[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Rules and Regulations]
[Pages 24654-24656]
[FR Doc No: 2018-11659]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0492; Product Identifier 2018-NM-083-AD; Amendment
39-19303; AD 2018-11-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A320-271N airplanes, and Model A321-271N, -271NX, -272N
and -272NX airplanes. This AD requires replacing certain full authority
digital engine control (FADEC) electronic engine controllers (EECs); or
installing software standard FCS4.4 and re-identifying the FADEC EECs.
This AD was prompted by a report that, when operated at low speed and
high engine thrust, an engine did not restart following a fuel
interruption shorter than five seconds. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD becomes effective May 30, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 30,
2018.
    We must receive comments on this AD by July 16, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email [email protected]; internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0492.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0492; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0110, dated May 18, 2018 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for all Airbus Model A320-271N airplanes, and Model
A321-271N, -271NX, -272N, and -272NX airplanes. The MCAI states:

    During certification test flights of an A320-271N aeroplane, it
has been identified that, when operated at low speed and high engine
thrust, the tested engine did not re-start in case of a fuel
interruption shorter than 5 seconds. Investigation revealed that
this was due to the software logic implemented in the FADEC EEC of
affected A320 family models.
    This condition, if not corrected, could prevent restart of a
shut down engine while operating in high power conditions [after a
single or dual in-flight engine shutdown].
    To address this potentially unsafe condition, software (SW)
standard FCS4.4 for the FADEC EEC has been developed, and Airbus
published the SB [Airbus Service Bulletin A320-73-1128, Revision 01,
dated May 17, 2018] providing modification instructions.
    For the reasons described above, this [EASA] AD requires
modification of aeroplanes by [replacing the affected FADEC EECs or
by] installation of this FADEC EEC SW [software] standard [and re-
identification of the affected FADEC EECs].

    You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0492.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A320-73-1128, Revision 01, dated
May 17, 2018. This service information describes procedures for
replacing affected FADEC EECs and for installing software standard
FCS4.4 and re-identifying affected FADEC EECs. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another

country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because a
FADEC EEC software defect might prevent restart of an engine after a
single or dual in-flight engine shutdown under certain conditions.
Therefore, we determined that notice and opportunity for public comment
before issuing this AD are impracticable and that good cause exists for
making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2018-0492; Product
Identifier 2018-NM-083-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 16 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
            Labor cost                Parts cost      Cost per product            Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 7 work-hours x $85 per hour             (1)   Up to $595..........  Up to $9,520.
 = Up to $595.
----------------------------------------------------------------------------------------------------------------
1 We have received no definitive data that would enable us to provide cost estimates for parts needed to comply
  with the actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-11-15 Airbus: Amendment 39-19303; Docket No. FAA-2018-0492;
Product Identifier 2018-NM-083-AD.

(a) Effective Date

    This AD becomes effective May 30, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD, certificated in any category, all
manufacturer serial numbers (MSN).
    (1) Model A320-271N airplanes.
    (2) Model A321-271N, -271NX, -272N and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 72, Turbine/
turboprop engine.

(e) Reason

    This AD was prompted by a report that, when operated at low
speed and high engine thrust, an engine did not restart following a
fuel interruption shorter than five seconds. We are issuing this AD
to address engines that might not restart while operating in high

power conditions after a single or dual in-flight engine shutdown.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definitions

    (1) For the purposes of this AD, an affected full authority
digital engine control (FADEC) electronic engine controller (EEC) is
one with a part number listed in table 1 to paragraph (g)(1) of this
AD.

 Table 1 to Paragraph (g)(1) of This AD--Affected FADEC EEC Part Numbers
------------------------------------------------------------------------
                       Affected FADEC EEC part No.
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5315126
5315126SK02
5323434
5323745
5323746
5324836
5324836-001
5324836-002
5324837
5325185
5325971
5325975
------------------------------------------------------------------------

    (2) For the purposes of this AD, Group 1 airplanes are defined
as those that have an affected FADEC EEC installed.
    (3) For the purposes of this AD, Group 2 airplanes are defined
as those that do not have an affected FADEC EEC installed.

(h) Modification

    For Group 1 airplanes: Within 30 days after the effective date
of this AD, modify the airplane by replacing affected FADEC EECs
installed on both engines with FADEC EEC part number 5327582
(software standard FCS4.4), or by installing software standard
FCS4.4 and re-identifying the affected FADEC EEC, in accordance with
the Accomplishment Instructions of Airbus Service Bulletin A320-73-
1128, Revision 01, dated May 17, 2018.

(i) Parts Installation Limitation

    As of 30 days after the effective date of this AD, do not
install an affected FADEC EEC on any airplane.

(j) Later-Approved Parts

    Installation on an airplane of a FADEC EEC or software standard
having a part number approved after the effective date of this AD is
acceptable for compliance with the requirements of paragraph (h) of
this AD, provided the conditions in paragraphs (j)(1) and (j)(2) of
this AD are met.
    (1) The FADEC EEC or software standard part number must be
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or
Airbus's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (2) The installation of the FADEC EEC or software standard must
be accomplished in accordance with a method approved by the Manager,
International Section, Transport Standards Branch, FAA; or EASA; or
Airbus's EASA DOA. If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Clarification of Affected Airplanes

    An airplane on which Airbus modification 163473 has been
embodied in production is not affected by the requirements of
paragraph (h) of this AD, provided it can be conclusively determined
that no affected FADEC EEC is installed on that airplane.

(l) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Airbus Service Bulletin A320-73-
1128, dated May 15, 2018.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (n)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2018-0110, dated May 18, 2018,
for related information. You may examine the MCAI on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2018-0492.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (o)(4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A320-73-1128, Revision 01, dated May
17, 2018.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email [email protected]; internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on May 23, 2018.
James Cashdollar,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-11659 Filed 5-29-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Page 42745]
[FR Doc No: 2010-17902]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1725-000]

Hardscrabble Wind Power LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

July 9, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Hardscrabble Wind Power LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 29, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-17902 Filed 7-21-10; 8:45 am]
BILLING CODE 6717-01-P


 [Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)] [Notices] [Page 25732] [FR Doc No: C1-2011-9971]

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64312; File No. SR-NASDAQ-2011-053]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;  Notice of Filing and Immediate Effectiveness of Proposed Rule Change To  Adopt an Order Price Protection Feature

Correction

    In notice document 2011-9971 appearing on pages 23351-23352 in the  issue of Tuesday, April 26, 2011, make the following correction:     On page 23352, in the second column, in the last line ``May 16,  2011'' should read ``May 17, 2011''.

[FR Doc. C1-2011-9971 Filed 5-4-11; 8:45 am] BILLING CODE 1505-01-D


[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Page 34527]
[FR Doc No: 2014-14118]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9912-28-Region-6]

Clean Water Act Section 303(d): Withdrawal of One Total Maximum
Daily Load

AGENCY: U.S. Environmental Protection Agency.

ACTION: Notice of Withdrawal of One Total Maximum Daily Load.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) hereby issues
notice of the withdrawal of one Total Maximum Daily Load (TMDL) for
lead, as found in the document titled ``TMDLs for Lead and Siltation/
Turbidity for Big Creek near Sheridan, Arkansas.'' The TMDL was
established by the EPA in March of 2008. This withdrawal action will
not affect the TMDLs for Siltation/Turbidity established in the same
TMDL document.
    The lead TMDL is being withdrawn in this unique circumstance based
on uncertainty in the representativeness of the data associated with
the original listing for lead in Big Creek near Sheridan (reach
08040203-904) and, therefore, the questionable need for the TMDL.

SUPPLEMENTARY INFORMATION: The TMDLs were developed under EPA Contract
Number 68-C-02-108. The Federal Register (FR) notice of availability,
seeking public comments on the draft TMDLs, was published on December
17, 2007 (72 FR 71409). Public comments were received by January 16,
2008, and a response to each comment was provided. The FR notice of
availability for the final TMDLs was published on August 14, 2008 (see
73 FR 47596). The FR notice seeking public comments on the proposed
withdrawal for the lead TMDL for reach 08040203-904 was published on
April 21, 2014. The comment period ended on May 21, 2014, and the EPA
did not receive any adverse comments relating to the proposed
withdrawal action.

FOR FURTHER INFORMATION CONTACT: Evelyn Rosborough, Water Quality
Protection Division, U.S. EPA Region 6, 1445 Ross Avenue, Dallas, TX
75202-2733,<PHONE_NUMBER>.

    Dated: June 5, 2014.
William K. Honker,
Director, Water Quality Protection Division, EPA Region 6.
[FR Doc. 2014-14118 Filed 6-16-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68488-68490]
[FR Doc No: 2013-27240]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70832; File No. SR-NYSEMKT-2013-88]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of
Proposed Rule Change Amending Certain Rules That Address Wash Sales in
Order To Harmonize the Exchange's Rules With the Rules of New York
Stock Exchange LLC and the Financial Industry Regulatory Authority

November 7, 2013.
    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 October 29, 2013, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 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 proposes to amend certain rules that address wash
sales in order to harmonize the Exchange's rules with the rules of New
York Stock Exchange LLC (``NYSE'') and the Financial Industry
Regulatory Authority (``FINRA''). The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.com, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend certain rules that address wash
sales in order to harmonize the Exchange's rules with the rules of NYSE
and FINRA.
Background on Harmonization
    On July 30, 2007, FINRA's predecessor, the National Association of
Securities Dealers, Inc. (``NASD''), and NYSE Regulation, Inc.
(``NYSER'') consolidated their member firm regulation operations into a
combined organization, FINRA. Pursuant to Rule 17d-2 under the Act,
NYSE, NYSER, and FINRA entered into an agreement (the ``Agreement'') to
reduce regulatory duplication for their members by allocating to FINRA
certain regulatory responsibilities for certain NYSE rules and rule
interpretations (``FINRA Incorporated NYSE Rules''). The Exchange
became a party to the Agreement effective December 15, 2008.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release Nos. 56148 (July 26,
2007), 72 FR 42146 (August 1, 2007) (order approving the Agreement);
56147 (July 26, 2007), 72 FR 42166 (August 1, 2007) (SR-NASD-2007-
054) (order approving the incorporation of certain NYSE Rules as
``Common Rules''); and 60409 (July 30, 2009), 74 FR 39353 (August 6,
2009) (order approving the amended and restated Agreement, adding
NYSE MKT LLC as a party). Paragraph 2(b) of the Agreement sets forth
procedures regarding proposed changes by FINRA, NYSE, or NYSE MKT to
the substance of any of the Common Rules.
---------------------------------------------------------------------------

    As part of its effort to reduce regulatory duplication and relieve
firms that are members of FINRA and NYSE of conflicting or unnecessary
regulatory burdens, FINRA is now engaged in the process of reviewing
and amending the NASD and FINRA Incorporated NYSE Rules in order to
create a consolidated FINRA rulebook.\5\ In furtherance of this
harmonization process, NYSE recently deleted NYSE Rule 476(a)(8) and
amended NYSE Rule 6140, both of which address wash sales.\6\ To
facilitate further the rule harmonization among exchanges, the Exchange
proposes to make corresponding changes to its wash sale rules for
equities and options.\7\
---------------------------------------------------------------------------

    \5\ FINRA's rulebook currently has three sets of rules: (1) NASD
Rules, (2) FINRA Incorporated NYSE Rules, and (3) consolidated FINRA
Rules. The FINRA Incorporated NYSE Rules apply only to those members
of FINRA that are also members of the NYSE (``Dual Members''), while
the consolidated FINRA Rules apply to all FINRA members. For more
information about the FINRA rulebook consolidation process, see
FINRA Information Notice, March 12, 2008.
    \6\ See Securities Exchange Act Release No. 69751 (June 13,
2013), 78 FR 36611 (June 18, 2013) (SR-NYSE-2013-29).
    \7\ All references to rules herein are to NYSE MKT rules unless
otherwise noted.
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Background on Wash Sales Rules
    Since at least 1970, Rule 4 in Part 1 of the General Rules has
provided that no member or member organization shall execute or cause
to be executed, or participate in an account for which there is
executed on the Exchange, the purchase of any security at successively
higher prices or the sale of any security at successively lower prices
for the purpose of creating or inducing a false, misleading or
artificial appearance of activity in such security or for the purpose
of unduly or improperly influencing the market price of such security
or for the purpose of making a price which does not reflect the true
state of the market in such security. Rule 4 applies to both the
Exchange's equities and options markets.
    When the Exchange was acquired by NYSE Euronext, it adopted the
text of certain NYSE rules, including NYSE Rule 476. Exchange Rule
476(a)(8) currently prohibits a member, member organization, principal
executive, approved person, registered or non-registered employee of a
member or member organization, or person otherwise subject to the
jurisdiction of the Exchange from (i) making a fictitious bid, offer,
or transaction, (ii) giving an order for the purchase or sale of
securities the execution of which would involve no change of beneficial
ownership, or (iii) executing such an order with knowledge of its
character. Because Rule 476 generally governs disciplinary procedural
matters, Rule 476(a)(8) appears in Section 9A of the Office Rules, and
as such, by its terms applies to both the Exchange's equities and
options markets.
    In 2009, the Exchange adopted Rules 6140(a)--Equities and 6140(b)--
Equities,\8\ which are substantially the same as FINRA Rules 6140(a)
and (b) and NYSE Rules 6140(a) and (b), and also address wash sale
activity. Rule 6140(a)--Equities is substantially the same as Rule 4
and provides that no member or member organization may execute or cause
to be executed or participate in an account for which there are
executed purchases of any NMS stock as defined in Rule 600(b)(47) of
SEC Regulation NMS (``designated security'') \9\ at successively higher

prices, or sales of any such security at successively lower prices, for
the purpose of creating or inducing a false, misleading or artificial
appearance of activity in such security or for the purpose of unduly or
improperly influencing the market price for such security or for the
purpose of establishing a price that does not reflect the true state of
the market in such security. Rule 6140(b)--Equities prohibits a member
or member organization, for the purpose of creating or inducing a false
or misleading appearance of activity in a designated security or
creating or inducing a false or misleading appearance with respect to
the market in such security, from:
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 59975 (May 26,
2009), 74 FR 26449 (June 2, 2009) (SR-NYSEALTR-2009-26).
    \9\ Under Rule 600(b)(47), an NMS stock means any national
market system security other than an option.
---------------------------------------------------------------------------

    (1) Executing any transaction in such security which involves no
change in the beneficial ownership thereof;
    (2) entering any order or orders for the purchase of such security
with the knowledge that an order or orders of substantially the same
size, and at substantially the same price, for the sale of any such
security, has been or will be entered by or for the same or different
parties; or
    (3) entering any order or orders for the sale of any such security
with the knowledge that an order or orders of substantially the same
size, and at substantially the same price, for the purchase of such
security, has been or will be entered by or for the same or different
parties.
    The Exchange notes that Rule 476(a)(8), which the NYSE adopted when
it was operating in a manual on-Floor trading environment, has a
different scienter standard than Rule 6140--Equities, NYSE Rule 6140,
FINRA Rule 6140, and Rule 4. These latter rules provide that a market
participant is prohibited from engaging in wash sales that have the
purpose of creating or inducing a false or misleading appearance of
activity in a designated security. The ``purpose'' or scienter
requirement in Rule 6140--Equities, NYSE Rule 6140, and FINRA Rule 6140
recognizes that in today's markets there can be certain instances of
trading activity that may inadvertently and unknowingly result in
executions with no change in beneficial ownership, for example trades
entered from an off-Floor participant that experience latency issues
over which the participant has little or no control, and that such
conduct should not always be treated as a wash sale violation if the
market participant did not act with purpose.
    On the other hand, Rule 476(a)(8) prohibits (i) making a fictitious
bid, offer, or transaction, (ii) giving an order for the purchase or
sale of securities the execution of which would involve no change of
beneficial ownership, or (iii) executing such an order with knowledge
of its character. The second prong can be read as having no scienter
requirement.\10\ As such, the example given above involving an off-
Floor market participant's algorithmic orders that inadvertently
execute against themselves due to latency issues could be deemed a
violation of the second prong of Rule 476(a)(8).
---------------------------------------------------------------------------

    \10\ In at least one case involving the Exchange's affiliate,
NYSE, a hearing panel was divided as to whether scienter is required
in order to find a violation of the second prong of NYSE Rule
476(a)(8), which is identical to Rule 476(a)(8), and adjudged the
respondent not guilty. See In the Matter of X, NYSE Hearing Panel
Decision 92-163 (October 23, 1992).
---------------------------------------------------------------------------

Proposed Rule Change
    The Exchange proposes to amend its wash sale rules to achieve a
greater level of internal consistency as well as consistency with
FINRA's and NYSE's rules. The Exchange believes that the proposed rule
change would promote harmonization, consistency, transparency, and
clarity with respect to the Exchange's rules and thereby facilitate
FINRA's enforcement of them.\11\
---------------------------------------------------------------------------

    \11\ The Exchange notes that it can bring disciplinary actions
under Rule 476(a)(8) for conduct that occurred prior to the time the
rule is deleted. Thus, the proposed rule change would have no impact
on ongoing disciplinary actions involving violations of Rule
476(a)(8).
---------------------------------------------------------------------------

    First, the Exchange proposes to eliminate Rule 476(a)(8). The
Exchange believes that the conduct described in that rule should not be
treated as a wash sale violation in all instances. The Exchange would
instead utilize Rule 6140--Equities for wash sale disciplinary actions
in its equities market.
    Second, so that there is no change in the scope of equity market
participants subject to disciplinary action for wash sales, the
Exchange proposes to make a conforming amendment to Rules 6140(a)--
Equities and 6140(b)--Equities to provide that the rules apply not only
to members and member organizations but also to principal executives,
approved persons, registered or non-registered employees of a member or
member organization or persons otherwise subject to the jurisdiction of
the Exchange.
    Finally, the Exchange proposes to delete Rule 4, marking it
``Reserved,'' and add substantially the same text as Rules 6140(a)--
Equities and 6140(b)--Equities to Rule 995NY as new subparagraphs (e)
and (f) so that the substance of the wash sale prohibitions in Rules
6140(a)--Equities and 6140(b)--Equities also applies to trading on the
Exchange's options market, thereby creating greater consistency in the
prohibitions against wash sale trading between the Exchange's equities
and options markets. The references to a ``designated security'' in the
text of these equities rules would be replaced with ``listed option''
in proposed Rule 995NY and similarly references to a ``member'' or
``member organization'' would be replaced with ``ATP Holder.'' The
Exchange believes that locating these provisions in the options rules
will give options market participants better notice of this prohibited
conduct.\12\
---------------------------------------------------------------------------

    \12\ The Exchange also proposes a technical amendment to move a
definition of a term that is used in Rule 995NY(c) to that
subparagraph of the rule. Specifically, the definition of the term
``related instrument'' currently appears at the end of the rule
following the designation of subparagraph (d) and the text thereof,
although that term is used in subparagraph (c). As such, the
Exchange proposes to move the text of the definition of ``related
instrument'' to Rule 995NY(c).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change would not
result in any material diminution of the Exchange's enforcement
authority or any material change in surveillance of potentially
violative activity. The Exchange may still bring a disciplinary action
in appropriate cases where a market participant engages in a
significant amount of trades without change of beneficial ownership,
even if such activity does not violate proposed Rule 6140(b)--Equities
or proposed Rule 995NY(f) per se because the participant did not act
with ``purpose.'' Such conduct could also give rise to other
violations, such as a failure to supervise under Rule 342--Equities or
Rule 922, and the Exchange's affiliate has brought at least one such
case.\13\ Such conduct could also violate just and equitable principles
of trade or otherwise constitute unethical activity under Rule
476(a)(6) or Rule 2010--Equities.\14\
---------------------------------------------------------------------------

    \13\ See In the Matter of Goldman Sachs & Co., NYSE Hearing
Board Decision 12-3 (April 4, 2012) (between January 2009 and at
least September 2011, member firm violated NYSE Rule 342, which is
substantially the same as Rule 342--Equities, in its capacity as a
NYSE Supplemental Liquidity Provider by failing to maintain
supervisory procedures that were reasonably designed to detect and
prevent potentially violative wash trading activity).
    \14\ See Calvin David Fox, 56 SE.C. 1371, 1376 (2003) (``With
respect to a charge that conduct was inconsistent with just and
equitable principles of trade, we have held that a self-regulatory
organization need not find that the respondent acted with scienter,
but must find that the respondent acted in bad faith or
unethically.''). Rule 2010--Equities is a broad ethical concept that
covers all unethical business-related conduct. See also In the
Matter of Merrill Lynch, Pierce, Fenner & Smith Incorporated, NYSE
Hearing Board Decision 10-13 (May 14, 2010) (firm violated just and
equitable principles of trade in that it introduced prearranged or
wash sales in the round-lot portion of a partial round lot order);
In the Matter of Robert Cutter Matlock, Jr., NYSE Hearing Board
Decision 06-19 (March 27, 2006) (Exchange need not prove scienter
for violations of just and equitable principles of trade, but rather
is required to show the respondent acted in bad faith or
unethically); In the Matter of Mary Roy Wong, NYSE Hearing Board
Decision 06-187 (February 13, 2007) (Exchange need not prove
scienter for violations of just and equitable principles of trade,
but rather is required to show the respondent acted in bad faith or
unethically).

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

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\15\ in general, and furthers the objectives of Section
6(b)(5),\16\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Specifically, the Exchange
believes that the proposed rule change supports the objectives of the
Act by addressing an inconsistency in the scienter requirements between
Rule 476(a)(8) on the one hand and Rule 4, Rule 6140--Equities, NYSE
Rule 6140, and FINRA Rule 6140 on the other. Eliminating this
inconsistency would provide member organizations with better notice of
prohibited wash sale activities in the Exchange's equities and options
markets and promote transparency and clarity with respect to the
Exchange's rules, thereby facilitating FINRA's enforcement of them. The
proposed rule change also would achieve greater consistency between the
Exchange's options and equities rules that prohibit wash sale activity.
Moreover, the proposed rule change would not result in any material
diminution of the Exchange's overall enforcement authority or any
material change in surveillance of potentially problematic trading
activity. The Exchange may still bring a disciplinary action in
appropriate cases where a market participant engages in a significant
amount of trades without change of beneficial ownership, even if such
activity does not violate proposed Rule 6140(b)--Equities or proposed
Rule 995NY(f) per se because the participant did not act with
``purpose,'' because such conduct could violate supervision rules, just
and equitable principles of trade, or other Exchange rules prohibiting
unethical conduct. As such, the Exchange's rules would continue to
protect investors and the public interest.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition
    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues, but rather to achieve
greater consistency both within the Exchange's rules and among
Exchange, NYSE, and FINRA rules.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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 up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the 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 No. SR-NYSEMKT-2013-88 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 No. SR-NYSEMKT-2013-88. 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 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 No. SR-NYSEMKT-2013-88 and should be
submitted on or before December 5, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27240 Filed 11-13-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]
[Page 52340-52342]
[DOCID:fr25au10-64]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0623; FRL-8843-1]

Fenoxycarb; Notice of Receipt of Request To Voluntarily Cancel
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of requests by registrants to voluntarily cancel
registrations of products containing the pesticide fenoxycarb. The
request would terminate the last fenoxycarb products registered for use
in the United States. EPA intends to grant these requests at the close
of the comment period for this announcement unless the Agency receives
substantive comments within the comment period that would merit its
further review of the request, or unless a registrant withdraws its
request. If these requests are granted, any sale, distribution, or use
of products listed in this notice will be permitted after the
registrations have been canceled only if such sale, distribution, or
use is consistent with the terms as described in the final order.

DATES: Comments must be received on or before September 24, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0623, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0623. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Katie Weyrauch, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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

    1.  Submitting CBI. Do not submit this information to EPA through

regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel Registrations

    This notice announces receipt by EPA of requests from registrants
Syngenta Crop Protection, Inc. and Whitmire Micro-Gen Research
Laboratories, Inc. to cancel fenoxycarb product registrations.
Fenoxycarb is an O-ethyl carbamate derivative insecticide used to
control fire ants and big-headed ants on turf, home lawns, agricultural
areas, non-agricultural areas, horse farms, and ornamental nursery
stock, among other areas. Fenoxycarb is also used to control a variety
of insects in greenhouses in a total release fogger product. In letters
received by the Agency, Syngenta Crop Protection, Inc. and Whitmire
Micro-Gen Research Laboratories, Inc. requested EPA to cancel pesticide
product registrations identified in Table 1 of Unit III. This request
for voluntary cancellation was submitted in response to the data call-
in issued for the Registration Review of fenoxycarb. This action on the
registrants' requests will terminate the last fenoxycarb products
registered in the United States.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel fenoxycarb product registrations. The affected products and
the registrants making the requests are identified in Tables 1 and 2 of
this unit.
    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order canceling the
affected registrations. The cancellation of the technical product
(product number 100-723) will be effective upon publication of the
final cancellation order. The cancellation of the end-use product
number 499-437 will be effective upon publication of the final
cancellation order. The cancellation of the end-use product number 100-
722 will be effective December 31, 2012.

  Table 1.--Fenoxycarb Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
100-722                           Award Fire Ant      Syngenta Crop
                                   Bait                Protection, Inc.
------------------------------------------------------------------------
100-723                           Fenoxycarb          Syngenta Crop
                                   Technical           Protection, Inc.
------------------------------------------------------------------------
499-437                           Whitmire PT 2120    Whitmire Micro-Gen
                                   TF Prelcude         Research
                                                       Laboratories,
                                                       Inc.
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the products listed in Table 1 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in Table 1
of this unit.

     Table 2.--Registrants Requesting Voluntary Cancellation and/or
                               Amendments
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
100                                         Syngenta Crop Protection,
                                             Inc. PO Box 18300
                                             Greensboro, NC 27419-8300
------------------------------------------------------------------------
499                                         Whitmire Micro-Gen Research
                                             Laboratories, Inc. 3568
                                             Tree Court Industrial Blvd.
                                             St. Louis, MO 63122-6682
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The fenoxycarb registrants have requested that EPA waive the 180-
day comment period. Accordingly, EPA will provide a 30-day comment
period on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use deletion should submit the withdrawal in writing to
the person listed under FOR FURTHER INFORMATION CONTACT. If the
products have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. If the requests for voluntary cancellation are
granted, the Agency intends to publish the cancellation order in the
Federal Register.
    In any order issued in response to these requests for cancellation
of product registrations, EPA proposes to include the following
provisions for the treatment of any existing stocks of the products
listed in Table 1 of Unit III.
    Syngenta Crop Protection, Inc. may formulate existing stocks of
product number 100-723 into end-use product until supplies of product
number 100-723 are exhausted. Syngenta Crop Protection, Inc. will be
permitted to sell and distribute end-use product (product number 100-
722) until December 31, 2012, the effective date of the cancellation of
product number 100-722. Thereafter, Syngenta Crop Protection, Inc. will
be prohibited from selling or distributing the product number 100-722,
except for export consistent with FIFRA section 17 or for proper
disposal.
    Whitmire Micro-Gen Research Laboratories, Inc. will be permitted to
sell and distribute existing stocks of voluntarily canceled end-use
product (product number 499-437) until December 31, 2013. Thereafter,
Whitmire Micro-Gen Research Laboratories, Inc. will be prohibited from
selling or distributing product number 499-437, except for export
consistent with FIFRA section 17 or for proper disposal.
    Persons other than the registrants may sell, distribute, or use
existing stocks of the canceled products listed in Table 1 of Unit III,
until supplies are exhausted, provided that such sale, distribution, or
use is consistent with the terms of the previously approved labeling
on, or that accompanied, the canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 18, 2010.
Peter Caulkins,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-21145 Filed 8-24-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8881-8884]
[FR Doc No: 2015-03418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1525]

Mixing, Diluting, or Repackaging Biological Products Outside the
Scope of an Approved Biologics License Application; Draft Guidance for
Industry; Availability

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Mixing, Diluting, or Repackaging Biological Products Outside the
Scope of an Approved Biologics License Application.'' This draft
guidance describes the conditions under which FDA does not intend to
take action against a state-licensed pharmacy, a Federal facility, or
outsourcing facility that mixes, dilutes, or repackages certain
biological products without obtaining an approved biologics license
application (BLA).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 20, 2015.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3128, 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Leah Christl, Center for Drugs
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20903, 301-796-
0869; or 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,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Mixing, Diluting, or Repackaging of Biological Products
Outside the Scope of an Approved Biologics License Application.''
Certain licensed biological products may need to be mixed, diluted, or
repackaged in a way not described in the approved labeling for the
product to meet the needs of a specific patient. For example, for some
biological products there is no licensed pediatric strength and/or
dosage form. In addition, there may be certain circumstances when a
person would remove a licensed biological product from its original
container and place it into a different container(s) (repackage it), in
a manner that is not within the scope of the approved labeling for the
product. As described in the draft guidance, mixed, diluted, or
repackaged biological products are not eligible for the statutory
exemptions available to certain compounded drugs under sections 503A
and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353A and 353B). In addition, a biological product that is mixed,
diluted, or repackaged outside the scope of an approved BLA is
considered an unlicensed biological product under section 351 of the
Public Health Service (PHS) Act (21 U.S.C. 262).
    This draft guidance describes the conditions under which FDA does
not intend to take action for violations of section 351 of the PHS Act
and section 502(f)(1) (21 U.S.C. 352(f)(1) and where specified, section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B) of the FD&C Act, when a state-
licensed pharmacy, a Federal facility, or an outsourcing facility
dilutes, mixes, or repackages certain biological products without
obtaining an approved BLA.
    Elsewhere in this issue of the Federal Register, the Agency is
making available for comment a draft guidance entitled ``Repackaging of
Certain Human Drug Products by Pharmacies and Outsourcing Facilities.''
When these two guidances become final, they will address and clarify
the Agency's policy regarding hospital pharmacies repackaging and
safely transferring repackaged drug, including biological products, to
other hospitals within the same health system during a drug shortage.
Therefore, under section 506F(d) of the FD&C Act (21 U.S.C. 356f(d),
when FDA issues these as final guidances, section 506F will no longer
apply.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance, when
finalized, will represent FDA's current thinking on mixing, diluting,
and repackaging of biological products not within the scope of the
product's approved BLA as described in the approved labeling for the
product. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collection are given under this section
with an estimate of the annual reporting and recordkeeping burdens.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Draft Guidance for Industry: Mixing, Diluting, or
Repackaging of Biological Products Outside the Scope of an Approved
Biologics License Application.
    Description: The draft guidance describes FDA's policy with respect
to the mixing, diluting, and repackaging of certain types of biological
products that have been licensed under section 351 of the PHS Act when
such activities are not within the scope of the product's approved BLA
as described in the approved labeling for the product. The draft
guidance describes the conditions under which FDA does not intend to
take action for violations of section 351 of the PHS Act and section
502(f)(1) and where specified, section 501(a)(2)(B) of the FD&C Act,
when a state-licensed pharmacy, a Federal facility, or an outsourcing
facility mixes, dilutes, or repackages certain biological products
without obtaining an approved BLA.
    The draft guidance includes the following collection of information
under the PRA.
    One condition described in the draft guidance is that, if the
biological product is mixed, diluted, or repackaged by an outsourcing
facility, the label on the immediate container (primary packaging,
e.g., the syringe) of the mixed, diluted, or repackaged product
includes the following information:
     The statement ``This product was mixed or diluted by [name
of outsourcing facility],'' or ``This product was repackaged by [name
of outsourcing facility]'' whichever statement is appropriate;
     the address and phone number of the outsourcing facility
that mixed, diluted, or repackaged the biological product;
     the proper name of the original biological product that
was mixed, diluted, or repackaged;
     the lot or batch number of the mixed, diluted, or
repackaged biological product;
     the dosage form and strength;
     a statement of either the quantity or the volume of the
mixed, diluted, or repackaged biological product, whichever is
appropriate;
     the date the biological product was mixed, diluted, or
repackaged;
     the beyond-use-date (BUD) of the mixed, diluted, or
repackaged biological product;
     storage and handling instructions for the mixed, diluted,
or repackaged biological product;
     the National Drug Code (NDC) number of the mixed, diluted,
or

repackaged biological product, if available; \1\
---------------------------------------------------------------------------

    \1\ The NDC number of the original licensed biological product
should not be placed on the mixed, diluted, or repackaged biological
product.
---------------------------------------------------------------------------

     The statement ``Not for resale,'' and, if the biological
product is distributed by an outsourcing facility other than pursuant
to a prescription for an individual identified patient, the statement
``Office Use Only''; and
     If included on the label of the FDA-licensed product from
which the biological product is being mixed, diluted, or repackaged, a
list of the active and inactive ingredients; and if the ingredients are
listed because they were listed on the original product, the label of
the mixed, diluted, or repackaged product should include any additional
ingredients that appear in the mixed, diluted, or repackaged product.
    Another condition in the draft guidance is that, if the immediate
product label is too small or the mixed, diluted, or repackaged product
is otherwise unable to accommodate a label with sufficient space to
bear the active and inactive ingredients, such information should be
included on the label of the container from which the individual units
are removed for administration (secondary packaging, e.g., the bag,
box, or other package in which the mixed, diluted, or repackaged
biological products are distributed).
    In addition, the draft guidance describes the conditions that the
container label include directions for use, including, as appropriate,
dosage and administration, and the following information to facilitate
adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-
1088. Another condition in the draft guidance is that each mixed,
diluted, or repackaged biological product is also accompanied by a copy
of the prescribing information that accompanied the original licensed
biological product that was mixed, diluted, or repackaged.
    We estimate that annually a total of approximately five registered
outsourcing facilities that mix, dilute, or repackage biological
products (``Number of Respondents'' in table 1, row 1) will each
design, test, and produce approximately five different labels
(``Frequency per Disclosure'' in table 1, row 1), for a total of 25
labels that include the information set forth in section III.B of the
draft guidance (including directions for use) (``Total Disclosures'' in
table 1, row 1). We also estimate that designing, testing, and
producing each label will take approximately 0.5 hours (``Hours per
Disclosure'' in table 1, row 1). The provision to add http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden
estimate because it is not considered a collection of information under
the PRA because the information is ``originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
    Section III.C of the draft guidance discusses the preparation of
prescription sets (i.e., licensed allergenic extracts that are combined
to provide subcutaneous immunotherapy to an individual patient) by a
physician, state-licensed pharmacy, a Federal facility, or outsourcing
facility. Under the draft guidance, if the prescription set is mixed or
diluted by an outsourcing facility, the label on the immediate
container of the prescription set (primary packaging) includes:
     The patient's name as identified on the prescription;
     the statement ``This prescription set was prepared by
[name of outsourcing facility]'';
     the address and phone number of the outsourcing facility
that prepared the prescription set;
     the identity of each allergenic extract in the
prescription set and the quantity of each;
     the dilution of each dilution vial;
     the lot or batch number of the prescription set;
     the date the prescription set was prepared;
     the BUD of the prescription set;
     storage and handling instructions for the prescription
set; and
     the statement ``Not for resale''.
    In addition, under the draft guidance, the label of the container
from which the individual units of the prescription set are removed for
administration (secondary packaging) includes the following information
to facilitate adverse event reporting: http://www.fda.gov/medwatch and
1-800-FDA-1088. Each prescription set prepared is also accompanied by
instructions for use and the FDA approved package insert for each
allergenic extract.
    We estimate that annually a total of approximately five outsourcing
facilities that prepare prescription sets (``Number of Respondents'' in
table 2, row 1) will each include the information set forth in section
III.C of the draft guidance (including directions for use) on the
labels, packages, and/or containers of approximately 300 prescription
sets (``Frequency per Disclosure'' in table 2, row 1) for a total of
1500 disclosures (``Total Disclosures'' in table 2, row 1). We also
estimate that the initial process of designing, testing, and producing,
and attaching each label, package, and/or container to each
prescription set will take approximately 0.5 hours (``Hours per
Disclosure'' in table 2, row 1). The provision to add the statement
http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this
burden estimate because it is not considered a collection of
information under the PRA because the information is ``originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
    We also estimate that a total of approximately five outsourcing
facilities (``Number of Respondents'' in table 2, row 2) will each
design, test, and produce the instructions for use and a copy of
prescribing information, as set forth in section III.C of the draft
guidance, for approximately 300 prescription sets (``Frequency per
Disclosure'' in table 2, row 2) for a total of 1500 disclosures (total
disclosures'' in table 2, row 2), which we estimate will take
approximately 1 hour for each prescription set (``Hours per
Disclosure'' in table 2, row 2). The provision to include http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden
estimate because they are not considered a collection of information
under the PRA because the information is ``originally supplied by the
Federal Government to the recipient for the purpose of disclosure to
the public'' (5 CFR 1320.3(c)(2)).
    The total estimated third-party disclosure burden resulting from
the draft guidance is as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
   Biological product mixing,       Number of     Frequency per       Total         Hours per
   diluting, and repackaging       respondents     disclosure      disclosures     disclosure      Total hours
----------------------------------------------------------------------------------------------------------------
Designing, testing, and                       5               5              25             0.5             12.5
 producing the label,
 container, packages, and/or
 outer containers for each
 mixed, diluted, or repackaged
 biological product............
Prescribing information                       5               5              25               1             25
 labeling accompanying each
 mixed, diluted, or repackaged
 drug product..................
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ..............             37.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
*(30 minutes)

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
  Preparation of prescription       Number of     Frequency per       Total         Hours per
              sets                 respondents     disclosure      disclosures     disclosure      Total hours
----------------------------------------------------------------------------------------------------------------
Designing, testing, and                       5             300            1500             0.5            750
 producing each label on
 immediate containers,
 packages, and/or outer
 containers....................
Including instructions for use                5             300            1500               1           1500
 labeling and the original
 package insert(s) for each
 prescription set..............
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ..............           2250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
*(30 minutes)

    The draft guidance also references registration, product reporting,
current good manufacturing practice (CGMP) requirements, and the
payment of certain fees by human drug compounding outsourcing
facilities. In the Federal Register of December 4, 2013 (78 FR 72899),
FDA estimated the burden resulting from outsourcing facility
registration. In the Federal Register of December 4, 2013 (78 FR
72897), FDA estimated the burden resulting from outsourcing facility
interim product reporting. In the Federal Register of April 1, 2014 (79
FR 18297), FDA estimated the burden resulting from the payment of
certain fees by outsourcing facilities. In the Federal Register of July
2, 2014 (79 FR 37743), FDA estimated the burden resulting from
outsourcing facility compliance with CGMP requirements.

IV. Electronic Access

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

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03418 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P


                                    Attachment C                                            Summary of Consultations for the Renewal ICR, entitled " Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides (Renewal)" OMB Control No. 2070-0027; EPA ICR No. 0161.14; Docket No. EPA-HQ-OPP-2018-0266

 Representatives contacted from the following Industries:  Syngenta Crop Protection LLC  International Trade Compliance  Neogen  FMC Corporation  Suterra LLC  MGK  Marketing Arm International  Monsanto Company  Wellmark International  Questions and Responses: 	EPA provided the same set of questions to each representative for their consideration and feedback. EPA received responses from the following two representatives:  Marketing Arm International   An anonymous submission to the public docket (Docket No. EPA-HQ-OPP-2018-0266-0008)

The questions asked, and their feedback to those questions, are provided below:

Responses from Marketing Arm International

 Publicly Available Data

 Is the data that the Agency seeks available from any public source, or already collected by another office at EPA or by another agency?                 YES

 If yes, where can you find the data? (Does your answer indicate a true duplication, or does the input indicate that certain data elements are available, but that they don't meet our data needs very well?)                 EACH TIME (12 TIMES A YEAR) OUR EPA ESTABLISHEMNT WILL IMPORT RAW MATERIAL TO RE-EXPORT AS UNREGISTERED PRODUCT, WE HAVE TO SUPPLY TO THE EPA AGENCY IN ATLANTA:

 EPA NOTICE OF ARRIVAL.  BOL AN SHIPPING DOCS....PLUS...  A COPY OF THE ALL FPAS (ALREADY SUBMITTED TO US-EPA IN WASHINGTON).  COPY OF IMPORT LABELS  COPY OF EXPORT LABEL FOR EACH PRODUCT EXPORTED.

  Frequency of Collection

 Can the Agency collect the information less frequently and still produce the same outcome?                 IN THE PAST....... ONLY EPA NOTICE OF ARRIVAL AND SHIPPING DOCS (BOL, INCOICE, ETC.)

 Clarity of Instructions

 The ICR is intended to require that respondents provide certain data so that the Agency can utilize them.

 Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions?	 	YES

 Do you understand that you are required to maintain records?                 YES

 Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete?                 NO

 Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear, logical, and easy to complete?                 NO

   Electronic Reporting and Record keeping          The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.

 What do you think about electronic alternatives to paper-based records and data submissions?	Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency's Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format?

 Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper?                             I LIKE PAPER                What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?                             NONE                Burden and Costs

 Are the labor rates accurate?                 YES          The Agency assumes there is no capital cost associated with this activity. Is that correct?                 YES          Bearing in mind that the burden and cost estimates include only burden hours and costs associated with the paperwork involved with this ICR, e.g., the ICR does not include estimated burden hours and costs for conducting studies, are the estimated burden hours and labor rates accurate? If you provide burden and cost estimates that are substantially different from EPA's, please provide an explanation of how you arrived at your estimates.                 NA          Are there other costs that should be accounted for that may have been missed?                 NA

Anonymous comments submitted through the docket (EPA-HQ-OPP-2018-0266-0008)

(2)	Frequency of Collection

a) Can the Agency collect the information less frequently and still produce the same outcome?

Yes, I think it could be more beneficial and efficient for everyone if the Agency would accept collections quarterly.

(3) 	Clarity of Instructions   b) Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions?

Yes

c) Do you understand that you are required to maintain records?

Yes

d) Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete?

No, but our company created our own clear, logical template that includes all of the required data. However, it could be nice if there was a standard submission format issued by the EPA.

(4) 	Electronic Reporting and Record keeping  The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.

a) What do you think about electronic alternatives to paper-based records and data submissions? Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency's Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format?

I think electronic alternatives to paper-based records and data submissions are a great idea. Yes, I would be interested in pursuing electronic reporting. Yes, we keep our records electronically and stored as PDFs within files.

            1) Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper?

I would be more inclined to submit CBI via web rather than on paper, diskette, CD, or DVD.

2) What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?

I think there would be cost reductions (postage/mail/paper/ink) and greater efficiency in submitting if electronic submissions via the web were an option.


[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Page 7995]
[FR Doc No: 2020-02823]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2322-069]

Brookfield White Pine Hydro LLC; Notice of Application Tendered
for Filing With the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2322-069.
    c. Date Filed: January 31, 2020.
    d. Applicant: Brookfield White Pine Hydro LLC (Brookfield).
    e. Name of Project: Shawmut Hydroelectric Project.
    f. Location: The existing project is located on the Kennebec River
in Kennebec and Somerset Counties, Maine. The project does not affect
federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Frank Dunlap, 150 Main Street, Lewiston,
Maine 04240;<PHONE_NUMBER>.
    i. FERC Contact: Matt Cutlip,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The project consists of the following
constructed facilities: (1) A 24-foot-high, 1,480-foot-long concrete
gravity dam consisting of: (i) A 380-foot-long overflow section with
hinged flashboards, (ii) a 730-foot-long overflow section with an
inflatable bladder, (iii) 25-foot-wide sluice section; (iv) a non-
overflow section; and (v) a headworks containing 11 headgates that
regulate flow into a forebay; (2) a 1,310-acre impoundment extending
about 12 miles upstream; (3) two powerhouses adjacent to the forebay,
separated by a 10-foot-high by 7-foot-wide Tainter gate and a 6-foot-
high by 6-foot-wide deep gate; (4) eight turbine-generating units; (5)
a 300-foot-long tailrace; (6) 250-foot-long generator leads connecting
the powerhouses with a substation; and (7) appurtenant facilities.
    Brookfield operates the project in a run-of-river mode and
implements specific operating procedure to facilitate upstream and
downstream fish passage at the project. Upstream passage for American
eel is provided by a dedicated eel passage facility located adjacent to
one of the powerhouses. There are no constructed upstream anadromous
fishways at the project. Currently anadromous fish are captured and
transported upstream of the Shawmut Project via a fish lift and
transport system at the Lockwood Dam Hydroelectric Project No. 2574,
located about 6 miles downstream. Downstream fish passage for American
eel and anadromous fish at the Shawmut Project is provided via a
combination of routing flows through the project's spillways, turbines,
and other flow regulating equipment (e.g., Tainter gate between the
powerhouses).
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's website at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY).
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule: The application will be processed according
to the following preliminary Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready    March 2020.
 for Environmental Analysis.
Filing of recommendations, preliminary  May 2020.
 terms and conditions, and fishway
 prescriptions.
Commission issues Draft Environmental   November 2020.
 Assessment (EA).
Comments on Draft EA..................  December 2020.
Modified terms and conditions.........  February 2021.
Commission issues Final EA............  May 2021.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than thirty (30) days from the issuance date of the
notice of ready for environmental analysis.

    Dated: February 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-02823 Filed 2-11-20; 8:45 am]
 BILLING CODE 6717-01-P