[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Notices]
[Page 65193-65195]
[DOCID:fr09de09-117]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61106; File No. SR-NYSEAmex-2009-74]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the Penny
Pilot Through December 31, 2010

December 3, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on October 26, 2009, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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. 78a.
    \3\ 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 proposes to amend its option trading rules to (i)
extend the Penny Pilot in options classes in certain issues (``Pilot
Program'') previously approved by the Securities and Exchange
Commission (``Commission'') through December 31, 2010; and (ii) expand
the number of issues included in the Pilot. The text of the proposed
rule change is attached as Exhibit 5 to the 19b-4 form. A copy of this
filing is available on the Exchange's Web site at http://www.nyse.com,
at the Exchange'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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange hereby proposes to extend the time period of the Pilot
Program \4\ which is currently scheduled to expire on October 31, 2009,
through December 31, 2010. Moreover, the Exchange proposes the
following changes to its Penny Pilot Program which are consistent with
recent changes to the NYSE Arca Penny Pilot Program.\5\
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    \4\ See Securities Exchange Act Release No. 34-55162 (January
24, 2007), 72 FR 4738 (February 1, 2007); Securities Exchange Act
Release No. 34-56567 (September 27, 2007), 72 FR 56396 (October 3,
2007).
    \5\ See Securities Exchange Act Release No. 60711 (September 23,
2009), 74 FR 49419 (September 28, 2009) (Order Granting Partial
Accelerated Approval of a Proposed Rule Change, as Modified by
Amendment Nos. 1 and 3 Thereto, Amending NYSE Arca Rule 6.72 and
Expanding the Penny Pilot Program); see also Securities Exchange Act
Release No. 60833 (October 16, 2009), 74 FR 54617 (October 22, 2009)
(notice of filing and immediate effectiveness of SR-NYSEArca-2009-
91).
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    Top 300:
    The Exchange also proposes to expand the number of issues included
in the Pilot Program. Specifically, NYSE Amex proposes to add the top
300 most actively traded multiply listed options classes that are not
yet included in the Pilot Program (``Top 300''). The Exchange proposes
to determine the identity of the Top 300 based on national average
daily volume over a six month period preceding their addition to the
Pilot Program, as set forth below.\6\ In determining the identity of
the Top 300, the Exchange will exclude options classes with high
premiums. Pursuant to Commentary .02 to NYSE Amex Rule 960NY, the Pilot
Program issues will be announced to the Exchange's membership via
Regulatory Bulletin and published by the Exchange on its Web site.\7\
This will bring the total number of options classes traded pursuant to
the Pilot Program to 363. NYSE Amex represents that the Exchange has
the necessary system capacity to support any additional series listed
as part of the Pilot Program.
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    \6\ The Exchange will not include options classes in which the
issuer of the underlying security is subject to an announced merger
or is in the process of being acquired by another company, or if the
issuer is in bankruptcy. For purposes of assessing national average
daily volume, the Exchange will use data compiled and disseminated
by the Options Clearing Corporation.
    \7\ The Exchange shall also identify the classes to be added to
the Pilot Program, per each phase, in a filing with the Commission.
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    NYSE Amex believes that it is appropriate to exclude high priced
underlying securities, as the benefit to the public from including such
issues is minimal because of the high price of at-the-money options.\8\
The Exchange believes an appropriate threshold for designation as
``high priced'' at the time of selection of new issues to be included
in the Pilot is $200 per share or a calculated index value of 200. At
$200 per share or a calculated index value of 200, strike prices are in
$10 increments, so the ``at the money'' strike is more likely to carry
an intrinsic value of $3 or more, and thus not trade in a penny
increment. With a greater distance between strikes, there are fewer
series that are actively traded. The determination of whether a
security is trading above $200 or above a calculated index value of 200
shall be based on the price at the close of trading on the Expiration
Friday prior to being added to the Pilot. This approach is consistent
with the approach NYSE Amex has taken for high-priced issues when
selecting Pilot issues in the past.
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    \8\ For instance, as of August 12, 2009, the near term at the
money call in GOOG (August 460 Calls) was trading at $6.50 with the
underlying at $459.84. The lowest strike price September call
trading below $3 (with the underlying at the same price) was the
September 500 Call.
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    Phased Implementation:
    The Exchange proposes to phase-in the additional classes to the
Pilot Program over four successive quarters. Specifically, the Exchange
proposes to add 75 classes on November 2, 2009; February 1, 2010; May
3, 2010; and August 2, 2010. The issues to be added on November 2, 2009
will be based on the most actively traded multiply listed issues for
the six month period from April 1, 2009 through September 30, 2009. The
issues to be added on February 1, 2010 will be based on the most
actively traded multiply listed issues for the six month period from
July 1, 2009 through December 31, 2009. The issues to be added on May
3, 2010 will be based on the most actively traded multiply listed
issues for the six month period from October 1, 2009 through March 31,
2010. The issues to be added on August 2, 2010 will be based on the
most actively traded multiply listed issues for the six month period
from January 1, 2010 through June 30, 2010.
    Delistings:
    Additionally, the Exchange proposes that any Pilot Program issues
that have been delisted may be replaced on a semi-annual basis by the
next most actively traded multiply listed options classes that are not
yet included in the Pilot, based on trading activity in the previous
six months. The replacement issues would be added to the Pilot Program
on the second trading day following January 1, 2010 and July 1,
2010.\9\
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    \9\ The replacement issues will be announced to the Exchange's
membership via Regulatory Bulletin and published by the Exchange on
its Web site.
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    Report:
    The Exchange agrees to submit semi-annual reports to the Commission
that will include sample data and analysis of information collected
from April 1 through September 30, and from October 1 through March 31,
for each year, for the ten most active and twenty least active options
classes added to the Pilot Program, in addition to continuing to
provide data concerning the existing Pilot Program classes. As the
Pilot Program matures and expands, the Exchange believes that this
proposed sampling approach provides an appropriate means by which to
monitor and assess the Pilot Program's impact. The Exchange will also
identify, for comparison purposes, a control group consisting of the
ten least active options classes from the existing Pilot Program
classes. This report will include, but is not limited to: (1) Data and
analysis on the number of quotations generated for options included in
the report; (2) an assessment of the quotation spreads for the options
included in the report; (3) an assessment of the impact of the Pilot
Program on the capacity of the Exchange's automated systems; (4) data
reflecting the size and depth of markets, and (5) any capacity problems
or other problems that arose related to the operation of the Pilot
Program and how the Exchange addressed them.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
and furthers the objectives of Section 6(b)(5) of the Act,\10\ in that
it is designed to prevent fraudulent and manipulative practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanisms of a free and open market and a national
market system and, in general, to protect investors and the public
interest.
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    \10\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6)(iii) thereunder.\14\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\15\
However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because doing so will
allow the Exchange to extend the Penny Pilot Program without
interruption and expand the Penny Pilot Program on the same schedule as
the other exchanges. Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\17\
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    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this pre-filing requirement.
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission 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.

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-NYSEAmex-2009-74 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-NYSEAmex-2009-74. 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 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 self-regulatory
organization. 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-
NYSEAmex-2009-74 and should be submitted on or before December 30,
2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-29302 Filed 12-8-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 1 (Friday, January 2, 2015)]
[Notices]
[Pages 83-85]
[FR Doc No: 2014-30706]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73947; File No. SR-NYSEMKT-2014-110]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Extending the Operation
of Its Supplemental Liquidity Providers Pilot, Until the Earlier of the
Securities and Exchange Commission's Approval To Make Such Pilot
Permanent or July 31, 2015

December 24, 2014.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on December 18, 2014, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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. 78a.
    \3\ 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 proposes to extend the operation of its Supplemental
Liquidity Providers Pilot (``SLP Pilot'' or ``Pilot'') (see Rule 107B--
Equities), currently scheduled to expire on December 31, 2014, until
the earlier of the Securities and Exchange Commission's
(``Commission'') approval to make such Pilot permanent or July 31,
2015. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
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 those 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 parts 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 proposes to extend the operation of its SLP Pilot,\4\
currently scheduled to expire on December 31, 2014, until the earlier
of Commission approval to make such Pilot permanent or July 31, 2015.
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    \4\ See Securities Exchange Act Release No. 61308 (January 7,
2010), 75 FR 2573 (January 15, 2010) (SR-NYSEAmex-2009-98)
(establishing the NYSE Amex Equities SLP Pilot). See also Securities
Exchange Act Release Nos. 61841 (April 5, 2010), 75 FR 18560 (April
12, 2010) (SR-NYSEAmex-2010-33) (extending the operation of the SLP
Pilot to September 30, 2010); 62814 (September 1, 2010), 75 FR 54671
(September 8, 2010) (SR-NYSEAmex-2010-88) (extending the operation
of the SLP Pilot to January 31, 2011); 63615 (December 29, 2010), 76
FR 611 (January 5, 2011) (SR-NYSEAmex-2010-123) (extending the
operation of the SLP Pilot to August 1, 2011); 64772 (June 29,
2011), 76 FR 39455 (July 6, 2011) (SR-NYSEAmex-2011-44) (extending
the operation of the SLP Pilot to January 31, 2012); 66041 (December
23, 2011), 76 FR 82328 (December 30, 2011) (SR-NYSEAmex-2011-103)
(extending the operation of the SLP Pilot to July 31, 2012); 67496
(July 25, 2012), 77 FR 45390 (July 31, 2012) (SR-NYSEMKT-2012-22)
(extending the operation of the SLP Pilot to January 31, 2013);
68557 (January 2, 2013), 78 FR 1284 (January 8, 2013) (SR-NYSEMKT-
2012-85) (extending the operation of the SLP Pilot to July 31,
2013); 69820 (June 21, 2013), 78 FR 38748 (June 27, 2013) (SR-
NYSEMKT-2013-52) (extending the operation of the SLP Pilot to
January 31, 2014); 71361 (January 21, 2014), 79 FR 4364 (January 27,
2014) (SR-NYSEMKT-2014-03) (extending the operation of the SLP Pilot
to July 31, 2014); and 72623 (July 16, 2014), 79 FR 41592 (July 22,
2014) (SR-NYSEMKT-2014-58 (extending the operation of the SLP Pilot
to December 31, 2014).
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Background \5\
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    \5\ The information contained herein is a summary of the ``New
Market Model'' Pilot and the SLP Pilot. See supra note 4 and infra
note 6 for a fuller description of those pilots.
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    In October 2008, the New York Stock Exchange LLC (``NYSE'')
implemented significant changes to its market rules, execution
technology and the rights and obligations of its market participants
all of which were designed to improve execution quality on the NYSE.
These changes were all elements of the NYSE's and the Exchange's
enhanced market model referred to as the ``New Market Model'' (``NMM
Pilot'').\6\ The NYSE SLP Pilot was launched in coordination with the
NMM Pilot (see NYSE Rule 107B).
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    \6\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46).
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    As part of the NMM Pilot, NYSE eliminated the function of
specialists on the Exchange creating a new category of market
participant, the Designated Market Maker or ``DMM.'' \7\ Separately,
the NYSE established the SLP Pilot, which established SLPs as a new
class of market participants to supplement the liquidity provided by
DMMs.\8\
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    \7\ See NYSE Rule 103.
    \8\ See NYSE Rule 107B and NYSE MKT Rule 107B--Equities. NYSE
amended the monthly volume requirements to an average daily volume
(``ADV'') that is a specified percentage of NYSE consolidated ADV.
See Securities Exchange Act Release No. 67759 (August 30, 2012), 77
FR 54939 (September 6, 2012) (SR-NYSE-2012-38).
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    The NYSE adopted NYSE Rule 107B governing SLPs as a six-month pilot
program commencing in November 2008. This NYSE pilot has been extended
several times, most recently to December 31, 2014.\9\ The NYSE is in
the

process of requesting an extension of their SLP Pilot until July 31,
2015 or until the Commission approves the pilot as permanent.\10\ The
extension of the NYSE SLP Pilot until July 31, 2015 runs parallel with
the extension of the NMM Pilot until July 31, 2015, or until the
Commission approves the NMM Pilot as permanent.
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    \9\ See Securities Exchange Act Release Nos. 58877 (October 29,
2008), 73 FR 65904 (November 5, 2008) (SR-NYSE-2008-108) (adopting
SLP Pilot program); 59869 (May 6, 2009), 74 FR 22796 (May 14, 2009)
(SR-NYSE-2009-46) (extending SLP Pilot program until October 1,
2009); 60756 (October 1, 2009), 74 FR 51628 (October 7, 2009) (SR-
NYSE-2009-100) (extending SLP Pilot program until November 30,
2009); 61075 (November 30, 2009), 74 FR 64112 (December 7, 2009)
(SR-NYSE-2009-119) (extending SLP Pilot program until March 30,
2010); 61840 (April 5, 2010), 75 FR 18563 (April 12, 2010) (SR-NYSE-
2010-28) (extending the SLP Pilot until September 30, 2010); 62813
(September 1, 2010), 75 FR 54686 (September 8, 2010) (SR-NYSE-2010-
62) (extending the SLP Pilot until January 31, 2011); 63616
(December 29, 2010), 76 FR 612 (January 5, 2011) (SR-NYSE-2010-86)
(extending the operation of the SLP Pilot to August 1, 2011); 64762
(June 28, 2011), 76 FR 39145 (July 5, 2011) (SR-NYSE-2011-30)
(extending the operation of the SLP Pilot to January 31, 2012);
66045 (December 23, 2011), 76 FR 82342 (December 30, 2011) (SR-NYSE-
2011-66) (extending the operation of the SLP Pilot to July 31,
2012); 67493 (July 25, 2012), 77 FR 45388 (July 31, 2012) (SR-NYSE-
2012-27) (extending the operation of the SLP Pilot to January 31,
2013); 68560 (January 2, 2013), 78 FR 1280 (January 8, 2013) (SR-
NYSE-2012-76) (extending the operation of the SLP Pilot to July 31,
2013); 69819 (June 21, 2013), 78 FR 38764 (June 27, 2013) (SR-NYSE-
2013-44) (extending the operation of the SLP Pilot to January 31,
2014); 71362 (January 21, 2014), 79 FR 4371 (January 27, 2014) (SR-
NYSE-2014-03) (extending the operation of the SLP Pilot to July 31,
2014); and 72628 (July 16, 2014), 79 FR 42588 (July 22, 2014) (SR-
NYSE-2014-34) (extending the operation of the SLP Pilot to December
31, 2014).
    \10\ See SR-NYSE-2014-72.
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Proposal To Extend the Operation of the NYSE MKT SLP Pilot
    The Exchange established the SLP Pilot to provide incentives for
quoting, to enhance competition among the existing group of liquidity
providers, including the DMMs, and add new competitive market
participants. NYSE MKT Rule 107B--Equities is based on NYSE Rule 107B.
NYSE MKT Rule 107B--Equities was filed with the Commission on December
30, 2009, as a ``me too'' filing for immediate effectiveness as a pilot
program.\11\ The Exchange's SLP Pilot is scheduled to end operation on
December 31, 2014 or such earlier time as the Commission may determine
to make the rules permanent.
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    \11\ See Securities Exchange Act Release No. 61308 (January 7,
2010), 75 FR 2573 (January 15, 2010) (SR-NYSEAmex-2009-98).
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    The Exchange believes that the SLP Pilot, in coordination with the
NMM Pilot and the NYSE SLP Pilot, allows the Exchange to provide its
market participants with a trading venue that utilizes an enhanced
market structure to encourage the addition of liquidity, facilitate the
trading of larger orders more efficiently and operates to reward
aggressive liquidity providers. As such, the Exchange believes that the
rules governing the SLP Pilot (NYSE MKT Rule 107B--Equities) should be
made permanent.
    Through this filing the Exchange seeks to extend the current
operation of the SLP Pilot until July 31, 2015, in order to allow the
Exchange to formally submit a filing to the Commission to convert the
SLP Pilot rule to a permanent rule. The Exchange is currently preparing
a rule filing seeking permission to make the Exchange's SLP Pilot
permanent, but does not expect that filing to be completed and approved
by the Commission before December 31, 2014.\12\
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    \12\ The NMM Pilot was scheduled to expire on December 31, 2014
as well. The Exchange has filed to extend the NMM Pilot until July
31, 2015. See SR-NYSEMKT-2014-109.
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    The proposed change is not otherwise intended to address any other
issues and the Exchange is not aware of any problems that member
organizations would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\13\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\14\ in particular, 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 regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices and to promote
just and equitable principles of trade because it seeks to extend a
pilot program that has already been approved by the Commission. The
Exchange believes the proposed rule change is designed to facilitate
transactions in securities and to remove impediments to, and perfect
the mechanisms of, a free and open market and a national market system
because the SLP Pilot provides its market participants with a trading
venue that utilizes an enhanced market structure to encourage the
addition of liquidity and operates to reward aggressive liquidity
providers. Moreover, requesting an extension of the SLP Pilot will
permit adequate time for: (i) The Exchange to prepare and submit a
filing to make the rules governing the SLP Pilot permanent; (ii) public
notice and comment; and (iii) completion of the 19b-4 approval process.
Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition. For these reasons, the Exchange
believes that the proposal is consistent with the Act.

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

    In accordance with section 6(b)(8) of the Act,\15\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that extending the operation
of the SLP Pilot will enhance competition among liquidity providers and
thereby improve execution quality on the Exchange. The Exchange will
continue to monitor the efficacy of the program during the proposed
extended pilot period.
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    \15\ 15 U.S.C. 78f(b)(8).
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    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues. In such an environment, the Exchange must continually
review, and consider adjusting the services it offers and the
requirements it imposes to remain competitive with other U.S. equity
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \18\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant

to Rule 19b-4(f)(6)(iii),\19\ the Commission may designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative before
the pilot's expiration. The Exchange states that an immediate operative
date is necessary in order to immediately implement the proposed rule
change so that member organizations could continue to benefit from the
pilot program without interruption after December 31, 2014.
---------------------------------------------------------------------------

    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Specifically, the Commission believes that the proposal would allow the
pilot to continue uninterrupted, thereby avoiding any potential
investor confusion that could result from the temporary interruption in
the pilot program. For this reason, the Commission designates the
proposed rule change to be operative on December 31, 2014.\20\
---------------------------------------------------------------------------

    \20\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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.

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-NYSEMKT-2014-110 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-NYSEMKT-2014-110. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such 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-NYSEMKT-2014-110 and should
be submitted on or before January 23, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2014-30706 Filed 12-31-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57908-57910]
[FR Doc No: 2022-20523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1358]

How To Obtain a Covered Product Authorization; Draft Guidance for
Industry; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, Department of Health and Human
Services (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 ``How To
Obtain a Covered Product Authorization.'' This guidance describes how
eligible product developers can obtain a Covered Product Authorization
(CPA) from FDA under the law widely known as the CREATES Act. The
CREATES Act provides a pathway for eligible product developers to
obtain access to the product samples they need to fulfill testing and
other regulatory requirements to support their applications. As
described in further detail below, to make use of this pathway, an
eligible product developer seeking to develop a product subject to a
Risk Evaluation and Mitigation Strategies (REMS) with elements to
assure safe use (ETASU) must obtain a CPA from the Agency. This
guidance replaces the December 2014 draft guidance for industry ``How
To Obtain a Letter From FDA Stating That Bioequivalence Study Protocols
Contain Safety Protections Comparable to Applicable REMS for RLD,''
which has been withdrawn. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by November 21, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by November
21, 2022.

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-1358 for ``How To Obtain a Covered Product Authorization.''
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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Rana Carroll, Center for Drug
Evaluation and Research, Food and Drug Administration, Building 51, Rm.
6218, 10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``How To Obtain a Covered Product Authorization.'' In December
2019, the law widely known as CREATES (referred to herein as
``CREATES'' or ``the CREATES Act'') was enacted as part of the Further
Consolidated Appropriations Act of 2020.\1\ CREATES makes available a
pathway for developers of potential drug and biological products to
obtain samples of brand products that they need to support their
applications. CREATES establishes a private right of action that allows
eligible developers to sue brand companies that refuse to sell them
product samples needed to support their applications. If the product
developer prevails, the court will order the sale of samples, award
attorneys' fees and litigation costs to the product developer, and may
impose a monetary penalty on the brand company (21 U.S.C. 355-2(b)(4)).
---------------------------------------------------------------------------

    \1\ See Public Law 116-94 (Further Consolidated Appropriations
Act, 2020, enacting Division N, Title I, Subtitle F, Section 610--
Actions for Delays of Generic Drugs and Biosimilar Biological
Products (Dec. 20, 2019)). The provisions of this law related to
access to product samples were codified at 21 U.S.C. 355-2 and 355-
1(l).
---------------------------------------------------------------------------

    The product developer must take several specific steps (outlined in
the CREATES Act) before the brand company must sell them product
samples. One of these steps--if the brand product for which samples are
sought is subject to a REMS with ETASU--is that the product developer
must first obtain a CPA from FDA (21 U.S.C. 355-2(b)(2)). CREATES does
not require this step for products that are not subject to REMS with
ETASU. This guidance describes how an eligible product developer can
obtain a CPA from FDA.
    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 ``How To
Obtain a Covered Product Authorization.'' 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

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry: How To Obtain a Covered Product Authorization

OMB Control Number 0910-0014--Revision

    The revised information collection described in this guidance
supports FDA Center for Drug Evaluation and Research's implementation
of the law widely known as the CREATES Act, which was enacted as part
of the Further Consolidated Appropriations Act of 2020. As described
above, the CREATES Act establishes a pathway for eligible product
developers to obtain samples of brand products needed to support their
applications.
    FDA applications referenced in this guidance include abbreviated
new drug applications (ANDAs) submitted under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), new
drug applications (NDA) submitted pursuant to section 505(b)(2) of the
FD&C Act (21 U.S.C. 355(b)(2)), and applications for biosimilar
products submitted under section 351(k) of the Public Health Service
Act (42 U.S.C. 262(k)).
    Product developers typically need brand product samples to, among
other things, conduct testing comparing their proposed version of a
product to the brand product. For example, an ANDA applicant generally
needs to show that its proposed generic drug product is bioequivalent
to the brand product (see section 505(j)(2)(A) of the FD&C Act).
Bioequivalence is generally demonstrated by conducting studies
comparing the proposed generic drug product to the brand product and
generic applicants are required to retain samples of the brand product
used in testing after a study is complete. Developers of 505(b)(2) and
biosimilar

products must also typically conduct comparative testing requiring
access to brand product samples.
    Under the CREATES Act, the product developer must take several
specific steps (outlined in the CREATES Act) before the brand company
is required to sell them product samples. If the brand product for
which samples are sought is subject to a REMS with ETASU, the product
developer must first obtain a CPA from FDA (21 U.S.C. 355-2(b)(2)).
(CPAs are only available for products that are subject to a REMS with
ETASU. To prevail in the private right of action established by
CREATES, an eligible product developer seeking samples of a product
that is not subject to a REMS with ETASU does not need to obtain a
CPA.)
    This information collection enables eligible product developers to
obtain CPAs from FDA so that they can utilize the pathway made
available by the CREATES Act. An ANDA, 505(b)(2), or biosimilar product
developer's use of the CREATES pathway is voluntary, as is the product
developer's request for a CPA. Accordingly, under this information
collection, FDA will collect information voluntarily provided by
eligible product developers in the form of requests for CPAs and
supporting documentation. Requests for CPAs for samples of brand
products used for purposes of development and testing that involve
human clinical trials should be accompanied by study protocols,
informed consent documents, and informational materials for testing
demonstrating that safety protections comparable to those in the REMS
for the brand product will be provided for in the study(ies) for which
the samples are sought.
    For generic drug products, a request for a CPA is submitted through
the CDER NextGen collaboration Portal as complex controlled
correspondence to an ANDA. For 505(b)(2) applications and biosimilar
applications, the request for a CPA is submitted to the pre-
investigational new drug application (pIND) or investigational new drug
application (IND) file, and a copy is sent to any existing marketing
application for the product and to [email protected].
    Respondents for this information collection are drug and biological
product developers that are seeking to use the CREATES pathway to
obtain samples of brand products needed to support their applications.
    For ANDA, 505(b)(2), and biosimilar products, the burden of
requesting a CPA is being added to OMB Control No. 0910-0014.
    Based on prior experience, FDA estimates the burden of this
collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
      Guidance Section IV.          respondents    responses per     responses       response       Total hours
                                                    respondent                        (hours)
----------------------------------------------------------------------------------------------------------------
CPA Requests for NDA/Biologics                 1               1               1               5               5
 License Application products...
CPA Requests for ANDA products..              11               2              22               5             110
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             115
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

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

    Dated: September 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20523 Filed 9-21-22; 8:45 am]
BILLING CODE 4164-01-P