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  |Melanie King/RTP/USEPA/US@EPA
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  |RE: Your questions regarding MECA's stationary engine comments
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Hi again, Melanie.  Per your questions, see below.

1) MECA is currently only aware of one manufacturer of CCV systems for
stationary diesel engines -- Racor (www.parker.com/racor).  MECA members
Donaldson Company
(www.donaldson.com/en/exhaust/support/datalibrary/061798.pdf) and Engine
Control Systems (www.enginecontrolsystems.com/prod-cvv.aspx) both sell CCV
systems but only for mobile source applications.  (Note:  ECS's CCVs are Racor
units produced for ECS.)  In conversations with these two MECA members, they
said they would both consider offering products for existing stationary diesel
engines should EPA promulgate requirements in this market area.  Regarding
limitations, one MECA member said the limit to the size of CCVs, in terms of
commercial availability, is typically no larger than 30 L.

2) Regarding the feasibility of DPFs for existing stationary diesel engines,
the best guideline is the information contained in the list of ARB Level 3
verified technologies for stationary diesel engines
(www.arb.ca.gov/diesel/verdev/vt/stationary.htm).  The specifications for the
type of engine, minimum temperature for filter regeneration, fuel type, and
other operating conditions can be found in the individual Executive Order
letters.  Essentially, stationary diesel engines certified to ARB Tier 1, 2,
or 3 off-road standards would be suitable candidates for retrofit.  These same
parameters (e.g., minimum temperature for filter regeneration) would apply as
a general guideline to pre-1996 engines as well.  Also, some Level 3 systems
verified for mobile off-road (www.arb.ca.gov/diesel/verdev/vt/cvt.htm) could
be suitable for stationary applications as one of the test cycles used for
mobile off-road verification (ISO8178-C1, a steady-state cycle) is very
similar to the test cycle for stationary verification (ISO8178-D2).

In terms of examples of older engines that have been retrofitted with DPFs, as
noted in our testimony, the most comprehensive information on the application
of PM exhaust emission control technology to in-use stationary diesel engines
can be found in ARB's September 2003 Staff Report in support of its ATCM for
stationary compression-ignition engines.  In the report, ARB provides a
thorough list of in-use emergency standby engines and prime stationary engines
using emission control systems (mostly DPFs) in California.  The retrofit
devices were installed on stationary engines ranging from model years 1993 to
2002.
The list shows numerous DPF installations on large engines rated above 600 kW,
including Caterpillar 3516 engines rated in the 1490-2120 kW range.

I have also attached a short case study of two pre-1996 stationary diesel
engines that were retrofit with DPFs (this case study was also noted in our
testimony).

Hope this helps.  If I get further information from our members, I will
forward it along to you.

Antonio

-----Original Message-----
From<EMAIL_ADDRESS><EMAIL_ADDRESS>
Sent: Tuesday, October 20, 2009 2:49 PM
To: Antonio Santos
Subject: Re: Your questions regarding MECA's stationary engine comments

Hi,
Thanks for getting back to me.  There were two issues that I wanted to talk to
you guys about:

1) Closed crankcase ventilation - we asked for comment on CCV systems in the
proposed NESHAP revisions.  There was a paragraph in MECA's comments on CCV
systems and in that paragraph it stated that there was one manufacturer of CCV
systems that had been selling them for stationary diesel engines in the mid-
1990s.  I wanted to get more information regarding CCV systems for stationary
diesel engines.  I'm wondering about the applicability of CCV systems for
existing diesel engines - are there any limitations on what types of
stationary diesel engines the systems could be applied to (for example can all
sizes of diesel engines use them, all different applications, etc.)?  Is there
only one manufacturer who has the CCV systems available for stationary
engines?

2) Diesel particulate filters - specifically their feasibility for older
engines.  As discussed in the comments, there are DPF systems that are
verified by CARB for stationary engines and they are verified for 1996 and
newer engines.  How about for pre-1996 engines?  On page 4 of the MECA comment
letter there are some bulleted parameters that are considered, but what I
don't know is how many older engines would meet those parameters and be able
to be retrofit with DPF?  Also, can you be a little more specific about the
parameters, for example the second bullet talks about the need for the engine
operating temperature to be hot enough for regeneration - how hot does the
temperature need to be and do most existing stationary diesels reach that
temperature?  On page 10 of the MECA comments it says "MECA believes DPFs
should be installed on in-use stationary diesel engines wherever technically
feasible . . .
."  What I'm trying to get at is figuring out for a nationwide regulation,
where could the line be drawn as to what engines can feasibly be retrofit?
What are the oldest age engines that you have been able to install DPF and
demonstrate reductions (also what size were they and what reductions were
demonstrated)?

Melanie King
Energy Strategies Group
Sector Policies and Programs Division
Office of Air Quality Planning and Standards U.S. Environmental Protection
Agency

Mail Code D243-01
RTP, NC  27711

Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
<EMAIL_ADDRESS>

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  |10/19/2009 10:23 AM
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  |Your questions regarding MECA's stationary engine comments
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Hi, Melanie.  Joe Kubsh forwarded to me your voice mail you left for him last
week re: MECA's comments on EPA's NESHAP for existing stationary engines
proposed rulemaking.

He is out of the office and wanted me to follow up with you regarding your
questions.  Feel free to call me (202/296-4797 x108) or e-mail me (e-mail is
better, so I can forward your questions to Joe).

Thanks,
Antonio

---
Antonio Santos
Manufacturers of Emission Controls Association
(202) 296-4797 x108
<EMAIL_ADDRESS>

(See attached file: Application Fact Sheet 703 - J Cloud.pdf)


11.2  Notifications. The owner or operator shall provide notifications for each affected unit (or group of units monitored at a common stack) in accordance with §63.10030.
11.3  Monitoring Plan Reporting.  For each affected unit (or group of units monitored at a common stack) using HCl and/or HF CEMS, the owner or operator shall make electronic and hard copy monitoring plan submittals as follows:
11.3.1  Submit the electronic and hard copy information in section <IP_ADDRESS> of this appendix pertaining to the HCl and/or HF monitoring systems at least 21 days prior to the applicable date in §63.9984.  Also, if applicable, submit monitoring plan information pertaining to any required flow rate, diluent gas, and/or moisture monitoring systems within that same time frame, if the required records are not already in place.
11.3.2  Update the monitoring plan when required, as provided in paragraph <IP_ADDRESS> of this appendix.  An electronic monitoring plan information update must be submitted either prior to or concurrent with the quarterly report for the calendar quarter in which the update is required.
11.3.3  All electronic monitoring plan submittals and updates shall be made to the Administrator using the ECMPS Client Tool.  Hard copy portions of the monitoring plan shall be submitted to the permitting authority.
11.4  Certification, Recertification, and Quality-Assurance Test Reporting Requirements.  Except for daily QA tests (i.e., calibration error tests and flow monitor interference checks), which are included in each electronic quarterly emissions report, use the ECMPS Client Tool to submit the results of all required certification, recertification, quality-assurance, and diagnostic tests of the required monitoring systems electronically, either prior to or concurrent with the relevant quarterly electronic emissions report.
11.4.1  For daily calibration error (or calibration transfer standard error tests), report the information in §75.59(a)(1) of this chapter, excluding paragraphs (a)(1)(ix) and (a)(1)(xi).
11.4.2  For each quarterly gas audit of a HCl or HF CEMS, report:
<IP_ADDRESS>  Facility ID information;
<IP_ADDRESS>  Monitoring system ID number;
<IP_ADDRESS>  Type of test (e.g., quarterly gas audit);
<IP_ADDRESS>  Reason for test;
<IP_ADDRESS>  CEMS span and span scale;
<IP_ADDRESS>  Audit (spike) gas concentration value and documentation of certified value;
<IP_ADDRESS>  Measured value of undiluted audit (spike) gas, including date and time of injection and point in monitoring system that gas was injected;
<IP_ADDRESS>  Calculated dilution ratio for audit (spike) gas;
<IP_ADDRESS>  Date and time for each audit gas spike;
<IP_ADDRESS>  Units of measure;
<IP_ADDRESS>  The measured values for each spiked gas and unspiked gas sample, in appropriate units of measure;
<IP_ADDRESS>  Means of the measured spiked and unspiked sample concentrations and expected value of the spiked concentration as specified in section 12.1 of Performance Specification 15 in appendix B to part 60 of this chapter;
<IP_ADDRESS>  Bias at the spike level as calculated using equation 3 in section 12.1 of Performance Specification 15 in appendix B to part 60 of this chapter;
<IP_ADDRESS>  The differences for each pair of spiked and each pair of unspiked gas measurements;
<IP_ADDRESS>  Standard deviation of the spiked pairs of measurements and standard deviation of the unspiked pairs of measurements, as specified in section 12.0 of Performance Specification 15 in appendix B to part 60 of this chapter; and
<IP_ADDRESS>   Relative standard deviations for the spiked and unspiked measurements, respectively, calculated t-statistic, and result of the statistical significance of the bias test as specified in section 12.0 of Performance Specification 15 in appendix B to part 60 of this chapter
11.4.3 For each RATA of a HCl or HF CEMS, report:
<IP_ADDRESS>  Facility ID information;
<IP_ADDRESS>  Monitoring system ID number;
<IP_ADDRESS>  Type of test (i.e., initial or annual RATA);
<IP_ADDRESS>  Reason for test;
<IP_ADDRESS>  The reference method used;
<IP_ADDRESS>  Starting and ending date and time for each test run;
<IP_ADDRESS>  Units of measure;
<IP_ADDRESS>  The measured reference method and CEMS values for each test run, on a consistent moisture basis, in appropriate units of measure;
<IP_ADDRESS>  Flags to indicate which test runs were used in the calculations;
<IP_ADDRESS>  Arithmetic mean of the CEMS values, of the reference method values, and of their differences;
<IP_ADDRESS>  Standard deviation, as specified in Equation 2-4 of Performance Specification 2 in appendix B to part 60 of this chapter;
<IP_ADDRESS>  Confidence coefficient, as specified in Equation 2-5 of Performance Specification 2 in appendix B to part 60 of this chapter; and
<IP_ADDRESS>  Relative accuracy test results, as specified in Equation 2-6 of Performance Specification 2 in appendix B to part 60 of this chapter.
11.4.4  Reporting Requirements for Diluent Gas, Flow Rate, and Moisture Monitoring Systems. For the certification, recertification, diagnostic, and QA tests of stack gas flow rate, moisture, and diluent gas monitoring systems that are certified and quality-assured according to part 75 of this chapter, report the information in section <IP_ADDRESS> of this appendix.
11.5  Quarterly Reports.
11.5.1  No later than the end of the 180 day compliance demonstration period or the calendar quarter containing the applicable date in §63.10005(g), (h), or (j) (whichever is earlier), the owner or operator of any affected unit shall use the ECMPS Client Tool to submit electronic quarterly reports to the Administrator, in an XML format specified by the Administrator, for each affected unit (or group of units monitored at a common stack).
11.5.2  The electronic reports must be submitted within 30 days following the end of each calendar quarter, except for units that have been placed in long-term cold storage.
11.5.3  Each electronic quarterly report shall include the following information:
<IP_ADDRESS>  The date of report generation;
<IP_ADDRESS>  Facility identification information;
<IP_ADDRESS>  The information in sections 10.1.2 through 10.1.8 of this appendix, as applicable to the type(s) of monitoring system(s) used to measure the pollutant concentrations and other necessary parameters.
<IP_ADDRESS>  The results of all daily calibration error (or calibration transfer standard error tests) of the HCl or HF monitor as described in section <IP_ADDRESS>.1 of this appendix; and
<IP_ADDRESS>  If applicable, the results of all daily flow monitor interference checks, in accordance with section <IP_ADDRESS> of this appendix.
11.5.4  Compliance Certification.  Based on reasonable inquiry of those persons with primary responsibility for ensuring that all HCl and/or HF emissions from the affected unit(s) have been correctly and fully monitored, the owner or operator shall submit a compliance certification in support of each electronic quarterly emissions monitoring report.  The compliance certification shall include a statement by a responsible official with that official's name, title, and signature, certifying that, to the best of his or her knowledge, the report is true, accurate, and complete.


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29807-29808]
[FR Doc No: 2013-12024]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-21]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. Neither publication of this notice nor the inclusion or
omission of information in the summary is intended to affect the legal
status of the petition or its final disposition.

DATE:  Comments on this petition must identify the petition docket
number involved and must be received on or before June 10, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0322 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to

http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Michael Menkin, ANM-113, (425) 227-
2793, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA
98057-3356, or Andrea Copeland, ARM-208, Office of Rulemaking, Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591; email<EMAIL_ADDRESS>(202) 267-8081.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 15, 2013.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0322.
    Petitioner: The Boeing Company.
    Sections of 14 CFR Affected: 14 CFR 25.981(a)(3) and 25.901(c).
    Description of Relief Sought: To allow installation of the improved
fuel pump electrical connector independently of the Fault Current
Detector (FCD) or conversely, to allow installation of the FCD
independently of the improved electrical connector. The FCD will
provide an overall fuel pump electrical circuit. It includes the fuel
pump electrical connector and will provide protection against ignition
sources as required by the Equivalent Level of Safety (ELOS) and Sec.
25.901(c), Amendment 25-46. Boeing seeks this exemption until such time
as both the FCD and the electrical connector are installed. Compliance
to Special Federal Aviation Regulation (SFAR) 88 for the identified
unsafe condition at a fuel system level will be achieved at that time.

[FR Doc. 2013-12024 Filed 5-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 66 (Thursday, April 8, 2021)]
[Notices]
[Pages 18327-18328]
[FR Doc No: 2021-07213]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2018-0005]

Whistleblower Stakeholder Meeting

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of public meeting.

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

SUMMARY: The Occupational Safety and Health Administration (OSHA) is
announcing a public meeting to solicit comments and suggestions from
stakeholders on issues facing the agency in the administration of the
whistleblower laws it enforces.

DATES: The public meeting will be held on May 19, 2021, from 1:00 p.m.
to 4:00 p.m., ET via telephone. Persons interested in attending the
meeting must register by May 12, 2021. In addition, comments relating
to the ``Scope of Meeting'' section of this document must be submitted
in written or electronic form by May 12, 2021.

ADDRESSES:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking portal. Follow the on-line instructions for submissions.
All comments should be identified with Docket No. OSHA-2018-0005.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2018-0005,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Please note: While OSHA's Docket Office is continuing to accept and
process submissions by regular mail, due to the COVID-19 pandemic, the
Docket Office is closed to the public and not able to receive
submissions to the docket by hand, express mail, messenger, and courier
service.
    Registration to Attend and/or to Participate in the Telephonic
Meeting: If you wish to attend the public meeting, make an oral
presentation at the meeting, or participate in the meeting, you must
register using this link: https://www.eventbrite.com/e/whistleblower-stakeholder-meeting-tickets-146767279885 by close of business on May
12, 2021. Actual times provided for presentation will depend on the
number of requests, but no more than 10 minutes per participant will be
allowed. There is no fee to register for the public meeting. After
reviewing the requests to present, OSHA will contact each participant
prior to the meeting to inform them of the speaking order.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For general information: Mr. Anthony Rosa, Deputy Director, OSHA
Directorate of Whistleblower Protection Programs, U.S. Department of
Labor; telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Scope of Meeting

    OSHA is interested in obtaining information from the public on key
issues facing the agency's whistleblower program. This meeting is the
seventh in a series of meetings requesting public input on this
program. The agency is seeking suggestions on how it can improve the
program. Please note that the agency does not have the authority to
change the statutory language and requirements of the laws it enforces.
In particular, the agency invites input on the following:
    1. How can OSHA deliver better whistleblower customer service?
    2. What kind of assistance can OSHA provide to help explain the
agency's whistleblower laws to employees and employers?
    3. What can OSHA do to ensure that workers are protected from
retaliation for raising concerns related to the pandemic?

B. Request for Comments

    Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments (see ADDRESSES above). Submit
a single copy of electronic comments or two paper copies of any mailed
comments. To permit time for interested persons to submit data,
information, or views on the issues in the ``Scope of Meeting'' section
of this notice, please submit comments by May 12, 2021, and include
Docket No. OSHA-2018-0005.

C. Access to the Public Record

    Electronic copies of this Federal Register notice are available at:
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also is available on the Directorate of
Whistleblower Protection Programs' web page at: http://www.whistleblowers.gov.

Authority and Signature

    James S. Frederick, Principal Deputy Assistant Secretary for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by Secretary's Order 08-2020 (May
15, 2020).

    Signed at Washington, DC, on April 2, 2021.
James S. Frederick,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2021-07213 Filed 4-7-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76767-76768]
[FR Doc No: 2010-30945]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63426; File No. SR-CBOE-2010-107]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated: Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Amendment of the Hybrid Agency Liaison Step-Up
Rebate

December 3, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, 15 U.S.C. 78s(b)(1), notice is hereby given that on December 1,
2010, Chicago Board Options Exchange, Incorporated (``CBOE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by CBOE. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.

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

    Chicago Board Options Exchange, Incorporated (``CBOE'' or
``Exchange'') proposes to amend the Hybrid Agency Liaison (``HAL'')
step-up rebate. The text of the proposed rule change is available on
the Exchange's Web site (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary and at the Commission.

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

    In its filing with the Commission, CBOE 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. CBOE 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, Proposed Rule Change

1. Purpose
    In order to incent market makers to execute orders at CBOE versus
routing orders to other exchanges pursuant to the Options Order
Protection and Locked/Crossed Plan, the Exchange provides a rebate to
market-makers that ``step-up'' and trade all or part of certain orders
on the HAL system.\1\ Specifically, the Exchange rebates to a market-
maker $.20 per contract against transaction fees generated from a
transaction on the HAL system in a penny pilot class, provided that at
least 60% of the market-maker's quotes in that class (excluding quotes
in LEAPS series) in the prior calendar month were on one side of the
national best bid or offer (``NBBO'') price. Market-makers not meeting
this 60% qualifying threshold are not eligible to receive a rebate. The
Exchange proposes to reduce the amount of the rebate from $.20 per
contract to $.15 per contract effective December 1, 2010. All other
aspects of the rebate program would remain unchanged.
---------------------------------------------------------------------------

    \1\ See CBOE Fees Schedule, Section 19. HAL is a system for
automated handling of electronically received orders that are not
automatically executed upon receipt by the Hybrid System. CBOE Rule
6.14A governs the operation of the HAL system under the Options
Order Protection and Locked/Crossed Plan.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Securities Exchange Act of 1934 (``Act''),\2\ in
general, and furthers the objectives of Section 6(b)(4) \3\ of the Act
in particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
trading permit holders. The Exchange believes the proposed rebate is
reasonable because it provides an incentive for market-makers to
compete better for order flow in the penny pilot classes. The Exchange
believes the proposed rebate is equitable because it applies equally to
all market makers that trade orders in penny pilot classes on the HAL
system and that meet the qualifying quoting criteria.
---------------------------------------------------------------------------

    \2\ 15 U.S.C. 78f(b).
    \3\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of purposes of the Act.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \4\ and subparagraph (f)(2) of Rule 19b-4 \5\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2010-107 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.

All submissions should refer to File Number SR-CBOE-2010-107. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. 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-CBOE-2010-107 and should be
submitted on or before December 30, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-30945 Filed 12-8-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Pages 15986-15987]
[FR Doc No: 2011-6619]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Food and Drug Administration/Xavier University Global Medical
Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
co-sponsorship with Xavier University, is announcing a public
conference entitled ``FDA/Xavier University Global Medical Device
Conference.'' This 3-day public conference includes presentations from
key FDA officials and industry experts. The public conference has three
separate tracks of interest for quality, regulatory affairs, and
clinical research professionals, and is intended for companies of all
sizes and employees at all levels.
    Dates and Times: The public conference will be held on May 4, 2011,
from 8:30 a.m. to 5 p.m.; May 5, 2011, from 8:30 a.m. to 5 p.m.; and
May 6, 2011, from 8:30 a.m. to 1 p.m.
    Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy.,

Cincinnati, OH 45207,<PHONE_NUMBER> or<PHONE_NUMBER>.
    Contact Persons:
    For information regarding this notice: Gina Brackett, Food and Drug
Administration, 6751 Steger Dr., Cincinnati, OH 45237,<PHONE_NUMBER>,
ext 167, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>    For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, e-mail<EMAIL_ADDRESS>    Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, and dinners for the 3 days
of the conference. Early registration ends April 3, 2011. Standard
registration ends May 2, 2011. There will be onsite registration. The
cost of registration is as follows:

                       Table 1--Registration Fees
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                                                   Fee by
                   Attendee                       April 3,    Fee by May
                                                    2011       3, 2011
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Industry......................................         $995       $1,200
Small Business (<100 employees)...............          800        1,000
Academic......................................          600          750
FDA/Government Employee.......................          140          140
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    The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
    To register online for the public conference, please visit the
``Registration'' link on the conference Web site at http://www.XavierMedCon.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
    To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, e-mail, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Pkwy., Cincinnati, OH 45207. An e-mail will be sent confirming your
registration.
    Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West 5th St., Cincinnati, OH, 45202, 513-421-
9100. Special conference block rates are available through April 12,
2011. To make reservations online, please visit the ``Venue/Logistics''
link at http://www.XavierMedCon.com. If you need special accommodations
due to a disability, please contact Marla Phillips (see Contact
Persons) at least 7 days in advance of the conference.

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
     Changes Within the Center for Devices and Radiological
Health (CDRH) That Will Impact Our Industry.
     510(k) Changes: Panel Discussion.
     Combination Products Panel.
     Update on Quality System Regulations. Warning Letter and
Enforcement Action Trends.
     MDUFMA Legislation.
     Corrective and Preventive Actions.
     Clinical Data Requirement Changes--Premarket Clearance.
     Reimbursement Panel.
     MDR Reporting/Vigilance.
     Ethical Issues Leading to Non-Compliance In Clinical
Trials.
     Risk Management and Design Controls.
     510(k) SE Decision Making Process.
     Warning Letter Trends for Sponsor-Monitors and CRO's.
     Supplier Controls.
     Advertising, and Promotion and Labeling Pre- and Post-
Market.
     Ensuring Site Compliance in Clinical Trials.
     FDA's Bioresearch Monitoring Program-Overview and Current
Activities.
     Inspection Readiness.
     Training.
     International Regulatory Update.
     FDCA, Anti Kickback and False Claims Act, Implications of
Investigator-Initiated Trials.
     Recalls, Requirements and Challenges.
     CE Mark.
     Adverse Event Reporting During Clinical Investigation in
the EU.
     Clinical Evaluation for EU Market Access.
     Using Electronic Medical Records.
     Cooperative Research Activities Between Academia and
Industry.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (21 U.S.C. 393), which includes working closely with stakeholders
and maximizing the availability and clarity of information to
stakeholders and the public. The conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government agencies to
small businesses.

    Dated: March 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6619 Filed 3-21-11; 8:45 am]
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