[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Rules and Regulations]
[Pages 19065-19067]
[FR Doc No: 2012-7004]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0295; Directorate Identifier 2011-NM-057-AD;
Amendment 39-16993; AD 2012-06-12]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A340-600 series airplanes. This AD requires a detailed
inspection for abnormalities of the ball lock retainer on the off-wing
ramp slides; for closure of the soft cover; for full engagement of the
slide release pin; for broken, missing, and improper placement of the
safety tie thread on the slide release pin; and for proper functioning
of the vent valve; and replacement of the off-wing ramp slides if
necessary. This AD was prompted by reports of in-flight loss of the
blow-out panel and the slide unit from a right-hand off-wing ramp-
slide. We are issuing this AD to detect and correct abnormalities of
the ball lock retainer, if the soft cover is open, if the slide pin
release is not engaged or the safety tie thread is missing, broken, or
improperly placed and the vent valve is not functioning properly, which
could result in in-flight loss of the off-wing ramp slide.

DATES: This AD becomes effective April 16, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of April 16,
2012.
    We must receive comments on this AD by May 14, 2012.

ADDRESSES: You may send comments 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA 1601
Lind Avenue SW., Renton, Washington 98057-3356; telephone (425) 227-
1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0017, dated February 3, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    An A340-600 operator has reported an in-flight loss of the blow-
out panel and the slide unit from a Right Hand (RH) off-wing ramp-
slide.
    Investigation has revealed that the two main contributor factors
of a potential in-flight loss of the slide are the packboard soft
covers not fully closed and the vent valve not activated.
    In flight, the air contained in the inflatable assembly could
increase in volume due to air pressure changes. Consequently, pack
growth could occur and apply loads on the packboard soft covers and
the blow-out panel attachment hardware. To prevent a pack growth, a
vent valve is installed and when activated can balance pressure
inside the inflatable assembly with the ambient air pressure.
    Analysis indicates that non activation of the vent valve,
followed by soft cover opening, could cause the packboard blow-out
panel to separate from the slide enclosure, resulting in in-flight
loss of the off-wing ramp slide, which would constitute an unsafe
condition.
    For the reasons described above, this AD requires a one-time
inspection [check] of the soft cover condition and check of the vent
valve function on each off-wing ramp slide, and accomplishment of
the applicable corrective actions [replacement of the off-wing ramp
slide].

The one-time inspection consists of a detailed inspection for
abnormalities of the ball lock retainer on the off-wing ramp slides;
for closure of the soft cover; for full engagement of the slide release
pin; for broken, missing, and improper placement of the safety tie
thread on the slide release pin; and for proper functioning of the vent
valve. You may obtain further information by examining the MCAI in the
AD docket.

Relevant Service Information

    Airbus has issued All Operators Telex A340-25A5191, dated January
18, 2011. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD are
unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2012-0295; Directorate
Identifier 2011-NM-057-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

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 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); and
    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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-06-12 Airbus: Amendment 39-16993. Docket No. FAA-2012-0295;
Directorate Identifier 2011-NM-057-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 16,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A340-642 airplanes, certificated
in any category, all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 25: Equipment/
Furnishings.

(e) Reason

    This AD was prompted by reports of in-flight loss of the blow-
out panel and the slide unit from a right-hand off-wing ramp-slide.
We are issuing this AD to detect and correct abnormalities of the
ball lock retainer, if the soft cover is open, if the slide pin
release is not engaged or the safety tie thread is missing or
broken, and the vent valve is not functioning properly, which could
result in in-flight loss of the off-wing ramp slide.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    Within 90 days after the effective date of this AD, do a
detailed inspection for abnormalities of the ball lock retainer on
the off-wing ramp slides; for closure of the soft cover; for full
engagement of the slide release pin; for broken, missing, and
improper placement of the safety tie thread on the slide release
pin; and for proper function of the vent valve; in accordance with
Airbus All Operators Telex (AOT) A340-25A5191, dated January 18,
2011. If the ball lock retainer has abnormalities, the soft cover is
open, or the slide pin release is not engaged, or the safety tie
thread is broken, missing, or improperly placed, or the vent valve
is not functioning properly, before further flight, replace the off-
wing ramp slide, in accordance with Airbus AOT A340-25A5191, dated
January 18, 2011.

(h) Parts Installation

    As of the effective date of this AD, no person may install any
off-wing ramp slide having part number 4A3931-X on any airplane,
unless the check required by paragraph (g) of this AD has been done
and none of the conditions specified in paragraph (g) of this AD are
found.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, FAA, has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the International Branch, send it
to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch,
ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149. 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) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European Aviation Safety Airworthiness Directive 2011-0017, dated
February 3, 2011; and Airbus AOT A340-25A5191, dated January 18,
2011; for related information.

(k) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51:
    (i) Airbus All Operators Telex A340-25A5191, dated January 18,
2011. The document number and date are identified only on the first
page of the document.
    (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.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the 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/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on March 9, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-7004 Filed 3-29-12; 8:45 am]
BILLING CODE 4910-13-P


   DEPARTMENT OF HEALTH & HUMAN SERVICES default		         		Public
Health Service

 ADVANCE \r360  ADVANCE \d3 	Food and Drug Administration

 ADVANCE \r360 	Rockville, MD  20857

February 22, 2005

Deborah A. Jaskot

Vice President, Regulatory Affairs

Teva Pharmaceuticals USA

1090 Horsham Road

North Wales, PA  19454

Dear Ms. Jaskot:

Your petition requesting the Food and Drug Administration to determine
whether Vioxx Tablets, manufactured by Merck has been voluntarily
withdrawn or withheld from sale for safety or efficacy reasons, was
received by this office on 02/22/2005.  It was assigned docket number
2005P-0079/CP 1 and it was filed on 02/22/2005. Please refer to this
docket number in future correspondence on this subject with the Agency.

Please note that the acceptance of the petition for filing is a
procedural matter in that it in no way reflects an agency decision on
the substantive merits of the petition.

Sincerely,

Lyle D. Jaffe

Division of Dockets Management

Office of Management Programs

Office of Management


[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58019-58020]
[FR Doc No: 2011-23875]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 26 and 27, 2011,
from 8 a.m. to 6 p.m.
    Location: Hilton Washington, DC, North/Gaithersburg, salons A, B,
C, and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, e-mail<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for

up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
    Agenda: On October 26, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application sponsored by AtriCure, Inc., for the AtriCure
Synergy Ablation System to be used for the treatment of atrial
fibrillation in patients who are undergoing open concomitant cardiac
surgery. The AtriCure Synergy Ablation System consists of the
following:
     The AtriCure Isolator Synergy Handpieces (models OLL2 and
OSL2), which resemble surgical clamps, include a syringe-type grip
handle/actuator, connected by a cylindrical shaft to a pair of grasping
jaws with electrodes on each jaw. The electrodes deliver radiofrequency
(RF) energy to the tissue grasped by the jaws.
     The Ablation and Sensing Unit is an RF generator used to
power the Isolator Synergy Handpieces.
     The Isolator Switch Matrix is an accessory interface
module allowing the Isolator Synergy Handpieces to connect to the RF
generator.
    On October 27, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Medtronic Ablation Frontiers Cardiac
Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation
Frontiers Cardiac Ablation System is a catheter-based device developed
for the treatment of atrial fibrillation. The system consists of the
following:
     The Pulmonary Vein Ablation Catheter, which is designed to
create lesions in the left atrium via five pairs of electrodes to
isolate the pulmonary veins. It has a deflectable distal end and
bidirectional steering to aid in positioning the catheter
appropriately.
     The Multi-Array Septal Catheter, which is designed to
create lesions on the septal wall of the left atrium via six pairs of
electrodes. It is not steerable and is intended to be used in a
transseptal approach.
     The Multi-Array Ablation Catheter, which is designed to
create ``X''-like lesions in the left and/or right atrium via four
pairs of electrodes. It has a deflectable distal segment and
bidirectional steering within a single plane.
     The GENius Multi-Channel RF Ablation Generator.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 19, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on October 26 and 27. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 11, 2011. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by October 13,
2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff,<PHONE_NUMBER>, at least 7 days in advance
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-23875 Filed 9-16-11; 8:45 am]
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[Federal Register: January 25, 2010 (Volume 75, Number 15)]
[Notices]
[Page 3948]
[DOCID:fr25ja10-89]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Big Sky Energy Corp., Biomedical Waste Systems, Inc., Biometrics
Security Technology, Inc., Biosys, Inc., Bolder Technologies Corp.,
Boyds Wheels, Inc., Breakaway Solutions, Inc., and BRE-X Minerals,
Ltd.; Order of Suspension of Trading

January 21, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Big Sky Energy Corp. because it has not filed any periodic reports
since the period ended December 31, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Biomedical Waste Systems, Inc. because it has not filed any periodic
reports since the period ended March 31, 1995.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Biometrics Security Technology, Inc. because it has not filed any
periodic reports since December 31, 2002.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Biosys, Inc. because it has not filed any periodic reports since the
period ended September 30, 1996.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Bolder Technologies Corp. because it has not filed any periodic reports
since the period ended September 30, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Boyds Wheels, Inc. because it has not filed any periodic reports since
the period ended September 30, 1997.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Breakaway Solutions, Inc. because it has not filed any periodic reports
since the period ended December 31, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
BRE-X Minerals, Ltd. because it has not filed any periodic reports
since the period ended August 19, 1996.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EST
on January 21, 2010, through 11:59 p.m. EST on February 3, 2010.

    By the Commission.

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2010-1441 Filed 1-21-10; 11:15 am]
BILLING CODE 8011-01-P