[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69447-69449]
[FR Doc No: 2010-28441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0555]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of

information, including each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on information
collection requirements for the tracking of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by January 11, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    In preparing this notice, the agency reviewed a comment that was
posted in response to the 60-day notice of February 5, 2008 (73 FR
6729) (Docket No. FDA-2008-N-0050). FDA transitioned to the Federal
Dockets Management System (FDMS) in January 2008, and this comment was
not posted to the docket until after the closing of the comment period.
The comment responded to item 1 (whether the information collection is
necessary) and item 3 (how to enhance quality of ICR). With regard to
item 1, the comment emphasized the importance of medical device
tracking and supported the information collection request in full. With
regard to item 3, the comment said that implementing the unique device
identification provision (UDI) of the Food and Drug Administration
Modernization Act (FDAMA) would go a long way in enhancing medical
device tracking, and the agency is currently undertaking this effort.

Medical Devices; Device Tracking--21 CFR Part 821 (OMB Control Number
0910-0442)--Extension

    Section 211 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA
amended the previous medical device tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i(e)(1) and (e)(2)) and were added by the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the
tracking provisions under SMDA which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria, and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule which
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
    Section 519(e)(1) of the act, as amended by FDAMA, provides that
FDA may require by order, that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
    Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary), use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
    In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; records and inspection requirements; (4) confidentiality;
and (5) record retention requirements.
    Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
           CFR section               Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
821.1(d)........................               1               1               1               1               1
821.2 and 821.30(e).............               1               1               1               1               1
821.25(a).......................              12               1              12              76             912

821.25(d).......................               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
           CFR section               Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
821.25(b).......................              12          46,260         555,120               1         555,120
821.25(c)\2\....................              12               1              12              63             756
821.25(c)(3)....................              12           1,124          13,488               1          13,488
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         569,364
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One time burden.

                           Table 3--Estimated Annual Third-Party Disclosure Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR section              Number of     frequency of    Total annual      Hours per      Total hours
                                    respondents     disclosure      disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
821.30(a) and (b)...............          17,000               1          17,000               1          17,000
821.30(c) and (d)...............          17,000               1          17,000               1          17,000
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............          34,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The annual hourly burden for respondents involved with medical
device tracking is estimated to be 604,279 hours per year. The burden
estimates cited in tables 1, 2, and 3 of this document are based on the
number of device tracking orders issued in the last 3 years.
    This regulation also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information found in 21 CFR 821.2(b), 821.25(e), and 821.30(e) have
been approved under OMB control number 0910-0183.

    Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28441 Filed 11-10-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Rules and Regulations]
[Pages 13379-13382]
[FR Doc No: 2017-04515]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9069; Directorate Identifier 2016-NM-012-AD;
Amendment 39-18821; AD 2017-05-10]
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) 2015-16-02 for
all Airbus Model A330 series airplanes. AD 2015-16-02 required revising
the maintenance or inspection program to incorporate certain
maintenance requirements and airworthiness limitations. This new AD
requires revising the maintenance or inspection program to incorporate
new maintenance requirements and airworthiness limitations. This AD was
prompted by a revision of the airworthiness limitations items (ALI)
document, which provides new and more restrictive maintenance
requirements and airworthiness limitations for airplane structures and
systems. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective April 17, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of April 17,
2017.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
September 15, 2015 (80 FR 48019, August 11, 2015).

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet: http://www.airbus.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2016-9069.

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-2016-
9069; 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: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2015-16-02, Amendment 39-18227 (80 FR 48019,
August 11, 2015) (``AD 2015-16-02''). AD 2015-16-02 applied to all
Airbus Model A330 series airplanes. The NPRM published in the Federal
Register on September 12, 2016 (81 FR 62672). The NPRM was prompted by
a revision of the ALI document, which provides new and more restrictive
maintenance requirements and airworthiness limitations for airplane
structures and systems. The NPRM proposed to require revising the
maintenance or inspection program to incorporate new maintenance
requirements and airworthiness limitations. We are issuing this AD to
prevent reduced structural integrity and reduced control of these
airplanes due to the failure of system components.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2016-0011, dated January 13, 2016 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus Model A330 and A340 series
airplanes. The MCAI states:

    The airworthiness limitations are currently defined and
published in the Airbus A330 and A340 Airworthiness Limitations
Section (ALS) documents. The airworthiness limitations applicable to
the System Equipment Maintenance Requirements, which are approved by
EASA, are specified in Airbus A330 and A340 ALS Part 4. Failure to
comply with these instructions could result in an unsafe condition.
    EASA issued AD 2013-0268 (for A330 aeroplanes) [which
corresponds to FAA AD 2015-16-02] and AD 2013-0269 (for A340
aeroplanes) [which corresponds to FAA AD 2014-23-17, Amendment 39-
18033 (79 FR 71304, December 2, 2014) (``AD 2014-23-17'')] to
require the actions as specified in Airbus A330 and A340 ALS Part 4
at Revision 04 and Revision 03, respectively.
    Since those [EASA] ADs were issued, Airbus issued Revision 05
and Revision 04, respectively, of Airbus A330 and A340 ALS Part 4,
which introduce new and more restrictive maintenance requirements
and/or airworthiness limitations.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2013-0268 and AD 2013-0269, which are
superseded, and require accomplishment of the actions specified in
Airbus A330 ALS Part 4 Revision 05, or A340 ALS Part 4 Revision 04,
as applicable (hereafter collectively referred to as `the ALS' in
this [EASA] AD).

    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-2016-
9069.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Adopt ALS Variation

    American Airlines (AAL) requested that Airbus A330 ALS Part 4--
System Equipment Maintenance Requirements (SEMR)--Variation 5.1, dated
December 20, 2015 (``Variation 5.1''), also be adopted in the final
rule. AAL noted that Variation 5.1 was approved as an alternative
method of compliance (AMOC) to AD 2015-16-02 via ANM-116-16-272, dated
April 13, 2016.
    We agree that AMOCs approved previously for AD 2015-16-02 continue
to be approved as AMOCs for the corresponding provisions of paragraph
(g) of this AD, as stated in paragraph (l)(1)(ii) of this AD. We also
agree to include Variation 5.1 as a method of compliance for the
requirements of paragraph (j) of this AD for components specified in
Variation 5.1. We have revised paragraph (j) of this AD accordingly.

Request To Re-Open the Comment Period

    Airbus requested that we re-open the comment period specified in
the NPRM in order to introduce Revision 06 of Airbus A330 ALS Part 4--
SEMR. Airbus pointed out that, since the MCAI was published, multiple
new variations to Airbus A330 ALS Part 4 have been issued and have been
or are being approved by EASA. Airbus stated that these variations will
be included in Revision 06 of Airbus A330 ALS Part 4--SEMR, which is
expected to be approved under Airbus's EASA Design Organization
Approval in mid-January 2017. Airbus asserted that a new EASA AD will
be issued to supersede EASA AD 2016-0011 once Revision 06 is issued.
    We disagree. We have determined that more restrictive maintenance
requirements and airworthiness limitations for airplane structures and
systems are necessary to prevent reduced structural integrity and
reduced control of these airplanes, due to the failure of system
components. Therefore, we do not consider that delaying this action by
reopening the comment period until such time as the manufacturer's
planned service information is released is warranted, since the
necessary service information is currently available. However, under
the provisions of paragraph (l)(1) of this AD, we will consider
requests for approval to use Revision 06 of Airbus A330 ALS Part 4--
SEMR once it is approved and available. We have not changed the AD in
this regard.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
this adopting this AD with the changes described previously and 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.

Related Service Information Under 1 CFR Part 51

    Airbus issued A330 ALS Part 4--SEMR, Revision 05, dated October 19,
2015. This service information describes preventative maintenance
requirements and associated airworthiness limitations applicable to
aircraft systems susceptible to aging effects.
    Airbus also issued Airbus A330 ALS Part 4--System Equipment
Maintenance Requirements (SEMR)--Variation 5.1, dated December 20,
2015. This service information describes revising the maintenance or
inspection program by increasing the life limits for certain
components.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 104 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Maintenance or inspection program    1 work-hours x $85 per hour              $0             $85          $8,840
 revision (retained actions from AD   = $85.
 2015-16-02).
Maintenance or inspection program    1 work-hours x $85 per hour               0              85           8,840
 revision (new action).               = $85.
----------------------------------------------------------------------------------------------------------------

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)
AD 2015-16-02, Amendment 39-18227 (80 FR 48019, August 11, 2015), and
adding the following new AD:

2017-05-10 Airbus: Amendment 39-18821; Docket No. FAA-2016-9069;
Directorate Identifier 2016-NM-012-AD.

(a) Effective Date

    This AD is effective April 17, 2017.

(b) Affected ADs

    This AD replaces AD 2015-16-02, Amendment 39-18227 (80 FR 48019,
August 11, 2015) (``AD 2015-16-02'').

(c) Applicability

    This AD applies to Airbus Model A330-201, A330-202, A330-203,
A330-223, A330-243, A330-223F, A330-243F, A330-301, A330-302, A330-
303, A330-321, A330-322, A330-323, A330-341, A330-342, and A330-343
airplanes, certificated in any category, with an original
certificate of airworthiness or original export certificate of
airworthiness issued on or before October 19, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a revision of the airworthiness
limitations items (ALI) document, which provides new and more
restrictive maintenance requirements and airworthiness limitations
for airplane structures and systems. We are issuing this AD to
prevent reduced structural integrity and reduced control of these
airplanes due to the failure of system components.

(f) Compliance

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

(g) Retained Maintenance Program Revision and Actions, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2015-16-02, with no changes. Within 6 months after September 15,
2015 (the effective date of AD 2015-16-02), revise the maintenance
program or inspection program, as applicable, by incorporating
Airbus A330 Airworthiness Limitations Section (ALS) Part 4-Aging
Systems Maintenance, Revision 04, dated August 27, 2013; and Airbus
A330 ALS Part 4-Aging Systems Maintenance (ASM), Variation 4.1 and
Variation 4.2, both dated July 23, 2014. The initial compliance
times for the actions are within the applicable compliance times
specified in the Record of Revisions pages of Airbus A330 ALS Part
4-Aging Systems Maintenance, Revision 04, dated August 27, 2013; and
Airbus A330 ALS Part 4-Aging Systems Maintenance (ASM), Variation
4.1 and Variation 4.2, both dated July 23, 2014; or within 6 months
after September 15, 2015; whichever is later; except as required by
paragraph (h) of this AD.

(h) Retained Exceptions to Initial Compliance Times, With References to
New Service Information

    This paragraph restates the requirements of paragraph (h) of AD
2015-16-02, with references to new service information.
    (1) Where Airbus A330 ALS Part 4--Aging Systems Maintenance,
Revision 04, dated August 27, 2013; or Airbus A330 ALS Part 4--
System Equipment Maintenance Requirements (SEMR), Revision 05, dated
October 19, 2015; define a calendar compliance time for elevator
servo-controls having part number (P/N) SC4800-2, SC4800-3, SC4800-
4, SC4800-6, SC4800-7, or SC4800-8 as ''August 31, 2004,'' the
calendar compliance time is June 13, 2007 (34 months after August
13, 2004 (the effective date of AD 2004-13-25, Amendment 39-13707
(69 FR 41394, July 9, 2004))).
    (2) Where Airbus A330 ALS Part 4--Aging Systems Maintenance,
Revision 04, dated August 27, 2013; or Airbus A330 ALS Part 4--SEMR,
Revision 05, dated October 19, 2015; define a calendar compliance
time for spoiler servo-controls (SSCs) having P/N 1386A0000-01,
1386B0000-01, 1387A0000-01, or 1387B0000-01 as ''December 31,
2003,'' the calendar compliance time is November 19, 2005 (13 months
after October 19, 2004 (the effective date of AD 2004-18-14,
Amendment 39-13793 (69 FR 55326, September 14, 2004))).
    (3) Where Airbus A330 ALS Part 4--Aging Systems Maintenance,
Revision 04, dated August 27, 2013; or Airbus A330 ALS Part 4--SEMR,
Revision 05, dated October 19, 2015; define a calendar compliance
time for elevator servo-controls having P/N SC4800-73, SC4800-93,
SC4800-103, and SC4800-113 as ``June 30, 2008,'' the calendar
compliance time is September 16, 2009 (17 months after April 16,
2008 (the effective date of AD 2008-06-07, Amendment 39-15419 (73 FR
13103, March 12, 2008; corrected April 15, 2008 (73 FR 20367)))).
    (4) The initial compliance time for replacement of the
retraction brackets of the main landing gear (MLG) having a part
number specified in paragraphs (h)(4)(i) through (h)(4)(xvi) of this
AD is before the accumulation of 19,800 total landings on the
affected retraction brackets of the MLG, or within 900 flight hours
after April 9, 2012 (the effective date of AD 2012-04-07, Amendment
39-16963 (77 FR 12989, March 5, 2012)), whichever occurs later.
    (i) 201478303.
    (ii) 201478304.
    (iii) 201478305.
    (iv) 201478306.
    (v) 201478307.
    (vi) 201478308.
    (vii) 201428380.
    (viii) 201428381.
    (ix) 201428382.
    (x) 201428383.
    (xi) 201428384.
    (xii) 201428385.
    (xiii) 201428378.
    (xiv) 201428379.
    (xv) 201428351.
    (xvi) 201428352.
    (5) Where Airbus A330 ALS Part 4--Aging Systems Maintenance,
Revision 04, dated August 27, 2013; or Airbus A330 ALS Part 4--SEMR,
Revision 05, dated October 19, 2015; define a calendar compliance
time for the modification of SSCs on three hydraulic circuits having
P/N MZ4339390-01X, MZ4306000-01X, MZ4339390-02X, MZ4306000-02X,
MZ4339390-10X, or MZ4306000-10X as ``March 5, 2010,'' the calendar
compliance time is April 14, 2011 (18 months after October 14, 2009
(the effective date of AD 2009-18-20, Amendment 39-16017 (74 FR
46313, September 9, 2009))) (``AD 2009-18-20'').
    (6) Where Note (6) of ``ATA 27-64-00 Flight Control--Spoiler
Hydraulic Actuation,'' of Sub-part 4-2-1, ``Life Limits,'' of Sub-
part 4-2, ``Systems Life Limited Components,'' of Airbus A330 ALS
Part 4-Aging Systems Maintenance, Revision 04, dated August 27,
2013; or Note (17) of Sub-Part 1, ``Life Limits,'' of Section 3,
``System Life-Limited Components,'' of Airbus A330 ALS Part 4--SEMR,
Revision 05, dated October 19, 2015; define a calendar date of
``September 5, 2008,'' as a date for the determination of
accumulated flight cycles since the aircraft initial entry into
service, the date is October 14, 2009 (the effective date of AD
2009-18-20).
    (7) Where Note (6) of ``ATA 27-64-00 Flight Control--Spoiler
Hydraulic Actuation,'' of Sub-part 4-2-1, ``Life Limits,'' of Sub-
part 4-2, ``Systems Life Limited Components,'' of Airbus A330 ALS
Part 4--Aging Systems Maintenance, Revision 04, dated August 27,
2013; or Note (17) of Sub-Part 1, ``Life Limits,'' of Section 3,
``System Life-Limited Components,'' of Airbus A330 ALS Part 4--SEMR,
Revision 05, dated October 19, 2015; define a calendar compliance
time as ``March 5, 2010,'' for the modification of affected servo
controls, the calendar compliance time is April 14, 2011 (18 months
after October 14, 2009 (the effective date of AD 2009-18-20)).

(i) Retained No Alternative Actions or Intervals, With Revised
Compliance Language

    This paragraph restates the requirements of paragraph (i) of AD
2015-16-02, with revised compliance language. Except as required by
paragraph (j) of this AD: After accomplishing the revision required
by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (l)(1) of
this AD.

(j) New Requirement of This AD: Maintenance or Inspection Program
Revision and Actions

    Within 90 days after the effective date of this AD, revise the
maintenance program or inspection program, as applicable, by
incorporating Airbus A330 Airworthiness Limitations Section (ALS)
Part 4--SEMR, Revision 05, dated October 19, 2015. The initial
compliance times for the actions specified in Airbus A330 ALS Part
4--SEMR, Revision 05, dated October 19, 2015, are within the
applicable compliance times specified in Airbus A330 ALS Part 4--
SEMR, Revision 05, dated October 19, 2015, or within 60 days after
the effective date of this AD, whichever is later, except as
required by paragraph (h) of this AD. Accomplishing the revision of
the maintenance program or inspection program, as applicable,
required by this paragraph terminates the requirements of paragraph
(g) of this AD. Revising the maintenance program or inspection
program, as applicable, by incorporating Airbus A330 ALS Part 4--
SEMR--Variation 5.1, dated December 20, 2015, is an acceptable
method of compliance for the components specified in the variation.

(k) New Requirement of This AD: No Alternative Actions or Intervals

    After accomplishing the revision required by paragraph (j) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used unless the actions or intervals are approved as an AMOC in
accordance with the procedures specified in paragraph (l)(1) of this
AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>    (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. The AMOC approval letter must specifically
reference this AD.
    (ii) AMOCs approved previously for AD 2015-16-02 are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or 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.

(m) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA AD 2016-0011, dated January 13, 2016, 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-
2016-9069.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 4--
System Equipment Maintenance Requirements (SEMR), Revision 05, dated
October 19, 2015.
    (ii) Airbus A330 ALS Part 4--System Equipment Maintenance
Requirements (SEMR)--Variation 5.1, dated December 20, 2015.
    (3) The following service information was approved for IBR on
September 15, 2015 (80 FR 48019, August 11, 2015).
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 4--
Aging Systems Maintenance, Revision 04, dated August 27, 2013.
    (ii) Airbus A330 ALS Part 4--Aging Systems Maintenance (ASM),
Variation 4.1, dated July 23, 2014.
    (iii) Airbus A330 ALS Part 4--Aging Systems Maintenance (ASM),
Variation 4.2, dated July 23, 2014.
    (4) 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.
    (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 February 28, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-04515 Filed 3-10-17; 8:45 am]
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