options to continue to trade, ISE would not list any
additional series and would permit only closing transactions in open
series.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release Nos. 53857 (June 1, 2006),
71 FR 31246 (May 24, 2006) and 54113 (July 7, 2006), 71 FR 39694
(July 13, 2006) [File No. SR-ISE-2006-24].
---------------------------------------------------------------------------

    ISE notes in its filing that there is a risk of confusion with
respect to quarterly options series and other options in the same
class. The risk of confusion is lessened with respect to conventional
options because those options cannot expire in the same week as
quarterly options. However, short term options, which are one-week
options that normally are listed on a Friday and expire on the next
following Friday, could expire on the same day as quarterly options. In
order to lessen the likelihood of confusion with respect to short term
options and quarterly options in the same class, ISE will not list a
series of short term options if that series would expire on the same
date as a series of quarterly options in the same class.\5\ Because of
their differing expiration dates, quarterly options are not be fungible
with conventional options or short term options.
---------------------------------------------------------------------------

    \5\ Supplementary Material .02(b) to ISE Rule 2009.
---------------------------------------------------------------------------

    Because quarterly options differ from conventional options and
short term options only in their expiration date, the P.M. settlement
feature of quarterly index options, and other modifications relating to
business day expiration, quarterly options can be cleared and settled
by OCC with relatively minor revisions to OCC's By-Laws and Rules. A
new defined term for ``quarterly options'' is added to Article I of the
By-Laws, and the definition of ``expiration date'' in that Article is
amended to clarify that quarterly options do not expire on the same
date as conventional options. Rules 801 and 805 are amended to include
quarterly options among the exceptions to the general rule that options
may not be exercised on the business day before their expiration date.
Rules 801 and 1804 are amended to provide for the automatic exercise of
quarterly index options when those options are in-the-money by a
specified amount. Finally, a reference in Article XVII to ``quarterly
index expiration options'' or ``QIX,'' which are no longer traded, has
been removed to avoid confusion. A conforming reference to short term
options has been added to Rule 801(b) to provide clarity that such
options on indexes are subject to automatic exercise, as presently
provided in Rule 1804(c).
    OCC believes that the proposed rule change is consistent with the
purposes and requirements of Section 17A of the Act because it is
designed to promote the prompt and accurate clearance and settlement of
securities transactions, to foster cooperation and coordination with
persons engaged in the clearance and settlement of securities
transactions, to remove impediments to and perfect the mechanism of a
national system for the prompt and accurate clearance and settlement of
securities transactions, and, in general, to protect investors and the
public interest. The proposed changes promote these objectives by
applying to quarterly options the same basic governing principles that
are applicable to other classes of options. The proposed changes are
not inconsistent with the existing By-Laws and rules of OCC, including
those proposed to be amended.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.

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

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change, and none have been 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)(iii) of the Act \6\ and Rule 19b-4(f)(4) \7\ promulgated
thereunder because the proposal effects a change in an existing service
of OCC that (A) does not adversely affect the safeguarding of
securities or funds in the custody or control of OCC or for which it is
responsible and (B) does not significantly affect the respective rights
or obligations of OCC or persons using the service. At any time within
sixty days of the filing of the proposed rule change, the Commission
may summarily abrogate 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.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

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-OCC-2006-11 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-OCC-2006-11. This
file

number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of OCC and on OCC's
Web site at http://www.optionsclearing.com.

    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-OCC-2006-11
and should be submitted on or before September 8, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-13617 Filed 8-17-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 41 (Monday, March 2, 2020)]
[Notices]
[Page 12287]
[FR Doc No: 2020-04214]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0039; FRL-10004-57]

Pesticide Product Registration; Receipt of Applications for a New
Active Ingredient (December 2019)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice
of receipt and opportunity to comment on these applications.

DATES: Comments must be received on or before April 1, 2020.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the File Symbol of interest as shown in
the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register pesticide products
containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the provisions of FIFRA
section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice
of receipt and opportunity to comment on these applications. Notice of
receipt of these applications does not imply a decision by the Agency
on these applications.

New Active Ingredients

    1. File Symbol: 71637-E. Docket ID number: EPA-HQ-OPP-2019-0410.
Applicant: Kwizda Agro GmbH (Val d`Iz[eacute]), ZA du Bourgneuf, Route
de Dourdain, 35450 Val d`Iz[eacute], France (c/o Compliance Services
International, 7501 Bridgeport Way West, Lakewood, WA 98499). Product
name: Trico. Active ingredient: Repellent--Sheep fat at 6.4%. Proposed
use: For preventing browsing, rubbing, and bark stripping damage to
certain plants (e.g., ornamentals, shrubs, and garden plants before
food commodities are present) caused by deer, rabbits, elk, and moose.
    2. File Symbol: 71637-R. Docket ID number: EPA-HQ-OPP-2019-0410.
Applicant: Kwizda Agro GmbH (Val d`Iz[eacute]), ZA du Bourgneuf, Route
de Dourdain, 35450 Val d`Iz[eacute], France (c/o Compliance Services
International, 7501 Bridgeport Way West, Lakewood, WA 98499). Product
name: Sheep Fat Technical. Active ingredient: Repellent--Sheep fat at
99.94%. Proposed use: For manufacturing use.

    Authority: 7 U.S.C. 136 et seq.

    Dated: January 24, 2020.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2020-04214 Filed 2-28-20; 8:45 am]
 BILLING CODE 6560-50-P


Explanation of the Source Data for this Screening Level Usage Analysis
(SLUA)

Quinclorac (128974)

Date:  05-29-2007

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active
ingredient that is used on agricultural crops in the United States.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used
on.

Available pesticide usage information (i.e., does not include all of the
United States).

Annual percent of crop treated (average & maximum) for each agricultural
crop.

Average annual pounds of the pesticide applied for each agricultural
crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by
merging pesticide usage data sources together; averaging by year,
averaging across all years, & then rounding.  Note:  If the estimated
value is less than 500, then that value is labeled <500.  Estimated
values between 500 & <1,000,000 are rounded to 1 significant digit.
Estimated values of 1,000,000 or greater are rounded to 2 significant
digits.)

Average percent of crop treated - Values are calculated by merging data
sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5.  Note:  If the estimated value is
less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5.  Note:  If the estimated value is less than 2.5,
then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National
Agricultural Statistics Service) – pesticide usage data from 1999 to
2005.

Private Pesticide Market Research – pesticide usage data from 1999 to
2005.

NCFAP 97 (National Center for Food and Agricultural Policy), and NPUD
2002 (National Pesticide Use Database) – insecticide usage data from
NCFAP 97, and fungicide and herbicide usage data from NPUD 02, of the
CropLife Foundation,  are used only if data are not available from the
other sources.

California DPR data can be requested separately.

What are the data limitations?

Additional registered uses may exist but are not included because either
the available surveys do not report usage (e.g., small acreage crops) or
these uses are not covered in the available surveys.

Lack of reported usage data for the pesticide on a crop does not imply
zero usage.

Usage data on a particular site may be noted in data sources, but not
quantified.  In these instances, the site would not be reported in the
SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control,
etc.) are not reported in the SLUA.  A separate request must be made to
receive these estimates.

Some sites show some use, even though they are not on the label.  This
usage could be due to Section 18 requests, existing stocks of the
chemical, data collection errors, experimental use permit (EUP), and/or
because of an illegal use.

Who do I contact for further information and/or questions on this SLUA?

Analyst:  Arthur H. Grube (Phone number:<PHONE_NUMBER>)

Jihad A. Alsadek (Phone number:<PHONE_NUMBER>)

May 23, 2007

Screening Level Estimates of Agricultural Uses of QUINCLORAC 128974

Sorted Alphabetically

	  	Crop					Lbs. A.I.			Percent Crop Ttd.

	  	 									Avg.		Max.

	1 	Corn	1,000	<1                 <2.5

	2 	Fallow, Summer	1,000	<1                 <2.5

	3 	Rice	300,000	30                  35

	4 	Sorghum	10,000	<1                 <2.5

	5 	Wheat	1,000	<1                 <2.5

______________________________________

All numbers rounded.

'<500' indicates less than 500 pounds of active ingredient.

'<2.5' indicates less than 2.5 percent of crop is treated.

'<1' indicates less than 1 percent of crop is treated.

** California data only. No information available about use of this
chemical on this crop in other states.

SLUA data sources include:

	USDA-NASS (United States Department of Agriculture's

	National Agricultural Statistics Service); 2000-2006

	Private Pesticide Market Research, 2000-2006

	NPUD 2002 (National Pesticide Use Database) of the CropLife America
Foundation

	and California DPR data.

	These results reflect merged data developed

	by the Agency and are releasable to the public.

 PAGE

 PAGE   - 1 -

Form was last revised on May, 29, 2007.


[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72063-72064]
[DOCID:fr26no08-85]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Sex Differences in the Cardiovascular Device Trials; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Sex Differences in the Cardiovascular Device
Trials.'' FDA is co-sponsoring the conference with the Advanced Medical
Technology Association (AdvaMed). The purpose of the workshop is to
facilitate discussion between FDA and other interested parties on the
study and analysis of sex and gender differences in cardiovascular
medical device trials, in anticipation of issuance of draft guidance on
this subject.

DATES: The workshop will be held on December 9, 2008, from 9 a.m. to 5
p.m. Participants are encouraged to arrive early to ensure time for
parking and security screening before the meeting. Security screening
will begin at 8 a.m. and reception will begin at 8:30 a.m. Please
register by December 2, 2008, using the instructions in this document.
Non-U.S. citizens are subject to additional security screening and
should register as soon as possible.

ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., rm. 230D,<PHONE_NUMBER>,
Rockville, MD 20850<EMAIL_ADDRESS>or
    Ashley Boam, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., rm. 230J, 240-276-
4188, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion
between FDA and other interested parties on the study and analysis of
sex and gender differences in cardiovascular medical device trials, in
anticipation of issuance of draft guidance on this subject.

II. What Are the Topics We Intend to Address at the Public Workshop?

    We hope to discuss a large number of issues at the public workshop,
including, but not limited to:
     Current FDA perspective on sex/gender differences in
pharmaceutical and medical device evaluation.
     Medical device development in the U.S. regulatory
environment.
     Sex/gender-specific considerations in product design and
clinical study design.
     The current state of cardiovascular treatment for women.
     Referral biases for women at risk for cardiovascular
disease.
     The Clinical Research Organization and Institutional
Review Board perspectives on inclusion, exclusion, recruitment, and
retention issues related to women in clinical trials.
     The investigator/clinician perspective on the impact of
sex/gender-specific issues on study design and conduct and available
treatment options and limitations of use in women.
     The female patient perspective on enrollment and
participation in clinical trials.
     The biostatistician perspective on statistical approaches
and subgroup analysis in significant subpopulations.
     Case studies on gender-specific trials.

III. Is There a Fee and How Do I Register for the Public Workshop?

    There is a modest fee to attend the conference to defray the costs
of meals provided and other expenses. The fee for the meeting for
registrants from industry is $125.00, and the fee for government
registrants is $75.00. Fees will be waived for invited speakers and
panelists. The registration process will be handled by AdvaMed, which
has extensive experience in planning, executing, and organizing
educational meetings. Register online at http://www.AdvaMed.org.
Although the

facility is spacious, registration will be on a first-come, first-
served basis. Non-U.S. citizens are subject to additional security
screening, and should register as soon as possible.
    If you need special accommodations because of a disability, please
contact Kathryn O'Callaghan at least 7 days before the public workshop.

IV. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.AdvaMed.org and http://www.fda.gov/cdrh/dsma/workshop.html.

    Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28169 Filed 11-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12374-12375]
[FR Doc No: 2023-03949]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0073]

Neovascular Age-Related Macular Degeneration: Developing Drugs
for Treatment; Draft Guidance 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 a draft guidance for industry entitled
``Neovascular Age-Related Macular Degeneration: Developing Drugs for
Treatment.'' This guidance is intended to provide recommendations to
sponsors developing drugs intended to treat neovascular age-related
macular degeneration focusing on eligibility criteria, trial design
considerations, and efficacy endpoints to enhance clinical trial data
quality and to foster greater efficiency in development programs.

DATES: Submit either electronic or written comments on the draft
guidance by May 30, 2023 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-2022-D-0073 for ``Neovascular Age Related Macular Degeneration:
Developing Drugs for Treatment.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    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 guidance 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; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, 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 document.

FOR FURTHER INFORMATION CONTACT: Wiley A. Chambers, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6108, Silver Spring, MD 20993, 301-796-
0690; or Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Neovascular Age-Related Macular Degeneration: Developing
Drugs for Treatment.'' This draft guidance document, once finalized,
will foster greater efficiency in development programs for drugs
intended to treat neovascular age-related macular degeneration.
    This draft guidance is being issued consistent with FDA's good
guidance

practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Neovascular
Age-Related Macular Degeneration: Developing Drugs for Treatment.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 pertaining to the submission of
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 pertaining to the submission of new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 601 pertaining to biologics license
applications have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03949 Filed 2-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Rules and Regulations]
[Pages 42683-42685]
[FR Doc No: 2014-17243]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2014-0333; FRL-9914-11-OAR]

Approval and Promulgation of Implementation Plans; Washington:
Infrastructure Requirements for the 2008 Lead National Ambient Air
Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is partially approving and partially disapproving the
State Implementation Plan (SIP) submittal from the State of Washington
(Washington or the State) demonstrating that the SIP meets the
infrastructure requirements of the Clean Air Act (CAA) for the National
Ambient Air Quality Standards (NAAQS) promulgated for lead on October
15, 2008. The CAA requires that each state, after a new or revised
NAAQS is promulgated, review their SIP to ensure that it meets the
infrastructure requirements necessary to implement the new or revised
NAAQS. On April 14, 2014, Washington certified that the Washington SIP
meets the infrastructure requirements of the CAA for purposes of the
2008 lead NAAQS, except for those requirements related to the
Prevention of Significant Deterioration (PSD) permitting program
currently operated under a Federal Implementation Plan (FIP). The EPA
has determined that Washington's 2008 lead SIP is adequate for purposes
of the infrastructure SIP requirements of CAA section 110, with the
exception of the requirements related to PSD permitting and portions of
the interstate transport requirements. The EPA finds that the SIP
deficiencies related to PSD permitting, however, have been adequately
addressed by the existing EPA FIP and, therefore, no further action is
required by Washington or the EPA. The EPA will address the remaining
interstate transport requirements in a separate action.

DATES: This final rule is effective on August 22, 2014.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification No. EPA-R10-OAR-2014-0333. All documents in the
docket are listed on the http://www.regulations.gov Web site. Although
listed in the index, some information may not be publicly available,
i.e., Confidential Business Information or other information the
disclosure of which is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy at EPA Region 10, Office of Air,
Waste, and Toxics, AWT-107, 1200 Sixth Avenue, Seattle, Washington
98101. The EPA requests that you contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to schedule your inspection. The
Regional Office's official hours of business are Monday through Friday,
8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

Table of Contents

I. Background
II. Final Action
III. Statutory and Executive Order Reviews

I. Background

    On April 14, 2014, Washington submitted a certification that the
State SIP meets the requirements of CAA sections 110(a)(1) and (2) for
the 2008 lead NAAQS, except for the requirements related to PSD
permitting and portions of the interstate transport requirements. On
May 14, 2014, The EPA proposed to partially approve and partially
disapprove the submittal (79 FR 27533). An explanation of the CAA
requirements and implementing regulations that are met by this SIP
submittal, a detailed explanation of the revision, and the EPA's
reasons for approving it were provided in the notice of proposed
rulemaking, and will not be restated here. The public comment period
for this proposed rule ended on June 13, 2014. We did not receive any
comments on the proposal.

II. Final Action

    The EPA is partially approving the April 14, 2014, submittal from
Washington to demonstrate that the SIP meets the requirements of
sections 110(a)(1) and (2) of the CAA for the lead NAAQS promulgated on
October 15, 2008, except for the requirements related to PSD permitting
and portions of the interstate transport requirements as discussed in
the proposed rulemaking for this action. Specifically, we have
determined that the current EPA-approved Washington SIP meets the
following CAA section 110(a)(2) infrastructure elements for the 2008
lead NAAQS: (A), (B), (C)--except for those elements covered by the PSD
FIP, (D)(i)(II)--except for those elements covered by the PSD FIP,
(D)(ii)--except for those elements covered by the PSD FIP, (E), (F),
(G), (H), (J)--except for those elements covered by the PSD FIP, (K),
(L), and (M). As noted in the proposed rulemaking, the EPA anticipates
that there would be no adverse consequences to Washington or to sources
in the State resulting from this partial disapproval of the
infrastructure SIP related to PSD. The EPA, likewise, has no additional
FIP responsibilities as a result of this partial disapproval for
requirements related to PSD. Remaining interstate transport
requirements under CAA section 110(a)(2)(D)(i)(I) for the 2008 lead
NAAQS will be addressed in a separate action.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501, et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601, et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because it will not impose substantial direct costs on tribal
governments or preempt tribal law. The SIP is not approved to apply in
Indian country located in the state, except for non-trust land within
the exterior boundaries of the Puyallup Indian Reservation, also known
as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement
Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and
local agencies in Washington authority over activities on non-trust
lands within the 1873 Survey Area and the EPA is therefore approving
this SIP on such lands. Consistent with EPA policy, the EPA nonetheless
provided a consultation opportunity to the Puyallup Tribe in a letter
dated September 3, 2013. The EPA did not receive a request for
consultation.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 22, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Carbon monoxide, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Sulfur dioxide, Reporting and
recordkeeping requirements.

    Dated: July 7, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart WW--Washington

0
2. In Sec.  52.2470, paragraph (e) is amended by adding the entry
``110(a)(2) Infrastructure Requirements--2008 Lead Standard'' to Table
2--ATTAINMENT, MAINTENANCE, AND OTHER PLANS under the heading
``110(a)(2) Infrastructure and Interstate Transport'' after the entry
for ``110(a)(2) Infrastructure Requirements--1997 ozone standard'' to
read as follows:

Sec.  52.2470  Identification of plan.

* * * * *
    (e) * * *

                                                    Table 2--Attainment, Maintenance, and Other Plans
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                                       Applicable geographic or   State submittal
        Name of SIP provision             nonattainment area           date              EPA approval date                       Comments
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                                                    110(a)(2) Infrastructure and Interstate Transport
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                                                                      * * * * * * *
110(a)(2) Infrastructure               Statewide...............           4/14/14  7/23/14 [Insert Federal        This action addresses the following
 Requirements--2008 Lead Standard.                                                  Register citation].            CAA elements: 110(a)(2)(A), (B), (C),
                                                                                (D)(i)(II), (D)(ii), (E), (F), (G),
                                                                                (H), (J), (K), (L), and (M).

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[FR Doc. 2014-17243 Filed 7-22-14; 8:45 am]
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