[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Rules and Regulations]
[Pages 24364-24365]
[FR Doc No: 2019-10949]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-1074; Airspace Docket No. 18-AWP-29]
RIN 2120-AA66

Amendment of Class E Airspace; Hawaiian Islands, HI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the Hawaiian Islands Class E airspace
extending upward from 1,200 feet and 5,500 feet above the surface of
the earth by removing that portion that extends beyond the Territorial
Sea. This action supports the operation of Instrument Flight Rules
(IFR) under standard instrument approach and departure procedures in
the Hawaiian Islands, for the safety and management of aircraft within
the National Airspace System.

DATES: Effective 0901 UTC, August 15, 2019. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11C, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 2200
S. 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace extending upward from 1,200 feet and
5,500 feet above the surface for the Hawaiian Islands, HI, to correct
an error in which US airspace extends into international airspace.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 7837; March 5, 2019) for Docket No. FAA-2018-1074 to
modify Class E airspace extending upward from 1,200 feet and 5,500 feet
above the surface of the earth for the Hawaiian Islands, HI. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and
Reporting Points, dated August 13, 2018, and effective September 15,
2018. FAA Order 7400.11C is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11C lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying Class E airspace extending upward from 1,200 feet
and 5,500 feet above the surface of the earth. The FAA identified that
the Hawaiian Islands Class E airspace was established, in error, beyond
the United States Territorial Sea and into international airspace. The
Territorial Sea of the United States was defined by Presidential
Proclamation number 5928, on December 27, 1988, as that area extending
to 12 nautical miles beyond the land territory and internal waters of
the United States and the airspace above it. This action will modify
the Class E Airspace extending upward from 1,200 feet above the surface
of the earth by adjusting the airspace's outer boundary to coincide
with the Hawaiian Islands' Territorial Sea and remove the Class E
airspace that extends upward from 5,500 feet above the surface of the
earth. This action removes references to the Hilo and South Kauai
VORTACs in the legal description for the Class E airspace extending
upward from 1,200 feet. The airspace is being redesigned without the
use of these references. This legal description will establish the
Hawaiian Islands as an archipelagic whole consistent with the
definition established in the Constitution of the State of Hawaii. This
designation includes all islands, together with their appurtenant reefs
and territorial and archipelagic waters, included in the Territory of
Hawaii on the date of enactment of the Admission Act, except the atoll
known as Palmyra Island, together with its appurtenant reefs and
territorial waters; but this State shall not be deemed to include the
Midway Islands, Johnston Island, Sand Island (offshore from Johnston
Island) or Kingman Reef, together with their appurtenant reefs and
territorial waters. This action is being submitted coincidental with an
FAA proposal, submitted on April 11, 2018 (83 FR 15521), to establish
Hawaiian Islands' High and Low Offshore Airspace Areas within
international airspace. The Offshore Airspace would extend from the
Hawaiian Islands' Territorial Sea outward to the boundary of the Flight
Information Region. The offshore airspace will provide for the
application

of domestic air traffic control procedures, beyond the Territorial Sea,
within areas of domestic radio navigational signal or Air Traffic
Control radar coverage.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018, and
effective September 15, 2018, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AWP HI E5 Hawaiian Islands, HI [Amended]

    That airspace extending upward from 1,200 feet above the surface
within 12 NM of the Hawaiian Islands shoreline Beginning at lat.
22[deg]06'28'' N, long. 159[deg]04'39'' W, to lat. 21[deg]46'57'' N,
long. 158[deg]14'41'' W, to 12 NM from the shoreline of Oahu.
    Thence, clockwise along the line 12 NM from and parallel to the
shoreline of the State of Hawaii, to lat. 20[deg]30'29'' N, long.
155[deg]53'40'' W, to lat. 20[deg]28'08'' N, long. 155[deg]52'03''
W, to 12 NM from the shoreline of Hawaii.
    Thence, clockwise along the line 12 NM from and parallel to the
shoreline of Hawaii to lat. 20[deg]03'26'' N, long. 156[deg]05'30''
W, to lat. 20[deg]22'48'' N, long. 156[deg]18'51'' W, to 12 NM from
the shoreline of Maui.
    Thence clockwise along the line 12 NM from and parallel to the
shoreline of the State of Hawaii, to lat. 21[deg]25'19'' N, long.
158[deg]26'08'' W, to lat. 21[deg]44'34'' N long. 159[deg]15'27'' W,
to 12 NM from the shoreline of Kauai.
    Thence, clockwise along the line 12 NM from and parallel to the
shoreline of the State of Hawaii to the beginning.

    Issued in Seattle, Washington, on May 6, 2019.
Maria Aviles,
Group Manager (A), Operations Support Group, Western Service Center.
[FR Doc. 2019-10949 Filed 5-24-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Rules and Regulations]
[Pages 14865-14870]
[FR Doc No: 2019-07290]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 876, 878, and 886

[Docket No. FDA-2018-N-3066]

Medical Devices; Classification of Accessories Distinct From
Other Devices; Finalized List of Accessories Suitable for Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Final classification action.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
classifying suitable accessories into class I as required by the FDA
Reauthorization Act of 2017 (FDARA). The Agency has determined that
general controls alone are sufficient to provide reasonable assurance
of safety and effectiveness for these accessories. We made this
determination based on the risks of the accessories when used as
intended with other devices such as the parent or system.

DATES: This final classification action is effective May 13, 2019.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final
classification action into the ``Search'' box and follow the prompts,
and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-
796-5678.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 18, 2017, FDARA was signed into law (Pub. L. 115-52).
Section 707 of FDARA amended section 513(f) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)) and, among other
amendments, created a process for FDA to propose a list of accessories
suitable for distinct classification into class I. Section
513(f)(6)(D)(i) of the FD&C Act mandated that FDA make the first such
proposal within a year of enactment of FDARA, and FDA published that
proposal in the Federal Register of August 17, 2018 (83 FR 41023).
Section 513(f)(6)(D)(i) also requires that FDA publish a final action
classifying suitable accessories into class I within 180 days after the
end of the comment period. This final classification action fulfills
that requirement.
    In the proposal, we explained that the classification of each
accessory is based on the risks of the accessory when used as intended
and the level of regulatory controls necessary to provide a reasonable
assurance of safety and effectiveness of the accessory, notwithstanding
the classification of any other device with which such accessory is
intended to be used (see section 513(f)(6)(A) of the FD&C Act).
    In general, we considered an accessory to be eligible for
classification into class I distinct from another device if the
accessory: (1) Is not for use in supporting or sustaining human life,
or of substantial importance in preventing impairment to human health;
(2) does not represent a potential unreasonable risk of illness or
injury; and (3) general controls alone would be sufficient to provide a
reasonable assurance of safety and effectiveness of the accessory.
    Note that by regulation, design controls apply to class I devices
only if the devices are automated with computer software or are listed
under Sec.  820.30(a)(2)(ii) (21 CFR 820.30(a)(2)(ii)). Thus, if an
accessory is not automated with computer software but would require
design controls to provide reasonable assurance of safety and
effectiveness, we did not consider it eligible for this classification
process.
    In this final classification action, we are classifying into class
I all of the accessories that we proposed as suitable for distinct
classification in class I. We are not including additional accessories
in this final classification action, but FDA intends to publish another
proposed list of accessories that may be suitable for distinct
classification into class I in accordance with the statutory deadline
of 5 years from the first such proposal (see 21 U.S.C.
360c(f)(6)(D)(i)).

II. Comments on the Proposal

    FDA received comments from industry, trade associations, and
individuals on FDA's proposal. Various comments were regarding topics
that were determined to be outside the scope of this final
classification action. We have considered the remaining comments and
respond briefly to them as follows. The order of response to the
commenters is purely for organizational purposes and does not signify
the comment's value or importance nor the order in which comments were
received. Certain comments are grouped together under a single number
because the subject matter is similar. In several comments, commenters
requested ``guidance'' on various topics, which we have interpreted to
mean additional information rather than FDA guidance within the meaning
of 21 CFR 10.115(b).
    (Comment 1) One commenter stated that class I devices should
include a disclaimer that serious harm may result from their improper
use or installation. The commenter believes this will provide an
incentive for patients to ask their doctors about the proper use of
devices because patients may not see device labeling.
    (Response) Class I devices are subject to general controls, which
are defined in section 513(h)(1) of the FD&C Act. These general
controls include, but are not limited to, certain labeling requirements
under the FD&C Act and part 801 (21 CFR part 801), among other
provisions. Changes to labeling requirements under the FD&C Act and
part 801 are outside the scope of this final classification action.
    (Comment 2) Several commenters suggested that additional product
codes be considered for distinct classification into class I. One of
these commenters believes that many of the accessories listed in the
comment were considered by FDA to have a higher classification solely
due to the risk of the parent device and FDA's previous review
practices. That commenter believes some of these accessories fall under
existing class I classification regulations and should be placed into
class I through this final classification action.
    (Response) We have reviewed all product codes suggested for
distinct classification into class I in response to comments and have
determined that additional product codes identified are not appropriate
for this list at the present time for one or more of the following
reasons: (1) The accessory type is already distinctly classified; (2)
the accessory is of a type that is already class I; or (3) insufficient
information was provided to demonstrate that general controls alone
will provide reasonable assurance of safety and effectiveness.
    FDA will consider additional product codes for distinct
classification into class I as part of a future proposal in accordance
with the statutory deadline of 5 years from the first such proposal
under section 513(f)(6)(D)(i) of the FD&C Act. If a manufacturer or
importer with marketing authorization for an accessory believes its
accessories are suitable for distinct classification, the manufacturer
or importer can also request a class I designation through an existing
accessory request pursuant to section 513(f)(6)(D)(ii) of the FD&C Act.
    (Comment 3) One commenter requested clarification on two of FDA's

proposed regulations for penile implant surgical accessories and
implanted mechanical/hydraulic urinary continence device surgical
accessories. This includes the identification of product code FAE for
penile implant surgical accessories, and specific edits to the list of
accessories included in FDA's proposal.
    (Response) FDA agrees with the commenter. The identified
accessories intended for use with a penile prosthesis under product
codes FAE and FTQ were within FDA's intent, but the proposal did not
make that clear. FDA has also clarified that penile implant surgical
accessories suitable for class I include the cylinder insertion needle,
device placement tool, tubing plug, and blunt needle. Additionally,
implanted mechanical/hydraulic urinary continence device surgical
accessories suitable for class I include the tubing plug and blunt
needle. For both types of accessories, FDA has found that general
controls alone provide a reasonable assurance of safety and
effectiveness.
    (Comment 4) Two commenters noted that section III of the proposal
``Policy Clarification for Classification of Certain Accessories Used
in Orthopedic Surgery'' was inconsistent with the risk-based approach
to classification of accessories as outlined in FDARA, and
classification should not be based upon whether or not an instrument is
considered ``general use'' or ``device-specific''. These commenters
also requested that FDA either revert back to ``previous longstanding
practice and treat all manual surgical instruments provided with Class
II or Class III orthopedic implant systems as Class I (510(k)/PMA
[premarket approval application] exempt) devices, in accordance with
their current classification designation'' or publish new
classifications for instruments that carry a higher risk. One commenter
further noted administrative challenges (e.g., tracking recalls, unique
device identifier markings) for those instruments that have taken on
the classification of the parent device and do not carry their own
product code or regulation.
    (Response) This policy clarification does not impose new regulatory
requirements upon devices that had previously been cleared or approved,
but rather provides transparency for the Agency's existing policy
concerning classification of certain orthopedic accessories. We agree
that the classification of existing accessories should and must be
based upon the risk of the accessory when used as intended and the
level of regulatory controls necessary to provide a reasonable
assurance of safety and effectiveness of the accessory, notwithstanding
the classification of the parent device, and that the provisions in
section 513(f)(6) of the FD&C Act may be appropriate to distinctly
classify certain orthopedic accessory types. By clarifying how we have
regulated different types of instruments for orthopedic surgery, we
aimed to explain the limited scope of accessories that would be
appropriate for distinct classification through mechanisms outlined in
section 513(f)(6) of the FD&C Act and provide clarity regarding
accessories that fit within existing class I classification
regulations. If an accessory is distinctly classified, a separate
classification regulation will be created. We believe this will support
separate identification of the accessory distinct from the parent
device.
    After reviewing the comments, we continue to believe that the
existing policy concerning classification of certain accessories used
in orthopedic surgery should not be changed. Namely, such accessories
are appropriately classified as orthopedic manual surgical instruments
(Sec.  888.4540 (21 CFR 888.4540)) provided they do not meet the
definition of a device-specific orthopedic accessory as outlined in
FDA's proposal and their risk profile and regulatory controls are
commensurate with that of orthopedic manual surgical instruments.
Further, we continue to believe that certain device-specific orthopedic
instruments have new or different risks to health compared to
orthopedic manual surgical instruments, and general controls alone will
not provide reasonable assurance of safety and effectiveness. These
``device-specific'' accessories are specifically designed for
appropriate implantation or placement of the parent device and have
unique dimensions, geometry, or deployment mechanisms. These
accessories are critical for precise and proper placement of the parent
device, and therefore, FDA considers design controls to be an important
element in the regulation of such accessories to ensure appropriate
compatibility between the accessory and the parent device (see Sec.
820.30).
    (Comment 5) Two commenters noted that additional guidance should be
provided for manufacturers who wish to seek distinct classification of
orthopedic accessories, namely ``considerations for reclassification of
instruments that have been previously classified through a premarket
submission based on their association with a particular implant
system'' and ``the specific information that FDA would expect to see in
the requests for instrument reclassification, preferably in a
standardized submission format.''
    (Response) Although the question pertains to a different provision
than this final classification action, we believe that clarification in
this case may assist manufacturers and FDA staff for future accessory
classification actions. Any manufacturer or importer may submit a
request for appropriate classification of an existing accessory per
section 513(f)(6)(D)(ii) of the FD&C Act. According to FDA's guidance
``Medical Device Accessories: Describing Accessories and Classification
Pathways'' (available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429672.pdf), such a
request should include ``[t]he proposed classification of the accessory
(i.e., class I or class II), as well as the current classification,
should also be clearly identified in the cover letter and/or the
request. An Existing Accessory Request should include the necessary
information, based on Least Burdensome principles, to establish the
risk profile of the accessory when used as intended with the identified
parent device. . . . Note that requests for classification of an
accessory in class II must include an initial draft proposal for
special controls, if special controls would be required pursuant to
subsection 513(a)(1)(B) of the FD&C Act.'' Additional information
regarding reclassification processes are described in sections 513(e)
and (f)(3) of the FD&C Act. FDA recommends manufacturers submit a Pre-
Submission if they have specific questions regarding such a request.
More information regarding the Pre-Submission Program can be found in
FDA's guidance entitled ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' (available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf).
    (Comment 6) One commenter included several comments regarding the
definition of ``device-specific instrument'' that we provided in
section III of the proposal (the ``Policy Clarification for
Classification of Certain Accessories Used in Orthopedic Surgery'').
The commenter noted the definition was vague and sought clarity on what
is meant by ``unique dimensions, geometry, and/or deployment.''
    (Response) To provide further clarity regarding how we interpret
``unique dimensions, geometry, and/or

deployment'' in the definition for device-specific orthopedic
instrument outlined in FDA's proposal, we provide the following
examples to illustrate the types of instruments that we would consider
to be ``device-specific'' and types that are not:
    Examples of instruments that would be considered ``device-
specific'':
    (1) A screwdriver that mates through a unique geometry or
connection to a specially designed screw, which could not be inserted
by a standard, generally available screwdriver. Such an instrument
would possess a unique geometry that could not be utilized with screws
of industry standard dimensions (such as cortical (HA) and cancellous
(HB) bone screws per ASTM F543 \1\). In contrast, a general use
screwdriver could be used across screws ``from multiple
manufacturers''.
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    \1\ ASTM F543, Standard Specification and Test Methods for
Metallic Medical Bone Screws. For the current edition of the FDA
recognized standard referenced in this document, see the FDA
Recognized Consensus Standards Database, available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
---------------------------------------------------------------------------

    (2) An inserter instrument that is designed to specifically
interface with features of the parent device to allow for insertion of
the device. Such an instrument would possess unique dimensions or
geometry to mate specifically with the parent device. In contrast,
impactors are used to place an implant and do not require a specific
interface with the parent device. These are general use instruments
that could be used across multiple device types and are not based on
unique dimensions, geometry, or deployment of a parent device.
    Examples of instruments that would not be considered ``device-
specific'':
    (1) Bone taps solely to create a preliminary hole to help guide
subsequent placement of a screw and can be used across multiple screw
types/sizes. These are not based upon unique dimensions, geometry, or
deployment of a parent device.
    (2) Reamers are not based upon unique dimensions, geometry, or
deployment of a parent device and can be used across multiple device
types to prepare a site for implantation.
    In all such examples, a general use version of the instrument may
still be designed based upon certain dimensions of the parent device
(e.g., according to industry standard screw dimensions). However,
device-specific instruments are designed specifically for use with a
particular parent device based upon ``unique dimensions, geometry, or
deployment'' of the parent device (e.g., sizes that would not be
compatible with industry standard dimensions, or specific features that
are only present on the parent device).
    (Comment 7) One commenter proposed an alternative definition for
``device-specific instrument'' as follows: ``A device-specific
orthopedic instrument is considered to be an accessory designed
specifically for appropriate implantation or placement of the parent
device, based upon unique dimensions, geometry, and/or deployment when
the instrument has an intended use or fundamental scientific technology
that differs from those of the generic types of instruments either
listed in the regulation or previously accepted as being contained
within the regulation.''
    The commenter notes that these revisions are necessary to avoid the
definition applying to instruments that clearly fall within an existing
class I classification regulation (e.g., Sec.  888.4540), citing a
screwdriver as being an example of such an instrument that could be
interpreted, based upon the definition, to be ``device-specific.''
    (Response) FDA does not agree with the proposed additional text
(i.e., ``. . . when the instrument has an intended use or fundamental
scientific technology that differs from those of the generic types of
instruments either listed in the regulation or previously accepted as
being contained within the regulation''). This text suggests that such
instruments could fit under existing class I regulations (i.e., would
exceed the limitation of exemption under 21 CFR 888.9(a) and (b)) but
would subsequently be appropriately regulated under such regulation
following submission of a 510(k)). However, this does not address the
Agency's position that general controls alone are insufficient to
mitigate risks to health. Furthermore, the phrase ``previously accepted
as being contained within the regulation'' is unclear.
    We also disagree with the commenter's statement that the definition
as written would result in such a screwdriver being deemed device-
specific, as such an instrument would not be ``based upon unique
dimensions, geometry, and/or deployment'' of the parent device, unless
the parent device (screw) was somehow unique in design (e.g., a screw
head which would not fit a standard screwdriver).
    (Comment 8) One commenter posed several specific scenarios to
better understand circumstances under which an accessory would be
deemed ``device-specific,'' such as whether branding makes an accessory
device-specific, whether an accessory remains ``device-specific'' if
used with another device made by a manufacturer, or whether accessories
to be used ``across systems'' applies to systems from the same
manufacturer. Similarly, they asked if a combination of two general
accessories from two different systems could still be considered a
general use accessory.
    (Response) In response to the comments, we are clarifying that the
sole presence of a branding statement would not render an accessory
``device-specific'' according to this definition. An accessory for use
with other devices made by a manufacturer may or may not be determined
to be ``device-specific,'' depending on the design of the accessory.
For example, an accessory designed for use for a specific system, i.e.,
across multiple-device sizes within the same family of devices, would
be device-specific if it is designed specifically for appropriate
implantation or placement of the parent device, based upon unique
dimensions, geometry, and/or deployment.
    In some cases, an accessory may also be designed for use across
multiple systems from the same manufacturer. Accessories that can be
used across systems from the same manufacturer may or may not be
considered device-specific, depending on technology, design, and
configuration. For example, one manufacturer may have several systems
of intervertebral body fusion devices, with inserter instruments that
are specifically designed to mate with a unique feature on all devices
in the systems and would therefore be considered device-specific. Such
an instrument would possess unique dimensions or geometry to mate
specifically with the parent device.
    In contrast, the combination of two general use accessories would
result in a general use accessory. This is because neither accessory
has a design, geometry, and/or deployment suited to a particular device
or device family.
    (Comment 9) One commenter sought clarity on how the device-specific
definition should be applied retroactively to previously cleared/
approved orthopedic accessories.
    (Response) The definition of ``device-specific'' was intended to
clarify existing policy regarding regulation of orthopedic accessories,
not to establish new policy. If a device was cleared within a 510(k) as
an accessory but appropriately fits into an existing class I
classification regulation based on the policy clarification, this
determination can be documented to file by the manufacturer along with
updating the listing accordingly.
    (Comment 10) One commenter provided several comments regarding

sizing templates, noting that they would meet the definition of
``device-specific'' but are otherwise distinctly classified in a class
I classification regulation (Sec.  888.4800 (21 CFR 888.4800)). This
commenter also included several examples of other devices (e.g.,
sizers, cutting guides, and trials) that would fall under this
classification regulation.
    (Response) In recent history, Sec.  888.4800 has been interpreted
to apply to imaging templates used to estimate proper device size prior
to surgery rather than physical trials/sizers to be used in a surgical
procedure. The initial classification panel identified the following
risks to health associated with devices under this classification
regulation: Tissue damage and adverse tissue reaction. Fracture of the
device could injure surrounding tissue and, if device fragments remain
in the tissue, could cause an adverse tissue reaction.
    Further review in response to this comment has led FDA to
reconsider the instruments that were to be subject to this
classification regulation. We agree that trials or templates that are
basic sizing devices for proper implant selection may be appropriately
regulated under Sec.  888.4800, despite the recent practice of
regulating these trials with the parent device.
    The Agency does not, however, consider cutting guides to fall
within this classification regulation, as Sec.  888.4800 specifically
calls out devices that are used for ``guiding the marking of tissue
before cutting'' but does not expressly include a physical guide to
direct the orientation of a cut. These devices carry a higher risk than
devices simply intended to mark tissues, as in addition to the risk
associated with this classification regulation (i.e., tissue damage and
adverse tissue reaction), an improper physical cut in the tissue leads
to improper placement of the parent device and potential for resulting
device malfunction or failure.
    (Comment 11) One commenter sought clarity on the application of
design controls to class I instruments that interface with higher-
classification parent devices. The commenter notes that ``any interface
with a mating instrument (regardless of instrument classification)
would be subject to design controls via requirements for the parent
device.''
    (Response) As FDA stated in the proposal, by regulation, design
controls apply to class I devices only if the devices are automated
with computer software or are listed under Sec.  820.30(a)(2)(ii).
    (Comment 12) One commenter sought clarity as to whether a risk-
based justification could be utilized in determining if a device is an
accessory to a parent device. While an instrument may have device-
specific features, the risk may be commensurate with that of orthopedic
manual surgical instruments.
    (Response) The determination of whether a device meets the
definition of an accessory is not a risk-based decision. We have
outlined in FDA's proposal why we consider devices with features
specific to a parent device to pose additional risk beyond those of
general use orthopedic manual surgical instruments.
    (Comment 13) One commenter stated that the definition of ``device-
specific'' instrument is not consistent with FDA's definition of an
accessory as outlined in the guidance document entitled ``Medical
Device Accessories: Describing Accessories and Classification
Pathways.''
    (Response) We do not consider the proposed definition for device-
specific instrument to be inconsistent with FDA's definition of an
accessory, as device-specific orthopedic instruments are those designed
specifically for appropriate implantation or placement of the parent
device, based upon unique dimensions, geometry, and/or deployment.
Furthermore, the device-specific orthopedic instrument definition is
derived from the definition of accessories (i.e., in that ``design
specifications are critical to the proper use of the accessory in
supporting, supplementing, and/or augmenting the performance of the
parent device and/or a specific system.'').
    (Comment 14) One commenter notes that FDA stated in its proposal
that ``certain device-specific instruments are accessories and require
precise technical specifications or design characteristics to function
as intended to support, supplement or augment the parent device and if
they are not designed appropriately could cause implant malpositioning
or migration,'' and, thus, ``are ineligible for reclassification in
class I.'' The commenter sought clarity as to why other class I exempt
devices would not also ``require precise technical specifications or
design characteristics.''
    (Response) We expect that any device would have certain technical
specifications or design characteristics that dictate their
manufacture. However, for some devices, including device-specific
orthopedic instruments, the safety, performance, and dependability of
the device are critical for precise and proper placement of the parent
device. Design controls, among other benefits, increase the likelihood
that the design transferred to production will translate into a device
that is appropriate for its intended use, including precise and proper
placement of the parent.\2\ Therefore, device-specific orthopedic
instruments require the application of design controls for reasonable
assurance of safety and effectiveness.
---------------------------------------------------------------------------

    \2\ For more information about design controls, refer to FDA's
guidance document entitled ``Design Control Guidance for Medical
Device Manufacturers,'' available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf.
---------------------------------------------------------------------------

    (Comment 15) One commenter asked for examples of what ``other
regulatory controls'' beyond design controls may be necessary to ensure
compatibility, as stated in the proposal.
    (Response) Another regulatory control could be, for example,
premarket notification. For these devices for which verification of
compatibility would be necessary, this may be evaluated through
information (e.g., device description, performance testing) provided in
a premarket submission.
    (Comment 16) One commenter sought guidance on the type of
information needed to describe a device-specific orthopedic instrument
in premarket submissions, as well as guidance for manufacturers whose
accessories have been reclassified under section 513(f)(6)(D)(ii) of
the FD&C Act. This commenter also suggested that FDA consider
classification of the orthopedic instruments as class I with design
controls.
    (Response) The commenter's requests are outside the scope of this
final classification action.
    (Comment 17) One commenter noted that one of the proposed
accessories for classification into class I is a handle to an inserter
device for a class III product. They sought further clarity to
determine whether handles for modular orthopedic instruments could be
distinctly classified from their working end.
    (Response) The referenced corneal inlay implant device is class
III, and we proposed distinct classification of the associated handles
into class I. Similarly, other such instrument handles associated with
orthopedic devices cleared through 510(k) or PMA could be distinctly
classified from the parent device using mechanisms outlined in section
513(f)(6)(D)(ii) of the FD&C Act.
    (Comment 18) One commenter noted that some instruments provided in
sets used during a surgery may not be considered ``accessories'' but
are provided within these sets for ease of processing and access for
the surgeon. Furthermore, some of these instruments may fall under
existing class I classification regulations.

    (Response) We agree with the commenter. Many instruments in
instrument sets would not be considered accessories to the device, and
some accessories may already be distinctly classified in existing class
I classification regulations.

III. Policy Clarification for Classification of Certain Accessories
Used in Orthopedic Surgery

    In the proposal, FDA provided a policy clarification for the
regulatory approach for certain accessories used in orthopedic surgery
to distinguish which accessories may be candidates for classification
under section 513(f)(6)(D)(i) of the FD&C Act. This policy
clarification acknowledged that instruments used in orthopedic surgery
span a wide range of complexity, with many ``general use'' instruments
falling within existing class I classification regulations (e.g., Sec.
888.4540), while other ``device-specific'' instruments have
historically been reviewed in the same premarket submission as the
parent device.
    In an effort to ensure a common understanding as to which
orthopedic accessories are considered ``device-specific,'' thereby not
falling within an existing class I classification regulation, and which
may be candidates for classification under section 513(f)(6)(D)(i) of
the FD&C Act, we provided the following definition: A device-specific
orthopedic instrument is considered to be an accessory designed
specifically for appropriate implantation or placement of the parent
device, based upon unique dimensions, geometry, and/or deployment. In
these cases, design specifications are critical to the proper use of
the accessory in supporting, supplementing, and/or augmenting the
performance of the parent device and/or a specific system. FDA
considers design controls (see Sec.  820.30) to be an important element
in the regulation of device-specific accessories, among other
regulatory controls, to ensure appropriate compatibility between the
accessory and the parent device. This excludes general use orthopedic
instruments that are provided as a part of a system.
    Based upon comments in response to this section of the proposal,
FDA has not altered the policy clarification or definition of device-
specific orthopedic instruments as previously described but has
provided additional clarification and examples in the responses
discussed in section II above. FDA intends to engage with industry
stakeholders on the topic to resolve additional questions regarding the
existing policy or future proposals for distinct classification of
accessories under section 513(f)(6)(D)(ii) of the FD&C Act.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this final
classification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

V. Paperwork Reduction Act of 1995

    This final classification action refers to previously approved
collections of information. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                                                                                OMB  control
            21 CFR part; guidance; or FDA form                             Topic                        No.
----------------------------------------------------------------------------------------------------------------
807, subpart E...........................................  Premarket notification...............       0910-0120
814, subparts A through E................................  Premarket approval...................       0910-0231
``De Novo Classification Process (Evaluation of Automatic  De Novo classification process.......       0910-0844
 Class III Designation)''.
800, 801, and 809........................................  Medical Device Labeling Regulations..       0910-0485
820......................................................  Current Good Manufacturing Practice         0910-0073
                                                            (CGMP); Quality System (QS)
                                                            Regulation.
``Medical Device Accessories: Describing Accessories and   Medical Device Accessories...........       0910-0823
 Classification Pathways for New Accessory Types.''.
``Requests for Feedback on Medical Device Submissions:     Q-submissions........................       0910-0756
 The Pre-Submission Program and Meetings with Food and
 Drug Administration Staff''.
----------------------------------------------------------------------------------------------------------------

List of Subjects

21 CFR Part 876

    Medical devices.

21 CFR Part 878

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
876, 878, and 886 are amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.1080 to subpart B to read as follows:

Sec.  876.1080   Gastroenterology-urology accessories to a biopsy
instrument.

    (a) Identification. A gastroenterology-urology accessory to a
biopsy instrument is an accessory used to remove a specimen of tissue
for microscopic examination by cutting or aspiration. This generic type
of device includes a syringe for specimen aspiration and a biopsy
channel adaptor. This device does not include accessories to biopsy
instruments used in other medical specialty areas.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

0
3. Add Sec.  876.3500 to subpart D to read as follows:

Sec.  876.3500   Penile implant surgical accessories.

    (a) Identification. Penile implant surgical accessories are manual
devices designed to be used for surgical procedures associated with the
implantation of a penile inflatable implant or penile rigidity implant.
This generic type of device includes the cylinder sizer, cylinder
insertion tool

and needle, device placement tool, connector assembly tool, incision
closing tool, corporeal dilator, tubing passer, measurement tool or
tape, tubing plug, blunt needle, and hemostat shod tubing.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

0
4. Add Sec.  876.4630 to subpart E to read as follows:

Sec.  876.4630  Ureteral stent accessories.

    (a) Identification. Ureteral stent accessories aid in the insertion
of the ureteral stent that is placed into the ureter to provide
ureteral rigidity and allow the passage of urine. This generic type of
device includes the stent positioner, wire guide, and pigtail
straightener.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

0
5. Add Sec.  876.5012 to subpart F to read as follows:

Sec.  876.5012  Biliary stent, drain, and dilator accessories.

    (a) Identification. Biliary stent, drain, and dilator accessories
are manual devices that aid in the introduction and connection of
biliary stents, drains, or dilators. This generic type of device
includes the guiding catheter, pushing catheter, pigtail straightener,
flap protector, nasal transfer tube, and drainage connecting tube.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

0
6. Add Sec.  876.5100 to subpart F to read as follows:

Sec.  876.5100  Suprapubic catheter accessories.

    (a) Identification. Suprapubic catheter accessories are manual
devices that are used to facilitate the placement of a suprapubic
catheter. This generic type of device includes the introducer, access
dilator, and peel-away sheath.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

0
7. Add Sec.  876.5290 to subpart F to read as follows:

Sec.  876.5290   Implanted mechanical/hydraulic urinary continence
device surgical accessories.

    (a) Identification. Implanted mechanical/hydraulic urinary
continence device surgical accessories are manual devices designed to
be used for surgical procedures associated with the implantation of an
implanted mechanical/hydraulic urinary continence device. This generic
type of device includes the measurement tool or tape, connector
assembly tool, tubing plug, incision closing tool, tubing passer, blunt
needle, and hemostat shod tubing.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
8. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
9. Add Sec.  878.5080 to subpart F to read as follows:

Sec.  878.5080   Air-handling apparatus accessory.

    (a) Identification. An air-handling apparatus accessory is a
supplementary device that is intended to be used with an air-handling
apparatus for a surgical operating room. This device provides an
interface between the components of the device or can be used to switch
electrical power. This generic type of device includes fittings,
adapters, couplers, remote switches, and footswitches.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  878.9.

PART 886--OPHTHALMIC DEVICES

0
10. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
11. Add Sec.  886.4355 to subpart F to read as follows:

Sec.  886.4355   Corneal inlay inserter handle.

    (a) Identification. The corneal inlay inserter handle is a hand-
held device intended to be used as an accessory to a corneal inlay
inserter. The device extends the length of the inlay inserter to aid in
delivering the inlay implant.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  886.9.

    Dated: April 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07290 Filed 4-11-19; 8:45 am]
 BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

January 14, 2008

MEMORANDUM:

Subject:	Dietary and Drinking Water Exposure Chapter for
Tributlytin-Containing Compounds for the Reregistration Eligibility
Decision (RED) Document (Case 2620)

To:		Jill Bloom, Chemical Review Manager

		Special Review & Reregistration Division (SRRD)

From: 		Cassi Walls, Ph.D., Chemist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:		Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode: 		347646

Chemical Names:	Tributyltin oxide (TBTO)

	Tributyltin benzoate (TBTB)

	Tributyltin maleate (TBTM)

PC Codes:		 083001, 083106, 083118

CAS Registry No. 	TBTO:  56-35-9

			TBTB:  4342-36-3

			TBTM:  4027-18-3

Attached is a review of the dietary and drinking water exposures for the
antimicrobial uses of tributyltin-containing compounds (TBTO, TBTB, and
TBTM) to support the Reregistration Eligibility Decision (RED) document.

I.  SEQ CHAPTER \h \r 1  	Dietary Exposures to Tributlytin-Containing
Compounds

	The Antimicrobials Division (AD) assessed the potential dietary
exposures for the antimicrobial uses of tributyltin (TBT)-containing
compounds, tributyltin oxide (TBTO), tributyltin benzoate (TBTB), and
tributyltin maleate (TBTM).

	TBT compounds can be used in following use sites where a potential for
food contact appears to exist:

Algicides in water cooling systems for pasteurization/canneries, soft
drink and food canning plants

Algicides in paper mills

Materials preservative in adhesives

	However, all of the TBT labels that have one of these use sites that
might pose a potential for contacting food, contain specific “non-food
contact” requirements or use directions that minimize the indirect
dietary exposure.  For example, the label of a product containing
directions for use in paper mills (EPA Registration #47371-29) contains
the statement, “Do not use in the manufacture of paper which will have
direct or indirect contact with food.”  At this time, no registrant
has indicated that it wishes to support of the use of TBT in
pasteurization/canning or paper mills.

	The registrants of products bearing labels with directions for use in
manufacturing adhesives have indicated that such adhesives are used in
applications such as attaching face fibers to carpet backing.  It should
be noted that TBTO has an FDA clearance under 21 CFR 175.105 as a
material preservative in adhesives for use in food packaging, implying
that there is a potential for indirect dietary exposure.  However,
during the SMART meeting, the registrants indicated that they did not
intend to support this indirect food use.  Therefore, all of the TBTO
labels used as a materials preservative for adhesives must state “for
non-food contact adhesives.”

	It should be further noted that although there are no FDA clearances
for any TBT compounds for the pulp and paper uses, the labels all state
for non-food contact paper.  In order  for AD to accept non-food contact
language for pulp and paper mill uses, examples of non-food contact
paper (i.e., newsprint, Kraft paper, brown paper mills, sheets for
corrugated board) must be listed on the labels.

	One registrant holds a registration for a product that is used to
manufacture household sponges, scouring pads, and sponge mop-heads.
This registration (EPA Registration  #10466-28) contains the TBTM active
ingredient.  The use of TBTM will be assessed for incidental exposure
for food contact surfaces and floors in the ORE assessment.

	In the livestock operation use, hogs, cattle, and poultry are removed
prior to the microbiocide treatment and the feeding equipment is rinsed
prior to use.  The premises must be aired for 24 hours after treatment,
and another 24 hours must pass before animals can be returned to the
treated areas—a total of 48 hours after application.

	AD assumes that removing animals prior to treatment and rinsing feeding
equipment after treatment results in negligible residues in the animals
living in treated facilities.  For this reason, AD does not typically
assess livestock premises.

	 In the case of the TBTO product used in animal housing facilities, the
Agency believes there may be a greater potential for animals to be
exposed, and thus, a potential for human dietary exposure.  This
potential is a result of the way in which such treatments are conducted
and the particular fate characteristics of TBT.  Specifically, 1) the
product label does not require rinsing or removal of TBT solution or
fogging residue after treatment (except for feed bowls not removed
during treatment), 2) animal premises may be treated frequently, and 3)
TBT is environmentally persistent and bioaccumulative.  The product
label should indicate that treated surfaces must be rinsed before
animals can be re-housed, although whether this is feasible when
applications are made with a fogger rather than by immersion, spraying,
mopping, or foaming is not clear.  Data are needed to improve our
understanding of the scope of actual exposures in animals exposed to TBT
via this use.  Data on the effectiveness of rinsing in removing TBT
residues from the treated premises, and residue data in the associated
food commodities will enable the Agency to further refine the assessment
of the animal premises use.

	AD has, in the past, assumed that incubating eggs do not absorb
pesticide chemicals as the result of hatchery treatments, but data are
lacking to support the assumption.  The hatchery use of TBTO (hatchery
rooms, incubators, and hatchers) may pose a greater likelihood of
producing residues in  eggs.  As discussed above, the environmental fate
characteristics of TBT may present additional opportunities for dietary
exposure.  The label of the one TBTO product registered for use in
hatcheries provides use directions for fogging equipment, and incubating
eggs are not removed from the premises during treatment.  The registrant
has indicated that eggs removed from the premises for repeated
applications of the product will not be viable.  In addition, premises
may be treated as frequently as once a day.  The label does not require
that surfaces exposed via fogging be rinsed after treatment, and
removing the residues left behind after fogging may not be adequately
achieved by rinsing.  A chemical like TBT, with its large potential for
persistence and bioaccumulation, could pose an increased risk of
residues in eggs relative to other pesticides of lesser persistence and
bioaccumulative potential.  Data appropriate for use in examining the
assumption that this pesticide does not penetrate eggshells in
incubation would facilitate a quantitative assessment of dietary
exposures resulting from the use of TBT in hatcheries.

II.  	Drinking Water Exposure to Tributlytin-Containing Compounds

	AD assessed the potential drinking water exposures for the
antimicrobial uses of tributyltin-containing compounds, tributyltin
oxide (TBTO), Tributyltin benzoate (TBTB), and Tributyltin maleate
(TBTM).  Based on the use patterns, the potential for TBT, TBTM, or TBTO
to impact drinking water sources is negligible and therefore a
quantitative drinking water assessment was not conducted.  However, data
are lacking to characterize the effectiveness of water used to rinse
animal housing facilities after treatment, and conversely, the fate and
concentrations of TBT in the rinse water.

 PAGE

 PAGE  3


[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Proposed Rules]
[Pages 9374-9379]
[FR Doc No: 2016-03699]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3701; Directorate Identifier 2015-NM-015-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2013-25-
08, for all Airbus Model A330-200, -200 Freighter, and -300 series
airplanes; and Model A340-200 and -300 series airplanes. AD 2013-25-08
currently requires a repetitive inspection program on certain check
valves in the hydraulic systems that includes, among other things,
inspections for lock wire presence and integrity, traces of seepage or
black deposits, proper torque, alignment of the check valve and
manifold, installation of new lock wire, and corrective actions if
needed. Since we issued AD 2013-25-08, Airbus has developed an improved
check valve. This proposed AD would add airplanes to the applicability,
and require modifying the green, blue and yellow high pressure
hydraulic manifolds by replacing certain check valves with improved
check valves, which would terminate the repetitive inspections required
by this proposed AD. We are proposing this AD to detect and correct
hydraulic check valve loosening; loosened valves could result in
hydraulic leaks, possibly leading to the loss of all three hydraulic
systems and consequent loss of control of the airplane.

DATES: We must receive comments on this proposed AD by April 11, 2016.

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.
    For service information identified in this NPRM, 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>.

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-
3701; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-3701;
Directorate Identifier 2015-NM-015-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On November 26, 2013, we issued AD 2013-25-08, Amendment 39-17704
(78 FR 78694, December 27, 2013) (``AD 2013-25-08''). AD 2013-25-08
requires actions intended to address an unsafe condition on all Airbus
Model A330-200 and -300 series airplanes; and Model A340-200 and -300
series airplanes.
    Since we issued AD 2013-25-08, which superseded AD 2009-24-09
Amendment 39-16068 (74 FR 62208, November 27, 2009), the European
Aviation Safety Agency (EASA), which is the Technical Agent for the
Member States of the European Union, has issued EASA Airworthiness
Directive 2015-0009, dated January 16, 2015 (referred to after this as
the Mandatory Continuing Airworthiness Information, or ``the MCAI''),
to correct an unsafe condition. The MCAI states:

An A330 operator experienced a Yellow hydraulic circuit low level
due to a loose check valve, Part Number (P/N) CAR401. During the
inspection on the other two hydraulic systems, the other three check
valves P/N CAR401 were also found to be loose with their lock wire
broken in two instances. Airbus A340 aeroplanes are also equipped
with P/N CAR401 high pressure manifold check valves.
Additional cases of P/N CAR401 check valve loosening have been
reported on aeroplanes having accumulated more than 1,000 flight
cycles (FC). The check valve fitted on the Yellow hydraulic system
is more affected, due to additional system cycles induced by cargo
door operation.
This condition, if not detected and corrected, could result in
hydraulic leaks, possibly leading to the loss of all three hydraulic
systems and consequent loss of control of the aeroplane.
To address this unsafe condition, EASA issued Emergency AD 2009-
0223-E (http://ad.easa.europa.eu/blob/easa_ad_2009_0223E_superseded.pdf/EAD_2009-0223-E_1) [which
corresponds to FAA AD 2009-24-09, Amendment 39-16068 (74 FR 62208,
November 27, 2009)] to require an inspection programme to detect any
check valve loosening and, if necessary, to apply the applicable
corrective actions.
EASA AD 2010-0145 (http://ad.easa.europa.eu/blob/easa_ad_2010_0145_Superseded.pdf/AD_2010-0145_1), which superseded
EASA EAD 2009-0223-E retaining its requirements, was issued to
expand the applicability to the newly certified models A330-223F and
A330-243F.
Prompted by further reported in-service events of check valve P/N
CAR401 loosening before reaching the threshold of 700 FC, EASA AD
2011-0139 (http://ad.easa.europa.eu/blob/easa_ad_2011_0139_superseded.pdf/AD_2011-0139_1), which superseded
EASA AD 2010-0145, retaining its requirements, was issued to:

--extend the requirement to identify the P/N CAR401 check valves to
all aeroplanes, and
--reduce the inspection threshold for aeroplanes fitted with check
valve P/N CAR401, either installed in production through Airbus
modification 54491, or installed in service through Airbus Service
Bulletin (SB) A330-29-3101 or Airbus SB A340-29-4078.

EASA AD 2012-0070 (http://ad.easa.europa.eu/blob/easa_ad_2012_0070_Correction_superseded.pdf/AD_2012-0070_1), which
superseded EASA AD 2011-0139, retaining its requirements, was issued
to require an increased torque value of the check valve tightening
and High Pressure (HP) manifold re-identification.
Since EASA AD 2012-0070 was issued, additional in-service events
have been reported on aeroplanes fitted with check valves on which
the increased torque value had been applied. Based on those events,
it has been concluded that the action to re-torque the check valves
with an increased value is not a satisfactory terminating action for
addressing the issue of those check valves.
To address that, EASA issued AD 2012-0244, which partially retained
the requirements of EASA AD 2012-0070, which was superseded.
Additionally, for aeroplanes equipped with P/N CAR401 on which the
increased torque value had been applied, EASA AD 2012-0244 required
repetitive inspections of the check valves and HP manifolds.
Finally, EASA AD 2012-0244 also required application of a lower
torque value when a check valve P/N CAR401 is installed on an
aeroplane.
Note: The reporting and the torque value increase requirements for
check valves P/N CAR401 of EASA AD 2012-0070 were no longer part of
EASA AD 2012-0244.
EASA AD was revised to clarify which actions are required for P/N
CAR401 check valves, depending on applied (or not) torque value.
Since EASA AD 2012-0244R1 (http://ad.easa.europa.eu/blob/easa_ad_2012_0244_R1_superseded.pdf/AD_2012-0244R1_1) was issued,
Airbus developed an improved check valve P/N CAR402, which is
embodied in production through Airbus modification 203972, and in
service through associated Airbus SB A330-29-3125, or Airbus SB
A340-29-4096, as applicable to aeroplane type. In addition, these
SBs provide instructions about the torque value (between 230 and 250
Nm) and re-identification of HP manifolds after check valve P/N
CAR402 installation.
For the reasons described above, this [EASA] AD retains the
requirements of EASA AD 2012-0244R1, which is superseded, and
requires the installation of check valves P/N CAR402 as terminating
action to the repetitive inspections [and adds airplanes to the
applicability].

    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-
3701.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A330-29-3125, Revision 01,
including Appendixes 01 and 02, dated July 30, 2015; and Service
Bulletin A340-29-4096, Revision 01, including Appendixes 01 and 02,
dated July 30, 2015. This service information describes procedures for
modifying the green, blue, and yellow high pressure hydraulic manifolds
by replacing each check valve having part number (P/N) CAR401 with an
improved check valve having P/N CAR402. 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.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Explanation of a Certain Alternative Method of Compliance (AMOC)

    Paragraph (t)(1)(iii) of this proposed AD states that AMOC ANM-116-
14-429 is not approved as an AMOC for the corresponding provisions of
this AD. This AMOC defines a terminating action when Airbus
Modification 203972 is introduced in production or when the Airbus
Service Bulletin A330-29-3125, dated August 8, 2014, is embodied in
service. This proposed AD will exclude from the applicability airplanes
with Airbus Modification 203972 and will mandate actions in accordance
with Airbus Service Bulletin A330-29-3125, Revision 01, including
Appendixes 01 and 02, dated July 30, 2015.

Costs of Compliance

    We estimate that this proposed AD affects 88 airplanes of U.S.
registry.
    The actions required by AD 2013-25-08, and retained in this
proposed AD take about 10 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 2013-25-08 is $850 per product.
    We also estimate that it would take about 32 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $239,360, or
$2,720 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD. We have no way of determining the number of aircraft that might
need these actions.
    According to the manufacturer, some of the costs of this proposed
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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013), and
adding the following new AD:

Airbus: Docket No. FAA-2016-3701; Directorate Identifier 2015-NM-
015-AD.

(a) Comments Due Date

    We must receive comments by April 11, 2016.

(b) Affected ADs

    This AD replaces AD 2013-25-08, Amendment 39-17704 (78 FR 78694,
December 27, 2013).

(c) Applicability

    This AD applies to Airbus airplanes, certificated in any
category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model A330-201, -202, -203, -223, -223F, -243, -243F, -301,
-302, -303, -321, -322, -323, -341, -342, and -343 airplanes; all
manufacturer serial numbers except those on which Airbus
modification 203972 has been embodied in production.
    (2) Model A340-211, -212, -213, -311, -312, and -313 airplanes;
all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
power.

(e) Reason

    This AD was prompted by multiple reports of hydraulic line check
valves loosening. We are issuing this AD to detect and correct
hydraulic check valve loosening, which could result in hydraulic
leaks, possibly leading to the loss of all three hydraulic systems
and consequent loss of control of the airplane.

(f) Compliance

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

(g) Retained Inspections, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. Except for Model A330-223F and A330-243F airplanes:
Do the actions required by paragraphs (g)(1) and (g)(2) of this AD.
    (1) For airplanes that do not have Airbus Modification 54491
embodied in production, or Airbus Service Bulletin A330-29-3101 or
Airbus Service Bulletin A340-29-4078 embodied in service: Within 100
flight cycles or 28 days after December 14, 2009 (the effective date
of AD 2009-24-09, Amendment 39-16068 (74 FR 62208, November 27,
2009)), whichever occurs first, inspect the check valves on the
blue, green, and yellow hydraulic systems to identify their part
numbers (P/Ns), in accordance with the instructions of Airbus All
Operators Telex (AOT) A330-29A3111, Revision 1, dated October 8,
2009 (for Model A330-200 and -300 series airplanes); or AOT A340-
29A4086, Revision 1, dated October 8, 2009

(for Model A340-200 and -300 series airplanes). Accomplishment of
the inspection required by paragraph (h) of this AD terminates the
requirements of this paragraph.
    (i) If check valves having P/N CAR401 are installed on all three
hydraulic systems, before further flight, do the actions specified
in paragraph (g)(2)(i) of this AD. After accomplishing the actions
required by paragraph (g)(2)(i) of this AD, do the actions specified
in paragraphs (g)(2)(ii) and (g)(2)(iii) of this AD at the
applicable compliance times specified in those paragraphs.
Accomplishment of the inspection required by paragraph (i) of this
AD terminates the requirements of this paragraph.
    (ii) If check valves having P/N CAR401 are not installed on all
three hydraulic systems, no further action is required by this
paragraph until any check valve having P/N CAR400 is replaced with a
check valve having P/N CAR401. If any check valve having P/N CAR400
is replaced by a check valve having P/N CAR401, before further
flight, do the inspection specified in paragraph (g)(1) of this AD
to determine if all three hydraulic systems are equipped with check
valves having P/N CAR401. Accomplishment of the inspection required
by paragraph (h) of this AD terminates the requirements of this
paragraph.
    (2) For airplanes on which Airbus Modification 54491 was
embodied in production, or Airbus Service Bulletin A330-29-3101; or
Airbus Service Bulletin A340-29-4078 was embodied in service, do the
actions specified in paragraphs (g)(2)(i), (g)(2)(ii), and
(g)(2)(iii) of this AD.
    (i) Except as required by paragraph (g)(1)(i) of this AD, at the
applicable times specified in paragraphs (g)(2)(i)(A) and
(g)(2)(i)(B) of this AD, as applicable: Do the inspection program
(detailed inspection of the lock wire for presence and integrity, a
detailed inspection for traces of seepage or black deposits, and an
inspection for proper torque) on yellow and blue high pressure
manifolds, install new lock wires, and do all applicable corrective
actions, in accordance with the instructions of paragraph 4.1.1 of
Airbus AOT A330-29A3111, Revision 1, dated October 8, 2009 (for
Model A330-200 and -300 series airplanes); or AOT A340-29A4086,
Revision 1, dated October 8, 2009 (for Airbus Model A340-200 and -
300 series airplanes). Do all applicable corrective actions before
further flight. Accomplishment of the inspection required by
paragraph (h)(1) of this AD terminates the requirements of this
paragraph.
    (A) For airplanes on which Airbus Modification 54491 has been
embodied in production: At the later of the times specified in
paragraphs (g)(2)(i)(A)(1) and (g)(2)(i)(A)(2) of this AD.
    (1) Before the accumulation of 1,000 total flight cycles since
first flight but no earlier than the accumulation of 700 total
flight cycles since first flight.
    (2) Within 100 flight cycles or 28 days after December 14, 2009
(the effective date of AD 2009-24-09, Amendment 39-16068 (74 FR
62208, November 27, 2009)), whichever occurs first.
    (B) For airplanes on which Airbus Service Bulletin A330-29-3101
or A340-29-4078 was embodied in service: At the later of the times
specified in paragraphs (g)(2)(i)(B)(1) and (g)(2)(i)(B)(2) of this
AD.
    (1) Within 1,000 flight cycles since the embodiment of Airbus
Service Bulletin A330-29-3101 or A340-29-4078 but no earlier than
700 flight cycles after the embodiment of Airbus Service Bulletin
A330-29-3101 or A340-29-4078.
    (2) Within 100 flight cycles or 28 days after December 14, 2009
(the effective date of AD 2009-24-09, Amendment 39-16068 (74 FR
62208, November 27, 2009)), whichever occurs first.
    (ii) Within 900 flight hours after accomplishment of paragraph
(g)(2)(i) of this AD, do the inspection program (detailed inspection
of the lock wire for presence and integrity, a detailed inspection
for traces of seepage or black deposits, and an inspection for
proper torque) and install a new lock wire on the green high
pressure manifold; and do an inspection (detailed inspection for
traces of seepage or black deposits, and detailed inspection to
determine alignment of the check valve and manifold) on the yellow
and blue high pressure manifolds, and do all applicable corrective
actions; in accordance with the instructions of paragraph 4.1.2 of
Airbus AOT A330-29A3111, Revision 1, dated October 8, 2009 (for
Model A330-200 and -300 series airplanes); or AOT A340-29A4086,
Revision 1, dated October 8, 2009 (for Model A340-200 and -300
series airplanes). Do all applicable corrective actions before
further flight. Accomplishment of the inspection program required by
paragraph (i) of this AD terminates the requirements of this
paragraph.
    (iii) Within 900 flight hours after accomplishment of paragraph
(g)(2)(ii) of this AD, and thereafter at intervals not to exceed 900
flight hours, do the inspection program (detailed inspection for
traces of seepage or black deposits, and detailed inspection to
determine alignment of the check valve and manifold) on the green,
yellow, and blue high pressure manifolds, and do all applicable
corrective actions, in accordance with the instructions of paragraph
4.1.3 of Airbus AOT A330-29A3111, Revision 1, dated October 8, 2009
(for Model A330-200 and -300 series airplanes); or AOT A340-29A4086,
Revision 1, dated October 8, 2009 (for Model A340-200 and -300
series airplanes). Do all applicable corrective actions before
further flight. Accomplishment of the inspection program required by
paragraph (i) of this AD terminates the requirements of this
paragraph.

(h) Retained Inspection, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013, with
no changes. For airplanes equipped with check valves having P/N
CAR400; and for airplanes equipped with check valves having P/N
CAR401, except for airplanes on which Airbus Modification 201384 has
been embodied during production, or on which Airbus Service Bulletin
A330-29-3119 (for Model A330-200, -200F, and -300 series airplanes)
or Airbus Service Bulletin A340-29-4091 (for Model A340-200 and -300
series airplanes) has been embodied in service: Within 900 flight
hours after January 31, 2014 (the effective date of AD 2013-25-08,
Amendment 39-17704 (78 FR 78694, December 27, 2013)), inspect the
check valves on the blue, green, and yellow hydraulic systems to
identify their part numbers, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-29-3111, Revision 02,
dated June 23, 2011 (for Model A330-200, -200F and -300 series
airplanes); or Airbus Service Bulletin A340-29-4086, Revision 02,
dated June 23, 2011 (for Model A340-200 and -300 series airplanes).
Accomplishment of the actions required by this paragraph terminates
the requirements specified in paragraphs (g)(1) and (g)(1)(ii) of
this AD.
    (1) If check valves having P/N CAR401 are installed on all three
hydraulic systems: Before further flight, do the inspection program
(detailed inspection for red mark presence and alignment integrity
of the check valve and manifold, a detailed inspection for traces of
seepage or black deposits, and an inspection for proper torque) on
yellow and blue high pressure manifolds, and do all applicable
corrective actions, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-29-3111, Revision 02,
dated June 23, 2011 (for Model A330-200, -200F, and -300 series
airplanes); or Airbus Service Bulletin A340-29-4086, Revision 02,
dated June 23, 2011 (for Model A340-200 and -300 series airplanes).
Accomplishment of the actions required by this paragraph terminates
the requirements specified in paragraph (g)(2)(i) of this AD.
    (2) If check valves having P/N CAR401 are not installed on all
three hydraulic systems, no further action is required by this
paragraph until any check valve having P/N CAR400 is replaced with a
check valve having P/N CAR401. If any check valve having P/N CAR400
is replaced by a check valve having P/N CAR401: Before further
flight after such replacement, do the actions specified in paragraph
(h) of this AD, to determine if all three hydraulic systems are
equipped with check valves having P/N CAR401. If check valves having
P/N CAR401 are installed on all three hydraulic systems: Before
further flight, do the actions specified in paragraphs (h)(1) and
(i) of this AD.

(i) Retained Repetitive Inspection Program and Corrective Actions, With
No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. Within 900 flight hours after accomplishment of
paragraph (h)(1) of this AD, do the inspection program (detailed
inspection for red mark presence and alignment integrity of the
check valve and manifold, a detailed inspection for traces of
seepage or black deposits, and an inspection for proper torque) on
the green, yellow, and blue system check valves, and do all
applicable corrective actions, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-29-3111, Revision 02,
dated June 23, 2011 (for Model A330-200, -200F, and -300 series
airplanes);

or Airbus Service Bulletin A340-29-4086, Revision 02, dated June 23,
2011 (for Model A340-200 and -300 series airplanes). Do all
applicable corrective actions before further flight. Repeat the
inspection program thereafter at intervals not to exceed 900 flight
hours. Accomplishment of the actions required by this paragraph
terminates the requirements specified in paragraphs (g)(1)(i),
(g)(2)(ii), and (g)(2)(iii) of this AD.

(j) Retained Repetitive Inspection for Certain Airplanes, With No
Changes

    This paragraph restates the requirements of paragraph (j) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. For airplanes equipped with check valves having P/N
CAR401 and on which Airbus Modification 201384 has been embodied
during production, or on which Airbus Service Bulletin A330-29-3119
(for Model A330-200, -200F, and -300 series airplanes); or Airbus
Service Bulletin A340-29-4091 (for Model A340-200 and -300 series
airplanes) has been embodied in service: Within 1,000 flight hours
after January 31, 2014 (the effective date of AD 2013-25-08,
Amendment 39-17704 (78 FR 78694, December 27, 2013)), do a general
visual inspection of the green, yellow, and blue high pressure
manifolds and check valves having P/N CAR401 for any sign of
rotation of the check valve head, and for any signs of hydraulic
fluid leakage or seepage (including black deposits), in accordance
with the instructions of Airbus Alert Operators Transmission
A29L001-12, dated October 11, 2012. Repeat the inspection thereafter
at interval not to exceed 900 flight hours.

(k) Retained Corrective Action for Certain Airplanes, With No Changes

    This paragraph restates the requirements of paragraph (k) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. If, during any inspection required by paragraph (j)
of this AD, any sign of rotation of the check valve head is found,
or any sign of hydraulic fluid leakage or seepage (including black
deposits) is found: Before further flight, do all applicable
corrective actions, in accordance with the instructions of Airbus
Alert Operators Transmission A29L001-12, dated October 11, 2012.

(l) Retained Provisions Regarding Terminating Action, With No Changes

    This paragraph restates the provisions of paragraph (l) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. Accomplishment of the corrective actions required
by this AD does not constitute terminating action for the repetitive
inspections required by this AD.

(m) Retained Replacement Check Valve Torque Value, With No Changes

    This paragraph restates the requirements of paragraph (m) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. As of January 31, 2014 (the effective date of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013)), at
each replacement of a check valve with a check valve having P/N
CAR401, apply a torque of 141 to 143 newton meter (N.m) (103.98 to
105.45 pounds-foot (lbf.ft)) during installation.

(n) Retained Credit for Previous Actions, With No Changes

    This paragraph restates the provisions of paragraph (n) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes.
    (1) This paragraph provides credit for actions required by
paragraph (g)(2)(i) of this AD, if those actions were performed
before December 14, 2009 (the effective date of AD 2009-24-09,
Amendment 39-16068 (74 FR 62208, November 27, 2009)), using the
applicable service information specified in paragraphs (n)(1)(i) and
(n)(1)(ii) of this AD.
    (i) Airbus AOT A330-29A3111, dated September 2, 2009 (for Model
A330-200 and -300 series airplanes), which is not incorporated by
reference in this AD.
    (ii) Airbus AOT A340-29A4086, dated September 2, 2009 (for Model
A340-200 and -300 series airplanes), which is not incorporated by
reference in this AD.
    (2) This paragraph provides credit for actions required by
paragraph (h) of this AD, if those actions were performed before
January 31, 2014 (the effective date of AD 2013-25-08, Amendment 39-
17704 (78 FR 78694, December 27, 2013)) using the applicable service
information specified in paragraphs (n)(2)(i) through (n)(2)(iv) of
this AD.
    (i) Airbus AOT A330-29A3111, dated September 2, 2009 (for Model
A330-200 and -300 series airplanes), which is not incorporated by
reference in this AD.
    (ii) Airbus AOT A330-29A3111, Revision 1, dated October 8, 2009
(for Model A330-200 and -300 series airplanes).
    (iii) Airbus AOT A340-29A4086, dated September 2, 2009, (for
Model A340-200 and -300 series airplanes), which is not incorporated
by reference in this AD.
    (iv) Airbus AOT A340-29A4086, Revision 1, dated October 8, 2009
(for Model A340-200 and -300 series airplanes).

(o) Retained Provisions for Reporting, With No Changes

    This paragraph restates the provisions of paragraph (o) of AD
2013-25-08, Amendment 39-17704 (78 FR 78694, December 27, 2013),
with no changes. Although the service information specified in
paragraphs (o)(1) through (o)(5) of this AD specifies to submit
certain information to the manufacturer, this AD does not include
that requirement.
    (1) Airbus Alert Operators Transmission A29L001-12, dated
October 11, 2012.
    (2) Airbus Mandatory Service Bulletin A330-29-3111, Revision 02,
dated June 23, 2011.
    (3) Airbus Mandatory Service Bulletin A340-29-4086, Revision 02,
dated June 23, 2011.
    (4) Airbus AOT A330-29A3111, Revision 1, dated October 8, 2009.
    (5) Airbus AOT A340-29A4086, Revision 1, dated October 8, 2009.

(p) New Requirement of This AD: Modify Hydraulic Systems

    Within 36 months after the effective date of this AD, modify the
green, blue, and yellow high pressure hydraulic manifolds by
replacing each check valve having P/N CAR401 with an improved check
valve having P/N CAR402, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-29-3125, Revision 01,
including Appendixes 01 and 02, dated July 30, 2015; or Airbus
Service Bulletin A340-29-4096, Revision 01, including Appendixes 01
and 02, dated July 30, 2015; as applicable.

(q) New Requirement of This AD: Repetitive Inspection Terminating
Action

    Modification of an airplane, as required by paragraph (p) of
this AD, constitutes terminating action for the repetitive
inspections required by this AD.

(r) New Requirement of This AD: Parts Installation Limitations

    (1) For an airplane that, as of the effective date of this AD,
has a check valve having P/N CAR401 installed, after modification of
an airplane as required by paragraph (p) of this AD, no person may
install a check valve having P/N CAR401, on that airplane.
    (2) For an airplane that does not have a check valve having P/N
CAR401 installed, as of the effective date of this AD, no person may
install a check valve having P/N CAR401, on that airplane.

(s) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(p) of this AD, if those actions were performed before the effective
date of this AD using Airbus Service Bulletin A330-29-3125, dated
August 8, 2014; or Airbus Service Bulletin A340-29-4096, dated
August 8, 2014; as applicable; which are not incorporated by
reference in this AD.

(t) 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) AMOC ANM-116-14-180 R1, dated February 21, 2014, is
approved as an AMOC for the corresponding provisions of this AD.

    (iii) AMOC ANM-116-14-429, dated September 25, 2014, is not
approved as an AMOC for the corresponding provisions 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.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(u) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2015-0009, dated January 16,
2015, 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-2016-3701.
    (2) Service information identified in this AD that is not
incorporated by reference may be obtained at 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) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 15, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-03699 Filed 2-24-16; 8:45 am]
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