[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Page 67365]
[FR Doc No: 2013-26891]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Circulatory System Devices Panel of the Medical
Devices 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 December 11, 2013, from
8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>.
    Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On December 11, 2013, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application regarding the Boston Scientific WATCHMAN Left
Atrial Appendage (LAA) Closure Technology. The WATCHMAN LAA Closure
Technology is a percutaneously delivered permanent cardiac implant
placed in the left atrial appendage. This device is intended to prevent
thrombus embolization from the left atrial appendage, thereby
preventing the occurrence of ischemic stroke and systemic embolism, and
reduce the risk of life-threatening bleeding events in patients with
non-valvular atrial fibrillation who are eligible for warfarin therapy.
    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 meeting
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
November 27, 2013. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 November 19, 2013. 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 November 20, 2013.
    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 Ann Marie Williams,
Conference Management Staff, at<EMAIL_ADDRESS>or 301-
796-5966 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: November 5, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-26891 Filed 11-8-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 172 (Wednesday, September 5, 2012)]
[Notices]
[Page 54601]
[FR Doc No: 2012-21747]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4078-DR; Docket ID FEMA-2012-0002]

Oklahoma; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oklahoma (FEMA-4078-DR), dated August 22,
2012, and related determinations.

DATES: Effective Date: August 22, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 22, 2012, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Oklahoma resulting from the Freedom Wildfire during the period of
August 3-14, 2012, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Oklahoma.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance in the
designated area and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation and Other Needs Assistance will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, William J. Doran III, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Oklahoma have been designated
as adversely affected by this major disaster:

    Creek County for Individual Assistance.
    All counties within the State of Oklahoma are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-21747 Filed 9-4-12; 8:45 am]
BILLING CODE 9110-23-P


[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Pages 3850-3853]
[FR Doc No: 2016-01199]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76920; File No. SR-OC-2015-03]

Self-Regulatory Organizations; OneChicago, LLC; Notice of Filing
of Proposed Rule Change Relating to the Summary Imposition of Fines

January 15, 2016.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(the ``Act''),\1\ notice is hereby given that on December 30, 2015,
OneChicago, LLC (``OneChicago,'' ``OCX,'' or the ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change described in Items I, II, and III 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. OneChicago has also filed
this rule change with the Commodity Futures Trading Commission
(``CFTC''). OneChicago filed a written certification with the CFTC
under Section 5c(c) of the Commodity Exchange Act (``CEA'') on December
29, 2015.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    OneChicago is proposing to amend OCX Rule 717 (Summary Imposition
of Fines) and concurrently issue Notice to Members (``NTM'') 2015-48.
OCX Rule 717 lays out OneChicago's summary fine procedure.
Specifically, OCX Rule 717 lists the violations for which the Exchange
may impose summary fines, as well as the process the Exchange must
follow to impose such fines. OneChicago proposes to amend Rule 717 to
add several rule violations to the list of items for which the Exchange
may impose summary fines. In addition to adding several rule violations
for which the Exchange may impose summary fines, OCX is also proposing
to add a summary fine schedule for each rule violation. The summary
fine schedule informs market participants of the fines for each rule
violation based on the number of offenses within a rolling twelve month
period. OCX developed this summary fine schedule with input from the
CFTC staff, and many of the summary fines are in line with summary
fines for similar violations at other security futures exchanges.\2\
OneChicago is also making minor technical changes to OCX Rule 717 to
support the foregoing amendments to the rule.
---------------------------------------------------------------------------

    \2\ See, e.g., CFE Rule 714(f).
---------------------------------------------------------------------------

    OneChicago is concurrently issuing NTM 2015-48. The NTM informs
market participants that OneChicago is amending OCX Rule 717.
Additionally, the NTM lists the violations for which summary fines may
be imposed. Then, in order to provide market participants with more
clarity regarding the rule violations, guidance is provided regarding
what activity or omission the Exchange would consider to constitute a
violation of the listed rules.
    Finally, OneChicago is also amending OCX Rule 705 (Review of
Investigative Reports). OCX Rule 705 describes the process by which the
OneChicago Chief Regulatory Officer (``CRO'') will review investigation
reports conducted by the Compliance Department. OneChicago proposes to
amend OCX Rule 705 to allow the CRO to authorize the summary imposition
of fines as a result of an investigation.
    The text of the proposed rule change is attached as Exhibit 4 to
the filing submitted by the Exchange but is not attached to the
published notice of the filing.

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

    In its filing with the Commission, OneChicago 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 self-regulatory organization has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
OCX Rule 717 (Summary Imposition of Fines)
    OCX Rule 717 lays out the Exchange's summary fine authority.
Currently, the Rule describes that the Chief Regulatory Officer may
summarily impose a fine against a Member for failing (i) to make timely
payments of original or variation margin, options premiums, fees, cost,
charges or fines to the Exchange or the Clearinghouse; (ii) to make
timely and accurate submissions to the Exchange of notices, reports or
other information required by the Rules of the Exchange; and (iii) to
keep any books and records required by the Rules of the Exchange.
    Additionally, in its current form, the Rule describes what
requirements the Exchange must follow when issuing a summary fine
pursuant to Rule 717. The Exchange must provide notice of any summary
fine imposed, and the notice must contain the violations of the Rules
of the Exchange for which the fine was imposed, the violation date, and
the amount of the fine. Furthermore, the Rule describes the
requirements for the Member or Access Person to pay the fine or to
appeal the fine pursuant to OCX Rule 716. Finally, Rule 717 then sets
the maximum fine for each violation at $5,000, and explains that the
summary imposition of fines does not preclude the Exchange from
bringing any other action against the fined market participant.
    OneChicago is now proposing to make certain amendments to this Rule
717. Namely, OCX is proposing to add to Rule 717 a list of items for
which summary fines may be imposed. The items added generally relate to
violations of reporting, audit trail, recordkeeping, and other Exchange
Rules. The list of items which OneChicago proposes to add to Rule 717
and their associated proposed summary fines as described below:
     Failure to make timely payments of fees, costs, or charges
to the Exchange or Clearinghouse. The proposed summary fines for this
rule violation are a warning letter for the first offense, $1,000 fine
for the second offense, $2,500 fine for the third offense, and $5,000
for all subsequent offenses within a rolling twelve month period.
     Failure to make timely and accurate submissions to the
Exchange of notices, reports or other information required by the Rules
of the Exchange. The proposed summary fines for this rule

violation are a warning letter for the first offense, $2,500 fine for
the second offense, $5,000 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses,
within a rolling twelve month period. The proposed summary fines for
this rule violation are elevated because failure to submit timely and
accurate reports to the Exchange impairs the Exchange's ability to
carry out its self-regulatory obligations.
     Failure to maintain front-end audit trail information for
all electronic orders entered into the OneChicago System, including
order modifications and cancellations. The proposed summary fines for
this rule violation are a warning letter for the first offense, $1,000
fine for the second offense, $2,500 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period.
     Failure to keep any books and records required by the
Rules of the Exchange. The proposed summary fines for this rule
violation are a warning letter for the first offense, $1,000 fine for
the second offense, $2,500 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period.
     Failure to comply with order form preparation and
recordkeeping requirements relating to orders which cannot be
immediately entered into the OneChicago System. The proposed summary
fines for this rule violation are a warning letter for the first
offense, $1,000 fine for the second offense, $2,500 fine for the third
offense, and the commencement of disciplinary proceedings for all
subsequent offenses within a rolling twelve month period.
     Failure to comply with exposure requirements related to
pre-execution discussions. The proposed summary fines for this rule
violation are a warning letter for the first offense, $10,000 fine for
the second offense, and a $15,000 fine for all subsequent offenses
within a rolling twelve month period. The proposed summary fines for
this rule violation are elevated because pre-arranged trading in
violation of an exchange's pre-execution discussion policy presents the
potential for fraudulent or manipulative behavior on an exchange.
     Failure to comply with Exchange of Future for Physical
transaction reporting requirements. The proposed summary fines for this
rule violation are a warning letter for the first offense, $7,500 fine
for the second offense, $15,000 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period. The proposed summary fines for
this rule violation are elevated because EFPs are bilateral
transactions, the price of which remains unknown to the marketplace
until the trade is reported by the parties to the transaction.
     Failure to identify correct account designation in order
entry into the OneChicago System. The proposed summary fines for this
rule violation are a warning letter for the first offense, $1,000 fine
for the second offense, $2,500 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period.
     Failure to comply with order marking requirement for
Exchange of Future for Physical transactions or block trades. The
proposed summary fines for this rule violation are a warning letter for
the first offense, $1,000 fine for the second offense, $2,500 fine for
the third offense, and the commencement of disciplinary proceedings for
all subsequent offenses within a rolling twelve month period.
     Failure to comply with block trade reporting requirements.
The proposed summary fines for this rule violation are a warning letter
for the first offense, $7,500 fine for the second offense, $15,000 fine
for the third offense, and the commencement of disciplinary proceedings
for all subsequent offenses within a rolling twelve month period. The
proposed summary fines for this rule violation are elevated because
block trades are bilateral transactions, the price of which remains
unknown to the marketplace until the trade is reported by the parties
to the transaction.
     Failure to comply with the prohibition on netting down
concurrent long and short positions during the last five days of
trading. The proposed summary fines for this rule violation are a
warning letter for the first offense, $2,500 fine for the second
offense, $5,000 fine for the third offense, and the commencement of
disciplinary proceedings for all subsequent offenses within a rolling
twelve month period. The proposed summary fines for this rule violation
are elevated because netting down concurrent long and short positions
during expiry week may cause a change in open interest in a particular
product with no commensurate trading activity.
     Failure to identify correct account type in order entry
into the OneChicago System. The proposed summary fines for this rule
violation are a warning letter for the first offense, $1,000 fine for
the second offense, $2,500 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period.
     Failure to timely correct an error in the handling of an
order via transfer. The proposed summary fines for this rule violation
are a warning letter for the first offense, $1,000 fine for the second
offense, $2,500 fine for the third offense, and the commencement of
disciplinary proceedings for all subsequent offenses within a rolling
twelve month period.
     Failure to comply with reporting requirements for
reportable positions. The proposed summary fines for this rule
violation are a warning letter for the first offense, $2,500 fine for
the second offense, $5,000 fine for the third offense, and the
commencement of disciplinary proceedings for all subsequent offenses
within a rolling twelve month period. The proposed summary fines for
this rule violation are elevated because failure to report large trader
positions impairs the Exchange's ability to carry out its self-
regulatory obligations.
     Failure to submit ownership and control reports. The
proposed summary fines for this rule violation are a warning letter for
the first offense, $2,500 fine for the second offense, $5,000 fine for
the third offense, and the commencement of disciplinary proceedings for
all subsequent offenses within a rolling twelve month period. The
proposed summary fines for this rule violation are elevated because
failure to report ownership and control reports impairs the Exchange's
ability to carry out its self-regulatory obligations.
    Additionally, Rule 717 is being amended to increase the maximum
summary fine from $5,000 to $15,000. This change is being made to
accommodate OCX's proposed summary fine schedule, which contains
varying levels of fines ranging from $1,000 to $15,000. The level of
fines for each rule violation generally depend upon the severity of the
rule violation and the potential harm to customers, other market
participants, or the marketplace itself.
    In addition to the above, OCX is proposing to make several other
changes to OCX Rule 717. First, OCX is proposing to add that the CRO
may consider the severity of a rule violation in determining whether to
impose a summary fine for that violation. OCX is making this change to
grant the Exchange flexibility in addressing rule violations based on
the severity of the violation. As is more fully explained in OCX Rule
705, the CRO reserves the right to determine whether an investigation
should be closed with no further action, by issuing a warning

letter, by imposing summary fines, or by commencing disciplinary
proceedings.
    Rule 717 is also being amended to clarify that OCX may impose
summary fines against a Clearing Member, Exchange Member, or Access
Person. Finally, OCX is proposing to remove certain items from OCX Rule
717(a)(i). Currently, that subparagraph allows the CRO to impose
summary fines for a failure to make timely payments of original or
variation margin, options premiums, fees, costs, charges or fines. OCX
is proposing to remove original or variation margin and options
premiums from this list of items because they are not relevant to OCX.
OCX is also removing fines from this list because summary fines would
not be an effective deterrent for a market participant that has failed
to make timely payment of fines already imposed by the Exchange.
NTM 2015-48
    In addition to amending Rule 717, OCX is proposing to concurrently
issue NTM 2015-48, which provides notice to OneChicago's market
participants of the planned amendments to Rule 717, and provides
guidance regarding several of the violations included in the summary
fine schedule. The NTM provides guidance by explaining what may
constitute a rule violation that may be subject to the imposition of
summary fines.
OCX Rule 705 (Review of Investigative Reports)
    OCX Rule 705 describes the process by which the CRO reviews the
Compliance Department's investigative reports in order to determine
whether a reasonable basis exists to believe that a violation within
the Exchange's jurisdiction has occurred or is about to occur. The Rule
then lays out various dispositions the CRO may authorize, including the
commencement of disciplinary proceedings, the informal disposition of
the investigation, or the closing of the investigation with no further
action. OneChicago now proposes to add the summary imposition of fines
to the list of dispositions which the CRO may authorize as a result of
an investigation.
    By way of background, OCX Rule 717 itself does not limit the
summary imposition of fines to the conclusion of an investigation. The
CRO may authorize summary fines in the absence of an investigation
report if a Rule violation is detected. OCX is now clarifying in Rule
705 that the summary imposition of fines is one of the several
dispositions the CRO may authorize upon the Compliance Department's
completion of an investigation.
2. Statutory Basis
    OneChicago believes that the proposed rule change is consistent
with Section 6(b) of the Act,\3\ in general, and furthers the
objectives of Section 6(b)(5) \4\ and 6(b)(7) \5\ in particular in that
it is designed:
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
    \5\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

     To prevent fraudulent and manipulative acts and practices,
     to promote just and equitable principles of trade,
     to foster cooperation and coordination with persons
engaged in facilitating transactions in securities,
     to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and in general, to
protect investors and the public interest, and
     to provide a fair procedure for the disciplining of market
participants.
    The Exchange believes that the proposed rule change will strengthen
its ability to carry out its responsibilities as a self-regulatory
organization. Summary fines provide an efficient an effective way for a
self-regulatory organization to penalize rule violations without
requiring the commencement of disciplinary proceedings. The broad
authority to impose summary fines allows the Exchange to discipline its
market participants, and provides a deterrent from futures violations.
    Furthermore, the Exchange believes that the proposed summary fine
schedule is fair and reasonable in light of each rule violation. OCX
has structured its proposed summary fine schedule such that routine or
clerical violations warrant lower summary fines, whereas more serious
violations, such as the failure to comply with the Exchange's pre-
execution discussion policy, warrant higher summary fines.
    Finally, the Exchange believes that the proposed rule change and
associated NTM are equitable and not unfairly discriminatory because
they would apply equally to all market participants that are subject to
the applicable requirements of each Rule.

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

    OneChicago does not believe that the rule change and associated NTM
will impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, in that the rule change and
associated NTM enhances OneChicago's ability to deter and discipline
certain rule violations.
    OneChicago further notes that the proposed summary fine schedule is
consistent with fine schedules established by other domestic futures
exchanges. The proposed summary fine schedule distinguishes the
severity of rule violations by imposing varying levels of fines for
different violations. Specifically, those violations that are generally
perceived as more clerical in nature are subject to lower summary fines
than those violations that may involve harm to the marketplace.

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

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

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

    The proposed rule change and NTM will become operative on January
14, 2016.
    At any time within 60 days of the date of effectiveness of the
proposed rule change, the Commission, after consultation with the CFTC,
may summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\6\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

 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-OC-2015-03 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-OC-2015-03. 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 offices 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-OC-
2015-03, and should be submitted on or before February 12, 2016.
    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(73).

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-01199 Filed 1-21-16; 8:45 am]
BILLING CODE 8011-01-P


9-14-06  TABASHNIK ANSWERS TO MATTEN MODELING QUESTIONS

Date: Thu, 14 Sep 2006 13:45:11 -0400

From<EMAIL_ADDRESS>
Bruce -- I have some modeling analysis questions (Vol. 5 of the
submission). Please send answers to me ASAP.  I am trying to finish
everything up today, if possible, but at the latest tomorrow
afternoon. Thank you for your help.

 Sincerely, Sharlene

1.  Resistance allele frequency, genetics of resistance, likely
inheritance pattern is based on Cry1Ac resistance only? Yes or No?

Yes.     Do you have the data on the acreage in Arizona of Cry1Ac cotton
vs. Cry1Ac + Cry2Ab cotton?

How are these parameters addressed for Cry2Ab resistance?

We are not considering Cry2Ab resistance in the modeling.

There could be two different resistance mechanisms and two different
inheritance patters?

Yes.

How should I use the model to address resistance to both toxins?

If some or all of Arizona’s Bt cotton had two toxins, Cry1Ac + Cry2Ab,
evolution of resistance would be much less likely than it is with only
Cry1Ac.  If you want, I can summarize the reasoning for that conclusion.
 By modeling resistance to cotton that produces only Cry1Ac, we are
choosing a more pessimistic scenario than one that includes cotton with
Cry1Ac + Cry2Ab.  So, in this aspect, all of the modeling predictions
are conservative, i.e., they tend to overestimate resistance risk.

2.  What values/parameters would be changed based on the 2006 field
data?

We will use data from the field to test the model’s predictions about
the ratios of sterile:native moths and resistance allele frequency.  If
the model’s predictions are wrong,  incorrect assumptions will be
changed to improve the accuracy of the model.

Are additional simulations planned to used these data?

Yes.  We are also conducting additional simulations now.  We have
modified some of the assumptions and run another set of scenarios using
sensitivity analysis varying emigration (10, 55, or 75%), dominance
(recessive or dominant), number of fields in the region (400 or 4096),
percentage of Bt fields (80, 95, 100), carrying capacity per field
(2,885,  28,885, 288,850), and numbers of steriles per ha per release in
Bt and non-Bt cotton fields (0,0; 2,10; 100, 500; and 200, 1000).
Again, with one exception, all scenarios yielded regional loss in 2
years.  The only case in which loss did not occur was with no steriles
released in Bt or non-Bt cotton (0, 0).  The lowest non-zero release
rate tested was 2 per ha per release in Bt cotton and 10 per ha per
release in non-Bt cotton (2,10).  This low release rate scenario yielded
regional loss in 2 years.

3.  The modeling output is represented in a qualitative way.  Do you
have another table that summarizes each of the twelve scenarios?  I
think this would be clearer.

If you let me know more specifically what additional information you
seek, we can probably provide it.  Regional loss means zero PBW in the
region.  So, we could put zeroes in the table instead of “regional
loss.”  R allele frequency is not relevant when regional loss occurs.

4. Do I understand that for 11/12 scenarios, resistance did not evolve
and no PBW were present after the 4 year eradication program.

Correct.  In 11/12 scenarios, no PBW were present after 4 years.

One scenario had a 98% population suppression with a r frequency of 0.02
(below resistance threshold of 0.50).  The r frequency in question is
Cry1Ac only?

Yes.

5.  Sterile release rates in the model.  The sampling/trapping protocol
description in vol. 1 indicates that steriles were released at a rate of
20 steriles/acre/day (3X per week) in Bt fields and 100 steriles (or
more)/acre/day (3X per week) in non-Bt fields.  I converted these to
hectacres and so the sterile rate in Bt fields = 8 steriles/ha/day and
in non-Bt fields = 40 steriles/ha/day.  However, in the model, I see
that the default values are much higher than what was actually done in
2006, i.e., 75 steriles/ha/day in Bt cotton fields and 500
steriles/ha/per release in non-Bt cotton fields.  How do you explain
this difference?  How does this difference affect the model outcome?

Your conversions are off by ca. 6.25X (too low) because the conversion
requires multiplying X 2.47 (not dividing by 2.5).  Also, the model
assumptions are stated in steriles per release (not per day).  The
sensitivity analysis results submitted to EPA at the beginning of August
included 1, 2, 3, 4, 5, 10, and 15 steriles per ha per release in Bt
cotton.  These lower levels also yielded regional loss (i.e., no pink
bollworm) in 2 years.  More recent simulations show regional loss with 2
per ha per release in Bt cotton and 10 per ha per release in non-Bt
cotton.


[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43096-43099]
[FR Doc No: 2015-17809]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2076]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Restaurant
Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
20, 2015.

ADDRESSES: To ensure that comments on the information collection are
received,

OMB recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-7285, or emailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0744. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Restaurant Facility Types (2013-2022)

    OMB Control Number 0910-0744

I. Background

    In 2013-2014, the U.S. Food and Drug Administration (FDA) initiated
a study in two foodservice facility types: Full service and fast food
restaurants. The study will span 10 years in its entirety and aims to:
     Assist FDA with developing retail food safety initiatives
and policies focused on the control of foodborne illness risk factors--
preparation practices and employee behaviors most commonly reported to
the Centers for Disease Control and Prevention as contributing factors
to foodborne illness outbreaks at the retail level. (i.e. food from
unsafe sources, poor personal hygiene, inadequate cooking, improper
holding time and temperature, and contaminated equipment/cross-
contamination);
     Identify retail food safety work plan priorities and
allocate resources to enhance retail food safety nationwide;
     Track changes in the occurrence of foodborne illness risk
factors in retail and foodservice establishments over time; and
     Inform recommendations to the retail and foodservice
industry and state, local, tribal, and territorial regulatory
professionals on reducing the occurrence of foodborne illness risk
factors.

    Table 1--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
            Facility type                         Description
------------------------------------------------------------------------
Full Service Restaurants.............  A restaurant where customers
                                        place their order at their
                                        table, are served their meal at
                                        the table, receive the service
                                        of the wait staff, and pay at
                                        the end of the meal.
Fast Food Restaurants................  A restaurant that is not a full
                                        service restaurant. This
                                        includes restaurants commonly
                                        referred to as quick service
                                        restaurants and fast casual
                                        restaurants.
------------------------------------------------------------------------

    The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (42 U.S.C. 243, section 311(a)).
Responsibility for carrying out the provisions of the Act relative to
food protection was transferred to the Commissioner of Food and Drugs
in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq) and the Economy Act (31
U.S.C. 1535) require FDA to provide assistance to other Federal, state,
and local government bodies.
    The objectives of the study are to:
     Identify the foodborne illness risk factors that are in
most need of priority attention during each data collection period;
     Track trends in the occurrence of foodborne illness risk
factors over time;
     Examine potential correlations between operational
characteristics of food establishments and the control of foodborne
illness risk factors;
     Examine potential correlations between elements within
regulatory retail food protection programs and the control of foodborne
illness risk factors; and
     Evaluate the impact of industry food safety management
systems in controlling the occurrence of foodborne illness risk
factors.
    The data from the 2013-2014 information collection in restaurants
is currently being analyzed by FDA. A report summarizing the findings
is expected to be released in 2015. In order to analyze trends, FDA is
proposing to conduct two additional data collections in 2017-2018 and
2021-2022 using the same methodology employed in the 2013-2014 data
collection. This methodology is described as follows.
    In order to obtain a sufficient number of observations to conduct
statistically significant analysis, FDA will conduct approximately 400
data collections in each restaurant facility type during each data
collection period. This sample size has been calculated to provide for
sufficient observations to be 95 percent confident that the compliance
percentage is within 5 percent of the true compliance percentage.
    A geographical information system database containing a listing of
businesses throughout the United States will be used as the
establishment inventory for the data collections. FDA will sample
establishments from the inventory based on the descriptions in table 1.
FDA does not intend to sample operations that handle only prepackaged
food items or conduct low risk food preparation activities. The FDA
Food Code contains a grouping of establishments by risk, based on the
type of food preparation that is normally conducted within the
operation (Ref. 1). The intent is to sample establishments that fall
under risk categories 2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who will serve as the data collectors for the 10 year
study. The Specialists are geographically dispersed throughout the
United States and possess technical expertise in retail food safety and
a solid understanding of the operations within each of the facility
types to be surveyed. The Specialists are also standardized by FDA's
Center for Food Safety and Applied Nutrition personnel in the
application and interpretation of the FDA Food Code (Ref. 1).
    Sampling zones will be established which are equal to the 150 mile
radius around a Specialist's home location. The sample will be selected
randomly from among all eligible establishments located within these
sampling zones. The Specialists are generally located in major
metropolitan areas (i.e. population centers) across the contiguous
United States. Population centers usually contain a large concentration
of the establishments FDA intends to sample. Sampling from the 150 mile
radius sampling zones around the Specialists' home locations provides
three advantages to the study:
    1. It provides a cross section of urban and rural areas from which
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory
entities having jurisdiction over the eligible establishments.

    3. It reduces overnight travel and therefore reduces travel costs
incurred by the Agency to collect data.
    The sample for each data collection period will be evenly
distributed among Specialists. Given that participation in the study by
industry is voluntary and the status of any given randomly selected
establishment is subject to change, substitute establishments will be
selected for each Specialist for cases where the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
    Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain whether the selected
facility is under legal notice from the state or local regulatory
authority. If the selected facility is under legal notice, the
Specialist will not conduct a data collection, and a substitute
establishment will be used. An invitation will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
    A standard form will be used by the Specialists during each data
collection. The form is divided into three sections: Section 1--
``Establishment Information;'' Section 2--``Regulatory Authority
Information;'' and Section 3--``Foodborne Illness Risk Factor and Food
Safety Management System Assessment.'' The information in Section 1--
``Establishment Information'' will be obtained during an interview with
the establishment owner or person in charge by the Specialist and will
include a standard set of questions.
    The information in Section 2--``Regulatory Authority Information''
will be obtained during an interview with the program director of the
state or local jurisdiction that has regulatory responsibility for
conducting inspections for the selected establishment. Section 3
includes three parts: Part A for tabulating the Specialists'
observations of the food employees' behaviors and practices in limiting
contamination, proliferation, and survival of food safety hazards; Part
B for assessing the food safety management being implemented by the
facility; and Part C for assessing the frequency and extent of food
employee hand washing. The information in Part A will be collected from
the Specialists' direct observations of food employee behaviors and
practices. Infrequent, nonstandard questions may be asked by the
Specialists if clarification is needed on the food safety procedure or
practice being observed. The information in Part B will be collected by
making direct observations and asking follow up questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C will be collected by making direct
observations of food employee hand washing. No questions will be asked
in the completion of Section 3, Part C of the form.
    FDA will collect the following information associated with the
establishment's identity: Establishment name, street address, city,
state, zip code, county, industry segment, and facility type. The
establishment identifying information is collected to ensure the survey
is not duplicative. The establishment identifying information is
collected to ensure the data collections are not duplicative. Other
information related to the nature of the operation, such as seating
capacity and number of employees per shift, will also be collected.
Data will be consolidated and reported in a manner that does not reveal
the identity of any establishment included in the study.
    FDA is working with the National Center for Food Protection and
Defense to develop a Web-based platform in FoodSHIELD to collect,
store, and analyze data for the Retail Risk Factor Study. Once
developed, this platform will be accessible to state, local,
territorial, and tribal regulatory jurisdictions to collect data
relevant to their own risk factor studies. FDA is currently
transitioning from the manual entry of data to the use of hand-held
technology. FDA will be pilot testing the use of hand-held technology
during its 2015-2016 risk factor study data collection in institutional
foodservice and retail food stores, with the goal to have it fully
implemented for the 2017-2018 data collection in restaurants. When a
data collector is assigned a specific establishment, he or she will
conduct the data collection and enter the information into the Web-
based data platform. The interface will support the manual entering of
data, as well as the ability to upload a fillable PDF.
    In the Federal Register of December 11, 2014 (79 FR 73596), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment; however, this
comment did not address the information collection.
    The burden for the 2017-2018 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected restaurant facility (whether it be a fast food
or full service restaurant); and (2) the program director (or
designated individual) of the respective regulatory authority. In order
to provide the sufficient number of observations needed to conduct a
statistically significant analysis of the data, FDA has determined that
the same number of data collections will be required in each of the two
restaurant facility types as was required in the 2013-2014 data
collection (i.e. 400). Therefore, the total number of responses for
restaurants will be 1,600 (400 data collections x 2 facility types x 2
respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of
the form is specific to the person in charge of the selected
facilities. It includes the time it will take the person in charge to
accompany the data collector as he or she completes Sections 1 and 3 of
the form. The burden related to the completion of Section 2 of the form
is specific to the program directors (or designated individuals) of the
respective regulatory authorities. It includes the time it will take to
answer the data collectors' questions and is the same regardless of the
facility type.
    To calculate the estimate of the hours per response, FDA will use
the average data collection duration for the same facility types during
the 2013-2014 data collection. FDA estimates that it will take the
persons in charge of full service restaurants and fast food restaurants
104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectfully, to
accompany the data collectors while they complete Sections 1 and 3 of
the form. In comparison, for the 2013-2014 data collection, the burden
estimate was 106 minutes (1.76 hours) in full service restaurants and
73 minutes (1.21 hours) in fast food restaurants. FDA estimates that it
will take the program director (or designated individual) of the
respective regulatory authority 30 minutes (0.5 hours) to answer the
questions related to Section 2 of the form. This burden estimate is
unchanged from the last data collection. Hence, the total burden
estimate for a data collection in a full service restaurant, including
both the program director's and the person in charge's responses, is
134 minutes (104 + 30) (2.23 hours). The total burden estimate for a
data collection in a fast food restaurant, including both the program
director's and the person in charge's responses, is 112 minutes 82 + 30
(1.86 hours).

    Based on the number of entry refusals from the 2013-2014 data
collection, we estimate a refusal rate of 2 percent. The estimate of
the time per non-respondent is five minutes (0.08 hours) for the person
in charge to listen to the purpose of the visit and provide a verbal
refusal of entry.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of                              Number of
                                                   Number of    responses      Total      Number of    responses      Total       Average
                    Activity                      respondents      per         annual        non-       per non-   annual non-   burden per  Total hours
                                                                respondent   responses   respondents   respondent   responses     response
--------------------------------------------------------------------------------------------------------------------------------------------------------
2017-2018 Data Collection (Fast Food                      400            1          400  ...........  ...........  ...........         1.36          544
 Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection (Full Service                   400            1          400  ...........  ...........  ...........         1.73          692
 Restaurants)--Completion of Sections 1 and 3...
2017-2018 Data Collection-Completion of Section           800            1          800  ...........  ...........  ...........          0.5          400
 2--All Facility Types..........................                                                                                (30
                                                                                minutes)
2017-2018 Data Collection-Entry Refusals--All     ...........  ...........  ...........           16            1           16         0.08         1.28
 Facility Types.................................                                                                                (5 minutes)
                                                 -------------------------------------------------------------------------------------------------------
    Total Hours.................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........     1,637.28
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov.

1. FDA Food Code available at http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17809 Filed 7-20-15; 8:45 am]
 BILLING CODE 4164-01-P