[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Notices]
[Page 23687-23690]
[DOCID:fr20my09-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 12, 2009.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC07-97-003.
    Applicants: Ecofin Holdings Limited.
    Description: Request of Ecofin Holdings Limited for Amended Order
under Section 203 of the Federal Power Act.
    Filed Date: 04/27/2009.
    Accession Number: 20090427-5166.
    Comment Date: 5 p.m. Eastern Time on Monday, May 18, 2009.

    Docket Numbers: EC09-78-000.
    Applicants: Otter Tail Power Company, Cascade Investment, L.L.C.
    Description: Joint Application of Cascade Investment, L.L.C. and
Otter Tail Power Company for Authorization Under Section 203 of the
Federal Power Act.
    Filed Date: 05/07/2009.
    Accession Number: 20090507-5031.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG09-41-000.
    Applicants: Conectiv Vineland Solar, LLC.
    Description: Conectiv Vineland Solar, LLC submits notice of self
certification of exempt wholesale generator status.
    Filed Date: 05/06/2009.
    Accession Number: 20090507-0216.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER96-1085-013.
    Applicants: South Carolina Electric & Gas Company
    Description: South Carolina Electric & Gas Company submits their
responses to the Commission's 4/9/09 requests concerning an updated
market power analysis in compliance with Order 697.
    Filed Date: 05/07/2009.
    Accession Number: 20090512-0027.

    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER97-2846-013; ER99-2311-010.
    Applicants: Florida Power Corporation; Carolina Power & Light
Company.
    Description: Carolina Power & Light Co et al. submits response to
FERC data request re the supplemental Simultaneous Import Limitation
study information for updated market power analysis.
    Filed Date: 05/08/2009.
    Accession Number: 20090512-0033.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER98-542-022.
    Applicants: Central & South West Services, Inc.
    Description: CSW Operating Companies submits revised tariff sheet
to the market based rate tariff to reflect FERC's grant of authority
for CSW to sell the energy imbalance service in the imbalance market
administered by the Southwest Power Pool, Inc.
    Filed Date: 05/06/2009.
    Accession Number: 20090507-0213.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER99-2342-012.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits response to FERC's 4/9/
09 additional information request re updated market power analyses.
    Filed Date: 05/08/2009.
    Accession Number: 20090512-0001.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER00-1712-011; ER00-1703-006; ER00-2186-006; ER01-
1559-007; ER02-1327-008; ER02-1747-006; ER00-744-009; ER02-1749-006;
ER02-2408-006; ER99-4503-008.
    Applicants: PPL Electric Utilities Corporation, Lower Mount Bethel
Energy, LLC, PPL Brunner Island, LLC, PPL Holtwood, LLC, PPL Martins
Creek, LLC, PPL Montour, LLC, PPL Susquehanna, LLC, PPL University
Park, LLC, PPL EnergyPlus, LLC, PPL Edgewood Energy, LLC, PPL Shoreham
Energy, LLC, PPL Great Works, LLC, PPL Maine, LLC, PPL Wallingford
Energy LLC.
    Description: PPL Companies submits Fourth Revised Sheet 2 et al. to
FERC Electric Tariff, First Revised Volume 5.
    Filed Date: 05/08/2009.
    Accession Number: 20090511-0105.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER06-615-050.
    Applicants: California Independent System Operator Corporation.
    Description: Informational Filing of Negotiated Default Energy Bids
by California Independent System Operator Corporation.
    Filed Date: 05/07/2009.
    Accession Number: 20090507-5137.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER06-738-019; ER02-537-022; ER03-983-018; ER06-739-
019; ER07-501-018; ER07-758-014; ER08-649-011.
    Applicants: Cogen Technologies Linden Venture, L.P.; Shady Hills
Power Company, L.L.C.; Fox Energy Company, LLC; East Coast Power Linden
Holding, LLC; Birchwood Power Partners, L.P.; Inland Empire Energy
Center, L.L.C.; EFS Parlin Holdings LLC.
    Description: Supplement to Notification of Non-Material Change in
Status of East Coast Power Liden Holding, LLC, et al.
    Filed Date: 05/06/2009.
    Accession Number: 20090506-5107.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER07-188-005.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC provides information
responding to FERC's 4/9/09 request for additional information
pertaining to the Simultaneous Import Limitation study submitted with
the updated market analysis.
    Filed Date: 05/08/2009.
    Accession Number: 20090512-0003.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER07-189-005, ER07-190-005, ER07-191-005, ER07-192-
003.
    Applicants: Duke Energy Indiana, Inc., Duke Energy Kentucky, Inc.,
Duke Energy Ohio, Inc.;
    Description: Duke Energy Indiana, Inc. et al. submits Second
Substitute Original Sheet 2 et al. to FERC Electric Tariff, Second
Revised Volume 1 & First Revised Volume 1.
    Filed Date: 05/07/2009.
    Accession Number: 20090512-0013.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER09-482-001.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Golden Spread Electric Cooperative, Inc. submits
substitute amendments to Golden Spread Eighth Revised Rate Schedule
FERC 35, a long-term, bilateral Replacement Energy Agreement etc.
    Filed Date: 05/07/2009.
    Accession Number: 20090508-0098.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER09-660-001; ER09-660-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits response to Commission's letter dated 4/6/09 requesting
additional information on, and requiring amendment of the Midwest ISO's
2/6/09 proposal etc.
    Filed Date: 05/06/2009.
    Accession Number: 20090508-0042.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER09-740-002.
    Applicants: Carolina Power & Light Company.
    Description: Carolina Power & Light Company submits for acceptance
Substitute Original Sheet 4 et al. to FERC's Rate Schedule 182
effective 5/24/09.
    Filed Date: 05/11/2009.
    Accession Number: 20090512-0037.
    Comment Date: 5 p.m. Eastern Time on Monday, June 1, 2009.

    Docket Numbers: ER09-797-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC's Response to the
Commission's 5/4/09 request for clarification providing additional
information & clarification re proposed changes to Schedule 1 of the
Amended & Restated Operating Agreement.
    Filed Date: 05/06/2009.
    Accession Number: 20090506-4001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER09-886-001.
    Applicants: Conectiv Vineland Solar, LLC.
    Description: Conectiv Vineland Solar, LLC submits Substitute
Original Sheet No 2 of CVS proposed market based rate tariff.
    Filed Date: 05/06/2009.
    Accession Number: 20090507-0215.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER09-1025-001.
    Applicants: New England Gas & Electric, Inc.
    Description: New England Gas & Electric, Inc. submits a Petition
for Acceptance of Initial Tariff, Waivers and Blanket Authority.
    Filed Date: 05/07/2009.
    Accession Number: 20090508-0100.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER09-1095-000.
    Applicants: Vermont Electric Cooperative, Inc.
    Description: Vermont Electric Cooperative, Inc. submits its 2009

transmission formula rate update to its charges produced by the formula
rates applicable to the VEC-specific Local Service Schedules of the ISO
New England Open Access Transmission etc.
    Filed Date: 05/04/2009.
    Accession Number: 20090505-0110.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 26, 2009.

    Docket Numbers: ER09-1097-000.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits long term
firm point to point transmission service agreement with Foresight Wind
Energy, LLC and High Lonesome Mesa, LLC.
    Filed Date: 05/05/2009.
    Accession Number: 20090506-0171.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 26, 2009.

    Docket Numbers: ER09-1098-000.
    Applicants: DownEast Power Company, LLC.
    Description: DownEast Power Company, LLC submits application for
Market-Based Rate Authority.
    Filed Date: 05/07/2009.
    Accession Number: 20090508-0044.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER09-1099-000.
    Applicants: Empire Generating Co, LLC.
    Description: Application of Empire Generating Co, LLC for order
accepting initial tariff, waiving regulations, and granting blanket
approvals, including Blanket Approval under 18 CFR Part 34 for all
future issuances etc.
    Filed Date: 05/08/2009.
    Accession Number: 20090512-0015.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER09-1100-000.
    Applicants: Baltimore Gas and Electric Company.
    Description: Baltimore Gas and Electric Company, et al., Electronic
Informational Filing of 2009 Formula Rate Annual Update.
    Filed Date: 05/04/2009.
    Accession Number: 20090504-5109.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 26, 2009.

    Docket Numbers: ER09-1101-000.
    Applicants: Exelon Generation Company, LLC.
    Description: Exelon Generation Company, LLC submits lease of
transmission facilities between Exelon Generation and PECO Energy
Company.
    Filed Date: 05/06/2009.
    Accession Number: 20090507-0214.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER09-1102-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits First Revised Service Agreement 1355 et al. to its FERC
Electric Tariff, Fourth Revised Volume 1.
    Filed Date: 05/06/2009.
    Accession Number: 20090508-0055.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.

    Docket Numbers: ER09-1103-000.
    Applicants: Bangor Hydro-Electric Company.
    Description: Bangor Hydro-Electric Company et al. submits Original
Service Agreement 66 to FERC Electric Tariff 3--Section II--Open Access
Transmission Tariff Schedule 21.
    Filed Date: 05/08/2009.
    Accession Number: 20090511-0101.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER09-1104-000; OA09-28-000.
    Applicants: Story Wind, LLC.
    Description: Story Wind, LLC submits jurisdictional service
agreement (Shared Facilities Agreement).
    Filed Date: 05/08/2009.
    Accession Number: 20090511-0102.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER09-1105-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM submits executed Interconnection Construction
Service Agreement with Exelon Generation Company et al.
    Filed Date: 05/08/2009.
    Accession Number: 20090511-0103.
    Comment Date: 5 p.m. Eastern Time on Friday, May 29, 2009.

    Docket Numbers: ER09-1109-000; ER09-1109-001; ER09-1110-000; ER09-
1110-001; ER09-1111-000; ER09-1111-001; ER09-1112-000; ER09-1112-001;
ER09-1113-000; ER09-1113-001; ER09-1114-000; ER09-1114-001; ER09-1115-
000; ER09-1115-001; ER09-1116-000; ER09-1106-001; ER09-1107-000; ER09-
1107-001; ER09-1108-000; ER09-1108-001.
    Applicants: RRI Energy Coolwater, Inc; RRI Energy Electric
Solutions, LLC; RRI Energy Ellwood, Inc.; RRI Energy Etiwanda, Inc.;
RRI Energy Florida, LLC; RRI Energy Mandalay, Inc.; RRI Energy Mid-
Atlantic Power Holdings, RRI Energy Ormond Beach, Inc.; RRI Energy
Services, Inc.; RRI Energy Solutions East, LLC; RRI Energy Wholesale
Generation, LLC.
    Description: RRI Companies submits notices of succession to notify
the Commission of the corporate name change of each of the RRI
Companies effective as of 5/2/09 and a notice of non-material change in
status.
    Filed Date: 05/07/2009.
    Accession Number: 20090511-0106.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 28, 2009.

    Docket Numbers: ER09-1119-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submit Service
Agreement for Wholesale Distribution Service and Interconnection
between PG&E and City and County of San Francisco.
    Filed Date: 05/11/2009.
    Accession Number: 20090512-0038.
    Comment Date: 5 p.m. Eastern Time on Monday, June 1, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:
    Docket Numbers: OA08-19-002.
    Applicants: Ohio Valley Electric Corporation.
    Description: Compliance Filing of Ohio Valley Electric Corporation.
    Filed Date: 05/11/2009.
    Accession Number: 20090511-5181.
    Comment Date: 5 p.m. Eastern Time on Monday, June 1, 2009.

    Take notice that the Commission received the following public
utility holding company filings:
    Docket Numbers: PH09-17-000.
    Applicants: Continental Energy Systems LLC.
    Description: FERC-65A Exemption Notification and Notice of Material
Change in Facts of Continental Energy Systems LLC.
    Filed Date: 05/06/2009.
    Accession Number: 20090506-5106.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 27, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.

    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-11668 Filed 5-19-09; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

           WASHINGTON, D.C. 20460

						FEB 24 2006

OFFICE OF PREVENTION,
PESTICIDES AND TOXIC
                   SUBSTANCES

MEMORANDUM

SUBJECT:	Review of Application to Extend/Amend the Experimental Use
Permit (EPA

		Reg. No. 67979-EUP-4) and existing temporary exemption from the
requirement

		of tolerance [40 CFR Part 174.456] for Modified Cry3A (mCry3A)
Bacillus

		thuringiensis insect control protein as expressed in Event MIR604 corn
plants

		and Breeding stack of Event MIR604 corn with Event Bt11 Corn
expressing a

		Cry1Ab Bt insect control protein (MIR604 x Bt11), submitted by
Syngenta

		Seeds, Inc. – Field Crops- NAFTA.

TO:		Mike Mendelsohn, Regulatory Action Leader

		Microbial Pesticides Branch, Biopesticides and

		Pollution Prevention Division (7511C)

FROM:	Annabel Fellman, Environmental Protection Specialist		[signed]

		Microbial Pesticides Branch, Biopesticides and

		Pollution Prevention Division (7511C)

THROUGH:	John L. Kough, Ph.D., Biologist					[signed]

		Microbial Pesticides Branch, Biopesticides and

		Pollution Prevention Division (7511C)

ACTION REQUESTED: To review Syngenta Seeds, Inc.’s application to
extend and amend the Experimental Use permit (EPA Reg. No. 67979-EUP-4)
and existing temporary exemption from the requirement of tolerance [40
CFR Part 174.456] for mCry3A Bt insect control protein as expressed in
Event MIR604 corn plants and Breeding stack of Event MIR604 corn with
Event Bt11 Corn expressing a Cry1Ab Bt insect control protein (MIR604 x
Bt11).

CONCLUSION:    In previously reviewed studies, the product
characterization, protein expression, toxicological and allergenicity
data support the finding that there is a reasonable certainty of no harm
to humans from the aggregate exposure to the residues of the mCry3A
protein, including all anticipated dietary exposures and all other
exposures for which there is reliable information.  These data support
the extension and amendment of the EUP for the period of March 2006
through February 28, 2007 as well as extending the expiration date for
the current temporary exemption from the requirement of tolerance for
mCry3A until October 17, 2007.

*THIS REVIEW DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION*

DATA REVIEW RECORD:

Active Ingredient:		Modified Cry3A (mCry3A) Bacillus thuringiensis
insecticidal protein and the genetic material necessary for their
production (via pZM26) in transgenic maize (corn) plants derived from
transformation Event MIR604 and Breeding stack of Event MIR604 corn with
Event Bt11 Corn expressing a Cry1Ab Bt insect control protein (MIR604 x
Bt11).

Product Name:			Event MIR604 Maize Plants Expressing Modified Cry3A
Bacillus thuringiensis Protein

Company Name:			Syngenta Seeds, Inc. – Field Corps- NAFTA

ID No:				67979

Chemical Number:	 	006509

Decision Number:		360263

DP Barcode:			324829

MRID No:

Not Assigned			Administrative Materials:  Application to Extend/Amend

				Experimental Use Permit [EPA Reg. No. 97979-EUP-4] and Petition

				for Extension of the Temporary Exemption from the Requirement of

				Tolerance for mCry3A Bt insect control protein.

BACKGROUND:

Syngenta Seeds Inc. synthetically modified a cry3A gene from Bacillus
thuringiensis subsp. tenebrionis to optimize the gene for expression in
maize (corn) and to enhance its activity against the western corn
rootworm (WCRM; Diabrotica virgifera vigifera) and northern corn
rootworm (NCRM; D. longicornis barberi).  Syngenta’s maize Event
MIR604 corn plants were a result of a corn plant transformation with the
synthetic modified cry3A gene, which provides resistance to these pests.
 Transformation was conducted using immature maize embryos derived from
a proprietary Zea mays line, via Agrobacterium-mediated transformation.

Event MIR604 maize also contains the pmi gene, which was introduced
along with the mCry3A protein via the same pZM26 transformation vector.
The gene represents the manA gene from Escherichia coli and encodes the
enzyme phosphomannose isomerase (PMI), which was employed as a
selectable marker during the process of regenerating plant material
following transformation.  An existing permanent exemption from the
requirement of a tolerance has been established for PMI in all crops
when used as a plant-incorporated protectant inert ingredient (see 40
CFR 180.1252, effective May 14, 2004).

EPA issued an experimental permit for the use Bt mCry3A protein and the
genetic material necessary for their production (via plasmid pZM26) in
Event MIR604 corn and associated activities (such as collection of field
data; harvesting & processing of seed after last planting) on 575 acres
of field corn.  In the Federal Register of  April 6, 2005 (70 FR 17323),
the Agency also established a temporary exemption from the requirement
of a tolerance for Modified Cry3A and the genetic material necessary for
their production in corn, which will expire October 15, 2006.  To
support their requests for EUP and a temporary tolerance exemption,
Syngenta Seeds, Inc. submitted product characterization and protein
expression analyses, toxicological and allergenicity data [see memoranda
from A. Fellman through J. Kough to M. Mendelsohn, dated 02/11/2005,
02/23/2005, 03/03/2005, and 05/31/2005].

On April 30, 2004, Syngenta Seeds, Inc. submitted an application for
FIFRA Sec. 3 Registration of the mCry3A PIP in MIR604 corn (EPA Reg. No.
67979-L).  The final study to complete remaining data requirements for
Sec. 3 registration for Event MIR604 corn was reviewed and is pending
upon Agency approval [see memorandum from A. Fellman through J. Kough to
M. Mendelsohn, dated 02/15/2006].

In this report, Syngenta Seeds, Inc. is seeking an extension and
amendment of its current  EUP [EPA Reg. No. 67979-EUP-4] to allow:  1)
continued field testing of the mCry3A Bt insect control protein and the
genetic material necessary for its production in Event MIR604-derived
field corn plants, and 2) the first large-scale field testing of a
conventional breeding ‘stack’ of Event MIR604 corn with Event Bt11
corn expressing a Cry1Ab Bt insect control protein (MIR604 x Bt11 corn).
 MIR604 plants are currently being field tested, which was approved
Marcy 23, 2005 and allows plantings through February 28, 2006.  The
Cry1Ab PIP in Bt11 field corn has been registered since 1996 under EPA
Reg. No. 67979-1.  By combining the MIR604 and Bt11 via conventional
breeding, corn hybrids produce both the mCry3A protein for control of
key coleopteran pests and Cry1Ab protein for control of key lepidopteran
pests.  Syngenta is requesting authorization for plantings beginning in
mid-March 2006 and continuing through February 2007, with associated
field activities (i.e. data collection, harvesting and processing of
seed) continuing through October 15, 2007.  The purpose of this report
is to confirm that the previously submitted data can support the
extension and amendment to the EUP and there are no new data
requirements or concerns.

Extension of Temporary Exemption from the Requirement of a Tolerance
(4F6838)

EPA has established an exemption from tolerance requirements pursuant to
FFDCA section 408(j)(3) for Bacillus thuringiensis Cry3A delta-endotoxin
and the genetic material necessary for its production in potatoes, and
this tolerance exemption has been reassessed and meets the 408(c)(2)
standard (see 40 CFR 180.1147).  An exemption from the requirement of a
tolerance has been established for PMI in all crops when used as a
plant-incorporated protectant inert ingredient (see 40 CFR 180.1252,
effective May 14, 2004).

For the combination of MIR604 and Bt11 traits in the conventionally bred
MIR604 x Bt11 plants, an exemption from the requirement of a tolerance
has been established for Bt Cry1Ab delta-endotoxin and the genetic
material necessary for its production in all crops (see 40 CFR
180.1173).  Moreover, the marker protein in Bt11 corn, phosphinothricin
acetyltransferase (PAT), is also exempt from the requirement of a
tolerance (see 40 CFR 180.1151).

Concurrently with the issuance of the EUP permit, in the Federal
Register of  April 6, 2005 (70 FR 17323), the Agency established a
temporary exemption from the requirement of a tolerance for Modified
Cry3A and the genetic material necessary for their production in corn
which will expire October 15, 2006.  Syngenta Seeds, Inc. also submitted
a petition for a permanent exemption from the requirement of a tolerance
pursuant to section 408(d)(1) of the FFDCA for the PIP mCry3A Bt insect
control protein and the genetic material necessary for its production in
all corn (Petition File Symbol PP 4F6838).  This petition was reviewed
and is also pending upon Agency approval [see memorandum from A. Fellman
through J. Kough to M. Mendelsohn, dated 02/15/2006].

In this report, the present EUP amendment/extension application is
accompanied by a petition to extend the expiration date on the current
mCry3A temporary tolerance exemption by one year, October 17, 2007.

DATA SUMMARY:

Previously submitted studies demonstrate the lack of toxicity of the
mCry3A protein following acute oral high-dose exposure to mice, the lack
of post-translational glycosylation, rapid degradation of mCry3A upon
exposure to simulated mammalian gastric fluid, and the lack of
significant amino acid sequence homology of the mCry3A protein to
proteins known to be mammalian toxins or human allergens. Moreover,
little to no human dietary exposure to mCry3A protein is expected to
occur via transformed corn.  Collectively, these data allowed the Agency
to make a determination that for human health, there is a reasonable
certainty that no harm will result from aggregate exposure to the U.S.
population to mCry3A protein and the genetic material necessary for its
production [as stated in the memoranda from A. Fellman, through J.
Kough, Ph.D., to M. Mendelsohn, dated May 31, 2005 and Feb. 15, 2006].
It was concluded that there are no adverse effects on human health from
the proposed use of mCry3A protein expressed in corn and the Agency
still supports this contention.  The same rationale supporting the
permanent tolerance determination would justify extending the temporary
tolerance until October 17, 2007 since the limited acreage would further
limit potential dietary exposure.

Upon review of the application to extend/amend the EUP for mCry3A, the
product chemistry and toxicology data were referenced to previously
submitted data. These data have been reviewed and found acceptable by
the Agency  [see memoranda from A. Fellman through J. Kough to M.
Mendelsohn, dated 02/11/2005, 02/23/2005, 03/03/2005, 05/31/2005, and
02/16/2006].  Furthermore, the petition for the extension of the
temporary tolerance exemption does not contain any new data and the
safety conclusions are the same as previously determined by the Agency
[see memorandum from A. Fellman through J. Kough to M. Mendelsohn, dated
02/16/2006].

CONCLUSION:

In previously reviewed studies, the product characterization, protein
expression, toxicological and allergenicity data support the finding
that there is a reasonable certainty of no harm to humans from the
aggregate exposure to the residues of the mCry3A protein, including all
anticipated dietary exposures and all other exposures for which there is
reliable information, given the limited duration and acreage involved in
this EUP.  There were no additional data neither submitted by Syngenta
Seeds, Inc. nor requested by the Agency in conjunction with this request
for an extension and amendment for the EUP (EPA Reg. No. 67979-EUP-4)
and temporary tolerance exemption (40 CFR 174.456).  Therefore, these
data support the extension and amendment of the EUP for the period of
March 2006 through February 28, 2007 as well as extending the expiration
date for the current temporary exemption from the requirement of
tolerance for mCry3A until October 17, 2007.

 PAGE

 PAGE   1


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46173-46174]
[FR Doc No: 2018-19811]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4853]

Receipt of Notice That a Patent Infringement Complaint Was Filed
Against a Biosimilar Applicant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing notice
that an applicant for a proposed biosimilar product notified FDA that a
patent infringement action was filed in connection with the applicant's
biologics license application (BLA). Under the Public Health Service
Act (PHS Act), an applicant for a proposed biosimilar product or
interchangeable product must notify FDA within 30 days after the
applicant was served with a complaint in a patent infringement action
described under the PHS Act. FDA is required to publish notice of the
complaint in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Angela Hoague, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301-
348-3915, [email protected].

SUPPLEMENTARY INFORMATION: The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
The BPCI Act amended the PHS Act and created an abbreviated licensure
pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference

product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the
BPCI Act, describes the requirements for a BLA for a proposed
biosimilar product or a proposed interchangeable product (351(k) BLA).
Section 351(l) of the PHS Act, also added by the BPCI Act, describes
certain procedures for exchanging patent information and resolving
patent disputes between a 351(k) BLA applicant and the holder of the
BLA reference product. If a 351(k) applicant is served with a complaint
for a patent infringement described in section 351(l)(6) of the PHS
Act, the applicant is required to provide the FDA with notice and a
copy of the complaint within 30 days of service. FDA is required to
publish notice of a complaint received under section 351(l)(6)(C) of
the PHS Act in the Federal Register.
    FDA received notice of the following complaint under section
351(l)(6)(C) of the PHS Act: Genentech, Inc. and City of Hope v. Amgen
Inc., 1:18-cv-00924-GMS (D. Del., filed July 2, 2018).
    FDA has only a ministerial role in publishing notice of a complaint
received under section 351(l)(6)(C) of the PHS Act, and does not
perform a substantive review of the complaint.

    Dated: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19811 Filed 9-11-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18791-18797]
[DOCID:fr12ap06-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53602; File No. SR-NYSE-2005-40]

Self-Regulatory Organizations; New York Stock Exchange, Inc.;
Notice of Filing of a Proposed Rule Change and Amendment Nos. 1 and 2
Thereto Relating to Amendments to the Exchange's Allocation Policy and
Procedures (NYSE Rules 103A, 103B, 123E and 476A)

April 5, 2006.
    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 June 6, 2005, New York Stock Exchange, Inc. (``NYSE'' 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 prepared by NYSE. NYSE filed
Amendment No. 1 to the proposed rule change on October 28, 2005.\3\
NYSE filed Amendment No. 2 to the proposed rule change on February 9,
2006.\4\ 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\ In Amendment No. 1, the Exchange clarified certain aspects
of the purpose section and rule text of the proposed rule change.
Amendment No. 1 clarified that certain of the proposed amendments to
NYSE Rules 103A, 103B and 123E are organizational changes that are
intended to provide clarity with respect to the operation of the
allocation policy and procedures. Amendment No. 1 also further
explained the Exchange's decision to move from a subjective standard
in the allocation process to an objective standard. Amendment No. 1
supersedes the original filing in its entirety.
    \4\ In Amendment No. 2, the Exchange further clarified certain
aspects of the purpose section and rule text of the proposed rule
change. Amendment No. 2 clarified that the proposed amendments to
NYSE Rule 103B includes a requirement that specialist firms describe
in their blanket allocation applications any contacts they, or any
individual acting on their behalf, have had with any employee of the
listing company, or any individual acting on behalf of that company,
with regard to its prospective listing on the Exchange. In addition,
Amendment No. 2 further explained the data that will be provided to
the Allocation Committee (``Committee''). Amendment No. 2 supersedes
Amendment No. 1 in its entirety.
---------------------------------------------------------------------------

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

    The Exchange is proposing to amend NYSE Rules 103A, 103B, 123E and
476A with respect to the manner in which securities are allocated to
specialist organizations.
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.nyse.com), at the Exchange's Office of the

Secretary, and at the Commission's Public Reference Room. The text of
the proposed rule change is also available on the Commission's Web site
(http://www.sec.gov/rules/sro.shtml).

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 Exchange included statements
concerning the purpose of, and basis for, the proposed rule change, as
amended, and discussed any comments it received on the proposed rule
change, as amended. The text of these statements may be examined at the
places specified in Item IV below. The Exchange has prepared summaries,
set forth in Sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend NYSE Rules 103A, 103B, 123E and 476A
with respect to the manner in which securities are allocated to
specialist organizations on the Exchange.
    The Exchange proposes to amend its allocation policy and procedures
by placing greater emphasis on performance measures that objectively
assess specialist market-making in order to provide more meaningful
information for the Committee's consideration. The Exchange represents
that this would be accomplished by eliminating the Specialist
Performance Evaluation Questionnaire (``SPEQ''), a subjective tool that
has become less meaningful as a result of the sharp reduction in the
number of specialist firms, and replacing it with a series of objective
measures that compare specialist performance against defined standards
based on actual trading data. Unlike the SPEQ, which provided tier
rankings for firms only, the objective performance measures will permit
comparisons by stock, panel, and post, as well as by firm, and thus,
will more clearly distinguish between strong and weak performance. In
addition, the objective performance measures will evaluate individual
specialist performance as well as performance of the entire firm. The
SPEQ is limited to an evaluation of firm-wide performance. The use of
these measures will also enable specialist

firms to better manage and more easily improve performance.
    The objective performance measures will improve the allocation
process by preventing specialist firms from proposing sub-par
performers as the designated specialist for new listings and may serve
to disqualify entire specialist firms from the allocation process for a
period of time based on continued poor performance. In this way, the
new measures will serve as a potent incentive to improved market-making
and encourage superior specialist performance.
    The Exchange is also proposing additional changes to the allocation
policy (NYSE Rule 103B) and related changes to the rules governing
performance improvement actions (NYSE Rule 103A), the issuance of
summary fines (NYSE Rule 476A), and specialist combination review
policy (NYSE Rule 123E).\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 53382 (February 27,
2006), 71 FR 11251 (March 6, 2006) (order approving SR-NYSE-2005-77)
(``Merger Release''). The Merger Release contains conforming
language changes to reflect the new entities that will exist as a
result of the Exchange's merger with Archipelago Holdings, Inc. In
addition, the Merger Release amended NYSE Rule 103B, with respect to
the allocation of the proposed new NYSE Group stock to: (i) Give
NYSE Group the right to determine the number and identity of
specialist firms that will be included in the group from which it
shall choose its specialist, provided the group consists of at least
four specialist firms; and (ii) provide NYSE Group with the same
material with respect to each specialist firm applicant as would
have been reviewed by the Committee in allocating other securities.
Telephone conversation between Deanna Logan, Principal Rule Counsel,
NYSE and David Michehl, Attorney, Division of Market Regulation
(``Division''), Commission on February 28, 2006.
---------------------------------------------------------------------------

Allocation Policy and Procedures

    NYSE Rule 103B contains the Exchange's requirements with respect to
allocation of securities to specialist member organizations
(``Allocation Policy''). The Exchange represents that the intent of the
Allocation Policy is: (1) To ensure that securities are allocated in an
equitable and fair manner and that all specialist units have a fair
opportunity for allocations based on established criteria and
procedures; (2) to provide an incentive for ongoing enhancement of
performance by specialist units; (3) to provide the best possible match
between the specialist unit and security; and (4) to contribute to the
strength of the specialist system.
    The Exchange represents that decisions as to the allocation of
securities on the Exchange are made by the Committee. This Committee is
comprised of market professionals who use their judgment to make
allocation decisions based on the allocation criteria specified in the
Allocation Policy. The current allocation criteria includes the SPEQ,
objective performance measures, listing company input, allocations
received, capital, disciplinary history, and the Committee's
professional judgment.

Elimination of SPEQ

    The Exchange states that the SPEQ is a quarterly survey on
specialist performance completed by Floor Broker members of the
Exchange. The SPEQ requires Floor Brokers to rate and provide written
comments on the performance of specialist firms with whom they deal
regularly on the Floor. Floor Broker evaluations of specialist firm
performance focuses on five functional areas--dealer, service,
competitiveness, communications and administrative. Floor Brokers rate
specialist firms on a 0% to 100% scale, in ten-point increments, that
reflect the percentage of the time that the broker feels the specialist
firm engaged in the described behavior. An evaluation of 100% is
defined as ``always'' and an evaluation of 0% is defined as ``never''.
    The Exchange represents that the SPEQ process uses a relative
scoring methodology that combines Floor Broker scores for any one
specialist firm to determine each firm's overall performance and
performance in each of the five functional areas. The scores are then
arrayed from highest to lowest, and the specialist firms receive a
ranking for the overall score and within each function. Also, a range
of ranks is determined that identifies where a firm stood in relation
to other units whose scores were not statistically different. From
these rankings, the specialist firms are aligned into tiers, up to a
maximum of four, with each tier containing those specialist firms with
similar rankings. The Committee receives information on SPEQ results
only as to the tier classifications.
    Although SPEQ has been an important mechanism for evaluation of
specialist performance for both allocation and performance improvement
action purposes, the Exchange represents that certain weaknesses in its
use as an assessment tool have become apparent. For example, SPEQ
evaluations are subjective, with ratings based on personal experiences
rather than comparisons with accepted objective standards. Further,
except for the written comments, which are not incorporated into the
formula for SPEQ rankings, SPEQ does not focus on market-making by
individual specialists. Importantly, as the number of specialist firms
has decreased, SPEQ tier classifications have become tightly clustered
with statistically insignificant differences among the firms.\6\ Also,
SPEQ participants recognize the limitations of SPEQ and have requested
a more meaningful process for evaluating specialist performance. For
these reasons, the Exchange proposes eliminating SPEQ and replacing it
with the objective measures described below. The Exchange represents
that by addressing the deficiencies of SPEQ in today's environment,
these measures will enable a more meaningful comparison of specialist
performance at all levels, based on truly objective criteria.
---------------------------------------------------------------------------

    \6\ The Exchange states that there are currently seven firms
registered as specialists in equity securities on the NYSE. As
recently as 2000, there were 25 specialist firms.
---------------------------------------------------------------------------

Expansion of the Use of Objective Measures

    The Exchange also proposes to add objective measures designed to
evaluate market quality using pre-determined standards of performance
based on actual trading data. The measures will rate the performance of
stocks, individual specialists and specialist firms overall. Data will
be provided to specialists on a daily basis, and monthly and quarterly
to the Committee. In addition, the performance information derived from
the objective measures will be made available to listing companies to
aid in their decision as to the choice of a specialist firm.
    The Exchange proposes to add two new objective measures of
specialist performance and to change an existing measure. The Exchange
represents that one new measure is price continuity. Price continuity
measures the absolute value of the price change, if any, from one trade
to the next, in the same stock. Currently, price continuity is part of
the existing near neighbor analysis,\7\ which is among the information
provided to specialists and the Committee. However, current continuity
percentages are too tightly clustered because of tighter markets,
making it difficult to derive useful data for comparison purposes. In
addition, there are no trading standards specifically related to price
continuity against which to measure performance. The Exchange proposes
making price continuity an independent measure and has

developed appropriate benchmarks and standards to enable an objective
comparison of each individual specialist's market-making as it relates
to price continuity. The Exchange has also developed a system to
identify acceptable and unacceptable performance for this measure.
---------------------------------------------------------------------------

    \7\ An explanation of the near neighbor performance measure was
given in SR-NYSE-1995-05. See Securities Exchange Act Release No.
35927 (June 30, 1995), 60 FR 35764 (July 11, 1995); See also
Securities Exchange Act Release No. 38158 (January 10, 1997), 62 FR
2704 (January 17, 1997) (making permanent the near neighbor pilot).
Telephone conversation between Deanna Logan, Principal Rule Counsel,
NYSE and David Michehl, Attorney, Division, Commission on February
28, 2006.
---------------------------------------------------------------------------

    The second new objective measure is depth. Depth refers to the
price movement of a stock during a sequence of transactions totaling a
particular volume. Currently, depth is measured over 3,000-share volume
sequences and is also part of the near neighbor analysis. The Exchange
is proposing to make depth an independent measure \8\ and to add three
new volume sequences--5,000, 10,000 and 25,000 shares--and has
developed appropriate benchmarks and standards for this measure as
well.
---------------------------------------------------------------------------

    \8\ Telephone conversation between Deanna Logan, Principal Rule
Counsel, NYSE and David Michehl, Attorney, Division, Commission on
March 2, 2006.
---------------------------------------------------------------------------

    According to the Exchange, the benchmarks and standards developed
for continuity and depth have been reviewed with two university
professors from the Massachusetts Institute of Technology, with whom
the Exchange consults on matters relating to allocation measures. For
each measure, eligible securities \9\ are grouped by price and non-
block volume into categories. Eligibility requirements for securities
include minimum average price, volume, and number of trades.\10\ Each
category has two performance benchmarks based on actual trading data.
Each benchmark has upper and lower performance ranges. Each trading
day, the performance of eligible securities will be compared with the
upper and lower ranges for the two benchmarks used for each measure and
assigned a classification of upper, middle or lower. Upper
classifications are worth two points, middle classifications are worth
one point and lower classifications are worth negative one point. The
points earned for each of the two performance benchmarks within each
measure will be combined to determine an overall score for the relevant
measure. The overall scores for each measure are combined to determine
the security's daily score. Scores range from four points (for upper
classifications in both continuity and depth) to negative two points
(for lower classifications in both continuity and depth). Daily scores
will be provided to specialist firms at the end of each day, monthly
scores at the end of each month and quarterly scores at the end of each
quarter.\11\
---------------------------------------------------------------------------

    \9\ Eligible securities are all Exchange-listed domestic common
stocks.
    \10\ An eligible security will be evaluated on any day when any
of the following conditions exists: (a) The security's average
trading price is between $1 and $200; (b) the security's Exchange
non-block volume (trades under 25,000 shares) is at least 100
shares; or (c) the security had at least five depth sequences on the
Exchange (for depth only) or at least five Exchange transactions
(for continuity only); (d) an individual security's overall
quarterly depth and continuity score will be calculated only if it
had daily scores on more than 31 days in the quarter.
    \11\ Telephone conversation between Deanna Logan, Principal Rule
Counsel, NYSE and David Michehl, Attorney, Division, Commission on
March 2, 2006.
---------------------------------------------------------------------------

    The Committee will be provided with the monthly scores for each
specialist firm. In addition, the Exchange will provide the Committee
with average daily non-block volume and price activity and average
continuity and depth scores for each of the maximum of twenty most
active stocks \12\ handled by the individual who is identified by his/
her firm to be the designated specialist for the stock of the listing
company. The information will include trading data for the current
month through the week preceding the distribution of the security data
sheet to the specialists plus the three preceding calendar months.
---------------------------------------------------------------------------

    \12\ The Exchange represents that the average daily non-block
volume is generally determined using data on the total number of
shares traded during the most recent prior three months divided by
the number of trading days in that period. The number of stocks is
determined by creating a list of stocks traded most frequently by a
specialist, ranked by average daily non-block volume. If the list
contains less than twenty stocks, information on all stocks
contained in the list is provided to the Committee. If the list
contains more than twenty stocks, information on only the twenty
most active stocks contained in the list is provided to the
Committee. Telephone conversation between Deanna Logan, Principal
Rule Counsel, NYSE and David Michehl, Attorney, Division, Commission
on April 4, 2006.
---------------------------------------------------------------------------

    The existing measure to be changed is SuperDOT[reg] turnaround for
orders received by the specialist. Currently, this measure is based on
the percentage of total post-opening market orders that are either
executed or ``stopped'' within 60 seconds of the time they are received
by the specialist. The Exchange proposes tightening this benchmark to
30 seconds to better reflect actual trading conditions and to focus
performance on the individual post and panels rather than the firm
overall performance.\13\
---------------------------------------------------------------------------

    \13\ The Exchange intends to review the continued applicability
of this measure after the implementation of the NYSE HYBRID
MARKETsm. See Securities Exchange Act Release No. 53539
(March 22, 2006), 71 FR 16353 (March 31, 2006) (order approving the
NYSE HYBRID MARKETsm).
---------------------------------------------------------------------------

    The Exchange believes that the use of these objective measures will
provide for a more meaningful comparison of specialist performance and
will promote better market-making as a result of the availability of
more objective and detailed information and competition among the firms
for allocations. Unlike the subjective criteria, which provided tier
rankings for firms only, the objective performance measures will permit
comparisons by stock, panel, and post, as well as by firm, and thus,
will more clearly distinguish between strong and weak performance. The
use of these measures will also enable specialist firms to better
manage and more easily improve performance.
    Although the Exchange believes that the objective measures provide
the more meaningful comparison, it is also acknowledged that subjective
input from the Floor brokers and off-Floor customers with direct
knowledge of the performance of specialist firms and individual
specialists, may serve a useful purpose in the evaluation process. To
this end, the proposed rule change includes a provision for providing
subjective information to the Committee. The Exchange continues to
develop the specific format of how the subjective information will be
provided to the Committee, in consultation with constituent committees
\14\ that have previously provided feedback on the allocation process.
---------------------------------------------------------------------------

    \14\ The Exchange represents that the constituent committees
consist of the Institutional Traders Advisory Committee, the
Upstairs Traders Advisory Committee, the Exchange Traders Advisory
Committee, the Market Performance Committee and the proposed Hybrid
Performance Committee. Telephone conversation between Deanna Logan,
Principal Rule Counsel, NYSE and David Michehl, Attorney, Division,
Commission on March 2, 2006.
---------------------------------------------------------------------------

    In addition, the Exchange proposes a number of other changes to
NYSE Rule 103B. In summary, these changes are as follows:
    A. As noted above, the Committee will receive performance
information regarding both the specialist firm and the individual
designated by the firm to handle the security should the firm receive
the allocation. Currently, the Committee only receives performance
information with respect to the firm.
    B. In order to provide an incentive to specialist firms to ensure
quality performance, provisions will be added that poor performance may
result in the inability of an individual specialist or a specialist
firm from applying for or receiving allocations, as follows:

                             Specialist Firm
------------------------------------------------------------------------
                                       Duration of         Period of
             Criteria                   criteria         ineligibility
------------------------------------------------------------------------
Overall depth or continuity score  Two consecutive     One month.
 below 1.90 and more than one       months.
 standard deviation below average
 score for all specialist firms.
Same as above....................  Three consecutive   Two months.
                                    months.
Same as above....................  Three out of six    Two months.
                                    months.
Overall 30-second DOT turnaround   One month.........  One month.
 percentage below 90%.
Two panels at same post with 30-   One month.........  One month.
 second DOT turnaround
 percentages below 75%.
------------------------------------------------------------------------

                          Individual Specialist
------------------------------------------------------------------------
                                       Duration of         Period of
             Criteria                   criteria         ineligibility
------------------------------------------------------------------------
Any of the assigned securities     Three consecutive   Two months.
 that the individual specialist     months.
 handled most frequently during a
 month receive overall a depth or
 continuity score below 0.50\15\.
Same as above....................  Three out of five   Two months.
                                    months.
Panel with 30-second DOT           One month.........  One month.
 turnaround percentage below 75%.
------------------------------------------------------------------------
\15\ Telephone conversation between Deanna Logan, Principal Rule
  Counsel, NYSE and David Michehl, Attorney, Division, Commission on
  April 4, 2006.

    C. The composition of the nine-member Committee will be changed, as
illustrated in the chart below, in order to equalize representation on
the Allocation Panel and the Committee and to give non-Floor
constituents a greater role in the allocation process.

------------------------------------------------------------------------
    Committee member type         Current rule            Proposed
------------------------------------------------------------------------
Floor Broker................  3 Governors (1 may    4 At least 1 Floor
                               be Independent).      Governor, Executive
                                                     Floor Official or
                                                     Senior Floor
                                                     Official.
                              3 Others (1 must be
                               Independent).
Allied Member...............  2...................  4 At least 1 Allied
                                                     Member and at least
                                                     1 Institutional
                                                     Representative.
Institutional...............  1...................
Chairperson.................  Floor Broker........  1 Floor Broker or
                                                     Allied Member/
                                                     Institutional
                                                     Representative.
                              ....................  In alternating
                                                     terms, an
                                                     additional Floor
                                                     Broker or Allied
                                                     Member/
                                                     Institutional
                                                     Representative will
                                                     be chosen for the
                                                     Committee.
                                                    The Committee
                                                     members will select
                                                     a chairperson from
                                                     the dominant group
                                                     on the Committee
                                                     that term.
                                                    No reappointments as
                                                     chairperson until
                                                     all members of
                                                     Allocation Panel in
                                                     same category have
                                                     served a term as
                                                     chairperson.
------------------------------------------------------------------------

    D. Each standing Committee will be selected one month before its
term commences and will elect its chairperson at that time. Currently,
the rule provides that the chairperson is elected two months before
his/her term starts.
    E. The requirement that the Committee chairperson be approved by
the Quality of Markets Committee (``QOM'') of the Exchange Board of
Directors will be eliminated. As a result of corporate governance
changes in December 2003, the Exchange's Board of Directors no longer
has an active QOM.
    F. In order to encourage more participation from various
constituent representatives on the Committee, the term of service for
Committee members will be modified as follows:

------------------------------------------------------------------------
        Current terms of service            Proposed terms of service
------------------------------------------------------------------------
4-month term...........................  2-month term.
Terms staggered so that every 2 months,  No staggered terms.
 4-5 members rotate off.
Reappointment possible, provided a       No reappointment until all
 minimum of 2 months have passed since    members of Allocation Panel in
 expiration of term.                      same category have served a
                                          term.
------------------------------------------------------------------------

    G. Provide standing Committee with quarterly information
identifying the individuals designated in each allocation application
and the number of allocations they received, to provide informational
continuity among Committees.
    H. As a mechanism to facilitate greater efficiency in the
allocation process, the Committee quorum requirement is modified as
follows:

------------------------------------------------------------------------
    Committee member type         Current rule            Proposed
------------------------------------------------------------------------
Floor Broker................  6, at least 2         Any 7 members of the
                               Governors.            standing Committee.
Allied Member...............  1...................
Institutional...............  None required.......
------------------------------------------------------------------------

    I. Increase the number of Allocation Panel members from 69+ to 75+
to encompass the need for added allied member and institutional
representation on the Committee.
    J. Modify the composition of the Allocation Panel:

------------------------------------------------------------------------
      Panel member type           Current rule            Proposed
------------------------------------------------------------------------
Floor Broker................  28..................  20
Floor Broker Governors......  10..................  10
Sr./Exec. Floor Officials...  5 (minimum).........  5 (minimum).
Allied Members..............  15 including those    20 including those
                               on MPC\16\.           on MPC.
Institutional...............  11 including those    20 including those
                               on MPC.               on MPC.
------------------------------------------------------------------------
\16\ MPC stands for Market Performance Committee.

    K. In order to make the process more efficient, the number of
specialist firms selected for the interview pool under Option 2 of the
Allocation Policy will be modified to four firms, including one firm
designated as instrumental by the listing company. Currently, the rule
provides that the pool may be composed of three, four or five firms.
    L. Redefine the ``quiet period'' for specialist contact with a
listing company so that it commences solely with the date that
allocation applications are solicited for that issuer.
    M. Extend the requirement that the specialist firm's designated
specialist remain the primary specialist in an allocated security from
six months to one year unless the listed company agrees to a change, in
which case the specialist must provide written notice of the change and
the listed company's agreement to the Committee and Market
Surveillance.
    N. Extend the ``Allocation Sunset Policy'' for initial public
offerings (``IPOs'') from three months to six months and for Exchange
traded funds (``ETFs'') from three months to one year. Updated
information on objective performance measures and disciplinary data
will be provided to companies after three months (IPOs) and six months
(ETFs).
    O. Provide the Committee with more disciplinary history:

------------------------------------------------------------------------
              Current rule                           Proposed
------------------------------------------------------------------------
Provided as to firms only..............  Provided for designated
                                          specialist and firm.
Informal discipline (Summary Fines and   All informal discipline for 12
 Admonition and Education letters) is     months from time of issuance.
 reported as follows: market
 maintenance--12 months from time of
 issuance; non-market maintenance--6
 months from time of issuance.
Significant pending Enforcement matters  Same.
 once action is authorized.
Hearing Panel decisions, for 12 months   Final Hearing Panel decisions,
 after they become final.                 for three years after they
                                          become final.
------------------------------------------------------------------------

    P. Eliminate the provision that NYSE Rule 103A performance
improvement action criteria (timeliness of openings, SuperDOTreg;
turnaround, etc.) be reported to the Committee. Currently, the rule
requires this information to be reported as a ``pass'' or ``fail''. The
revised system will provide the Committee with more detailed
information.
    Q. In order to expedite the process, specialist firms will be
required to designate an individual specialist for each listing,
regardless of whether they apply for the allocation. Included in this
requirement is the specialist firm's obligation to describe any
contacts they, or any individual acting on their behalf, have had with
any employee of the listing company, or any individual acting on behalf
of that company, with regard to its prospective listing on the
Exchange. This will enable staff to produce individual performance data
in a timely manner for firms that may be selected for interview pools
on a ``without prejudice'' basis.
    R. Provide the listing company with the same objective performance
measure information the Committee considered, with respect to the
members of its interview pool. In addition, as noted in ``N'' and ``T''
herein, provide the listing company with disciplinary history for the
firms in the interview pool and their designated specialists.
    S. Preclude specialists, and anyone acting in their behalf, from
offering to pay for or subsidize the cost of services or other
incentives provided to a listing company in whole or in part by third
parties in order to avoid even the semblance of impropriety.
    T. Provide that interview pools for the allocation of closed-end
funds by the same issuer will remain operative for a nine-month period
following the selection of a specialist. Any further closed-end fund
listings from the same issuer in the nine-month period will be able to
select any specialist from this group or ask for the matter to be
referred to the Committee, in which case the group dissolves. The fund
will be given updated objective performance and disciplinary
information before making its decision. If a specialist firm/individual
is ineligible for an allocation, that firm will be dropped from the
group. If an individual specialist is no longer with a firm at the time
of a new allocation of a closed-end fund, the firm will be dropped from
the group.
    U. Delete references to QOM from NYSE Rule 103B.
    V. Substitute the term ``admonition letter'' for ``cautionary
letter.''
    W. Eliminate the requirement that the Committee chair receive
orientation from the QOM.
    X. In order to provide an incentive for ongoing enhancement of
performance

by specialist firms, add the following to the list of factors
considered by a special committee consisting of certain members of the
Committee, which determines the allocation of ETFs under this policy:
The extent to which a specialist organization has supported in the
past, and will continue to support, the Exchange's efforts to
strengthen and expand its ETF market.
    Y. Allow the issuer of a structured product to participate in the
specialist interview via a senior official of its subsidiary
participating in the issuance of the structured product.
    Additionally, the following amendments are proposed to NYSE Rule
103A:
    A. Delete references to SPEQ.
    B. Provide new criteria for performance improvement actions, as
follows:
    i. SuperDOT[supreg] market order turnaround:
    In any case where a firm:
    (a) Does not turn around 90% of its DOT orders in 30 seconds or
less (previously 60 seconds) during any quarter (previously two
quarters) in a rolling four-quarter period; or
    (b) Has two panels at the same post with 30-second turnaround
percentages below 75% for any one quarter.
    ii. Market Depth:
    In any case where a firm has:
    (a) An overall quarterly Depth score below 1.90 and more than one
standard deviation below the average quarterly Depth score for all
specialist firms for two consecutive quarters, or
    (b) An overall quarterly Depth score below 1.90 and more than one
standard deviation below the average quarterly Depth score for all
specialist firms for two out of four consecutive quarters, or
    (c) More than ten percent of its eligible stocks with overall
quarterly Depth scores below 0.50 and the percent is more than one
standard deviation above the Floor average for two consecutive
quarters.
    iii. Price Continuity
    In any case where a firm has:
    (a) An overall quarterly Continuity score that is below 1.90 and
more than one standard deviation below the average quarterly Continuity
score for all specialist firms for two consecutive quarters, or
    (b) An overall quarterly Continuity score that is below 1.90 and
more than one standard deviation below the average quarterly Continuity
score for all specialist firms for two out of four consecutive
quarters, or
    (c) More than ten percent of its eligible stocks with overall
quarterly Continuity scores below 0.50 and the percent is more than one
standard deviation above the Floor average for two consecutive
quarters.
    Further, the Exchange proposes to eliminate references to SPEQ and
add references to the proposed objective measures in NYSE Rule 123E
(Specialist Combination Review Policy).
    Finally, the Exchange proposes to add NYSE Rule 103B to the list of
rules for which summary fines are available, specifically NYSE Rule
476A (Imposition of Fines for Minor Violation(s) of Rules) to allow the
Exchange to sanction members' and member organizations' less serious
violations of NYSE Rule 103B pursuant to the minor fine provisions of
NYSE Rule 476A.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b)(5) of the Act \17\ because it is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The Exchange believes that the proposed rule change is
consistent with these objectives in that it enables the Exchange to
further enhance the process by which securities are allocated.
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    \17\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change will 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

    The Exchange has not solicited, and does not intend to solicit,
comments regarding the proposed rule change. The Exchange has not
received any unsolicited written comments from members or other
interested parties.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, as amended; or
    B. Institute proceedings to determine whether the proposed rule
change, as amended, should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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-NYSE-2005-40 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-NYSE-2005-40. 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 office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2005-40 and should be submitted on or before May 3,
2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-5368 Filed 4-11-06; 8:45 am]

BILLING CODE 8010-01-P