[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Rules and Regulations]
[Page 14932]
[DOCID:fr02ap09-4]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2009-0152]

Drawbridge Operation Regulation; Merrimack River, MA, Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Hines Memorial (Main Street) Bridge across the Merrimack River at mile
5.8, between Amesbury and Newburyport, Massachusetts. Under this
temporary deviation the bridge may remain closed for six weeks.

DATES: This deviation is effective from March 17, 2009 through May 15,
2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0152 and are available online
at http: //www.regulations.gov. They are also available for inspection
or copying two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and the First
Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue,
Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: John McDonald, Project Officer, First
Coast Guard District, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The Hines Memorial (Main Street) Bridge has a vertical clearance in
the closed position of 13 feet at mean high water and 20 feet at mean
low water. The existing drawbridge operation regulations are listed at
33 CFR 117.5.
    The bridge was damaged by a collision with a tug and barge last
November. The bridge was closed to vehicular traffic as a result of
that accident.
    Massachusetts Highway Department (MHD), the bridge owner, requested
a temporary deviation to help facilitate load testing necessary to
determine if the bridge will be able to bear the vehicular traffic
loads that will be present when the bridge is scheduled to be re-opened
to vehicular traffic on May 15, 2009.
    The waterway has seasonal recreational vessels of various sizes.
There have been few requests to open the bridge during April and May in
past years according to the bridge logs.
    This temporary deviation is therefore necessary in order to insure
that the bridge continues to operate in a safe reliable manner.
    Under this temporary deviation, in effect from March 17, 2009
through May 15, 2009, the Hines Memorial (Main Street) Bridge may
remain in the closed position.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 17, 2009.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E9-7400 Filed 4-1-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Rules and Regulations]
[Pages 55362-55366]
[FR Doc No: 2016-19481]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-8463; Directorate Identifier 2014-NM-226-AD;
Amendment 39-18612; AD 2016-16-14]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2013-20-11,
for all Airbus Model A318, A319, A320, and A321 series airplanes. AD
2013-20-11 required modifying the passenger emergency oxygen container
assembly. This new AD expands the affected group of oxygen containers
to include those labeled ``DAe Systems.'' This AD was prompted by a
determination that the unsafe condition also affects oxygen containers
labeled ``DAe Systems.'' We are issuing this AD to prevent a high
temperature oxygen generator and mask from falling down and possibly
resulting in an ignition source in the passenger compartment, injury to
passengers, and reduced availability of supplemental oxygen.

DATES: This AD is effective September 23, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 2,
2013 (78 FR 64162, October 28, 2013).

ADDRESSES: For Airbus 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_ADDRESS>
Internet http://www.airbus.com.
    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 425-
227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8463.

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-
8463; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, 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:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2013-20-11, Amendment 39-17617 (78 FR 64162,
October 28, 2013) (``AD 2013-20-11''). AD 2013-20-11 applied to all
Model A318, A319, A320, and A321 series airplanes. The NPRM published
in the Federal Register on January 20, 2016 (81 FR 3061) (``the
NPRM''). The NPRM was prompted by a determination that the unsafe
condition also affects oxygen containers labeled ``DAe Systems.'' The
NPRM proposed to continue to require modifying the passenger emergency
oxygen container assembly. The NPRM also proposed to expand the
affected group of oxygen containers to include those labeled ``DAe
Systems.'' We are issuing this AD to prevent a high temperature oxygen
generator and mask from falling down and possibly resulting in an
ignition source in the passenger compartment, injury to passengers, and
reduced availability of supplemental oxygen.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2014-0207, dated September 16, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition. The MCAI states:

    It was determined that oxygen generators, installed on a
specific batch of Type 1 (22 min) passenger emergency oxygen
container assemblies, may become detached by extreme pulling of the
mask tube at the end of oxygen supply. Investigations revealed that
such detachment can be caused by the increase in temperature towards
the end of the generator operation, which may weaken the plastic
housing in the attachment area of the bracket.
    This condition, if not corrected, could make the rivets slip
through the plastic housing, causing a `hot' oxygen generator and
mask to fall down, possibly resulting in injury to passengers.
    To address this potential unsafe condition, EASA issued AD 2012-
0055 (later revised) [which corresponds to FAA AD 2013-20-11,
Amendment 39-17617 (78 FR 64162, October 28, 2013)] to require
modification of the affected oxygen container assemblies. That
[EASA] AD also prohibited installation of unmodified containers on
any aeroplane as replacement parts.
    Since that [EASA] AD was issued, it was found that the affected
containers have not only been marked with company name B/E
Aerospace, as was specified, but also, for a brief period, with the
former company name DAe Systems.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2012-0055R1, which is superseded, and
expands the affected group of containers to include those that have
the name ``DAe Systems'' on the identification plate.
    This [EASA] AD also clearly separates the serial number (s/n)
groups of containers into those manufactured by B/E Aerospace and
those manufactured by DAe Systems, for which additional compliance
time is provided.

    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-
8463.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    We estimate that this AD affects 4 airplanes of U.S. registry.
    The actions required by AD 2013-20-11 and retained in this AD take
about 2 work-hours per product, at an average labor rate of $85 per
work-hour. Based on these figures, the estimated cost of the actions
that are required by AD 2013-20-11 is $170 per product.
    We also estimate that it would take about 2 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $680, or $170 per product.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all available costs in our
cost estimate.

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 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 removing Airworthiness Directive (AD)
2013-20-11, Amendment 39-17617 (78

FR 64162, October 28, 2013), and adding the following new AD:

2016-16-14 Airbus: Amendment 39-18612; Docket No. FAA-2015-8463;
Directorate Identifier 2014-NM-226-AD.

(a) Effective Date

    This AD is effective September 23, 2016.

(b) Affected ADs

    This AD replaces AD 2013-20-11, Amendment 39-17617 (78 FR 64162,
October 28, 2013) (``AD 2013-20-11'').

(c) Applicability

    This AD applies to the Airbus airplanes, certificated in any
category, specified in paragraphs (c)(1) through (c)(4) of this AD,
all manufacturer serial numbers.
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.
    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by a determination that oxygen generators
installed on a certain batch of passenger emergency oxygen container
assemblies might become detached by extreme pulling of the mask tube
at the end of the oxygen supply causing a high temperature oxygen
generator and mask to fall down. This AD was also prompted by a
determination that the unsafe condition affects oxygen containers
labeled ``DAe Systems.'' We are issuing this AD to prevent a high
temperature oxygen generator and mask from falling down and possibly
resulting in an ignition source in the passenger compartment, injury
to passengers, and reduced availability of supplemental oxygen.

(f) Compliance

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

(g) Retained Oxygen Container Assembly Modification, With Service
Information Referenced in a New Paragraph

    This paragraph restates the requirements of paragraph (g) of AD
2013-20-11 with service information referenced in a new paragraph.
Except as specified in paragraphs (g)(1), (g)(2), and (g)(3) of this
AD, within 5,000 flight cycles, or 7,500 flight hours, or 24 months,
whichever occurs first, after December 2, 2013 (the effective date
of AD 2013-20-11): Modify each type 1 (22 minute) passenger
emergency oxygen container assembly installed on an airplane, having
a part number (P/N) listed in paragraph (g)(1)(i) of this AD and a
serial number (S/N) listed in paragraph (g)(1)(ii) of this AD, in
accordance with the Accomplishment Instructions of the applicable
Airbus service information specified in paragraphs (k)(1) through
(k)(7) of this AD.
    (1) An oxygen container that has a part number listed in
paragraph (g)(1)(i) of this AD and a serial number as listed in
paragraph (g)(1)(ii) of this AD, and that has been modified using
the instructions of B/E Aerospace Service Bulletin 1XC22-0100-35-
006, is compliant with the modification requirement of paragraph (g)
of this AD.
    (i) Oxygen container part numbers listed in paragraphs
(g)(1)(i)(A) through (g)(1)(i)(D) of this AD, where xxxxx stands for
an alphanumerical value.
    (A) 13C22Lxxxxx0100.
    (B) 13C22Rxxxxx0100.
    (C) 14C22Lxxxxx0100.
    (D) 14C22Rxxxxx0100.
    (ii) Oxygen container serial numbers listed in paragraphs
(g)(1)(ii)(A) through (g)(1)(ii)(H) of this AD.
    (A) ARBC-0182 to ARBC-9999, inclusive.
    (B) ARBD-0000 to ARBD-9999, inclusive.
    (C) ARBE-0000 to ARBE-9999, inclusive.
    (D) BEBF-0000 to BEBF-9999, inclusive.
    (E) BEBH-0000 to BEBH-9999, inclusive.
    (F) BEBK-0000 to BEBK-9999, inclusive.
    (G) BEBL-0000 to BEBL-9999, inclusive.
    (H) BEBM-0000 to BEBM-0454, inclusive.
    (2) Airplanes on which Airbus Modification 150704 has not been
embodied in production are excluded from the requirements of
paragraph (g) of this AD, unless an oxygen container with a part
number listed in paragraph (g)(1)(i) of this AD and a serial number
listed in paragraph (g)(1)(ii) of this AD is installed.
    (3) Airplanes on which Airbus Modification 150704 has been
embodied in production and that are not listed by model and
manufacturer serial number in the applicable Airbus service
information specified in paragraphs (k)(1) through (k)(7) of this
AD; are excluded from the requirements of paragraph (g) of this AD,
unless an oxygen container with a part number listed in paragraph
(g)(1)(i) of this AD and a serial number listed in paragraph
(g)(1)(ii) of this AD is installed.

    Note 1 to paragraph (g) of this AD: The oxygen container
assemblies listed in paragraph (g)(1)(i) of this AD and paragraph
(g)(1)(ii) of this AD are B/E Aerospace products with the mark ``B/E
AEROSPACE'' on the identification plate.

(h) Retained Parts Installation Limitation, With Service Information
Referenced in a New Paragraph

    This paragraph restates the requirements of paragraph (h) of AD
2013-20-11 with service information referenced in a new paragraph.
As of December 2, 2013 (the effective date of AD 2013-20-11), no
person may install, on any airplane, an oxygen container with a part
number listed in paragraph (g)(1)(i) of this AD, and serial number
listed in paragraph (g)(1)(ii) of this AD, unless the oxygen
container has been modified according to the applicable Airbus
service information specified in paragraphs (k)(1) through (k)(7) of
this AD.

(i) New Requirement of This AD: Modification of Additional Oxygen
Containers

    At the applicable times specified in paragraphs (i)(1) and
(i)(2) of this AD: Modify each type 1 (22 minute) passenger
emergency oxygen container assembly installed on an airplane, having
a part number and a serial number listed in paragraph (j) of this
AD, in accordance with the Accomplishment Instructions of the
applicable Airbus service information specified in paragraphs (k)(1)
through (k)(7) of this AD; except as specified in paragraph (l) of
this AD.
    (1) For units with ``B/E AEROSPACE'' on the identification plate
and having a part number and a serial number listed in paragraph
(j)(1) of this AD: Within 5,000 flight cycles, or 7,500 flight
hours, or 24 months, whichever occurs first after the effective date
of this AD.
    (2) For units with ``DAe Systems'' on the identification plate
and having a part number and a serial number listed in paragraph
(j)(2) of this AD: Within 2,500 flight cycles, or 3,750 flight
hours, or 12 months, whichever occurs first after the effective date
of this AD.

(j) New Part Numbers and Serial Numbers for the Parts Affected by
Paragraph (i) of This AD

    Affected parts for the actions required by paragraph (i) of this
AD are identified in paragraphs (j)(1) and (j)(2) of this AD.
    (1) For oxygen containers with ``B/E AEROSPACE'' on the
identification plate: Units having a part number identified in
paragraphs (j)(1)(i) through (j)(1)(iv) of this AD, where part
number ``xxxxx'' stands for any alphanumerical value, and a serial
number of BEBM-0455 to BEBM-9999, inclusive.
    (i) 13C22Lxxxxx0100.
    (ii) 13C22Rxxxxx0100.
    (iii) 14C22Lxxxxx0100.
    (iv) 14C22Rxxxxx0100.
    (2) For oxygen containers with ``DAe Systems'' on the
identification plate: Units having a part number identified in
paragraphs (j)(1)(i) through (j)(1)(iv) of this AD, where part
number ``xxxxx'' stands for any alphanumerical value, and a serial
number identified in paragraphs (j)(2)(i) through (j)(2)(iv) of this
AD.
    (i) ARBC-0000 to ARBC-9999 inclusive.
    (ii) ARBD-0000 to ARBD-9999 inclusive.
    (iii) ARBE-0000 to BEBE-9999 inclusive.
    (iv) BEBE-0000 to BEBE-9999 inclusive.

(k) Service Information for the Requirements of Paragraphs (g), (h),
(i), and (m) of This AD

    Accomplish the requirements specified in paragraphs (g), (h),
(i), and (m) of this AD in accordance with the Accomplishment
Instructions of the applicable Airbus service information identified
in paragraphs (k)(1) through (k)(7) of this AD.
    (1) Airbus Service Bulletin A320-35-1049, dated June 15, 2011.
    (2) Airbus Service Bulletin A320-35-1053, dated June 15, 2011.
    (3) Airbus Service Bulletin A320-35-1054, dated June 15, 2011.
    (4) Airbus Service Bulletin A320-35-1055, dated June 15, 2011.
    (5) Airbus Service Bulletin A320-35-1056, dated June 15, 2011.
    (6) Airbus Service Bulletin A320-35-1057, dated June 15, 2011.
    (7) Airbus Service Bulletin A320-35-1058, dated June 15, 2011.

(l) New Exceptions to the Requirements of Paragraph (i) of This AD

    (1) An oxygen container that has a part number and a serial
number listed in paragraph (j) of this AD, and that has been
modified as specified in B/E Aerospace Service Bulletin 1XC22-0100-
35-006, is compliant with the modification requirement of paragraph
(i) of this AD.
    (2) Airplanes on which Airbus Modification 150704 has not been
embodied in production are excluded from the requirements of
paragraph (i) of this AD, unless an oxygen container with a part
number and a serial number listed in paragraph (j) of this AD is
installed.
    (3) Airplanes on which Airbus Modification 150704 has been
embodied in production and that are not listed by model and
manufacturer serial number in the Airbus service information
specified in paragraphs (k)(1) through (k)(7) of this AD, as
applicable, are excluded from the requirements of paragraph (i) of
this AD, unless an oxygen container with a part and a serial number
listed in paragraph (j) of this AD is installed.
    (4) Airplanes on which the design of the passenger oxygen
container is not Design A, as defined in figure 1 to paragraph
(l)(4) of this AD, are excluded from the requirements of paragraph
(i) of this AD for that passenger oxygen container.

    Note 2 to paragraph (l)(4) of this AD: For ``Design A,'' the
placard on the passenger oxygen container test button is as
described in ``Picture A'' in figure 1 to paragraph (l)(4) of this
AD. The mask configuration (``ZZ'' in ``Picture A'') is a number,
and the test button is as shown in ``Picture B.''

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[GRAPHIC] [TIFF OMITTED] TR19AU16.002

BILLING CODE 4910-13-P

(m) New Requirement of This AD: Parts Installation Limitation

    As of the effective date of this AD, no person may install, on
any airplane, an oxygen container with a part number and a serial
number listed in paragraph (j) of this AD, unless the oxygen
container has been modified in accordance with the Accomplishment
Instructions of the applicable Airbus service information specified
in paragraphs (k)(1) through (k)(7) of this AD.

(n) 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: Sanjay
Ralhan, 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>    (i) 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.
    (ii) AMOCs approved previously for AD 2013-20-11 are approved as
AMOCs for the corresponding provisions of paragraphs (g) and (h) of
this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, 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 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.

(o) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA AD 2014-0207, dated September 16, 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-2015-8463.

(p) 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.
    (3) The following service information was approved for IBR on
December 2, 2013 (78 FR 64162, October 28, 2013).
    (i) Airbus Service Bulletin A320-35-1049, dated June 15, 2011.
    (ii) Airbus Service Bulletin A320-35-1053, dated June 15, 2011.
    (iii) Airbus Service Bulletin A320-35-1054, dated June 15, 2011.
    (iv) Airbus Service Bulletin A320-35-1055, dated June 15, 2011.
    (v) Airbus Service Bulletin A320-35-1056, dated June 15, 2011.
    (vi) Airbus Service Bulletin A320-35-1057, dated June 15, 2011.
    (vii) Airbus Service Bulletin A320-35-1058, dated June 15, 2011.
    (4) 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_ADDRESS>Internet
http://www.airbus.com.
    (5) 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
425-227-1221.
    (6) 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 Renton, Washington, on August 3, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-19481 Filed 8-18-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4310-4311]
[FR Doc No: 2016-01473]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-3053]

Determination That IZBA (Travoprost Ophthalmic Solution), 0.003
Percent, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that IZBA (travoprost ophthalmic solution), 0.003 percent,
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for travoprost ophthalmic solution/drops, 0.003
percent, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the clinical testing otherwise necessary to gain approval of a
new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    IZBA (travoprost ophthalmic solution), 0.003 percent, is the
subject of NDA 204822, held by Alcon Laboratories, Inc., and initially
approved on May 15, 2014. IZBA is indicated for the reduction of
elevated intraocular pressure in patients with open-angle glaucoma or
ocular hypertension.
    In a letter dated September 4, 2015, Alcon Laboratories, Inc.
notified FDA that IZBA (travoprost ophthalmic solution), 0.003 percent,
was discontinued. IZBA (travoprost ophthalmic solution), 0.003 percent,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book.
    Jonathan Goodman of Florek & Endres PLLC submitted a citizen
petition dated August 20, 2015 (Docket No. FDA-2015-P-3053), under 21
CFR 10.30, requesting that the Agency determine whether IZBA
(travoprost ophthalmic solution), 0.003 percent, was withdrawn from
sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that IZBA (travoprost ophthalmic solution), 0.003
percent, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
IZBA (travoprost ophthalmic solution), 0.003 percent, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of IZBA (travoprost
ophthalmic solution), 0.003 percent, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list IZBA (travoprost
ophthalmic solution), 0.003 percent, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to IZBA (travoprost ophthalmic
solution), 0.003 percent, may be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: January 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01473 Filed 1-25-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 14, 2009 (Volume 74, Number 176)]
[Notices]
[Page 47032-47034]
[DOCID:fr14se09-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60627; File No. SR-Phlx-2009-78]

Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
an Extension of the FLEX Minimum Size Pilot Program

September 4, 2009.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on September 3, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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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 Phlx rules to amend its Rule 1079
(FLEX Index, Equity and Currency Options), to amend its Rule 1079 (FLEX
Index, Equity and Currency Options), [sic] to extend through September
4, 2010, the Exchange's pilot program that reduced from 250 contracts
to 150 contracts the minimum value size for an opening transaction
(other than FLEX Quotes responsive to a FLEX Request for Quotes) \5\ in
any FLEX Equity Option \6\ series in which there is no open interest at
the time a FLEX Request for Quotes (``RFQ'') is submitted (the ``Pilot
Program'').\7\
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    \5\ FLEX Quotes responsive to a FLEX Request for Quote (``RFQ'')
have different parameters that were not changed by the pilot program
proposal. See Phlx Rule 1079(a)(8)(C).
    \6\ FLEX Equity Options are flexible exchange-traded options
contracts that overlie equity securities. FLEX Equity Options
provide investors with the ability to customize basic option
features including size, expiration date, exercise style, and
certain exercise prices. FLEX Equity Options (as also FLEX index
options) may have expiration dates within five years. See Phlx Rule
1079.
    \7\ See Securities Exchange Act Release No. 57824 (May 15,
2008), 73 FR 29805 (May 22, 2008) (SR-Phlx-2008-35) (notice of
filing and immediate effectiveness establishing the Pilot Program).
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    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to extend the Pilot
Program through September 4, 2010.
    On or about May 15, 2008, the Exchange filed SR-Phlx-2008-35 with
the Commission to establish the Pilot Program. The Pilot Program
reduced the minimum value size for an opening transaction (other than
FLEX Quotes responsive to a FLEX RFQ) in any FLEX Equity Option series
in which there is no open interest at the time an RFQ is submitted.\8\
The proposed extension of the Pilot Program for opening FLEX option
transactions should provide members that use FLEX Equity Options
greater flexibility in structuring the terms of such options to better
comport with the particular needs of the members and their customers.
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    \8\ See Securities Exchange Act Release No. 57824 (May 15,
2008), 73 FR 29805 (May 22, 2008) (SR-Phlx-2008-35) (notice of
filing and immediate effectiveness establishing the Pilot Program).
The filing also modified the minimum value size for an opening
transaction in a currently-opened FLEX Equity series (other than
FLEX Quotes responsive to a RFQ) to the lesser of 100 contracts or
the number of contracts overlying $1 million in the underlying
securities. Other options exchanges have established FLEX pilot
programs that are similar to the Exchange's. See, e.g., Securities
Exchange Act Release No. 57429 (March 4, 2008), 73 FR 13058 (March
11, 2008) (SR-CBOE-2006-36) (approval order).
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    Prior to the Pilot Program, Phlx Rule 1079(a)(8)(A) set the minimum
opening transaction value size in the case of a FLEX Equity Option in a
newly

established series as the lesser of (i) 250 contracts or (ii) the
number of contracts overlying $1 million in the underlying securities.
Under the Pilot Program, the Exchange reduced the ``250 contracts''
component to ``150 contracts''; the $1 million underlying value
component continued to apply unchanged.\9\
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    \9\ Under the Pilot Program, an opening transaction in a FLEX
Equity series in a stock priced at approximately $66.67 or more
would reach the $1 million limit before it would reach the contract
size limit, i.e., 150 contracts times the multiplier (100) times the
stock price ($66.67) equals just over $1 million in underlying
value. For a FLEX Equity series in a stock priced at less than
$66.67, the 150 contract size limit would apply.
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    The Exchange now proposes to extend the Pilot Program.
    Given that FLEX Equity Option transactions can occur in increments
of 100 or more contracts in subsequent opening transactions,\10\ the
Exchange believes it is reasonable to permit the initial series opening
transaction size to be 150 contracts (or $1 million in underlying
value, whichever is less). The Exchange notes that the opening size
requirement for FLEX Equity Options was originally put in place to
limit participation in FLEX Equity Options to sophisticated, high net
worth investors rather than retail investors.\11\ The Exchange believes
that the reduction of the minimum value size for opening a series, per
the Pilot Program, provides FLEX-participating members and their
customers with greater flexibility in structuring the terms of FLEX
Equity Options to better suit the FLEX traders' particular needs. The
Exchange believes that market participants benefit from being able to
trade these customized options in an exchange environment in several
ways, including, but not limited to, enhanced efficiency in initiating
and closing out positions; increased market transparency; and
heightened contra-party creditworthiness due to the role of The Options
Clearing Corporation as issuer and guarantor of FLEX Equity Options.
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    \10\ Specifically, for FLEX Equity Options the minimum value
size for a transaction in any currently-opened FLEX series is the
lesser of 100 contracts or the number of contracts overlying $1
million in the underlying securities; or the lesser of 25 contracts
or the remaining size in the case of a closing transaction.
Additionally, the minimum value size for a FLEX Quote entered in
response to a RFQ in FLEX Equity Options is the lesser of 25
contracts or the remaining size in a closing transaction. See Phlx
Rules 1079(a)(8)(B)(ii) and 1079(a)(8)(C)(ii).
    \11\ The existing customer base for FLEX Options includes
institutional investors, retail investors, and high net worth
individuals.
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    In support of extending the Pilot Program, the Exchange has
submitted to the Commission a FLEX Pilot Program Report (``Report'')
detailing the Exchange's experience with the Pilot Program.
Specifically, the Report contains data and written analysis regarding:
(i) The open interest and trading volume in FLEX Equity Options for
which series were opened with a minimum opening size of 150 to 249
contracts and less than $1 million in underlying value; and (ii)
analysis on the types of investors that initiated opening FLEX Equity
Options transactions (i.e., institutional, high net worth, or retail,
if any). The Report was submitted under separate cover and seeks
confidential treatment under the Freedom of Information Act.
    The Exchange believes there is sufficient investor interest and
demand in the Pilot Program to warrant its extension. The Exchange
believes that, during the time that the Pilot Program has been in
operation, it has afforded investors with additional means of managing
their risk exposures and carrying out their investment objectives. The
Exchange represents that it has the necessary system capacity to
continue to support the option series listed under the Pilot Program.
    Should the Exchange desire to propose an extension, expansion, or
permanent implementation of the Pilot Program, the Exchange would
submit, along with a filing proposing any necessary amendments to the
Pilot Program, a pilot program Report for the extended period during
which the Pilot Program is in effect.\12\ The Report, along with any
filing to extend or permanently implement the Pilot Program, would be
submitted to the Commission at least forty-five days prior to the
expiration date of the Pilot Program.
---------------------------------------------------------------------------

    \12\ The report would provide: (i) Data and analysis on the open
interest and trading volume in FLEX Equity Options for which series
were opened with a minimum opening size of 150 to 249 contracts and
less than $1 million in underlying value; and (ii) analysis on the
types of investors that initiated opening FLEX Equity Options
transactions (i.e., institutional, high net worth, or retail, if
any).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \13\ in general, and furthers the objectives of Section
6(b)(5) of the Act \14\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by extending the Exchange's Pilot Program in respect of FLEX
options. The Exchange believes that extension of the Pilot Program will
result in a continuing benefit to investors by allowing them additional
means to manage their risk exposure and carry out their investment
objectives, and will allow the Exchange to further study investor
interest in the Pilot Program.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 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 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

    No written comments were either solicited or received.

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

    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 \15\ and Rule 19b-
4(f)(6) thereunder.\16\
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing.\17\ However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest.\18\ The Exchange has requested that the Commission
waive the 30-day operative delay so that the proposal may become
operative immediately upon filing, thereby allowing the Exchange to
seamlessly continue the Pilot Program in respect of FLEX options.
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ See id.
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of

investors and the public interest because such waiver will allow the
Exchange to continue its Pilot Program without interruption in its
current form. The Commission notes that the Exchange did not provide a
pilot program report to the Commission at least ninety days prior to
the expiration date of the Pilot Program as the Exchange had undertaken
to do as part of its original proposal.\19\ Waiving the operative delay
to accommodate an extension of the Pilot Program will provide investors
with a continued ability to utilize the lower minimum value size for an
opening transaction in a FLEX Equity Option series on Phlx and also
will provide the Exchange with additional time to collect data and
prepare and submit to the Commission a pilot program report in the
event that it seeks to extend or permanently implement the Pilot
Program.\20\ For these reasons, the Commission designates the proposed
rule change as operative upon filing.\21\
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    \19\ See Securities Exchange Act Release No. 57824 (May 15,
2008), 73 FR 29805, 29806 (May 22, 2008) (SR-Phlx-2008-35).
    \20\ The Commission notes that the Exchange has undertaken in
this filing to submit a pilot program report at least forty-five
days prior to the expiration date of the Pilot Program.
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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.\22\
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    \22\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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-Phlx-2009-78 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2009-78. 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 Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2009-78 and should be
submitted on or before October 5, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-21993 Filed 9-11-09; 8:45 am]

BILLING CODE 8010-01-P