[Federal Register: April 24, 2007 (Volume 72, Number 78)]
[Notices]
[Page 20392-20395]
[DOCID:fr24ap07-112]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55640; File No. SR-Amex-2007-04]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Its Buy-In Rules

April 17, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 8, 2007, the
American Stock Exchange LLC (``Amex'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II, and III below, which items have been prepared primarily
by Amex. Amex filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \2\ and Rule 19b-4(f)(6) thereunder \3\ so that
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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The purpose of the proposed rule change is to amend Amex Rules 759,
783, 784, and 789 and to adopt new Rule 798 to standardize Amex's buy-
in rules.

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

    In its filing with the Commission, Amex 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. Amex has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by Amex.
---------------------------------------------------------------------------

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

    Amex is amending its Rules 783, 784, and 789 and is adopting new
Rule 798

to permit buyer executed buy-ins,\5\ to reduce the waiting period to
execute a buy-in from twenty-one (21) days to three (3) days, and to
otherwise provide more standardized and consistent industry buy-in
rules and procedures. Amex is also making conforming changes to Rules
759, 784, and 789. This proposal seeks to substantially mirror the
recent New York Stock Exchange (``NYSE'') amendments to its buy-in
rules approved by the Commission, which were made mainly for the
purpose of achieving industry uniformity.\6\
---------------------------------------------------------------------------

    \5\ A ``buy-in'' is a transaction between broker-dealers where
because the securities are not delivered on time by the broker-
dealer on the sell-side, the broker-dealer on the buy-side purchases
the securities from another source.
    \6\ Securities Exchange Act Release No. 52842 (November 28,
2005), 70 FR 72321 (December 2, 2005) [File No. SR-NYSE-2005-50].
---------------------------------------------------------------------------

Introduction

    The Amex buy-in rules apply to transactions that are not subject to
the rules of a qualified clearing agency, such as The Depository Trust
Company (``DTC'') \7\ and the National Securities Clearing Corporation
(``NSCC'') \8\, including transactions processed in NSCC's Continuous
Net Settlement service (``CNS'') \9\ that settle through them.\10\ In
the event that a buy-in is sent to the Amex floor for execution, then
Amex buy-in rules apply.
---------------------------------------------------------------------------

    \7\ DTC is a member of the U.S. Federal Reserve System, a
limited-purpose trust company under New York State banking law, and
a clearing agency registered with the Commission.
    \8\ NSCC is a central counterparty that provides centralized
clearance, settlement, and information services for virtually all
broker-to-broker equity, corporate bond and municipal bond,
exchange-traded funds, and unit investment trust trades in the U.S.
NSCC provides clearing and settlement, risk management, central
counterparty services, and a guarantee of completion for trades.
NSCC also nets trades and payments among its members thereby
reducing the volume of securities and payments that need to be
exchanged each day.
    \9\ CNS is an automated accounting system that centralizes and
nets the settlement of compared security transactions in order to
maintain an orderly flow of security and money balances.
    \10\ See Securities Exchange Act Release No. 53528 (March 21,
2006), 71 FR 15506 (March 28, 2006) [File No. SR-NSCC-2005-15]
(approving NSCC's CNS buy-in rules).
---------------------------------------------------------------------------

    However, under current Amex rules that place the responsibility for
the actual execution of the buy-in on the defaulting member or member
organization (``defaulting member'' or ``seller''), there are
disincentives for the defaulting member to execute the buy-in. For
example, the defaulting member could potentially manipulate the extent
to which it has market exposure by timing its purchase of the necessary
securities to benefit itself. Therefore, an initiating member or member
organization (``initiating member'' or ``buyer'') may receive negative
customer reaction if the customer learns that its trade has not been
settled and that their securities are not available because a buy-in
has not been executed in a timely manner by the defaulting member.
    Other self-regulatory organizations (``SROs'') have recognized this
conflict of interests, and their buy-in rules assign responsibility
accordingly by allowing the buyer to execute the buy-in. By allowing
buyers to execute their own buy-ins, the defaulting members' conflicts
of interest are avoided, and the process is expedited.
    The Securities Industry Association (``SIA'') Securities Operations
Division Buy-In Committee (``Committee'') \11\ has expressed a strong
preference that Amex consider amending its buy-in rules to eliminate is
buy-in notice procedures and to change who executes the buy-in to the
buyer from the seller. The purpose of the Committee's recommendation is
to identify and to standardize various buy-in rules and procedures
regarding the buy-in process related to non-CNS transactions and to
help formulate uniformity among industry rules. The Committee requested
that Amex conform its rules to those of the other exchanges that allow
the initiating member to execute buy-ins to close out a contract.
---------------------------------------------------------------------------

    \11\ The Committee is made up of representatives from a broad
cross-section of broker-dealers and industry groups.
---------------------------------------------------------------------------

Current Requirements

    Amex Rule 784 sets forth the ``mandatory closing of fails'' process
by which a buyer is required to close-out a contract that has not been
completed by the seller for a period of twenty-one (21) business days.
A mandatory closing of fails requires that a notice of intention be
delivered in quadruplicate and on the twenty-first (21st) business day
after the original due date of the contract by the initiating member to
the seller. The member organization receiving the notice of intention
must indicate its position with respect to the resolution of the failed
trade (e.g., doesn't know the trade, knows the trade but cannot
deliver, will deliver) and return the notice of intention to the
initiating member no later than three business days after the notice
was sent. If the notice of intention is not returned when due or is
returned with the indication that the contract is not known, the
initiating member shall itself close the contract by buying or selling
the securities involved through its own floor representative. If the
notice of intention is returned when due with an indication that the
contract is known but that delivery cannot be made and if the contract
is one which has been designated as acceptable for clearance as a fail
item by a registered clearing agency of which both parties are clearing
members, it shall be submitted for clearance by the defaulting member.
If the notice of intention is returned when due with an indication that
the contract is known but that delivery cannot be made and the contract
is one which has not been designated as acceptable for clearance as a
fail item by a registered clearing agency of which both parties are
clearing members, the initiating member shall close the contract
according to the procedures in Amex Rule 783. Therefore, the rule
currently provides that more than three weeks may lapse before the
contract is closed.
    Amex Rule 783 sets forth a permissive procedure by which an
initiating member may close-out a contract that has not been executed
by the defaulting member. The initiating member must provide notice of
its intention to make a closing. Pursuant to Amex Rule 783, Amex
determines the times for the delivery of such notices of intention to
close and orders to close and the time for the closing of contracts. If
the times within which securities may be delivered are extended or
shortened, the time limits established by Amex may be similarly
extended or shortened.\12\ Once the initiating member sends the notice
to the defaulting member, the defaulting member shall be given a copy
of the order to close for execution on that day. If the order is not
executed, the defaulting member shall return the original order within
fifteen minutes of the close of trading indicating why it cannot be
executed, and the buy-in desk will deliver a copy of the floor report
to the initiating member. The initiating member may then close the
contract and must notify the defaulting party with respect to any money
differences that it will claim as damages. If the order is executed by
the defaulting member, it shall furnish a copy of the order to close
and a copy of the floor report to the buy-in desk on the floor.
---------------------------------------------------------------------------

    \12\ Contracts made for cash within one and one-half hour before
the close of trading are given different treatment with respect to
timing. When a contract made for cash within one and one-half hour
before the close of trading is to be closed on the same day, the
time of the transaction shall be stated on the order and notice,
which shall be delivered within thirty minutes after the time of the
transaction, and the contract shall not be closed until thirty-five
minutes after the time of the transaction.
---------------------------------------------------------------------------

    Amex Rule 789 requires an initiating member to accept physical
delivery of some or all of the securities that are the

subject of a buy-in thereby halting the buy-in execution for those
securities if the defaulting member tenders the securities prior to the
buy-in. The defaulting member must promptly tender the securities, and
if they are not promptly delivered, such member or member organization
is liable for any resulting damages.

Proposal

    Amex is amending Rule 784 to allow the member or member
organization failing to receive the securities to execute the buy-in
and to reduce the waiting period to execute a buy-in from twenty-one
(21) days to three (3) days after delivery on the contract was due. The
elimination of Commentary .01 through .06 to Rule 784 is intended to
facilitate the amendments to the buy-in procedures. The amendments to
these procedures are largely proposed in the text of Rule 784. Amex
believes that once the responsibility is shifted to the buy-side of the
transaction, the buy-in process will work more efficiently.
    The amendments to Rule 784 provide that the initiating member may
close a contract no sooner than three business days after the original
due date for delivery (``Effective Date''). The initiating member must
deliver a written notice to the defaulting member at least two days
before the proposed buy-in. After receipt of the buy-in notice, the
defaulting member must then send a signed, written response to the
initiating member stating its position. If the response is not received
by 5 p.m. ET on the day of receipt of the buy-in notice or it is
returned with an indication that the contract is not known or that it
is known but that delivery cannot be made, the buy-in may be executed
on the Effective Date. The initiating member shall be required to
accept any portion of the securities called for by the contract from
the defaulting member that the defaulting member submits prior to the
execution of the buy-in, but the initiating member shall not be
required to accept any securities from the defaulting member if the
buy-in has already been executed and if the buy-in could not have been
reasonably cancelled by the initiating member. Once the buy-in has been
executed, the initiating member shall notify the defaulting member
confirming the purchase along with a bill or payment.
    Amex is also eliminating the requirements for quadruplicate paper
notices and will permit electronic notices, including notices from a
computerized network facility, or the electronic functionality of a
Qualified Clearing Agency, such as DTC and NSCC. The amendments also
change the existing time deadlines for delivering notices, securities,
and executions and adopt those used by other self-regulatory
organizations.
    Amex is also adopting new Commentary .01 to Rule 784 to help ensure
that members and member organizations comply with the requirements of
Regulation SHO.\13\ Members and member organizations are obligated to
comply with the marking, locate, and delivery requirements of
Regulation SHO for short sales of equity securities. As a result,
members and member organizations should have policies and procedures in
place to comply with these requirements, including close-out
procedures.\14\
---------------------------------------------------------------------------

    \13\ 17 CFR 242.200 through 242.203. Securities Exchange Act
Release No. 50103 (July 28, 2004), 69 FR 48008 (August 6, 2004),
[File No. S7-23-03] (adoption of Regulation SHO).
    \14\ At the same time the changes noted above were being
developed, the SEC implemented Regulation SHO, Regulation of Short
Sales, which shares a similar purpose, the reduction of fails to
deliver, with the buy-in rules. Rule 203 to Regulation SHO imposes
locate and borrowing/ delivery requirements on broker-dealers that
sell equity securities, including close-out requirements on certain
open fail to deliver positions.
---------------------------------------------------------------------------

    Amex is rescinding Rule 783 and has incorporated the permissive
buy-in procedures of Rule 783 into Rule 784. Amex is also amending Rule
789 to conform it to this proposal to permit buyer executed buy-ins and
to create a Rule 798 to clarify the requirements and time frames upon
which a defaulting member may deliver against a buy-in notice. Finally,
Amex is making technical amendments to Rules 759, 784 and 789 to better
coordinate the rules with industry practice.
    Amex believes that the revisions to its buy-in rules will help
standardize Amex's procedure and practice by allowing members and
member organizations to clean-up fails and efficiently deliver Amex-
listed securities. Amex believes that the proposed rule change is
consistent with Section 6 of the Act in general and furthers the
objectives of Section 6(b)(5) in particular in that 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 perfect the mechanism of a free
and open market and a national market system, and, in general, to
protect investors and the public interest. By amending the Amex buy-in
rules to permit buyers to execute buy-ins, firms are expected to find
it easier to execute buy-ins of Amex-listed securities. In addition,
the amendments seek to remove inefficient requirements and amend time
deadlines to conform to current industry practice.

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

    Amex does not believe that the proposed rule change will impose any
burden on competition.

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

    Because the foregoing proposed rule change (1) Does not
significantly affect the protection of investors or the public
interest, (2) does not impose any significant burden on competition,
and (3) does not become operative for 30 days from the date of filing
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)(iii) of the
Act \15\ and Rule 19b-4(f)(6) thereunder.\16\ As required by Rule 19b-
4(f)(6)(iii), Amex provided the Commission with written notice of its
intent to file the proposed rule change at least five business days
prior to filing the proposal with the Commission or within such shorter
period as designated by the Commission.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within sixty (60) days of the filing of the proposed
rule change, the Commission could have summarily abrogated such rule
change if it appeared to the Commission that such action was 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-Amex-2007-04 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-Amex-2007-04. 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. The text of the proposed rule change is
available at Amex, the Commission's Public Reference Room, and http://www.amex.com/atamex/ruleFilings/at_rulefilings.html.
 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-Amex-2007-04 and should be
submitted on or before May 15, 2007.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-7711 Filed 4-23-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Notices]
[Pages 27833-27835]
[FR Doc No: 2012-11465]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Requirements for Recognizing the Aviation and Aerospace
Innovation in Science and Engineering Award

AGENCY: Office of the Secretary of Transportation, U.S. Department of
Transportation.

ACTION: Notice of the announcement of Requirements for the Secretary of
Transportation's RAISE (Recognizing

Aviation and Aerospace Innovation in Science and Engineering) Award.

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

    Authority:  15 U.S.C. 3719 (America COMPETES Act).
    Award Approving Official: Ray LaHood, Secretary of Transportation.

SUMMARY: Pursuant to a recommendation by the DOT's Future of Aviation
Advisory Committee, the Secretary of Transportation is announcing an
award to recognize students who develop unique scientific and
engineering innovations in aerospace. With this award, the Secretary of
Transportation intends to create an incentive for participants at high
schools, colleges, and universities to develop innovative solutions to
aviation and aerospace issues, and to share those innovations with the
broader community.

DATES: Effective on April, 2012 to October, 2012.

FOR FURTHER INFORMATION CONTACT: Patricia Watts, Ph.D., Federal
Aviation Administration,<PHONE_NUMBER> or James Brough, Federal
Aviation Administration,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Subject of Challenge Competition: The RAISE
Award will recognize innovative scientific and engineering achievements
that will have a significant impact on the future of aerospace or
aviation. The award is open to students at the high school,
undergraduate, and graduate levels. Following an open solicitation, the
Award Review Board Chair will submit nominations to the Secretary of
Transportation for final consideration.
    Eligibility Rules for Participating in the Competition:

Selection Criteria

    1. Candidates must be U.S. citizens or permanent residents and must
have been enrolled for at least two semesters at a high school (or
equivalent approved home school program), college, or university to be
eligible to receive the award.
    2. Students may participate as individuals or in groups. Each
member of the group must meet the above criteria.
    Further, to be eligible to win the award under this announcement,
every candidate--
    1. Shall first submit a project in the competition under the rules
promulgated by the U.S. Department of Transportation;
    2. Shall agree to execute indemnifications and waivers of claims
against the federal government as provided in the registration
materials;
    3. May not be a Federal entity or Federal employee acting within
the scope of employment; and
    4. May not be an employee of the Department of Transportation or
the Federal Aviation Administration.
    A candidate shall not be deemed ineligible because the individual
used Federal facilities or consulted with Federal employees during a
competition, if the facilities and employees are made available to all
individuals participating in the competition on an equitable basis.
    Rules for Participants:
    Rules for this competition will be available for download at
www.challenge.gov. There is no charge to enter. A submission package
will consist of the following sections in this order:
    1. Nomination letter from at least one teacher, advisor, faculty
member, and others as appropriate. The nomination letter(s) must
communicate the following accomplishments in two areas:

Technical Merit of the Concept

    Evidence of technical merit based upon teacher (parent or legal
guardian in the case of home schooled applicants), advisor, or faculty
nomination and evaluation of the submitted proposal, written paper,
and/or reports.

Professionalism and Leadership

    Evidence of professionalism and leadership can be in the form of,
but not limited to:
    (1) Membership and offices held in various groups
    (2) Presentations made to various groups, meetings, and at symposia
    (3) Leadership in student professional activities
    (4) Community outreach activities
    2. An overall summary of the innovation, not to exceed one page,
which includes a statement of the impact that the innovation will have
on the field of aviation or aerospace;
    3. A copy of the student's academic transcript or certified grade
report (as applicable);
    4. A copy of the paper(s) and related materials describing the
innovative concept written by the student(s) being nominated (no page
limit).
    All materials should be forwarded with a cover letter to the
attention of: Patricia Watts, Ph.D., Centers of Excellence Program
Director, Federal Aviation Administration, L-28, FAA William J. Hughes
Technical Center, Atlantic City International Airport, NJ 08405.
    Hardcopy is preferred; however, the package also may be transmitted
by email to<EMAIL_ADDRESS>All entries must be received by
11:59 p.m. Pacific standard time on July 27, 2012. Award administrators
assume no responsibility for lost or untimely submissions for any
reason.
    Award:
    The winner will be announced in October. A trophy with the winner's
name and date of award will be displayed at the Department of
Transportation and a display copy of the trophy will be sent to the
winner's school/college/university. An additional trophy will be
awarded to the individual or team.
    Basis Upon Which the Winner Will Be Selected:
    All submissions will be initially reviewed by the FAA Center for
Excellence (COE) Program Director upon receipt to determine if the
submissions meet the eligibility requirements. Registration packages
meeting the eligibility requirements will be judged by advisory panels
consisting of academic experts, government officials including FAA,
DOT, and others. The advisory panels will select the most highly
qualified submissions and present them to the Secretary of the
Department of Transportation, who will select the winning entrant.
    Submissions will be judged on the following criteria:
    Originality:
     Is this concept new or a variation of an existing idea,
and in what way(s)?
     How is this work unique?
     Was the concept developed independently or in cooperation
with others?
    Impact:
     To what extent has this contribution:
    [cir] Made a fundamental change?
    [cir] Made a major contribution to the future of the aviation
environment?
    Practicality:
     Who directly benefits from this work?
     Can this program or activity be implemented in a practical
fashion?
     What are the costs anticipated to be incurred and saved by
executing this concept?
    Measurability:
     How has this individual/group measured the impact on the
aviation environment?
     To what extent does the innovation result in measurable
improvements?
    Applicability:
     Can this effort be scaled?
     Is this work specific to one region, various regions, or
to the entire nation?
     How does this activity lead to future changes in aviation?
    Technical Merit:

     Has the submission presented a clear understanding of the
associated problems?
     Has the submission developed a logical and workable
solution and approach to solving the problem/s?
     What are the most significant aspects of this concept?
     Has the submission clearly demonstrated the breadth of
impact of the innovation?
    All factors are important and will be given consideration, but the
advisory panels will give the ``technical merit'' factor the most
weight in the screening process. The Secretary of Transportation
retains sole discretion to select the winning entrant.
    Additional Information:
    Federal grantees may not use Federal funds to develop COMPETES Act
challenge applications unless such use is consistent with the purpose
of their grant award.
    Federal contractors may not use Federal funds from a contract to
develop COMPETES Act challenge applications or to fund efforts in
support of a COMPETES Act challenge submission.

    Issued On: April 30, 2012.
Susan L. Kurland,
Assistant Secretary of Aviation and International Affairs.
[FR Doc. 2012-11465 Filed 5-10-12; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Page 1697]
[FR Doc No: 2012-326]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Arthritis Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Arthritis Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 12, 2012, from 8
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room, (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Philip A. Bautista, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: (301)
847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-(800) 741-8138 ((301) 443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss the anti-nerve growth factor
(Anti-NGF) drug class that is currently under development and the
safety issues possibly related to these drugs. These drugs are being
developed for the treatment of a variety of chronic painful conditions
including osteoarthritis, chronic lower back pain, diabetic peripheral
neuropathy, post-herpetic neuralgia, chronic pancreatitis,
endometriosis, interstitial cystitis, vertebral fracture, thermal
injury, and cancer pain. The committee will be asked to determine
whether reports of joint destruction represent a safety signal related
to the Anti-NGF class of drugs, and whether the risk benefit balance
for these drugs favors continued development of the drugs as
analgesics.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 27, 2012. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before February 16, 2012.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by February 17, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Philip A. Bautista
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-326 Filed 1-10-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16868-16870]
[FR Doc No: 2018-08010]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1203]

Pilot Meetings Program for Model-Informed Drug Development
Approaches

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The sixth iteration of the Prescription Drug User Fee Act
(PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017
(FDARA), highlights the goal of advancing model-informed drug
development (MIDD). The Food and Drug Administration (FDA or Agency) is
announcing a pilot program that affords sponsors or applicants who are
selected for participation the opportunity to meet with Agency staff to
discuss MIDD approaches in medical product development. Meetings under
the pilot program will be conducted by FDA's Center for Drug Evaluation
and Research (CDER) and Center for Biologics Evaluation and Research
(CBER) during fiscal years 2018 to 2022. This pilot program is being
conducted to fulfill FDA's performance commitment under PDUFA VI. For
this pilot program, MIDD is defined as the application of exposure-
based, biological, and/or statistical models derived from preclinical
and clinical data sources to address drug development and/or regulatory
issues (see Supplementary Information, I. Background, and II.
Eligibility and Selection for Participation of this notice). For each
approved proposal, the pilot program consists of two meetings between
sponsors or applicants and the relevant center and will provide an
opportunity for drug developers and FDA to discuss the application of
MIDD approaches to the development and regulatory evaluation of medical
products in development.

DATES: FDA will accept requests to participate in the program on a
continuous basis beginning on April 17, 2018 through June 15, 2022. See
section III of this notice for instructions about how to request
participation in the pilot program. Meeting-granted and -denied
decisions will be made the last 2 weeks of each quarter of the fiscal
year based on submissions received to date. Requesters will receive a
meeting-granted or -denied notification the first week of the new
quarter.
    The pilot program meetings will begin in Q4 of FY 2018 (July 1-
September 30, 2018), and run through Q4 of FY 2022 (September 30,
2022). Proposals not selected for a given quarter will be so notified
by the Agency. Sponsors who are not chosen to participate in the pilot
program may seek Agency interaction through existing channels (e.g.,
Type C meeting requests, critical path innovation meetings).

ADDRESSES: Comments about this pilot program can be submitted until May
17, 2018. You may submit comments about the MIDD pilot meetings program
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-2018-N-1203 for ``Pilot Meetings Program for Model-Informed Drug
Development Approaches.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed

except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    CDER: Yvonne Knight, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2142,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected],
with the subject line ``MIDD Pilot Meetings Program for CDER.''
    CBER: Jason Claeys, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
1223, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected], with the subject line ``MIDD Pilot Meetings
Program for CBER.''

SUPPLEMENTARY INFORMATION:

I. Background

    Under FDARA FDA agreed, in accordance with the ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2018
Through 2022: I. Ensuring the Effectiveness of the Human Drug Review
Program, Part J. Enhancing Regulatory Decision Tools to Support Drug
Development and Review'' to provide information on how a sponsor can
apply to participate in a pilot meetings program with FDA to discuss
MIDD approaches (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf).
    FDA is announcing this pilot meetings program to satisfy the above-
mentioned commitment and to facilitate MIDD approaches. This excludes
statistical designs involving complex adaptations, Bayesian methods, or
other features requiring computer simulations to determine the
operating characteristics of a confirmatory clinical trial. MIDD
approaches use a variety of quantitative methods to help balance the
risks and benefits of drug products in development. When successfully
applied, MIDD approaches can improve clinical trial efficiency,
increase the probability of regulatory success, and optimize drug
dosing/therapeutic individualization in the absence of dedicated
trials.
    The goal of the early meeting discussions granted under this pilot
program is to provide advice on how specific, proposed MIDD approaches
can be used in a specific drug development program. FDA has committed
to accepting two to four meeting requests quarterly each fiscal year.
The meetings granted will include an initial and followup meeting on
the same drug development issues within the span of approximately 120
days.
    The listed eligibility factors and procedures outlined in this
Federal Register notice reflect the current thinking at the time of
publication. Processes may be revised and will be communicated as this
pilot program evolves. The most current pilot program eligibility
factors and procedures may be found on the MIDD Pilot Program website:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm600311.htm.

II. Eligibility and Selection for Participation in the MIDD Pilot
Program

    The requester should be a drug/biologics development company
(interested consortia or software/device developer should come in
partnership with a drug development company) and have an
investigational new drug application (IND) or pre-IND (PIND) number for
the relevant program. Recognizing that FDA will learn both from the
number and types of submissions received for consideration into the
pilot program, FDA welcomes submissions related to any relevant MIDD
topics. However, given that the Agency expects to grant two to four
meeting requests per quarter as part of the pilot program, the Agency
will initially prioritize selecting requests that focus on:
     Dose selection or estimation (e.g., for dose/dosing
regimen selection or refinement).
     Clinical trial simulation (e.g., based on drug-trial-
disease models to inform the duration of a trial, select appropriate
response measures, predict outcomes).
     Predictive or mechanistic safety evaluation (e.g., use of
systems pharmacology/mechanistic models for predicting safety or
identifying critical biomarkers of interest).

III. Procedures and Submission Information

A. General Information

    The MIDD pilot program will be jointly administered by CDER's
Office of Clinical Pharmacology, in the Office of Translational
Sciences, which is the point of contact for all communications for CDER
products, and CBER's Office of Biostatistics and Epidemiology, which is
the point of contact for all communications for CBER products.

B. How To Submit a Meeting Request and Meeting Package

    Meeting requests should be submitted electronically to the relevant
application (i.e., PIND, IND) with ``MIDD Pilot Program Meeting Request
for CDER'' (CDER applications) or ``MIDD Pilot Program Meeting Request
for CBER'' (CBER applications) in the subject line. Information about
providing regulatory submissions in electronic format is available at:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/%20ElectronicSubmissions/ucm153574.htm.

C. Content and Format of the Meeting Request

    Include the following information in the meeting request (no more
than three to four pages):
    1. Product name.
    2. Application number.
    3. Chemical name and structure.
    4. Proposed indication(s) or context of product development.
    5. Brief statement of the purpose and objectives of the meeting.
The statement should include a brief background of the MIDD issues
underlying the agenda.
    6. MIDD approach(es) considered for the product under development
and how MIDD can assess uncertainties about issues (e.g., dosing,
duration, patient selection) in a way that can inform regulatory
decision-making.
    7. List of issues for discussion with the Agency about the specific
MIDD proposed approach for the applicable drug development program.

D. Content and Format of the Meeting Information Package

    Sponsors or applicants whose meeting requests are granted as part
of the pilot program should submit a meeting information package
electronically with ``MIDD Pilot Program Meeting Package for CDER''
(CDER applications) or ``MIDD Pilot Program Meeting Package for CBER''
(CBER applications) in the subject line no later than 30 days before
each (initial and followup) meeting. This meeting package should
include the following information:

    1. Product name.
    2. Application number.
    3. Chemical name and structure.
    4. Proposed indication(s) or context of product development.
    5. Background section that includes a brief history of the
development program and the events leading up to the meeting, and the
status of product development.
    6. Proposed agenda, including estimated times needed for discussion
of each agenda item.
    7. List of questions for discussion with a brief summary for each
question to explain the need or context for the question.
    8. Drug development issue (e.g., dosing, clinical trial design,
safety prediction), including the proposed MIDD approach to the
solution, information to support discussion (e.g., a description of the
data used for developing the models, model development, simulation
plan, results), and how the Agency can help guide any next steps
relative to the regulatory decision making process, which should be
summarized and clearly articulated with any supporting data imperative
to the discussion.

E. Meeting Summaries

    A meeting summary will be sent to the requester within 60 days of
each meeting.

IV. Paperwork Reduction Act of 1995

    This notice refers to collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection
of information resulting from formal meetings between sponsors or
applicants and FDA has been approved under OMB control number 0910-
0429. The collection of information in 21 CFR part 312 (INDs) has been
approved under OMB control number 0910-0014.

    Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08010 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35349-35351]
[FR Doc No: 2013-13897]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69710; File No. SR-MIAX-2013-26]

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

June 6, 2013.
    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 30, 2013, Miami International Securities Exchange LLC
(``MIAX'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing a proposal to amend its Fee Schedule.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to waive all transaction fees in Section
1(a)(i) of the MIAX Options Fee Schedule that apply to Market Makers
\3\ registered on the Exchange for the period beginning June 3, 2013
and ending July 31, 2013.\4\ Specifically, during this period, the
Exchange will waive the following transaction fees: (i) RMMs $0.23 per
contract for standard options or $0.023 for Mini Options; (ii) LMMs
$0.20 per contract for standard options or $0.020 for Mini Options;
(iii) DLMMs and PLMMs $0.18 per contract for standard options or $0.018
for Mini Options; and (iv) DPLMMs $0.16 per contract for standard
options or $0.016 for Mini Options.\5\
---------------------------------------------------------------------------

    \3\ Market Makers may be registered as a Lead Market Maker or as
a Registered Market Maker. See Exchange Rule 600(b). Market Makers
registered on the Exchange for purposes of the transaction fee
waiver and Section 1(a)(i) of the Fee Schedule include: (i)
Registered Market Maker (``RMM''); (ii) Lead Market Maker (``LMM'');
(iii) Directed Order Lead Market Maker (``DLMM''); (iv) Primary Lead
Market Maker (``PLMM''); and Directed Order Primary Lead Market
Maker (``DPLMM''). See MIAX Options Fee Schedule, Section 1(a)(i)--
Market Maker Transaction Fees.
    \4\ The fee waiver will only apply to Market Maker transaction
fees in Section 1(a)(i) of the MIAX Options Fee Schedule. See MIAX
Options Fee Schedule, Section 1(a)(i)--Market Maker Transaction
Fees. The Exchange notes that the proposal will have no effect on
other fees and dues that may apply to Market Makers including
marketing fees, Options Regulatory Fees, market data, and membership
application fees. At the end of the period, Market Maker Transaction
Fees will return to the prior fee rates unless the Exchange files
another 19b-4 Rule Filing to amend its fees.
    \5\ See MIAX Options Fee Schedule, Section 1(a)(i)--Market Maker
Transaction Fees.
---------------------------------------------------------------------------

    The proposed fee waiver is designed to both enhance the Exchange's
competitiveness with other option exchanges and strengthen its market
quality. The Exchange believes that the proposed change would increase
both intermarket and intramarket competition by incenting market
participants and market makers on other exchanges to register as Market
Makers on the Exchange. In addition, the Exchange believes that waiving
transaction fees for Market Makers registered on the Exchange will
promote tighter bid-ask spreads by Market Makers, and increase the
volume of transactions in order to allow the Exchange to compete more
effectively with other options exchanges for such transactions.
    The Exchange notes that, while the proposal is not based on that of
another exchange, that fee waivers are often used by exchanges to
increase their competitiveness.\6\
---------------------------------------------------------------------------

    \6\ See e.g., Securities Exchange Act Release Nos. 66427
(February 21, 2012), 77 FR 11608 (February 27, 2012) (SR-BATS-2012-
011); 65007 (August 2, 2011), 76 FR 48190 (August 8, 2011) (SR-CBOE-
2011-071); 56862 (November 29, 2007), 72 FR 68918 (December 6, 2007)
(SR-CBOE-2007-135); 55833 (May 31, 2007), 72 FR 31358 (June 6, 2007)
(SR-ISE-2007-28).
---------------------------------------------------------------------------

    The proposed rule change will take effect on June 3, 2013.
Technical Change
    In addition to the changes above, the Exchange proposes a technical
change to the Fee Schedule to delete an obsolete date. Specifically,
the Exchange proposes to delete the language ``Effective April 17,
2013'' from the heading in Section 1 of the Fee Schedule. The Exchange
believes that including this date in the Fee Schedule in this location
is unnecessary going forward.
2. Statutory Basis
    The Exchange believes that its proposal to amend its fee schedule
is consistent with Section 6(b) of the Act \7\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \8\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among Exchange members.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed fee waiver is fair,
equitable and not unreasonably discriminatory. The proposed fee waiver
is reasonable because it waives transaction fees for a limited period
in order to enable the Exchange to improve its overall competitiveness
and strengthen its market quality for all market participants. The
proposed fee waiver is fair and equitable and not unreasonably
discriminatory because it will apply equally to all Market Makers. All
similarly situated Market Makers are subject to the same fee waiver,
and access to the Exchange is offered on

terms that are not unfairly discriminatory. The registration as an
Exchange Market Maker is equally available to all market participants
and Electronic Exchange Members (``EEMs'') that satisfy the
requirements of Rule 600. Any market participant may choose to satisfy
the additional requirements and obligations of being a Market Maker in
order to qualify for the transaction fee waiver.
    The proposal to waive the transaction fees for Market Makers, and
no other market participants, is equitable and not unfairly
discriminatory because Market Markers on the Exchange have enhanced
quoting obligations measured in both quantity (% time) and quality
(minimum bid-ask differentials) that other market participants do not
have.\9\ The proposal is reasonably designed to enhance the quality of
quoting and volume transactions by limiting the proposal to those
market participants that have these enhanced obligations to deliver
quality markets. Waiving fees during this period should incent market
participants and market makers on other exchanges to register as Market
Makers on the Exchange, which will enhance the quality of quoting and
increase the volume of contracts traded here. To the extent that this
purpose is achieved, all the Exchange's market participants should
benefit from the improved market liquidity. Enhanced market quality and
increased transaction volume that results from the anticipated increase
in Market Maker activity on the Exchange will benefit all market
participants and improve competition on the Exchange.
---------------------------------------------------------------------------

    \9\ See MIAX Rules 603, 604, 605.
---------------------------------------------------------------------------

    The Exchange believes that an increase in the number of Market
Makers, and an increase in the execution volume from Market Makers,
will result in increased revenue from other fees and dues that may
apply to Market Makers that may potentially offset a portion of the fee
waiver.\10\ While the Exchange believes that an increase in the number
of Market Makers, and an increase in the execution volume from Market
Makers, may potentially result in increased trading activity of other
market participants, the Exchange does not believe that the fee waiver
will result in other market participants subsidizing the activity of
Market Makers during the fee waiver period since the Exchange is not
proposing any changes to increase the existing fees of other market
participants in order to compensate for the temporary transaction fee
waiver.
---------------------------------------------------------------------------

    \10\ The Exchange notes that the proposal will have no effect on
other fees and dues that may apply to Market Makers including
marketing fees, Options Regulatory Fees, market data, and membership
application fees.
---------------------------------------------------------------------------

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
proposed change would increase both intermarket and intramarket
competition by incenting market participants and market makers on other
exchanges to register as Market Makers on the Exchange, which will
enhance the quality of quoting and increase the volume of contracts
traded here. To the extent that there is addition [sic] competitive
burden on non-Market Makers, the Exchange believes that this is
appropriate because Market Markers registered on the Exchange have
enhanced quoting obligations measured in both quantity (% time) and
quality (minimum bid-ask differentials) that other market participants
do not have. Waiving fees during this period should incent market
participants and market makers on other exchanges to register as Market
Makers on the Exchange, which will enhance the quality of quoting and
increase the volume of contracts traded here. To the extent that this
purpose is achieved, all the Exchange's market participants should
benefit from the improved market liquidity. Enhanced market quality and
increased transaction volume 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
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive. In such an environment, the
Exchange must continually adjust its fees to remain competitive with
other exchanges and to attract order flow. The Exchange believes that
the proposed rule change reflects this competitive environment because
it reduces the Exchange's fees in a manner that encourages market
participants to register as Market Makers, to provide liquidity, and to
attract order flow to the Exchange. Given the robust competition for
volume among options markets, many of which offer the same products,
implementing a fee waiver program to attract Market Maker volume like
the one being proposed in this filing is consistent with the above-
mentioned goals of the Act. This is especially true for the smaller
options markets, such as MIAX, which is competing for volume with much
larger exchanges that dominate the options trading industry. As a new
exchange, MIAX has a nominal percentage of the average daily trading
volume in options, so it is unlikely that the fee waiver could cause
any competitive harm to the options market or to market participants.
Rather, the fee waiver is a modest attempt by a small options market to
attract order volume away from larger competitors by adopting an
innovative pricing strategy. The Exchange notes that if the fee waiver
resulted in a modest percentage increase in the average daily trading
volume in options executing on MIAX, while such percentage would
represent a large volume increase for MIAX, it would represent a
minimal reduction in volume of its larger competitors in the industry.
The Exchange believes that the proposal will help further competition,
because market participants will have yet another additional option in
determining where to execute orders and post liquidity if they factor
the benefits of Market Maker transaction fees into the determination.

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.\11\ 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.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-MIAX-2013-26 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 No. SR-MIAX-2013-26. 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 No. SR-MIAX-2013-26 and should be
submitted on or before July 3, 2013.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13897 Filed 6-11-13; 8:45 am]
BILLING CODE 8011-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="08/07/2008 11:01:20 ">
<TITLE></TITLE>