[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Notices]
[Pages 41994-41996]
[FR Doc No: 2019-17578]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1953]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain

management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities. The flood hazard determinations
are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
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Arizona:
    Pima........................  City of Tucson (19-  The Honorable       Planning and        https://msc.fema.gov/  Nov. 18, 2019........       040076
                                   09-0058P).           Jonathan            Development         portal/advanceSearch.
                                                        Rothschild,         Services, Public
                                                        Mayor, City of      Works Building,
                                                        Tucson, City        201 North Stone
                                                        Hall, 255 West      Avenue, Tucson,
                                                        Alameda Street,     AZ 85701.
                                                        10th Floor,
                                                        Tucson, AZ 85701.
    Pima........................  Unincorporated       The Honorable       Pima County Flood   https://msc.fema.gov/  Nov. 18, 2019........       040073
                                   Areas of Pima        Richard Elias,      Control District,   portal/advanceSearch.
                                   County, (19-09-      Chairman, Board     201 North Stone
                                   0058P).              of Supervisors,     Avenue, 9th
                                                        Pima County, 130    Floor, Tucson, AZ
                                                        West Congress       85701.
                                                        Street, 11th
                                                        Floor, Tucson, AZ
                                                        85701.
California:
    Napa........................  Unincorporated       The Honorable Ryan  Napa County,        https://msc.fema.gov/  Nov. 4, 2019.........       060205
                                   Areas of Napa        Gregory,            Public Works        portal/advanceSearch.
                                   County, (18-09-      Chairman, Board     Department, 1195
                                   1735P).              of Supervisors,     3rd Street, Suite
                                                        Napa County, 1195   101, Napa, CA
                                                        3rd Street, Suite   94559.
                                                        310, Napa, CA
                                                        94559.
    Orange......................  City of Fountain     The Honorable       City Hall, 10200    https://msc.fema.gov/  Nov. 15, 2019........       060218
                                   Valley, (19-09-      Steve Nagel,        Slater Avenue,      portal/advanceSearch.
                                   0812P).              Mayor, City of      Fountain Valley,
                                                        Fountain Valley,    CA 92708.
                                                        10200 Slater
                                                        Avenue, Fountain
                                                        Valley, CA 92708.
    Orange......................  City of Huntington   The Honorable Erik  City Hall, 2000     https://msc.fema.gov/  Nov. 15, 2019........       065034
                                   Beach, (19-09-       Peterson, Mayor,    Main Street,        portal/advanceSearch.
                                   0812P).              City of             Huntington Beach,
                                                        Huntington Beach,   CA 92648.
                                                        2000 Main Street,
                                                        Huntington Beach,
                                                        CA 92648.
    Orange......................  City of              The Honorable Tri   City Hall, 8200     https://msc.fema.gov/  Nov. 15, 2019........       060237
                                   Westminster, (19-    Ta, Mayor, City     Westminster         portal/advanceSearch.
                                   09-0812P).           of Westminster,     Boulevard,
                                                        8200 Westminster    Westminster, CA
                                                        Boulevard,          92683.
                                                        Westminster, CA
                                                        92683.
    Orange......................  Unincorporated       The Honorable Lisa  Orange County       https://msc.fema.gov/  Nov. 15, 2019........       060212
                                   Areas of Orange      A. Bartlett,        Flood Control       portal/advanceSearch.
                                   County, (19-09-      Chair, Board of     Division, H.G.
                                   0812P).              Supervisors,        Osborne Building,
                                                        Orange County,      300 North Flower
                                                        333 West Santa      Street, 7th
                                                        Ana Boulevard,      Floor, Santa Ana,
                                                        Santa Ana, CA       CA 92703.
                                                        92701.
Florida:
    Clay........................  Unincorporated       The Honorable Mike  Clay County,        https://msc.fema.gov/  Nov. 22, 2019........       120064
                                   Areas of Clay        Cella, Chairman,    Public Works        portal/advanceSearch.
                                   County, (19-04-      Clay County Board   Department, 5
                                   3655P).              of County           Esplanade Avenue,
                                                        Commissioners,      Green Cove
                                                        P.O. Box 1366,      Springs, FL 32043.
                                                        Green Cove
                                                        Springs, FL 32043.
    St. Johns...................  Unincorporated       Mr. Paul M.         St. Johns County    https://msc.fema.gov/  Nov. 14, 2019........       125147
                                   Areas of St. Johns   Waldron, Chair,     Administration      portal/advanceSearch.
                                   County, (19-04-      St. Johns County    Building, 4020
                                   2832P).              Board of            Lewis Speedway,
                                                        Commissioners,      St. Augustine, FL
                                                        500 San Sebastian   32084.
                                                        View, St.
                                                        Augustine, FL
                                                        32084.
Idaho:
    Latah.......................  City of Moscow, (18- The Honorable Bill  Paul Mann           https://msc.fema.gov/  Nov. 20, 2019........       160090
                                   10-1024P).           Lambert, Mayor,     Building, 221       portal/advanceSearch.
                                                        City of Moscow,     East 2nd Street,
                                                        P.O. Box 9203,      Moscow, ID 83843.
                                                        Moscow, ID 83843.
Indiana:
    Hamilton....................  City of Carmel, (19- The Honorable       Department of       https://msc.fema.gov/  Nov. 21, 2019........       180081
                                   05-0850P).           James Brainard,     Community           portal/advanceSearch.
                                                        Mayor, City of      Services, 1 Civic
                                                        Carmel, City        Square, Carmel,
                                                        Hall, 1 Civic       IN 46032.
                                                        Square, Carmel,
                                                        IN 46032.

    Hamilton....................  City of              The Honorable John  City Hall,          https://msc.fema.gov/  Nov. 21, 2019........       180082
                                   Noblesville, (19-    Ditslear, Mayor,    Department of       portal/advanceSearch.
                                   05-0850P).           City of             Planning and
                                                        Noblesville, City   Zoning, 16 South
                                                        Hall, 16 South      10th Street,
                                                        10th Street,        Suite 150,
                                                        Noblesville, IN     Noblesville, IN
                                                        46060.              46060.
    Hamilton....................  Town of Fishers (19- The Honorable       City Hall, 1        https://msc.fema.gov/  Nov. 21, 2019........       180423
                                   05-0850P).           Scott Fadness,      Municipal Drive,    portal/advanceSearch.
                                                        Mayor, Town of      Fishers, IN 46038.
                                                        Fishers, City
                                                        Hall, 1 Municipal
                                                        Drive, Fishers,
                                                        IN 46038.
    Hamilton....................  Unincorporated       The Honorable       Hamilton County     https://msc.fema.gov/  Nov. 21, 2019........       180080
                                   Areas of Hamilton    Steve Dillinger,    Government and      portal/advanceSearch.
                                   County, (19-05-      President, Board    Judicial Center,
                                   0850P).              of Hamilton         1 Hamilton County
                                                        County              Square,
                                                        Commissioners,      Noblesville, IN
                                                        Hamilton County     46060.
                                                        Government and
                                                        Judicial Center,
                                                        1 Hamilton County
                                                        Square, Suite
                                                        157, Noblesville,
                                                        IN 46060.
Michigan:
    Macomb......................  Township of Macomb,  Ms. Janet Dunn,     Township Hall,      https://msc.fema.gov/  Nov. 7, 2019.........       260445
                                   (18-05-5405P).       Supervisor,         54111 Broughton     portal/advanceSearch.
                                                        Township of         Road, Macomb, MI
                                                        Macomb, 54111       48042.
                                                        Broughton Road,
                                                        Macomb, MI 48042.
Minnesota:
    Olmsted.....................  City of Rochester,   The Honorable Kim   City Hall, 201 4th  https://msc.fema.gov/  Oct. 31, 2019........       275246
                                   (19-05-0734P).       Norton, Mayor,      Street Southeast,   portal/advanceSearch.
                                                        City of             Rochester, MN
                                                        Rochester, City     55904.
                                                        Hall, 201 4th
                                                        Street Southeast,
                                                        Room 281,
                                                        Rochester, MN
                                                        55904.
    Olmsted.....................  Unincorporated       Commissioner Jim    Olmsted County      https://msc.fema.gov/  Oct. 31, 2019........       270626
                                   Areas of Olmsted     Bier,               Government          portal/advanceSearch.
                                   County (19-05-       Chairperson,        Center, 151 4th
                                   0734P).              Olmsted County      Street Southeast,
                                                        Board of            Rochester, MN
                                                        Commissioners,      55904.
                                                        151 4th Street
                                                        Southeast,
                                                        Rochester, MN
                                                        55904.
New York:
    Rockland....................  Town of Ramapo, (19- The Honorable       Ramapo Office of    https://msc.fema.gov/  Dec. 20, 2019........       365340
                                   02-0049P).           Michael B.          the Building        portal/advanceSearch.
                                                        Specht,             Inspector, 237
                                                        Supervisor, Town    Route 59,
                                                        of Ramapo, Town     Suffern, NY 10901.
                                                        Hall, 237 Route
                                                        59, Suffern, NY
                                                        10901.
Ohio:
    Hamilton....................  City of Cincinnati,  The Honorable John  City Hall, 801      https://msc.fema.gov/  Nov. 1, 2019.........       390210
                                   (19-05-2371P).       Cranley, Mayor,     Plum Street,        portal/advanceSearch.
                                                        City of             Cincinnati, OH
                                                        Cincinnati, City    45202.
                                                        Hall, 801 Plum
                                                        Street, Suite
                                                        150, Cincinnati,
                                                        OH 45202.
Texas:
    Tarrant.....................  City of Arlington,   The Honorable Jeff  City Hall, 101      https://msc.fema.gov/  Nov. 8, 2019.........       485454
                                   (18-06-3755P).       Williams, Mayor,    West Abram          portal/advanceSearch.
                                                        City of             Street,
                                                        Arlington, City     Arlington, TX
                                                        Hall, 101 West      76010.
                                                        Abram Street,
                                                        Arlington, TX
                                                        76010.
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[FR Doc. 2019-17578 Filed 8-15-19; 8:45 am]
 BILLING CODE 9110-12-P


P-19-0137 Sanitized Support Documents Index:
 P-19-0137 Sanitized Determination Document (linked)
 P-19-0137 Sanitized CHEM Report (attached)
 P-19-0137 Sanitized ECO Report (attached)
 P-19-0137 Sanitized ENG Report (attached)
 P-19-0137 Sanitized EXP Report (attached)
 P-19-0137 Sanitized Fate Report (attached)
 P-19-0137 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Notices]
[Pages 52756-52757]
[FR Doc No: 2017-24628]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32898; File No. 812-14775]

Meeder Funds Trust, et al.

November 8, 2017.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application for an order under section 12(d)(1)(J) of
the Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 12(d)(1)(A) and (B) of the Act and under sections 6(c) and
17(b) of the Act for an exemption from sections 17(a)(1) and (2) of the
Act.
    The requested order would permit certain registered open-end
investment companies to acquire shares of certain registered open-end
investment companies that are outside of the same group of investment
companies as the acquiring investment companies, in

excess of the limits in section 12(d)(1) of the Act.

APPLICANTS:  Meeder Funds Trust (the ``Trust''), a Massachusetts
business trust registered under the Act as an open-end investment
company with multiple series; Meeder Asset Management, Inc., an Ohio
corporation registered as an investment adviser under the Investment
Advisers Act of 1940 (the ``Adviser,''), and Adviser Dealer Services,
Inc. (the ``Distributor''), an Ohio corporation registered as a broker-
dealer under the Securities Exchange Act of 1934 (``Exchange Act'').

FILING DATES:  The application was filed on May 16, 2017 and amended on
September 15, 2017.

HEARING OR NOTIFICATION OF HEARING:  An order granting the requested
relief 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 December 4, 2017 and should be accompanied by proof of
service on the 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: Michael Wible,
Thompson Hine LLP, 41 South High Street, Suite 1700, Columbus, Ohio
43215.

FOR FURTHER INFORMATION CONTACT: James D. McGinnis, Senior Counsel, at
(202) 551-3025, or Parisa Haghshenas, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

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

Summary of the Application

    1. Applicants request an order to permit (a) registered open-end
management investment companies (the ``Investing Funds'') that are not
part of the same ``group of investment companies,'' as defined in
section 12(d)(1)(G)(ii) of the Act, as the Trust, to acquire shares in
series of the Trust (the ``Funds'') \1\ in excess of the limits in
section 12(d)(1)(A) of the Act \2\ and (b) the Funds, any principal
underwriter for a Fund, and any broker or dealer registered under the
Exchange Act (a ``Broker'') to sell shares of the Funds to the
Investing Funds in excess of the limits of section 12(d)(1)(B) of the
Act. Applicants also request an order under sections 6(c) and 17(b) of
the Act to exempt applicants from section 17(a) to the extent necessary
to permit a Fund to sell its shares to, and redeem its shares from, an
Investing Fund.
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    \1\ Applicants request that the relief apply to: (1) Each
registered, open-end management investment company or series thereof
that currently or subsequently is part of the same `group of
investment companies,' within the meaning of Section 12(d)(1)(G)(ii)
of the Act, as the Trust and is advised by the Adviser (included in
the term `Funds'); (2) each Investing Fund that enters into a
Participation Agreement (as defined in the Application) with a Fund
to purchase shares of the Fund; and (3) any principal underwriter to
a Fund or Broker selling shares of a Fund.
    \2\ Certain of the Funds created in the future may be registered
under the Act as open-end management investment companies and may
have received exemptive relief to permit their shares to be listed
and traded on a national securities exchange at negotiated prices.
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    2. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the Application.
Such terms and conditions are designed to, among other things, help
prevent any potential (i) undue influence over a Fund through control
or in connection with certain services, transactions, and
underwritings; (ii) excessive layering of fees; and (iii) overly
complex fund structures, which are the concerns underlying the limits
in sections 12(d)(1)(A) and (B) of the Act.
    3. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security, or transaction, or any class or classes of
persons, securities, or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Section 17(b) of the Act authorizes the
Commission to grant an order permitting a transaction otherwise
prohibited by section 17(a) if it finds that (a) the terms of the
proposed transaction are fair and reasonable and do not involve
overreaching on the part of any person concerned; (b) the proposed
transaction is consistent with the policies of each registered
investment company involved; and (c) the proposed transaction is
consistent with the general purposes of the Act. Section 6(c) of the
Act permits the Commission to exempt any persons or transactions from
any provision of the Act if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24628 Filed 11-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: December 29, 2009 (Volume 74, Number 248)]
[Notices]
[Page 68888-68889]
[DOCID:fr29de09-137]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61215; File No. SR-NSCC-2009-10]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Order Granting Accelerated Approval
of a Proposed Rule Change Regarding National Securities Clearing
Corporation's Board of Directors Election Process and Delegation
Authority

December 22, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on December 16, 2009,
National Securities Clearing Corporation (``NSCC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II below, which items have been
prepared primarily by NSCC. The Commission is publishing this notice
and order to solicit comments on the proposed rule change from
interested persons and to grant approval on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NSCC's parent company, The Depository Trust & Clearing Corporation
(``DTCC'') intends in the future to consider nominating for election to
its Board of Directors candidates that are not participants of its
clearing agency subsidiaries (``non-participant candidates'').\2\
Because certain of DTCC's organizational documents mandate that the
directors of DTCC shall be the same as the directors of NSCC, in the
future NSCC's Board of Directors may include directors who are not
employees of its participants (``non-participant directors'').
---------------------------------------------------------------------------

    \2\ DTCC's clearing corporation subsidiary participants include
The Depository Trust Company, National Securities Clearing
Corporation, and Fixed Income Clearing Corporation.
---------------------------------------------------------------------------

    In addition, the rules of NSCC are being revised to allow the Board
to delegate certain responsibilities.

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

    In its filing with the Commission, NSCC 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. NSCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of such
statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified parts of these statements.
---------------------------------------------------------------------------

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

    DTCC has in the past nominated for election to its Board of
Directors employees of its clearing corporation subsidiaries'
participants. In the future, DTCC intends to consider nominating for
election to its Board of Directors people who are not employees of its
clearing corporation subsidiaries' participants (``non-participant
candidates''). Because certain of DTCC's organizational documents
mandate that the directors of DTCC shall be the same as the directors
of NSCC, in the future NSCC's Board may include directors who are not
employees of its participants (``non-participant directors''). NSCC
believes that non-participant directors may bring additional skills and
expertise and introduce different perspectives to its Board.
    In addition, the rules of NSCC currently assign to its Board
certain responsibilities such as, for example, responsibilities related
to approving membership applications and other related matters. NSCC is
revising its rules to allow its Board to delegate such
responsibilities.\4\
---------------------------------------------------------------------------

    \4\ The text of the proposed rule change can be found at http://
www.dtcc.com/downloads/legal/rule_filings/2009/nscc/2009-10.pdf.
---------------------------------------------------------------------------

    These changes will conform NSCC's rules and practices to the rules
and practices of DTCC's other clearing corporation subsidiaries--The
Depository Trust Company and Fixed Income Clearing Corporation.
    NSCC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act and the rules and regulations
thereunder applicable to NSCC because NSCC's rules will continue to
provide for a fair representation of its participants in the selection
of its

directors and in the administration of its affairs and will enable NSCC
to act in a more expedient manner and therefore, to better promote the
prompt and accurate clearing and settlement of securities transactions.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    NSCC does not believe that the proposed rule change would have any
impact on or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not yet
been solicited or received. NSCC will notify the Commission of any
written comments received by NSCC.

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

    Section 17A(b)(3)(C) of the Act requires that the rules of a
clearing agency assure a fair representation of its shareholders (or
members) and participants in the selection of its directors and
administration of its affairs. The Commission has previously found that
NSCC's participants are fairly represented in the selection of its
Board and in the administration of its affairs.\5\ This rule change
should not have any adverse effect on NSCC's participants'
representation in the selection of NSCC's Board or in the
administration of NSCC's affairs. The Commission also recognizes that
it may benefit NSCC to have non-participants directors on its Board
because such directors may provide skills or perspectives not possessed
by participant directors. Therefore, the Commission finds that NSCC's
proposed rule change to have non-participant directors serve on its
Board should provide benefits while continuing to provide for the fair
representation of NSCC's participants in the selection of its directors
and administration of its affairs.
---------------------------------------------------------------------------

    \5\ See, e.g., Securities Exchange Act Release No. 52922
(December 7, 2005), 70 FR 74070 (December 14, 2005) (File Nos. SR-
DTC-2005-16, SR FICC-2005-19, and SR-NSCC-2005-14).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires that the rules of a
clearing agency are designed to promote the prompt and accurate
clearing and settlement of securities transactions. The Commission
finds that by providing its Board with additional authority to delegate
certain of its responsibilities, such as, for example, responsibilities
related to approving membership applications and other related matters,
NSCC will be able to act in a more expedient manner and therefore,
better able to promote the prompt and accurate clearing and settlement
of securities transactions.
    NSCC has requested that the Commission approve this rule change
prior to the thirtieth day after the date of publication of notice of
the filing. The Commission finds good cause for approving the proposed
rule change prior to the thirtieth day after publication of notice
because by so approving NSCC will be able to implement the rule change
in time to include non-participant directors on its Board for the 2010
Board term.

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-NSCC-2009-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NSCC-2009-10. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NSCC and on NSCC's
Web site at http://www.dtcc.com/downloads/legal/rule_filings/2009/
nscc/2009-10.pdf. 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-
NSCC-2009-10 and should be submitted on or before January 19, 2010.

V. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act and the
rules and regulations thereunder applicable.\6\
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    \6\ In approving the proposed rule changes, the Commission
considered the proposals' impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (File No. SR-NSCC-2009-10) be, and hereby
is, approved on an accelerated basis.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-30786 Filed 12-28-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: November 16, 2009 (Volume 74, Number 219)]
[Notices]
[Page 58957-58959]
[DOCID:fr16no09-37]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0735; FRL-8797-8]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before December 16, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number specified in Unit II. of the SUPPLEMENTARY INFORMATION by
one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number specified
for the pesticide of interest as shown in the registration application
summaries. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or e-mail. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DCD 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
If you are commenting in a docket that addresses multiple products,
please indicate to which registration number(s) your comment applies.
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

     EPA received applications as follows to register pesticide
products containing currently registered active ingredients pursuant to
the provisions of section 3(c) of FIFRA, and is publishing this notice
of such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
    1. Registration Number/File Symbol: 100-542, 100-620. Docket
Number: EPA-HQ-OPP-2008-0773. Company name and address: Syngenta Crop
Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. Active
ingredient: Prometryn. Proposed Uses: Carrot; celeriac; cilantro; leaf
petioles subgroup 4B; okra; parsley. Contact: Mindy Ondish, (703) 605-
0723<EMAIL_ADDRESS>    2. Registration Number/File Symbol: 100-815, 100-816. Docket
Number: EPA-HQ-OPP-2009-0814. Company name and address: Syngenta Crop
Protection, PO Box 18300, Greensboro, NC 27419. Active ingredient: S-
metolachlor. Proposed Use: Sesame; melon subgroup 9A; bushberry
subgroup 13-07B; lowbush blueberry; caneberry subgroup 13-07A; sweet
sorghum; leafy brassica greens subgroup 5B; turnip greens; carrot;
cucumber; okra; bulb onion subgroup 3-07A; and green onion subgroup 3-
07B. Contact: Kathryn Montague,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    3. Registration Number/File Symbol: 100-1131. Docket Number: EPA-
HQ-OPP-2008-0811. Company name and address: Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419. Active ingredient:
Mesotrione. Proposed Use: Soybean. Contact: James M. Stone, (703) 305-
7391<EMAIL_ADDRESS>    4. Registration Number/File Symbol: 264-660. Docket Number: EPA-HQ-
OPP-2009-0813. Company name and address: Bayer CropScience, P.O. Box
12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. Active
ingredient: Glufosinate-ammonium. Proposed Use: Sweet corn. Contact:
James M. Stone,<PHONE_NUMBER><EMAIL_ADDRESS>    5. Registration Number/File Symbol: 279-3189, 279-3149, 279-3220.
Docket Number: EPA-HQ-OPP-2008-0125. Company name and address: FMC
Corporation, 1735 Market Street, Philadelphia, PA 19103. Active
ingredient: Sulfentrazone. Proposed Uses: Head and stem brassica
subgroup 5A; leafy brassica greens subgroup 5B; melon subgroup 9A;
fruiting vegetables Group 8; okra; succulent pea; flax; strawberry; and
tuberous and corm vegetables subgroup 1C. Contact: Dianne L. Morgan,
(703) 305-6217<EMAIL_ADDRESS>    6. Registration Number/File Symbol: 352-IRO. Docket Number: EPA-HQ-
OPP-2009-0057. Company name and address: E.I du Pont de Nemours and
Company, DuPont Crop Protection, Stine-Haskell Research Center, P.O.
Box 30, Newark, DE 19714. Active ingredient: Nicosulfuron. Proposed
Use: Established bermudagrass pastures. Contact: Mindy Ondish, (703)
605-0723<EMAIL_ADDRESS>    7. Registration Number/File Symbol: 352-529, 352-633. Docket
Number: EPA-HQ-OPP-2009-0134. Company name and address: E.I du Pont de
Nemours and Company, DuPont Crop Protection, Stine-Haskell Research
Center, P.O. Box 30, Newark, DE 19714. Active ingredient:
Thifensulfuron methyl. Proposed Use: Safflower. Contact: Mindy Ondish,
(703) 605-0723<EMAIL_ADDRESS>    8. Registration Number/File Symbol: 7969-113. Docket Number: EPA-
HQ-OPP-2008-0937. Company name and address: BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. Active
ingredient: Quinclorac. Proposed Uses: Pastures (including pastures
grown for hay), Rangeland, Conservation Reserve Program Land (CRP), and
switchgrass establishment and maintenance. Contact: Hope Johnson, (703)
305-5410<EMAIL_ADDRESS>    9. Registration Number/File Symbol: 46386-2. Docket Number: EPA-HQ-
OPP-2008-0773. Company name and address: Verolit Chemical
Manufacturers, Ltd. c/o Makhteshim Agan of North America, Inc., 4515
Falls of Neuse Rd., Suite 300, Raleigh, NC 27609. Active ingredient:
Prometryn. Proposed Uses: Carrot; celeriac; cilantro; leaf petioles
subgroup 4B; okra; parsley. Contact: Mindy Ondish,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    10. Registration Number/File Symbol: 59639-RAL. Docket Number: EPA-
HQ-OPP-2009-0796. Company name and address: Valent U.S.A. Corporation,
1600 Riviera Ave, Suite 200, Walnut Creek, CA 94596. Active ingredient:
Bispyribac-sodium. Proposed Uses: Selective management of surface,
submersed and emergent aquatic weeds in bayous, canals, drainage
ditches, lakes, marshes, non-irrigation canals, ponds, reservoirs and
other slow moving or quiescent bodies of water. Contact: Hope Johnson,
(703) 305-5410<EMAIL_ADDRESS>    11. Registration Number/File Symbol: 59639-2, 59639-83, 59639-132,
59639-148. Docket Number: EPA-HQ-OPP-2009-0307. Company name and
address: Valent U.S.A. Corporation, 1600 Riviera Ave, Suite 200, Walnut
Creek, CA 94596. Active ingredient: Clethodim. Proposed Uses: Caneberry
subgroup 13-07A; bushberry subgroup 13-07B; peach; artichoke, globe.
Contact: James M. Stone,<PHONE_NUMBER><EMAIL_ADDRESS>    12. Registration Number/File Symbol: 59639-97, 59639-99, 59639-119,
Docket Number: EPA-HQ-OPP-2008-0885. Company name and address: Valent
U.S.A. Corporation, 1600 Riviera Ave, Suite 200, Walnut Creek,
California 94596. Active ingredient: Flumioxazin. Proposed Uses:
Cucurbit group 9; leaf petioles subgroup 4B; hops. Contact: James M.
Stone,<PHONE_NUMBER><EMAIL_ADDRESS>    13. Registration Number/File Symbol: 62719-80, 62719-81, 62719-84.
Docket Number: EPA-HQ-OPP-2009-0092. Company name and address: Dow
AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268-1054. Active
ingredient: Clopyralid. Proposed Uses: Swiss chard; bushberry subgroup
13-07B; Annual strawberry. Contact: James M. Stone,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    14. Registration Number/File Symbol: 63588-12. Docket Number: EPA-
HQ-OPP-2009-0796. Company name and address: K-1 Chemical U.S.A., Inc.,
11

Martine Avenue, Suite 970, White Plains, NY 10606. Active ingredient:
Bispyribac-sodium. Proposed Uses: For formulation of herbicides for
selective management of surface, submersed and emergent aquatic weeds
in bayous, canals, drainage ditches, lakes, marshes, non-irrigation
canals, ponds, reservoirs and other slow moving or quiescent bodies of
water. Contact: Hope Johnson,<PHONE_NUMBER><EMAIL_ADDRESS>    15. Registration Number/File Symbol: 66222-15. Docket Number: EPA-
HQ-OPP-2008-0773. Company name and address: Makhteshim Agan of North
America, Inc., 4515 Falls of Neuse Rd., Suite 300, Raleigh, NC 27609.
Active ingredient: Prometryn. Proposed Uses: Carrot; celeriac;
cilantro; leaf petioles subgroup 4B; okra; parsley. Contact: Mindy
Ondish,<PHONE_NUMBER><EMAIL_ADDRESS>    16. Registration Number/File Symbol: 66222-35 (Rimon 10 EC); 11678-
57 (Rimon Technical). Docket Number: EPA-HQ-OPP-2009-0273. Company name
and address: Makhteshim-Agan of North America, Inc., 4515 Falls of
Neuse Rd., Raleigh, NC 27609. Active ingredient: Novaluron. Proposed
Uses: Vegetables, cucurbit; vegetables, fruiting; beans (dry); Beans
snap, succulent; berries, low growing, subgroup 13-07G; swiss chard;
and sorghum. Contact: Jennifer Gaines<PHONE_NUMBER>,
<EMAIL_ADDRESS>    17. Registration Number/File Symbol: 71512-4;a 71512-6. Docket
Number: EPA-HQ-OPP-2009-0826. Company name and address: ISK Biosciences
Corporation, 7470 Auburn Road, Suite A, Concord, OH 440077. Active
ingredient: Fosthiazate. Proposed Uses: Potato and peanut. Contact:
Rita Kumar,<PHONE_NUMBER><EMAIL_ADDRESS>    18. Registration Number/File Symbol: 73049-UAT. Docket Number: EPA-
HQ-OPP-2009-0262. Company name and address: Valent BioSciences
Corporation, 870 Technology Way, Libertyville, IL 60048. Active
ingredient: Clothianidin. Proposed Uses: Poultry houses. Contact: Kable
Bo Davis,<PHONE_NUMBER><EMAIL_ADDRESS>    19. Registration Number/File Symbol: 81880-2, 81880-15, 81880-18.
Docket Number: EPA-HQ-OPP-2009-0797. Company name and address: Gowan
Company, P.O. Box 5569, Yuma, AZ 85366-5569. Active ingredient:
Halosulfuron-methyl. Proposed Uses: Selective herbicide used for the
control of weeds including nutsedge in pea and bean, succulent shelled,
subgroup 6B; pea and bean, dried shelled, except soybean, subgroup 6C;
vegetables, tuberous and corm, subgroup 1C; rhubarb; bushberry subgroup
13-07B; apple, and okra. Contact: Erik Kraft,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    20. Registration Number/File Symbol: 59639-135. Docket Number: EPA-
HQ-OPP-2009-0013. Company name and address: Valent U.S.A. Corporation,
1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. Active
ingredient: Dinotefuran. Proposed Uses: Turnip greens. Contact: Rita
Kumar,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: November 4, 2009.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E9-27423 Filed 11-13-09; 8:45 am]

BILLING CODE 6560-50-S


samples that were discriminatory nonreactive but
multiplex reactive, 22 came from those tested as
singles.  One hundred fifty-nine came from those tested
as pools.  So there were a total of 181 that were
discriminatory nonreactive, but multiplex reactive.  Of
these, none were seroreactive and of these -- now this
number should be changed.  We have, of the 181, we have
follow up samples on 95 of these individuals, and all of
them are negative.
Next slide.  Looking at those that are
discriminatory reactive, both multiplex and
discriminatory reactive, 92 came from those tested as
singles.  Six hundred thirty-five came from those tested
as pools, a total of 727 discriminatory reactives.  Of
these, obviously serology positives, most of which are
HCV, 15 of which are HIV.  This is the group that we're
most interested in.  These are the 44 serology
nonreactive, 44 of which were HCV.  This data comes
before the HIV case that we talked about earlier.  So
this is the group that obviously could be considered
yield samples.
Next slide.  In looking at these, we were
unfortunately not able to do both follow up and

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supplemental testing on all of them, but of the 44,
three of them confirmed positive for HCV.  The rest of
them, I think we can consider as false positives or
those for which we have no corroborating evidence.  We
do have two samples that were positive on a supplemental
assay which is the Roche Ampliscreen and the Roche
Monitor assays.  Both of these samples that you see
here, one was negative by follow up, one was not tested
by follow up, were positive on the Ampliscreen test, but
negative on the Monitor.  We think these are sample
contaminations.
This column shows seven samples on which we
had an alternate sample.  So we think again, these are
-- these false positives are really derived from sample
contaminations because an alternate tube from the same
in-depth sample was negative.
And then we have a number of them that were
negative by either supplemental or follow up and six
here that you see that were either not tested by either
follow up supplemental.  These we had some that were
invalid runs, repeated as nonreactive; two that were
reactive on an invalid run, Q&S for repeat and one donor
who did not come back for follow up.
Next slide.  Looking at invalid runs and

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for a total of a little over 1100 runs, we're seeing a
total invalid run rate or failed run rate of over 14
percent.  Now I will tell you that if you look at this
by month you will see a marked decrease and our data for
the last couple of months looks very much like what Sue
reported in our total invalid or failed run rate is
about six percent.  You can see the reasons here for the
failures.  Kit calibrators, kit controls, instrument
failures, about 30 percent due to technician error,
external control failures and this is the five percent
rule which has now become the ten percent rule of those
internal control failures within one run.  So this
number really has come down to about six percent.
Next slide.  In looking at and in keeping
in tune with Sue's definitions, this is just our data in
terms of the definitions that we're trying to
standardize.  So we're looking at an initial reactive
rate of 1.9 percent, generated from both pools, those
samples tested as pools and singles.  So this is numbers
of tests with 1.9 percent.  Repeatedly reactive pools,
since we don't repeat the single test is about 1.9
percent.
The repeat reactive unresult pools
which Sue described the definition for, those are pools
which have no individuals that are confirmed.  1.01

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percent.  Repeat reactive nondiscriminated donations.
We have some from each one of these two types of sample
tests.  We had a total of 181 for .02 percent.  And then
the false positive, this really should be repeatedly
reactive, or those that we consider false positives.  We
had 41 total or .005 percent.
Next slide.  In summary then, our
specificity, we're looking at both pool specificity and
I think Sue showed the formula for this.  We're looking
at a pool specificity of 99.94 percent and then of an
individual specificity of 98.93 percent.
Thank you.
(Applause.)
DR. BISWAS:  Thank you very much.  We're
going to switch speakers.  Michael Strong will speak
first and then Richard Gammon.
Dr. Strong comes from -- will be speaking
for Roche American Blood Centers Group.  He's from the
Puget Sound Blood Center in Seattle, Washington.
DR. STRONG:  Being from the older
generation, I won't have nearly as much data to present
as the previous two speakers.
Slide.  The Roche Group is comprised of 13
test centers throughout the U.S. with an annual

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collection volume of 4.5 million from 150 test sites and
you can see the distribution here across the country.
Next.  This is our total yield at this
state.  We're in the process of breaking out the data to
conform to the new definitions.  We have 2.1 million
units that have been tested with a yield now of ten HCV
positives, four of which are confirmed by the previous
seroconversion definition and an additional six that are
in the category of positive on the basis of a separate
sample, for example, the plasma unit being positive.
Not all of our donors will have follow up donations to
allow us to put them into the seroconversion positive
category.
Next.  Here's a breakout of the donors that
have been picked up through HCV screening.  First donor
back in June, we have started the testing as of April,
so we're still only a little more than six months into
the testing scheme.  These initial donors have all
seroconverted.  We don't have RIBA data on every one,
but you can see here on a couple of these they are
indeterminant reaction rates for RIBA with C33
positivity.  And here a donor that has elected not to
participate in the follow up and of course, like the
other tests that we perform, we do run into donors who

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not only don't want to participate in the study, but
also get quite angry when you call them and tell them
about their test result.
Next.  Here's the last five donors that
have been picked up, a couple again, who have yet to
have a second sample drawn, but were positive on the
plasma unit and again another donor that has elected not
to participate in the study.  This yield basically fits
the new definition.
Next.  In terms of test performance, again,
we haven't broken out according to the new definitions
into the different categories.  Our turnaround times are
about the same as they've been in the last few months
with the test turnaround time ranging from 10 to 14
hours, a turnaround time for final resolution because we
go through a separate set of tests to get to resolution
of up to 72 hours.  Again, this pretty much depends on
the distance that these samples have to travel to the
test laboratories.  And then finally, our estimated
false positive rate, based on total donations, again,
and not yet complying with our new breakout of
definitions is less than .01 percent and our run failure
rates range between less than one percent up to about
five percent and as previous speakers mentioned, that

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part of it is due to learning curve.  We certainly see
a decrease in run failures as the laboratories get up
and running and get more accustomed to the test
themselves.
Next.  So that's a very quick update of the
Roche data and the next time we get a chance to meet,
which seems to be quite frequently these days, we'll
hopefully have a breakout with the new definitions.
Thanks.
(Applause.)
DR. BISWAS:  Our next speaker is Richard
Gammon for the Association of Independent Blood Centers
from West Palm Beach, Florida.
DR. GAMMON:  He's getting the laptop set up
right now.  While we're waiting, I just want to take the
chance to invite anyone to come down and visit.  I grew
up in the Northeast part of the country and when I left
the airport yesterday from Florida it was 80 degrees and
sunny.
(Laughter.)
DR. BISWAS:  While we're waiting I want to
congratulate all the speakers on the sort of catching up
a bit on time.  But sometimes advance of technology does
hold one up.

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DR. TABOR:  This is the modern equivalent
of when someone turns the slide carousel upside down and
the cap isn't on it.  I've seen that happen and someone
suggested that people get up and tell jokes until the
slides are put back in order, but I think in this case,
Dr. Biswas and Dr. Dayton, perhaps you could entertain
some discussion while we're waiting.
DR. DAYTON:  Yes, actually, I do have a
question that I'd like to address to Dr. Heldebrant.  In
fact, you may even want to come to a microphone.  Where
are you?  Why don't you come up to a microphone.  I was
very interested in the data that you provided on the
eclipse periods where in HIV, where you had an initial
weak PCR reactive.  I think you had four of them and
then you had it disappear for several donations and then
reappear?
DR. HELDEBRANT:  Yes.
DR. DAYTON:  And that has tremendous
implications for mechanisms of infection depending upon
how the people were infected.  So how were those
individuals infected?  Were they transfusions or IVDUs
or sexual activity?
DR. HELDEBRANT:  As far as we know, they
denied transfusion.  They denied IDU.  We would assume

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that they're environmentally or behaviorally acquired,
but beyond that we don't have any specific data on any
of the four to determine what their --
DR. DAYTON:  If it's some kind of
parenteral introduction, it's not terribly surprising to
see a little peak and then a clearance, so that's
interesting.  For sexual transmission, that's very
interesting, if it's sexually transmitted because we all
think of sexual transmission as involving the
transmission of a very small number of viruses.  So the
implications are if it's sexual transmission, the
implications are either they had an open wound and there
was a large amount of the initial inoculum which seems
hard to believe, or that there's an initial burst and
then a nonspecific clearance, possibly, then the eclipse
period and then the acute phase, even before you get
antibody.  Maybe we can talk in private about that
afterwards.  I'd certainly be interested in pursuing
that.
DR. HELDEBRANT:  Yes, those are remarkably
interesting samples.  In a way, we kind of wish we had
a lot more data on the individuals who donated them, but
we have what we have.
DR. DAYTON:  So are they now lost to follow

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up or --
DR. HELDEBRANT:  I have a feeling we could
identify them if we had to.  Currently, they're lost to
follow up since they have seroconverted to antibody.
DR. DAYTON:  Uh-huh, but they are --
DR. HELDEBRANT:  But they're permanently
deferred as donors so they're lost to our system.
DR. DAYTON:  But they are contactable?
DR. HELDEBRANT:  I would assume so, yes.
DR. DAYTON:  Okay, the carousel is still
upside down, apparently.
DR. BISWAS:  Is Alan Liss, could Alan Liss,
I have a question for Alan.
DR. TABOR:  Come up to a microphone.
DR. BISWAS:  It's a bit unfair, we're
hogging the questions.
DR. TABOR:  Chairman's prerogative.
DR. BISWAS:  The question I have is of the
HBV DNA positives that you have, have you done any
antibody testing like anticor or anti-HBS and will you
be doing it?
DR. LISS:  We are doing anti-HBS Ag
antigen.
DR. BISWAS:  Anti-HBS Ag.

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DR. LISS:  SAG antigen, but no antibody
test.
DR. BISWAS:  No antibody tests?
DR. LISS:  Right.  We were compensating the
core and so forth.
DR. BISWAS:  Okay.
DR. LISS:  Nice suggestion.
DR. BISWAS:  Yes, I think so.  I think it
would be --
DR. LISS:  It's been suggested before.
It's a matter of putting it into the scheme.
DR. BISWAS:  Okay.  Dr. Gammon?
DR. GAMMON:  We're all set to go here.
Could I have the next slide, please?  The Association of
Independent Blood Centers or AIBC, testing began on all
donations collected on April 1, 1999.  As of November
30th, we have tested about 235,849 donations from 23
collection sites.  We have tested about 9800 master
pools for a 3.30 percent reactivity rate in those pools.
Now out of the 324 pools that were positive, 13 of them
or approximately four percent of the reactive pools were
nonreactive upon individual multiplex testing, giving
the specificity of the assay at our center of 99.9
percent.

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Next slide, please.  Average turnaround
time for specimen receiving to result reporting is about
nine hours, with a range of 6 to 12.  Again we tested
324 pools.  The number of reactions of units tested by
discriminatory assays was 332.
Next slide, please.  Now for the data
presentation.  Okay, in our experience, all 20 donors
who were EIA positive for HIV as well as NAT positive
for HIV were also Western blot positive.  All 118 donors
here were EIA positive for HCV and NAT positive for HCV
were also RIBA positive.
Next slide, please.  This slide just shows
these were donors in which the quantity we tested was
insufficient.  It speaks to the limitation of specimen
when drawing one PPT tube and the difficulty of having
donors return for collection of additional specimen on
a voluntary basis.
Next slide, please.  This slide shows
donors who were EIA serology positive, but NAT negative.
I just want to make a couple of comments.  We had 97
donors, 97 donors who were EIA positive for HIV, but not
confirmed by Western blot.  We had seven donors who were
p24 positive for HIV, but not confirmed by
neutralization.  We have one donor who was EIA positive

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for HIV and p24 positive, however, neither of the
confirmatory tests panned out.
We also had 17 donors who were Western blot
indeterminant and we had 118 donors who were EIA
positive for HCV, however, they were RIBA negative.  The
above cases may speak to the problem of serological
false positives which defer donors at blood centers
every day.
There's also 31 donors here who are EIA
positive for HCV and RIBA positive and this may
potentially speak to situations seen with a donor who
has cleared the virus so it's not detected by NAT or a
donor who has a low level viremia below the level of
detection or problems inherent with pool testing such as
an inhibitor versus dilutional effect.
Next slide, please.  These are our
sub-study donors.  We've had nine of the 19 donors in
the sub-study return.
Next slide, please.  A little bit about the
specifics of our sub-study donors.  Twelve of the donors
positive for HCV by NAT; eight on follow-up were
negative for HCV by NAT and EIA negative.  We do have
one donor that was just in October was positive for HCV
by NAT and on follow-up bleed was also positive for HCV

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by NAT.  I'm going to talk about that a little further.
Three of the donors under this category did not return.
They're either first or second donors.  We have a donor
who is positive for HIV by NAT.  This was a first time
donor that did not return.
Next slide, please.  We have six donors
that were positive for both HIV and HCV in the study.
Three were positive.  Three were EIA positive as well
as Western blot positive for HIV.  Two were negative for
Western blot but positive for p24 neutride and one is
EIA reactive/RIBA positive.  These donors have not
returned either and were either first or second time
donors.
All donors who do not return for additional
testing were either first or second donors in our study.
Five bleeds after the initial donation is the maximum
number of returns that we have had so far.
Next slide.  This is a slide showing the
signal to cutoff ratio of the individual Multiplex
testing of our sub-study donors on the initial donation.
And I want to point out this is the last donor here
that initial donation was in October that was NAT
positive for HCV on the initial donation as well as the
follow-up bleed in November.  And you can clearly see

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that the signal to cutoff ratio at 8.3 is higher than
any of the previous signal to cutoff ratios.
Next slide, please.  This is that same
individual donor, again, a donor from Tennessee who the
signal to cutoff ratio of HCV was 17.3 on the October
18th donation and on November 18th was even higher at
19.08.  And we're working closely with
Gen-Probe and I'm working with the Medical Director at
the blood center from Tennessee to get this donor back
in for additional testing.
Next slide, please.  This slide shows five
cases out of the 236,000 donations so far in which the
pool, NAT pool was negative and the EIA result, initial
EIA test was positive and so the NAT laboratory did
individual testing and the individual testing was
positive by discriminatory testing.  And of particular
note are two, in this case here in which the RIBA was
positive for HCV.  This case here in which, from
Florida, in which the Western blot was positive for HIV
and I just got a call this morning, actually during the
conference that the Western blot here for this donor
here is positive now from this donor here also from
Florida.  Again, these are specimens in which the pool
was originally negative, but the individual was positive

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as well with discriminatory testing.
Next slide, please.  In summary, we've
tested about 236,000 specimens and out of those we have
one donation so far that may have detected HCV and
increased their conversion window period and follow up
testing is in progress.
Next slide, please.  Thank you.  I don't
know how well this turned out.  This is a gentleman
practicing the ancient art of uroscopy, the study of the
urine, and I hope we progressed a little further since
those days.  Thank you very much.
(Applause.)
DR. DAYTON:  Well, let's open up this
entire session to questions.  I guess if you're going to
field a question, please go to the nearest microphone
because no one can hear you otherwise.
We have a question back here.
AUDIENCE PARTICIPANT:  Yes.  Focusing on
the how shall I say -- not to be anti-semantic about it,
but there's a variety discussion about what is a true
positive, what is a true negative.  And one of the
questions I would have is given the phase one nature of
much of the samples that were done, were any of these


[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56749]
[DOCID:fr28se05-199]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 1-07657]

Issuer Delisting; Notice of Application of American Express
Company To Withdraw Its Common Stock, $.20 Par Value, From Listing and
Registration on the Boston Stock Exchange, Inc.

September 21, 2005.
    On August 24, 2005, American Express Company, a New York
corporation (``Issuer''), filed an application with the Securities and
Exchange Commission (``Commission''), pursuant to Section 12(d) of the
Securities Exchange Act of 1934 (``Act'')\1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock, $.20 par value
(``Security''), from listing and registration on the Boston Stock
Exchange, Inc. (``BSE'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    The Board of Directors (``the Board'') of the Issuer approved a
resolution on July 25, 2005 to withdraw the Security from listing on
BSE. The Issuer stated that the following reason factored into the
Board's decision to withdraw the Security from BSE: The staff time and
costs associated with maintaining a listing on regional exchanges has
outweighed the benefits. The Issuer stated in its application that the
Security is listed on the New York Stock Exchange, Inc. (``NYSE'').
    The Issuer stated in its application that it has complied with
applicable rules of BSE by complying with all applicable laws in the
State of New York, the state in which the Issuer is incorporated, and
by providing BSE with the required documents governing the withdrawal
of securities from listing and registration on BSE. The Issuer's
application relates solely to the withdrawal of the Security from
listing on BSE and shall not affect its continued listing on NYSE or
the Chicago Stock Exchange, Inc. (``CHX''),\3\ or its obligation to be
registered under Section 12(b) of the Act.\4\
---------------------------------------------------------------------------

    \3\ On August 24, 2005, the Issuer filed an application with the
Commission to withdraw the Security from listing and registration on
CHX. Notice of such application will be published separately.
    \4\ 15 U.S.C. 78l(b).
---------------------------------------------------------------------------

    Any interested person may, on or before October 11, 2005 comment on
the facts bearing upon whether the application has been made in
accordance with the rules of BSE, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Send an e-mail to<EMAIL_ADDRESS>Please include
the File Number 1-07657 or;

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number 1-07657. This file
number should be included on the subject line if e-mail is used. To
help us 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/delist.shtml).

Comments are also available for public inspection and copying in the
Commission's Public Reference Room. All comments received will be
posted without change; we do not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5307 Filed 9-27-05; 8:45 am]

BILLING CODE 8010-01-P


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

      	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY        		WASHINGTON, D.C. 20460                                                               February 7, 2012                                                                                OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM

SUBJECT:	Product Chemistry Scoping Document for the Registration Review of Methyl Nonyl Ketone.

            Registration Review Case #:		3094             PC Code:						044102             CAS Numbers:					112-12-9             Chemical Class:					Biochemical                                                                    FROM:		Jacob S Moore /s/ 2/7/12             Biochemical Pesticides Branch             Biopesticides & Pollution Prevention Division (7511P)

TO:			Leonard Cole, Regulatory Action Leader             Biochemical Pesticides Branch             Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED 	A preliminary assessment of available information on product chemistry data associated with the biopesticide methyl nonyl ketone in support of the development of a registration review work plan.

Introduction The EPA has made the determination that there is adequate information available on 2-undecanone, commonly known as methyl nonyl ketone, and does not foresee the need for additional biochemical pesticide product chemistry data for products that currently contain methyl nonyl ketone as the technical grade active ingredient.

Methyl nonyl ketone is currently formulated into 18 formulations registered with the Agency. Of these 18 registrations, 3 are manufacturing-use products and the remaining 15 are end-use products. The active ingredient has been registered since May 1966 and a Reregistration Eligibility Decision for methyl nonyl ketone was issued in July 1995. Methyl nonyl ketone is used as a dog and cat repellent and iris borer deterrent.

Concerning the product chemistry of methyl nonyl ketone, all biochemical pesticide data requirement for the technical grade active ingredient have been satisfied and are summarized in Table 2. While no further product chemistry data are necessary for the products currently registered, future registrations must adequately address all of the biochemical pesticides product chemistry data requirements. .

Table 1. Product Identity and Composition for Methyl Nonyl Ketone Common Name Methyl Nonyl Ketone Chemical Name, IUPAC 2-undecanone Molecular Weight 170.29 g/mol PC Code 044102 CAS Registry Number 112-12-9 Empirical Formula C11H22O Registration Review Case Number Case Number Chemical Structure

Product Chemistry Summary The Agency has conducted a review of the available product chemistry data and information.  These data are summarized below.

Table 2. Biochemical Pesticides Product Chemistry Data Requirements for AVG                                  Guideline No.                        Physical and Chemical Properties                                    Status[1]                                      Value                                      MRID/                                     Source 830.1100 Product Identity and Composition                                        A Refer to Table 1.

830.1200 Description of starting materials, production and formulation process                                        A CBI

830.1400 Discussion of formation of impurities                                        A CBI

830.1700 Preliminary analysis                                        A CBI

830.6302 Color                                        A Colorless RED 830.6303 Physical state (20°C)                                        A Liquid RED 830.6304 Odor                                        A Slight acrid odor RED 830.6313 Stability to normal and elevated temperatures, metals and metal ions                                        A Stable RED 830.7000 pH                                       N/A See 40 CFR §180.2030(e)(11)

830.7050 UV/Visible light absorption  Neutral sample pH=2 pH=12                                        A ε (L/cm·mol) 26.0 27.4 25.8 44857701 830.7200 Melting point/melting range                                        A 11-14°C RED 830.7220 Boiling point/boiling range                                        A 233-234°C RED 830.7300 Density (20°C)                                        A 0.827 g/mL RED 830.7520 Particle size, fiber length, and diameter distribution                                       N/A See 40 CFR §180.2030(e)(15) or  OCSPP 830.7520(a)(3)(i)

830.7550 830.7560 830.7570 Partition coefficient (n-Octanol/Water)                                        A Koc = 16,601 RED 830.7840 Water solubility                                         A Insoluble

18.0x10[-3] g/L Merck Index RED 830.7950 Vapor pressure (20°C)                                        A 4.49x10[-2] Torr RED    1. A=Acceptable. N/A=Not Applicable. N/D=Not Determined.

                                                                                References

Merck Index, Online. 02/07/12


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an Electronic Cigarette Retailer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of my business, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a retailer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.