[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Proposed Rules]
[Pages 34098-34101]
[FR Doc No: 2015-14229]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1981; Directorate Identifier 2014-NM-204-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200,
and A340-300 series airplanes. This proposed AD was prompted by reports
that the inner bore of some main landing gear (MLG) unit bogie beams
were insufficiently re-protected against corrosion after inspection or
maintenance actions were accomplished. This proposed AD would require,
for certain MLG units, determining which revision of the component
maintenance manual (CMM) was used to accomplish the most recent MLG
unit overhaul; a detailed inspection for missing or damaged paint, and
if necessary, a detailed inspection of the cadmium plating for
discrepancies, measurement of the depth of the cadmium plating, a
general visual inspection of the base metal for corrosion or damage, a
detailed inspection of repaired areas for cracking or corrosion; and
corrective actions if necessary. We are proposing this AD to detect and
correct corrosion in the bore of each MLG unit bogie beam, which could
result in collapse of a MLG unit, and subsequent damage to the airplane
and injury to occupants.

DATES: We must receive comments on this proposed AD by July 30, 2015.

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 Airbus service information identified in this proposed AD,
contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 45 80; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. For Messier-Dowty service information contact
Messier-Dowty Limited, Cheltenham Road, Cloucester, GL2 9QH, England;
telephone +44(0) 1452 712424; fax+ 44(0) 1452 713821; Internet http://www.messier-dowtycom). You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

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-2015-
1981; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed 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: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-1981;
Directorate Identifier

2014-NM-204-AD at the beginning of your comments. We specifically
invite comments on the overall regulatory, economic, environmental, and
energy aspects of this proposed AD. We will consider all comments
received by the closing date and may amend this proposed 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 proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0222, dated October 6, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A330-200 Freighter, A330-200, A330-300, A340-200, and A340-300 series
airplanes. The MCAI states:

    From in-service experience, it was found that the inner bore of
some bogie beams had been insufficiently re-protected against
corrosion after inspection and/or possible maintenance actions
accomplished in this area (absence of corrosion inhibitor and damage
to paint have been found in some specific areas).
    This condition, if not detected and corrected, could lead to
corrosion on the bore of the bogie beam, potentially resulting in
Main Landing Gear (MLG) collapse, ultimately resulting in damage to
the aeroplane and injury to the occupants.
    To address this potential unsafe condition, Airbus issued Alert
Operators Transmission (AOT) A32L004-14, providing inspection
instructions for some aeroplane configurations.
    For the reasons described above, this [EASA] AD requires
identification of the MLG units that are possibly affected, [a
detailed] inspection [for missing or damaged paint] of the MLG Bogie
Beam bore and, depending on findings, accomplishment of the
applicable corrective actions.
    This [EASA] AD also prohibits the installation of MLG units that
have been overhauled by using instructions from an earlier
Components Maintenance Manual (CMM) revision.

Required actions also include a detailed inspection of the cadmium
plating for discrepancies (gray in color), measurement of the depth of
the cadmium plating if necessary, and a general visual inspection of
the base metal for corrosion or damage, and a detailed inspection of
repaired areas for cracking or corrosion. Corrective actions include
removing cadmium plating and repairing any cracked, corroded, or
damaged areas; re-applying cadmium plating and paint; and re-applying
temporary corrosion protection to the bores of the MLG bogie beams.
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1981.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Alert Operators Transmission A32L004-14, dated
July 28, 2014, including Appendices 1, 2, 3, and 4, which are not
dated. This service information describes procedures for inspections of
the bogie beam bore of the MLG.
    Messier-Dowty has issued the following service information, which
describes procedures for inspections of the internal diameter of the
bogie beam for corrosion.
     Service Bulletin A33/34-32-272, including Appendices A, B,
C, and D, dated November 16, 2007.
     Service Bulletin A33/34-32-272, Revision 1, including
Appendices A, B, C, and D, dated September 22, 2008.
    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 of this
NPRM.

FAA's Determination and Requirements of This Proposed 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 proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 89 airplanes of U.S.
registry.
    We also estimate that it would take about 12 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $90,780, or $1,020
per product.
    We have received no definitive data that would enable us to provide
cost estimates for any necessary follow-on actions.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed AD is mandatory. Comments concerning the
accuracy of this burden and suggestions for reducing the burden should
be directed to the FAA at 800 Independence Ave. SW., Washington, DC
20591, ATTN: Information Collection Clearance Officer, AES-200.

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.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

Airbus: Docket No. FAA-2015-1981; Directorate Identifier 2014-NM-
204-AD.

(a) Comments Due Date

    We must receive comments by July 30, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus airplanes, certificated in any
category, identified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model A330-201, A330-202, A330-203, A330-223, A330-223F,
A330-243, A330-243F, A330-301, A330-302, A330-303, A330-321, A330-
322, A330-323, A330-341, A330-342, and A330-343 airplanes; all
manufacturer serial numbers; except those on which Airbus
Modification 58896 has been embodied in production or embodied
through Airbus Service Bulletin A330-32-3237.
    (2) Model A340-211, A340-212, A340-213, A340-311, A340-312, and
A340-313 airplanes; all manufacturer serial numbers; except those on
which Airbus Modification 58896 has been embodied in production or
embodied through Airbus Service Bulletin A340-32-4279.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by reports that the inner bore of some main
landing gear (MLG) unit bogie beams were insufficiently re-protected
against corrosion after inspection or maintenance actions were
accomplished. We are issuing this AD to detect and correct corrosion
in the bore of each MLG unit bogie beam, which could result in
collapse of a MLG unit, and subsequent damage to the airplane and
injury to occupants.

(f) Compliance

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

(g) Identification of Affected MLG Units

    Within 12 months after the effective date of this AD: For MLG
units having a 201252 series or 201490 series part number, determine
the revision of the Airbus component maintenance manual (CMM) used
to do the most recent MLG unit overhaul. If it is determined that
the Airbus CMM revision specified in paragraph (g)(1) or (g)(2) of
this AD was used to accomplish the most recent MLG unit overhaul:
Within 12 months after the effective date of this AD, clean the area
between the bogie pivot pin and the bogie beam bore of each MLG unit
and do a detailed inspection for missing or damaged paint, in
accordance with the instructions of Airbus Alert Operators
Transmission A32L004-14 dated July 28, 2014.
    (1) For MLG units having a part number in the 201252 series:
Airbus CMM 32-11-74, Revision 25 or earlier.
    (2) For MLG units having a part number in the 201490 series:
Airbus CMM 32-12-05, Revision 20 or earlier.

(h) Inspection of Cadmium Plating

    If, during the inspection required by paragraph (g) of this AD,
any missing or damaged paint is found: Before further flight, do a
detailed inspection of the cadmium plating for discrepancies,
measure the depth of the plating as applicable, and do a general
visual inspection of the base metal for corrosion or damage. If any
discrepancy, damage, or corrosion is found, before further flight,
do all applicable corrective actions, and do a detailed inspection
of repaired areas for cracking or corrosion, in accordance with
Airbus Alert Operators Transmission A32L004-14, dated July 28, 2014,
except where Airbus Alert Operators Transmission A32L004-14, dated
July 28, 2014, specifies to contact Messier-Dowty if cracking or
corrosion is found in a repaired area, before further flight, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA).

(i) Reporting Requirement

    At the applicable time specified in paragraph (i)(1) or (i)(2)
of this AD, report the findings of the inspection required by
paragraph (g) of this AD to Airbus, Customer Services Engineering--
SEEL1, Attn: Philippe Kerangueven, Product Leader A330/A340, ATA-32,
Landing Gear Systems, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; phone +33 (0) 5 67 19 18 42; fax +33 0 5 67 19 12-05;
email<EMAIL_ADDRESS>The report must include the
information specified in Appendix 2 of Airbus Alert Operators
Transmission A32L004-14, dated July 28, 2014.
    (1) If the inspection was done on or after the effective date of
this AD: Within 90 days after that inspection.
    (2) If the inspection was done before the effective date of this
AD: Within 90 days after the effective date of this AD.

(j) Optional Method of Compliance

    Accomplishment of the boroscope inspection of the internal
diameter of the bogie beam for corrosion or damage to the protective
treatments, measurement of the depth of the protective treatments as
applicable, and accomplishment of all applicable corrective actions,
in accordance with the Accomplishment Instructions of Messier-Dowty
Service Bulletin A33/34-32-272, dated November 16, 2007; or Revision
1, including Appendices A, B, C, and D, dated September 22, 2008;
are acceptable for the corresponding actions required by paragraphs
(g) and (h) of this AD for that MLG unit, provided the actions in
the Messier-Dowty Service Bulletins identified in paragraphs (j)(1)
through (j)(5) of this AD have not been accomplished on that MLG
unit. Where Messier-Dowty Service Bulletin A33/34-32-272, dated
November 16, 2007; or Revision 1, including Appendices A, B, C, and
D, dated September 22, 2008; specify to contact Messier-Dowty for
repair information, the repair must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA.
    (1) Messier-Dowty Service Bulletin A33/34-32-285, dated July 9,
2010.
    (2) Messier-Dowty Service Bulletin A33/34-32-285, Revision 1,
dated October 4, 2011.
    (3) Messier-Dowty Service Bulletin A33/34-32-285, Revision 2,
dated October 4, 2012.
    (4) Messier-Dowty Service Bulletin A33/34-32-285, Revision 3,
dated September 11, 2013.
    (5) Messier-Dowty Service Bulletin A33/34-32-285, Revision 4,
dated January 23, 2014.
    Note 1 to paragraph (j) of this AD: Inspections done using the
instructions in Messier-Dowty Service Bulletin A33/34-32-285,
Revision 5, dated August 14, 2014, do not affect the optional method
of compliance provided by this paragraph.

(k) Parts Installation Limitation

    As of the effective date of this AD, any overhauled MLG unit
having a 201252 series or 201490 series part number may be installed
on an airplane, provided the most recent MLG overhaul was done using
an Airbus CMM that is not specified in paragraph (g)(1) or (g)(2) of
this AD, or, prior to installation, the MLG unit passes the
inspection required by paragraph (g) of this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International

Branch, ANM-116, Transport Airplane Directorate, 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 Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (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
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus's EASA DOA. If approved by the DOA, the approval must include
the DOA-authorized signature.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0222, dated October 6,
2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-1981.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 3, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-14229 Filed 6-12-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29724-29725]
[FR Doc No: 2015-12397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0126]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product FLUCELVAX
(A/Brisbane/10/2010 (wild type), A/California 7/2009-like virus (H1N1),
A/Victoria/361/2011 virus IVR-165(H3N2, B/Wisconsin/1/2010 (wildtype) B
Yamagata lineage)). FLUCELVAX is indicated for active immunization for
the prevention of influenza disease caused by influenza virus subtypes
A and type B contained in the vaccine. Subsequent to this approval, the
USPTO received a patent term restoration application for FLUCELVAX
(U.S. Patent No. 6,656,720) from Novartis AG, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated May 22, 2014, FDA advised the USPTO
that this human biological product had undergone a regulatory review
period and that the approval of FLUCELVAX represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
FLUCELVAX is 2,589 days. Of this time, 2,224 days occurred during the
testing phase of the regulatory review period, while 365 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 21,
2005. The applicant claims March 31, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 21, 2005,
which was the date the IND was removed from clinical hold.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 22, 2011. The applicant claims
October 31, 2011, as the date the biologics license application (BLA)
for FLUCELVAX (BLA 125408) was initially submitted. However, FDA
records indicate that BLA 125408 was submitted on November 22, 2011.
    3. The date the application was approved: November 20, 2012. FDA
has verified the applicant's claim that BLA 125408 was approved on
November 20, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,773 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 21, 2015. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for

extension acted with due diligence during the regulatory review period
by November 18, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. 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. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12397 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 222 (Tuesday, November 17, 2020)]
[Notices]
[Pages 73348-73350]
[FR Doc No: 2020-25321]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2020-0232]

Agency Information Collection Activities: Renewed Approval of
Information Collection

AGENCY: Office of the Secretary (OST), DOT.

ACTION: 60-Day notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
on our intention to request Office of Management and Budget (OMB)
approval for an information collection in accordance with the
requirements of the Paperwork Reduction Act of 1995. The collection is
necessary for administration of the ``Discretionary Grants for
Nationally Significant Freight and Highway Projects (FASTLANE/INFRA)
Program''. FASTLANE/INFRA grants support surface transportation
infrastructure projects that have a significant local or regional
impact.

DATES: Written comments should be submitted by January 19, 2021.

ADDRESSES: To ensure that you do not duplicate your docket submissions,
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W-12-140,
1200 New Jersey Ave. SE, between 9 a.m. and 5 p.m., Monday through
Friday, except

Federal holidays. The telephone number is<PHONE_NUMBER>.
    Instructions: To ensure proper docketing of your comment, please
include the agency name and docket number DOT-OST-2020-0232 at the
beginning of your comments. All comments received will be posted
without change to http://www.regulations.gov, including any personal
information provided.

FOR FURTHER INFORMATION CONTACT: For further information regarding this
notice, please contact the Office of the Secretary via email at
<EMAIL_ADDRESS>or call Paul Baumer at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: New Collection. OMB number will be issued
after the collection is approved.
    Title: Discretionary Grants for Nationally Significant Freight and
Highway Projects (FASTLANE/INFRA) Program.
    Form Numbers: None.
    Type of Review: New Information Collection Request (ICR).
    Background: The Office of the Secretary (OST) within the Department
of Transportation (DOT) provides financial assistance to State and
local Governments, including U.S. territories, tribal Governments,
transit agencies, port authorities, metropolitan planning organizations
(MPOs), and other political subdivisions of State or local Governments
through the Nationally Significant Freight and Highway Projects
Program, which was established in the Fixing American's Surface
Transportation Act of 2015 (``FAST ACT''), Public Law 1105. These
discretionary grants were previously referred to by the DOT as
``Fostering Advancements in Shipping and Transportation for the Long-
Term Achievement of National Efficiencies'', or ``FASTLANE''
Discretionary Grants, and are now referred to as ``Infrastructure for
Rebuilding America'' or ``INFRA'' Discretionary Grants. The Office of
the Secretary of Transportation (``OST'') is referring to these grants
as ``FASTLANE'' or ``INFRA'' Discretionary Grants, depending on the
year of award. The purpose of each program is to advance projects that
will have a significant impact on the Nation, metropolitan area or a
region.
    This notice seeks comments on the proposed information collection,
which will collect information necessary to support the ongoing
oversight and administration of previous awards, the evaluation and
selection of new applications, and the funding agreement negotiation
stage for new awards.
    The reporting requirements for the program is as follows:
    To be considered to receive a FASTLANE/INFRA grant, a project
sponsor must submit an application to DOT containing a project
narrative, as detailed in the Notice of Funding Opportunity. The
project narrative should include the information necessary for the
Department to determine that the project satisfies eligibility
requirements as warranted by law.
    Following the announcement of a funding award, the recipient and
DOT will negotiate and sign a funding agreement. In the agreement, the
recipient must describe the project that DOT agreed to fund, which is
the project that was described in the FASTLANE/INFRA application or a
reduced-scope version of that project. The agreement also includes a
project schedule and budget.
    During the project monitoring stage, grantees will submit reports
on the financial condition of the project and the project's progress.
Grantees will submit progress and monitoring reports to the Government
on a quarterly basis until completion of the project. The progress
reports will include an SF-425, Federal Financial Report, and other
information determined by the administering DOT Operating
Administration. This information will be used to monitor grantees' use
of Federal funds, ensuring accountability and financial transparency in
the FASTLANE/INFRA program.
    For the purposes of estimating the information collection burden
below for new applicants and awardees, the Department is assuming that
for each year 2021-2023, the Department will review approximately 200
applications in Year 1, negotiate 20 funding agreements in Year 2, and
begin quarterly project monitoring for 20 projects in Year 3. For a new
applicant in 2021, their burden will be 100 hours in 2020, 4 hours in
2022, and 20 hours in 2023. See Table 1 below:

                                                                         Table 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Year 1 (2021)                   Year 2 (2022)                   Year 3 (2023)
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Respondent                      Hours         Frequency         Hours         Frequency         Hours         Frequency         Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
2021 Applicant (200)....................             100               1  ..............  ..............  ..............  ..............           20000
2021 Awardee (20).......................  ..............  ..............               4               1  ..............  ..............              80
2021 Recipient (20).....................  ..............  ..............  ..............  ..............               5               4             400
2022 Applicant (200)....................             100               1  ..............  ..............  ..............  ..............           20000
2022 Awardee (20).......................  ..............  ..............               4               1  ..............  ..............              80
2022 Recipient (20).....................  ..............  ..............  ..............  ..............  ..............  ..............
2023 Applicant (200)....................             100               1  ..............  ..............  ..............  ..............           20000
2023 Awardee (20).......................  ..............  ..............  ..............  ..............  ..............  ..............
2023 Recipient (20).....................  ..............  ..............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    This Notice is separately estimating the information collection
burden for projects awarded from 2016-2020. Approximately 60 of these
projects are in the project monitoring phase in Year 1, while 40
projects are still negotiating funding agreements. In Year 2,
approximately 30 of these projects will begin project monitoring, while
approximately 20 projects will cease reporting once their projects are
completed. In Year 3, 10 projects will begin project monitoring while
20 projects will cease reporting. The individual burden for a project
awarded from 2016-2020 will depend on when they were selected, when
they completed negotiation of their funding agreement, and when their
project reaches completion. See Table 2 below:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Year 1                           Year 2                           Year 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Respondent                    Number      Hrs        Freq      Number      Hrs        Freq      Number      Hrs        Freq      Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016-2020 Awardee.........................         40          4          1         10          4          1          0          4          1        200
2016-2020 Recipient.......................         60          5          4         70          5          4         60          5          4       3800
2016-2020 Project Closed..................          0          0          0         20          0          0         40          0          0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Department's estimated burden for this information collection
is as follows:
    New Applications:
    Expected Number of Respondents: Approximately 200 per year.
    Frequency: Once.
    Estimated Average Burden per Response: 100 hours for each new
Application;
    For Funding Agreements:
    Expected Number of Respondents: Approximately 30 in Year 1 and 2,
20 in Year 3.
    Frequency: Once.
    Estimated Average Burden per Response: 4 hours for each new Funding
Agreement.
    For Project Monitoring:
    Expected Number of Respondents: Estimated 60 in Year 1, 70 in Year
2, 80 in Year 3.
    Frequency: Quarterly.
    Estimated Average Burden per Response: 5 hours for each request for
Quarterly Progress and Monitoring Report;
    Estimated Total 3-year Burden on Respondents: 64,560 hours. (New
Applicants [60,000 hrs], New Awardees/Recipients [560 hrs] + Prior
Awardees/Recipients [4000 hrs]).
    The following is detailed information and instructions regarding
the specific reporting requirements for each report identified above:

Application Stage

    To be considered to receive a FASTLANE or INFRA grant, a project
sponsor must submit an application to DOT containing a project
narrative, as detailed in the Notice of Funding Opportunity. The
project narrative should include the information necessary for the
Department to determine that the project satisfies eligibility
requirements.
    Applications must be submitted through www.Grants.gov. Instructions
for submitting applications can be found at https://www.transportation.gov/buildamerica/infragrants. The application must
include the Standard Form 424 (Application for Federal Assistance),
Standard Form 424C (Budget Information for Construction Programs),
cover page, and the Project Narrative.
    The application should include a table of contents, maps, and
graphics, as appropriate, to make the information easier to review. The
Department recommends that the application be prepared with standard
formatting preferences (i.e., a single-spaced document, using a
standard 12-point font such as Times New Roman, with 1-inch margins).
The project narrative may not exceed 25 pages in length, excluding
cover pages and table of contents. The only substantive portions that
may exceed the 25-page limit are documents supporting assertions or
conclusions made in the 25-page project narrative. If possible, website
links to supporting documentation should be provided rather than copies
of these supporting materials. If supporting documents are submitted,
applicants should clearly identify within the project narrative the
relevant portion of the project narrative that each supporting document
supports. At the applicant's discretion, relevant materials provided
previously to a modal administration in support of a different USDOT
financial assistance program may be referenced and described as
unchanged.
    OST estimates that it takes approximately 100 person-hours to
compile an application package for a FASTLANE/INFRA application. Since
OST expects to receive 200 applications per funding round, the total
hours required are estimated to be 20,000 hours (100 hours x 200
applications = 20,000 hours) on a one-time basis, per funding round.

Funding Agreement Stage

    DOT enters a funding agreement with each recipient. In the
agreement, the recipient describes the project that DOT agreed to fund,
which is typically the project that was described in the FASTLANE/INFRA
application or a reduced-scope version of that project. The agreement
also includes the project schedule and budget.
    OST estimates that it takes approximately 4 person-hours to respond
to provide the information necessary for funding agreements. Based on
previous rounds of FASTLANE/INFRA awards, OST estimates that there will
likely be 20 agreements negotiated per additional funding round. The
total hours required are estimated to be 40 (4 hours x 40 agreements =
40 hours) on a one-time basis, per funding round.

Project Monitoring Stage

    OST requires each recipient to submit quarterly reports during the
project to ensure the proper and timely expenditure of Federal funds
under the grant.
    The requirements comply with 2 CFR part 200 and are restated in the
funding agreement. During the project monitoring stage, the grantee
will complete Quarterly Progress Reports to allow DOT to monitor the
project budget and schedule.
    OST estimates that it takes approximately 5 person-hours to develop
and submit a quarterly progress report. OST expects approximately 20
projects to be awarded per funding round, while grants awarded in prior
years will reach completion during the year and would no longer need to
submit these reports. OST expects recipients and awardees from 2016-
2020 will require 3800 hours to submit project monitoring reports while
new recipients and awardees will require 560 hours from 2021-2023.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on November 12, 2020.
John Augustine,
Director of the Office of Infrastructure Finance and Innovation, Office
of the Under Secretary for Transportation Policy.
[FR Doc. 2020-25321 Filed 11-16-20; 8:45 am]
BILLING CODE 4910-9X-P


  SEQ CHAPTER \h \r 1 Dear Honorable Tribal Leaders,

The purpose of this letter is to seek your advice on how the US
Environmental Protection Agency (“EPA”) can best consult with your
Tribe and other federally-recognized Indian Tribes (“Tribes”) on the
Minor Source New Source Review (“Tribal NSR rule”) rulemaking
effort.  As a pilot project for tribal consultation, we will be using
the Tribal NSR rule for Indian Country.  This rule may affect businesses
located in Indian Country and may affect Tribal governments and
communities.

The EPA is starting the initial steps to develop the Tribal NSR rule to
address significant regulatory gaps in the protection of air quality in
Indian Country. The Clean Air Act requires a new source review program
for sources of air pollution.  The Tribal NSR rule will address smaller
air pollution sources (usually called “minor sources”) of air
pollution.  Minor sources could be new businesses or existing businesses
that are making changes in equipment or in their operation that would
result in small increases in emissions. Collectively, they may be a
significant source of air quality problems in Indian Country because
they are much more numerous than large sources.  Examples of minor
sources could include gasoline stations, dry cleaners, spray paint
operations, automotive repair shops, etc.  Currently, minor sources in
Indian Country are unregulated, and Tribes have expressed concerns to us
about the cumulative impacts.  Although many States have developed
regulatory programs for minor sources, these do not apply in Indian
country, and there is currently no Federal minor source program. Our
plan is that the Tribal NSR rule will put a Federal minor source program
in place within Indian Country.

The EPA wishes to work with Tribal governments to develop sustainable
processes for consulting meaningfully with Tribal governments.  In this
effort, we hope to conduct our efforts with sensitivity to the needs and
culture of Tribes and with attention to the impact of our actions on
Tribal sovereignty.  We recognize that one Tribe does not speak for
another, and that there is no one organization that represents all
Tribes.  The EPA’s goal, therefore, is to reach as many Tribes as
possible through a consultation process.

We note that resource constraints upon the Tribes and the EPA make
meaningful consultation with all Tribal governments an enormous
challenge.  The EPA will share information in an early, open and
continuing basis and facilitate Tribal participation as much as
possible.  We will strive to clearly define our objectives, Clean Air
Act requirements and the limitations on our activities.  In recognition
of the practical realities of undertaking this effort, we are asking for
your help in developing these processes.

The EPA is considering several ways to consult with tribes, such as
calling Tribal contacts directly, or meeting at workshops and national
tribal meetings across the United States.  Also, to develop a
communication strategy, the EPA is considering electronic mailings,
publishing articles in Indian Country newsletters, mailing information
to tribal governments and posting materials on EPA’s TribalAir
website.  Please let us know of other particular mechanisms that could
be used between your Tribe and EPA.  Attached below is a check list of
various options.  We would be grateful if you would please fill it out
and either mail, email, or fax the sheet back to us at<PHONE_NUMBER> by
July 31, 2002.

The input received will be invaluable to EPA in developing a
consultation process which will best serve both tribal needs and Clean
Air Act requirements. The process will be developed in accordance with
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, and will facilitate coordination, if needed, for the
requirements of the Small Business Regulatory Enforcement Fairness Act
(SBREFA).  The presence of small businesses on tribal lands requires
that these entities have an opportunity for meaningful input as required
by the Small Business Regulatory Enforcement Fairness Act.

We encourage you or your staff to respond with your ideas and
recommendations on how to develop the consultation process.  We would
also like to know your interest in consulting on the minor source New
Source Review rule.

Sincerely,

Thomas C. Curran

Acting Director

Office of Air Quality Planning

and Standards

Enclosure:

Minor Source New Source Review

Please check off all options your Tribe would prefer for input on the
Rule:

___	Direct call with appropriate Tribal contact.

___	Electronic mailings with appropriate Tribal contact.

___	Participating in Tribal workshops/stakeholder meetings.

___	Publish articles in Indian Country newsletters, asking for comment.

___	Mail information to Tribal Governments/Environmental staff, asking
for comment.

___	Post materials on EPA’s TribalAir website, asking for comment.

___	Other recommendations.  Explain:
_____________________________________
_________________________________________________________________
   _________________________________________________________________
       _________________________________________________________________

___	Would you prefer a face to face meeting if it could be arranged, and
where?
__________________________________________________________________

Do you have a specific person we could talk to on a regular basis
regarding the Tribal rule?

Name: __________________    Phone : ________________ Fax :
__________________

Mailing Address:_______________________

                            _______________________

                            _______________________

Your name and phone number if different from above:

Name: __________________   Tribe Name: ___________________

Phone: __________________

Please return this form to: 	Joyce Barkley, Project Lead

				US Environmental Protection Agency

				OAQPS/Integrated Implementation Group

				Mailcode-C339-03

				Research Triangle Park, NC 27711

<PHONE_NUMBER> (telephone)

<PHONE_NUMBER> (fax)

<EMAIL_ADDRESS>


[Federal Register Volume 87, Number 91 (Wednesday, May 11, 2022)]
[Notices]
[Pages 28822-28823]
[FR Doc No: 2022-10103]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3562-026]

KEI (Maine) Power Management (III) LLC; Notice of Settlement
Agreement and Soliciting Comments

    Take notice that the following settlement agreement has been filed
with the Commission and is available for public inspection.
    a. Type of Application: Settlement Agreement.
    b. Project No.: 3562-026.
    c. Date filed: April 29, 2022.
    d. Applicant: KEI (Maine) Power Management (III) LLC.
    e. Name of Project: Barker Mill Upper Hydroelectric Project (a.k.a.
Upper Barker Project).
    f. Location: On the Little Androscoggin River, in the City of
Auburn, Androscoggin County, Maine. The project does not affect federal
lands.
    g. Filed Pursuant to: Rule 602 of the Commission's Rules of
Practice and Procedure, 18 CFR 385.602.
    h. Applicant Contact: Lewis C. Loon, General Manager, KEI (USA)
Power Management Inc., 423 Brunswick Avenue, Gardiner, ME 04345; phone
at<PHONE_NUMBER>; email at [email protected].
    i. FERC Contact: John Matkowski, telephone<PHONE_NUMBER>, and
email [email protected].
    j. Deadline for filing comments: May 25, 2022. Reply comments due
June 4, 2022.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to
6,000 characters, without prior registration, using the eComment system
at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-3562-026.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. KEI (Maine) Power Management (III) LLC (KEI Power) filed a
Settlement Agreement for the Barker's Mill Project (FERC No. 2808),\1\
Upper Barker Project (FERC No. 3562), and Marcal Project (FERC No.
11482) (Settlement) executed by and between the licensee and the U.S.
Department of Justice, the U.S. Fish and Wildldife Service, the
National Marine Fisheries Service, the Maine

Department of Marine Resources (Maine DMR), and the Maine Department of
Inland Fisheries and Widlife (Settlement Parties). The purpose of the
Settlement is to resolve the parties' disagreements over the issues
related to fish and aquatic resource management, including upstream and
downstream passage measures for American eel, river herring, American
shad, sea lamprey, and Atlantic salmon; minimum flow releases; and,
aquatic invasive species. Specifically for the relicensing of the Upper
Barker Project, the Settlement provides for: (1) Coordinating the time
frame for providing upstream and downstream fish passage at the Upper
Barker Project; (2) aligning the minimum and seasonal flows at the
Upper Barker and the Lower Barker Projects; (3) aligning the Upper
Barker and Lower Barker Projects license terms by extending the 40-year
license term of the Lower Barker Project to 50 years and requesting a
license term of 47 years for the Upper Barker Project; (4) establishing
an off-license agreement to fund an Androscoggin Basin Stewardship Fund
administered by Maine DMR to benefit spawning and rearing habitat in
the basin; and (5) assuring, through an off-license agreement, the
resources agencies' support for KEI Power's request for Low Impact
Hydropower Institute certification for the Upper Barker Project.
---------------------------------------------------------------------------

    \1\ The Barker's Mill Project is also known as and referred
herein as the Lower Barker Project.
---------------------------------------------------------------------------

    l. A copy of the Settlement Agreement is available for review 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 (i.e., P-3562). For
assistance, contact FERC Online Support.
    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.

    Dated: May 5, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-10103 Filed 5-10-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 21, 2010 (Volume 75, Number 13)]
[Notices]
[Page 3508-3509]
[DOCID:fr21ja10-96]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61348: File No. SR-ISE-2010-01]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of a Proposal To
Codify Certain Provisions of the Options Listing Procedures Plan Into
ISE's Rules

January 14, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 4, 2010, the International Securities Exchange, LLC
(the ``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Exchange filed the proposal as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
\3\ and Rule 19b-4(f)(6) thereunder.\4\ The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Rule 504 and adopt Rule 504A to
apply uniform objective standards to the range of options series
exercise (or strike) prices available for trading on the Exchange. The
text of the proposed rule change is available on the Exchange's Web
site http://www.ise.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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The self-regulatory organization has prepared summaries,
set forth in Sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to implement in ISE
rules changes that were recently made to the Plan for the Purpose of
Developing and Implementing Procedures Designated to Facilitate the
Listing and Trading of Standardized Options Submitted Pursuant to
Section 11A(a)(3)(B) of the Securities Exchange Act of 1934, also known
as the Options Listing Procedures Plan (``OLPP''), in Amendment No. 3
thereto.\5\ Proposed new ISE Rule 504A incorporates uniform objective
standards to the range of options series exercise (or strike) prices
available for trading on the Exchange, as a quote mitigation strategy
intended to reduce the overall number of option series available for
trading, which will in turn lessen the rate of increase in quote
traffic (``range limitations'' or ``range limitation strategy'').
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 60531 (August 19,
2009), 74 FR 43173 (August 26, 2009) (Order approving Amendment No.
3 to the OLPP, which would apply uniform objective standards to the
range of options series exercise or strike prices available for
trading on exchanges that are sponsors of OLPP). The sponsors of
OLPP include ISE, Chicago Board Options Exchange, Inc.; NASDAQ OMX
PHLX, Inc.; NASDAQ OMX BX, Inc.; The NASDAQ Stock Market LLC; NYSE
Amex, LLC; and NYSE Arca, Inc. (together known as the ``Plan Sponsor
Exchanges''). The OLPP is a national market system plan that, among
other things, sets forth procedures governing the listing of new
options series and replaces and supersedes the Joint-Exchange
Options Plan (``JEOP''). See Securities Exchange Act Release No.
44521 (July 6, 2009) [sic], 66 FR 36809 (July 13, 2001) (Order
approving OLPP). See also Securities Exchange Act Release No. 29698
(September 17, 1991), 56 FR 48954 [sic] (September 25, 1991) (Order
approving JEOP).
---------------------------------------------------------------------------

    Rule 504 currently indicates what series of option contracts may be
open for trading after a particular class of options has been approved
for trading on the Exchange. Proposed new Rule 504A applies certain
``range limitations'' to the addition of new series for options classes
overlying equity securities, Exchange Traded Fund Shares (``ETFs''), or
Trust Issued Receipts (``TIRs'').
    As proposed in Rule 504A, if the price of the underlying security
is less than or equal to $20, the Exchange would not list new option
series with an exercise price more than 100 percent above or below the
price of the underlying security.\6\ If the price of the underlying
security is greater than $20, the Exchange would not list new options
series with an exercise price more than 50 percent above or below the
price of the underlying security. The proposal provides for an
objective basis upon which the underlying prices for the price range
limitations described above shall be determined, specifically in regard
to intra-day add-on series and next-day series additions, new
expiration months and for options series to be added as a result of
pre-market trading.
---------------------------------------------------------------------------

    \6\ This restriction would not prohibit the listing of at least
three options series per expiration month in an options class.
---------------------------------------------------------------------------

    This proposed rule change also allows the Exchange to designate up
to five underlying securities to which, instead of the aforementioned
50 percent restriction, a 100 percent restriction would apply. These
designations would be made on an annual basis and cannot be removed
during the calendar year unless the options class is delisted by the
Exchange, in which case the Exchange may designate another class to
replace the delisted class. If a designated class is delisted by the
Exchange but continues to trade on at least one other exchange, any
additional series for the class which are added from that point forward
would again be subject to the proposed exercise price range
limitations, unless the class is subsequently designated by another
exchange. The proposal also provides a procedure for the Exchange to
request, if conditions warrant, additional case-by-case exceptions even
when it has already so designated five underlying securities.
    In addition, the Exchange may request, on a case-by-case basis, an
exemption when it desires to list a series from the 100 percent range
limitation. This procedure would enable the Exchange to list options
series with strike prices that are more than 100 percent above or below
the price of an underlying security, if unanimously agreed upon by all
exchanges that list options overlying the security.\7\
---------------------------------------------------------------------------

    \7\ Application of any of the aforementioned exceptions and/or
exemptions to the strike price range limitations for an underlying
security would be available to all exchanges listing options on such
security.
---------------------------------------------------------------------------

    The Exchange notes that the proposal would not restrict its ability
to list options series in two situations. First, the Exchange would not
be restricted from listing options series that have been properly
listed by another exchange. And second, the proposal expressly
eliminates the applicability of range limitations with regard to the

listing of $1 strike prices in option classes participating in the $1
Strike Program, and the listing of series of FLEX options.
    The Exchange believes that the proposed rule change implementing
range limitation strategies for equity, ETF, and TIR options should be
beneficial in reducing quote traffic on the Exchange and in the options
industry.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations under the Act applicable to a national securities exchange
and, in particular, the requirements of Section 6(b) of the Act.\8\
Specifically, the Exchange believes the proposed rule change is
consistent with Section 6(b)(5) of the Act's \9\ requirements that the
rules of a national securities exchange be designed to promote just and
equitable principles of trade, to prevent fraudulent and manipulative
acts and, in general, to protect investors and the public interest. In
particular, the Exchange believes that codifying certain range
limitation provisions of the OLPP, as amended, serves to foster
investor protection.
---------------------------------------------------------------------------

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

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6)(iii) thereunder.\13\
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    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to give the Commission written
notice of the Exchange's intent to file the proposed rule change
along with a brief description and the text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied the pre-filing requirement.
---------------------------------------------------------------------------

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

 IV. Solicitation of Comments

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

Electronic Comments:

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-01 on the subject line.

Paper Comments:

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

All submissions should refer to File Number SR-ISE-2010-01. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-ISE-
2010-01 and should be submitted on or before February 11, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-1019 Filed 1-20-10; 8:45 am]
BILLING CODE 8011-01-P


PP# 4E6867

Research Project #4 and Valent U.S.A Corporation

EPA has received a pesticide petition from the Interregional Research
Project #4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540 for Valent U.S.A.
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, California
94596-8025, proposing, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR Part
180.466 by establishing tolerances for residues of fenpropathrin in or
on the raw agricultural commodities, fruit, stone, group 12 at 5.0 ppm;
nut, tree, group 14 at 0.10 ppm, pistachio at 0.10 ppm and almond hulls
at 5.0 ppm.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of the
FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.

Residue Chemistry

Plant and animal metabolism.  The qualitative nature of fenpropathrin
residues in plants and animals is adequately understood and was
previously published in the Federal Register of March 2, 2000 (65 FR
11234) (FRL-6492-6).

 Analytical method.  Adequate enforcement methods are available for
determination of fenpropathrin residues in plant commodities.  The
available analytical enforcement methodology was previously reviewed in
the Federal Register of March 2, 2000 (65 FR 11234) (FRL-6492-6).

Magnitude of residues.  Complete residue data for fenpropathrin on stone
fruit and tree nuts (including pistachio) has been submitted.  The
requested tolerances are adequately supported.

Toxicological Profile

The toxicological profile and endpoints of concern for Fenpropathrin,
which supports this petition to establish tolerances, were previously
reviewed in the Federal Register of March 2, 2000 (65 FR 11234)
(FRL-6492-6).

Aggregate Exposure

Dietary exposure.  Assessments were conducted to evaluate potential
risks due to acute and chronic dietary exposure of the general U.S.
population and various population subgroups to residues of
fenpropathrin.  These analyses include all registered crops, uses
pending with the Agency as well as all active and proposed Section 18
uses.  There are no residential uses for fenpropathrin; therefore
aggregate exposure consists entirely of dietary (food and drinking
water) exposures.  Toxicity endpoints of concern were identified by the
Agency’s Health Effects Division, HIARC on July 17, 1997 and revised
November 14, 1997.

Food.  Tier 3 acute and chronic dietary exposures and risk analyses were
conducted to assess potential dietary exposure to residues of
fenpropathrin. These risk analyses were conducted using the Cumulative
and Aggregate Risk Evaluation System (CARES) and are completely
consistent with the USEPA’s Tier 3 approach.

Acute exposure.  Acute dietary exposure was calculated for the U.S.
population and 20 population subgroups.  At the 99.9th percentile of
exposure, the highest exposed population subgroup was children 1-2 years
old with an estimated exposure of 0.0238 mg/kg bwt/day, representing
39.7% of the acute population adjusted dose (aPAD) of 0.06 mg/kg bwt/day
and an MOE of 250.

Chronic exposure.  Chronic dietary exposure was calculated for the U.S.
population and 12 population subgroups.  For the US population, the
chronic exposure for fenpropathrin was 0.00027 mg/kg bwt/day,
representing 1.08% of the cPAD, and an MOE of 9,250.

Chronic exposure was also calculated for 12 sub-populations.  For the
various sub-populations, the 100th percentile of chronic exposure was
highest among children 1-2 years old at 0.00145 mg/kg bwt/day,
representing 5.8% of the cPAD, and an MOE of 1,700.

Drinking water.  A worst-case estimate of potential fenpropathrin
drinking water acute and chronic exposure of 2.26 ppb was obtained from
the peak concentration from Tier I modeling using GENEEC 1.2.  Because
of mitigating factors such as dilution from rain or other water sources,
and soil binding, actual concentrations of fenpropathrin that might
occur in drinking water derived from surface water sources are likely to
be much lower than levels predicted by GENEEC.

Acute drinking water risk.  Acute Drinking Water Levels of Concern
(aDWLOC) were calculated based on the aPAD, worst-case acute dietary
(food) exposure from the CARES analysis, and default assumptions about
drinking water consumption and body weight.  The aDWLOC value calculated
for non-nursing infants, the subpopulation with the greatest dietary
(food) exposure was 362 ppb.  Since the aDWLOC of 362 ppb is
considerably higher than the worst-case drinking water exposure of 2.26
ppb, the EPA should not have a concern for acute risk from drinking
water exposure.

Chronic drinking water risk.  Chronic Drinking Water Levels of Concern
(cDWLOC) were calculated based on the cPAD, worst-case chronic dietary
(food) exposure from the CARES analysis, and default assumptions about
drinking water consumption and body weight.  The cDWLOC value calculated
for non-nursing infants, the subpopulation with the greatest dietary
(food) exposure was 236 ppb.  Since the cDWLOC of 236 ppb is
considerably higher than the worst-case drinking water exposure of 2.26
ppb, the EPA should not have a concern for chronic risk from drinking
water exposure.

Non-dietary exposure.  Fenpropathrin is registered for professional
non-food use both indoors and outdoors on ornamentals and non-bearing
nursery fruit trees. Fenpropathrin has no animal health, homeowner,
turf, termite, indoor pest control, or industrial uses. Quantitative
information concerning human exposure from this ornamental use is not
available, but exposure to the general public from this use of
fenpropathrin is expected to be minimal.  No endpoints of concern were
identified by the Health Effects Division, Hazard Identification
Assessment Review Committee for occupational or residential, dermal or
inhalation exposures of any duration.  Thus, no additional risk
assessment is needed.

Cumulative Effects

Section 408(b)(2)(D)(v) requires that the Agency must consider
"available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common
mechanism of toxicity." Available information in this context include
not only toxicity, chemistry, and exposure data, but also scientific
policies and methodologies for understanding common mechanisms of
toxicity and conducting cumulative risk assessments.  For most
pesticides, although the Agency has some information in its files that
may turn out to be helpful in eventually determining whether a pesticide
shares a common mechanism of toxicity with any other substances, EPA has
not at this time developed the methodologies to resolve the complex
scientific issues concerning common mechanism of toxicity.

There are numerous other pesticidal compounds, pyrethroids and natural
pyrethrins that are structurally related to fenpropathrin and may have
similar effects on animals.  In consideration of potential cumulative
effects of fenpropathrin and other substances that may have a common
mechanism of toxicity, there are currently no available data or other
reliable information indicating that any toxic effects produced by
fenpropathrin would be cumulative with those of other chemical
compounds.  Thus, only the potential risks of fenpropathrin have been
considered in this assessment of aggregate exposure and effects.

Valent will submit information for EPA to consider concerning potential
cumulative effects of fenpropathrin consistent with the schedule
established by EPA at 62 Federal Register 42020 (Aug. 4, 1997) and other
EPA publications pursuant to the Food Quality Protection Act.

Safety Determination

U.S. Population.  Valent concludes, based upon the information provided
above, that there is a reasonable certainty that no harm to the U.S.
population will result from aggregate acute or chronic dietary (food and
drinking water) exposure to fenpropathrin residues on stone fruits and
tree nuts (including pistachio) in addition to all currently registered
crops.

Infants and children.  In assessing the potential for additional
sensitivity of infants and children to residues of fenpropathrin, FFDCA
section 408 provides that EPA shall apply an additional margin of
safety, up to ten-fold, for added protection for infants and children in
the case of threshold effects unless EPA determines that a different
margin of safety will be safe for infants and children.

The toxicological data base for evaluating pre- and post-natal toxicity
for fenpropathrin is complete with respect to current data requirements.
 There are no special pre- or post-natal toxicity concerns for infants
and children, based on the results of the rat and rabbit developmental
toxicity studies or the reproductive toxicity study in rats.  EPA’s
HED Hazard ID Committee (Revised Memorandum, November 14, 1997) has
concluded that reliable data support use of the standard 100-fold
uncertainty factor and that an additional uncertainty factor is not
needed for fenpropathrin to be further protective of infants and
children.

Valent concludes, based upon the information provided above, that there
is reasonable certainty that no harm to infants and children will result
from aggregate acute or chronic dietary (food and drinking water)
exposure to fenpropathrin residues on stone fruits and tree nuts
(including pistachio) in addition to all currently registered crops.

International Tolerances

Codex MRLs have been established for residues of fenpropathrin in/on
grapes (5.0 ppm), peppers, sweet (1.0 ppm), pome fruits (5.0 ppm),
tomato (1.0 ppm), gherkin (0.2 ppm), eggplant (0.2 ppm), cotton seed
(1.0 ppm), cotton seed oil, crude (3.0 ppm), cattle meat (0.5 ppm), milk
(0.1 ppm), edible offal (0.05 ppm), eggs (0.01 ppm), poultry meat (0.02
ppm), edible offal (0.01 ppm).

There are small differences between the Section 408 tolerances and the
Codex MRL values for secondary residues in animal products.  These minor
differences are mainly caused by differences in the methods used to
calculate animal feed dietary exposure.