81_FR_37608 81 FR 37496 - Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine

81 FR 37496 - Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37496-37499
FR Document2016-13542

We are adopting a new airworthiness directive (AD) for various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a design change of the engine cylinder head temperature sensor without a concurrent revision of the engine model designation, the engine part number, or the cockpit indication to the pilot. We are issuing this AD to require actions to address the unsafe condition on these products.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016)
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37496-37499]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13542]


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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-4878; Directorate Identifier 2016-CE-001-AD; 
Amendment 39-18551; AD 2016-12-02]
RIN 2120-AA64


Airworthiness Directives; Various Aircraft Equipped With BRP-
Powertrain GmbH & Co KG 912 A Series Engine

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for various 
aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax 
Aircraft Engines) 912 A series engine. This AD results from mandatory 
continuing airworthiness information (MCAI) issued by an aviation 
authority of another country to identify and correct an unsafe 
condition on an aviation product. The MCAI describes the unsafe 
condition as a design change of the engine cylinder head temperature 
sensor without a concurrent revision of the engine model designation, 
the engine part number, or the cockpit indication to the pilot. We are 
issuing this AD to require actions to address the unsafe condition on 
these products.

DATES: This AD is effective July 15, 2016.
    The Director of the Federal Register approved the incorporation by 
reference of a certain publication listed in the AD as of July 15, 
2016.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
4878; or in person at Document Management Facility, U.S. Department of 
Transportation, Docket Operations, M-30, West Building Ground Floor,

[[Page 37497]]

Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact BRP-
Powertrain GmbH & Co. KG, Welser Strasse 32, A-4623 Gunskirchen, 
Austria; phone: +43 7246 601 0; fax: +43 7246 601 9130; Internet: 
www.rotax-aircraft-engines.com. You may view this referenced service 
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas 
City, Missouri 64106. For information on the availability of this 
material at the FAA, call (816) 329-4148. It is also available on the 
Internet at http://www.regulations.gov by searching for Docket No. FAA-
2016-4878.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer, 
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, 
Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR 
part 39 by adding an AD that would apply to various aircraft equipped 
with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 
912 A series engine. The NPRM was published in the Federal Register on 
March 28, 2016 (81 FR 17109). The NPRM proposed to correct an unsafe 
condition for the specified products and was based on mandatory 
continuing airworthiness information (MCAI) originated by an aviation 
authority of another country. The MCAI states:

    A design change of the engine cylinder heads was introduced by 
BRP-Powertrain in March 2013 which modifies the engine/aircraft 
interfaces by substituting the previous cylinder head temperature 
(CHT) measurement (limit temperature 135 [deg]C/150 [deg]C) with a 
coolant temperature (CT) measurement (limit temperature 120 [deg]C). 
The design change was communicated on 15 May 2013 by BRP-Powertrain 
Service Instruction (SI) 912-020R7/914-022R7 (single document) but 
was not identified by a change of the engine model designation or of 
the engine P/N, but only through the cylinder head P/N and the 
position of the temperature sensor.
    Consequently, engines with the new cylinder heads (installed 
during production or replaced in-service during maintenance) may be 
installed on an aircraft without concurrent modification of that 
aircraft, instructions for which should be provided by the Type 
Certificate (TC) holder or Supplemental Type Certificate (STC) 
holder, as applicable. In this case, the coolant temperature with a 
maximum engine operating limit of 120 [deg]C (valid for engines 
operated with water diluted glycol coolant) is displayed on a CHT 
indicator with a typical limit marking (red radial/range) of more 
than 120 [deg]C.
    This condition, if not detected and corrected, will prevent the 
pilot to identify coolant limit exceedances, with subsequent loss of 
coolant (120 [deg]C is the boiling temperature of the coolant), 
which could lead to engine in-flight shut-down, possibly resulting 
in a forced landing, with consequent damage to the aircraft and 
injury to occupants.
    BRP-Powertrain published revised SI-912-020R8/914-022R8 to 
clarify that, on the new cylinder heads, the coolant temperature, 
instead of the cylinder head temperature in the aluminum, is 
measured. EASA issued SIB 2014-34 to raise awareness that 
installation of affected engines and spare parts, without concurrent 
incorporation of aircraft TC/STC holder approved modifications, and 
even if unintended and unnoticed by production or maintenance, 
constitutes an unapproved aircraft modification.
    Since EASA published the SIB, further investigation has finally 
determined that sufficient reason exists to warrant AD action.
    For the reason stated above, this AD requires a one-time 
inspection to determine the actual engine configuration and, 
depending on findings, engine reidentification and (depending on TC 
or STC holder installation) modification of the affected aircraft. 
This also affects engines that are operated with waterless coolant.

The MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/#!documentDetail;D=FAA-2016-4878-0002.

Comments

    We gave the public the opportunity to participate in developing 
this AD. We received no comments on the NPRM (81 FR 17109, March 28, 
2016) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and 
the public interest require adopting the AD as proposed except for 
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the 
NPRM (81 FR 17109, March 28, 2016) for correcting the unsafe condition; 
and
     Do not add any additional burden upon the public than was 
already proposed in the NPRM (81 FR 17109, March 28, 2016).

Related Service Information Under 1 CFR Part 51

    We reviewed BRP-Powertrain GmbH & CO KG issued Rotax Aircraft 
Engines BRP Service Bulletin SB-912-068 and SB-914-049 (co-published as 
one document), dated April 16, 2015. The service information describes 
procedures for re-identifying the engine that has new cylinder heads, 
part numbers 413235 and 413236 installed. 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 of the AD.

Costs of Compliance

    We estimate that this AD will affect 65 products of U.S. registry.
    We also estimate that it will take about 1 work-hour per product to 
comply with the engine re-identification requirement of this AD. The 
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of this portion of 
this AD on U.S. operators to be $5,525, or $85 per product.
    We also estimate that it will take about 1 work-hour per product to 
comply with the engine installation modification to indicate a Maximum 
Coolant Temperature requirement of this AD. The average labor rate is 
$85 per work-hour.
    Based on these figures, we estimate the cost of this portion of 
this AD on U.S. operators to be $5,525, or $85 per product.
    We also estimate that it will take about 1.5 work-hours per product 
to comply with the cylinder head replacement option of this AD. The 
average labor rate is $85 per work-hour. Required parts will cost about 
$2,500 to replace a single engine cylinder head.
    Based on these figures, we estimate the cost of this portion of 
this AD on U.S. operators to be $2,627.50 per engine cylinder head.

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.

[[Page 37498]]

Regulatory Findings

    We determined that this AD will not have federalism implications 
under Executive Order 13132. This AD will not have a substantial direct 
effect on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive 
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies 
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or 
negative, on a substantial number of small entities under the criteria 
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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


Sec.  39.13  [Amended]

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

2016-12-02 Various Aircraft: Amendment 39-18551; Docket No. FAA-
2016-4878; Directorate Identifier 2016-CE-001-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective July 15, 
2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all serial numbers of the airplanes listed in 
table 1 of paragraph (c) of this AD, that are:
    (1) equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax 
Aircraft Engines) 912 A series engine with a part number (P/N) 
413235 or 413236 cylinder head installed in position 2 or 3; and
    (2) certificated in any category.

              Table 1 of Paragraph (c)--Affected Airplanes
------------------------------------------------------------------------
   Type certificate holder         Aircraft model        Engine model
------------------------------------------------------------------------
Aeromot-Ind[uacute]stria       AMT-200..............  912 A2
 Mec[acirc]nico-
 Metal[uacute]rgica Ltda.
Diamond Aircraft Industries..  HK 36 R ``SUPER        912 A
                                DIMONA''.
DIAMOND AIRCRAFT INDUSTRIES    HK 36 TS and HK 36 TC  912 A3
 GmbH.
Diamond Aircraft Industries    DA20-A1..............  912 A3
 Inc..
HOAC-Austria.................  DV 20 KATANA.........  912 A3
Iniziative Industriali         Sky Arrow 650 TC.....  912 A2
 Italiane S.p.A..
SCHEIBE-Flugzeugbau GmbH.....  SF 25C...............  912 A2, 912 A3
------------------------------------------------------------------------

(d) Subject

    Air Transport Association of America (ATA) Code 72: Engine--
Reciprocating.

(e) Reason

    This AD results from mandatory continuing airworthiness 
information (MCAI) issued by an aviation authority of another 
country to identify and correct an unsafe condition on an aviation 
product. This AD was prompted by design change of the engine 
cylinder head temperature sensor without a concurrent revision of 
the engine model designation, the engine part number, or the cockpit 
indication to the pilot. The sensor now measures the coolant 
temperature rather than the cylinder head temperature. If the engine 
coolant temperature with a maximum engine operating limit of 120 
[deg]C is displayed on a Cylinder Head Temperature indicator with a 
typical limit marking greater than 120 [deg]C, the pilot will be 
unable to identify coolant temperature limit exceedances. This could 
result in loss of coolant, which could cause an inflight engine 
shutdown and forced landing.

(f) Actions and Compliance

    Unless already done, do the following actions:
    (1) Within 6 months after July 15, 2016 (the effective date of 
this AD), for engines with cylinder heads listed in paragraph (c)(1) 
of this AD installed on both position 2 and position 3, change the 
engine model designation on the engine type data plate to include a 
``-01'' suffix following paragraph 3.1.1) of the Accomplishment/
Instructions in Rotax Aircraft Engines BRP Service Bulletin SB-912-
068 and SB-914-049 (co-published as one document), dated April 16, 
2015.
    (2) Within 6 months after July 15, 2016 (the effective date of 
this AD), for engines with only one cylinder head listed paragraph 
(c)(1) of this AD installed in a position 2 or 3, in order to keep 
such cylinder installed, you must replace the cylinder head 
installed on the unchanged position (2 or 3, as applicable) with a 
cylinder head having a P/N listed in paragraph (c)(1) of this AD, 
and change the engine model designation on the engine type data 
plate to include a ``-01'' suffix following paragraph 3.1.1) of the 
Accomplishment/Instructions in Rotax Aircraft Engines BRP Service 
Bulletin SB-912-068 and SB-914-049 (co-published as one document), 
dated April 16, 2015.
    (3) Before further flight after doing the required actions in 
paragraphs (f)(1) or (f)(2) of this AD as applicable, modify the 
aircraft and related documentation to indicate a Maximum Coolant 
Temperature limit of 120 [deg]C using FAA-approved procedures.
    (i) Such procedures can be found by contacting your aircraft 
type certificate holder or the FAA contact specified in paragraph 
(g)(1) of this AD. The service documents referenced in paragraph (h) 
of this AD are examples of FAA-approved procedures for the 
applicable aircraft.
    (ii) These re-identified engines remain eligible for 
installation on approved aircraft-engine combinations.
    (4) As of July 15, 2016 (the effective date of this AD), do not 
install any other P/N cylinder head unless that installation is done 
following approved instructions provided by BRP-Powertrain at the 
address provided in paragraph (i)(3) of this AD.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, 
Standards Office, FAA, has the authority to approve AMOCs for this 
AD, if requested using the procedures found in 14 CFR 39.19. Send 
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small 
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 
64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: 
[email protected]. Before using any approved AMOC on any 
airplane to which the AMOC applies, notify your appropriate 
principal inspector (PI) in the FAA Flight Standards District Office 
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain 
corrective actions from a manufacturer or other source, use these 
actions if they are FAA-approved. Corrective actions are considered 
FAA-approved if they are approved by the State of Design Authority 
(or their delegated agent). You are required to assure the product 
is airworthy before it is returned to service.

[[Page 37499]]

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 
2015-0240, dated December 18, 2015; Rotax Aircraft Engines BRP 
Service Bulletin SB-912-066 R1/SB-914-047 R1 (published as one 
document), Revision 1, dated April 23, 2015; Diamond Aircraft 
Industries GmbH Optional Service Bulletin OSB 36-111, dated 
September 17, 2015; Diamond Aircraft Industries GmbH Work 
Instruction WI-OSB 36-111, dated September 17, 2015; Diamond 
Aircraft Service Bulletin No.: DA20-72-04, dated January 22, 2015; 
Diamond Aircraft Industries GmbH Optional Service Bulletin OSB 20-
066, dated September 17, 2015; Diamond Aircraft Industries GmbH Work 
Instruction WI-OSB 20-066, dated September 17, 2015; and Scheibe 
Aircraft GmbH Service Information 02/14-1, dated December 15, 2014, 
for related information. You may examine the MCAI on the Internet at 
https://www.regulations.gov/#!documentDetail;D=FAA-2016-4878-0002. 
For information on the availability of the service documents above, 
contact the FAA, Small Airplane Directorate, at 816-329-4148.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the 
incorporation by reference (IBR) of the service information listed 
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do 
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rotax Aircraft Engines BRP Service Bulletin SB-912-068 and 
SB-914-049 (co-published as one document), dated April 16, 2015.
    (ii) Reserved.
    (3) For BRP-Powertrain GmbH & CO KG service information 
identified in this AD, contact BRP-Powertrain GmbH & Co. KG, Welser 
Strasse 32, A-4623 Gunskirchen, Austria; phone: +43 7246 601 0; fax: 
+43 7246 601 9130; Internet: www.rotax-aircraft-engines.com.
    (4) You may view this service information at the FAA, Small 
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For 
information on the availability of this material at the FAA, call 
(816) 329-4148. In addition, you can access this service information 
on the Internet at http://www.regulations.gov by searching for and 
locating Docket No. FAA-2016-4878.
    (5) You may view this service information that is incorporated 
by reference at the National Archives and Records Administration 
(NARA). For information on the availability of this material at 
NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.


    Issued in Kansas City, Missouri, on June 1, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification 
Service.
[FR Doc. 2016-13542 Filed 6-9-16; 8:45 am]
 BILLING CODE 4910-13-P



                                                  37496                Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations

                                                     (1) For any airplane that has had a wing             FAA Flight Standards District Office (FSDO),           National Archives and Records
                                                  removed and reinstalled or replaced between             or lacking a PI, your local FSDO.                      Administration (NARA). For information on
                                                  June 2007 and July 15, 2016 (the effective                 (2) Airworthy Product: For any requirement          the availability of this material at NARA, call
                                                  date of this AD): Within the next 12 months             in this AD to obtain corrective actions from           202–741–6030, or go to: http://
                                                  after July 15, 2016 (the effective date of this         a manufacturer or other source, use these              www.archives.gov/federal-register/cfr/ibr-
                                                  AD), inspect the torlon plates in the forward           actions if they are FAA-approved. Corrective           locations.html.
                                                  lower wing-to-fuselage attachments (both left           actions are considered FAA-approved if they
                                                                                                                                                                   Issued in Kansas City, Missouri, on June 1,
                                                  hand (LH) and right hand (RH) sides) for                are approved by the State of Design Authority
                                                                                                                                                                 2016.
                                                  correct installation following the                      (or their delegated agent). You are required
                                                  accomplishment instructions in PILATUS                  to assure the product is airworthy before it           Pat Mullen,
                                                  AIRCRAFT LTD. PC–12 Service Bulletin No:                is returned to service.                                Acting Manager, Small Airplane Directorate,
                                                  57–007, dated September 29, 2015.                          (3) Reporting Requirements: For any                 Aircraft Certification Service.
                                                     (2) For any airplane that has had a wing             reporting requirement in this AD, a federal            [FR Doc. 2016–13372 Filed 6–9–16; 8:45 am]
                                                  removed and reinstalled or replaced, between            agency may not conduct or sponsor, and a               BILLING CODE 4910–13–P
                                                  June 2007 and July 15, 2016 (the effective              person is not required to respond to, nor
                                                  date of this AD): If an incorrect installation          shall a person be subject to a penalty for
                                                  of the torlon plates is found during the                failure to comply with a collection of
                                                  inspection required in paragraph (f)(1) of this                                                                DEPARTMENT OF TRANSPORTATION
                                                                                                          information subject to the requirements of
                                                  AD, remove the affected torlon plates,                  the Paperwork Reduction Act unless that
                                                  visually inspect the torlon plates and the                                                                     Federal Aviation Administration
                                                                                                          collection of information displays a current
                                                  affected lugs using a mirror and light source           valid OMB Control Number. The OMB
                                                  (if necessary) for any damage, and reinstall            Control Number for this information                    14 CFR Part 39
                                                  the torlon plates in the correct sequence,              collection is 2120–0056. Public reporting for
                                                  following the accomplishment instructions in                                                                   [Docket No. FAA–2016–4878; Directorate
                                                                                                          this collection of information is estimated to
                                                  paragraph 3.C. of PILATUS AIRCRAFT LTD.                                                                        Identifier 2016–CE–001–AD; Amendment
                                                                                                          be approximately 5 minutes per response,
                                                  PC–12 Service Bulletin No: 57–007, dated                                                                       39–18551; AD 2016–12–02]
                                                                                                          including the time for reviewing instructions,
                                                  September 29, 2015.                                     completing and reviewing the collection of             RIN 2120–AA64
                                                     (3) For any airplane that has had a wing             information. All responses to this collection
                                                  removed and reinstalled or replaced, between            of information are mandatory. Comments
                                                  June 2007 and July 15, 2016 (the effective
                                                                                                                                                                 Airworthiness Directives; Various
                                                                                                          concerning the accuracy of this burden and             Aircraft Equipped With BRP-
                                                  date of this AD): If any damage is found                suggestions for reducing the burden should
                                                  during the inspection of the torlon plates and                                                                 Powertrain GmbH & Co KG 912 A
                                                                                                          be directed to the FAA at: 800 Independence
                                                  lugs required in paragraph (f)(2) of this AD,           Ave. SW., Washington, DC 20591, Attn:
                                                                                                                                                                 Series Engine
                                                  before further flight, contact PILATUS                  Information Collection Clearance Officer,
                                                  AIRCRAFT LTD. for FAA-approved repair                                                                          AGENCY:  Federal Aviation
                                                                                                          AES–200.                                               Administration (FAA), Department of
                                                  instructions and accomplish those
                                                  instructions accordingly. You may find                  (h) Related Information                                Transportation (DOT).
                                                  contact information for PILATUS AIRCRAFT                  Refer to MCAI European Aviation Safety               ACTION: Final rule.
                                                  LTD. in paragraph (h) of this AD.                       Agency (EASA) AD No.: 2016–0037, dated
                                                     (4) For all airplanes: As of July 15, 2016           February 26, 2016, for related information.            SUMMARY:   We are adopting a new
                                                  (the effective date of this AD), do not install         The MCAI can be found in the AD docket on              airworthiness directive (AD) for various
                                                  or re-install a wing on any airplane, unless            the Internet at: https://www.regulations.gov/          aircraft equipped with a BRP-Powertrain
                                                  concurrent with the wing installation, the              #!documentDetail;D=FAA-2016-5284-0002.
                                                  torlon plates of the forward lower wing-to-                                                                    GmbH & Co KG (formerly Rotax Aircraft
                                                  fuselage attachment (both LH and RH sides)              (i) Material Incorporated by Reference                 Engines) 912 A series engine. This AD
                                                  of the airplane are inspected and found to be              (1) The Director of the Federal Register            results from mandatory continuing
                                                  installed correctly in accordance with the              approved the incorporation by reference                airworthiness information (MCAI)
                                                  accomplishment instructions in paragraph                (IBR) of the service information listed in this        issued by an aviation authority of
                                                  3.B. of PILATUS AIRCRAFT LTD. PC–12                     paragraph under 5 U.S.C. 552(a) and 1 CFR              another country to identify and correct
                                                  Service Bulletin No: 57–007, dated                      part 51.                                               an unsafe condition on an aviation
                                                  September 29, 2015.                                        (2) You must use this service information           product. The MCAI describes the unsafe
                                                     Note 2 to paragraph (f)(4) of this AD:               as applicable to do the actions required by            condition as a design change of the
                                                  Installation of a wing on an airplane in                this AD, unless the AD specifies otherwise.            engine cylinder head temperature
                                                  accordance with the instructions of PILATUS                (i) PILATUS AIRCRAFT LTD. PC–12
                                                  aircraft maintenance manual (AMM) 02049,                                                                       sensor without a concurrent revision of
                                                                                                          Service Bulletin No: 57–007, dated
                                                  Revision 28 or later, or AMM 02300, Revision            September 29, 2015.                                    the engine model designation, the
                                                  11 or later, is an acceptable alternative                  (ii) Reserved.                                      engine part number, or the cockpit
                                                  method to comply with this inspection                      (3) For PILATUS AIRCRAFT LTD. service               indication to the pilot. We are issuing
                                                  requirement.                                            information identified in this AD, contact             this AD to require actions to address the
                                                                                                          PILATUS AIRCRAFT LTD., Customer                        unsafe condition on these products.
                                                  (g) Other FAA AD Provisions                             Support Manager, CH–6371 STANS,                        DATES: This AD is effective July 15,
                                                     The following provisions also apply to this          Switzerland; phone: +41 (0)41 619 33 33; fax:
                                                                                                                                                                 2016.
                                                  AD:                                                     +41 (0)41 619 73 11; email: SupportPC12@
                                                     (1) Alternative Methods of Compliance                pilatus-aircraft.com; Internet: http://                   The Director of the Federal Register
                                                  (AMOCs): The Manager, Standards Office,                 www.pilatus-aircraft.com.                              approved the incorporation by reference
                                                  FAA, has the authority to approve AMOCs                    (4) You may view this service information           of a certain publication listed in the AD
                                                  for this AD, if requested using the procedures          at the FAA, Small Airplane Directorate, 901            as of July 15, 2016.
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  found in 14 CFR 39.19. Send information to              Locust, Kansas City, Missouri 64106. For               ADDRESSES: You may examine the AD
                                                  ATTN: Doug Rudolph, Aerospace Engineer,                 information on the availability of this                docket on the Internet at http://
                                                  FAA, Small Airplane Directorate, 901 Locust,            material at the FAA, call (816) 329–4148. In
                                                                                                                                                                 www.regulations.gov by searching for
                                                  Room 301, Kansas City, Missouri 64106;                  addition, you can access this service
                                                  telephone: (816) 329–4059; fax: (816) 329–              information on the Internet at http://                 and locating Docket No. FAA–2016–
                                                  4090; email: doug.rudolph@faa.gov. Before               www.regulations.gov by searching for and               4878; or in person at Document
                                                  using any approved AMOC on any airplane                 locating Docket No. FAA–2016–5284.                     Management Facility, U.S. Department
                                                  to which the AMOC applies, notify your                     (5) You may view this service information           of Transportation, Docket Operations,
                                                  appropriate principal inspector (PI) in the             that is incorporated by reference at the               M–30, West Building Ground Floor,


                                             VerDate Sep<11>2014   16:32 Jun 09, 2016   Jkt 238001   PO 00000   Frm 00012   Fmt 4700   Sfmt 4700   E:\FR\FM\10JNR1.SGM   10JNR1


                                                                       Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations                                         37497

                                                  Room W12–140, 1200 New Jersey                           limit marking (red radial/range) of more than          that has new cylinder heads, part
                                                  Avenue SE., Washington, DC 20590.                       120 °C.                                                numbers 413235 and 413236 installed.
                                                     For service information identified in                   This condition, if not detected and                 This service information is reasonably
                                                  this AD, contact BRP-Powertrain GmbH                    corrected, will prevent the pilot to identify
                                                                                                                                                                 available because the interested parties
                                                                                                          coolant limit exceedances, with subsequent
                                                  & Co. KG, Welser Strasse 32, A–4623                                                                            have access to it through their normal
                                                                                                          loss of coolant (120 °C is the boiling
                                                  Gunskirchen, Austria; phone: +43 7246                   temperature of the coolant), which could lead          course of business or by the means
                                                  601 0; fax: +43 7246 601 9130; Internet:                to engine in-flight shut-down, possibly                identified in the ADDRESSES section of
                                                  www.rotax-aircraft-engines.com. You                     resulting in a forced landing, with                    the AD.
                                                  may view this referenced service                        consequent damage to the aircraft and injury
                                                  information at the FAA, Small Airplane                  to occupants.                                          Costs of Compliance
                                                  Directorate, 901 Locust, Kansas City,                      BRP-Powertrain published revised SI–912–              We estimate that this AD will affect
                                                  Missouri 64106. For information on the                  020R8/914–022R8 to clarify that, on the new            65 products of U.S. registry.
                                                  availability of this material at the FAA,               cylinder heads, the coolant temperature,
                                                                                                                                                                   We also estimate that it will take
                                                                                                          instead of the cylinder head temperature in
                                                  call (816) 329–4148. It is also available                                                                      about 1 work-hour per product to
                                                                                                          the aluminum, is measured. EASA issued SIB
                                                  on the Internet at http://                              2014–34 to raise awareness that installation           comply with the engine re-identification
                                                  www.regulations.gov by searching for                    of affected engines and spare parts, without           requirement of this AD. The average
                                                  Docket No. FAA–2016–4878.                               concurrent incorporation of aircraft TC/STC            labor rate is $85 per work-hour.
                                                  FOR FURTHER INFORMATION CONTACT: Jim                    holder approved modifications, and even if               Based on these figures, we estimate
                                                  Rutherford, Aerospace Engineer, FAA,                    unintended and unnoticed by production or              the cost of this portion of this AD on
                                                  Small Airplane Directorate, 901 Locust,                 maintenance, constitutes an unapproved                 U.S. operators to be $5,525, or $85 per
                                                  Room 301, Kansas City, Missouri 64106;                  aircraft modification.                                 product.
                                                                                                             Since EASA published the SIB, further
                                                  telephone: (816) 329–4165; fax: (816)                   investigation has finally determined that                We also estimate that it will take
                                                  329–4090; email: jim.rutherford@                        sufficient reason exists to warrant AD action.         about 1 work-hour per product to
                                                  faa.gov.                                                   For the reason stated above, this AD                comply with the engine installation
                                                  SUPPLEMENTARY INFORMATION:                              requires a one-time inspection to determine            modification to indicate a Maximum
                                                                                                          the actual engine configuration and,                   Coolant Temperature requirement of
                                                  Discussion                                              depending on findings, engine                          this AD. The average labor rate is $85
                                                     We issued a notice of proposed                       reidentification and (depending on TC or               per work-hour.
                                                  rulemaking (NPRM) to amend 14 CFR                       STC holder installation) modification of the             Based on these figures, we estimate
                                                                                                          affected aircraft. This also affects engines that
                                                  part 39 by adding an AD that would                      are operated with waterless coolant.
                                                                                                                                                                 the cost of this portion of this AD on
                                                  apply to various aircraft equipped with                                                                        U.S. operators to be $5,525, or $85 per
                                                  a BRP-Powertrain GmbH & Co KG                           The MCAI can be found in the AD                        product.
                                                  (formerly Rotax Aircraft Engines) 912 A                 docket on the Internet at https://                       We also estimate that it will take
                                                  series engine. The NPRM was published                   www.regulations.gov/                                   about 1.5 work-hours per product to
                                                  in the Federal Register on March 28,                    #!documentDetail;D=FAA-2016-4878-                      comply with the cylinder head
                                                  2016 (81 FR 17109). The NPRM                            0002.                                                  replacement option of this AD. The
                                                  proposed to correct an unsafe condition                 Comments                                               average labor rate is $85 per work-hour.
                                                  for the specified products and was                                                                             Required parts will cost about $2,500 to
                                                  based on mandatory continuing                             We gave the public the opportunity to
                                                                                                                                                                 replace a single engine cylinder head.
                                                  airworthiness information (MCAI)                        participate in developing this AD. We
                                                                                                                                                                   Based on these figures, we estimate
                                                  originated by an aviation authority of                  received no comments on the NPRM (81
                                                                                                                                                                 the cost of this portion of this AD on
                                                  another country. The MCAI states:                       FR 17109, March 28, 2016) or on the
                                                                                                                                                                 U.S. operators to be $2,627.50 per
                                                                                                          determination of the cost to the public.
                                                    A design change of the engine cylinder                                                                       engine cylinder head.
                                                  heads was introduced by BRP-Powertrain in               Conclusion
                                                                                                                                                                 Authority for This Rulemaking
                                                  March 2013 which modifies the engine/                     We reviewed the relevant data and
                                                  aircraft interfaces by substituting the                                                                           Title 49 of the United States Code
                                                  previous cylinder head temperature (CHT)
                                                                                                          determined that air safety and the
                                                                                                          public interest require adopting the AD                specifies the FAA’s authority to issue
                                                  measurement (limit temperature 135 °C/150                                                                      rules on aviation safety. Subtitle I,
                                                  °C) with a coolant temperature (CT)                     as proposed except for minor editorial
                                                  measurement (limit temperature 120 °C). The             changes. We have determined that these                 section 106, describes the authority of
                                                  design change was communicated on 15 May                minor changes:                                         the FAA Administrator. ‘‘Subtitle VII:
                                                  2013 by BRP-Powertrain Service Instruction                • Are consistent with the intent that                Aviation Programs,’’ describes in more
                                                  (SI) 912–020R7/914–022R7 (single                        was proposed in the NPRM (81 FR                        detail the scope of the Agency’s
                                                  document) but was not identified by a change            17109, March 28, 2016) for correcting                  authority.
                                                  of the engine model designation or of the                                                                         We are issuing this rulemaking under
                                                  engine P/N, but only through the cylinder
                                                                                                          the unsafe condition; and
                                                  head P/N and the position of the temperature              • Do not add any additional burden                   the authority described in ‘‘Subtitle VII,
                                                  sensor.                                                 upon the public than was already                       Part A, Subpart III, section 44701:
                                                    Consequently, engines with the new                    proposed in the NPRM (81 FR 17109,                     General requirements.’’ Under that
                                                  cylinder heads (installed during production             March 28, 2016).                                       section, Congress charges the FAA with
                                                  or replaced in-service during maintenance)                                                                     promoting safe flight of civil aircraft in
                                                  may be installed on an aircraft without                 Related Service Information Under 1                    air commerce by prescribing regulations
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                                                  concurrent modification of that aircraft,               CFR Part 51                                            for practices, methods, and procedures
                                                  instructions for which should be provided by              We reviewed BRP-Powertrain GmbH                      the Administrator finds necessary for
                                                  the Type Certificate (TC) holder or                     & CO KG issued Rotax Aircraft Engines                  safety in air commerce. This regulation
                                                  Supplemental Type Certificate (STC) holder,
                                                  as applicable. In this case, the coolant
                                                                                                          BRP Service Bulletin SB–912–068 and                    is within the scope of that authority
                                                  temperature with a maximum engine                       SB–914–049 (co-published as one                        because it addresses an unsafe condition
                                                  operating limit of 120 °C (valid for engines            document), dated April 16, 2015. The                   that is likely to exist or develop on
                                                  operated with water diluted glycol coolant) is          service information describes                          products identified in this rulemaking
                                                  displayed on a CHT indicator with a typical             procedures for re-identifying the engine               action.


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                                                  37498                      Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations

                                                  Regulatory Findings                                                   on a substantial number of small entities                               § 39.13       [Amended]
                                                    We determined that this AD will not                                 under the criteria of the Regulatory                                    ■ 2. The FAA amends § 39.13 by adding
                                                  have federalism implications under                                    Flexibility Act.                                                        the following new AD:
                                                  Executive Order 13132. This AD will                                   List of Subjects in 14 CFR Part 39                                      2016–12–02 Various Aircraft: Amendment
                                                  not have a substantial direct effect on                                                                                                           39–18551; Docket No. FAA–2016–4878;
                                                  the States, on the relationship between                                 Air transportation, Aircraft, Aviation                                    Directorate Identifier 2016–CE–001–AD.
                                                  the national government and the States,                               safety, Incorporation by reference,
                                                                                                                                                                                                (a) Effective Date
                                                  or on the distribution of power and                                   Safety.
                                                  responsibilities among the various                                                                                                               This airworthiness directive (AD) becomes
                                                  levels of government.                                                 Adoption of the Amendment                                               effective July 15, 2016.
                                                    For the reasons discussed above, I                                    Accordingly, under the authority                                      (b) Affected ADs
                                                  certify this AD:                                                      delegated to me by the Administrator,                                     None.
                                                    (1) Is not a ‘‘significant regulatory                               the FAA amends 14 CFR part 39 as
                                                  action’’ under Executive Order 12866,                                                                                                         (c) Applicability
                                                                                                                        follows:                                                                   This AD applies to all serial numbers of the
                                                    (2) Is not a ‘‘significant rule’’ under
                                                  the DOT Regulatory Policies and                                                                                                               airplanes listed in table 1 of paragraph (c) of
                                                                                                                        PART 39—AIRWORTHINESS                                                   this AD, that are:
                                                  Procedures (44 FR 11034, February 26,                                 DIRECTIVES                                                                 (1) equipped with a BRP-Powertrain GmbH
                                                  1979),                                                                                                                                        & Co KG (formerly Rotax Aircraft Engines)
                                                    (3) Will not affect intrastate aviation                                                                                                     912 A series engine with a part number (P/
                                                                                                                        ■ 1. The authority citation for part 39
                                                  in Alaska, and                                                                                                                                N) 413235 or 413236 cylinder head installed
                                                    (4) Will not have a significant                                     continues to read as follows:
                                                                                                                                                                                                in position 2 or 3; and
                                                  economic impact, positive or negative,                                    Authority: 49 U.S.C. 106(g), 40113, 44701.                             (2) certificated in any category.

                                                                                                             TABLE 1 OF PARAGRAPH (c)—AFFECTED AIRPLANES
                                                                               Type certificate holder                                                                             Aircraft model                                              Engine model

                                                  Aeromot-Indústria Mecânico-Metalúrgica Ltda ...........................                   AMT–200 ...................................................................................     912   A2
                                                  Diamond Aircraft Industries ........................................................         HK 36 R ‘‘SUPER DIMONA’’ ....................................................                   912   A
                                                  DIAMOND AIRCRAFT INDUSTRIES GmbH .............................                               HK 36 TS and HK 36 TC ..........................................................                912   A3
                                                  Diamond Aircraft Industries Inc. .................................................           DA20–A1 ...................................................................................     912   A3
                                                  HOAC-Austria .............................................................................   DV 20 KATANA .........................................................................          912   A3
                                                  Iniziative Industriali Italiane S.p.A. ..............................................        Sky Arrow 650 TC .....................................................................          912   A2
                                                  SCHEIBE-Flugzeugbau GmbH ...................................................                 SF 25C ......................................................................................   912   A2, 912 A3



                                                  (d) Subject                                                           include a ‘‘–01’’ suffix following paragraph                              (4) As of July 15, 2016 (the effective date
                                                    Air Transport Association of America                                3.1.1) of the Accomplishment/Instructions in                            of this AD), do not install any other P/N
                                                  (ATA) Code 72: Engine—Reciprocating.                                  Rotax Aircraft Engines BRP Service Bulletin                             cylinder head unless that installation is done
                                                                                                                        SB–912–068 and SB–914–049 (co-published                                 following approved instructions provided by
                                                  (e) Reason                                                            as one document), dated April 16, 2015.                                 BRP-Powertrain at the address provided in
                                                     This AD results from mandatory                                        (2) Within 6 months after July 15, 2016 (the
                                                                                                                                                                                                paragraph (i)(3) of this AD.
                                                  continuing airworthiness information (MCAI)                           effective date of this AD), for engines with
                                                                                                                        only one cylinder head listed paragraph (c)(1)                          (g) Other FAA AD Provisions
                                                  issued by an aviation authority of another
                                                                                                                        of this AD installed in a position 2 or 3, in
                                                  country to identify and correct an unsafe                                                                                                        The following provisions also apply to this
                                                                                                                        order to keep such cylinder installed, you
                                                  condition on an aviation product. This AD                                                                                                     AD:
                                                                                                                        must replace the cylinder head installed on
                                                  was prompted by design change of the engine                           the unchanged position (2 or 3, as applicable)                             (1) Alternative Methods of Compliance
                                                  cylinder head temperature sensor without a                            with a cylinder head having a P/N listed in                             (AMOCs): The Manager, Standards Office,
                                                  concurrent revision of the engine model                               paragraph (c)(1) of this AD, and change the                             FAA, has the authority to approve AMOCs
                                                  designation, the engine part number, or the                           engine model designation on the engine type                             for this AD, if requested using the procedures
                                                  cockpit indication to the pilot. The sensor                           data plate to include a ‘‘–01’’ suffix following                        found in 14 CFR 39.19. Send information to
                                                  now measures the coolant temperature rather                           paragraph 3.1.1) of the Accomplishment/
                                                  than the cylinder head temperature. If the                                                                                                    ATTN: Jim Rutherford, Aerospace Engineer,
                                                                                                                        Instructions in Rotax Aircraft Engines BRP                              FAA, Small Airplane Directorate, 901 Locust,
                                                  engine coolant temperature with a maximum                             Service Bulletin SB–912–068 and SB–914–
                                                  engine operating limit of 120 °C is displayed                                                                                                 Room 301, Kansas City, Missouri 64106;
                                                                                                                        049 (co-published as one document), dated
                                                  on a Cylinder Head Temperature indicator                              April 16, 2015.                                                         telephone: (816) 329–4165; fax: (816) 329–
                                                  with a typical limit marking greater than 120                            (3) Before further flight after doing the                            4090; email: jim.rutherford@faa.gov. Before
                                                  °C, the pilot will be unable to identify                              required actions in paragraphs (f)(1) or (f)(2)                         using any approved AMOC on any airplane
                                                  coolant temperature limit exceedances. This                           of this AD as applicable, modify the aircraft                           to which the AMOC applies, notify your
                                                  could result in loss of coolant, which could                          and related documentation to indicate a                                 appropriate principal inspector (PI) in the
                                                  cause an inflight engine shutdown and forced                          Maximum Coolant Temperature limit of 120                                FAA Flight Standards District Office (FSDO),
                                                  landing.                                                              °C using FAA-approved procedures.                                       or lacking a PI, your local FSDO.
                                                                                                                           (i) Such procedures can be found by                                     (2) Airworthy Product: For any requirement
                                                  (f) Actions and Compliance
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                                                                                                                        contacting your aircraft type certificate                               in this AD to obtain corrective actions from
                                                     Unless already done, do the following                              holder or the FAA contact specified in
                                                  actions:                                                                                                                                      a manufacturer or other source, use these
                                                                                                                        paragraph (g)(1) of this AD. The service
                                                     (1) Within 6 months after July 15, 2016 (the                       documents referenced in paragraph (h) of this                           actions if they are FAA-approved. Corrective
                                                  effective date of this AD), for engines with                          AD are examples of FAA-approved                                         actions are considered FAA-approved if they
                                                  cylinder heads listed in paragraph (c)(1) of                          procedures for the applicable aircraft.                                 are approved by the State of Design Authority
                                                  this AD installed on both position 2 and                                 (ii) These re-identified engines remain                              (or their delegated agent). You are required
                                                  position 3, change the engine model                                   eligible for installation on approved aircraft-                         to assure the product is airworthy before it
                                                  designation on the engine type data plate to                          engine combinations.                                                    is returned to service.



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                                                                       Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations                                          37499

                                                  (h) Related Information                                 DEPARTMENT OF HEALTH AND                               device under the criteria set forth in
                                                     Refer to MCAI European Aviation Safety               HUMAN SERVICES                                         section 513(a)(1) of the FD&C Act.
                                                  Agency (EASA) AD No.: 2015–0240, dated                                                                         Under the first procedure, the person
                                                  December 18, 2015; Rotax Aircraft Engines               Food and Drug Administration                           submits a premarket notification under
                                                  BRP Service Bulletin SB–912–066 R1/SB–                                                                         section 510(k) of the FD&C Act for a
                                                  914–047 R1 (published as one document),                 21 CFR Part 886                                        device that has not previously been
                                                  Revision 1, dated April 23, 2015; Diamond                                                                      classified and, within 30 days of
                                                  Aircraft Industries GmbH Optional Service               [Docket No. FDA–2016–N–1308]
                                                                                                                                                                 receiving an order classifying the device
                                                  Bulletin OSB 36–111, dated September 17,
                                                                                                          Medical Devices; Ophthalmic Devices;                   into class III under section 513(f)(1) of
                                                  2015; Diamond Aircraft Industries GmbH
                                                  Work Instruction WI–OSB 36–111, dated                   Classification of Nasolacrimal                         the FD&C Act, the person requests a
                                                  September 17, 2015; Diamond Aircraft                    Compression Device                                     classification under section 513(f)(2).
                                                  Service Bulletin No.: DA20–72–04, dated                                                                        Under the second procedure, rather than
                                                  January 22, 2015; Diamond Aircraft                      AGENCY:    Food and Drug Administration,               first submitting a premarket notification
                                                  Industries GmbH Optional Service Bulletin               HHS.                                                   under section 510(k) of the FD&C Act
                                                  OSB 20–066, dated September 17, 2015;                   ACTION:   Final order.                                 and then a request for classification
                                                  Diamond Aircraft Industries GmbH Work                                                                          under the first procedure, the person
                                                  Instruction WI–OSB 20–066, dated                        SUMMARY:   The Food and Drug                           determines that there is no legally
                                                  September 17, 2015; and Scheibe Aircraft                Administration (FDA) is classifying the                marketed device upon which to base a
                                                  GmbH Service Information 02/14–1, dated                 nasolacrimal compression device into                   determination of substantial
                                                  December 15, 2014, for related information.             class I (general controls). The Agency is              equivalence and requests a classification
                                                  You may examine the MCAI on the Internet                classifying the device into class I
                                                  at https://www.regulations.gov/
                                                                                                                                                                 under section 513(f)(2) of the FD&C Act.
                                                  #!documentDetail;D=FAA-2016-4878-0002.
                                                                                                          (general controls) in order to provide a               If the person submits a request to
                                                  For information on the availability of the              reasonable assurance of safety and                     classify the device under this second
                                                  service documents above, contact the FAA,               effectiveness of the device.                           procedure, FDA may decline to
                                                  Small Airplane Directorate, at 816–329–4148.            DATES: This order is effective June 10,                undertake the classification request if
                                                                                                          2016. The classification was applicable                FDA identifies a legally marketed device
                                                  (i) Material Incorporated by Reference
                                                                                                          on April 20, 2016.                                     that could provide a reasonable basis for
                                                     (1) The Director of the Federal Register                                                                    review of substantial equivalence with
                                                  approved the incorporation by reference                 FOR FURTHER INFORMATION CONTACT:
                                                                                                          Daniel Fedorko, Center for Devices and                 the device or if FDA determines that the
                                                  (IBR) of the service information listed in this
                                                                                                          Radiological Health, Food and Drug                     device submitted is not of ‘‘low-
                                                  paragraph under 5 U.S.C. 552(a) and 1 CFR
                                                  part 51.                                                Administration, 10903 New Hampshire                    moderate risk’’ or that general controls
                                                     (2) You must use this service information            Ave., Bldg. 66, Rm. 2414, Silver Spring,               would be inadequate to control the risks
                                                  as applicable to do the actions required by             MD 20993–0002, 301–796–6620.                           and special controls to mitigate the risks
                                                  this AD, unless the AD specifies otherwise.                                                                    cannot be developed.
                                                                                                          SUPPLEMENTARY INFORMATION:                                In response to a request to classify a
                                                     (i) Rotax Aircraft Engines BRP Service
                                                  Bulletin SB–912–068 and SB–914–049 (co-                 I. Background                                          device under either procedure provided
                                                  published as one document), dated April 16,                                                                    by section 513(f)(2) of the FD&C Act,
                                                  2015.                                                      In accordance with section 513(f)(1) of             FDA will classify the device by written
                                                     (ii) Reserved.                                       the Federal Food, Drug, and Cosmetic                   order within 120 days. This
                                                     (3) For BRP-Powertrain GmbH & CO KG                  Act (the FD&C Act) (21 U.S.C.                          classification will be the initial
                                                  service information identified in this AD,              360c(f)(1)), devices that were not in                  classification of the device.
                                                  contact BRP-Powertrain GmbH & Co. KG,                   commercial distribution before May 28,                    On June 27, 2014, Innovatex, Inc.,
                                                  Welser Strasse 32, A–4623 Gunskirchen,                  1976 (the date of enactment of the                     submitted a request for classification of
                                                  Austria; phone: +43 7246 601 0; fax: +43                Medical Device Amendments of 1976),
                                                  7246 601 9130; Internet: www.rotax-aircraft-
                                                                                                                                                                 the Tear Duct Occluder (originally
                                                                                                          generally referred to as postamendments                referred to as the Glaucoma Companion
                                                  engines.com.
                                                                                                          devices, are classified automatically by               Nasolacrimal Compression Device)
                                                     (4) You may view this service information
                                                  at the FAA, Small Airplane Directorate, 901             statute into class III without any FDA                 under section 513(f)(2) of the FD&C Act.
                                                  Locust, Kansas City, Missouri 64106. For                rulemaking process. These devices                      The manufacturer recommended that
                                                  information on the availability of this                 remain in class III and require                        the device be classified into class I (Ref.
                                                  material at the FAA, call (816) 329–4148. In            premarket approval, unless and until                   1).
                                                  addition, you can access this service                   the device is classified or reclassified                  In accordance with section 513(f)(2) of
                                                  information on the Internet at http://                  into class I or II, or FDA issues an order             the FD&C Act, FDA reviewed the
                                                  www.regulations.gov by searching for and                finding the device to be substantially                 request in order to classify the device
                                                  locating Docket No. FAA–2016–4878.                      equivalent, in accordance with section                 under the criteria for classification set
                                                     (5) You may view this service information            513(i) of the FD&C Act, to a predicate                 forth in section 513(a)(1) of the FD&C
                                                  that is incorporated by reference at the
                                                                                                          device that does not require premarket                 Act. FDA classifies devices into class I
                                                  National Archives and Records
                                                  Administration (NARA). For information on               approval. The Agency determines                        if general controls by themselves are
                                                  the availability of this material at NARA, call         whether new devices are substantially                  sufficient to provide reasonable
                                                  202–741–6030, or go to: http://                         equivalent to predicate devices by                     assurance of safety and effectiveness of
                                                  www.archives.gov/federal-register/cfr/ibr-              means of premarket notification                        the device for its intended use. After
                                                  locations.html.                                         procedures in section 510(k) of the                    review of the information submitted in
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                                                                                                          FD&C Act (21 U.S.C. 360(k)) and part                   the de novo request, FDA determined
                                                    Issued in Kansas City, Missouri, on June 1,           807 (21 CFR part 807) of the regulations.              that the device can be classified into
                                                  2016.                                                      Section 513(f)(2) of the FD&C Act, as               class I. FDA believes general controls
                                                  Pat Mullen,                                             amended by section 607 of the Food and                 will provide reasonable assurance of the
                                                  Acting Manager, Small Airplane Directorate,             Drug Administration Safety and                         safety and effectiveness of the device.
                                                  Aircraft Certification Service.                         Innovation Act (Pub. L. 112–144),                         Therefore, on April 20, 2016, FDA
                                                  [FR Doc. 2016–13542 Filed 6–9–16; 8:45 am]              provides two procedures by which a                     issued an order to the requestor
                                                  BILLING CODE 4910–13–P                                  person may request FDA to classify a                   classifying the device into class I. FDA


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Document Created: 2018-02-08 07:35:43
Document Modified: 2018-02-08 07:35:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis AD is effective July 15, 2016.
ContactJim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected]
FR Citation81 FR 37496 
RIN Number2120-AA64
CFR AssociatedAir Transportation; Aircraft; Aviation Safety; Incorporation by Reference and Safety

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