[Federal Register: May 8, 2007 (Volume 72, Number 88)]
[Notices]
[Page 26190-26191]
[DOCID:fr08my07-115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55679; File No. SR-NYSEArca-2007-35]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to
Exchange Fees and Charges

April 27, 2007.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on April 3, 2007, NYSE Arca, Inc. (the ``Exchange''),
through its wholly owned subsidiary, NYSE Arca Equities, Inc. (``NYSE
Arca Equities''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Exchange. The Exchange has
filed this proposal pursuant to Section 19(b)(3)(A) of the Act \4\ and
Rule 19b-4(f)(2) thereunder,\5\ which renders the proposed rule change
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 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

    NYSE Arca is proposing to amend its Schedule of Fees and Charges
for Exchange Services (``Schedule''). The text of the proposed rule
change is available at http://www.nysearca.com, at the Exchange's

Office of the Secretary, 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 Exchange included statements
concerning the purpose of and basis for the proposed rule changes and
discussed any comments it received regarding the proposal. 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 purpose of this filing is to amend the existing NYSE Arca Rate
Schedule by revising or eliminating certain fees and adding clarifying
language to either footnotes or explanatory text, associated with
certain fees. The Exchange also proposes making minor technical changes
to the Schedule. A brief description of each proposed change is shown
below.
OTP Trading Participant Rights
    NYSE Arca Market Makers pay a fee of $4,000 per month for each
Options Trading Permit (OTP) used. The fee is presently capped at
$16,000 per month, which represents four OTPs. Pursuant to NYSEArca
Rule 6.35(d)(4), a Market Maker with four OTPs is permitted to trade
all issues on the Exchange. Because of this provision, there would
never be an occasion for a Market Maker to need more than four OTPs,
thereby negating any need for a fee cap. As a result, the Exchange
proposes to eliminate the $16,000 fee cap from the Schedule.
LMM Options Issue Relinquishment Fee
    This fee was initially implemented to help offset the costs
incurred by the Exchange when a Lead Market Maker (``LMM'')
relinquished an allocated option issue. Previously, the relinquishment
process involved administrative and technological changes, both of
which were mostly manual processes. Much of the process has now been
automated and the associated cost has been significantly reduced.
Accordingly, the Exchange proposes eliminating the Issue Relinquishment
Fee in its entirety.
DEA Fee
    The Exchange charges a one time $75 registration fee, for new
applicants, when the Exchange also acts as the Designated Examining
Authority. This fee helps to offset administrative expenses involved in
processing new applications. Much of the processing is now done over
the NASD Central Registration Depository (``CRD''). Included in the
fees that NASD collects on behalf of the Exchange, is a $55 assessment
for new applicants. The Exchange believes that these fees are
duplicitous and as such, will eliminate the $75 one time registration
fee.
Weekly Bulletin Subscription Fee
    NYSE Arca distributes a Weekly Bulletin (``Bulletin'') to OTP
Holders and OTP Firms in order to provide them with regulatory
bulletins, rule adoption notices, and other official communications.
The Bulletin has been available either electronically or via U.S. Mail.
To offset the cost of postage and handling, the Exchange charges a $200
per year subscription fee to anyone electing to receive the Bulletin
via regular mail.
    NYSE Arca Rule 2.25 requires that Each OTP Holder and OTP Firm must
maintain with NYSE Arca an electronic mail account for communication
with the NYSE Arca. Presently, all OTP Holders and OTP Firms receive
the Bulletin via e-mail subscriptions. As a result, the Exchange will
no longer offer the option of receiving the Bulletin via regular mail.
Therefore, the Exchange proposes eliminating the Subscription Fee.
Transaction Fees
    The Exchange proposes making minor changes to the Order Types
included in the Transaction Fee section of the Schedule.
    Orders executed on behalf of registered Broker Dealers (``BD''), or
Broker Dealer Firms, are presently assessed the ``BD rate.'' In order
to avoid any misunderstanding and to clarify that the ``BD rate'' is
applicable to the BD Firms as well as the BDs, the BD Electronic rate
and BD Manual rate will now read ``Broker Dealer & Firm Electronic''
and ``Broker Dealer & Firm Manual.''
    Presently, the ``Firm rate'' applies to any transaction involving a
proprietary trading account of an OTP Firm that has a customer of that
OTP Firm on the contra side of the transaction. This explanation
presently appears on the Schedule as a footnote to the Firm fee. This
practice is generally referred to as ``facilitating'' an order. In
order to better explain that the ``Firm rate'' is only applicable when
a firm facilitates their customer's order, the Schedule will now read
``Firm Facilitation.''
Marketing Charge--QQQQ
    The Exchange assesses Market Makers a Marketing Charge on certain
transactions. The Standard and Poor's Depository Receipts (QQQQ) carry
a $1.00 per contract charge. Marketing Charges are not assessed on
issues that

trade as part of the Penny Pilot. QQQQ has now been included in the
Penny Pilot and therefore the Exchange will no longer assess a
Marketing Charge on any trades in this issue. The Exchange also
proposes making minor technical changes to this section of the Schedule
with this filing.
Royalty Fees
    In an effort to reduce costs associated with trading on NYSE Arca,
the Exchange proposes to eliminate certain Royalty Fees. The Exchange
proposes to eliminate the $0.10 per contract Royalty Fee for options
traded on the following ETFs; the Financial Select Sector SPDR (XLF),
the Technology Select Sector SPDR (XLK), and the Healthcare Select
Sector SPRD (XLV). By eliminating these fees, the Exchange hopes to
attract additional order flow and encourage more trading by market
participants.
Vendor Equipment Room Usage Fee
    This fee covers the use of server cabinets in the vendor equipment
room located adjacent to the trading floor. This fee will now be called
the Vendor Equipment Room Cabinet Fee, and the footnote associate with
the fee will now be moved into the body of the Schedule. These minor
changes simply serve to offer clarity as to how this fee is assessed,
and makes no change to the fee itself.
Technical and Formatting Changes
    The Exchange proposes making minor changes to the schedule in order
correct certain typographical and grammatical errors and to make
certain formatting changes. These changes will have no effect on
existing fees or the application of the existing fees.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) \6\ of the Act, in general, and Section 6(b)(4),\7\ in particular,
in that it provides for the equitable allocation of dues, fees and
other charges among its members.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 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 purpose of the Act.

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    The foregoing rule change is subject to Section 19(b)(3)(A)(ii) of
the Act \8\ and Rule 19b-4(f)(2) thereunder \9\ because it establishes
or changes a due, fee, or other charge applicable only to a member
imposed by the self-regulatory organization. Accordingly, the proposal
is effective upon Commission receipt of the filing. At any time within
60 days of the filing of the proposed rule change, the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 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 e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NYSEArca-2007-35 on the subject line.

Paper Comments

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

All submissions should refer to file Number SR-NYSEArca-2007-35. 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
filings will also 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-NYSEArca-2007-35 and should be submitted by May 29,
2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-8732 Filed 5-7-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Proposed Rules]
[Pages 36482-36486]
[FR Doc No: 2011-15620]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2011-0002; Internal Agency Docket No. FEMA-B-1198]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this proposed
rule is to seek general information and comment regarding the proposed
regulatory flood elevations for the reach described by the downstream
and upstream locations in the table below. The BFEs and modified BFEs
are a part of the floodplain management measures that the community is
required either to adopt or to show evidence of having in effect in
order to qualify or remain qualified for participation in the National
Flood Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before September 20, 2011.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community is available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1198, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, Federal Emergency Management Agency, 500
C Street, SW., Washington, DC 20472,

(202) 646-4064, or (e-mail<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. These proposed elevations
are used to meet the floodplain management requirements of the NFIP and
also are used to calculate the appropriate flood insurance premium
rates for new buildings built after these elevations are made final,
and for the contents in those buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                *Elevation in feet
                                                                                (NGVD)  + Elevation in
                                                                                feet (NAVD)
                                                                                Depth in feet above
                State                      City/town/county                  Source of flooding                                     Location **                              ground  [caret]
                                                                                Elevation in meters
                                                                                (MSL)
                                                                                -------------------------
                                                                                Existing     Modified
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               City of Colonial Heights, Virginia
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Virginia.............................  City of Colonial Heights  Old Town Creek...........................  Approximately 0.63 mile downstream of Conduit Road........         + 10         + 11
                                                                                Approximately 0.48 mile upstream of the railroad..........         + 67         + 68
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood
 Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
 20472.

                                                                                ADDRESSES

                                                                                City of Colonial Heights
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Maps are available for inspection at 202 James Avenue, Colonial Heights, VA 23834.
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                                                                     Unincorporated Areas of Halifax County, North Carolina
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
North Carolina.......................  Unincorporated Areas of   Fishing Creek............................  Approximately 1.1 miles upstream of the Fishing Creek              + 60         + 59
                                        Halifax County.                                                      Tributary 2 confluence.
                                                                                Approximately 50 feet downstream of White Oak Road........        + 129        + 132
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood
 Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
 20472.

                                                                                ADDRESSES

                                                                             Unincorporated Areas of Halifax County
                                         Maps are available for inspection at the Halifax County Office, 15 West Pittsylvania Street, Halifax, NC 27839.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet  (NAVD)
                                                                  Depth in feet above
         Flooding source(s)            Location of referenced       ground  [caret]        Communities affected
                                            elevation **          Elevation in meters
                                                                         (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                 Osceola County, Florida, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Bass Slough (Lower Reach)...........  Approximately 1,211             None         + 57  City of Kissimmee,
                                       feet downstream of                                 Unincorporated Areas
                                       County Route 525.                                  of Osceola County.
----------------------------------------------------------------------------------------------------------------
                                      Approximately 0.6 mile          None         + 76
                                       upstream of State
                                       Route 530.
Bass Slough (Upper Reach)...........  Approximately 1,863             None         + 79  City of Kissimmee,
                                       feet downstream of the                             Unincorporated Areas
                                       Bass Slough Tributary                              of Osceola County.
                                       confluence.
                                      Approximately 337 feet          None         + 80
                                       upstream of Florida
                                       Parkway.
Bass Slough Tributary...............  At the Bass Slough              None         + 79  Unincorporated Areas of
                                       (Upper Reach)                                      Osceola County.
                                       confluence.
                                      Approximately 0.4 mile          None         + 79
                                       upstream of the Bass
                                       Slough (Upper Reach)
                                       confluence.
Clay Hole Pond......................  Entire shoreline.......         None         + 66  Unincorporated Areas of
                                                                                Osceola County.
Courthouse Pond.....................  Entire shoreline.......         None         + 68  Unincorporated Areas of
                                                                                Osceola County.
Eagle Pond..........................  Entire shoreline.......         None         + 65  Unincorporated Areas of
                                                                                Osceola County.
East City Canal Tributary 1.........  At the upstream side of         + 65         + 66  City of Kissimmee.
                                       Vine Street.
                                      Approximately 637 feet          + 65         + 66
                                       upstream of Vine
                                       Street.
Lake Marian.........................  Entire shoreline.......         None         + 59  Unincorporated Areas of
                                                                                Osceola County.
Multiple Ponding Areas..............  Area bound by San Remo          None         + 69  Unincorporated Areas of
                                       Road to the north and                              Osceola County.
                                       east, Cypress Parkway
                                       to the south, and
                                       Marigold Avenue to the
                                       west.
Multiple Ponding Areas..............  Area bound by Florida's         None         + 65  City of Kissimmee.
                                       Turnpike to the north
                                       and east and State
                                       Route 523 to the south
                                       and west.
Multiple Ponding Areas..............  Area approximately 0.8          None         + 69  Unincorporated Areas of
                                       mile northwest of the                              Osceola County.
                                       intersection of
                                       Brandon Lane and
                                       County Route 523,
                                       bound by Williams Road
                                       to the north, U.S.
                                       Route 441 to the east,
                                       and Florida's Turnpike
                                       to the south and west.
Multiple Ponding Areas..............  Area bound by County            None         + 69  Unincorporated Areas of
                                       Route 523 to the                                   Osceola County.
                                       north, U.S. Route 441
                                       to the east, Hayman
                                       Ranch Road to the
                                       south, and Florida's
                                       Turnpike to the west.
Multiple Ponding Areas..............  Area approximately 2.4          None         + 67  Unincorporated Areas of
                                       miles north of the                                 Osceola County.
                                       intersection of 3rd
                                       Street and 4th Avenue,
                                       bound by Williams Road
                                       to the north, U.S.
                                       Route 441 to the east,
                                       and Florida's Turnpike
                                       to the south and west.
Otter Pond..........................  Entire shoreline.......         None         + 69  Unincorporated Areas of
                                                                                Osceola County.

Ponding Area........................  Area bound by West              + 65         + 66  Unincorporated Areas of
                                       Orange Street to the                               Osceola County.
                                       north, North Main
                                       Street to the east,
                                       Sumner Street to the
                                       south, and U.S. Routes
                                       17/92 to the west.
Ponding Area........................  Area bound by Pleasant          None         + 64  Unincorporated Areas of
                                       Hill Road to the                                   Osceola County.
                                       north, Florida's
                                       Turnpike to the east,
                                       and Scrub Jay Trail to
                                       the south and west.
Ponding Area........................  Area approximately 0.9          None         + 63  Unincorporated Areas of
                                       mile east of the                                   Osceola County.
                                       intersection of
                                       Martigues Drive and
                                       Amiens Road, bound by
                                       West Southport Road to
                                       the north, Florida's
                                       Turnpike to the east,
                                       and Scrub Jay Trail to
                                       the south and west.
Ponding Area........................  Area bound by Amiens            None         + 62  Unincorporated Areas of
                                       Road to the north and                              Osceola County.
                                       east, Chestnut Street
                                       to the south, and
                                       Bordeaux Road to the
                                       west.
Ponding Area........................  Area approximately 0.6          None         + 62  Unincorporated Areas of
                                       mile east of the                                   Osceola County.
                                       intersection of Saint
                                       Michel Way and Amiens
                                       Road, bound by West
                                       Southport Road to the
                                       north, Florida's
                                       Turnpike to the east,
                                       and Scrub Jay Trail to
                                       the south and west.
Ponding Area........................  Area bound by Old               None         + 60  Unincorporated Areas of
                                       Pleasant Hill Road to                              Osceola County.
                                       the north, Scrub Jay
                                       Trail to the east, and
                                       the Polk County
                                       boundary to the south
                                       and west.
Ponding Area........................  Area bound by Chestnut          None         + 63  Unincorporated Areas of
                                       Street to the north,                               Osceola County.
                                       Scrub Jay Trail to the
                                       east, and the Polk
                                       County boundary to the
                                       south and west.
Ponding Area........................  Area approximately 2.2          None         + 66  Unincorporated Areas of
                                       miles north of the                                 Osceola County/
                                       intersection of
                                       Coulter Drive and
                                       County Route 523,
                                       bound by Williams Road
                                       to the north, U.S.
                                       Route 441 to the east,
                                       and Florida's Turnpike
                                       to the south and west.
Unnamed Connecting Channel            Just upstream of Eagle          None         + 65  Unincorporated Areas of
 downstream of Clay Hole Pond.         Pond.                                              Osceola County/
                                      Just downstream of Clay         None         + 66
                                       Hole Pond.
Unnamed Connecting Channel            Approximately 0.6 mile          None         + 65  Unincorporated Areas of
 downstream of Eagle Pond.             downstream of Eagle                                Osceola County.
                                       Pond.
                                      Just downstream of              None         + 65
                                       Eagle Pond.
Unnamed Connecting Channel upstream   Just upstream of Lake           None         + 59  Unincorporated Areas of
 of Lake Marian.                       Marian.                                            Osceola County.
                                      Approximately 0.4 mile          None         + 65
                                       upstream of Lake
                                       Marian.
Unnamed Connecting Channel upstream   Just upstream of Lake           None         + 59  Unincorporated Areas of
 of Lake Marian.                       Marian.                                            Osceola County.
                                      Approximately 1.0 mile          None         + 69
                                       upstream of Lake
                                       Marian.
Unnamed Flooding Area upstream of     Just upstream of Lake           None         + 59  Unincorporated Areas of
 Lake Marian.                          Marian.                                            Osceola County.
                                      Approximately 0.5 mile          None         + 65
                                       upstream of Lake
                                       Marian.
WPA Canal Tributary 1...............  Approximately 1,612             None         + 71  City of St. Cloud,
                                       feet upstream of the                               Unincorporated Areas
                                       WPA Canal confluence.                              of Osceola County.
                                      Approximately 1.6 miles         None         + 75
                                       upstream of Snail Kite
                                       Avenue.
WPA Canal Tributary 1-1.............  At the WPA Canal                None         + 75  City of St. Cloud,
                                       Tributary 1 confluence.                            Unincorporated Areas
                                                                                of Osceola County.
                                      Approximately 0.7 mile          None         + 75
                                       upstream of the WPA
                                       Canal Tributary 1
                                       confluence.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
                                                City of Kissimmee
Maps are available for inspection at City Hall, Engineering Department, Suite 301, 101 North Church Street,
 Kissimmee, FL 34741.
                                                City of St. Cloud
Maps are available for inspection at City Hall, Public Works Department, Building A, 2nd Floor, 1300 9th Street,
 St. Cloud, FL 34769.

                                     Unincorporated Areas of Osceola County

Maps are available for inspection at the Osceola County Stormwater Section, 1 Courthouse Square, Suite 1400,
 Kissimmee, FL 34741.
----------------------------------------------------------------------------------------------------------------

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

    Dated: June 10, 2011.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2011-15620 Filed 6-21-11; 8:45 am]
BILLING CODE 9110-12-P


  SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision for Pyrethrins (PC
069001)

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the pyrethrins case covered
by this RED.  It contains generic data requirements that apply
pyrethrins in all products, including data requirements for which a
“typical formulation” is the test substance.

The data table is organized in the following formats:

Data requirement (Column 1).  The data requirements are listed in the
order in which they appear in 40 CFR 158.  The reference numbers
accompanying each test refer to the test protocols set in the Pesticide
Assessment Guidance, which is available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161.  (703)
487-4650.

Use Pattern (Column 2).  This column indicates the use patterns for
which the data requirements apply.  The following letter designations
are used for the given use patterns.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

Indoor non-food

Indoor medical

Indoor residential

3.  Bibliographic Citation (Column 3).  If the Agency has acceptable
data in its files, this column lists the identifying number of each
study.  This normally is the Master Record Identification (MRID) number,
but may be a “GS” number is no MRID number has been assigned.  Refer
to the Bibliography appendix for a complete citation of the study.

Data Requirement	Use Patterns	Citations

New Guideline Number	Old Guideline Number	Description

PRODUCT CHEMISTRY

(unknown)	61-2 	Description of Beginning Materials and Manufacturing
Process	All	43495201

(unknown)	61-3  	Discussion of Formation of Impurities	All	43495201

830.1550	61-1	Product Identity and Composition	All	40836301, 41311201,
41474601, 43495201

830.1600	61-2A	Description of materials used to produce the product	All
45923201, 41311201, 00161540, 41474601, 41474601,

00156652, 41365501, 44325201

830.1620	61-2B	Description of production process	Al	44245101, 45923201,
00161540, 41311201, 41474601, 41193901, 00156652,  41365501, 44325201

830.1670	61-2B	Formation of Impurities	All	40836301,  41311201,
41474601, 45923201, 41193901, 41365501, 44325201

830.1700	62-1	Preliminary Analysis	All	41311201, 00165269, 41193901,
41365501, 44325201,40836302

830.1750	62-2	Certification of Limits	All	40836302, 41311201, 41474601,
40836302

830.1800	62-3	Analytical Method	All	40836301, 45923201, 41311202,
41474601,, 41193901, 41365501, 40836302

830.6302	63-2	Color	All	40836303, 45625306, 41311203, 41474601,
41474601, 41193901, 41365501

830.6303	63-3	Physical State	All	40836303,  40836303

45625306, 41311203, 41474601, 41193901, 45923201, 41365501

830.6304

	63-4	Odor	All	40836303, 41311203, 41474601, 41474601, 45625306,
41193901, 41474601, 41365501

830.6313	63-13	Stability to normal and elevated temperatures, metals,
and metal ions	All	40836303,  42103901, 41311203 , 41193901, 41365501

830.7000	63-12	pH	All	45625306, 41474601,

41474601, 45625306

830.7050	None	UV/Visible Absorption	All	DATA GAP

830.7220	63-6	Boiling Point/boiling range	All	40836303,  41311203,
41193901, 41365501

830.7300	63-7	Density	All	40836303, 42103901, 45625306, 41474601,

41474601, 45625306, 41365501

830.7370	63-10	Dissociation Constants in Water	All	41311203, 41193901

830.7550	63-11	Partition coefficient, shake flask method	All	40836303,
41311203, 41193901, 41365501

830.7840	63-8	Solubility	All	40836303, 41311203, 41193901, 41365501

830.7860	63-8	Water solubility, generator column method	All	40836303,
41311203, 41193901, 41365501

830.7950

	63-9	Vapor Pressure	All	40836303,

41311203, 41193901, 41365501

ECOLOGICAL EFFECTS

850.1010	72-2   	Acute Toxicity to Freshwater Invertebrates	A, B, C,
K	43082305, 43082306

850.1025	72-3B	Estuarine/Marine Toxicity – Mollusk	A, B, C, K
43082309, 43082310

850.1035	72-3C	Estuarine/Marine Toxicity – Shrimp	A, B, C, K	43082311,
43082312

850.1045	72-3	Panaeid Acute Toxicity Test	A, B, C, K	43082307, 43082308,
43082311, 43082312

850.1075	72-1A	Fish Toxicity Bluegill	A, B, C, K	43082301, 43082302,
43082303, 43082304

850.1075	72-3A	Estuarine/Marine Toxicity – Fish	A, B, C, K	43082307

43082308

850.1300	72-4A	Daphnid Chronic Toxicity Test	A, B, C, K	43252701

850.1350	72-4B	Estuarine/Marine Invertebrate Life Cycle	A, B, C, K
43252702, DATA GAP

850.1400	72-4C	Early-life Stage Freshwater Fish	A, B, C, K	43252701,
DATA GAP

850.2100	71-1A	Avian Acute Oral Toxicity	A, B, C, K	42010901

850.2200	71-2A	Avian Dietary Toxicity – Quail	A, B, C, K	41968801,
41968802

850.3020	141-1

	Honey bee acute contact LD50	A, B, C, K	41968803

Atkins et al., 1967

Stevenson, 1968

Stevenson, 1978

850.4100	122-1	Seedling Emergence, Tier 1	A, B, C, K	DATA GAP

850.4150	122-1	Vegetative Vigor, Tier 1	A, B, C, K	DATA GAP

850.4400	123-2	Aquatic Plant Toxicity	A, B, C, K	DATA GAP

850.5400	122-2B	Aquatic Plant Growth, Tier 2	A, B, C, K	DATA GAP

Non-Guideline Study	Non-Guideline Study	Chronic Freshwater Sediment
Testing	A, B, C, K	DATA GAP

Non-Guideline Study	Non-Guideline Study	Chronic Estuarine/Marine
Sediment Testing	A, B, C, K	DATA GAP

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity - Rat	A, B, C,H, I,  K, L, M, O
42008101, 42599501, 263780

870.1200	81-2	Acute Dermal Toxicity – Rabbit/Rat	A, B, C,H, I,  K, L,
M, O	41964801

870.1300	81-3	Acute Inhalation Toxicity – Rat	A, B, C,H, I,  K, L, M,
O	42008001,

870.2400	81-4	Primary Eye Irritation  - Rabbit	A, B, C,H, I,  K, L, M, O
41964802

870.2500	81-5	Primary Skin Irritation	A, B, C,H, I,  K, L, M, O	41964803

870.2600	81-6	Dermal Sensitization	A, B, C,H, I,  K, L, M, O	41964804

870.3200	82-2	21-Day Dermal – Rabbit/Rat	A, B, C,H, I,  K, L, M, O
42212601

870.3465	82-5	90- Day Inhalation Toxicity	A, B, C,H, I,  K, L, M, O
42478201

870.3700A	83-3A	Developmental Toxicity – Rat	A, B, C,H, I,  K, L, M, O
40288202

870.3700B	83-3B	Developmental Toxicity – Rabbit	A, B, C,H, I,  K, L,
M, O	40288203

870.3800	83-4	2-Generation Reproduction – Rat	A, B, C,H, I,  K, L, M,
O	41327501

870.4100A	83-1	Chronic Toxicity Rodents	A, B, C,H, I,  K, L, M, O
41559501

870.4100B	83-1B	Chronic Feeding Toxicity Study - Non-rodent	A, B, C,H,
I,  K, L, M, O	41496501

870.4200	83-2	Carcinogenicity - Rat	A, B, C,H, I,  K, L, M, O	41559501

870.4300	83-5	Combined Chronic Toxicity/Carcinogenicity: Rats	A, B, C,H,
I,  K, L, M, O	41559401

870.5265	84-2	Gene Mutation Ames Assay	A, B, C,H, I,  K, L, M, O
41344701

870.5375	84-2	Cytogenetis – CHO Chromosomal Aberrations	A, B, C,H, I,
K, L, M, O	41344601, 43987001

870.5550	84-2	Unscheduled DNA Synthesis in Mammalian Cells in Culture	A,
B, C,H, I,  K, L, M, O	41344501

870.6200a	81-8   	Acute neurotoxicity screen study in rats	A, B, C,H,
I,  K, L, M, O	42925801

870.6300	83-6	Developmental Neurotoxicity Study	A, B, C,H, I,  K, L, M,
O	DATA GAP

870.7485	85-1	General Metabolism	A, B, C,H, I,  K, L, M, O	43554304,
43884101

Non-guideline Study	Non-guideline Study	Definitive Mechanistic Toxicity
Study in Rats	A, B, C,H, I,  K, L, M, O	45889802, 45889803

Non-guideline Study	Non-guideline Study	Toxicology:  Cellular Changes in
Larynx 	A, B, C,H, I,  K, L, M, O	46605701

Non- guideline Study	Non- guideline Study	Developmental Thyroid Assay	A,
B, C,H, I,  K, L, M, O	DATA GAP

ENVIRONMENTAL FATE

835.1240	163-1	Leaching/Adsorption/Desorption	A, B, C, K	43096603

835.1410	163-2

	Laboratory Volatilization (from Soil) Study	A, B, C, K	43096604

850.1730	165-4	Accumulation in Fish	A, B, C, K	43302301, 43884102

835.2120	161-1	Hydrolysis	A, B, C, K	43188201, 43567502,

835.2240	161-2	Photodegradation - Water	A, B, C, K	43096601, 43567601

835.2410	161-3	Photodegradation - Soil	A, B, C, K	43096602

835.4100	162-1	Aerobic Soil Metabolism	A, B, C, K	43499803

835.4200

162-2

	Anaerobic Soil Metabolism	A, B, C, K	43499802

835.4300	162-4	Aerobic Aquatic Metabolism	A, B, C, K	43499801, 43499802

835.4400	162-3	Anaerobic Aquatic Metabolism	A, B, C, K	43499801

835.6100	164-1	Terrestrial Field Dissipation	A, B, C, K	42745501

835.6200	164-2	Aquatic Field Dissipation	A, B, C, K	43818501, 43195201

RESIDUE CHEMISTRY

860.1300	171-4A2	Nature of the Residue in Plants	A, B, H	43554301,
43554302, 43554303, 43628402,  43668001, 45900802, 43628401,

860.1300	171-4A3	Nature of the Residue in Livestock	A, B, H	43628301,
43628302, 43833403, 43837601, 45900802 43837602,

860.1340	171-4C	Residue Analytical Method – Plants	A, B, H	PAM Volume
II, 43910601

860.1360	171-4m	Multiresidue Method	A, B, H	PAM Volume I

860.1380	171-4E	Plant commodities: (oilseeds, non-oily grains, and root
crops)	A, B, H	DATA GAPS

43232801, 43248701,

43292701, 43440001,

43470801, 43470802,

43470806, 44126901,

45037101, 45037102,

45037103, 45037104,

45048001, 45256501,

45398401, 45900801

43440002, 43470801,

43470805, 44140401, 44140402, 43195201

860.1400	171-4f	Magnitude of the Residue - Water,

Fish, and Irrigated Crops	A, B, H	43195201

860.1460	171-4i 	  Mag. of res. food handling	A, B, H	42009801,
42009802, 42009803, 42009804, 42009805

860.1480	171-4j	Magnitude of the Residue - Meat, Milk, Poultry, Eggs	A,
B, H	43833401, 43833402

860.1500	171-4K	Crop field trials: Crop Groups 1, 2, 3, 4, 5, 6, 7, 8,
9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and the following
miscellaneous commodities: asparagus, atemoya, avocado, banana, cacao
bean, carob bean, cherimoya, coconut, coffee (green bean), cotton (seed
and gin byproduct), cranberry, date, durian, fig, flax, grape, guava,
jojoba, kiwifruit, lychee, mango, mushroom, okra, papaya, peanut,
persimmon, pomegranate, pineapple, safflower, strawberry, sugarcane,
sunflower, tea, and tobacco	A, B, H	DATA GAPS

107652, 43232801, 43248701, 43292701, 43298901, 43370801, 43440002,
43470805, 43470805, 43470806, 44249301, 45398401, 45900801

860.1520	171-4L	Magnitude of Residue in Processed Food/Feed:  apple,
barley, cacao bean, coconut, coffee, corn (field), cotton, fig, flax,
oat, peanut, pineapple, plum, rice, rye, safflower, sorghum, soybean,
sugarcane, sunflower, tea, and wheat	A, B, H	DATA GAPS

43470803, 45900801

43440001, 45900801

43470802, 45900801

43470804, 45900801, 43470801, 45900801

860.1850	165-1	Confined Accumulation in Rotational Crops	A, B, H	DATA
GAP

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

840.1100	201-1	Spray Droplet Size Spectrum	A, B, C, K	SDTF

840.1200	202-1	Spray Drift Field Deposition	A, B, C, K	SDTF

875.1300	232	Inhalation Exposure	L, M, O	ORETF

875.1400	234	Inhalation Indoor Exposure – Metered Release Device	L, M,
O	DATA GAP

875.1400	234	Inhalation Indoor Exposure – Ultra Low Volume Cold Fogger
L, M, O	DATA GAP

875.1700	none	Product Use Information – Metered Release Device	L, M, O
DATA GAP

875.2300	None	Indoor Surface Residue Dissipation, Post application	L, M,
O	46188602, 46188613, 46188618, 46188623, 46188629

875.2400	133-3	Dermal Exposure – Loading and application of dust	A, B,
C, K	44459801

875.2500	133-4	Inhalation Exposure – Outdoor Residential Misting
System 	C, K	47062801

875.2500	133-4	Inhalation Exposure – Fogging Data	L, M, O	45869301

875.2500	133-4	Inhalation Exposure – Trigger Pump Spray	L, M, O
41054701

875.2500	133-4	Inhalation Exposure – Loading and Application of Dust
A, B, C, K	44459801

OTHER

Non-guideline Study	Non-guideline Study	Incident Analysis	All	46694701,
46694801, 46757301

Non-guideline Study	Non-guideline Study	Pyrethrins Stewardship Program
All	DATA GAP

 Data owned by the Spray Drift Task Force.

 Data owned by the Outdoor Residential Exposure Task Force.


[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Page 60271]
[FR Doc No: 2013-23876]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14549-000]

Mid-Atlantic Hydro, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On August 16, 2013, Mid-Atlantic Hydro, LLC 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 Francis E. Walter
Hydroelectric Project (Francis Walter Project or project) to be located
at the U.S. Army Corps of Engineers' (Corps) Francis E. Walter Dam on
the Lehigh River in Luzerne County, Pennsylvania. 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 the following: (1) An 11-
foot-diameter steel penstock attached to the existing outlet; (2) a
concrete powerhouse to be located on the right descending bank; (3) 6-
megawatt (MW) and 3-MW generators for a total installed capacity of 9.0
MW; (4) a concrete tailrace to direct flow from the powerhouse back
into the Lehigh River; (5) a proposed 0.5-mile-long, 12.4-kilovolt
transmission line interconnecting with an existing Pennsylvania Power
and Light transmission line; and (6) appurtenant facilities. The
estimated annual generation of the project would be 26 gigawatt-hours.
    Applicant Contact: Jennifer Mesirow, Mid-Atlantic Hydro, LLC, 5425
Wisconsin Avenue, Suite 600, Chevy Chase, MD 20815; phone: (301) 718-
4826.
    FERC Contact: Woohee Choi; phone:<PHONE_NUMBER>.
    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-14549-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14549) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: September 25, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-23876 Filed 9-30-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61916]
[DOCID:fr17oc08-147]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Tuesday, October
21, 2008, at 10 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (6), (7), 9(B) and (10) and 17 CFR
200.402(a)(5), (6), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Tuesday,
October 21, 2008, will be:

Formal orders of investigation;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: October 14, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-24720 Filed 10-16-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Notices]
[Pages 4670-4671]
[FR Doc No: 2020-01322]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4964]

Demonstrating Substantial Evidence of Effectiveness for Human
Drug and Biological Products; Draft Guidance for Industry;
Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice entitled ``Demonstrating
Substantial Evidence of Effectiveness for Human Drug and Biological
Products; Draft Guidance for Industry; Availability'' that appeared in
the Federal Register of December 20, 2019. The Agency is taking this
action in response to requests for an extension to allow interested
persons additional time to submit comments.

DATES: FDA is extending the comment period for the notice published on
December 20, 2019 (84 FR 70196). Submit either electronic or written
comments on the draft guidance by March 19, 2020, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit either electronic or written comments as
follows.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4964 for ``Demonstrating Substantial Evidence of
Effectiveness for Human Drug and Biological Products.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002 or
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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 document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Ei Thu Lwin, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-0728.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 20, 2019 (84 FR 70196), FDA
published a notice with a 60-day comment period to request comments on
the draft guidance for industry entitled ``Demonstrating Substantial
Evidence of Effectiveness for Human Drug and Biological Products.'' The
Agency has received requests for extension of the comment period. The
requests conveyed that additional time is needed to provide comments.
FDA has considered the requests and is extending the comment period for
30 days, until March 19, 2020. The Agency believes that an additional
30 days will allow adequate time for interested persons to submit
comments without compromising the timely publication of the final
version of the guidance.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01322 Filed 1-24-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Page 4994]
[FR Doc No: 2023-01493]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15274-000]

Hurricane Cliffs PSH, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On April 22, 2022, Hurricane Cliffs PSH, LLC 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 Hurricane Cliffs
Pumped Storage Project to be located approximately 8 miles south of
Hurricane, Utah. 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 be primarily located on Bureau of Land
Management land and consist of the following: (1) a new upper reservoir
at a normal maximum operating elevation of 4,270 feet average mean sea
level, with a surface area of 200 acres and a total storage capacity of
3,920 acre-feet; (2) a new lower reservoir at a normal maximum
operating elevation of 3,550 feet average mean sea level, with a
surface area of 125 acres and a total storage capacity of 4,200 acre-
feet; (3) a new 1,500-foot-long low-pressure tunnel, 570-foot-long
vertical shaft, 1,440-foot-long high pressure tunnel, two 600-foot-long
buried headrace pipes, and a 2,700-foot-long tailrace tunnel or channel
connecting the two reservoirs with a maximum head of 1,230 feet; (3) a
new 300-foot-long, 100-foot-wide, and 50-foot-high powerhouse complex
comprised of three 85-foot-diameter shafts, each 250 feet deep and
housing a 166.6 megawatt reversible pump-turbine unit, and a subsurface
powerhouse building; (4) a new 25.3-mile-long (alternative A), or 25.9
mile-long (alternative B), 345-kilovolt (kV) transmission line
connecting the powerhouse to PacifiCorp's Purgatory Flat substation;
and (7) appurtenant facilities. The estimated annual power generation
at the Hurricane Cliffs Pumped Storage Project would be 876,000
megawatt-hours.
    Applicant Contact: Matthew Shapiro, rPlus Hydro, LLLP, 201 S. Main
St. Ste. 2100, Salt Lake City, Utah, 84111; phone:<PHONE_NUMBER>;
[email protected].
    FERC Contact: Benjamin Mann; email: [email protected]; phone:
(202) 502-8127.
    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 https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-15274.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-15274) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: January 19, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-01493 Filed 1-25-23; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on August 31, 2004

   NOTICE OF ACTION TAKEN -- DOCKET OST-2004-18878

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   Delta Air Lines, Inc. (Delta)  filed   8/10/04  for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Salt Lake City, Utah, and San Jose del Cabo, Mexico, and to
combine this authority with all of Delta’s existing certificate and
exemption authority, consistent with applicable international
agreements.  Delta proposes to operate this service on a seasonal basis,
beginning January 31, 2005.

Applicant reps: Alexander Van der Bellen,<PHONE_NUMBER>  DOT Analyst:
Linda Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:   August 31, 2004,  through
August 31, 2006 .

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX Holder’s certificates of public convenience and necessity

   	XX Standard exemption conditions (attached)

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our policy, the dormancy notice
period will begin on January 31, 2005, Delta’s proposed start-up date
for the Salt Lake City-San Jose del Cabo service.

The route integration authority granted is subject to the condition that
any service provided under this exemption shall be consistent with all
applicable agreements between the United States and the foreign
countries involved.  Furthermore, (a) nothing in the award of the route
integration authority granted should be construed as conferring upon
Delta rights (including fifth-freedom intermediate and/or beyond rights)
to serve markets where U.S. carrier entry is limited unless Delta
notifies the Department of its intent to serve such a market and unless
and until the Department has completed any necessary carrier selection
procedures to determine which carrier(s) should be authorized to
exercise such rights; and (b) should there be a request by any carrier
to use the limited-entry route rights that are included in Delta’s
authority by virtue of the route integration exemption granted here, but
that are not then being used by Delta, the holding of such authority by
route integration will not be considered as providing any preference for
Delta in a competitive carrier selection proceeding to determine which
carrier(s) should be entitled to use the authority at issue.

- see next page -												2

________________________________________________________________________
______

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004