[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66458-66460]
[FR Doc No: 2023-20955]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1158]

Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions; Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Cybersecurity in
Medical Devices: Quality System Considerations and Content of Premarket
Submissions.'' As more medical devices are becoming interconnected,
cybersecurity threats have become more numerous, more frequent, more
severe, and more clinically impactful. As a result, ensuring medical
device safety and effectiveness includes adequate medical device
cybersecurity, as well as its security as part of the larger system.
This final guidance supersedes the final guidance ``Content of
Premarket Submissions for Management of Cybersecurity in Medical
Devices,'' issued October 2, 2014.

DATES: The announcement of the guidance is published in the Federal
Register on September 27, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1158 for ``Cybersecurity in Medical Devices: Quality System
Considerations and Content of Premarket Submissions.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5410, Silver Spring, MD 20993-0002, 301-
796-6937; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    With the increasing integration of wireless, internet- and network-
connected capabilities, portable media (e.g., USB or CD), and the
frequent electronic exchange of medical device-related health
information and other information, the need for robust cybersecurity
controls to ensure medical device safety and effectiveness has become
more important. In addition, cybersecurity threats to the healthcare
sector have become more frequent and more severe, carrying increased
potential for clinical impact. Cybersecurity incidents have rendered
medical devices and hospital networks inoperable, disrupting the
delivery of patient care across healthcare facilities in the United
States and globally. Such cyberattacks and exploits may lead to patient
harm as a result of clinical hazards, such as delay in diagnoses and/or
treatment. As a result, ensuring device safety and effectiveness
includes adequate device cybersecurity, as well as its security as part
of the larger system.
    Additionally, section 3305 of the Consolidated Appropriations Act,
2023, enacted on December 29, 2022, added section 524B ``Ensuring
Cybersecurity of Medical Devices'' to the Federal Food, Drug, and
Cosmetic Act (FD&C Act). Under section 524B(a) of the FD&C Act, a
person who submits a 510(k), premarket approval application (PMA),
product development protocol, De Novo, or Humanitarian Device Exemption
for a device that meets the definition of a cyber device, as defined
under section 524B(c) of the FD&C Act, is required to submit
information to ensure that cyber devices meet the cybersecurity
requirements under section 524B(b) of the FD&C Act. Section 524B(c) of
the FD&C Act defines ``cyber device'' as a device that includes
software validated, installed, or authorized by the sponsor as a device
or in a device; has the ability to connect to the internet; and
contains any such technological characteristics validated, installed,
or authorized by the sponsor that could be vulnerable to cybersecurity
threats. The recommendations in this guidance are intended to help
manufacturers meet their obligations under section 524B of the FD&C
Act.
    This final guidance supersedes the final guidance ``Content of
Premarket

Submissions for Management of Cybersecurity in Medical Devices,''
issued October 2, 2014. The changes since the 2014 guidance are
intended to further emphasize the importance of ensuring that devices
are designed securely and are designed to be capable of mitigating
emerging cybersecurity risks throughout the total product lifecycle
(TPLC), and to clearly outline FDA's recommendations for premarket
submission information to address cybersecurity concerns. As discussed
in the guidance, one way these TPLC considerations for devices can be
achieved is through the implementation and adoption of the Secure
Product Development Framework. The recommendations in this guidance are
intended to promote consistency, facilitate efficient premarket review,
and help ensure that marketed medical devices are sufficiently
resilient to cybersecurity threats.
    A notice of availability of the draft guidance appeared in the
Federal Register of April 8, 2022 (87 FR 20873). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including aligning with industry best practices, as
well as further clarifying the level of documentation recommended.
Additionally, we have clarified interoperability considerations and
that cybersecurity controls should not be intended to prohibit a user
from accessing their device data.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cybersecurity in Medical Devices: Quality
System Considerations and Content of Premarket Submissions.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001825 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget under the Paperwork Reduction Act
of 1995. The collections of information in the following FDA
regulations, guidance, and forms have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
                                                            OMB Control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Use           0910-0332
                                     Devices;
                                     Humanitarian Device
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-Submissions and          0910-0756
 Meetings for Medical Device         early payor
 Submissions: The Q-Submission       feedback request
 Program''.                          programs for
                                     medical devices.
800, 801, 809, and 830............  Medical device             0910-0485
                                     labeling
                                     regulations; Unique
                                     device
                                     identification.
820...............................  Current good               0910-0073
                                     manufacturing
                                     practice (CGMP);
                                     Quality system (QS)
                                     regulation.
------------------------------------------------------------------------

    Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20955 Filed 9-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Page 73651]
[FR Doc No: 2014-29183]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission Advisory Committee on Small and Emerging Companies
will hold a public meeting on Wednesday, December 17, in Multi-Purpose
Room LL-006 at the Commission's headquarters, 100 F Street NE.,
Washington, DC.
    The meeting will begin at 9:30 a.m. (EDT) and will be open to the
public. Seating will be on a first-come, first-served basis. Doors will
open at 9:00 a.m. Visitors will be subject to security checks. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
    On December 3, 2014 the Commission published notice of the
Committee meeting (Release No. 33-9683), indicating that the meeting is
open to the public and inviting the public to submit written comments
to the Committee. This Sunshine Act notice is being issued because a
majority of the Commission may attend the meeting.
    The agenda for the meeting includes matters relating to rules and
regulations affecting small and emerging companies under the federal
securities laws.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: December 8, 2014.
 Brent J. Fields,
Secretary.
[FR Doc. 2014-29183 Filed 12-9-14; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 54 (Tuesday, March 23, 2021)]
[Proposed Rules]
[Pages 15431-15433]
[FR Doc No: 2021-05883]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0188; Project Identifier MCAI-2020-00642-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2, and
AS 365 N3 helicopters. This proposed AD was prompted by a report that
damage (scorch marks) was found on an internal life raft installation
that contained a half rescue kit. This proposed AD would require
identifying the part number and serial number of each half rescue kit
located in the internal life raft installation and, depending on the
findings, inspecting the life raft for damage, inspecting the condition
of the flashlight battery, testing the flashlight battery, and
replacing the life raft or flashlight battery (including the leak test)
as applicable, as specified in a European Aviation Safety Agency (now
European Union Aviation Safety Agency) (EASA) AD, which is proposed for
incorporation by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 7,
2021.

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 https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 0000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood
Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0188.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0188; 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 NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Program Manager,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax (206) 231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0188; Project Identifier
MCAI-2020-00642-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, 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 proposal 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
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

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 NPRM 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 NPRM, 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 NPRM. Submissions containing CBI should be sent to
Kathleen Arrigotti, Program Manager, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Discussion

    The EASA (now European Union Aviation Safety Agency), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2016-0028, dated February 15, 2016 (EASA AD 2016-0028) (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), to correct an unsafe condition for certain Airbus
Helicopters Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3
helicopters.

    This proposed AD was prompted by a report that damage (scorch
marks) was found on an internal life raft installation that contained a
half rescue kit. Investigation revealed that the damage was caused by
an unsuitable folding process for the life raft, which led to
compression of the flashlight battery in the half rescue kit. This
compression caused an electrolyte leakage, followed by a short-circuit
that damaged the internal life raft. The FAA is proposing this AD to
address leakage of the flashlight battery in a half rescue kit, which
could result in damage to the internal life raft, and subsequent
failure of the internal life raft to deploy (for example after a
ditching), which could impede or prevent safe evacuation of the
occupants from the helicopter. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2016-0028 describes procedures for identifying the part
number and serial number of each half rescue kit located in the
internal life raft installation, inspecting the life raft for damage
(scorch marks), inspecting the condition of the flashlight battery
(including cracks, impacts, swelling, damage, distorted case, and the
connecting wire), testing the flashlight battery (turning on the
flashlight), and replacing the life raft or flashlight battery
(including the leak test). 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 the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2016-0028 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD and except as discussed under ``Differences
Between this Proposed AD and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2016-0028
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2016-0028 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD 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 Time(s)'' in the EASA AD. Service information specified
in EASA AD 2016-0028 that is required for compliance with EASA AD 2016-
0028 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0188 after the FAA
final rule is published.

Differences Between This Proposed AD and the MCAI

    Although the service information referenced in EASA AD 2016-0028
specifies to return damaged life rafts to the manufacturer, this AD
does not include that requirement.
    Where EASA AD 2016-0028 refers to its effective date or to January
7, 2016 (the effective date of EASA AD 2015-0242), this AD requires
compliance within 3 months after the effective date of this AD.
    Although the service information referenced in EASA AD 2016-0028
specifies that trained and authorized Zodiac Aerospace personnel must
do the inspection of the half rescue kit, this AD does not require that
Zodiac Aerospace personnel do the inspection.

Costs of Compliance

    The FAA estimates that this proposed AD affects 30 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................          $3,000           $3,085          $92,550
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
7.5 work-hours x $85 per hour =                $77,900       $78,537.50
 $637.50..............................
------------------------------------------------------------------------

    According to Zodiac Aerospace, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Helicopters: Docket No. FAA-2021-0188; Project Identifier
MCAI-2020-00642-R.

(a) Comments Due Date

    The FAA must receive comments by May 7, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Model SA-365N, SA-365N1,
AS-365N2, and AS 365 N3 helicopters, certificated in any category,
as identified in European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2016-0028, dated February 15, 2016
(EASA AD 2016-0028).

(d) Subject

    Joint Aircraft System Component (JASC) Code 2564, Life Raft.

(e) Reason

    This AD was prompted by a report that damage (scorch marks) was
found on an internal life raft installation that contained a half
rescue kit. Investigation revealed that the damage was caused by an
unsuitable folding process for the life raft, which led to
compression of the flashlight battery in the half rescue kit. The
FAA is issuing this AD to address leakage of the flashlight battery
in a half rescue kit, which could result in damage to the internal
life raft, and subsequent failure of the internal life raft to
deploy (for example after a ditching), which could impede or prevent
safe evacuation of the occupants from the helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2016-0028.

(h) Exceptions to EASA AD 2016-0028

    (1) Where EASA AD 2016-0028 refers to its effective date or to
January 7, 2016 (the effective date of EASA AD 2015-0242), this AD
requires compliance within 3 months after the effective date of this
AD.
    (2) The ``Remarks'' section of EASA AD 2016-0028 does not apply
to this AD.
    (3) Although the service information referenced in EASA AD 2016-
0028 specifies to return certain parts, this AD does not include
that requirement.
    (4) Although the service information referenced in EASA AD 2016-
0028 specifies that trained and authorized Zodiac Aerospace
personnel must do the inspection of the half rescue kit, this AD
does not require that Zodiac Aerospace personnel do the inspection.

(i) Alternative Methods of Compliance (AMOCs):

    The Manager, International Validation 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 International Validation Branch, send it to the
attention of the person identified in paragraph (j)(2) of this AD.
Information may be emailed to<EMAIL_ADDRESS>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.

(j) Related Information

    (1) For EASA AD 2016-0028, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 0000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0188.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Program Manager, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on March 11, 2021.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-05883 Filed 3-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Rules and Regulations]
[Pages 49492-49494]
[FR Doc No: 2017-23256]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2017-0862; Special Conditions No. 25-703-SC]

Special Conditions: Boeing Model 777-300ER Airplanes; Passenger-
Cabin High-Wall Suites

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for Boeing Model 777-300ER
airplanes with high-wall suites installed in the passenger cabin. This
installation is novel or unusual, and the applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this interior configuration. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: This action is effective on Boeing on October 26, 2017. Send
your comments by December 11, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0862
using any of the following methods:
    [ssquf] Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
    [ssquf] Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
    [ssquf] Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    [ssquf] Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478).
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: John Shelden, Airframe and Cabin
Safety Section, AIR-675, Transport Standards Branch, Policy and
Innovation Division, Aircraft Certification Service, 1601 Lind Avenue
SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile
425-227-1232; email [email protected].

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been subject to the notice and comment period in several prior
instances and has been derived without substantive change from those
previously issued. It is unlikely that prior public comment would
result in a significant change from the substance contained herein.
Therefore, because a delay would significantly affect the certification
of the airplane, the FAA has determined that prior public notice and
comment are unnecessary and impracticable.
    In addition, since the substance of these special conditions has
been subject to the public comment process in several prior instances
with no substantive comments received, the FAA finds it unnecessary to
delay the effective date and finds that good cause exists for adopting
these special conditions upon publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On December 19, 2014, Boeing applied for a type certificate design
change to Type Certificate (TC) No. T00001SE to install high-wall
suites in the passenger compartment of Boeing Model 777-300ER
airplanes.
    The Model 777 series airplane is a swept-wing, conventional-tail,
twin-engine, turbofan- powered, transport-category airplane. The
airplane has seating for 365 passengers and a maximum takeoff weight of
775,000 pounds.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Boeing must show that the Model 777-300ER airplane, as
changed, continues to meet the applicable provisions of the regulations
listed in Type Certificate No. T00001SE or the applicable regulations
in effect on the date of application for the change, except for earlier
amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Boeing Model 777-300ER airplane
because of a novel or unusual design feature, special conditions are
prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Boeing Model 777-300ER airplane must comply with the
fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the
noise-certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of

the type-certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Boeing Model 777-300ER airplane will incorporate the following
novel or unusual design features:
    A passenger cabin with six high-wall suites arranged in two rows of
three suites each.

Discussion

    The Boeing Model 777-300ER airplane will include, as a customer
option, a passenger cabin with six high-wall suites arranged in two
rows of three suites each, in a 1-1-1 configuration. The suites have
doors and walls that are taller than has been previously certified by
the FAA on Boeing 777 series airplanes. The walls extend from the floor
to the ceiling or close to the ceiling.
    The characteristics of the suite design are unique such that the
suites are not fully open to the cabin, as are conventional mini-suites
with partial-height surrounds, and they are not remote from the main
cabin, as are overhead crew rests. Likewise, unique but suitable fire-
protection requirements for smoke detection and firefighting are needed
for this configuration. Furthermore, the proposed suite design
necessitates the development of additional conditions that do not
currently exist within associated airworthiness standards, including,
but not limited to, alerting and lighting when oxygen masks are needed,
crew procedures for managing hazards and suite occupants, and
maintaining cabin-egress route dimensions after deformations of the
walls and seats.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Boeing Model 777-300ER airplane with high-wall, single-occupant suites
with doors installed. Should Boeing apply at a later date for a change
to the type certificate to include another model incorporating the same
novel or unusual design feature, these special conditions would apply
to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model series of airplane. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Boeing Model 777-300ER airplanes.
    Note: In these special conditions, ``suite'' means high-wall suite.
    1. Where suites are installed, a supplemental oxygen system must
provide the following:
    a. The supplemental oxygen system for each suite must include a
minimum of two oxygen masks and meet the same 14 CFR part 25
regulations as do the supplemental oxygen system for the main
passenger-cabin occupants.
    b. An aural alert to warn occupants and to indicate the need to don
oxygen masks in the event of decompression. The aural alert must
activate concurrently with deployment of the oxygen masks in the main
passenger cabin.
    c. The illumination level of the normal suite lighting system must
be activated automatically and must be sufficient for each occupant to
locate a deployed oxygen mask.
    d. If a chemical oxygen generator is used as the oxygen supply
source, the suite oxygen installation must meet Sec. Sec.  25.795(d)
and 25.1450.
    2. A smoke-detection or fire-detection system (or systems) must be
provided that monitors each occupiable space within the suite. Flight
tests must be conducted to show compliance with this requirement. If a
fire occurs, each system (or systems) in the affected suite must
provide:
    a. A visual indication to the flight deck within one minute after
the start of a fire.
    b. An aural warning in the suite area where detection has occurred.
    c. A warning in the main passenger cabin. This warning must be
readily detectable by a flight attendant, taking into consideration the
locations of flight attendants throughout the main passenger
compartment during various phases of flight.
    3. Passenger-management procedures must be provided should
occupants need to be moved in the event of smoke detection, or
firefighting within the suite or where suites are installed:
    a. A limitation must be included in the airplane flight manual
(AFM) or other suitable means requiring that crewmembers be trained in
the suite passenger-management procedures.
    b. Approved procedures describing methods for suite passenger
management must be established. These procedures must be transmitted to
the operator for incorporation into its training programs and
appropriate operational manuals.
    4. The design of each suite, and the location of the firefighting
equipment where suites are installed, must allow the crewmembers to
conduct effective firefighting in the suite. For a manual, hand-held
extinguishing system (designed as the sole means to fight a fire) for
the suite:
    a. A limitation must be included in the AFM or other suitable means
requiring that crewmembers be trained in the firefighting procedures.
    b. Each suite design must allow crewmembers equipped for
firefighting to have unrestricted access to all parts of the suite
compartment.
    c. The time for a crewmember in the main passenger cabin to react
to the fire alarm and gain access to the suite must not exceed the time
it would take for the compartment to become filled with smoke, thus
making it difficult to locate the fire source(s).
    d. Approved procedures describing methods for searching the suite
compartment for fire source(s) must be established. These procedures
must be transmitted to the operator for incorporation into its training
programs and appropriate operational manuals.
    5. A means must be provided to prevent hazardous quantities of
smoke or extinguishing agent originating in each suite from entering
any other occupiable compartments.
    a. Small quantities of smoke may penetrate from the suite into
other occupied areas during the one-minute smoke detection time.
    b. Hazardous quantities of smoke may not enter any occupied
compartment during access to manually fight a fire in the suite. A
small amount of smoke may enter the occupied compartments while a
firefighter enters and exits the suite, and is not considered hazardous
provided the smoke dissipates quickly.
    c. Flight tests must be conducted to show compliance with this
requirement.
    6. If waste-disposal receptacles are fitted in the suite, the suite
must be equipped with an automatic fire-extinguishing system that meets
the performance requirements of Sec.  25.854(b).
    7. Each stowage compartment in the suite must be completely
enclosed. All enclosed stowage compartments within the suite
compartment that are not

limited to stowage of emergency equipment or airplane- supplied
equipment (i.e., bedding) must meet the design criteria described in
the table below. Enclosed stowage compartments greater than 57 feet 3
inches cubic interior volume are not permitted by these special
conditions.

   Design Criteria for Enclosed Stowage Compartments Not Limited to Stowage of Emergency or Airplane-Supplied
                                                    Equipment
----------------------------------------------------------------------------------------------------------------
                                            Applicability of fire-protection requirements by interior volume
                                      --------------------------------------------------------------------------
       Fire protection features          Less than  25 cubic     25 Cubic feet to  less
                                                 feet              than 57 Cubic feet         57 cubic feet
----------------------------------------------------------------------------------------------------------------
Compliant Materials of Construction    Yes....................  Yes....................  Yes.
 \1\.
Smoke or Fire Detectors \2\..........  No.....................  Yes....................  Yes.
Liner \3\............................  No.....................  Conditional............  Yes.
Fire Location Detector \4\...........  No.....................  Yes....................  Yes.
----------------------------------------------------------------------------------------------------------------
\1\ Compliant Materials of Construction: The material used in constructing each enclosed stowage compartment
  must at least be fire resistant and must meet the flammability standards established for interior components
  (i.e., 14 CFR part 25 Appendix F, Parts I, IV, and V) per the requirements of Sec.   25.853. For compartments
  less than 25 ft.3 in interior volume, the design must ensure the ability to contain a fire likely to occur
  within the compartment under normal use.
\2\ Smoke or Fire Detectors: Enclosed stowage compartments equal to or exceeding 25 ft.3 in interior volume must
  be provided with a smoke- or fire-detection system to ensure that a fire can be detected within a one-minute
  detection time. Flight tests must be conducted to show compliance with this requirement. Each system (or
  systems) must provide:
[ballot] A visual indication in the flight deck within one minute after the start of a fire.
[ballot] An aural warning in the suite compartment.
[ballot] A warning in the main passenger cabin. This warning must be readily detectable by a flight attendant,
  taking into consideration the locations of flight attendants throughout the main passenger compartment during
  various phases of flight.
\3\ Liner: If material used in constructing the stowage compartment can be shown to meet the flammability
  requirements of a liner for a Class B cargo compartment (i.e., Sec.   25.855 at Amendment 25-116, and Appendix
  F, part I, paragraph (a)(2)(ii)), then no liner would be required for enclosed stowage compartments equal to
  or greater than 25 ft.3 but less than 57 ft.3 in interior volume. For all enclosed stowage compartments equal
  to 57 ft.3 in interior volume, a liner must be provided that meets the requirements of Sec.   25.855 for a
  Class B cargo compartment.
\4\ Fire Location Detector: If a suite compartment has enclosed stowage compartments exceeding 25 ft.3 interior
  volume that are located separately from the other stowage compartments (located, for example, away from one
  central location, such as the entry to the suite compartment or a common area within the suite compartment,
  where the other stowage compartments are), that suite compartment would require additional fire-protection
  features and/or devices to assist the firefighter in determining the location of a fire.

    8. Where suites are installed, the design of each suite must:
    a. Maintain minimum main aisle(s), cross aisle(s), and
passageway(s) requirements of Sec.  25.815 when subjected to the
ultimate inertia forces listed in Sec.  25.561(d).
    b. Prevent structural failure or deformation of components that
could block access to the available evacuation routes (e.g., seats,
doors, contents of stowage compartments, etc.).
    9. In addition to the requirements of Sec.  25.562 for seat
systems, which are occupiable during taxi, takeoff, and landing, the
suite structure must be designed for the additional loads imposed by
the seats as a result of the conditions specified in Sec.  25.562(b).

    Issued in Renton, Washington, on October 19, 2017.
Suzanne Masterson,
Acting Manager, Transport Standards Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2017-23256 Filed 10-25-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Rules and Regulations]
[Pages 19080-19082]
[FR Doc No: 2020-07138]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-1015; Product Identifier 2018-SW-104-AD; Amendment
39-19882; AD 2020-06-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Airbus Helicopters Model AS332C, AS332C1, AS332L, and AS332L1
helicopters. This AD requires determining the accumulated hours time-
in-service (TIS) of certain part-numbered main gearbox (MGB) suspension
bar attachment fittings (fittings) and bolts, and establishes new life
limits. This AD was prompted by the outcome of tests and analyses
performed by Airbus Helicopters. The actions of this AD are intended to
address an unsafe condition on these products.

DATES: This AD is effective May 11, 2020.

ADDRESSES: For service information identified in this final rule,
contact Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html. You
may view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov in Docket No. FAA-2019-1015; 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 AD, the European Union
Aviation Safety Agency (previously European Aviation Safety Agency)
(EASA) AD, any comments received, and other information. The street
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On December 9, 2019, at 84 FR 67246, the Federal Register published
the FAA's notice of proposed rulemaking (NPRM), which proposed to amend
14 CFR part 39 by adding an AD that would apply to Airbus Helicopters
Model AS332C, AS332C1, AS332L, and AS332L1 helicopters, with an MGB
suspension bar right-hand side (RH) rear fitting part number (P/N)
330A22-2702-07 and bolt P/N 330A22-0135-20, MGB suspension bar left-
hand side (LH) rear fitting P/N 330A22-2702-06 and bolt P/N 330A22-
0135-20, or MGB suspension bar front bolt P/N 330A22-0134-20 installed.
The NPRM proposed to require within 50 hours TIS, reviewing the
helicopter records to determine the total hours TIS of the MGB
suspension bar RH and LH rear fittings. The NPRM also proposed to
require removing from service the RH rear fitting and its bolts and the
LH rear fitting and its bolts based on the accumulated total hours TIS
of the fittings and other conditions. Thereafter, the NPRM proposed to
require removing from service the RH rear fitting and its bolts at
intervals not to exceed 1,470 hours TIS, removing from service the LH
rear fitting at intervals not to exceed 13,600 hours TIS, and removing
from service the LH rear bolts during each Major Inspection ``G.''
Finally, the NPRM proposed to require removing from service the front
bolts during each Major Inspection ``G.''
    The proposed requirements were intended to prevent structural
failure of the MGB suspension bar fittings and bolts, possibly
resulting in detachment of the MGB suspension bars.
    The NPRM was prompted by EASA AD No. 2018-0260, dated December 3,
2018, issued by EASA, which is the Technical Agent for the Member
States of the European Union, to correct an unsafe condition for Airbus
Helicopters (formerly Eurocopter, Eurocopter France, Aerospatiale)
Model AS 332 C, AS 332 C1, AS 332 L, and AS 332 L1 helicopters. From
review of reported Model EC 225 LP data, EASA advises that the
installation of the MGB upper deck fittings of the three MGB suspension
bars could lead to tightening torque loss on the fittings' attachment
screws (bolts). Due to design similarities, Model AS 332 C, AS 332 C1,
AS 332 L, and AS 332 L1 helicopters could also be affected by the same
installation condition.

Investigations determined that a life limit reduction of the MGB
suspension bar fittings and screws was necessary for these model
helicopters.
    EASA states that this condition, if not corrected, could lead to
structural failure of the MGB suspension bar fittings and screws,
possibly resulting in detachment of the MGB suspension bars.
Accordingly, the EASA AD requires determining the accumulated service
life of the affected parts and introduced new life limits.

Comments

    The FAA gave the public the opportunity to participate in
developing this AD, but the FAA did not receive any comments on the
NPRM.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all information provided by EASA and determining the unsafe
condition exists and is likely to exist or develop on other helicopters
of these same type designs and that air safety and the public interest
require adopting the AD requirements as proposed.

Interim Action

    The FAA considers this AD to be an interim action. The design
approval holder is currently developing a modification that will
address the unsafe condition identified in this AD. Once this
modification is developed, approved, and available, the FAA might
consider additional rulemaking.

Differences Between This AD and the EASA AD

    The EASA AD allows an option for the first MGB RH rear fitting
replacement to inspect torque and specifies different replacement
compliance times based on the torque inspection results, whereas this
AD does not.

Related Service Information

    The FAA reviewed Airbus Helicopters Alert Service Bulletin No.
AS332-01.00.90, Revision 0, dated November 21, 2018. This service
information specifies determining the accumulated hours TIS of certain
part-numbered rear MGB suspension bar fittings and screws. This service
information further specifies criteria to determine the initial
replacement compliance time of those parts and a new life limit for
those parts thereafter. This service information also establishes a
life limit for the front MGB attachment screws.

Costs of Compliance

    The FAA estimates that this AD affects 14 helicopters of U.S.
Registry. The FAA estimates that operators may incur the following
costs in order to comply with this AD. Labor costs are estimated at $85
per work-hour.
    Determining the total hours TIS of the rear MGB fittings takes
about 0.5 work-hour for an estimated cost of $43 per helicopter and
$602 for the U.S. fleet.
    Replacing a rear MGB fitting and its set of four bolts takes about
8 work-hours and parts cost about $12,937, for an estimated cost of
$13,617 per replacement cycle.
    Replacing a set of four MGB attachment bolts takes about 4 work-
hours and parts cost about $224, for an estimated cost of $564 per
replacement cycle.
    Replacing a LH rear MGB fitting takes about 8 work-hours and parts
cost about $12,713, for an estimated cost of $13,393 per replacement
cycle.

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 helicopters 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,
    2. Will not affect intrastate aviation in Alaska, and
    3. 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 airworthiness
directive (AD):

2020-06-13 Airbus Helicopters: Amendment 39-19882; Docket No. FAA-
2019-1015; Product Identifier 2018-SW-104-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS332C, AS332C1,
AS332L, and AS332L1 helicopters, certificated in any category, with
a main gearbox (MGB) suspension bar right-hand side (RH) rear
attachment fitting (fitting) part number (P/N) 330A22-2702-07 and
bolt P/N 330A22-0135-20, MGB suspension bar left-hand side (LH) rear
fitting P/N 330A22-2702-06 and bolt P/N 330A22-0135-20, or MGB
suspension bar front bolt P/N 330A22-0134-20 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as MGB suspension bar
fittings and bolts remaining in service beyond their fatigue life.
This condition could result in failure of an MGB attachment
assembly, detachment of an MGB suspension bar, and subsequent loss
of helicopter control.

(c) Effective Date

    This AD becomes effective May 11, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 50 hours time-in-service (TIS), review records to
determine the total hours TIS of each MGB suspension bar RH and LH
rear fitting.
    (i) For any RH rear fitting that has accumulated 1,470 or more
total hours TIS,

before further flight, remove from service the RH rear fitting and
its bolts.
    (ii) For any RH rear fitting that has accumulated less than
1,470 total hours TIS, remove from service the RH rear fitting and
its bolts before the fitting accumulates 1,470 total hours TIS.
    (iii) For any LH rear fitting that has accumulated 13,600 or
more total hours TIS, before further flight, remove from service the
LH rear fitting and its bolts.
    (iv) For any LH rear fitting that has accumulated less than
13,600 total hours TIS:
    (A) If a Major Inspection ``G'' has not been completed since the
LH rear fitting has been installed, remove from service the LH rear
bolts during the next Major Inspection ``G'' inspection; or
    Note 1 to paragraph (e)(1)(iv)(A) of this AD: Major Inspection
``G'' (7,500 hours TIS between overhauls) is defined in Maintenance
Manual MET 05-29-00-601.
    (B) If a Major Inspection ``G'' has been completed since the LH
rear fitting has been installed, before further flight, remove from
service the LH rear bolts; and
    (C) Remove from service the LH rear fitting before the fitting
accumulates 13,600 total hours TIS.
    (2) Thereafter following paragraph (e)(1) of this AD, remove
from service any RH rear fitting and its bolts at intervals not to
exceed 1,470 hours TIS, remove from service any LH rear fitting at
intervals not to exceed 13,600 hours TIS, and remove from service
any LH rear bolts during each Major Inspection ``G.''
    (3) During the next Major Inspection ``G,'' remove from service
the MGB suspension bar front bolts. Thereafter, remove from service
the front bolts during each Major Inspection ``G.''

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(g) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin No. AS332-
01.00.90, Revision 0, dated November 21, 2018, which is not
incorporated by reference, contains additional information about the
subject of this AD. For service information identified in this AD,
contact Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at https://www.airbus.com/helicopters/services/technical-support.html. You may view the referenced service information at the
FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Union
Aviation Safety Agency (previously European Aviation Safety Agency)
(EASA) AD No. 2018-0260, dated December 3, 2018. You may view the
EASA AD on the internet at https://www.regulations.gov in Docket No.
FAA-2019-1015.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6320 Main Rotor
Gearbox.

    Issued on March 27, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-07138 Filed 4-3-20; 8:45 am]
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