[Federal Register: October 14, 2009 (Volume 74, Number 197)]
[Notices]
[Page 52802-52804]
[DOCID:fr14oc09-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

October 8, 2009.
    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

Agency Holding Meeting: Federal Energy Regulatory Commission.

Date and Time: October 15, 2009, 10 a.m.

Place: Room 2C, 888 First Street, NE., Washington, DC 20426.

Status: Open.

Matters To Be Considered: Agenda.*

    Note --Items listed on the agenda may be deleted without further
notice.

Contact Person For More Information: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>. For a recorded message

listing items struck from or added to the meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's Web site at http://www.ferc.gov using the eLibrary link,
or may be examined in the Commission's Public Reference Room.

952nd--Meeting

                                   Regular Meeting [October 15, 2009, 10 a.m.]
----------------------------------------------------------------------------------------------------------------
               Item No                        Docket No.                             Company
----------------------------------------------------------------------------------------------------------------
                                                 Administrative
----------------------------------------------------------------------------------------------------------------
A-1..................................  AD02-1-000.............  Agency Administrative Matters--FERC Strategic
                                                                 Plan.
A-2..................................  AD02-7-000.............  Customer Matters, Reliability, Security and
                                                                 Market Operations.
A-3..................................  AD06-3-000.............  Winter Energy Market Assessment.
----------------------------------------------------------------------------------------------------------------
                                                    Electric
----------------------------------------------------------------------------------------------------------------
E-1..................................  OA08-52-004............  New York Independent System Operator, Inc.
                                       OA08-52-006............  New York Transmission Owners.
E-2..................................  OA08-52-005............  New York Independent System Operator, Inc.
E-3..................................  RR09-9-000.............  North American Electric Reliability Corporation.
                                       RR08-6-004.............
                                       RR07-14-004............
E-4..................................  NP09-26-000............  North American Electric Reliability Corporation.
E-5..................................  Omitted.
E-6..................................  RM08-12-001............  Western Electricity Coordinating Council
                                                                 Regional Reliability Standard Regarding
                                                                 Automatic Time Error Correction.
E-7..................................  RM09-23-000............  Revisions to Form, Procedures, and Criteria for
                                                                 Certification of Qualifying Facility Status for
                                                                 a Small Power Production or Cogeneration
                                                                 Facility.
E-8..................................  RM09-24-000............  Interest Rates for Refunds.
E-9..................................  ER06-456-006...........  PJM Interconnection, L.L.C.
                                       ER06-954-002...........
                                       ER06-1271-001..........
                                       ER07-424-000...........
                                       EL07-57-000............
E-10.................................  ER08-15-002............  Midwest ISO Transmission Owners.
E-11.................................  Omitted.
E-12.................................  Omitted.
E-13.................................  ER02-2560-009..........  Louisville Gas & Electric Company
                                                                Kentucky Utilities Company.
----------------------------------------------------------------------------------------------------------------
                                                  Miscellaneous
----------------------------------------------------------------------------------------------------------------
M-1..................................  RM07-1-001.............  Standards of Conduct for Transmission Providers.
----------------------------------------------------------------------------------------------------------------
                                                       Gas
----------------------------------------------------------------------------------------------------------------
G-1..................................  RP99-480-024...........  Texas Eastern Transmission, LP.
                                       RP09-143-000...........
G-2..................................  RP09-70-000............  Texas Eastern Transmission LP.
                                       RP09-71-000............  Saltville Gas Storage Company L.L.C.
                                       RP09-76-000............  East Tennessee Natural Gas, L.L.C.
                                       RP09-77-000............  Egan Hub Storage, L.L.C.
                                       RP09-222-000...........  ANR Pipeline Co.
                                       RP09-227-000...........  Northwest Pipeline GP.
                                       RP09-240-000...........  Natural Gas Pipeline Co. of America.
                                       RP09-245-000...........  Transcontinental Gas Pipeline Co., L.L.C.
                                       RP09-256-000...........  Panhandle Eastern Pipeline Co., LP.
                                       RP09-258-000...........  Quest Pipelines (KPC).
                                       RP09-260-000...........  Tres Palacios Gas Storage, LLC.
                                       RP09-261-000...........  CenterPoint Energy Gas Transmission Co.
                                       RP09-262-000...........  CenterPoint Energy-Mississippi River
                                                                 Transmission Co.
                                       RP09-265-000...........  Kinder Morgan Interstate Gas Transmission LLC.
                                       RP09-266-000...........  Rockies Express Pipeline LLC.
                                       RP09-269-000...........  National Fuel Supply Corp.
                                       RP09-270-000...........  Questar Pipeline Co.
                                       RP09-275-000...........  Columbia Gulf Transmission Co.
                                       RP09-277-000...........  Dominion Transmission, Inc.
                                       RP09-282-000...........  Tennessee Gas Pipeline Co.
                                       RP09-284-000...........  El Paso Natural Gas Co.
                                       RP09-288-000...........  Southern Natural Gas Co.
                                       RP09-294-000...........  Columbia Gas Transmission, LLC.
                                       RP09-295-000...........  Colorado Interstate Gas Co.
                                       RP09-299-000...........  Wyoming Interstate Co., Ltd.
                                       RP09-300-000...........  Cheyenne Plains Gas Pipeline Co., LLC.

                                       RP09-301-000...........  Gulf South Pipeline Co., LP.
                                       RP09-304-000...........  Texas Gas Transmission, LLC.
                                       RP09-332-000...........  Enbridge Pipelines (Midla), LLC.
G-3..................................  RP09-792-000...........  Columbia Gas Transmission, LLC.
                                       RP09-792-001.            ................................................
----------------------------------------------------------------------------------------------------------------
                                                      Hydro
----------------------------------------------------------------------------------------------------------------
H-1..................................  P-2130-038.............  Pacific Gas and Electric Company.
H-2..................................  Omitted.                 ................................................
H-3..................................  P-459-282..............  AmerenUE.
H-4..................................  P-2197-096.............  Alcoa Power Generating Inc.
----------------------------------------------------------------------------------------------------------------
                                                  Certificates
----------------------------------------------------------------------------------------------------------------
C-1..................................  CP09-65-000............  Columbia Gas Transmission, LLC.
                                                                Jefferson Gas, LLC.
C-2..................................  CP09-454-000...........  BCR Holdings, Inc.
C-3..................................  CP08-431-001...........  Columbia Gas Transmission LLC
----------------------------------------------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
    A free Web cast of this event is available through http://
www.ferc.gov. Anyone with Internet access who desires to view this
event can do so by navigating to http://www.ferc.gov's Calendar of
Events and locating this event in the Calendar. The event will contain
a link to its Web cast. The Capitol Connection provides technical
support for the free Web casts. It also offers access to this event via
television in the DC area and via phone bridge for a fee. If you have
any questions, visit http://www.CapitolConnection.org or contact
Danelle Springer or David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. E9-24780 Filed 10-9-09; 4:15 pm]

BILLING CODE 0717-01-P


      Draft Risk Management Plan and Rationale for Thidiazuron -- 1/13/16

Human Health Risks
      No human health risks were identified, therefore no human health risk mitigation is necessary.
Ecological Risks
   Birds/Terrestrial-phase amphibians and reptiles
 There are no acute or chronic risks to birds (also surrogates for terrestrial-phase amphibians/reptiles).
 The risk assessment identified a potential pathway of concern for birds drinking water in thidiazuron-treated cotton fields on a chronic exposure basis.  However, SIP is a conservative screening model and assumes that thidiazuron is present in the water source at its solubility limit (31 mg/L), that 100% of drinking water needs are obtained from thidiazuron-treated cotton fields, and that the most sensitive bird (20 g) is exposed.  If the solubility limit is reduced by half (15 mg/L), there is no risk concern for birds.  Because even this exposure is unlikely, EPA does not have any concern for bird chronic effects from drinking water alone, given the current avian toxicity data.
   Terrestrial Plants
 Thidiazuron is expected to adversely affect the survival and growth of terrestrial plants, mainly dicots. The highest risk quotient (RQ) is 13 for exposure to a combination of surface water runoff and spray drift. This significantly exceeds the plant Level of Concern (LOC) of 1.0.
 The LOC is also exceeded by spray drift exposure alone for the most sensitive dicot at a distance of more than 1000 feet from the edge of cotton fields.
 For other dicots tested (n=9), only 1 species (other than the most sensitive species) exceeded the spray drift LOC up to a distance of 328 feet (based on spray drift EECs for plants inhabiting terrestrial areas) beyond the edge of field.  Along with monocots, the least susceptible dicots were not affected at the edge of the field.
Proposed Risk Mitigation Measures
   EPA is supportive of thidiazuron's continued use, as it is a chemical with low risks.  EPA is primarily interested in reducing spray drift risk to non-target plants, especially sensitive dicots such as lettuce.  We propose that the following language, which already appears on some labels, appear on all labels:
   1.	No aerial application within 0.5 miles of lettuce (this language already appears on some labels)
   2.	No aerial application within 5 miles upwind of citrus in flush (this language already appears on some labels)
   3.	No ground application within 100 feet of lettuce (this language already appears on some labels)
   4.	No ground application within 0.5 miles upwind from citrus (this language already appears on some labels)
   5.	Apply with medium or coarser spray (according to ASAE standard 572) for standard nozzles for both aerial and ground applications (this language already appears on some labels)
   6.	When using ground application, apply with nozzle height no more than 2 feet above the ground or crop canopy (this language already appears on some labels)
   7.	Mixtures with organophosphates can increase non-target crop phytotoxicity. Additional care should be exercised when lettuce, citrus, cantaloupes or any other edible crops are adjacent to treated cotton fields (this language already appears on some labels).
   8.	Maximum application rate of 0.3 pounds of active ingredient per acre per year (this was RED risk mitigation, this language already appears on most labels, all registrants need to check that this appears on their label).
   9.	Maximum of 2 applications, but not to exceed 0.3 pounds of active ingredient per acre per year (this language already appears on some labels)
   10.	Minimum retreatment interval of 21 days (this language already appears on some labels)

Rationale
   o	Including label advisory for sensitive crops such as lettuce and citrus helps prevent unnecessary harm to non-target crops and off-site native species
   o	Adding stronger spray drift precautions on labels for ground and aerial application helps to reduce spray drift risk to non-target crops and off-site native species.
   o	Noting that mixtures can increase phytoxicity may reduce non-target adverse effects
Considerations regarding benefits
   o	Thidiazuron is less toxic than some alternative cotton defoliants
   o	There are no risk concerns for most taxa

Current Data gaps

 Storage stability portion of terrestrial field dissipation study
 Enforcement analytical method for water
 Enforcement analytical method for soil
 Honeybee larval acute oral toxicity study (tier 1)
 Honeybee adult 10-day chronic oral toxicity (tier 1)
 Honeybee larval repeat dose study (tier 1)
 Semi-field testing for pollinators (tier 2)
 Field testing for pollinators (tier 3)
 Field trial of residues in pollen and nectar (tier 3)

Note: tier 2 and tier 3 honeybee testing should not be initiated until EPA has completed tier 1 pollinator screening for thidiazuron.


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5518-5522]
[FR Doc No: 2013-01483]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68689; File No. SR-Phlx-2013-03]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change To Amend Exchange Rules 507 and 1014 To
Establish Remote Streaming Quote Trader Organizations

January 18, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on January 4, 2013, NASDAQ OMX PHLX LLC (``Phlx'' 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 Exchange. 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\ 17 CFR 240.19b-4.

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

    The Exchange is filing with the Commission a proposal to amend Phlx
Rules 507 (Application for Approval as an SQT or RSQT and Assignment in
Options) and 1014 (Obligations and Restrictions Applicable to
Specialists and Registered Options Traders) to establish that member
organizations may qualify to be Remote Streaming Quote Trader
Organizations with which as many as three Remote Streaming Quote
Traders may be affiliated.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/NASDAQOMXPHLX/Filings/, at the principal office of the Exchange, 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 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 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 the proposed rule change is to amend Phlx Rules 507
and 1014 to establish that member organizations may qualify to be
Remote Streaming Quote Trader Organizations (``RSQTOs'') with which as
many as three Remote Streaming Quote Traders may be affiliated.
Background
    Remote Streaming Quote Traders (``RSQTs'') are, along with
specialists, one of several types of Registered Option Traders
(``ROTs'') on the Exchange. ROTs are market makers that include
Streaming Quote Traders (``SQTs''),\3\ RSQTs,\4\ Directed Streaming
Quote Traders (``DSQTs''), and Directed Remote Streaming Quote Traders
(``DRSQTs'') \5\ (SQTs, DSQTs, and DRSQTs are together known as the
``Other Streaming Quote Traders'').
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    \3\ An SQT is an ROT who has received permission from the
Exchange to generate and submit option quotations electronically in
eligible options to which such SQT is assigned. An SQT may only
submit such quotations while such SQT is physically present on the
floor of the Exchange. See Rule 1014(b)(ii)(A).
    \4\ An RSQT is an ROT that is a member or member organization
with no physical trading floor presence who has received permission
from the Exchange to generate and submit option quotations
electronically in eligible options to which such RSQT has been
assigned. An RSQT may only submit such quotations electronically
from off the floor of the Exchange. See Rule 1014(b)(ii)(B).
    \5\ A DSQT is an SQT and a DRSQT is an RSQT that receives a
Directed Order. Exchange Rule 1080(l)(i)(A) defines Directed Order
as any customer order (other than a stop or stop-limit order as
defined in Rule 1066) to buy or sell which has been directed to a
particular specialist, RSQT, or SQT by an Order Flow Provider and
delivered to the Exchange via its electronic quoting, execution and
trading system.
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    Rule 507 is one of the numerous rules administered by the Exchange
that deal with allocation and assignment of securities (the
``Allocation and Assignment Rules''). The Allocation and Assignment
Rules generally describe the process for: Application for becoming and
appointment of specialists; allocation of classes of options to
specialist units and individual specialists; application for becoming
and approval of SQTs and RQTs and assignment of options to them; and
performance evaluations. The Allocation and Assignment Rules also
indicate, among other things, under what circumstances new allocations
to specialists and assignments to Streaming Quote Traders may not be
made.\6\
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    \6\ See, for example, Supplementary Material .01 to Rule 506
(specialist may not apply for a new allocation for a period of six
months after an option allocation was taken away from the specialist
in a disciplinary proceeding or an involuntary reallocation
proceeding). See also Commentaries .01 to .05 to Rule 507 setting
forth procedures regarding the Maximum Number of Quoters (``MNQ'')
allowed in equity options.
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    Rule 1014 is the principal rule that deals with the obligations and
restrictions that are applicable to specialists and Registered Option
Traders. Rule 1014 states that, in addition to other requirements, on a
daily basis RSQTs and Other Streaming Quote Traders are responsible to
quote two-sided markets in not less than a specified percentage of
options assigned by the Exchange at the request of such traders,\7\
unless specifically exempted from such quoting (market-making)
responsibility.
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    \7\ Regarding RSQT and Other Streaming Quote Trader quoting
obligations, see Rule 1014(b)(ii)(D)(1). Regarding specialist
quoting obligations, see Rule 1014(b)(ii)(D)(2). See also Rule 1014
generally.
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Remote Streaming Quote Trader Organizations and Affiliated Remote
Streaming Quote Traders
    Rule 507 discusses the process of applying for approval as an RSQT
or SQT on the Exchange and assignment of options to them. Under Rule
507, RSQTs are actually Exchange member organizations while SQTs are
Exchange members; therefore, options are assigned to RSQTs as firms
(member organizations) and to SQTs as individual members (permit
holders). The criteria for successfully applying to be an RSQT or an
SQT is currently, with two exceptions, the same for both types of
streaming quoters: (1) Significant market-making and/or specialist
experience in a broad array of securities; (2) superior resources,
including capital, technology and personnel; (3) demonstrated history
of stability, superior electronic capacity, and superior operational
capacity; (4) proven ability to interact with order flow in all types
of markets; and (5) willingness and ability to make competitive markets
on the Exchange and otherwise to promote the Exchange in a manner that
is likely to enhance the ability of the Exchange to compete
successfully for order flow in the options it trades (together the
``readiness requirements'').\8\ Only RSQTs need to demonstrate two
additional criteria for successful approval as remote streaming
quoters: (1) Existence of order flow commitments; and (2) willingness
to accept allocations as an RSQT in options overlying 400 or more
securities.\9\ The Exchange continues to believe that the existence of
order floor commitments and the willingness to accept options
allocations overlying hundreds of securities are criteria that belong
at the firm level. As such, the Exchange proposes that all of the
current RSQT application criteria will become the application criteria
for RSQTOs (the ``RSQTO readiness requirements''), and all of the
current SQT application criteria will become application criteria for
both RSQTs and SQTs.\10\
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    \8\ See Rule 507(a)(i)(A) through (D) and (G) and Rule
507(a)(ii).
    \9\ See Rule 507(a)(i)(E) and (F). See also 1014(b)(ii)(B),
which indicates that an RSQT is an ROT that is a member with no
physical trading floor presence who has received permission from the
Exchange to generate and submit option quotations electronically.
    \10\ See proposed Rule 507(a)(ii). RSQTs will, in addition, have
to demonstrate that they have an ongoing affiliation with an
Exchange-approved RSQTO. Rule 507(a)(ii)(F).

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The Proposal
    Proposed Rule 507 adds the concept of RSQTOs, which does not
currently exist in Exchange rules. Any member organization of the
Exchange in good standing that satisfies the RSQTO readiness
requirements will be approved as an RSQTO.\11\ No limit is placed on
the number of member organizations that may become RSQTOs. Moreover, as
many as three RSQT applicants affiliated with an RSQTO may be approved
as an RSQT, to the extent that each such RSQT applicant is qualified as
an ROT in good standing, and satisfies the five readiness requirements
that are set out in Rule 507. The Exchange would continue to assign
options to RSQTs, but these RSQTs would no longer be corporate entities
but would be as many as three individual members per each Exchange-
approved RSQTO. Rule 507 would continue to indicate that there is no
limit on the number of qualifying ROTs that may be approved as RSQTs,
as long as the applicants are qualified as ROTs in good standing and
satisfy the readiness requirements.\12\
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    \11\ RSQTOs may also be referred to as Remote Market Maker
Organizations (``RMOs'') and RSQTs may also be referred to as Remote
Market Markers (``RMMs''). Proposed Rule 507(a).
    \12\ Rule 507 provides, however, that based on system
constraints, capacity restrictions or other factors relevant to the
maintenance of a fair and orderly market, the Board may defer, for a
period to be determined in the Board's discretion, approval of
qualifying applications for SQT or RSQT status pending any action
required to address the issue of concern to the Board; where the
basis for such deferral has been objectively determined by the
Board, subject to Commission approval or effectiveness pursuant to a
rule change filing under Section 19(b) of the Act.
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    The process for applying for RSQTO and applying for and assigning
options to RQSTs and SQTs is set out in Rule 507. The Exchange proposes
in subsection (b)(i) that each RSQTO application is submitted to the
Exchange's designated staff in writing (electronically or otherwise as
specified by the Exchange) in a form and/or format prescribed by the
Exchange and shall include, at a minimum: (1) The name of the RSQTO
applicant, (2) the appropriate Exchange account number, and (3) the
name of each RSQT associated with the RSQTO applicant. The Exchange
proposes to also add that each RSQT application, in addition to other
currently-requested minimum information,\13\ state the name of the
RSQTO with whom the RSQT is affiliated. If the Exchange does not have
applications from SQTs or RSQTs for assignment in a particular option
or options that it desires to assign or reassign, the Exchange may
request such applications.\14\
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    \13\ Other minimum information required of RSQT and SQT
applicants includes: (1) The name of the SQT or RSQT applicant, (2)
the appropriate Exchange account number, and (3) the requested start
date for each option applied for. Rule 507(b)(i).
    \14\ The Exchange is deleting obsolete language from 507(b)(i)
that it request (solicit) applications for all assignments, as such
language is no longer necessary or desirable in light of the updated
application process.
---------------------------------------------------------------------------

    The Exchange also clarifies in subsection (b)(ii) of Rule 507 that
the technological readiness and testing requirements are applicable to
RSQTO applicants just as they are applicable to RSQTs and SQTs. Thus,
no application for being RSQTO or assignment in an option will be
approved without verification that: (1) The RSQTO, SQT or RSQT
applicant has sufficient technological ability to support his/her
continuous quoting requirements as set forth in Rule 1014(b)(ii), and
(2) the RSQTO, SQT or RSQT applicant has successfully completed, or is
scheduled to complete, testing of its quoting system with the Exchange.
    The Exchange also proposes in subsection (a) of Rule 507 a
procedure to facilitate the process of RSQTs (currently, member
organizations) to convert to an RSQTO structure with associated RSQTs.
Upon approval of the proposal establishing RSQTOs and Exchange
notification via OTA of such approval, each member organization
operating as an RSQT pursuant this rule will automatically be deemed an
RSQTO. After this designation the RSQTO will have twenty one (21) days
to notify the Exchange of no more than three RSQTs to be affiliated
with the RSQTO (the ``Conversion Period''), each of whom is an ROT in
good standing and satisfies the technological readiness and testing
requirements described in sub-paragraph (b)(ii) of Rule 507.
    After the Conversion Period, per proposed subsection (a) of Rule
507 a member organization that is not currently qualified as an RSQTO
may apply to the Exchange to be an RSQTO with up to three affiliated
RSQTs. Each RSQTO application shall be submitted to the Exchange's
designated staff in writing (electronically or otherwise as specified
by the Exchange) in a form and/or format prescribed by the Exchange and
shall include, at a minimum, the name of the RSQTO applicant, the
appropriate Exchange account number, and the name of each RSQT
affiliated with the RSQTO applicant (the ``Application Process''). The
purpose for the sequential Conversion Period followed by the
Application Process is to use the Exchange's current administrative
process to ensure an accurate conversion from the existing RSQT
methodology to the proposed RSQTO concept with three associated
RSQTs.\15\
---------------------------------------------------------------------------

    \15\ There are currently 28 member organizations that will be
converted to RSQTOs pursuant to this proposal.
---------------------------------------------------------------------------

    Subsection (d) of Rule 507 indicates that once an RSQTO, SQT or
RSQT is approved for initial assignment in an option, he may not
withdraw from such option assignment for ten (10) or fewer business
days after the effective date of assignment. However, the Exchange may,
in exceptional circumstances, approve withdrawal from an option
assignment in ten (10) or fewer business days. If an RSQTO, SQT or RSQT
seeks to withdraw from assignment in an option, it should so notify the
Exchange at least one business day prior to the desired effective date
of such withdrawal.
    Finally, market makers may appeal if they believe that the
Exchange's determination in respect of Rule 507 was improper.\16\ The
current appeal rights provided in subsection (e) of Rule 507 are not
changed. Thus, an appeal to the Exchange's Board of Directors
(``Board'') from a decision of the Exchange may be requested by a
member or member organization interested therein by filing with the
Secretary of the Exchange written notice of appeal within ten (10) days
after the decision has been rendered. Any appeal from a decision
pursuant to Rule 507 shall be heard by a special committee of the Board
composed of three (3) Directors, of whom at least one (1) shall be an
Independent Director.\17\
---------------------------------------------------------------------------

    \16\ Decision concerning applications for assignment in options
shall be in writing and shall be distributed to all applicants.
Proposed Rule 507(c).
    \17\ Rule 507(e) states also that the person requesting review
shall be permitted to submit a written statement to and/or appear
before this special committee. The Secretary of the Exchange shall
certify the record of the proceeding, if any and the written
decision and shall submit these documents to the special committee.
The special committee's review of the action shall be based solely
on the record, the written decision and any statement submitted by
the person requesting the review. The special committee shall
prepare and deliver to such person a written decision and reasons
therefore. If the special committee affirms the action, the action
shall become effective ten (10) days from the date of the special
committee's decision. There shall be no appeal to the Board of
Directors from any decision of the special committee.
---------------------------------------------------------------------------

Restrictions Applicable to Remote Streaming Quote Traders and Remote
Streaming Quote Trader Organizations
    Rule 1014 describes, among other things, certain electronic quoting
obligations via the Exchange's electronic

quoting and trading system,\18\ as well as restrictions, pertaining to
the current market makers on the Exchange. One of these restrictions in
Rule 1014 indicates that no person who is either directly or indirectly
affiliated with an RSQT (``affiliated RSQT'') is allowed to submit
quotations as a specialist, SQT, RSQT or non-SQT ROT in options in
which such affiliated RSQT is assigned.\19\ In light of customer
requests, the establishment of RSQTOs and inherent RSQT affiliation(s),
and established quoting procedures, the Exchange proposes to clarify
the quoting restriction applicable to RSQTs.
---------------------------------------------------------------------------

    \18\ The Exchange's electronic quoting and trading system, which
has been denoted in Exchange rules as XL II, XL and AUTOM, has been
updated with recent enhancements and configurations. See Exchange
Act Release No. 59995 (May 28, 2009), 74 FR 26750 (June 3, 2009)
(SR-Phlx-2009-32) (approval order regarding current electronic
quoting and trading system known as XL II).
    \19\ See Rule 1014(b)(ii)(B).
---------------------------------------------------------------------------

    In particular, the Exchange proposes to amend subsection (b)(ii)(B)
of Rule 1014 to remove the provision that states that no person who is
either directly or indirectly affiliated with an RSQT shall submit
quotations as a specialist, SQT, RSQT or non-SQT ROT in options in
which such affiliated RSQT is assigned. This allows more than one RSQT
to submit a quote in an assigned option, to the extent that each RSQT
applies for and is approved as an RSQT affiliated with an RSQTO
pursuant to Rule 507. The Exchange notes that this proposal does not
otherwise affect the quoting responsibilities of RSQTs or other aspects
of Rule 1014.\20\ The Exchange also proposes to clarify subsection
(b)(ii)(A) of Rule 1014 to state that an SQT may only trade in a market
making capacity in classes of options in which the SQT is assigned.\21\
---------------------------------------------------------------------------

    \20\ The proposed rule change will not, for example, impact the
allocation received by a Directed RSQT or Directed SQT pursuant to
rule 1014(viii)(B)(2). Thus, if an order is directed to a member
organization that has more than one affiliated SQT or RSQT assigned
in an option, only one SQT or RSQT may receive an allocation as
Directed RSQT or Directed SQT, and the remaining non-Directed market
makers will simply receive the standard RSQT or SQT allocation. Each
RSQT and SQT would need to maintain Directed SQT and Directed RSQT
quoting requirements because it is possible that they could receive
a Directed Order, albeit only one market maker could be Directed per
order.
    \21\ The language regarding when an SQT may trade in a market
making capacity is exactly the same as what is currently applicable
to RSQTs. See Rule 1014(b)(ii)(B).
---------------------------------------------------------------------------

    The Exchange represents that it has an adequate surveillance
program in place for options that are quoted and traded on the Exchange
and intends to continue application of those program procedures as
necessary.\22\ The Exchange also represents that it has the systems
capacity to continue to support quoting and trading options subsequent
to the effectiveness of this proposal.
---------------------------------------------------------------------------

    \22\ Additionally, the Exchange is a member of the Intermarket
Surveillance Group (``ISG'') under the Intermarket Surveillance
Group Agreement, dated June 20, 1994. ISG members generally work
together to coordinate surveillance and investigative information
sharing in the stock and options markets. Moreover, the major
futures exchanges are affiliated members of the ISG, which allows
for the sharing of surveillance information for potential
intermarket trading abuses.
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change establishing
RSQTOs and affiliated RSQTs and enabling the submission of more than
one quotation in the same option class should encourage competition,
create additional trading opportunities and outlets and increase the
depth of markets, and promote a more robust system with specific
standards for member organizations that are RSQTOs, electronic market
makers that are affiliated with RSQTOs as RSQTs, and floor-based SQTs.
This should lead to tighter, more efficient markets to the benefit of
market participants including public investors that engage in trading
and hedging on the Exchange.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \23\ in general, and furthers the objectives of Section
6(b)(5) of the Act \24\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by enabling approval of RSQTOs with whom as many as three
RSQTs may be affiliated, and enabling multiple quotes in the same
option.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that its rule change proposal does not
engender unfair discrimination among specialists, specialist units,
SQTs and RSQTs in that it proposes to amend rules and procedures that
are equally applicable to all members and member organizations at the
Exchange. Moreover, the Exchange believes that the proposal will
promote a more robust system with specific standards for member
organizations that are RSQTOs, electronic market makers that are
affiliated with RSQTOs as RSQTs, and floor-based SQTs. By engendering
more competition among market makers, the proposal may also lead to
tighter, more efficient markets to the benefit of market participants
including public investors that engage in trading and hedging on the
Exchange.

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 not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the proposal
further promotes competition on the Exchange which should lead to
tighter, more efficient markets to the benefit of market participants
including public investors that engage in trading and hedging on the
Exchange, and thereby make the Exchange a desirable market vis a vis
other options exchanges.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change 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-Phlx-2013-03 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-Phlx-2013-03. 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2013-03 and should be
submitted on or before February 15, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01483 Filed 1-24-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Notices]
[Page 14086]
[FR Doc No: 2022-05164]

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

Federal Aviation Administration

[FAA Docket Number: FAA-2022-0334]

NextGen Advisory Committee; Notice of Public Meeting

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a meeting of the NextGen Advisory
Committee (NAC).

DATES: The meeting will be held virtually, on March 28, 2022, from 1:00
p.m.-4:00 p.m. ET. Requests to attend the meeting virtually and request
for accommodations for a disability must be received by March 17, 2022.
If you wish to make a public statement during the meeting, you must
submit a written copy of your remarks by March 17, 2022. Written
materials requested to be reviewed by NAC Members before the meeting
must be received no later than March 17, 2022.

ADDRESSES: This will be a virtual meeting. Virtual meeting information
will be provided upon registration. Information on the NAC, including
copies of previous meeting minutes, is available on the NAC internet
website at https://www.faa.gov/about/office_org/headquarters_offices/ang/nac/. Members of the public interested in attending must send the
required information listed in the SUPPLEMENTARY INFORMATION section to
[email protected].

FOR FURTHER INFORMATION CONTACT: Kimberly Noonan, NAC Coordinator, U.S.
Department of Transportation, at [email protected] or 202-267-
3760. Any requests or questions not regarding attendance registration
should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The Secretary of Transportation established the NAC under agency
authority in accordance with the provisions of the Federal Advisory
Committee Act (FACA), as amended, Public Law 92-463, 5 U.S.C. app. 2,
to provide independent advice and recommendations to the FAA, and to
respond to specific taskings received directly from the FAA. The NAC
recommends consensus-driven advice for FAA consideration relating to
Air Traffic Management System modernization.

II. Agenda

    At the meeting, the agenda will cover the following topics:
     NAC Chairman's Report
     FAA Report
     NAC Subcommittee Chairman's Report
    [cir] Risk and Mitigations update for the following focus areas:
Multiple Runway Operations, Data Communications, Performance Based
Navigation, Surface and Data Sharing, and Northeast Corridor
     NAC Chairman Closing Comments
    The detailed agenda will be posted on the NAC internet website at
least one week in advance of the meeting.

III. Public Participation

    This virtual meeting will be open to the public. Members of the
public who wish to attend are asked to register via email by submitting
their full legal name, country of citizenship, contact information
(telephone number and email address), and name of your industry
association, or applicable affiliation. Please email this information
to the email address listed in the ADDRESSES section. When registration
is confirmed, registrants will be provided the virtual meeting
information/teleconference call-in number and passcode. Callers are
responsible for paying associated long-distance charges (if any).
    Note: Only NAC Members, members of the public who have registered
to make a public statement, and NAC working groups and FAA staff who
are providing briefings will have the ability to actively participate.
All other attendees will be able to listen only.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section.
    Five minutes will be allotted for oral comments from members of the
public joining the meeting. This time may be extended if there is a
significant number of members of the public wishing to provide an oral
comment. To accommodate as many speakers as possible, the time for each
commenter may be limited. Individuals wishing to reserve speaking time
during the meeting must submit a request at the time of registration,
as well as the name, address, and organizational affiliation of the
proposed speaker. If the number of registrants requesting to make
statements is greater than can be reasonably accommodated during the
meeting, FAA may conduct a lottery to determine the speakers. Speakers
are required to submit a copy of their prepared remarks for inclusion
in the meeting records and for circulation to NAC members to the person
listed under the heading FOR FURTHER INFORMATION CONTACT. All prepared
remarks submitted on time will be accepted and considered as part of
the meeting's record.
    Members of the public may submit written statements for inclusion
in the meeting records and circulation to the NAC members. Written
statements need to be submitted to the person listed under the heading
FOR FURTHER INFORMATION CONTACT. Comments received after the due date
listed in the DATES section will be distributed to the members but may
not be reviewed prior to the meeting. Any member of the public may
present a written statement to the committee at any time.

    Signed in Washington, DC, this 8th day of March 2022.
Kimberly Noonan,
Manager, Stakeholder and Collaboration Division (A), NextGen Office of
Collaboration and Messaging, ANG-M, Office of the Assistant
Administrator for NextGen, Federal Aviation Administration.
[FR Doc. 2022-05164 Filed 3-10-22; 8:45 am]
BILLING CODE 4910-13-P


October 6, 2008

MEMORANDUM

SUBJECT:	Draft Final Report from the Human Studies Review Board on the
June 2008 Meeting

TO:		Paul I. Lewis, Ph.D.

		Designated Federal Official

		Human Studies Review Board

		Office of Science Advisor (8105R)

FROM:	William L. Jordan

		Senior Policy Adviser

		Office of Pesticide Programs (7501P)

This memorandum offers comments from the Office of Pesticide Programs
(OPP) on the draft Final Report from the Human Studies Review Board
(HSRB or Board) on its June 24-25, 2008, meeting.  The draft report
covered two topics: (1) proposals from the Agricultural Handlers
Exposure Task Force (AHETF) for two pesticide applicator exposure
monitoring studies under the closed-cab airblast scenario and (2) the
completed Insect Control and Research (ICR) mosquito repellent efficacy
study A117.

OPP has no comments on the Board’s advice concerning ICR study A117.

OPP offers the following observations with respect to the Board’s
advice concerning the research proposals submitted by the AHETF for
measuring handler exposure while applying liquid pesticide sprays using
conventional airblast equipment drawn by closed-cab vehicles.  Our
comments focus particularly on the HSRB’s recommendations to change
the sampling strategy and expand the sample size to produce more
scientifically useful data.  Unlike OPP’s previous reviews of draft
HSRB reports, these comments do not contain specific editorial
suggestions; rather our concern is with clarifying the overall thrust of
the Board’s recommendations about the AHETF proposals.

The design of the AHETF’s sampling strategy has drawn comments in
previous HSRB meetings in June 2006, April 2007, and June 2007.
Generally the Board has recommended that the exposure research employ a
probability-based sampling strategy so that the results would be
statistically representative of the population exposures that EPA will
be assessing when EPA performs risk assessments using these data.  The
Board has repeatedly stressed the limitations of any data collected on
research participants selected by a purposive sampling strategy, such as
that proposed by the AHETF.  In its draft Final Report the Board
continues to recommend that the AHETF change its sampling strategy and
expand the sample size.

The concerns raised by the HSRB in the earlier meetings cited above led
OPP to reconsider its position on what sampling methodologies to accept.
 As we explained in our presentations at the June meeting, we spent
nearly two years in discussions with the AHETF and with internal and
external experts before reaching a decision on this issue.  We carefully
weighed the factors relevant to assessing alternative sampling designs
– the feasibility and cost of different sampling methods; the
scientific value of the resulting data sets; and our intended use of the
datasets.  Fully appreciating the Board’s position on the importance
of obtaining statistically representative data, OPP has nonetheless
decided to accept data from the AHETF’s proposed purposive sampling
design.  In our professional judgment the data generated by the AHETF
research will provide scientifically reliable measurements of individual
participants’ exposures and, when used together with other information
on potential exposure available to the Agency, will support estimates of
high-end handler exposures.

Dr. Debra Edwards, Director of OPP, announced and explained this
decision to the Board at the June meeting.  She told the Board that we
regard the AHETF’s proposed research – including its proposal to use
a purposive sampling strategy – to be scientifically sound.  She
acknowledged plainly the limitations on use of the resulting data; she
also noted that the new data would represent a great improvement over
existing data, both qualitatively and quantitatively, and would be
adequate for our regulatory purposes.  She told the Board that she
believes getting the new data is important to improve our assessments of
handler exposure to pesticides.  OPP has been and remains eager for the
AHETF to perform this research.

We were not surprised when, at the June meeting, the HSRB again
commented critically on the AHETF sampling strategy.  We listened
closely to the Board’s discussions of the AHETF proposals, and our
overall impression was that, although the Board would prefer a research
program of a different kind, the HSRB understood and accepted OPP’s
decision.  The minutes of the June meeting, certified by Dr. Fisher,
reinforce this impression:

[Dr. Fenske] stated that the research is likely to generate
scientifically sound data that will be useful for EPA risk assessment
activities.  He commended the Agency’s evaluation and presentation of
the materials and the Task Force for addressing most of EPA’s concerns
in its June 13, 2008 letter.

[p. 33]

 Dr. Johnson agreed that the data would be scientifically reliable and
will be useful for assessing exposure.  He agreed with Dr. Edwards that
EPA needs this data for its risk assessment activities because existing
data are inadequate.

[p. 35]

Overall, the Board was impressed by the design of the research. The
Board questions the usefulness of the data and cautions EPA against use
of the data for other than the intended purpose. It is difficult to
conclude that the data will be “reliable” because of the lack of
replicate measures; however, the protocol will collect sound qualitative
data that will be useful to EPA.

[From Dr. Fisher’s summary of the Board discussion, p. 37]

In sum, what we heard from the Board during the June 2008 meeting did
not seem to challenge our decision, and did not lead us to change our
views.  In early July, we advised the AHETF to proceed with their
research after making certain revisions to their protocols; they have
done so.

In view of this history, we were surprised and confused by the
discussion of the AHETF sampling strategy in the HSRB’s draft Final
Report.  In its summary introduction the draft states:

If the approach presented in these protocols were adopted, then the
sample size would need to be increased.

(p. 1)

and

In conclusion, if the AHETF materials are revised in accordance with the
Agency’s suggestions and the Board’s recommendations, including
implementation of the Board’s recommended alternative design, several
limitations with the proposed research will be alleviated and the
research is more likely to generate scientifically reliable data, useful
for assessing the exposure of handlers who apply liquid pesticides using
airblast equipment drawn by vehicles with closed cabs.

(p. 2, emphasis added)

The draft Final Report presented detailed recommendations for what would
amount to a major change in the design of the sampling strategy (pp.
12-13), and then added:

Finally the Board urged the Agency to seriously consider the alternative
design presented earlier in this report before making a final decision
on study design. (p. 15)

The sense of the draft final report and the minutes of the meeting are
different.  While the minutes mention ways to improve the AHETF study
design, the minutes do not indicate that such changes were a
prerequisite to generating scientifically valid results.  In fact, the
generally favorable summary statements quoted from the minutes of the
meeting were not conditioned on a substantial change to the proposed
design of the research, and the Board did not discuss such a condition
in June.  In contrast, the draft Final Report seems to indicate that the
Board would not consider data generated by the proposed AHTETF protocols
to be scientifically useful unless the design had changed
significantly..

If the Board is only advising EPA to encourage the handler exposure task
forces to consider sampling strategies that would generate statistically
representative data, we do not disagree that data developed using a
different method could have broader scientific utility than data derived
using different sampling methods.  But, as Dr. Edwards explained, the
issue for EPA and the HSRB is not whether the research could be better;
the issue is whether the research, as proposed, is likely to generate
valid data useful for OPP’s regulatory purposes.  We think that the
AHETF proposals meet that standard, and we believe the Board agrees.  We
hope the Board will clarify its views.


[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Rules and Regulations]
[Pages 57147-57148]
[FR Doc No: 2022-20176]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2022-0360]

Drawbridge Operation Regulation; Back Bay of Biloxi, Biloxi, MS

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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

SUMMARY: The Coast Guard has issued a temporary deviation from how the
CSX Transportation railroad drawbridge across the Back Bay of Biloxi,
mile 0.4, Biloxi, MS will be operated. The bridge will continue to open
according to the drawbridge regulations but the bridge tender will
operate this bridge from a remote location at the CSX railroad terminal
in Mobile, Alabama. The Coast Guard is seeking comments from the public
regarding these proposed changes.

DATES: This deviation is effective from 7 a.m. September 19, 2022 until
March 20, 2023.
    Comments and relate material must reach the Coast Guard on or
before November 18, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0360 using Federal Decision

Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION: See section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this test
deviation, call or email Douglas Blakemore, Eighth Coast Guard District
Bridge Administration Branch Chief at<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background, Purpose and Legal Basis

    The CSX Transportation railroad drawbridge crosses the Back Bay of
Biloxi, mile 0.4, Biloxi, MS. The bridge will continue to open
according to the drawbridge regulations but the bridge tender will
operate this bridge from a remote location at the CSX railroad terminal
in Mobile, Alabama. This bridge has a 14-foot vertical clearance at
mean high water, an unlimited vertical clearance when in the open to
vessel position and a 132-foot horizontal clearance. The bridge
operates according to 33 CFR 117.5.
    CSX Transportation has requested to operate this bridge remotely
from their railroad terminal in Mobile, AL. CSX has installed a remote
operation system at the bridge and a remote control center, located in
Mobile, AL. At the bridge, CSX has installed infrared cameras, closed
circuit cameras and TVs, communication systems and information
technology systems on the bridge that allow an operator from Mobile to
monitor and control the bridge. This waterway is used primarily by
recreational boats and small towing vessels and opens to vessels
approximately 6 times per day.
    The Coast Guard will evaluate the impact of this test on vessels by
analyzing CSX bridge tender logs and public comments.
    The Coast Guard will also inform the users of the waterways through
our Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the test deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

II. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0360 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions.
    View material in the docket. To view documents mentioned in this
deviation as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of this deviation. We may choose
not to post off-topic, inappropriate, or duplicate comments that we
receive. Additionally, if you go to the online docket and sign up for
email alerts, you will be notified when comments are posted or a final
rule is published of any posting or updates to the docket.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).

    Dated: September 13, 2022.
Douglas Blakemore,
Chief, Bridge Administration Branch, U.S. Coast Guard, Eighth Coast
Guard District.
[FR Doc. 2022-20176 Filed 9-16-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89458-89460]
[FR Doc No: 2023-28507]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0926]

Determination of Regulatory Review Period for Purposes of Patent
Extension; CYTALUX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for CYTALUX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 26, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 24, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-

2022-E-0926 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; CYTALUX.'' Received comments, those filed
in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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 Sec.  10.20 (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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, CYTALUX
(pafolacianine), which is indicated in adult patients with ovarian
cancer as an adjunct for intraoperative identification of malignant
lesions. Subsequent to this approval, the USPTO received a patent term
restoration application for CYTALUX (U.S. Patent No. 9,061,057) from
Purdue Research Foundation, and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated September 21, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of CYTALUX represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
CYTALUX is 2,610 days. Of this time, 2,274 days occurred during the
testing phase of the regulatory review period, while 336 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 9, 2014. The applicant claims September 5, 2014, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was October
9, 2014, which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 29,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for CYTALUX (NDA 214907) was initially submitted on
December 29, 2020.
    3. The date the application was approved: November 29, 2021. FDA
has verified the applicant's claim that NDA 214907 was approved on
November 29, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 825 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th

Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28507 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on November 3, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-16300

________________________________________________________________________
________________________________________________________

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).

Applicant:  Lloyd Aereo Boliviano S.A. (LAB)				Date Filed:  October 8,
2003

Relief requested: exemption from 49 U.S.C. § 41301 to engage in
scheduled foreign air transportation of persons, property and mail
between points in Bolivia, on the one hand, and Washington, D.C.
(Dulles), on the other hand, and to serve Washington, D.C. (Dulles) as a
coterminal point on its exiting services to Miami, Florida.

Date and citation of last action:  New authority

Applicant representative:  Charles F. Donley II<PHONE_NUMBER>

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  The Washington Airports Task Force and
Metropolitan Washington Airports Authority filed answers in support of
LAB’s request.

	DISPOSITION

Action:  Approved								Action date:  November 3, 2003

Effective dates of authority granted:  November 3, 2003-November 3, 2004

Basis for approval (bilateral agreement/reciprocity):  Reciprocity with
Bolivia

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

X Standard exemption conditions (attached) & LAB’s foreign air carrier
permit (Order 79-2-68)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) 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/deferred/dismissed, 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

			Attachment

Foreign Carrier Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI 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;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

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

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

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

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

08/2003