[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20888-20889]
[FR Doc No: 2014-08198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 May 6 and 7, 2014, 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>, email:
<EMAIL_ADDRESS>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 May 6, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the RESQCPR System sponsored by Advanced
Circulatory Systems, Inc. The RESQCPR System is comprised of two
devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP
Active Compression Decompression CPR Device. These devices are used
together during manual cardiopulmonary resuscitation (CPR) in an
attempt to enhance venous return to the heart and blood flow to vital
organs during CPR to ultimately increase survival and neurologic
outcome in patients suffering from out of hospital cardiac arrest.
    Advanced Circulatory Systems, Inc. has proposed the following
indications for use: the RESQCPR System is intended for use in the
performance of CPR to increase survival with favorable neurologic
function in adult patients with non-traumatic cardiac arrest.
    On May 7, 2014, during session I, the committee will discuss and
make recommendations regarding the classification of membrane lung for
long-term pulmonary support systems, one of the remaining preamendment
Class III devices regulated under the 510(k) pathway. A membrane lung
for long-term pulmonary support refers to the oxygenator component of
an extracorporeal circuit used during long-term procedures, commonly
referred to as extracorporeal membrane oxygenation (ECMO). An ECMO
procedure provides assisted extracorporeal circulation and physiologic
gas exchange of a patient's blood when an acute (reversible) condition
prevents the patient's own body from providing the physiologic gas
exchange needed to sustain life. The circuit is comprised of multiple
device types, including, but not limited to, an oxygenator, blood pump,
cannulae, heat exchanger, tubing, filters, monitors/detectors, and
other accessories; the circuit components and configuration (e.g.,
arteriovenous, veno-venous) may differ based on the needs of the
individual patient or the condition being treated. ECMO is currently
used for patients with acute reversible respiratory or cardiac failure,
unresponsive to optimal ventilation and/or pharmacologic management.
    On January 8, 2013 the FDA issued a proposed order which, if made
final, would make the class III ECMO devices class II subject to
premarket notification (510(k)) and special controls. FDA discussed the
regulatory history of ECMO devices as part of the proposed order. On
September 12, 2013, the classification of ECMO was discussed at a
meeting of the Circulatory System Devices Panel. The Panel agreed with
FDA's proposal to reclassify ECMO to class II (special controls) as
outlined in the January 8, 2013, proposed order, but recommended that a
panel be reconvened to discuss use of ECMO in an adult patient
population as the September 12, 2013, panel meeting was focused on the
use of ECMO in a pediatric patient population.
    The discussion at this panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to premarket approval application (PMA)) or
reclassify to class II and comment on whether special controls are
adequate to assure the safety and effectiveness of this device in an
adult patient population.
    On May 7, 2014, during session II, the committee will discuss and
make recommendations regarding the classification of More-than-
Minimally Manipulated Allograft Heart Valves (MMM Allograft HVs). An
MMM Allograft HV is a human valve or valved-conduit that has been
aseptically recovered from qualified donors, dissected free from the
human heart, and then subjected to a manufacturing process(es) which
alters the original relevant characteristics of the tissue (cf. 21 CFR
1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then
stored until needed by a recipient. An

example of such a manufacturing process is one which intentionally
removes the cells and cellular debris, with the goal of reducing in
vivo antigenicity.
    MMM Allograft HVs are considered preamendment devices because they
were found substantially equivalent to devices in commercial
distribution prior to May 28, 1976, when the Medical Device Amendments
became effective. MMM Allograft HVs are currently regulated under the
heading of ``Heart Valve, More than Minimally Manipulated Allograft'',
Product Code OHA, as unclassified devices and reviewed under the
premarket notification, 510(k), authority. FDA is seeking committee
input on the safety and effectiveness of MMM Allograft HVs and the
regulatory classification for MMM Allograft HVs.
    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
April 28, 2014. On May 6, oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. On May 7, oral
presentations from the public will be scheduled between approximately
9:30 a.m. and 10 a.m. for session I and between 2 p.m. and 2:30 p.m.
for session II. 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 April 18, 2014. 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 April 21,
2014.
    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 James Clark,
Conference Management Staff, at<EMAIL_ADDRESS>or<PHONE_NUMBER>
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: April 4, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08198 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78519-78522]
[FR Doc No: 2014-30225]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-31388; File No. 812-14403]

Royal Bank of Canada, et al.; Notice of Application and Temporary
Order

December 19, 2014.
AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Temporary order and notice of application for a permanent
order under section 9(c) of the Investment Company Act of 1940
(``Act'').

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SUMMARY OF APPLICATION: Applicants have received a temporary order
(``Temporary Order'') exempting them from section 9(a) of the Act, with
respect to an injunction entered against Royal Bank of Canada (``RBC'')
on December 18, 2014 by the United States District Court for the
Southern District of New York (``Court''), in connection with a consent
order between RBC and the United States Commodity Futures Trading
Commission (``CFTC''), until the Commission takes final action on an
application for a permanent order (the ``Permanent Order,'' and with
the Temporary Order, the ``Orders''). Applicants also have applied for
a Permanent Order.

APPLICANTS: RBC, RBC Europe Limited (``RBC EL''), RBC Capital Markets
Arbitrage, S.A. (``CMA''), RBC Global Asset Management (U.S.) Inc.
(``GAM US''), BlueBay Asset Management LLP (``BlueBay LLP''), BlueBay
Asset Management USA LLC (``BlueBay USA''), and RBC Global Asset
Management (UK) Limited (``GAM UK'') (each an ``Applicant'' and
collectively, the ``Applicants'').

DATES: Filing Date: The application was filed on December 19, 2014.

HEARING OR NOTIFICATION OF HEARING: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving Applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on January 12, 2015, and should be accompanied by proof of service
on Applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES:  Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090; Applicants: RBC: 200 Bay Street,
Toronto, Ontario, Canada M5J 2J5, GAM US, 50 South 6th Street,
Minneapolis, MN 55402, BlueBay LLP, 77 Grosvenor Street, London W1K 3JR
United Kingdom, BBAM USA, 4 Stamford Plaza, 107 Elm Street, Suite 512,
Stamford, CT 06902, GAM UK and RBC EL, Riverbank House, 2 Swan Lane,
London EC4R 3BF United Kingdom, and CMA, 16 Rue Notre Dame, Luxembourg,
2240, Luxembourg.

FOR FURTHER INFORMATION CONTACT:  Bruce R. MacNeil, Senior Counsel, at
(202) 551-6817, or Melissa R. Harke, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:  The following is a temporary order and a
summary of the application. The complete application may be obtained
via the Commission's Web site by searching for the file number, or an
applicant using the Company name box, at http://www.sec.gov/search/search.htm, or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. RBC is a Canadian-chartered bank and a Canada-based global
financial services firm. RBC is the ultimate parent of the other
Applicants. RBC EL is a United Kingdom-based subsidiary of RBC that is
registered in the United Kingdom to engage in capital market
activities. CMA is a Luxembourg-based subsidiary of RBC that engages
primarily in interdealer market making and proprietary trading. GAM US
is a corporation formed under the laws of Minnesota. BlueBay LLP is a
limited liability partnership incorporated in England and Wales.
BlueBay USA is a limited liability company formed under the laws of
Delaware. GAM UK is a corporation formed under the laws of the United
Kingdom. GAM US, BlueBay LLP, BlueBay USA and GAM UK are each a wholly-
owned subsidiary of RBC and are each an investment adviser registered
under the Investment Advisers Act of 1940. GAM US, BlueBay LLP, BlueBay
USA and GAM UK each serve as investment adviser or investment sub-
adviser to investment companies registered under the Act, or series of
such companies (each a ``Fund'') and are collectively referred to as
the ``Fund Servicing Applicants.''
    2. While no existing company of which RBC is an affiliated person
within the meaning of section 2(a)(3) of the Act (``Affiliated
Person''), other than the Fund Servicing Applicants, currently serves
or acts as an investment adviser or depositor of any Fund, employees'
securities company or investment company that has elected to be treated
as a business development company under the Act, or principal
underwriter (as defined in section 2(a)(29) of the Act) for any open-
end management investment company registered under the Act (``Open-End
Fund''), unit investment trust registered under the Act (``UIT''), or
face-amount certificate company registered under the Act (``FACC'')
(such activities, ``Fund Services Activities''),\1\ Applicants request
that any relief granted also apply to any existing company of which RBC
is an Affiliated Person, other than RBC EL and CMA, and to any other
company of which RBC may become an Affiliated Person in the future
(together with the Fund Servicing Applicants, the ``Covered Persons'')
with respect to any activity contemplated by section 9(a) of the Act.
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    \1\ RBC, RBC EL, and CMA are parties to the application, but do
not and will not engage in Fund Services Activities.
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    3. On April 22, 2012, the CFTC filed a complaint, and on October
17, 2012, an amended complaint which superseded the original complaint
(the ``Complaint'') in the Court captioned Commodity Futures Trading
Commission v. Royal Bank of Canada (the ``Action''). The Complaint
alleged that RBC entered into certain stock futures contract
transactions in ``block trades,'' which are privately negotiated
transactions pursuant to exchange rules, and that RBC entered into
these block trades through its branches and internal trading accounts,
and it traded opposite RBC EL and CMA. The Complaint also alleged a
violation of Section 4c(a) of the Commodity Exchange Act (``CEA''),
whereby RBC entered into the block trades with an express or implied
understanding that the positions resulting from the trades would later
be offset or delivered opposite each other, which achieved an economic
and futures market nullity for the RBC corporate group because the RBC
corporate group as a whole was not exposed to risk in the futures
market. Furthermore, the Complaint alleged that, in violation of CFTC
Regulation 1.38(a), the express or implied understandings for later
trades were not reported to the OneChicago, LLC (``OneChicago'')
futures exchange ``without delay,'' as required by OneChicago's rules.
    4. RBC and the CFTC have reached an agreement to settle the Action.
As part of the agreement, the CFTC submitted a consent order (``Consent
Order'') to the Court. RBC has consented to the entry of the Consent
Order by the Court, without admitting or denying the findings set forth
therein (other than those relating to the jurisdiction of the Court and
the jurisdiction of the CFTC over the Conduct \2\). On December 18,
2014 the Court entered the Consent Order which enjoins RBC from
violating section 4c(a) of the CEA and CFTC Regulation 1.38(a) (the
``Injunction'') and required RBC to pay a civil monetary penalty of
$35,000,000.\3\
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    \2\ The alleged conduct giving rise to the Injunction (defined
below) is referred to herein as the ``Conduct.''
    \3\ See Consent Order, CFTC v. Royal Bank of Canada, 12-cv-2497,
Dkt. No. 124 (S.D.N.Y. Dec. 18, 2014).
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Applicants' Legal Analysis

    1. Section 9(a)(2) of the Act, in relevant part, prohibits a person
who has been enjoined from engaging in or continuing any conduct or
practice in connection with the purchase or sale of a security, or in
connection with activities as an underwriter, broker or dealer, from
acting, amCFTC v. Royal Bank of Canada, 12-CV-2497, (S.D.N.Y. Dec. 18,
2014).ong other things, as an investment adviser or depositor of any
registered investment company or a principal underwriter for any Open-
End Fund, UIT or FACC. Section 9(a)(3) of the Act makes the prohibition
in section 9(a)(2) applicable to a company, any affiliated person of
which has been disqualified under the provisions of section 9(a)(2).
Section 2(a)(3) of the Act defines ``affiliated person'' to include,
among others, any person directly or indirectly controlling, controlled
by, or under common control with, the other person. Applicants state
that, taken together, sections 9(a)(2) and 9(a)(3)

would have the effect of precluding the Fund Servicing Applicants and
Covered Persons from engaging in Fund Services Activities upon the
entry of the Injunction against RBC because RBC is an Affiliated Person
of each Fund Servicing Applicant and Covered Person.
    2. Section 9(c) of the Act provides that, upon application, the
Commission shall by order grant an exemption from the disqualification
provisions of section 9(a) of the Act, either unconditionally or on an
appropriate temporary or other conditional basis, to any person if that
person establishes that: (a) The prohibitions of section 9(a), as
applied to the person, are unduly or disproportionately severe or (b)
the conduct of the person has been such as not to make it against the
public interest or the protection of investors to grant the exemption.
Applicants have filed an application pursuant to section 9(c) seeking a
Temporary Order and a Permanent Order exempting the Fund Servicing
Applicants and other Covered Persons from the disqualification
provisions of section 9(a) of the Act. The Fund Servicing Applicants
and other Covered Persons may, if the relief is granted, in the future
act in any of the capacities contemplated by section 9(a) of the Act
subject to the applicable terms and conditions of the Orders.
    3. Applicants believe they meet the standards for exemption
specified in section 9(c). Applicants state that the prohibitions of
section 9(a) as applied to them would be unduly and disproportionately
severe and that the conduct of Applicants has not been such as to make
it against the public interest or the protection of investors to grant
the exemption from section 9(a).
    4. Applicants state the Conduct did not involve any of the
Applicants engaging in Fund Services Activities. Applicants also state
that the Conduct did not involve any Fund or the assets of any Fund. In
addition, Applicants state that the Conduct involved proprietary
trading in accounts owned by RBC, RBC EL and CMA and was not conducted
on behalf of any Fund or using assets of any Fund.
    5. Applicants state that: (a) None of the current directors,
officers or employees of the Fund Servicing Applicants (or any other
persons serving in such capacity during the time period covered by the
Complaint) participated in the Conduct and (b) the personnel at RBC,
RBC EL, or CMA who participated in the Conduct or who may subsequently
be identified by RBC, RBC EL, CMA, or any U.S. or non-U.S. regulatory
or enforcement agency as having been responsible for the Conduct have
had no, and will not have any involvement in providing Fund Services
Activities and will not serve as an officer, director, or employee of
any Covered Person. Applicants assert that because the personnel of the
Fund Servicing Applicants did not participate in the Conduct, the
shareholders of Funds were not affected any differently than if those
Funds had received services from any other non-affiliated investment
adviser or sub-adviser.
    6. Applicants submit that section 9(a) should not operate to bar
them from serving the Funds and their shareholders in the absence of
improper practices relating to their Fund Services Activities.
Applicants state that the section 9(a) disqualification could result in
substantial costs to the Funds to which the Fund Servicing Applicants
provide investment advisory services, and such Funds' operations would
be disrupted, as they sought to engage new advisers or sub-advisers.
Applicants assert that these effects would be unduly severe given the
Fund Servicing Applicants' lack of involvement in the Conduct.
Moreover, Applicants state that RBC has taken remedial actions to
address the Conduct, as outlined in the application. Thus, Applicants
believe that granting the exemption from section 9(a), as requested,
would be consistent with the public interest and the protection of
investors.
    7. Applicants state that the inability of the Fund Servicing
Applicants to continue to provide investment advisory services to Funds
would result in those Funds and their shareholders facing unduly and
disproportionately severe hardships. Applicants state that they will
distribute to the boards of directors of the Funds (the ``Boards'')
written materials describing the circumstances that led to the
Injunction and any impact on the Funds, and the application. The
written materials will include an offer to discuss the materials at an
in-person meeting with each Board for which the Fund Servicing
Applicants provide Fund Services Activities, including the directors
who are not ``interested persons'' of such Funds as defined in section
2(a)(19) of the Act, and their independent legal counsel as defined in
rule 0-1(a)(6) under the Act. Applicants state they will provide the
Boards with the information concerning the Injunction and the
application that is necessary for those Funds to fulfill their
disclosure and other obligations under the federal securities laws and
will provide them a copy of the Consent Order as entered by the Court.
    8. Applicants state that if the Fund Servicing Applicants were
barred under section 9(a) of the Act from providing investment advisory
services to the Funds, and were unable to obtain the requested
exemption, the effect on their businesses and employees would be unduly
and disproportionately severe because they have committed substantial
capital and other resources to establishing an expertise in advising
Funds. Applicants further state that prohibiting the Fund Servicing
Applicants from engaging in Fund Services Activities would not only
adversely affect their businesses, but would also adversely affect
their employees who are involved in those activities. Applicants state
that many of these employees working for the Fund Servicing Applicants
could experience significant difficulties in finding alternative fund-
related employment.
    9. Applicants state that certain affiliates of the Applicants have
previously received an order under section 9(c) of the Act, as the
result of conduct that triggered section 9(a), as described in greater
detail in the application.

Applicants' Conditions

    Applicants agree that any order granted by the Commission pursuant
to the application will be subject to the following conditions:
    1. Any temporary exemption granted pursuant to the application
shall be without prejudice to, and shall not limit the Commission's
rights in any manner with respect to, any Commission investigation of,
or administrative proceedings involving or against, Covered Persons,
including without limitation, the consideration by the Commission of a
permanent exemption from section 9(a) of the Act requested pursuant to
the application or the revocation or removal of any temporary
exemptions granted under the Act in connection with the application.
    2. Each Applicant and Covered Person will adopt and implement
policies and procedures reasonably designed to ensure that it will
comply with any terms and conditions of the Orders within 60 days of
the date of the Permanent Order.
    3. RBC will comply with the terms and conditions of the Consent
Order.
    4. Applicants will provide written notification to the Chief
Counsel of the Commission's Division of Investment Management with a
copy to the Chief Counsel of the Commission's Division of Enforcement
of a material violation of the terms and conditions of the Orders or
Consent Order within 30 days of discovery of the material violation.

Temporary Order

    The Commission has considered the matter and finds that Applicants
have made the necessary showing to justify granting a temporary
exemption.
    Accordingly,
    It is hereby ordered, pursuant to section 9(c) of the Act, that the
Fund Servicing Applicants and any other Covered Persons are granted a
temporary exemption from the provisions of section 9(a), solely with
respect to the Injunction, subject to the representations and
conditions in the application, from December 18, 2014, until the
Commission takes final action on their application for a permanent
order.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-30225 Filed 12-29-14; 8:45 am]
BILLING CODE 8011-01-P


Page 1 of 9 DRAFT September 15, 2004 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING OCTOBER 13 15, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0287 ISSUES ASSOCIATED WITH DEPLOYMENT OF A TYPE OF PLANTINCORPORATED PROTECTANT ( PIP), SPECIFICALLY THOSE BASED ON PLANT VIRAL COAT PROTEINS ( PVCP PIPS)

WEDNESDAY, OCTOBER 13, 2004 Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200

8: 30 AM Introduction and Identification of Panel Members   Stephen Roberts, Ph. D. ( FIFRA SAP Session Chair)

8: 45 AM Administrative Procedures by Designated Federal Official  Mr. Paul Lewis

8: 50 AM Welcome  Mr. Joseph J. Merenda, Jr. ( Director, Office of Science Coordination and Policy, EPA)

8: 55 AM Opening Remarks  Mr. Jim Jones ( Director, Office of Pesticide Programs, EPA)

9: 00 AM Opening Remarks  Mr. Dennis Szuhay ( Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA)

9: 05 AM PVCP PIPs: The Context   Elizabeth Milewski, Ph. D. ( Office of Science Coordination and Policy, EPA) and John Turner, Ph. D. ( Animal Plant Health and Inspection Service, USDA)

9: 35 AM Gene Flow in Viral Coat Protein Transgenic Plants   Anne Fairbrother, DVM, Ph. D. ( National Health and Environmental Research Effects Laboratory, ORD, EPA)

10: 15 AM BREAK

10: 30 AM Viral Interaction in Viral Coat Protein Transgenic Plants   Melissa Kramer, Ph. D. ( Office of Science Coordination and Policy, EPA)

11: 00 AM Other Considerations  Elizabeth Milewski, Ph. D. ( Office of Science Coordination and Policy, EPA)

11: 15 AM Public Comments Page 2 of 9

12: 30 PM LUNCH

1: 30 PM Panel Discussion Gene Flow Concerns about the transfer of virus resistance to wild or weedy relatives include the assumption that such resistance might confer a selective advantage to a wild or weedy relative that could increase its competitive ability and potential to become weedy or invasive. The Agency would like the panel to consider the evidence supporting this assumption.

1. What scientific evidence supports or refutes the idea that plant viruses have significant effects on reproduction, survival, and growth of plant populations in natural settings? Is there scientific evidence that plant populations freed from viral pressure could have increased competitive ability leading to changes in plant population dynamics?

2. Please comment on the validity of the Agency list of crops that have no wild or weedy relatives in the United States with which they can produce viable hybrids in nature ( i. e., tomato, potato, soybean, and corn).

3: 00 PM BREAK

3: 15 PM Panel Discussion ( continued)

3. Please identify other crops that have no wild or weedy relatives in the United States with which they can produce viable hybrids in nature, e. g., papaya, peanut, and/ or chickpea.

The Agency anticipates the need to evaluate data addressing whether transgenic plant species are capable of genetic exchange with wild or weedy plant relatives. In general, EPA is focused on the potential for genetic exchange that can occur in the field. However, evaluations of the potential for genetic exchange are likely to include laboratory studies that are not necessarily an accurate indicator of plants' ability to exchange genetic material outside the lab.

4. What laboratory techniques used to achieve genetic exchange between species ( e. g., embryo rescue, use of intermediate bridging crosses, protoplast fusion) are not indicative of possible genetic exchange between these species in the field? Conversely, what techniques, if any, used in laboratory or greenhouse experiments provide the most reliable indication of ability to hybridize in the field?

4: 30 PM ADJOURNMENT Page 3 of 9 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING OCTOBER 13 15, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0287 ISSUES ASSOCIATED WITH DEPLOYMENT OF A TYPE OF PLANTINCORPORATED PROTECTANT ( PIP), SPECIFICALLY THOSE BASED ON PLANT VIRAL COAT PROTEINS ( PVCP PIPS)

THURSDAY, OCTOBER 14, 2004 Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200

8: 30 AM Introduction and Identification of Panel Members   Stephen Roberts, Ph. D. ( FIFRA SAP Session Chair)

8: 35 AM Administrative procedures by Designated Federal Official  Mr. Paul Lewis

8: 40 AM Follow up from Previous Day's Discussion   Melissa Kramer, Ph. D. ( Office of Science Coordination and Policy, EPA)

9: 00 AM Panel Discussion ( continued)

EPA recognizes that it may be possible to genetically engineer a plant such that concerns about gene flow to wild or weedy relatives are significantly reduced. However, according to the 2004 NRC report, Biological Confinement of Genetically Engineered Organisms, current techniques for bioconfinement ( e. g., sterile triploids, male sterility) are imperfect and are not guaranteed to eliminate entirely gene flow to existing wild relatives. Recent modeling studies suggest imperfections in bioconfinement could result in significant levels of gene introgression in compatible plant relatives over a period of decades.

5. Given that current bioconfinement techniques are not 100% effective, what would the environmental implications be of extremely low transfer rates of virus resistance genes over time?

EPA recognizes that concerns about gene flow to wild or weedy relatives may be ameliorated if the introduced virus resistance trait would give little or no selective advantage to the recipient plant, as would occur if the plant were already tolerant or resistant to the virus to which resistance is conferred. It is obvious that such resistance does exist in some populations because traditional breeding for resistance relies on finding a source of resistance within related cultivated species, old varieties, or wild species. Page 4 of 9 6. Please comment on the prevalence of tolerance and/ or resistance to viruses in wild relatives of crops.

10: 00 AM BREAK

10: 15 AM Panel Discussion ( continued)

7. Please specify techniques that do or do not provide measures of tolerance and/ or resistance that are relevant to field conditions.

8. How do environmental or other factors ( e. g., temporal variations) affect tolerance and/ or resistance? Given the expected variability, what measures of tolerance and/ or resistance would be reliable?

9. What would be the ecological significance if a plant population acquired a small increase in viral tolerance and/ or resistance above a naturally occurring level?

Based on the hypothesis that concerns about the consequences of gene flow to a wild or weedy relative in the United States may be negligible in certain cases, the Agency is considering whether there are mechanisms to adequately address concerns associated with gene flow so that certain types of VCPs would be of such low risk that they would not need to be regulated by EPA. Below are examples of three conditions ( modified from those proposed in 1994) that are intended to significantly reduce any potential adverse effects of gene flow with plants containing a PVCP PIP.

( 1) The plant into which the PVCP PIP has been inserted has no wild or weedy relatives in the United States with which it can produce viable hybrids in nature, e. g., corn, tomato, potato, or soybean; or ( 2) Genetic exchange between the plant into which the PVCP PIP has been inserted and any existing wild or weedy relatives is substantially reduced by modifying the plant with a scientifically documented method ( e. g., through male sterility); or ( 3) It has been empirically demonstrated that all existing wild or weedy relatives in the United States with which the plant can produce a viable hybrid are tolerant or resistant to the virus from which the coat protein is derived.

10. Please comment on how necessary and/ or sufficient these conditions are to minimize the potential for the PVCP PIP to harm the environment through gene flow from the plant containing the PVCP PIP to wild or weedy relatives. Would any other conditions work as well or better?

12: 00 PM LUNCH

1: 00 PM Panel Discussion ( continued) Page 5 of 9 Viral Interactions Interactions between introduced plant virus sequences and other invading viruses in transgenic plants ( e. g., during recombination or heterologous encapsidation) may be a concern to the extent that such events may increase in frequency or be unlike those expected to occur in nature. It has been hypothesized that such events could lead to the creation of viruses with new disease states or transmission properties. The Agency is evaluating the circumstances that might increase the potential for such events to occur and the potential environmental consequences of novel viral interactions in light of the 2000 NRC report which stated that, "[ m] ost virus derived resistance genes are unlikely to present unusual or unmanageable problems that differ from those associated with traditional breeding for virus resistance." The report went on to suggest that risks might be managed by particular ways of engineering transgenes. However, under either of the 1994 proposed exemptions, the Agency would be unable to ensure that such strategies were implemented. The Agency's literature review, " Viral interactions in viral coat protein transgenic plants," discusses possible ways of managing these potential risks in detail.

Viral interactions may occur in natural, mixed infections which are common in plants. Hypothetical concerns related to potential adverse effects resulting from viral interactions between infecting viruses and PVCP PIPs in transgenic plants may be attributed to opportunities for interactions not expected to occur in nature. EPA is interested in evaluating the significance of novel viral interactions involving a viral transgene.

11. To what extent are novel viral interactions ( e. g., recombination, heterologous encapsidation) involving a viral transgene an environmental concern?

Mixed viral infections can be extremely common in crops and other plants. However, scientific uncertainty exists as to whether recombination and heterologous encapsidation would occur more or less frequently in the case of a viral transgene and an infecting virus interaction as compared to such interactions in mixed infections of a transgenic plant's non bioengineered counterpart.

12. What conclusions can be drawn as to whether the likelihood of recombination and/ or heterologous encapsidation would be increased or decreased in a transgenic plant compared to its non bioengineered counterpart?

3: 00 PM BREAK

3: 15 PM Panel Discussion ( continued)

A number of methods for reducing the frequency of recombination and heterologous encapsidation have been identified. While the effectiveness of these techniques has been verified for particular cases, their applicability to all PVCP PIPs is unclear. Recognizing that it would be difficult for a product developer to measure rates of recombination, heterologous encapsidation, or vector transmission under field conditions, Page 6 of 9 EPA is considering whether it would be necessary to verify that such methods worked in any particular instance by measuring rates in modified versus unmodified plants.

13. How effective is deleting the 3' untranslated region of the PVCP gene as a method for reducing the frequency of recombination in the region of the PVCP gene? Is this method universally applicable to all potential PVCP PIP constructs? Would any other methods work as well or better? Which methods are sufficiently effective and reproducible such that actual measurement of rates to verify rate reduction would be unnecessary?

14. Are any methods for inhibiting heterologous encapsidation or transmission by insect vectors universally applicable to all PVCP PIPs? Which methods are sufficiently effective and reproducible such that actual measurement of rates to verify rate reduction would be unnecessary?

15. How technically feasible would it be to measure rates of recombination, heterologous encapsidation, and vector transmission in PVCP PIP transgenic plants in order to show that rates are reduced?

5: 00 PM ADJOURNMENT Page 7 of 9 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING OCTOBER 13 15, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0287 ISSUES ASSOCIATED WITH DEPLOYMENT OF A TYPE OF PLANTINCORPORATED PROTECTANT ( PIP), SPECIFICALLY THOSE BASED ON PLANT VIRAL COAT PROTEINS ( PVCP PIPS)

FRIDAY, OCTOBER 15, 2004 Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200

8: 30 AM Introduction and Identification of Panel Members   Stephen Roberts, Ph. D. ( FIFRA SAP Session Chair)

8: 35 AM Administrative procedures by Designated Federal Official  Mr. Paul Lewis

8: 40 AM Follow up from Previous Day's Discussion   Melissa Kramer, Ph. D. ( Office of Science Coordination and Policy, EPA)

9: 00 AM Panel Discussion ( continued)

EPA recognizes that scientific disagreement exists as to the likelihood of environmental impacts due to novel viral interactions in transgenic plants modified with PVCP PIPs. The Agency is considering whether there are available mechanisms to adequately address concerns associated with novel viral interactions so that certain types of PVCP PIPs would be of such low risk that they would not need to be regulated by EPA. Below are examples of conditions that might significantly reduce either the novelty [( 1) and ( 2)] or frequency [( 3) and ( 4)] of viral interactions in PVCP PIP transgenic plants.

( 1) The genetic material of the PVCP PIP is translated and/ or transcribed in the same cells, tissues, and developmental stages naturally infected by every virus from which any segment of a coat protein gene used in the PVCP PIP was derived.

( 2) The genetic material of the PVCP PIP contains coat protein genes or segments of coat protein genes from viruses established throughout the regions where the crop is planted in the United States and that naturally infect the crop into which the genes have been inserted. Page 8 of 9 ( 3) The PVCP PIP has been modified by a method scientifically documented to minimize recombination, ( e. g., deletion of the 3' untranslated region of the coat protein gene).

( 4) The PVCP PIP has been modified by a method scientifically documented to minimize heterologous encapsidation or vector transmission, or there is minimal potential for heterologous encapsidation because no protein from the introduced PVCP PIP is produced in the transgenic plant or this virus does not participate in heterologous encapsidation in nature.

16. Please comment on how necessary and/ or sufficient each of these conditions is to minimize the potential for novel viral interactions. Please address specifically what combination would be most effective or what conditions could be modified, added, or deleted to ensure that potential consequences of novel viral interactions in PVCPPIP transgenic plants are minimized.

10: 00 AM BREAK

10: 15 AM Panel Discussion ( continued)

Other questions In 1994 EPA proposed exempting plant viral coat proteins from the requirement of a food tolerance under the Federal Food, Drug, and Cosmetic Act based on rationale that ( 1) virus infected plants have always been a part of the human and domestic animal food supply and ( 2) plant viruses have never been shown to be infectious to humans or mammals. The safety of consuming plant virus genes has been supported by experimental work ( Chen et al. 2003; Rogan et al. 2000; Shinmoto et al. 1995) and expert consultations including the 2000 NRC report which concluded that, " viral coat proteins in transgenic pest protected plants are not expected to jeopardize human health because consumers already ingest these compounds in nontransgenic food." However, EPA recognizes that PVCP PIP developers may wish to modify the PVCP PIP construct and that some methods of mitigating potential risks associated with recombination and heterologous encapsidation might actually require them to do so. Such modifications might result in changes to the protein( s) produced thus creating potential food safety concerns, e. g., inadvertent production of new toxins or allergens ( Day 1996). Modifications of the construct and alteration of the proteins produced creates the potential for health impacts on non target species as well as humans.

17. To what degree and in what ways might a PVCP gene be modified ( e. g., through truncations, deletions, insertions, or point mutations) while still retaining scientific support for the idea that humans have consumed the products of such genes for generations and that such products therefore present no new dietary exposures?

18. What are the potential adverse effects, if any, of such modifications on nontarget species ( e. g., wildlife and insects that consume the PVCP PIP)? Page 9 of 9 Modifications of the construct may also potentially create the opportunity for novel viral interactions because the inserted virus sequences could be unlike any that occur naturally.

19. To what degree and in what ways might a PVCP gene be modified ( e. g., through truncations, deletions, insertions, or point mutations) before it would be a concern that novel viral interactions due to the modifications could occur because the PVCP gene would be significantly different from any existing in nature?

The potential risk issues identified in this paper are specific to virus resistant transgenic plants. However, the Agency recognizes that it may be necessary to evaluate other information related to the PVCP PIP.

20. Would any additional requirements related to PVCP PIP identity and composition ( e. g., demonstration that the transgene has been stably inserted) be needed for significant reduction of risks associated with PVCP PIPs?

21. Are there any considerations beyond gene flow, recombination, and heterologous encapsidation as posed in the preceding questions that the Agency should consider in evaluating the risk potential of PVCP PIPs ( e. g., synergy)?

3: 00 PM ADJOURNMENT Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mr. Paul Lewis, via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: lewis. paul@ epa. gov


[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8817-8818]
[DOCID:fr27fe07-147]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55319; File No. SR-CHX-2007-01]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment No. 1 Thereto Relating to the Use of a ``SOLD'' Indicator

February 20, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 30, 2007, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The CHX has filed this proposal pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(5) thereunder,\4\ which
renders it effective upon filing with the Commission. On February 20,
2007, the Exchange filed Amendment No. 1 to the proposed rule
change.\5\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(5).
    \5\ See Form 19b-4 dated February 20, 2007 (``Amendment No.
1'').
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules to specify that a ``SOLD''
indicator must only be affixed to a trade to the extent required by
applicable intermarket trade reporting plans.
    The text of the proposed rule change is available on the CHX's Web
site at http://www.chx.com, the Exchange's principal office, and at the

Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange's institutional brokers may execute transactions in
the Exchange's Matching System or may report transactions through the
Exchange's Brokerplex system.\6\ Under Article 17, Rule 3(e) of the
Exchange's rules, if institutional brokers use the Brokerplex system's
trade reporting functionality, these brokers are required to use their
best efforts to report transactions within 10 seconds after execution.
A ``SOLD'' indicator must be affixed to the trade if this 10-second
window is exceeded.\7\
---------------------------------------------------------------------------

    \6\ The Exchange's Brokerplex system currently can be used by
CHX institutional brokers to receive and enter orders, manage their
orders, route orders to the Exchange's Matching System and other
destinations for execution and report executed trades.
    \7\ A ``SOLD'' indicator is used, when reporting trades in Tape
A and B securities, to identify trades that are being reported late
(i.e., after some delay from the time of execution) and out of
sequence. The Consolidated Tape Association Plan (the ``CTA Plan''),
which governs trade reporting in Tape A and B securities, provides
that a market should ``designate as `late' any last sale price not
collected and reported'' within 90 seconds after the execution
occurs.
---------------------------------------------------------------------------

    The CHX had established this 10-second time frame for affixing the
``SOLD'' indicator as part of its new trading model rules in the belief
that the CTA Plan would be amended to contain a similar provision. At
this point, however, the CTA Plan has not been amended to reflect this
shorter time frame.\8\
---------------------------------------------------------------------------

    \8\ The CTA Plan and specifications currently provide that the
indicator must be placed on trades reported more than 90 seconds
after they are executed.
---------------------------------------------------------------------------

    This proposal would change the Exchange's rules to specify that the
``SOLD'' indicator must only be affixed to a trade to the extent that
the indicator is required by an intermarket trade reporting plan, such
as the CTA Plan.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the Act
\9\ in general and furthers the objectives of Section 6(b)(5) \10\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, 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.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    Because the proposed rule change does not: (1) Significantly affect
the protection of investors or the public interest; (2) impose any
significant burden on competition; and (3) have the effect of limiting
the access to or availability of an existing order entry or trading
system of the Exchange, the foregoing rule change has become effective
immediately pursuant to Section 19(b)(3)(A)(iii) of the Act \11\ and
Rule 19b-4(f)(5) \12\ thereunder. At any time within 60 days of the
filing of such proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in the furtherance of the
purposes of the Act.\13\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(5).
    \13\ For the purposes of calculating the 60-day abrogation
period, the Commission considers the proposed rule change to have
been filed on February 20, 2007, when Amendment No. 1 was filed.
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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-CHX-2007-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-CHX-2007-01. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal offices of CHX. 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-CHX-2007-01 and should be submitted on or before March 20, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-3290 Filed 2-26-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25831]
[DOCID:fr02my06-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-312-000]

Mississippi Canyon Gas Pipeline, LLC; Notice of Proposed Changes
in FERC Gas Tariff

April 25, 2006.
    Take notice that on April 19, 2006, Mississippi Canyon Gas
Pipeline, LLC (Mississippi Canyon) tendered for filing as part of its
FERC Gas Tariff, First Revised Volume No. 1, the following tariff
sheets, to become effective May 19, 2006:

Sixth Revised Sheet No. 2.
Fifth Revised Sheet No. 55.
First Revised Sheet No. 155.
Original Sheet No. 156.

    Mississippi Canyon states that copies of its filing have been
mailed to all affected customers of Mississippi Canyon and any
interested state commissions. However, due to the voluminous nature of
this filing, Mississippi Canyon is not providing copies of the filed
agreements or red-lines of such agreements as part of each service
copy. Mississippi Canyon states that the entire filing (excluding
certain confidential information) will be available in its offices and
that it will provide copies of such agreements (excluding certain
confidential information) to any affected customer or interested state
commission who requests such copies.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6559 Filed 5-1-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]
[Page 46021-46022]
[DOCID:fr07au08-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Advisory Committee for Reproductive Health Drugs; Notice of
Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Advisory Committee for Reproductive Health
Drugs.
    General Function of the Committee: To provide advice and
recommendations to theagency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 8, 2008, from
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Rockville, Plaza Ballrooms I and II,
1750 Rockville Pike, Rockville, MD. The hotel phone number is 301-468-
1100.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5
milligrams (mg), Pfizer Inc., for the proposed indication of the
treatment of osteoporosis in postmenopausal women at increased risk of
fracture.
    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/ohrms/dockets/ac/acmenu.htm, click
on the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 27, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 August 19, 2008. 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 August
20, 2008.
    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 Kalyani Bhatt (301)
827-7001 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/oc/advisory/
default.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: July 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18131 Filed 8-6-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7363-7365]
[FR Doc No: 2019-03850]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1196; FRL-9990-29-OAR]

Recent Postings of Broadly Applicable Alternative Test Methods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the broadly applicable alternative test
method approval decisions that the Environmental Protection Agency
(EPA) has made under and in support of New Source Performance Standards
(NSPS) and the National Emission Standards for Hazardous Air Pollutants
(NESHAP) between January 1, 2018, and December 31, 2018.

FOR FURTHER INFORMATION CONTACT: An electronic copy of each alternative
test method approval document is available at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods. For questions
about this notice, contact Mrs. Lula H. Melton, Air Quality Assessment
Division, Office of Air Quality Planning and Standards (E143-02),
Environmental Protection Agency, Research Triangle Park, NC 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>For technical questions about individual
alternative test method decisions, refer to the contact person
identified in the individual approval document(s).

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This notice will be of interest to entities regulated under 40 Code
of Federal Regulations (CFR) parts 60, 61, and 63; state, local, and
tribal agencies; and the EPA Regional offices responsible for
implementation and enforcement of regulations under 40 CFR parts 60,
61, and 63.

B. How can I get copies of this information?

    You may access copies of the broadly applicable alternative test
method approval documents at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.

II. Background

    This notice identifies broadly applicable alternative test method
approval decisions made by the EPA in 2018 under the NSPS, 40 CFR part
60 and the NESHAP programs, and 40 CFR parts 61 and 63 (see Table 1).
Source owners and operators may voluntarily use these broadly
applicable alternative test methods in lieu of otherwise specified
reference test methods. Use of these broadly applicable alternative
test methods does not change the applicable emission standards.
    The Administrator has the authority to approve the use of
alternative test methods for compliance with requirements under 40 CFR
parts 60, 61, and 63. This authority is found in sections 60.8(b)(3),
61.13(h)(1)(ii), and 63.7(e)(2)(ii). Additional and similar authority
can be found in 40 CFR 65.158(a)(2). The criteria for approval and
procedures for submission and review of broadly applicable alternative
test methods are explained in a previous Federal Register notice
published at 72 FR 4257 (January 30, 2007) and located at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.
As explained in this notice, we will announce approvals for broadly
applicable alternative test methods at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods and publish an annual
notice that summarizes approvals for broadly applicable alternative
test methods during the preceding year.
    As also explained in the January 30, 2007 notice, our approval
decisions involve thorough technical reviews of numerous source-
specific requests for alternatives and modifications to test methods
and procedures. Based on these reviews, we have often found that these
modifications or alternatives would be equally valid and appropriate to
apply to other sources within a particular class, category, or
subcategory. Consequently, we have concluded that where a method
modification or an alternative method is clearly broadly applicable to
a class, category, or subcategory of sources, it is both equitable and
efficient to approve its use for all appropriate sources and situations
at the same time.
    Use of approved alternative test methods are not mandatory but
rather permissive. Sources are not required to employ such a method but
may choose to do so in appropriate circumstances. As per section
63.7(f)(5), however, a source owner or operator electing to use an
alternative method for 40 CFR part

63 standards must continue to use the alternative method until
otherwise authorized. Source owners or operators should, therefore,
review the specific broadly applicable alternative method approval
decision at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods before electing to employ any alternative
method.

III. Approved Alternative Test Methods and Modifications to Test
Methods

    This notice specifies ten broadly applicable alternative test
methods that the EPA approved between January 1, 2018, and December 1,
2018. The alternative method decision letter/memo number, the reference
method affected, sources allowed to use this alternative, and the
modification or alternative method allowed are summarized in Table 1 of
this notice. A summary of approval documents was previously made
available on our Technology Transfer Network between January 1, 2018,
and December 31, 2018. For more detailed information, please refer to
the complete copies of these approval documents available at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.
    As also explained in our January 30, 2007 notice, we will revisit
approvals of alternative test methods in response to written requests
or objections indicating that a particular approved alternative test
method either should not be broadly applicable or that its use should
in some way be limited. Any objection to a broadly applicable
alternative test method, as well as the resolution of that objection,
will be announced at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods and in a subsequent Federal Register
notice. If we decide to retract a broadly applicable test method, we
will likely consider the need for an appropriate transition period for
users either to request case-by-case approval or to transition to an
approved method.

    Dated: January 29, 2019.
Richard A. Wayland,
Director, Air Quality Assessment Division.

  Table 1--Approved Alternative Test Methods and Modifications to Test
 Methods Referenced in or Published Under Appendices in 40 CFR Parts 60,
        61, and 63 Posted Between January 2018 and December 2018
------------------------------------------------------------------------
                            As an
  Alternative method    alternative or
 decision letter/memo  modification to     For . . .      You may . . .
         No.                . . .
------------------------------------------------------------------------
ATL-123..............  Method 3A,       Sources subject  Use procedures
                        Method 3B, or    to 40 CFR part   specified in
                        ANSI/ASME PTC    63, subpart      the Appendix
                        19.10-1981.      UUUUU--Nationa   of the
                                         l Emission       Agency's
                                         Standards for    approval
                                         Hazardous Air    letter dated
                                         Pollutants:      February 13,
                                         Coal- and Oil-   2018, and the
                                         Fired Electric   modifications
                                         Utility Steam    specified in
                                         Generating       the Agency's
                                         Units.           approval
                                                          letter dated
                                                          March 6, 2018.
ALT-124..............  40 CFR 63.670    Sources subject  Use continuous
                        and 63.671.      to 40 CFR part   process mass
                                         63, subpart      spectrometry
                                         CC--National     in lieu of
                                         Emission         continuous gas
                                         Standards for    chromatography
                                         Hazardous Air    to measure Net
                                         Pollutants       Heating Value
                                         from Petroleum   (NHVVG) using
                                         Refineries.      the
                                                          measurement
                                                          approach and
                                                          requirements
                                                          specified in
                                                          the Agency's
                                                          approval
                                                          letter dated
                                                          February 5,
                                                          2018.
ALT-125..............  40 CFR 60.534..  Sources subject  Use ASTM E3053-
                                         to 40 CFR part   17 and ASTM
                                         60, subpart      E2515-11 both
                                         AAA--Standards   with the
                                         of Performance   change(s)
                                         for New          specified in
                                         Residential      the Agency's
                                         Wood Heaters.    approval
                                                          letter dated
                                                          February 28,
                                                          2018, and
                                                          Canadian
                                                          Standards
                                                          Administration
                                                          (CSA) Method
                                                          CSA-B415.1-10.
ALT-126..............  ASTM E2515-11,   Sources subject  Use the
                        section 10.2.2.  to 40 CFR part   procedure
                                         60, subpart      specified in
                                         AAA--Standards   the Agency's
                                         of Performance   approval
                                         for New          letter dated
                                         Residential      March 6, 2018,
                                         Wood Heaters     Method 5,
                                         and 40 CFR       sections 8.7,
                                         part 60,         11.2.1 and
                                         subpart QQQQ--   11.2.2, and
                                         New              ASTM E2515-11.
                                         Residential
                                         Wood Heaters,
                                         New
                                         Residential
                                         Hydronic
                                         Heaters and
                                         Forced-Air
                                         Furnaces.
ALT-127..............  40 CFR 60.534..  Sources subject  Use ASTM E3053-
                                         to 40 CFR part   17 and ASTM
                                         60, subpart      E2515-11 both
                                         AAA--Standards   with the
                                         of Performance   change(s)
                                         for New          specified in
                                         Residential      the Agency's
                                         Wood Heaters.    approval
                                                          letter dated
                                                          April 13,
                                                          2018, and
                                                          Canadian
                                                          Standards
                                                          Administration
                                                          (CSA) Method
                                                          CSA-B415.1-10.
ALT-128..............  Method 25--      Sources subject  Use an
                        Determination    to 40 CFR        alternative
                        of Total         parts 60 and     filter, filter
                        Gaseous          63, subparts     holder, and
                        Nonmethane       specified in     filter heater
                        Organic          the Agency's     box as
                        Emissions as     approval         specified in
                        Carbon.          letter dated     the Agency's
                                         April 18, 2018.  approval
                                                          letter dated
                                                          April 18,
                                                          2018.
ALT-129..............  Method 26--      Sources subject  Use sorbent
                        Determination    to 40 CFR part   trap method
                        of Hydrogen      63, subpart      (Other Test
                        Halide and       UUUUU--Nationa   Method (OTM)-
                        Halogen          l Emission       40) for HCl
                        Emissions From   Standards for    emissions from
                        Stationary       Hazardous Air    the specific
                        Sources Non-     Pollutants:      coal-fired
                        Isokinetic       Coal- and Oil-   electric
                        Method and       fired Electric   utility steam
                        Method 26A--     Utility Steam    generating
                        Determination    Generating       units and the
                        of Hydrogen      Units.           provisos in
                        Halide and                        the Agency's
                        Halogen                           approval
                        Emissions From                    letter dated
                        Stationary                        May 30, 2018.
                        Sources
                        Isokinetic
                        Method.

ALT-130..............  SW-846 Method    Sources subject  SW-846 Method
                        8260B.           to 40 CFR part   8260C and SW-
                                         63, subpart      846 Method
                                         HHHHHHH--Polyv   8260D with the
                                         inyl Chloride    performance
                                         and Copolymers   criteria
                                         Production:      specified in
                                         National         the Agency's
                                         Emission         approval
                                         Standards for    letter dated
                                         Hazardous Air    October 17,
                                         Pollutants       2018.
                                         (NESHAP).
ALT-131..............  Quality          Sources subject  Use the
                        assurance        to 40 CFR part   alternative
                        procedures in    63, subpart      quality
                        Performance      CC--National     assurance
                        Specification    Emission         procedures
                        9 and 40 CFR     Standards for    specified in
                        63.671(e)(2)     Hazardous Air    the Agency's
                        and (e)(3).      Pollutants       approval
                                         from Petroleum   letter dated
                                         Refineries.      December 13,
                                                          2018.
ALT-132..............  40 CFR           Sources subject  Use the
                        63.1350(k)(2)(   to 40 CFR part   alternative
                        ii) and (iii).   63, subpart      procedure for
                                         LLL--National    ``above span''
                                         Emission         mercury
                                         Standards for    calibrations
                                         Hazardous Air    only as
                                         Pollutants       specified in
                                         from the         the Agency's
                                         Portland         approval
                                         Cement           letter dated
                                         Manufacturing    December 18,
                                         Industry.        2018. This
                                                          alternative
                                                          procedure
                                                          replaces ALT-
                                                          120, which
                                                          expired
                                                          January 1,
                                                          2019.
------------------------------------------------------------------------

    Source owners or operators should review the specific broadly
applicable alternative method approval letter at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods before
electing to employ it.

[FR Doc. 2019-03850 Filed 3-1-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Rules and Regulations]
[Pages 5305-5306]
[FR Doc No: 2013-01449]

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

 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0611; FRL-9755-9]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is finalizing approval of revisions to the South Coast Air
Quality Management District (SCAQMD) portion of the California State
Implementation Plan (SIP). These revisions were proposed in the Federal
Register on September 19, 2012 and concern lead emissions from large
lead-acid battery recycling facilities. We are approving a local rule
that regulates these emission sources under the Clean Air Act as
amended in 1990 (CAA or the Act).

DATES: This rule is effective on February 25, 2013.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2011-0611 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps, multi-volume
reports), and some may not be available in either location (e.g.,
confidential business information (CBI)). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Adrianne Borgia, EPA Region IX, (415)
972-3576<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On September 19, 2012 (77 FR 58076), EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
            Local agency                  Rule No.            Rule Title            Adopted         Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD..............................          1420.1   Emissions Standard For          11/5/10          9/27/11
                                                        Lead From Large Lead-
                                                        Acid Battery Recycling
                                                        Facilities.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complies with the relevant CAA requirements. Our proposed action
contains more information on the rules and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received no relevant comments.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted rule complies with the relevant CAA requirements. Therefore,
as authorized in section 110(k)(3) of the Act, EPA is fully approving
this rule into the California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a

substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: November 6, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(404)(i)(A)(2) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (404) * * *
    (i) * * *
    (A) * * *
    (2) Rule 1420.1, ``Emissions Standard For Lead From Large Lead-Acid
Battery Recycling Facilities,'' adopted on November 5, 2010.
* * * * *
[FR Doc. 2013-01449 Filed 1-24-13; 8:45 am]
BILLING CODE P


[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7778-7779]
[FR Doc No: 2013-02322]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0793; FRL-9527-3]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Pesticide Environmental Stewardship Program
Annual Measures Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Pesticide Environmental
Stewardship Program Annual Measures Reporting'' (EPA ICR No. 2415.01,
OMB Control No. 2070-XXXX) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.). This is request for approval of a new
collection. Public comments were previously requested via the Federal
Register (75 FR 66084) on October 27, 2010 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before March 6, 2013.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPP-2010-0793, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Lily G. Negash, Field & External
Affairs Division, 7506P, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 703-347-
8515; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Pesticide Environmental Stewardship Program (PESP or
``the program'' hereinafter) is an EPA voluntary program implemented by
Environmental Protection Agency's (EPA) Office of Pesticide Programs
(OPP). PESP's goal is to promote environmental stewardship to protect
human health and the environment in accordance with Section 2(b) of the
Pollution Prevention Act of 1990, 42 U.S.C. 13101(b) that ``pollution
should be prevented or reduced at the source whenever feasible,'' and
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) which requires EPA to regulate pesticides to prevent
``unreasonable adverse effects.'' The program encourages the use of
integrated pest management (IPM) strategies to make the best
stewardship choices from a series of pest management practices. It
allows for economical pest management, and does so with the least
possible hazard to people, property, and the environment.
    This new information collection request (ICR) enables EPA to
implement IPM through partnerships with its members which are pesticide
user entities, and organizations which focus on training, educating, or
influencing pesticide users. To become a PESP member, a pesticide user
entity or an organization submits an application and a five-year
strategy. The program uses the information collected to establish
partner membership, develop stewardship strategies, offer technical
assistance, measure progress towards stewardship goals, and award
incentives. The stewardship strategy outlines how environmental and
human health risk reduction goals will be achieved through the
implementation of IPM, or through educating others on IPM. PESP
encourages its members to track progress towards IPM goals: Reduced use
of unnecessary pesticides, realize cost reductions, and share knowledge
about IPM methodologies.
    EPA has implemented procedures to protect any confidential, trade
secret or proprietary information from disclosure that provide strict
instructions regarding access to and contact with documents
confidential business information (CBI). These procedures comply with
EPA's CBI regulations at 40 CFR part 2.
    Form Numbers: PESP Membership Application Form (EPA Form 9600-02);
Strategy/Reporting Form for PESP Members that are Not Commercial/
Residential Pest Control Services (EPA Form No. 9600-01); PESP
Strategy/Progress Reporting Form for Residential/Commercial Pest
Control Service Providers (EPA Form No. 9600-03).
    Respondents/affected entities: Pesticide user companies and
organizations, or entities that represent them, that are committed to
reducing risks from pests and pesticides by practicing IPM; companies
or organizations that promote the use of IPM through education and
training. Below is a list of North American Industry Classification
System (NAICS) codes and associated industries that may be affected by
information collection requirements covered under this ICR. This list
is intended to be illustrative; entities from other industries may
elect to apply for recognition through PESP. However, EPA expects that
most applications will come from the following industries:

------------------------------------------------------------------------
               NAICS code                       Affected industry
------------------------------------------------------------------------
11.....................................  Agriculture, Forestry, Fishing
                                          and Hunting.
111....................................  Crop Production.
11142..................................  Nursery and Floriculture
                                          Production.
111421.................................  Nursery and Tree Production.
113....................................  Forestry and Logging.
22.....................................  Utilities.
2211...................................  Electric Power Generation,
                                          Transmission and Distribution.
5617...................................  Services to Buildings and
                                          Dwellings.
56171..................................  Exterminating and Pest Control
                                          Services.
56172..................................  Janitorial Services.
56173..................................  Landscaping Services.
6111...................................  Elementary and Secondary
                                          Schools.
6112...................................  Junior Colleges.
6113...................................  Colleges, Universities, and
                                          Professional Schools.
622....................................  Hospitals.
6244...................................  Child Day Care Services.
71391..................................  Golf Courses and Country Clubs.
813312.................................  Environment, Conservation and
                                          Wildlife Organizations.
------------------------------------------------------------------------

    Respondent's obligation to respond: Required to obtain or retain a
benefit.
    Estimated number of respondents: 424 total PESP members.
    Frequency of response: Varies depending on one of three required
activities, which are, one-time membership application, annual reports,
and five-year strategy updates.
    Total estimated burden: 43,023 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,755,363 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the total estimated
respondent burden. This is a new ICR.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-02322 Filed 2-1-13; 8:45 am]
BILLING CODE 6560-50-P