[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]
[Page 36099-36100]
[DOCID:fr24jn10-52]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-M-0317, FDA-2009-M-0369, FDA-2009-M-0370, FDA-
2009-M-0485, FDA-2009-M-0536, FDA-2009-M-0540]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-796-
6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification
of an order approving, denying, or withdrawing approval of a PMA will
continue to include a notice of opportunity to request review of the
order under section 515(g) of the act. The 30-day period for requesting
reconsideration of an FDA action under Sec.  10.33(b) (21 CFR 10.33(b))
for notices announcing approval of a PMA begins on the day the notice
is placed on the Internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day period. Reconsideration of a denial or
withdrawal of approval of a PMA may be sought only by the applicant; in
these cases, the 30-day period will begin when the applicant is
notified by FDA in writing of its decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from July 1, 2009, through September 30,
2009, and from October 1, 2009, through December 31, 2009. There were
no denial actions during either period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

 Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
      Made Available From July 1, 2009, through December 31, 2009.
------------------------------------------------------------------------
 PMA No.  Docket                                               Approval
       No.            Applicant            Trade Name            Date
------------------------------------------------------------------------
P070022            Hologic, Inc.   ADIANA PERMANENT           July 6,
FDA-2009-M-0317                     CONTRACEPTION SYSTEM       2009
------------------------------------------------------------------------
P060008/S11        Boston          TAXUS LIBERTE LONG         July 13,
FDA-2009-M-0369     Scientific      PACLITAXEL ELUING STENT    2009
                    Corp.           SYSTEM
------------------------------------------------------------------------
P030050/S2         Sanofi          SCULPTRA AESTHETIC         July 28,
FDA-2009-M-0370     Aventis, LLC                               2009
------------------------------------------------------------------------
P080013            Confluent       DURASEAL XACT SEALANT      September
FDA-2009-M-0485     Surgical,       SYSTEM                     4, 2009
                    Inc.
------------------------------------------------------------------------
P080008            bioMerieux,     VIDAS FREE PSA RT (fPSA)   October 8,
FDA-2009-M-0536     Inc.            ASSAY                      2009
------------------------------------------------------------------------
P030042            Wright Medical  CONSERVE PLUS TOTAL        November
FDA-2009-M-0540     Technology,     RESURFACING HIP SYSTEM     3, 2009
                    Inc.
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: June 17, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-15259 Filed 6-23-10; 8:45 am]
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[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Proposed Rules]
[Pages 43103-43105]
[FR Doc No: 2010-18021]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0735; Directorate Identifier 2010-CE-030-AD]
RIN 2120-AA64

Airworthiness Directives; CENTRAIR Models 101, 101A, 101P, and
101AP Gliders

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Damages to the rudder bar locking adjustment tube of a non-
reinforced version have been reported to Soci[eacute]t[eacute]
Nouvelle (SN) Centrair. This tube had been reinforced in 1984 with a
modification. Gliders produced before the introduction of this
modification have not been systematically retrofitted.
    In case of rudder bar locking adjustment tube breaking in flight
when adjusting the rudder pedals position, it might interfere with
the rudder pedals which could lead to rudder jam or a restricted
rudder movement and consequently, to reduced control of the
sailplane.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by September 7,
2010.

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 20590, 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 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 Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Greg Davison, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; 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-2010-0735;
Directorate Identifier 2010-CE-030-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 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 proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2010-0099, dated May 26, 2010, (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Damages to the rudder bar locking adjustment tube of a non-
reinforced version have been reported to Soci[eacute]t[eacute]
Nouvelle (SN) Centrair. This tube had been reinforced in 1984 with a
modification. Gliders produced before the introduction of this
modification have not been systematically retrofitted.
    In case of rudder bar locking adjustment tube breaking in flight
when adjusting the rudder pedals position, it might interfere with
the rudder pedals which could lead to rudder jam or a restricted
rudder movement and consequently, to reduced control of the
sailplane.
    For the reason described above, this AD requires inspecting the
rudder bar locking adjustment tube and, if necessary, replacing it.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Soci[eacute]t[eacute] Nouvelle Centrair has issued Service Bulletin
No. 101-29, dated July 30, 2009. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of the 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 this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 52 products of U.S.
registry. We also estimate that it would take about 1 work-hour 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 the proposed AD on
U.S. operators to be $4,420 or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour and require parts costing $51, for a cost of
$136 per product. We have no way of determining the number of products
that may need these actions.

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); and
    3. 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 proposed 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.

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

    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]

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

Centrair: Docket No. FAA-2010-0735; Directorate Identifier 2010-CE-
030-AD.

Comments Due Date

    (a) We must receive comments by September 7, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to CENTRAIR Models 101, 101A, 101P, and
101AP gliders, all serial numbers, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Damages to the rudder bar locking adjustment tube of a non-
reinforced version have been reported to Soci[eacute]t[eacute]
Nouvelle (SN) Centrair. This tube had been reinforced in 1984 with a
modification. Gliders produced

before the introduction of this modification have not been
systematically retrofitted.
    In case of rudder bar locking adjustment tube breaking in flight
when adjusting the rudder pedals position, it might interfere with
the rudder pedals which could lead to rudder jam or a restricted
rudder movement and consequently, to reduced control of the
sailplane.
    For the reason described above, this AD requires inspecting the
rudder bar locking adjustment tube and, if necessary, replacing it.

Actions and Compliance

    (f) Unless already done, do the following actions in accordance
with Soci[eacute]t[eacute] Nouvelle Centrair Service Bulletin No.
101-29, dated July 30, 2009:
    (1) Within the next 30 days after the effective date of this AD,
inspect the rudder bar locking adjustment tube to determine if it
has been reinforced and to determine if it has been damaged.
    (2) If the results of the inspection required in paragraph
(f)(1) of this AD show that the rudder bar locking adjustment tube
has not been reinforced and is not damaged, replace it with a
reinforced rudder bar locking adjustment tube, part number (P/N)
$Y186A, at the next scheduled maintenance event after the effective
date of this AD but no later than 12 months after the effective date
of this AD.
    (3) If the results of the inspection required in paragraph
(f)(1) of this AD show that the rudder bar locking adjustment tube
has not been reinforced but is damaged, replace it with a reinforced
rudder bar locking adjustment tube, P/N $Y186A, before further
flight.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Greg Davison, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any glider to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (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.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2010-0099, dated May 26, 2010; and Soci[eacute]t[eacute] Nouvelle
Centrair Service Bulletin No. 101-29, dated July 30, 2009, for
related information.

    Issued in Kansas City, Missouri, on July 16, 2010.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2010-18021 Filed 7-22-10; 8:45 am]
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