Airworthiness Directives; Safran Helicopter Engines, S.A. (Type Certificate Previously Held by Turbomeca, S.A.) Turboshaft Engines, 3631-3634 [2023-01101]
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
develop on products identified in this
rulemaking action.
Regulatory Findings
This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect on the States, on
the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
and
(2) Will not affect intrastate aviation
in Alaska.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
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 airworthiness
directive:
■
2023–01–12 Safran Helicopter Engines,
S.A. (Type Certificate Previously Held
by Turbomeca, S.A.): Amendment 39–
22306; Docket No. FAA–2023–0021;
Project Identifier MCAI–2022–01618–E.
(a) Effective Date
This airworthiness directive (AD) is
effective February 6, 2023.
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(c) Applicability
This AD applies to all Safran Helicopter
Engines, S.A. (Type Certificate previously
held by Turbomeca, S.A.) Arriel 1C, Arriel
1C1, and Arriel 1C2 model turboshaft
engines.
(d) Subject
Joint Aircraft System Component (JASC)
Code 7200, Engine (Turbine/Turboprop).
(e) Unsafe Condition
This AD was prompted by reports of false
engine fire warnings. The FAA is issuing this
AD to prevent false engine fire warnings. The
unsafe condition, if not addressed, could lead
15:54 Jan 19, 2023
Jkt 259001
(g) Required Actions
Except as specified in paragraphs (h) and
(i) of this AD: Perform all required actions
within the compliance times specified in,
and in accordance with European Union
Aviation Safety Agency (EASA) AD 2022–
0256, dated December 19, 2022 (EASA AD
2022–0256).
(h) Exceptions to EASA AD 2022–0256
(1) Where EASA AD 2022–0256 requires
compliance from its effective date, this AD
requires using the effective date of this AD.
(2) This AD does not adopt the ‘‘Remarks’’
section of EASA AD 2022–0256.
(3) Although the service information
referenced in EASA AD 2022–0256 specifies
to discard any removed fire detectors, this
AD requires removing those parts from
service.
(j) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, ECO Branch, FAA, has
the authority to approve AMOCs for this AD,
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to the attention of the person
identified in paragraph (k) of this AD and
email to: ANE-AD-AMOC@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(k) Additional Information
For more information about this AD,
contact Kevin Clark, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone: (781)
238–7088; email: kevin.m.clark@faa.gov.
(b) Affected ADs
None.
VerDate Sep<11>2014
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(i) No Reporting Requirement
Although the service information
referenced in EASA AD 2022–0256 specifies
to submit certain information to the
manufacturer, this AD does not include that
requirement.
PART 39—AIRWORTHINESS
DIRECTIVES
§ 39.13
to commanded in-flight engine shut-down,
possibly resulting in damage to the helicopter
and reduced control of the helicopter.
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference 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) European Union Aviation Safety Agency
(EASA) AD 2022–0256, dated December 19,
2022.
(ii) [Reserved]
(3) For EASA AD 2022–0256, contact
EASA, Konrad-Adenauer-Ufer 3, 50668
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
3631
Cologne, Germany; phone: +49 221 8999 000;
email: ADs@easa.europa.eu. You may find
this material on the EASA website at
ad.easa.europa.eu.
(4) You may view this service information
at the FAA, Airworthiness Products Section,
Operational Safety Branch, 1200 District
Avenue, Burlington, MA 01803. For
information on the availability of this
material at the FAA, call (817) 222–5110.
(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,
email: fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued on January 13, 2023.
Gaetano A. Sciortino,
Acting Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2023–01113 Filed 1–18–23; 11:15 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2023–0020; Project
Identifier MCAI–2022–01566–E; Amendment
39–22305; AD 2023–01–11]
RIN 2120–AA64
Airworthiness Directives; Safran
Helicopter Engines, S.A. (Type
Certificate Previously Held by
Turbomeca, S.A.) Turboshaft Engines
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; request for
comments.
AGENCY:
The FAA is adopting a new
airworthiness directive (AD) for all
Safran Helicopter Engines, S.A. (Safran)
Makila 1A and Makila 1A1 model
turboshaft engines. This AD was
prompted by reports of false engine fire
warnings. This AD requires replacing
the affected fire detectors, as specified
in a European Union Aviation Safety
Agency (EASA) AD, which is
incorporated by reference. This AD also
prohibits the installation of affected fire
detectors. The FAA is issuing this AD to
address the unsafe condition on these
products.
SUMMARY:
This AD is effective February 6,
2023.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in this AD
as of February 6, 2023.
The FAA must receive comments on
this AD by March 6, 2023.
DATES:
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
• Federal eRulemaking Portal: Go to
regulations.gov. Follow the instructions
for submitting comments.
• Fax: (202) 493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE,
Washington, DC 20590.
• Hand Delivery: Deliver to Mail
address above between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
AD Docket: You may examine the AD
docket at regulations.gov under Docket
No. FAA–2023–0020; or in person at
Docket Operations between 9 a.m. and
5 p.m., Monday through Friday, except
Federal holidays. The AD docket
contains this final rule, the mandatory
continuing airworthiness information
(MCAI), any comments received, and
other information. The street address for
Docket Operations is listed above.
Material Incorporated by Reference:
• For EASA material incorporated by
reference in this AD, contact EASA,
Konrad-Adenauer-Ufer 3, 50668
Cologne, Germany; phone: +49 221 8999
000; email: ADs@easa.europa.eu;
website: easa.europa.eu. You may find
this material on the EASA website at
ad.easa.europa.eu.
• You may view this service
information at the FAA, Airworthiness
Products Section, Operational Safety
Branch, 1200 District Avenue,
Burlington, MA 01803. For information
on the availability of this material at the
FAA, call (817) 222–5110. It is also
available at regulations.gov under
Docket No. FAA–2023–0020.
FOR FURTHER INFORMATION CONTACT:
Kevin Clark, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:
(781) 238–7088; email: kevin.m.clark@
faa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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Comments Invited
The FAA invites you to send any
written data, views, or arguments about
this final rule. Send your comments to
an address listed under ADDRESSES.
Include ‘‘Docket No. FAA–2023–0020;
Project Identifier MCAI–2022–01566–E’’
at the beginning of your comments. The
most helpful comments reference a
specific portion of the final rule, explain
the reason for any recommended
change, and include supporting data.
The FAA will consider all comments
received by the closing date and may
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15:54 Jan 19, 2023
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amend this final rule because of those
comments.
Except for Confidential Business
Information (CBI) as described in the
following paragraph, and other
information as described in 14 CFR
11.35, the FAA will post all comments
received, without change, to
regulations.gov, including any personal
information you provide. The agency
will also post a report summarizing each
substantive verbal contact received
about this final rule.
Confidential Business Information
CBI is commercial or financial
information that is both customarily and
actually treated as private by its owner.
Under the Freedom of Information Act
(FOIA) (5 U.S.C. 552), CBI is exempt
from public disclosure. If your
comments responsive to this AD contain
commercial or financial information
that is customarily treated as private,
that you actually treat as private, and
that is relevant or responsive to this AD,
it is important that you clearly designate
the submitted comments as CBI. Please
mark each page of your submission
containing CBI as ‘‘PROPIN.’’ The FAA
will treat such marked submissions as
confidential under the FOIA, and they
will not be placed in the public docket
of this AD. Submissions containing CBI
should be sent to Kevin Clark, Aviation
Safety Engineer, ECO Branch, FAA,
1200 District Avenue, Burlington, MA
01803. Any commentary that the FAA
receives which is not specifically
designated as CBI will be placed in the
public docket for this rulemaking.
Background
EASA, which is the Technical Agent
for the Member States of the European
Union, has issued EASA AD 2022–0244,
dated December 8, 2022 (EASA AD
2022–0244), (also referred to as the
MCAI), to correct an unsafe condition
for all Safran Makila 1A and Makila 1A1
model turboshaft engines. The MCAI
states that there were reports of false
engine fire warnings. The subsequent
investigation results identified a
manufacturing non-compliance on the
fire detectors, which caused a shift of
the detection threshold towards
temperature values that are lower than
specified, potentially leading to a false
engine fire warning. When two engines
on a helicopter are fitted with an
affected part, an engine fire warning
could occur on both engines during the
same flight. This condition, if not
addressed, could lead to commanded inflight engine shut-down, possibly
resulting in damage to the helicopter
and reduced control of the helicopter.
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
The FAA is issuing this AD to address
the unsafe condition on these products.
You may examine the MCAI in the
AD docket at regulations.gov under
Docket No. FAA–2023–0020.
Related Service Information Under 1
CFR Part 51
The FAA reviewed EASA AD 2022–
0244, which specifies procedures for
replacing affected fire detectors. This
material is reasonably available because
the interested parties have access to it
through their normal course of business
or by the means identified in
ADDRESSES.
FAA’s Determination
These products have been approved
by the aviation authority of another
country and are approved for operation
in the United States. Pursuant to the
FAA’s bilateral agreement with this
State of Design Authority, it has notified
the FAA of the unsafe condition
described in the MCAI described above.
The FAA is issuing this AD after
determining that the unsafe condition
described previously is likely to exist or
develop on other products of these same
type designs.
AD Requirements
This AD requires accomplishing the
actions specified in EASA AD 2022–
0244, except for any differences
identified as exceptions in the
regulatory text of this AD. This AD also
prohibits the installation of affected fire
detectors.
Explanation of Required Compliance
Information
In the FAA’s ongoing efforts to
improve the efficiency of the AD
process, the FAA developed a process to
use some civil aviation authority (CAA)
ADs as the primary source of
information for compliance with
requirements for corresponding FAA
ADs. The FAA has been coordinating
this process with manufacturers and
CAAs. As a result, EASA AD 2022–0244
is incorporated by reference in this AD.
This AD requires compliance with
EASA AD 2022–0244 in its entirety
through that incorporation, except for
any differences identified as exceptions
in the regulatory text of this AD. Using
common terms that are the same as the
heading of a particular section in EASA
AD 2022–0244 does not mean that
operators need comply only with that
section. For example, where the AD
requirement refers to ‘‘all required
actions and compliance times,’’
compliance with this AD requirement is
not limited to the section titled
‘‘Required Action(s) and Compliance
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
Time(s)’’ in EASA AD 2022–0244.
Service information required by EASA
AD 2022–0244 for compliance will be
available at regulations.gov under
Docket No. FAA–2023–0020 after this
AD is published.
Justification for Immediate Adoption
and Determination of the Effective Date
Section 553(b)(3)(B) of the
Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies
to dispense with notice and comment
procedures for rules when the agency,
for ‘‘good cause,’’ finds that those
procedures are ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ Under this section, an agency,
upon finding good cause, may issue a
final rule without providing notice and
seeking comment prior to issuance.
Further, section 553(d) of the APA
authorizes agencies to make rules
effective in less than thirty days, upon
a finding of good cause.
An unsafe condition exists that
requires the immediate adoption of this
AD without providing an opportunity
for public comments prior to adoption.
The FAA has found that the risk to the
flying public justifies foregoing notice
and comment prior to adoption of this
rule because fire detectors that do not
conform to the type design could lead
to false engine fire warnings. Safran was
informed of three occurrences of
illumination of the engine fire alarm
without confirmed fire (untimely
illumination) on airframes equipped
with affected fire detectors. False engine
fire warnings are an unsafe condition
requiring urgent corrective action
because, if a helicopter is equipped with
two engines with an affected fire
detector installed, an engine fire
warning could occur on both engines
during the same flight. This unsafe
condition, if not addressed, could lead
to commanded in-flight engine shutdown, possibly resulting in damage to
the helicopter and reduced control the
helicopter. Replacement of the fire
detectors must be accomplished within
30 flight hours or 60 days from the
effective date of this AD, whichever
occurs first. Accordingly, notice and
opportunity for prior public comment
are impracticable and contrary to the
public interest pursuant to 5 U.S.C.
553(b)(3)(B).
In addition, the FAA finds that good
cause exists pursuant to 5 U.S.C. 553(d)
for making this amendment effective in
less than 30 days, for the same reasons
the FAA found good cause to forego
notice and comment.
Regulatory Flexibility Act (RFA)
The requirements of the RFA do not
apply when an agency finds good cause
pursuant to 5 U.S.C. 553 to adopt a rule
without prior notice and comment.
Because the FAA has determined that it
has good cause to adopt this rule
without prior notice and comment, RFA
analysis is not required.
Costs of Compliance
The FAA estimates that this AD
affects 1 engine installed on a helicopter
of U.S. registry. The FAA estimates the
following costs to comply with this AD:
ESTIMATED COSTS
Action
Labor cost
Replace fire detectors .....................................
1 work-hour × $85 per hour = $85 .................
Authority for This Rulemaking
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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.
The FAA is issuing this rulemaking
under the authority described in
Subtitle VII, Part A, Subpart III, Section
44701: General requirements. Under
that section, Congress charges the FAA
with promoting safe flight of civil
aircraft in air commerce by prescribing
regulations for practices, methods, and
procedures the Administrator finds
necessary for safety in air commerce.
This regulation is within the scope of
that authority because it addresses an
unsafe condition that is likely to exist or
develop on products identified in this
rulemaking action.
Regulatory Findings
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
VerDate Sep<11>2014
15:54 Jan 19, 2023
Jkt 259001
Parts cost
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
and
(2) Will not affect intrastate aviation
in Alaska.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
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.
§ 39.13
[Amended]
Frm 00005
Fmt 4700
$1,800
Cost on U.S.
operators
$1,885
$1,885
2023–01–11 Safran Helicopter Engines,
S.A. (Type Certificate Previously Held
by Turbomeca, S.A.): Amendment 39–
22305; Docket No. FAA–2023–0020;
Project Identifier MCAI–2022–01566–E.
(a) Effective Date
This airworthiness directive (AD) is
effective February 6, 2023.
(b) Affected ADs
None.
(c) Applicability
This AD applies to all Safran Helicopter
Engines, S.A. (Type Certificate previously
held by Turbomeca, S.A.) Makila 1A and
Makila 1A1 model turboshaft engines.
(d) Subject
Joint Aircraft System Component (JASC)
Code 7200, Engine (Turbine/Turboprop).
(e) Unsafe Condition
This AD was prompted by reports of false
engine fire warnings. The FAA is issuing this
AD to prevent false engine fire warnings. The
unsafe condition, if not addressed, could lead
to commanded in-flight engine shut-down,
possibly resulting in damage to the helicopter
and reduced control of the helicopter.
(f) Compliance
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
■
PO 00000
Cost per
product
Sfmt 4700
Comply with this AD within the
compliance times specified, unless already
done.
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
(g) Required Actions
Except as specified in paragraphs (h) and
(i) of this AD: Perform all required actions
within the compliance times specified in,
and in accordance with European Union
Aviation Safety Agency (EASA) AD 2022–
0244, dated December 8, 2022 (EASA AD
2022–0244).
(h) Exceptions to EASA AD 2022–0244
(1) Where EASA AD 2022–0244 requires
compliance from its effective date, this AD
requires using the effective date of this AD.
(2) This AD does not adopt the ‘‘Remarks’’
section of EASA AD 2022–0244.
(3) Although the service information
referenced in EASA AD 2022–0244 specifies
to discard any removed fire detectors, this
AD requires removing those parts from
service.
(i) No Reporting Requirement
Although the service information
referenced in EASA AD 2022–0244 specifies
to submit certain information to the
manufacturer, this AD does not include that
requirement.
(j) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, ECO Branch, FAA, has
the authority to approve AMOCs for this AD,
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to the attention of the person
identified in paragraph (k) of this AD and
email to: ANE-AD-AMOC@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
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(k) Additional Information
For more information about this AD,
contact Kevin Clark, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone: (781)
238–7088; email: kevin.m.clark@faa.gov.
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference 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) European Union Aviation Safety Agency
(EASA) AD 2022–0244, dated December 8,
2022.
(ii) [Reserved]
(3) For EASA AD 2022–0244, contact
EASA, Konrad-Adenauer-Ufer 3, 50668
Cologne, Germany; phone: +49 221 8999 000;
email: ADs@easa.europa.eu. You may find
this material on the EASA website at
ad.easa.europa.eu.
(4) You may view this service information
at the FAA, Airworthiness Products Section,
Operational Safety Branch, 1200 District
VerDate Sep<11>2014
15:54 Jan 19, 2023
Jkt 259001
Avenue, Burlington, MA 01803. For
information on the availability of this
material at the FAA, call (817) 222–5110.
(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,
email: fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued on January 13, 2023.
Gaetano A. Sciortino,
Acting Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2023–01101 Filed 1–18–23; 11:15 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2022–N–3255]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Computerized Behavioral Therapy
Device for Treating Symptoms of
Gastrointestinal Conditions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency, or we) is
classifying the computerized behavioral
therapy device for treating symptoms of
gastrointestinal conditions into class II
(special controls). The special controls
that apply to the device type are
identified in this order and will be part
of the codified language for the
computerized behavioral therapy device
for treating symptoms of gastrointestinal
conditions’ classification. We are taking
this action because we have determined
that classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices.
DATES: This order is effective January
20, 2023. The classification was
applicable on November 25, 2020.
FOR FURTHER INFORMATION CONTACT:
Stephanie Cole, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2536, Silver Spring,
MD 20993–0002, 301–796–8587,
Stephanie.Cole@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
Upon request, FDA has classified the
computerized behavioral therapy device
for treating symptoms of gastrointestinal
conditions as class II (special controls),
which we have determined will provide
a reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
placing the device into a lower device
class than the automatic class III
assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (see 21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
device by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115) established
the first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
A device sponsor may utilize either
procedure for De Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
E:\FR\FM\20JAR1.SGM
20JAR1
Agencies
[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3631-3634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01101]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2023-0020; Project Identifier MCAI-2022-01566-E;
Amendment 39-22305; AD 2023-01-11]
RIN 2120-AA64
Airworthiness Directives; Safran Helicopter Engines, S.A. (Type
Certificate Previously Held by Turbomeca, S.A.) Turboshaft Engines
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Safran Helicopter Engines, S.A. (Safran) Makila 1A and Makila 1A1 model
turboshaft engines. This AD was prompted by reports of false engine
fire warnings. This AD requires replacing the affected fire detectors,
as specified in a European Union Aviation Safety Agency (EASA) AD,
which is incorporated by reference. This AD also prohibits the
installation of affected fire detectors. The FAA is issuing this AD to
address the unsafe condition on these products.
DATES: This AD is effective February 6, 2023.
The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 6,
2023.
The FAA must receive comments on this AD by March 6, 2023.
[[Page 3632]]
ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
Fax: (202) 493-2251.
Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0020; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
Material Incorporated by Reference:
For EASA material incorporated by reference in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone:
+49 221 8999 000; email: [email protected]; website: easa.europa.eu.
You may find this material on the EASA website at ad.easa.europa.eu.
You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call (817) 222-5110. It is
also available at regulations.gov under Docket No. FAA-2023-0020.
FOR FURTHER INFORMATION CONTACT: Kevin Clark, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7088; email: [email protected].
SUPPLEMENTARY INFORMATION:
Comments Invited
The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2023-0020; Project Identifier MCAI-
2022-01566-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.
Confidential Business Information
CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Kevin
Clark, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.
Background
EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0244, dated December 8, 2022
(EASA AD 2022-0244), (also referred to as the MCAI), to correct an
unsafe condition for all Safran Makila 1A and Makila 1A1 model
turboshaft engines. The MCAI states that there were reports of false
engine fire warnings. The subsequent investigation results identified a
manufacturing non-compliance on the fire detectors, which caused a
shift of the detection threshold towards temperature values that are
lower than specified, potentially leading to a false engine fire
warning. When two engines on a helicopter are fitted with an affected
part, an engine fire warning could occur on both engines during the
same flight. This condition, if not addressed, could lead to commanded
in-flight engine shut-down, possibly resulting in damage to the
helicopter and reduced control of the helicopter.
The FAA is issuing this AD to address the unsafe condition on these
products.
You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0020.
Related Service Information Under 1 CFR Part 51
The FAA reviewed EASA AD 2022-0244, which specifies procedures for
replacing affected fire detectors. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in
ADDRESSES.
FAA's Determination
These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI described above. The FAA is issuing this AD after determining
that the unsafe condition described previously is likely to exist or
develop on other products of these same type designs.
AD Requirements
This AD requires accomplishing the actions specified in EASA AD
2022-0244, except for any differences identified as exceptions in the
regulatory text of this AD. This AD also prohibits the installation of
affected fire detectors.
Explanation of Required Compliance Information
In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2022-0244 is incorporated by reference in this AD. This AD
requires compliance with EASA AD 2022-0244 in its entirety through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this AD. Using common terms that are the same as
the heading of a particular section in EASA AD 2022-0244 does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance
[[Page 3633]]
Time(s)'' in EASA AD 2022-0244. Service information required by EASA AD
2022-0244 for compliance will be available at regulations.gov under
Docket No. FAA-2023-0020 after this AD is published.
Justification for Immediate Adoption and Determination of the Effective
Date
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because fire detectors that do not conform to the type design could
lead to false engine fire warnings. Safran was informed of three
occurrences of illumination of the engine fire alarm without confirmed
fire (untimely illumination) on airframes equipped with affected fire
detectors. False engine fire warnings are an unsafe condition requiring
urgent corrective action because, if a helicopter is equipped with two
engines with an affected fire detector installed, an engine fire
warning could occur on both engines during the same flight. This unsafe
condition, if not addressed, could lead to commanded in-flight engine
shut-down, possibly resulting in damage to the helicopter and reduced
control the helicopter. Replacement of the fire detectors must be
accomplished within 30 flight hours or 60 days from the effective date
of this AD, whichever occurs first. Accordingly, notice and opportunity
for prior public comment are impracticable and contrary to the public
interest pursuant to 5 U.S.C. 553(b)(3)(B).
In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forego notice and
comment.
Regulatory Flexibility Act (RFA)
The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without prior notice and comment, RFA analysis is not
required.
Costs of Compliance
The FAA estimates that this AD affects 1 engine installed on a
helicopter of U.S. registry. The FAA estimates the following costs to
comply with this AD:
Estimated Costs
----------------------------------------------------------------------------------------------------------------
Cost per Cost on U.S.
Action Labor cost Parts cost product operators
----------------------------------------------------------------------------------------------------------------
Replace fire detectors................ 1 work-hour x $85 per $1,800 $1,885 $1,885
hour = $85.
----------------------------------------------------------------------------------------------------------------
Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.
Regulatory Findings
This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
(2) Will not affect intrastate aviation in Alaska.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
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 airworthiness
directive:
2023-01-11 Safran Helicopter Engines, S.A. (Type Certificate
Previously Held by Turbomeca, S.A.): Amendment 39-22305; Docket No.
FAA-2023-0020; Project Identifier MCAI-2022-01566-E.
(a) Effective Date
This airworthiness directive (AD) is effective February 6, 2023.
(b) Affected ADs
None.
(c) Applicability
This AD applies to all Safran Helicopter Engines, S.A. (Type
Certificate previously held by Turbomeca, S.A.) Makila 1A and Makila
1A1 model turboshaft engines.
(d) Subject
Joint Aircraft System Component (JASC) Code 7200, Engine
(Turbine/Turboprop).
(e) Unsafe Condition
This AD was prompted by reports of false engine fire warnings.
The FAA is issuing this AD to prevent false engine fire warnings.
The unsafe condition, if not addressed, could lead to commanded in-
flight engine shut-down, possibly resulting in damage to the
helicopter and reduced control of the helicopter.
(f) Compliance
Comply with this AD within the compliance times specified,
unless already done.
[[Page 3634]]
(g) Required Actions
Except as specified in paragraphs (h) and (i) of this AD:
Perform all required actions within the compliance times specified
in, and in accordance with European Union Aviation Safety Agency
(EASA) AD 2022-0244, dated December 8, 2022 (EASA AD 2022-0244).
(h) Exceptions to EASA AD 2022-0244
(1) Where EASA AD 2022-0244 requires compliance from its
effective date, this AD requires using the effective date of this
AD.
(2) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0244.
(3) Although the service information referenced in EASA AD 2022-
0244 specifies to discard any removed fire detectors, this AD
requires removing those parts from service.
(i) No Reporting Requirement
Although the service information referenced in EASA AD 2022-0244
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.
(j) Alternative Methods of Compliance (AMOCs)
(1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (k) of this AD and email to: [email protected].
(2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
(k) Additional Information
For more information about this AD, contact Kevin Clark,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone: (781) 238-7088; email:
[email protected].
(l) Material Incorporated by Reference
(1) The Director of the Federal Register approved the
incorporation by reference 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) European Union Aviation Safety Agency (EASA) AD 2022-0244,
dated December 8, 2022.
(ii) [Reserved]
(3) For EASA AD 2022-0244, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]. You may find this material on the EASA website
at ad.easa.europa.eu.
(4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call (817) 222-5110.
(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, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
Issued on January 13, 2023.
Gaetano A. Sciortino,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-01101 Filed 1-18-23; 11:15 am]
BILLING CODE 4910-13-P