Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine, 37496-37499 [2016-13542]
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37496
Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
asabaliauskas on DSK3SPTVN1PROD with RULES
(1) For any airplane that has had a wing
removed and reinstalled or replaced between
June 2007 and July 15, 2016 (the effective
date of this AD): Within the next 12 months
after July 15, 2016 (the effective date of this
AD), inspect the torlon plates in the forward
lower wing-to-fuselage attachments (both left
hand (LH) and right hand (RH) sides) for
correct installation following the
accomplishment instructions in PILATUS
AIRCRAFT LTD. PC–12 Service Bulletin No:
57–007, dated September 29, 2015.
(2) For any airplane that has had a wing
removed and reinstalled or replaced, between
June 2007 and July 15, 2016 (the effective
date of this AD): If an incorrect installation
of the torlon plates is found during the
inspection required in paragraph (f)(1) of this
AD, remove the affected torlon plates,
visually inspect the torlon plates and the
affected lugs using a mirror and light source
(if necessary) for any damage, and reinstall
the torlon plates in the correct sequence,
following the accomplishment instructions in
paragraph 3.C. of PILATUS AIRCRAFT LTD.
PC–12 Service Bulletin No: 57–007, dated
September 29, 2015.
(3) For any airplane that has had a wing
removed and reinstalled or replaced, between
June 2007 and July 15, 2016 (the effective
date of this AD): If any damage is found
during the inspection of the torlon plates and
lugs required in paragraph (f)(2) of this AD,
before further flight, contact PILATUS
AIRCRAFT LTD. for FAA-approved repair
instructions and accomplish those
instructions accordingly. You may find
contact information for PILATUS AIRCRAFT
LTD. in paragraph (h) of this AD.
(4) For all airplanes: As of July 15, 2016
(the effective date of this AD), do not install
or re-install a wing on any airplane, unless
concurrent with the wing installation, the
torlon plates of the forward lower wing-tofuselage attachment (both LH and RH sides)
of the airplane are inspected and found to be
installed correctly in accordance with the
accomplishment instructions in paragraph
3.B. of PILATUS AIRCRAFT LTD. PC–12
Service Bulletin No: 57–007, dated
September 29, 2015.
Note 2 to paragraph (f)(4) of this AD:
Installation of a wing on an airplane in
accordance with the instructions of PILATUS
aircraft maintenance manual (AMM) 02049,
Revision 28 or later, or AMM 02300, Revision
11 or later, is an acceptable alternative
method to comply with this inspection
requirement.
(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: Doug Rudolph, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust,
Room 301, Kansas City, Missouri 64106;
telephone: (816) 329–4059; fax: (816) 329–
4090; email: doug.rudolph@faa.gov. Before
using any approved AMOC on any airplane
to which the AMOC applies, notify your
appropriate principal inspector (PI) in the
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FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(3) Reporting Requirements: For any
reporting requirement in this AD, a federal
agency may not conduct or sponsor, and a
person is not required to respond to, nor
shall a person be subject to a penalty for
failure to comply with a collection of
information subject to the requirements of
the Paperwork Reduction Act unless that
collection of information displays a current
valid OMB Control Number. The OMB
Control Number for this information
collection is 2120–0056. Public reporting for
this collection of information is estimated to
be approximately 5 minutes per response,
including the time for reviewing instructions,
completing and reviewing the collection of
information. All responses to this collection
of information are mandatory. Comments
concerning the accuracy of this burden and
suggestions for reducing the burden should
be directed to the FAA at: 800 Independence
Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer,
AES–200.
(h) Related Information
Refer to MCAI European Aviation Safety
Agency (EASA) AD No.: 2016–0037, dated
February 26, 2016, for related information.
The MCAI can be found in the AD docket on
the Internet at: https://www.regulations.gov/
#!documentDetail;D=FAA-2016-5284-0002.
(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) PILATUS AIRCRAFT LTD. PC–12
Service Bulletin No: 57–007, dated
September 29, 2015.
(ii) Reserved.
(3) For PILATUS AIRCRAFT LTD. service
information identified in this AD, contact
PILATUS AIRCRAFT LTD., Customer
Support Manager, CH–6371 STANS,
Switzerland; phone: +41 (0)41 619 33 33; fax:
+41 (0)41 619 73 11; email: SupportPC12@
pilatus-aircraft.com; Internet: https://
www.pilatus-aircraft.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 https://
www.regulations.gov by searching for and
locating Docket No. FAA–2016–5284.
(5) You may view this service information
that is incorporated by reference at the
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National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Kansas City, Missouri, on June 1,
2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2016–13372 Filed 6–9–16; 8:45 am]
BILLING CODE 4910–13–P
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 BRPPowertrain GmbH & Co KG 912 A
Series Engine
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
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 https://
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,
SUMMARY:
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
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 https://
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: jim.rutherford@
faa.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with RULES
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 °C/150
°C) with a coolant temperature (CT)
measurement (limit temperature 120 °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 °C (valid for engines
operated with water diluted glycol coolant) is
displayed on a CHT indicator with a typical
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limit marking (red radial/range) of more than
120 °C.
This condition, if not detected and
corrected, will prevent the pilot to identify
coolant limit exceedances, with subsequent
loss of coolant (120 °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-2016-48780002.
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
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37497
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.
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
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.
§ 39.13
List of Subjects in 14 CFR Part 39
2016–12–02 Various Aircraft: Amendment
39–18551; Docket No. FAA–2016–4878;
Directorate Identifier 2016–CE–001–AD.
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
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
[Amended]
2. The FAA amends § 39.13 by adding
the following new 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
ˆ
´
´
Aeromot-Industria Mecanico-Metalurgica Ltda ...........................
Diamond Aircraft Industries ........................................................
DIAMOND AIRCRAFT INDUSTRIES GmbH .............................
Diamond Aircraft Industries Inc. .................................................
HOAC-Austria .............................................................................
Iniziative Industriali Italiane S.p.A. ..............................................
SCHEIBE-Flugzeugbau GmbH ...................................................
AMT–200 ...................................................................................
HK 36 R ‘‘SUPER DIMONA’’ ....................................................
HK 36 TS and HK 36 TC ..........................................................
DA20–A1 ...................................................................................
DV 20 KATANA .........................................................................
Sky Arrow 650 TC .....................................................................
SF 25C ......................................................................................
(d) Subject
Air Transport Association of America
(ATA) Code 72: Engine—Reciprocating.
(e) Reason
asabaliauskas on DSK3SPTVN1PROD with RULES
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 °C is displayed
on a Cylinder Head Temperature indicator
with a typical limit marking greater than 120
°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
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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
°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 aircraftengine combinations.
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Engine model
912
912
912
912
912
912
912
A2
A
A3
A3
A3
A2
A2, 912 A3
(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: jim.rutherford@faa.gov. 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.
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
(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.
asabaliauskas on DSK3SPTVN1PROD with RULES
(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 (copublished 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-aircraftengines.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 https://
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: https://
www.archives.gov/federal-register/cfr/ibrlocations.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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA–2016–N–1308]
Medical Devices; Ophthalmic Devices;
Classification of Nasolacrimal
Compression Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
nasolacrimal compression device into
class I (general controls). The Agency is
classifying the device into class I
(general controls) in order to provide a
reasonable assurance of safety and
effectiveness of the device.
DATES: This order is effective June 10,
2016. The classification was applicable
on April 20, 2016.
FOR FURTHER INFORMATION CONTACT:
Daniel Fedorko, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring,
MD 20993–0002, 301–796–6620.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
37499
device under the criteria set forth in
section 513(a)(1) of the FD&C Act.
Under the first procedure, the person
submits a premarket notification under
section 510(k) of the FD&C Act for a
device that has not previously been
classified and, within 30 days of
receiving an order classifying the device
into class III under section 513(f)(1) of
the FD&C Act, the person requests a
classification under section 513(f)(2).
Under the second procedure, rather than
first submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On June 27, 2014, Innovatex, Inc.,
submitted a request for classification of
the Tear Duct Occluder (originally
referred to as the Glaucoma Companion
Nasolacrimal Compression Device)
under section 513(f)(2) of the FD&C Act.
The manufacturer recommended that
the device be classified into class I (Ref.
1).
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1) of the FD&C
Act. FDA classifies devices into class I
if general controls by themselves are
sufficient to provide reasonable
assurance of safety and effectiveness of
the device for its intended use. After
review of the information submitted in
the de novo request, FDA determined
that the device can be classified into
class I. FDA believes general controls
will provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on April 20, 2016, FDA
issued an order to the requestor
classifying the device into class I. FDA
E:\FR\FM\10JNR1.SGM
10JNR1
]]>Agencies
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37496-37499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 https://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:
jim.rutherford@faa.gov.
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:
jim.rutherford@faa.gov. 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 https://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: https://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
