[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7807-7809]
[FR Doc No: 2016-02977]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0407]

Proposed Pilot Project(s) Under the Drug Supply Chain Security
Act; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Proposed Pilot Project(s) under the Drug Supply
Chain Security Act (DSCSA).'' This public workshop will provide a forum
for discussing proposed design objectives of pilot projects that will
explore and evaluate methods to enhance the safety and security of the
pharmaceutical distribution supply chain. FDA would like to obtain
information and input from interested pharmaceutical distribution
supply chain members about issues related to utilizing the product
identifier for product tracing, improving the technical capabilities of
the supply chain, and identifying the system attributes that are
necessary to implement the requirements established under the DSCSA.
The information gathered from the workshop and the public comments
submitted to the docket will further inform FDA's development of its
pilot project program.

DATES: The public workshop will be held on April 5, 2016, from 9 a.m.
to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for
submitting either electronic or written comments on this workshop is
April 21, 2016. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the confirmed
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-0407 for ``Proposed Pilot Project(s) under the Drug Supply
Chain Security Act; Public Workshop; Request for Comments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130<EMAIL_ADDRESS>(include ``DSCSA
pilot projects'' in the subject line).

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system by November
27, 2023, which will identify and trace certain prescription drugs as
they are distributed within the United States. Section 202 of the DSCSA
added the new sections 581 and 582 to the Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(j), FDA
is required to establish one or more pilot projects, in coordination
with authorized manufacturers, repackagers, wholesale distributors, and
dispensers, to explore and evaluate methods to enhance the safety and
security of the pharmaceutical distribution supply chain.
    FDA intends to establish a pilot project program to implement
section 582(j) of the FD&C Act. The overarching goals of this program
include assessing the ability of supply chain members to satisfy the
requirements of section 582 and to identify, manage, and prevent the
distribution of suspect and illegitimate drugs; identifying the system
attributes needed to implement the requirements of section 582,
particularly the requirement to utilize a product identifier for
product tracing purposes; and demonstrating the electronic,
interoperable exchange of product tracing information across the
pharmaceutical distribution supply chain. FDA intends to coordinate its
pilot project program efforts with stakeholders that reflect the
diversity of the pharmaceutical distribution supply chain, including
large and small entities from all industry sectors.

II. Purpose of the Public Workshop

    This public workshop is intended to provide an opportunity for
interested persons to provide comments on and discuss the proposed
design objectives of pilot projects that will explore and evaluate
methods to enhance the safety and security of the pharmaceutical
distribution supply chain. FDA would like to obtain information and
input from interested pharmaceutical distribution supply chain members
about issues related to utilizing the product identifier for product
tracing, improving the technical capabilities of the pharmaceutical
distribution supply chain, and identifying the system attributes that
are necessary to implement the requirements under section 582. FDA
would also like to learn more about the practices, processes, and
systems that supply chain stakeholders currently use or plan to use to
meet the requirements under section 582, particularly the product
tracing and verification requirements. These practices, processes, and
systems may include those that supply chain stakeholders would consider
using in pilot projects or those that supply chain stakeholders have
already used in other previous pilot projects.
    By March 29, 2016, FDA will post the workshop agenda and other
relevant materials under the DSCSA section of its Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Supply chain stakeholders
that might be interested in attending the public workshop include
manufacturers, repackagers, wholesale distributors, dispensers, State
and Federal authorities, solution providers, and standards
organizations. Participants at the workshop will not be asked to
develop consensus opinions during the discussion, but rather to provide
their individual perspectives.
    Regardless of attendance at the public workshop, interested
stakeholders may submit comments to the public docket related to any of
the public workshop materials, including the agenda and other posted
materials on FDA's Web site, in addition to comments specific to the
design of pilot projects that will explore and evaluate methods to

enhance the safety and security of the pharmaceutical distribution
supply chain. Stakeholders may comment on utilizing the product
identifier for product tracing and the technical capabilities of the
pharmaceutical distribution supply chain and the system attributes that
are necessary to implement the requirements under section 582. The
information gathered from the workshop participants and from the
comments submitted to the docket for the public workshop will further
inform FDA's development of its pilot project program under section
582(j) of the FD&C Act.

III. Registration for the Public Workshop

    To request registration for the public workshop, provide your
information including name, company or organization, address, telephone
number, and email address to FDA at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests should be received by
March 11, 2016. FDA is limiting workshop attendance due to limited
space. FDA may limit the number of participants from each organization
based on space limitations. FDA recommends that each organization
determine who should register for the workshop to represent his/her
organization. This will help ensure that the workshop will have broad
and varied representation across the pharmaceutical distribution supply
chain. Registrants will receive confirmation of participation for the
workshop from FDA by March 18, 2016. There is no registration fee for
the public workshop. There will be no onsite registration. If
registration reaches maximum capacity, FDA will post a notice closing
registration for the workshop on FDA's Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. If you need special accommodations due
to a disability, please contact Daniel Bellingham (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the public workshop.

IV. Webcasting of the Public Workshop

    Portions of this public workshop will be recorded and Webcasted on
the day of the workshop. Information for how to access the Webcast will
be available at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm by
March 29, 2016. The Webcast will be conducted in listening-mode only.

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02977 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63938-63940]
[FR Doc No: 2022-22329]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0886; Project Identifier MCAI-2022-00261-T;
Amendment 39-22193; AD 2022-20-09]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier, Inc., Model BD-700-2A12 airplanes. This AD was
prompted by reports of insufficient clearance between the surrounding
structure/skin of the aircraft and select bleed air ducts that supply
the wing ice protection system (WIPS) in the rear fuselage. This AD
requires inspecting the bleed air duct and surrounding structure for
minimum clearance and damage, and applicable corrective actions. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective November 25, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 25,
2022.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0886; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email bombardier.com">[email protected]bombardier.com; website
bombardier.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des

Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available at regulations.gov under
Docket No. FAA-2022-0886.

FOR FURTHER INFORMATION CONTACT: Elizabeth Dowling, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Bombardier,
Inc., Model BD-700-2A12 airplanes. The NPRM published in the Federal
Register on July 21, 2022 (87 FR 43462). The NPRM was prompted by AD
CF-2022-05, dated February 24, 2022, issued by Transport Canada Civil
Aviation (TCCA), which is the aviation authority for Canada (referred
to after this as the MCAI). The MCAI states that insufficient clearance
exists between the surrounding structure/skin of the aircraft and
select bleed air ducts that supply the WIPS in the rear fuselage on the
aircraft. Without sufficient clearance, the high pressure (HP) shroud
could interfere with the surrounding structures and possibly compromise
the HP ducting shroud's capability to provide bleed air leak routing,
which could result in a bleed air leak being undetected. A significant
undetected bleed air leak could expose the surrounding structure to
heat stress, resulting in reduced structural integrity of the airplane.
    In the NPRM, the FAA proposed to require inspecting the bleed air
duct and surrounding structure for minimum clearance and damage, and
applicable corrective actions. The FAA is issuing this AD to address
the unsafe condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-0886.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 700-36-7502, dated October
28, 2020. This service information describes procedures for inspecting
the bleed air duct and surrounding structure for minimum clearance and
damage (wear and chafing), and corrective actions. Corrective actions
include adjusting the ductwork if clearance is below the minimum
required, and repairing any damage. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 8 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hours x $85 per hour = $85............................              $1              $86             $688
----------------------------------------------------------------------------------------------------------------

                 Estimated Costs of On-Condition Actions
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                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
Up to 22 work-hours x $85 per hour =                $0           $1,870
 $1,870...............................
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and

    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-20-09 Bombardier, Inc.: Amendment 39-22193; Docket No. FAA-
2022-0886; Project Identifier MCAI-2022-00261-T.

(a) Effective Date

    This airworthiness directive (AD) is effective November 25,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-700-2A12
airplanes, certificated in any category, serial numbers 70006,
70007, 70009 through 70019 inclusive, 70021 through 70029 inclusive,
and 70031.

(d) Subject

    Air Transport Association (ATA) of America Code 36, Pneumatic.

(e) Unsafe Condition

    This AD was prompted by reports of insufficient clearance
between the surrounding structure/skin of the aircraft and select
bleed air ducts that supply the wing ice protection system (WIPS) in
the rear fuselage. The FAA is issuing this AD to address possible
interference between the high pressure (HP) shroud and the
surrounding structures, which could compromise the HP ducting
shroud's capability to provide bleed air leak routing and result in
a bleed air leak being undetected. A significant undetected bleed
air leak could expose the surrounding structure to heat stress,
resulting in reduced structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 21 months after the effective date of this AD: Inspect
the affected bleed air ducts and surrounding structure for minimum
clearance and damage (wear or chafing), and do all applicable
corrective actions in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 700-36-7502, dated
October 28, 2020. Do all applicable corrective actions before
further flight.

(h) No Reporting Requirement

    Although Bombardier Service Bulletin 700-36-7502, dated October
28, 2020, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(i) Other AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Additional Information

    (1) Refer to TCCA AD CF-2022-05, dated February 24, 2022, for
related information. This TCCA AD may be found in the AD docket at
regulations.gov under Docket No. FAA-2022-0886.
    (2) For more information about this AD, contact Elizabeth
Dowling, Aerospace Engineer, Mechanical Systems and Administrative
Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 700-36-7502, dated October 28,
2020.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email bombardier.com">[email protected]bombardier.com; website
bombardier.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 19, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-22329 Filed 10-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69465-69468]
[FR Doc No: 2013-27620]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70854; File No. SR-NYSEMKT-2013-90]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Commentary .09
to Rule 903 To Modify the Quarterly Option Series Program To Eliminate
the Cap on the Number of Additional Series That May Be Listed Per
Expiration Month for Each QOS in Exchange-Traded Fund Options

November 13, 2013.
    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 November 5, 2013, NYSE MKT LLC (the ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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.
---------------------------------------------------------------------------

    \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 Commentary .09 to Rule 903 to modify
the Quarterly Option Series (``QOS'') Program to eliminate the cap on
the number of additional series that may be listed per expiration month
for each QOS in exchange-traded fund (``ETF'') options. 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend Commentary .09(d) to Rule 903
related to the QOS Program to eliminate the cap on the number of
additional series that may be listed per expiration month for each QOS
in ETF options.\4\ As set out in Commentary .09, the Exchange may list
QOS for up to five currently listed options classes that are either
index options or options on ETFs. The Exchange may also list QOS on any
option classes that are selected by other securities exchanges that
employ a similar program under their respective rules. Currently, for
each QOS in ETF options that has been initially listed on the Exchange,
the Exchange may list up to 60 additional series per expiration month.
---------------------------------------------------------------------------

    \4\ A Quarterly Option Series is a series of an option class
that is approved for listing and trading on the Exchange in which
the series is opened for trading on any business day, and that
expires at the close of business on the last business day of a
calendar quarter. The Exchange lists series that expire at the end
of the next consecutive four (4) calendar quarters, as well as the
fourth quarter of the next calendar year. See Rules 900C(26) and
903, Commentary .09(a).
---------------------------------------------------------------------------

    The Exchange is proposing to amend Commentary .09(d) to make the
treatment of QOS in ETF options consistent with the treatment of QOS in
stock index options. Rule 900C(a)(iv) [sic] governs the QOS Program in
stock index options. A stock index option is ``an option contract on a
specific stock index group.'' \5\ Options on ETFs are similar to index
options because ETFs hold securities based on an index or portfolio of
securities.\6\ The requirements and conditions of the QOS Program in
index options, moreover, parallel those of the QOS Program in ETF
options. For example, like the QOS Program in ETF options, the QOS
Program in index options permits QOS in up to five currently-listed
options

classes; requires the listing of series that expire at the end of the
next (as of the listing date) consecutive four quarters, as well as the
fourth quarter of the next calendar year; requires the strike price of
each QOS to be fixed at a price per share; and establishes parameters
for the number of strike prices above and below the underlying index.
The QOS Program in index options, however, does not place a cap on the
number of additional series that the Exchange may list per expiration
month for each QOS in index options. Elimination of the cap set out in
Commentary .09(d), therefore, would result in similar regulatory
treatment of similar options products.\7\
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    \5\ Rule 900C(b)(2). ``Stock index group'' means: ``[A] group of
stocks each of whose inclusion and relative representation in the
group is determined by the inclusion and relative representation of
their current market values or market prices in a widely
disseminated stock index. A stock index group may relate to a stock
index which reflects representative stock market values or prices of
either a broad segment of the stock market (``broad stock index
group'') or stocks representing a particular industry or related
industries (``stock index industry group'').'' Rule 900C(b)(1).
    \6\ Rule 900.2NY(24) defines ``Exchange-Traded Fund Share'' as
``Exchange-listed securities representing interests in open-end unit
investment trusts or open-end management investment companies that
hold securities (including fixed income securities) based on an
index or a portfolio of securities.''
    \7\ The Exchange notes that Rule 903C(a)(iv)(4), which governs
the addition of new series of Quarterly Options Series on index
options, states: ``The Exchange may open additional strike prices of
a Quarterly Options Series that are above the value of the
underlying index provided that the total number of strike prices
above the value of the underlying index is no greater than five. The
Exchange may open additional strike prices of a Quarterly Options
Series that are below the value of the underlying index provided
that the total number of strike prices is below the value of the
underlying index is no greater than five. The opening of any new
Quarterly Options series shall not affect the series of options of
the same class previously opened.'' In practice, this means that the
Exchange may add Quarterly Options Series at strikes above and below
the current index value, so long as there are not more than five
strikes above, and five strikes below, the current index value after
such additions are made. The total number of Quarterly Options
Series that can be listed at any one time is, therefore,
theoretically unlimited, so long as there are no more than five
strikes above (or below) a given index value when new strikes are
added.
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    The Exchange believes that the proposed revision to the QOS Program
would provide market participants with the ability to better tailor
their trading to meet their investment objectives, including hedging
securities positions, by permitting the Exchange to list additional QOS
in ETF options that meet such objectives. The Exchange has observed
that situations arise in which the market value of the ETF underlying
QOS moves to the point that additional strike prices in smaller
intervals would be valuable to investors. However, due to the cap on
additional QOS series, the Exchange cannot always provide these
important at-the-money strikes. Elimination of the cap would remedy
this issue.
    Currently, the Exchange lists quarterly expiration options on six
ETFs, but the cap restricts the number of strikes on these options,
which often results in a lack of strike continuity. For example, the
Exchange lists quarterly expiration options on SPDR Gold Trust
(``GLD''). On January 2, 2013, the Exchange initially listed December
31, 2013 quarterly expiration options (``December 2013 Quarterlies'')
on GLD, which closed the previous trading day at $162.02, with initial
strikes from $115 to $210, and additional strikes in $1 intervals from
$131 to $189. But during 2013, GLD has closed at a range of $115.94 to
$163.67 and is currently trading around $125. As a result of the cap,
the Exchange cannot offer December 2013 Quarterlies on GLD in $1
intervals within $10 of the closing price of GLD because the number of
strikes would exceed the cap of 60 additional strikes. Consequently,
the Exchange is not able to list important at-the-money strikes due to
the cap on additional strikes. While the Exchange has the ability to
delist strikes with no open interest so that it may list strikes that
are closer to the money, delisting is not always possible. If all of
the existing strikes have open interest, the Exchange cannot delist
strikes so that it may list strikes closer to the money.
    But the Exchange is not subject to a similar cap on the number of
additional weekly or monthly expiration options it can list on ETFs.\8\
So, for example, the Exchange can list additional weekly expiration
options on GLD in $1 and $0.50 intervals within $5 of the closing price
of GLD, and additional monthly expiration options in $1 intervals from
$85 to $178. Therefore, due to the cap, the Exchange cannot list, and
an investor cannot structure, an investment on a quarterly basis with
the same granularity that can be achieved on a weekly or monthly basis.
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    \8\ For Short Term Options Series (``weekly options''),
commentary .10 to Rule 903 sets a maximum number of strikes, but the
Exchange can exceed this maximum number of strikes under certain
circumstances. Specifically, ``in the event that the underlying
security has moved such that there are no series that are at least
10% above or below the current price of the underlying security and
all existing series have open interest, the Exchange may list
additional series, in excess of the 30 allowed under Commentary .10,
that are between 10% and 30% above or below the price of the
underlying security.''
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    Similarly, the Exchange lists quarterly options on SPDR S&P 500 ETF
(``SPY''), which during 2013 closed at a range of $145.55 to $173.05.
Again, due to the cap, the Exchange cannot offer quarterly expiration
options on SPY in $1 intervals above $170 because the number of
additional strikes would exceed the cap of 60. Instead, the Exchange is
forced to list quarterly expiration options on SPY at $5 intervals
above $170, despite the fact that SPY has recently traded between $165
and $170. As such, if SPY would again increase to $170, then the
Exchange would only be able to offer options with a strike price $5
away from the price of the underlying ETF due to the cap on additional
strikes.
    On the other hand, in contrast to the limitations imposed on the
Exchange for quarterly expiration options on ETFs, the absence of a
similar cap on quarterly expiration options on indexes means that the
Exchange can list, and investors can achieve, more granularity in
index-based options. For example, S&P 500 Mini--SPX options (``SPX'')
are options on the S&P 500 index, as opposed to options on SPY, the ETF
based on that same S&P 500 index. SPX options are used to hedge SPY
positions and are traded at the equivalent of one point and one-half
point intervals. The SPX trades at 10 times the value of SPY, so that
if SPY trades at $168.70, SPX trades at $1687. Therefore, the strike
price for a quarterly expiration option on SPX, that is a hedge for a
quarterly expiration option on SPY at $170, would be $1700. The
Exchange can offer quarterly expiration options on SPX with strike
prices of $1670, $1680, $1690, and $1700 because there is no cap on
quarterly expiration index-based options. However, the Exchange cannot
similarly offer quarterly expiration options on SPY with similar strike
price continuity because of the cap on quarterly expiration ETF-based
options.
    Elimination of the cap would also help market participants meet
their investment objectives by providing expanded opportunities to roll
ETF options into later quarters. For example, a market participant that
holds one or more contracts in a QOS in an ETF put option that has a
strike price of $120 and an expiration date of the last day of the
third quarter may wish to roll that position into the fourth quarter.
That is, the market participant may wish to close out the contracts set
to expire at the end of the third quarter and instead establish a
position in the same number of contracts in a QOS in a put option on
the same ETF with the same strike price of $120, but with an expiration
date of the last day of the fourth quarter. Because of the cap on
additional QOS in ETF options, however, the Exchange may not be able to
list additional QOS in the ETF. Elimination of the cap, though, would
allow the Exchange to meet the investment needs of market participants
in such situations.
    The Exchange has sufficient capacity to handle increased quote and
trade reporting traffic that might be expected to result from listing
additional QOS in ETF options. The Exchange notes that it has purchased
capacity from the Options Price Reporting Authority (``OPRA'') to
handle its options quote and trade reporting traffic.\9\ The

Exchange believes that it has acquired sufficient capacity to handle
increased quote and trade reporting traffic that might be expected to
result from listing additional QOS in ETF options.\10\ In the
Exchange's view, it would be inconsistent to prohibit the listing of
additional QOS beyond a specified cap when each exchange independently
purchases capacity to meet its quote and trade reporting traffic needs.
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    \9\ See Exchange Act Release No. 48822 (Nov. 21, 2003), 68 FR
66892 (Nov. 28, 2003) (SR-OPRA-2003-01) (requiring exchanges to
acquire options market data transmission capacity independently,
rather than jointly).
    \10\ The SEC has relied upon an exchange's representation that
it has sufficient capacity to support new options series in
approving a rule amendment permitting the listing of additional
option series. See Exchange Act Release No. 57410 (Jan. 17 [sic],
2008), 73 FR 12483, 12484 (Mar. 7, 2008) (SR-CBOE-2007-96)
(amendments to CBOE Rule 5.5(e)(3)) (``In approving the proposed
rule change, the Commission has relied upon the Exchange's
representation that it has the necessary systems capacity to support
new options series that will result from this proposal'').
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    Moreover, the Exchange has in place a quote mitigation plan that
helps it maintain sufficient capacity to handle quote traffic. The
plan, which has been approved by the Commission, reduces the number of
quotations that the Exchange disseminates by limiting disseminated
quotes to active options series only.\11\
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    \11\ The Exchange's quote mitigation plan is set out in Rule
970.1NY, adopted in 2009.
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    To help ensure that only active options series are listed, the
Exchange also has in place procedures to delist inactive series.
Commentary .09(f) to Rule 903 requires the Exchange to review QOS that
are outside of a range of five strikes above and five strikes below the
current price of the underlying ETF. Based on that review, the Exchange
must delist series with no open interest in both the call and the put
series having (i) a strike price higher than the highest price with
open interest in the put and/or call series for a given expiration
month, and (ii) a strike price lower than the lowest strike price with
open interest in the put and/or call series for a given expiration
month.
    Finally, the Exchange is proposing to update an outdated cross-
reference in Commentary .09(d) to Rule 903. Commentary .09(d) currently
states that the term ``Exchange-Traded Fund Share'' is defined in Rule
900(b)(42); however, that term is defined in Rule 900.2NY(24). The
Exchange proposes to update the language accordingly.
 2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of Section
6(b)(5),\13\ in particular, in that it is designed to promote just and
equitable principles of trade, to remove impediments to, and perfect
the mechanism of a free and open market and, in general, to protect
investors and the public interest.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market because it will expand the investment options available to
investors and will allow for more efficient risk management. The
Exchange believes that removing the cap on the number of QOS in ETF
options permitted to be listed on the Exchange will result in a
continuing benefit to investors by giving them more flexibility to
closely tailor their investment and hedging decisions to their needs,
and therefore, the proposal is designed to protect investors and the
public interest. Additionally, by removing the cap, the proposed rule
change will make the treatment of QOS in ETF options consistent with
the treatment of QOS in index options, thus resulting in similar
regulatory treatment for similar options products.
    While the expansion of the number of QOS in ETF options is expected
to generate additional quote traffic, the Exchange believes that this
increased traffic will be manageable and will not present capacity
problems. As previously stated, the Exchange has in place a quote
mitigation plan that helps it maintain sufficient capacity to handle
quote traffic. To help ensure that only active options series are
listed, Exchange procedures are designed to delist inactive series,
ensuring that any additional quote traffic is a result of interest in
active series.
    Finally, amending Commentary .09(d) to Rule 903 to correct an
outdated cross-reference to the definition of Exchange-Traded Fund
Shares will remove impediments to, and perfect the mechanism of a free
and open market system. The Exchange believes that the proposed rule
change will resolve any investor confusion regarding the incorrect
cross-reference, and ensures that the Exchange provides a clear and
well-defined rule set.

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. Specifically, the Exchange
believes that investors would benefit from the introduction of
additional QOS in ETF options by providing investors with more
flexibility to closely tailor their investment and hedging decisions to
their needs. Additionally, Exchange procedures for delisting inactive
series will ensure that only active series with sufficient investor
interest will be made available and maintained on the Exchange.

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 does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(6)
\15\ thereunder.
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change 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.
---------------------------------------------------------------------------

    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 under
Section 19(b)(2)(B) \16\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \16\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-2013-90 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-NYSEMKT-2013-90. 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 the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2013-90 and should
be submitted on or before December 10, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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 Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27620 Filed 11-18-13; 8:45 am]
BILLING CODE 8011-01-P