[Federal Register: November 28, 2006 (Volume 71, Number 228)]
[Notices]
[Page 68850-68852]
[DOCID:fr28no06-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54795; File No. SR-BSE-2006-44]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Existing BSE Fee Schedules

November 20, 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 November 20, 2006, the Boston Stock Exchange, Inc. (``BSE'' 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 the BSE. The BSE has
designated this proposal as one changing a due, fee, or other charge
under Section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of this filing is to amend the existing BSE fee
schedule and to establish a fee schedule for the Boston Equities
Exchange trading system (``BeX''). The amendments to the existing BSE
fee schedule would delete of fees that are no longer applicable or that
will now be associated with BeX. The BeX fee schedule reflects the new
fees associated with the services and products available to BSE
Members, including Electronic Access Members (``EAMs''), in the BeX
fully electronic environment. The primary categories of new fees set
forth in the proposed BeX fee schedule include: transaction fees,
including regulatory transaction fees; clearing services fees; facility
fees; technology fees; and connectivity fees.
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.bostonstock.com) and at the Commission's Public

Reference Room.

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

    In its filing with the Commission, the BSE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The BSE 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
    On June 13, 2006, the BSE filed Amendment No. 3 to SR-BSE-2006-22
(the ``BeX Facility Filing''), a rule filing submitted in connection
with the implementation of the first of two phases of the BeX, a fully
automated electronic book for the display and execution of orders in
securities. On August 25, 2006, SR-BSE-2006-22 was approved by the
Commission.\5\ On August 3, 2006, the BSE filed, in connection with the
implementation of the second phase of the BeX trading system and in
connection with satisfying the requirements of Regulation NMS, SR-BSE-
2006-30. On September 29, 2006, the Commission approved SR-BSE-2006-
30.\6\
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    \5\ See Securities Exchange Act Release No. 54365 (Aug. 25,
2006), 71 FR 52192 (Sept. 1, 2006).
    \6\ See Securities Exchange Act Release No. 54546 (Sept. 29,
2006), 71 FR 59161 (Oct. 6, 2006).
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    The existing BSE fee schedule will be amended so as to delete all
Transaction Fees, Electronic File Access and Processing Fees, and Floor
Operation Fees. The Transaction Fees and Electronic File Access and
Processing Fees will now be contained in the BeX fee schedule and, in
view of the fact that there will no longer be a physical trading floor
in the traditional sense once the transition to the BeX fully
electronic platform occurs, there is no longer a need for the Floor
Operation Fees. The existing Membership and Other Fees will remain in
their present form. It should be noted that while BSE Members will
continue to be charged the Membership and Other Fees, EAMs will not be
charged those fees. That is due to the fact that, although EAMs and BSE
Members are treated equally, EAMs do not vote on matters related to
mergers, consolidations, dissolution, liquidation, transfer or
conversion of the assets of the Exchange and hold non-transferable
permits that are solely for trading on BeX. Therefore, EAMs are not
required to pay the Membership fees applicable to BSE Members.
    The BeX fee schedule reflects the new fees associated with the
services and products available to BSE Members in the BeX fully
electronic environment. The primary categories of new fees set forth in
the proposed BeX fee schedule are: transaction fees, including
regulatory transactions fees; clearing service fees; facility fees;
technology fees; and connectivity fees. Unless otherwise indicated on
the fee schedule, all fees are charged on a monthly basis. The
following is a description of the foregoing categories:
    Transaction Fees: Transaction fees in BeX are broken down based
upon share price and where they are listed, such as on the Nasdaq Stock
Exchange versus another exchange. For securities listed on an exchange
other than the Nasdaq that are traded with a share price greater than
or equal to $1.00, the Liquidity Provider will receive a $0.0023 credit
and the Liquidity Taker will be charged $0.0028 per share. For
securities that are listed on the Nasdaq that are traded with a share
price equal to or greater than $1.00, the Liquidity Provider will
receive a $0.0025 credit and the Liquidity Taker will be charged
$0.0028 per share.
    If a security is listed on an exchange other than the Nasdaq and
trades with a share price less than $1.00, the Liquidity Provider
receives a credit in

the amount of $0.0023, with a maximum of .3% of the quotation price per
share and the Liquidity Taker is charged $0.0028 with a maximum of .3%
of the quotation price per share. If a security is listed on the Nasdaq
and trades with a share price less than $1.00, the Liquidity Provider
receives a credit in the amount of $0.0025, with a maximum of .3% of
the quotation price per share and the Liquidity Taker is charged
$0.0028 with a maximum of .3% of the quotation price per share.
    Trades submitted as pre-matched cross trades are free.
Additionally, all transaction fees and credits are capped at $100.00
per trade side.
    Revenue Sharing: In the case of a trade that provides liquidity,
BeX will share 50% of gross revenue received (less any CQS/CTS capacity
and ETF registration fee expenses, if applicable) from CTA and SIP for
all Tape A, Tape B and Tape C issues with the liquidity providing side.
Similarly, BeX will share 50% of gross revenue with a Member Firm that
submits a pre-matched cross trade in the same manner as it shares
revenue with a liquidity provider.
    Smart Order Routing: BeX will charge $.0010 per order routed to an
away Trading Center on behalf of a Member.
    Regulatory Transaction Fees: In order to fund the Section 31
obligations of the BSE, Regulatory Transaction Fees will continue to be
assessed in accordance with Chapter XXIII, Section 2 of the BSE Rules.
    Clearing Services: Trades cleared through the Boston Stock Exchange
Clearing Corporation's account at the National Securities Clearing
Corporation will incur a $0.50 trade side charge.
    Technology: While BSE Members need not utilize technology made
available to them by BeX, BSE Members will have available to them
through BeX technology that will enable them to access the BeX
marketplace. That access is available through BeX Workstations. If a
BSE Member utilizes the Basic BeX Workstation, they will incur a fee of
$750.00 per logon. A ``logon'' is simply an identification number. Up
to five logons are available per workstation.
    Trading Floor Fees: While the Exchange will no longer have a
physical trading floor in the regulatory sense, the floor space will
continue to exist and be available to BSE Members for a fee should they
choose to maintain workspace on that floor. If BSE Members choose to
maintain workspace on the floor, they will be charged $500.00 per month
per post and $250.00 per month for each person who regularly shows up
to work at that post. There will be a $50.00 per voice circuit Port
Charge. The fee for unique telecommunications configurations will be
cost plus a 25% mark up. Fees to cover the cost cable television,
postage, courier service, fax, phone, after hours BeX staff assistance
and certain other items that may arise from time to time as a result of
the BSE Member's use of the floor space will be priced at cost.
    Reports: Daily P&S Blotters in PDF format will be available for
free. Daily electronic trade file access and processing will cost
$300.00 per month, per firm I.D. Special Report Development will also
be available and fees for such reports will be determined on a case by
case basis and will be subject to an appropriate rule filing.
    Connectivity: To the extent Members choose SIAC SFTI as their
network provider, the Members will be charged a one time SIAC SFTI fee
by BeX in the amount of $200.00 and a monthly fee of $200.00. Members
need not, however, utilize SIAC SFTI as their network provider. Members
can choose from among three other network providers, Radianz, TNS and
Savvis, in the event they do not wish to use SIAC SFTI as their network
provider. Should a Member choose a network provider other than SIAC
SFTI, the relationship between the Member and the network provider,
including any costs associated with the provision of network provider
services, are between the Member and that network provider and BeX will
have no involvement with that relationship.
    Members will also be charged for port connections. The first active
and first back up ports are free to the Member, but any additional
ports utilized by the Member beyond the first active and first back up
ports will incur a monthly charge which is set forth on the fee
schedule.
    Additionally, Members who choose to have their servers physically
located at the BSE will be charged for hosting and server management.
Hosting and server management services include the hosting of a server,
maintenance of network connectivity, provision of power to the server,
and day to day management of the server being hosted, such as making
sure the server is communicating properly with the network. A Member
who chooses to have their server hosted by BeX will have options
available to them with respect to the server's physical location and
the amount of power and bandwidth associated with the server, which is
expressed in terms of Cabinet and Power Services on the fee schedule.
In any event, fees related to hosting and server management, as with
all fees to be charged in the BeX environment, are set forth in detail
in the proposed fee schedule.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\7\ in general, and furthers
the objectives of Section 6(b)(4) of the Act,\8\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among Exchange Members and issuers and
other persons using Exchange facilities.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
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 neither solicited nor received comments on the
proposed rule change.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(2) thereunder,\10\ because it establishes or changes a due, fee or
other charge imposed by the Exchange. Accordingly, the proposal will
take effect upon filing with the Commission. At any time within 60 days
of the filing of such rule change the Commission may summarily abrogate
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml
); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BSE-2006-44 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-BSE-2006-44. 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 BSE. 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-BSE-2006-44 and should be submitted on or before
December 19, 2006.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-20132 Filed 11-27-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11098-11100]
[DOCID:fr16mr09-55]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0102; FRL-8405-5]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before April 15, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0102, 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 EPA-HQ-OPP-
2009-0102. 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: The Regulatory Action Leader,
Biopesticides and Pollution Prevention Division (7511P), listed in the
following table:

----------------------------------------------------------------------------------------------------------------
                                       Telephone Number and E-
       Regulatory Action Leader              mail Address           Mailing Address            File Symbol
----------------------------------------------------------------------------------------------------------------
Chris Pfeifer<PHONE_NUMBER>           Biopesticides and        73049-UAE
<EMAIL_ADDRESS>  Pollution Prevention
                                                                 Division (7511P),
                                                                Office of Pesticides
                                                                 Programs,
                                                                 Environmental
                                                                 Protection Agency,.
                                                                1200 Pennsylvania,
                                                                 Ave., NW., Washington,
                                                                 DC 20460-0001.
----------------------------------------------------------------------------------------------------------------
Chris Pfeifer<PHONE_NUMBER>           Do.                      83941-R
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------
Ann Sibold<PHONE_NUMBER>          Do.                      84059-L
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------
Ann Sibold<PHONE_NUMBER>           Do.                      84059-U
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------
John Fournier<PHONE_NUMBER>           Do.                      84565-E
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------
Chris Pfeifer<PHONE_NUMBER>           Do.                      84565-T
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------
Driss Benmhend<PHONE_NUMBER>           Do.                      84565-U
                                        benmhend.driss@
                                       epa.gov................
----------------------------------------------------------------------------------------------------------------

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).
     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 active ingredients not included in any

previously registered products pursuant to the provisions of section
3(c)(4) of FIFRA. Notice of receipt of these applications does not
imply a decision by the Agency on the applications.
    File Symbol: 73049-UAE. Applicant: Valent BioSciences Corporation,
870 Technology Way, Libertyville, IL 60048. Product name: VBC-30101.
Active ingredient: Plant Growth Regulator, S-Abscisic Acid; (S)-5-(1-
hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-
(2Z,4E)-dienoic Acid at 10 percent. Proposal classification/Use:
Biochemical pesticide/Plant Growth Regulator. (C. Pfeifer).
    File Symbol: 83941-R. Applicant: Laboratoires Goemar SA, Z.AC La
Madeline, Avenue General Patton, 35400 Saint-Malo, France c/o SciReg,
Inc. 12733 Director's Loop, Woodbridge, VA 22192. Product name:
Vacciplant. Active ingredient: Systemic Acquired Response Inducer,
Laminarin at 3.5 percent. Proposal classification/Use: Biochemical
pesticide/Systemic Acquired Response Inducer. (C. Pfeifer).
    File Symbol: 84059-L. Applicant: Marrone Organic Innovations, 2121
Second St., Ste B-107, Davis, CA 95618. Product name: MOI 401 Pf CL 145
A End Product. Active ingredient: Pseudomonas fluorescens CL 145A
strain toxins, molluscicide at 1 percent. Proposal classification/Use:
Microbial pesticide /molluscicide. (A. Sibold).
    File Symbol: 84059-U. Applicant: Marrone Organic Innovations, 2121
Second St., Ste B-107, Davis, CA 95618. Product name: MOI 401 Pf CL 145
A Tech Material. Active ingredient: Pseudomonas fluorescens CL 145A
strain toxins at 1 percent. Proposal classification/Use: Microbial
pesticide/manufacturing use. (A. Sibold).
    File Symbol: 84565-E. Applicant: Bull Run Scientific VBT, 7400
Beaufont Springs Drive, Suite 300, Richmond, VA 23225. Product name:
Bull Run Fly Attractant. Active ingredient: Sucrose at 42.1 percent and
Dried whole egg solids at 18.0 percent and Yeast at 5.5 percent and
Indole at 0.2 percent and Trimethylamine at 2.8 percent. Proposal
classification/Use: Biochemical pesticide/Insect Attractant. (J.
Fournier).
    File Symbol: 84565-T. Applicant: Bull Run Scientific VBT, 7400
Beaufont Springs Drive, Suite 300, Richmond, VA 23225. Product name:
Disposable Bull Run Yellow Jacket Trap E. Active ingredients:
Attractants, 2-Methyl-1 butanol at 5.1 percent and Calcium acetate at
19.8 percent. Proposal classification/Use: Biochemical pesticide/Insect
Attractants. (C. Pfeifer).
    File Symbol: 84565-U. Applicant: Bull Run Scientific VBT, 7400
Beaufont Springs Drive, Suite 300, Richmond, VA 23225. Product name:
Bull Run Yellow Jacket Trap. Active ingredient: Yellow Jacket's
Attractant and Heptyl Butyrate at 99.8 percent. Proposal
classification/Use: Biochemical pesticide/Insect attractant. (D.
Benmhend).

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: March 5, 2009.
 Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E9-5618 Filed 3-13-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32453]
[DOCID:fr08jn10-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232-579]

Duke Energy Carolinas, LLC; Notice of Application for Amendment
of License and Soliciting Comments, Motions To Intervene, and Protests

June 1, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for non-project use of project
lands and waters.
    b. Project No: 2232-579.
    c. Date Filed: February 2, 2010, supplemented on April 15, 2010.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Catawba-Wateree Hydroelectric Project.
    f. Location: Lake James in McDowell County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kelvin Reagan, Senior Lake Services
Representative, P.O. Box 1006, Charlotte, North Carolina, 28201-1006.
Tel:<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter, Telephone<PHONE_NUMBER>, and e-mail
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: July 1, 2010.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site (http://www.ferc.gov)
under the ``e-filing'' link. The Commission strongly encourages
electronic filings.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Please include the project number (P-2232-579) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, it
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Application: The licensee requests Commission
approval to grant Crescent Resources, LLC (applicant) a lease of 0.42
acres of land within the project boundary for use as a permanent
staging area for the loading and unloading of dirt, rock, and mulch,
related to dock building, excavations, and shoreline stabilization at
Lake James. The proposed lease area, which is currently a temporary
staging area, will be converted to a permanent staging area, and will
also be used to build and remove docks from the lake.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (P-2232) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-13565 Filed 6-7-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Notices]
[Page 9868-9869]
[DOCID:fr06mr09-73]

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

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0144; Notice 2]

Decision That Nonconforming 1997 and 1998 Left-Hand Drive and
1997 through 2001 Right-Hand Drive Jeep Cherokee Multipurpose Passenger
Vehicles Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of decision by the National Highway Traffic Safety
Administration (NHTSA) that nonconforming 1997 and 1998 left-hand drive
and 1997 through 2001 right-hand drive Jeep Cherokee multipurpose
passenger vehicles are eligible for importation.

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

SUMMARY: This document announces a decision by NHTSA that nonconforming
1997 and 1998 left-hand drive (LHD) and 1997 through 2001 right-hand
drive (RHD) Jeep Cherokee multipurpose passenger vehicles (MPVs) that
were not originally manufactured to comply with all applicable Federal
motor vehicle safety standards (FMVSS) are eligible for importation
into the United States because (1) they are substantially similar to
vehicles that were originally manufactured for sale in the United
States and that were certified by their manufacturer as complying with
the safety standards (the U.S.-certified version of the 1997 and 1998
LHD and 1997 through 2001 RHD Jeep Cherokee MPVs), and (2) they are
capable of being readily altered to conform to the standards.

DATES: This decision is effective on Friday, February 27, 2009.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for sale in the United States, certified under
49 U.S.C. 30115, and of the same model year as the model of the motor
vehicle to be compared, and is capable of being readily altered to
conform to all applicable FMVSS.
    Where there is no substantially similar U.S.-certified motor
vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle
to be admitted into the United States if its safety features comply
with, or are capable of being altered to comply with, all applicable
FMVSS based on destructive test data or such other evidence as NHTSA
decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Auto Boutique, Ltd., of Costa Mesa, California (ABL) (Registered
Importer 08-356), petitioned NHTSA to decide whether nonconforming
1997-2001 RHD Jeep Cherokee MPVs are eligible for importation into the
United States. Shortly after ABL's petition was filed, U.S. Drive Right
(USDR), of Spring Arbor, Michigan (Registered Importer 08-355)
separately petitioned NHTSA to decide whether nonconforming 1997 and
1998 RHD and LHD Jeep Cherokee MPVs are eligible for importation into
the United States. NHTSA published a combined notice of the petitions
on September 17, 2008 (73 FR 53927) to afford an opportunity for public
comment. The reader is referred to that notice for a thorough
description of the petitions.
    No comments were received in response to the notice of the
petitions.
    The ABL and USDR petitions differed in scope: USRD included LHD
versions of the subject vehicles for model years 1997 and 1998 but did
not address LHD or RHD 1999-2001 vehicles, while ABL only addressed RHD
1999-2001 vehicles.
    The following discussion applies equally to both LHD and RHD
vehicles. That is because in this unique case, the original
manufacturer of the vehicles certified as conforming to all applicable
FMVSS both LHD and RHD versions of the substantially similar U.S.-
certified models in model years 1997-2001. Moreover, the description of
the modifications required to convert these vehicles do not differ with
respect to the driver's seating position.
    The agency notes that the petitions differed significantly with
respect to the need for alterations to conform the vehicles to
applicable FMVSS. ABL did not indicate the need for any alterations
other than adding labeling to meet the requirements of 49 CFR part 565,
while USDR contended that the vehicles must be altered in order to meet
Standards No. 101, 108, 120 and 208 and 49 CFR part 565. A complete
description of the alterations described by the two petitioners can be
found in the notice of petition.
    To reconcile these differences, the agency has decided that all
vehicles covered by this decision must be examined for compliance with
Standards No. 101, 108, 120 and 208 as well as 49 CFR Part 565 and that
RIs must demonstrate, in the conformity statements submitted for any
vehicle imported under this eligibility decision, that each vehicle
either conformed to the standard as originally manufactured or has been
altered to conform by the RI.

Final Decision

    Accordingly, on the basis of the foregoing, NHTSA has decided that
nonconforming 1997 and 1998 LHD and 1997 through 2001 RHD Jeep Cherokee
MPVs that were not originally manufactured to comply with all
applicable FMVSS are substantially similar to nonconforming 1997 and
1998 LHD and 1997 through 2001 RHD Jeep Cherokee MPVs originally
manufactured for sale in the United States and certified under 49
U.S.C. 30115, and are capable of being readily altered to conform to
all applicable FMVSS.

Vehicle Eligibility Number for Subject Vehicles

    The importer of a vehicle admissible under any final decision must
indicate on the form HS-7 accompanying entry the appropriate vehicle
eligibility number indicating that the vehicle is eligible for entry.
VSP-516 is the vehicle eligibility number assigned to 1997 and 1998 LHD
Jeep Cherokee

MPVs and VSP-515 is the vehicle eligibility number assigned to 1997
through 2001 RHD Jeep Cherokee MPVs admissible under this notice of
final decision.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on February 27, 2009.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
 [FR Doc. E9-4808 Filed 3-5-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Page 3406]
[FR Doc No: 2016-01118]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-14721-000]

The City of Springfield; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On October 13, 2015, the City of Springfield, Massachusetts
(Springfield) filed an application for a preliminary permit, pursuant
to section 4(f) of the Federal Power Act (FPA), proposing to study the
feasibility of the Watershops Pond Dam Hydroelectric Project (project)
to be located on the Mill River, near Springfield, Hampden County,
Massachusetts. The sole purpose of a preliminary permit, if issued, is
to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed project would consist of: (1) The existing 105-foot-
long, 32-foot-high, concrete and masonry gravity Watershops Pond dam;
(2) an existing 198-acre impoundment with a normal maximum water
surface elevation of 155 feet above mean sea level; (3) a new 7-foot-
long, 4-foot-wide steel penstock; (4) a new 100-foot-long, 30-foot-wide
powerhouse containing a single turbine generator unit with an installed
capacity of 145 kilowatts; (5) a new 800-foot-long, 0.48-kilovolt
transmission line; and (6) appurtenant facilities. The project would
have an estimated average annual energy generation of 707 megawatt-
hours. There are no federal lands associated with the project.
    Applicant Contact: Mr. Peter J. Garvey, Director, Department of
Capital Asset Construction, 36 Court Street, Room 312, Springfield,
Massachusetts 01103; phone:<PHONE_NUMBER>.
    FERC Contact: Michael Watts; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14721-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14721) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: January 14, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-01118 Filed 1-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Pages 22020-22022]
[FR Doc No: 2012-8788]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66764; File No. SR-EDGA-2012-14]

 Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
New EDGA Rule 11.22 Requiring Members To Input Accurate Information
Into the System

April 6, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 2, 2012, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') 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 the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to adopt new EDGA Rule 11.22 to require
Members to input accurate information into the System,\3\ including,
but not limited to, identifying each order accurately as a principal,
agency, or riskless principal order. The text of the proposed rule
change is available on the Exchange's Web site at www.directedge.com,
at the Exchange's principal office, and at the Public Reference Room of
the Commission.
---------------------------------------------------------------------------

    \3\ The term ``System'' is defined in EDGA Rule 1.5(cc).
---------------------------------------------------------------------------

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 and
discussed any comments it received on the proposed rule change. The
text of these

statements may be examined at the places specified in Item IV below.
The self-regulatory organization has prepared summaries, set forth in
Sections A, B and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to add new EDGA Rule 11.22 for the purpose of
increasing transparency and to enhance the surveillance database and
audit trail of transaction data used by the Exchange in surveillance of
its market. The proposed rule change would require Members to input
accurate information into the System, including, but not limited to,
identifying the capacity of each order accurately as a principal,
agency, or riskless principal order. For purposes of surveillance, the
Exchange currently identifies the capacity of each order as principal,
agency, or riskless principal; however, several other capacities are
accepted upon order entry, including no response, which are thereafter
mapped to one of the above-listed order capacities. By requiring
Members to accurately submit an order capacity for each order and to
otherwise input accurate information into the System, the Exchange will
be able to more precisely identify the type of order received and more
effectively surveil for abusive trading.
    EDGA does not currently have a rule that makes an explicit
statement regarding a Member's obligation to input accurate information
into the System. However, currently, in FIX tag 47,\4\ Members are
asked to populate their capacity when entering orders into the
Exchange's System; however, if the field is left blank by the Member,
it is automatically populated with an ``A'' value (denoting agency).
---------------------------------------------------------------------------

    \4\ Members utilize an industry standard Financial Information
eXchange (``FIX'') protocol to electronically enter orders into the
System. Members populate certain FIX fields (i.e., tags) to indicate
certain terms of the order. FIX tag 47 is used to identify the
Member's capacity.
---------------------------------------------------------------------------

    Notwithstanding, EDGA believes that disciplinary cases against
Members entering inaccurate or incomplete information may be brought
appropriately under EDGA Rule 3.1, which requires Members to observe
high standards of commercial honor and just and equitable principles of
trade. Rule 3.1 protects the investing public and the securities
industry from dishonest practices that are unfair to investors or
hinder the functioning of a free and open market, even though those
practices may not be illegal or violate a specific rule or regulation.
Because of the regulatory importance of inputting accurate information
into the System, EDGA believes a rule that directly addresses Members'
obligation to provide accurate information is warranted. The proposed
rule makes clear Members' obligation to input accurate information into
the System and that failure to do so would be considered a violation of
EDGA Rules. In addition, once the rule is effective, if Members do not
input the capacity in which they are acting (principal, agent, or
riskless principal) into the System, the order will be rejected back to
the Member by the Exchange.
    EDGA notes that both BATS Exchange Inc. (``BATS'') and BATS-Y
Exchange, Inc. (``BYX'') have adopted rules materially identical to
proposed EDGA Rule 11.22.\5\ Similarly, the Commission has previously
approved rules proposed by the NASDAQ Stock Market LLC (``NASDAQ'')
requiring participants to ensure that accurate information is entered
into NASDAQ's system, including, but not limited to, the capacity in
which the participant is acting.\6\ Thus, the proposed rule change
would bring EDGA Rules in line with those of other self-regulatory
organizations.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 63969 (February 25,
2011), 76 FR 12155 (March 4, 2011); and Securities Exchange Act
Release No. 63970 (February 25, 2011), 76 FR 12204 (March 4, 2011).
    \6\ See Securities Exchange Act Release No. 59547 (March 10,
2009), 74 FR 11386 (March 17, 2009).
---------------------------------------------------------------------------

    In order to allow Members sufficient time to review and complete
any systems changes necessitated by this filing, the Exchange will
notify Members via information circular of an exact implementation date
for the proposed rule change, which will be no later than August 31,
2012.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of Section 19(b)(1) of the Act \7\ and the rules and
regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6(b) of
the Act.\8\ Specifically, for the reasons described above, the proposed
change is consistent with Section 6(b)(5) of the Act,\9\ because it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
to protect investors and the public interest. Specifically, the changes
proposed herein will serve to promote the accuracy of information input
into the Exchange. Accurate information is necessary for the efficient
and fair operation of the Exchange, and will assist the Exchange in
surveilling the markets for abusive or otherwise violative trading
activity.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(1).
    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
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 neither solicited nor received written comments on
the proposed rule change.

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

    The Exchange has designated this rule filing as non-controversial
under Section 19(b)(3)(A) of the Act \10\ and paragraph (f)(6) of Rule
19b-4 thereunder.\11\ The Exchange asserts that the proposed rule
change: (1) Will not significantly affect the protection of investors
or the public interest, (2) will not impose any significant burden on
competition, and (3) will not become operative for 30 days from the
date on which it was filed, or such shorter time as designated by the
Commission. The Exchange provided the Commission with written notice of
its intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing, or such shorter time as the
Commission may designate.\12\ In addition, the Exchange believes that
the proposal to require Members to identify the capacity of each order
as either a principal, agency, or riskless principal order does not
present any policy issues that have not previously been considered by
the

Commission, but rather, is a minor change to the Exchange's existing
rules that is consistent with the rules of other national securities
exchanges.\13\ For the foregoing reasons, this rule filing qualifies
for immediate effectiveness as a ``non-controversial'' rule change
under paragraph (f)(6) of Rule 19b-4.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See, e.g., NASDAQ Rule 4611(a)(6), BATS Rule 11.21 and BYX
Rule 11.21.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2012-14 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-EDGA-2012-14. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the 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-EDGA-2012-14 and should be
submitted on or before May 3, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8788 Filed 4-11-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76046-76049]
[FR Doc No: 2012-31028]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0176]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study:
Examination of Corrective Direct-to-Consumer Television Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by January
25, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title, ``Experimental Study: Examination of Corrective Direct-to-
Consumer Television Advertising.'' Also include

the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Experimental Study: Examination of Corrective Direct-to-Consumer
Television Advertising--(OMB Control Number 0910--New)

    Section 1701(a)(4) of the Public Health Service Act (42 CFR
300u(a)(4)) authorizes the Food and Drug Administration (FDA) to
conduct research relating to health information. Section 903(b)(2)(c)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 CFR
393(d)(2)(c)) authorizes FDA to conduct research relating to drugs and
other FDA regulated products in carrying out the provisions of the FD&C
Act.
    FDA regulations require prescription drug ads to contain accurate
information about the benefits and risks of the drug advertised. When
this is not the case, corrective advertising is designed to dissipate
or correct erroneous beliefs resulting from a false claim (Refs. 1 and
2). Corrective advertising emerged in public debate in the United
States in the 1970s as a hypothetical remedy for deceptive advertising,
having first been proposed by Georgetown University law students in
1969 as a way of dispelling the effects of deceptive advertising (Ref.
3). Corrective advertising is one remedy FDA may request in response to
false or misleading prescription drug promotion. In 2009, for example,
Bayer HealthCare Pharmaceuticals produced and aired corrective DTC
advertising for Yaz, a birth control pill, following a warning from FDA
regarding misleading claims (Ref. 4). Despite these developments,
researchers and policymakers currently lack empirical literature
regarding the various influences of corrective DTC ads on prescription
drug consumers. The current project will examine the influence of
corrective messages in the realm of consumer directed prescription drug
advertising.

Design Overview

    Phase 1 will vary the exposure to the messages (original ad alone
vs. original + corrective vs. corrective ad alone). The goal of Phase 1
is to examine how exposure to a combination of original and corrective
DTC ads affects message recall, message comprehension, perceived drug
efficacy, perceived drug risk, and intentions to ask about or use the
drug. Specifically, we will compare consumers who see both the original
and corrective ad with those who see only the original ad, only the
corrective ad, and neither ad. Participants in the Control condition
will see a reminder ad for the product to control for brand name
exposure.

  Table 1--Design of Phase 1: Original Exposure by Corrective Exposure
------------------------------------------------------------------------
                                         Exposure to corrective ad
     Exposure to original ad     ---------------------------------------
                                          Yes                 No
------------------------------------------------------------------------
Yes.............................  ..................  ..................
No..............................  ..................  Control (Reminder
                                                       ad)
------------------------------------------------------------------------

    Phase 2 will examine the similarity of the corrective ad's theme
and visual elements to those of the original ad (same ad elements vs.
some similar ad elements vs. different ad elements) and the exposure
delay (time) between viewing the original ad and the corrective ad (no
delay vs. 1 week delay vs. 1 month delay vs. 6 month delay). The
purpose of Phase 2 is to examine whether a corrective ad's ability to
correct misinformation is related to: (1) Corrective ad similarity to
the original ad and (2) time delay between original ad and corrective
ad exposure.
    We will systematically vary these two characteristics to create a
study with a 4 (similarity to original ad) x 4 (exposure delay) design
(see Table 2).

                   Table 2--Design of Phase 2: Corrective Ad Similarity by Exposure Time Delay
----------------------------------------------------------------------------------------------------------------
                                 Multiple exposure pod  (2           Time between Original and Corrective
   Corrective ad similarity     viewings per sitting, for a  ---------------------------------------------------
                                   total of 6 exposures*)         None        1 Week      1 Month      6 Months
----------------------------------------------------------------------------------------------------------------
Same ad elements as original
Some similar elements as
 original
Different ad elements than
 original
Control (Do not see
 corrective)*
----------------------------------------------------------------------------------------------------------------
*The control condition will be used to examine the impact of time delay on perceptions and intentions.

    Prior to conducting the main study, we will pretest the stimuli,
questionnaires, and data collection process. The first set of pretests
will focus on the stimuli to: (1) Ensure participants perceive the
stimuli as realistic and (2) ensure participants notice and comprehend
the original and corrective messages in the ads. The second pretest
will focus on the questionnaires and data collection process. Its
purpose will be to: (1) Ensure that survey questions solicit responses
that meet the study's analytic goals and (2) ensure data are captured
and stored accurately for each question. The pretests are not intended
to affect the study design, sample or burden.
    All parts of this study will be administered over the Internet. A
total of 6,650 interviews will be completed. Participants will be
randomly assigned to view one version of a DTC prescription drug
television ad. Following their perusal of this ad, they will answer
questions about their recall and understanding of the benefit and risk
information, their perceptions of the benefits and risks of the drug,
and their intent to ask a doctor about the medication.
    Demographic and numeracy information will be collected. In
addition, participants will answer questions about their familiarity
with their medical condition. The entire procedure is expected to last
approximately 25 minutes in Phase 1 and 1 hour in Phase 2. This will be
a one-time (rather than annual) information collection.
    Participants will be randomly assigned to view one version of a DTC
prescription drug television ad. Following their perusal of this ad,
they will answer questions about their recall and understanding of the
benefit and risk information, their perceptions of the benefits and
risks of the drug, and their intent to ask a doctor about the

medication. Demographic and numeracy information will be collected. In
addition, participants will answer questions about their familiarity
with their medical condition. The entire procedure is expected to last
approximately 20 minutes. This will be a one-time (rather than annual)
information collection.
    In the Federal Register of February 29, 2012 (77 FR 12307), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three public submissions. In
the following section, we outline the observations and suggestions
raised in the comments and provide our responses.
    (Comment 1) One comment expressed support for the survey.
    (Response) We thank this commenter for his support of our study.
    (Comment 2) One comment expressed the concern that the Internet
sample would not measure individuals over 65 due to difficulties using
the Internet.
    (Response) We have conferred with the Internet Panel provider for
this study about this issue. According to GfK,\1\ the 65+ Panelists are
among the most reliable respondents and their representation on the
panel (15.7 percent) is reasonably proportionate to their
representation in the General Population (16.7 percent).
---------------------------------------------------------------------------

    \1\ Formerly Knowledge Networks.
---------------------------------------------------------------------------

    (Comment 3) One comment stated a ``medium prevalence'' condition
may not represent conditions that cluster in particular demographic
groups.
    (Response) Recruitment to KnowledgePanel[supreg] is based upon a
random selection of residential addresses. Every residential address in
the United States has an equal probability of selection within each
recruitment cohort (cohort sizes may vary from recruitment wave to wave
and the residential housing stock changes over time which results in
differing probability of selection between recruitment waves). Thus,
mailings have a proportional likelihood of reaching any specific
demographic group. Finally, as the weights are calculated based upon
Current Population Survey benchmarks, final adjustment of survey
respondents to the U.S. population can be easily made. The panel
recruits in English and Spanish with all mailings being bilingual.
    We plan to use asthma and weight loss as our two medical
conditions. While the particulars of an individual corrective campaign
may vary, the type of violation (for example, overstatement of
efficacy, minimization of risk) can occur in any drug class. Therefore,
we believe that the cognitive processes involved in understanding a
claim and subsequently addressing problematic claims applies across
multiple medical conditions. Those with debilitating conditions might
be less likely to respond to the recruitment and survey invitations but
it is likely that they would be less likely to respond to other modes
of survey data collection as well.
    Finally, we note that this is a randomized control trial design: we
are not attempting to make population estimates from these results.
    (Comment 4) One comment asked if the participants would be a random
and representative selection of the target audience.
    (Response) We are planning to recruit panel members who self-report
having been diagnosed with asthma (Phase 1) or self-identify as having
a weight problem with a BMI of 25 or above (Phase 2). These are the
relevant target audiences for the medical conditions being advertised.
As described above, the panel of active profiled adults is weighted to
be representative of the U.S. population on age, gender, race, Hispanic
ethnicity, language proficiency, region, metro status, education,
household income, home ownership, and Internet access using post-
stratification adjustments to offset nonresponse or noncoverage bias.
    (Comment 5) One comment stated that even if participants are
randomly selected, the final study sample may be self-selected due to
dropout over time.
    (Response) We agree that dropout is a concern common to all
longitudinal research. We plan to employ the following techniques to
improve retention of respondents over time:
    1. It is very important to notify respondents at the time of their
invitation that this is a longitudinal survey and that we intend to
contact them multiple times during the duration of the survey. This in
an important part of the informed consent procedure. We will therefore
explicitly ask respondents if we can contact them in the future. This
will allow us to contact them even if they leave the panel.
    2. Periodic contact also provides a vehicle to retain engagement
with respondents and can be conducted via email. KnowledgePanel[supreg]
members are accustomed to receiving periodic communication about
surveys that they previously participated in and respond well to
periodic contact.
    3. When later survey waves are fielded, respondents will be
reminded that they participated in the earlier survey wave, that we
appreciated their agreeing to participate in subsequent survey waves
and that this survey is a follow-on to the prior survey wave. The date
of the prior survey field wave will be included.
    4. Finally, even if a respondent has left the panel, respondents
have given explicit permission, as was noted in item 1 above, to
contact them regarding this survey. Thus we do not anticipate an
unusual loss of participation on subsequent survey waves. In past
multiwave surveys, it was not unusual for 75 percent to 85 percent of
respondents to the first wave of a study to respond to a subsequent
survey wave more than 1 year later.
    (Comment 6) One comment questioned whether the study would be
adequately powered to ensure meaningful results.
    (Response) We have powered our study to detect small to medium
effect sizes. We have provided a power analysis for both the main study
phases and pretests.
    (Comment 7) One comment suggested that rather than similarity and
time delay, the proposed study should include an evaluation of both:
(1) A truly informative, nondistracting, clear and conspicuous
corrective ad and (2) an unclear and inconspicuous corrective ad.
    (Response) We appreciate the suggestion to include clarity as an
independent variable. Because we cannot study every variable of
potential interest in a single study, we offer the following
explanation for our choice of similarity and time delay. FDA has
previously provided guidance on ways in which separate ads may be
implemented in such a way as to be perceived as linked to one another:

    Psychology and marketing research suggests that the greater the
perceptual similarity between disease awareness communications and
reminder or product claim promotions (i.e., similarities in terms of
their themes, such as story lines, or other presentation elements,
such as colors, logos, tag lines, graphics, etc.), and the closer
they are presented physically or in time to one another, the more
likely it is that the separate messages contained in the two pieces
will be remembered together in memory as one entity. Perceptual
similarity is an important factor because research indicates that
pieces are most likely to be linked together in memory when they
have prominent cues in common, such as distinctive visual elements,
a common narrator or background music, or a common story line. (Ref.
5.)

The recommendations in this guidance were based on the social science
literature which suggests these properties influence people's
associations. We selected similarity and time delay as our independent
variables of interest in this study in order to

provide information on the effectiveness of FDA guidance on this issue.
    (Comment 8) Two comments expressed concern that the time delay
conditions were not realistic, stating that a time delay of 6 months to
a year might be more realistic.
    (Response) We agree that a 6-month exposure delay more closely
approximates real-world exposure to original and corrective messaging.
In response to concerns about the realism of our approach, we have
changed the study design in two ways (see Table 2). First, participants
will view the stimuli embedded in a ``clutter reel'' of other ads three
times over a 3-week period to approximate multiple exposures in a real-
world context. Second, we have added a 6-month delay condition.
    (Comment 9) One comment critiqued the references included in the
60-day Federal Register notice, stating:

    ``* * * the references offered in the instant [sic] notice
seemed less concerned with presenting corrective advertising in a
manner most likely to inform the consumer about the safety and
efficacy of a given product and more concerned with determining
whether the corrective ad might be bad for sales. Furthermore, the
only example of application of a judicial remedy to enforce
corrective advertising cited by one of these references distorted
the clear intent of the opinion cited.''

    (Response) Some of the research on corrective advertising, as the
commentator notes, has assessed potential damage to an advertiser's
reputation. Darke and colleagues (2008, Ref. 1) note the possibility of
reputational damage, for example. Other papers cited in the 60-day
notice, though, do not focus primarily on reputational damage. Mazis'
work, both in the 1970s and 1980s and then again more recently (e.g.,
Mazis, 2001, Ref. 6), as we have seen a resurgence of corrective
advertising, has been concerned with the efficacy of corrective
messages. Mazis and colleagues (1983, Ref. 3), for example, focused
attention on the extent to which viewers actually noticed and
remembered the corrective message inserted into Listerine ads.
Moreover, our study was designed to address a gap in the literature--
there is scant work on the specific efficacy of televised corrective
ads intended to address claims made regarding prescription drugs--
rather than to simply extend and replicate past literature. The primary
focus of our study is correction of misperceptions that arise from
prescription drug advertising. The dependent variables we describe in
the 60-day notice do not include advertiser reputation but rather are
comprised of constructs such as belief in advertised claims that
overstate efficacy or minimize risk, perceived risk of the advertised
drug, and perceived efficacy of the advertised drug.
    Please note that in response to all comments received, whether we
have adopted the suggestions or not, we will specifically examine the
items mentioned in cognitive testing. During this testing, nine
respondents will participate in the survey while explaining why and how
they have chosen their answers and which questions they find difficult
to respond to or to understand.
    FDA estimates the burden of this collection of information as
follows:

                                          Table 3--Estimated Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     No. of
            Activity                 No. of       responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses        response
----------------------------------------------------------------------------------------------------------------
Sample availability (pretests            24,635  ..............  ..............  ...............  ..............
 and main survey)..............
Screener completes (60%).......          14,891               1          14,891           0.0333             496
Eligible (85%).................          12,658  ..............  ..............  ...............  ..............
Pretest (stimuli) completes               1,450               1           1,450           0.333              483
 (65%).........................
Pretest (questionnaire)                     200               1             200           0.5                100
 completes (65%)...............
Phase 1 completes (65%)........           1,000               1           1,000            .416              417
Phase 2 completes (45%)........           4,000               1           4,000           1                4,000
Pretest/Study completes........           6,650  ..............  ..............  ...............  ..............
    Total......................  ..............  ..............  ..............  ...............           5,496
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

FDA estimates the total annual estimated burden imposed by this
collection of information as 5,496 hours for this one-time collection.
V. References
    The following references have been placed on display at the
Division of Dockets Management and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday (FDA has verified the
Web site addresses of the following references, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register).

1. Darke, P. R., Ashworth, L., and Ritchie, R. J. B. (2008). Damage
from corrective advertising: Causes and cures. Journal of Marketing,
72, 81-97;
2. Mazis, M. B. & Adkinson, J. E. (1976). An experimental evaluation
of a proposed corrective advertising remedy. Journal of Marketing
Research, 13, 178-183.
3. Mazis, M. B., McNeill, D. L., & Bernhardt, K. L. (1983). Day-
after recall of Listerine corrective commercials. Journal of Public
Policy & Marketing, 2, 29-37.
4. Singer, N. (2009, February 11). A birth control pill that
promised too much. The New York Times, p. B1.
5. From Guidance for Industry: ``Help-Seeking'' and Other Disease
Awareness Communications by or on Behalf of Drug and Device Firms.
Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf.
Last accessed November 23, 2012.
6. Mazis, M. B. (2001). FTC v. Novartis: The return of corrective
advertising? Journal of Public Policy & Marketing, 20, 114-122.

    Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31028 Filed 12-21-12; 4:15 pm]
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[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37230-37231]
[FR Doc No: 2013-14675]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products,'' which explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by August 19, 2013.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE
recommendations to http://www.regulations.gov. Submit written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute], Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as
a means to develop and disseminate product-specific BE recommendations
and provide a meaningful opportunity for the public to consider and
comment on those recommendations. Under that process, draft
recommendations are posted on FDA's Web site and announced periodically
in the Federal Register. The public is encouraged to submit comments on
those recommendations within 60 days of their announcement in the
Federal Register. FDA considers any comments received and either
publishes final recommendations or publishes revised draft
recommendations for comment. Recommendations were last announced in the
Federal Register of December 17, 2012 (77 FR 74669). This notice
announces draft product-specific recommendations, either new or
revised, that are being posted on FDA's Web site concurrently with
publication of this notice.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing new draft product-specific BE recommendations for
drug products containing the following active ingredients:

A
    Apixaban
    Artemether; Lumefantrine
    Asenapine maleate
B
    Balsalazide disodium
C
    Cycloserine
    Cyclosporine
E
    Eltrombopag olamine
F
    Fluoxetine
H
    Hydrochlorothiazide; Triamterene
M
    Medroxyprogesterone (multiple reference listed drugs)
    Methyltestosterone

    Mirabegron
S
    Sodium ferric gluconate
T
    Timolol maleate
    Trientine

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing revised draft product-specific BE recommendations
for drug products containing the following active ingredients:

A
    Albuterol sulfate (multiple reference listed drugs)
    Ambrisentan
C
    Carbidopa; Entacapone; Levodopa
    Colesevelam
D
    Dexamethasone; Tobramycin (multiple reference listed drugs and
dosage forms)
    Didanosine
    Drospirenone; Estradiol
E
    Entacapone
F
    Fentanyl citrate
I
    Isotretinoin
M
    Minocycline hydrochloride
P
    Phentermine hydrochloride; Topiramate
T
    Tenofovir disoproxil fumarate
    Topiramate (multiple reference listed drugs and dosage forms)

    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please go to
http://www.regulations.gov and enter docket number FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not create or confer any
rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit either electronic comments on any of
the specific BE recommendations posted on FDA's Web site to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. The guidances, notices, and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14675 Filed 6-19-13; 8:45 am]
BILLING CODE 4160-01-P