[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Page 59624]
[FR Doc No: 2012-23885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastrointestinal Drugs Advisory Committee; Notice of Postponement
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is postponing the
Gastrointestinal Drugs Advisory Committee Meeting scheduled for October
15, 2012. This meeting was announced in the Federal Register of August
16, 2012 (77 FR 49446). The postponement is due to scheduling issues.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), or visit our Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-23885 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Rules and Regulations]
[Pages 11410-11413]
[FR Doc No: 2021-03660]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0649; Product Identifier 2019-SW-061-AD; Amendment
39-21410; AD 2021-03-07]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Leonardo S.p.a. (Leonardo) Model AB139 and AW139 helicopters.
This AD requires removing certain engine mounting rods from service and
prohibits their installation on any helicopter. This AD was prompted by
a report of non-conforming engine mounting rods. The actions of this AD
are intended to address an unsafe condition on these products.

DATES: This AD is effective April 1, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of April 1, 2021.

ADDRESSES: For service information identified in this final rule,
contact Leonardo S.p.a. Helicopters, Emanuele Bufano, Head of
Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va)
Italy; telephone +39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. 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. It is
also available on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0649.

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-2020-
0649; 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 (EASA) AD, any
service information that is incorporated by reference, 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: Kristi Bradley, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Leonardo Model AB139
and AW139 helicopters with certain serial-numbered engine mounting rods
part number (P/N) 3G7120V00132. The NPRM published in the Federal
Register on July 9, 2020 (85 FR 41219). The NPRM proposed to require
removing the affected engine mounting rods from service and proposed to
prohibit installing an affected engine mounting rod on any helicopter.
The proposed requirements were intended to prevent failure of an
affected engine mounting rod, which could possibly result in loss of
control of the helicopter.
    The NPRM was prompted by EASA AD No. 2019-0149, dated June 24,
2019, issued by EASA, which is the Technical Agent for the Member
States of the European Union, to correct an unsafe condition for
Leonardo S.p.a. (formerly Finmeccanica S.p.A., AgustaWestland S.p.A.,
Agusta S.p.A.; and AgustaWestland Philadelphia Corporation, formerly
Agusta Aerospace Corporation) Model AB139 and AW139 helicopters with
certain serial numbered engine mounting rods P/N 3G7120V00132
installed. EASA advises of reports of a production non-conformity on a
specific batch of these engine mounting rods. EASA further advises that
this non-conformity degrades the material strength of the engine
mounting rods.
    EASA states this condition, if not corrected, could lead to failure
of an affected engine mounting rod, possibly resulting in loss of
control of the helicopter. Accordingly, the EASA AD requires removing
from service each affected engine mounting rod, emailing a completed
``Scrap Report'' to Leonardo Helicopters Division, and installing a
serviceable engine mounting rod. The EASA AD also prohibits installing
an affected engine mounting rod on any helicopter.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule, but the FAA did not receive any comments on
the NPRM or on the determination of the cost to the public.

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 of the information provided by EASA and determining the
unsafe condition exists and is likely to exist or develop on other
helicopters of the same type designs and that air safety and the public
interest require adopting the AD requirements as proposed.

Differences Between This AD and the EASA AD

    The EASA AD requires emailing a completed ``Scrap Report'' to
Leonardo Helicopters Division at the same compliance time as the engine
mounting rod removal, whereas this AD does not.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Leonardo Helicopters Alert Service Bulletin (ASB)
No. 139-593, Revision A, dated June 14, 2019 (ASB 139-593, Revision A),
which specifies procedures to replace the engine outboard and inboard
mounting rods from the Number 1 and Number 2 engines.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Leonardo Helicopters ASB No. 139-593, dated June
11, 2019. This service information contains the same procedures as ASB
139-593, Revision A. However, ASB 139-593, Revision A expands the
applicability from certain serial-numbered Model AB139 and AW139
helicopters to all Model AB139 and AW139 helicopters with affected
engine mounting rods installed.
    The FAA also reviewed Leonardo Helicopters AMP DM 39-A-71-21-05-
00A-520A-B, AMP DM 39-A-71-21-05-00A-720A-B, AMP DM 39-A-71-21-06-00A-
520A-B, AMP DM 39-A-71-21-06-00A-720A-B, AMP DM 39-A-71-21-07-00A-520A-
B, AMP DM 39-A-71-21-07-00A-720A-B, AMP DM 39-A-71-21-08-00A-520A-B,
and AMP DM 39-A-71-21-08-00A-720A-B, all dated October 4, 2019. This
service information specifies instructions for removing and installing
the outboard and inboard engine mounting rods.

Costs of Compliance

    The FAA estimates that this AD affects up to 126 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.
    Replacing an engine mounting rod requires about 8 work-hours and
parts cost about $1,000 for an estimated cost of $1,680 per engine
mounting rod.
    According to Leonardo Helicopter's service information, some of the
costs of this AD may be covered under warranty, thereby reducing the
cost impact on affected individuals. The FAA does not control warranty
coverage by Leonardo Helicopters. Accordingly, all costs are included
in this 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 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:

2021-03-07 Leonardo S.p.a.: Amendment 39-21410; Docket No. FAA-2020-
0649; Product Identifier 2019-SW-061-AD.

(a) Applicability

    This airworthiness directive (AD) applies to Leonardo S.p.a.
Model AB139 and AW139 helicopters, certificated in any category,
with an engine mounting rod part number (P/N) 3G7120V00132 with a
serial number (S/N) listed in Figures 2 or 3 of Leonardo Helicopters
Alert Service Bulletin No. 139-593, Revision A, dated June 14, 2019
(ASB 139-593), installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a non-conforming engine
mounting rod. This condition could result in structural failure of
the engine mounting rod and subsequent loss of control of the
helicopter.

(c) Effective Date

    This AD becomes effective April 1, 2021.

(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) Before further flight, determine the total hours time-in-
service (TIS) of each engine mounting rod.
    (2) Before reaching 225 total hours TIS or within 25 hours TIS,
whichever occurs later, with the battery and any other electrical
power supply disconnected, remove from service the engine mounting
rod as follows:
    (i) For the Number 1 engine outboard mounting rod, remove from
service the Number 1 engine outboard mounting rod and install an
airworthy Number 1 engine outboard mounting rod as shown in Detail
``B'' of Figure 1 of ASB 139-593 and by following the Accomplishment
Instructions, paragraphs 3.1 and 3.2 of ASB 139-593, except you are
not required to discard the Number 1 engine outboard mounting rod or
comply with the ``Scrap Report'' instruction in paragraph 3.1 of ASB
139-593.

    Note 1 to paragraphs (e)(2)(i) through (iv): Figure 1 of ASB
139-593 shows the engine outboard and inboard mounting rod
assemblies for the left-hand side only, the right-hand side is
symmetrical.

    (ii) For the Number 1 engine inboard mounting rod, remove from
service the Number 1 engine inboard mounting rod and install an
airworthy Number 1 engine inboard mounting rod as shown in Detail
``C'' of Figure 1 of ASB 139-593 and by following the Accomplishment
Instructions, paragraphs 3.3 and 3.4 of ASB 139-593, except you are
not required to discard the Number 1 engine inboard mounting rod or
comply with the ``Scrap Report'' instruction in paragraph 3.3 of ASB
139-593.
    (iii) For the Number 2 engine outboard mounting rod, remove from
service the Number 2 engine outboard mounting rod and install an
airworthy Number 2 engine outboard mounting rod as shown in Detail
``B'' of Figure 1 of ASB 139-593 and by following the Accomplishment
instructions, paragraphs 4.1 and 4.2 of ASB 139-593, except you are
not required to discard the Number 2 engine outboard mounting rod or
comply with the ``Scrap Report'' instruction in paragraph 4.1 of ASB
139-593.
    (iv) For the Number 2 engine inboard mounting rod, remove from
service the Number 2 engine inboard mounting rod and install an
airworthy Number 2 engine inboard mounting rod as shown in Detail
``C'' of Figure 1 of ASB 139-593 and by following the Accomplishment
instructions, paragraphs 4.3 and 4.4 of ASB 139-593, except you are
not required to discard the Number 2 engine inboard mounting rod or
comply with the ``Scrap Report'' instruction in paragraph 4.3 of ASB
139-593.
    (3) As of the effective date of this AD, do not install on any
helicopter an engine mounting rod with a P/N and S/N listed in
paragraph (a) of this AD.

(f) Credit for Previous Actions

    Actions accomplished before the effective date of this AD in
accordance with the procedures specified in Leonardo Helicopters
Alert Service Bulletin No. 139-593, dated June 11, 2019, are
considered acceptable for compliance with the corresponding actions
specified in paragraphs (e)(1) and (2) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, may
approve AMOCs for this AD. Send your proposal to: Kristi Bradley,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation 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.

(h) Additional Information

    (1) Leonardo Helicopters Alert Service Bulletin No. 139-593,
dated June 11, 2019, and Leonardo Helicopters AMP DM 39-A-71-21-05-
00A-520A-B, AMP DM 39-A-71-21-05-00A-720A-B, AMP DM 39-A-71-21-06-
00A-520A-B, AMP DM 39-A-71-21-06-00A-720A-B, AMP DM 39-A-71-21-07-
00A-520A-B, AMP DM 39-A-71-21-07-00A-720A-B, AMP DM 39-A-71-21-08-
00A-520A-B, and AMP DM 39-A-71-21-08-00A-720A-B, all dated October
4, 2019, which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this AD, contact Leonardo S.p.a. Helicopters, Emanuele
Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di
Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-229046;
or at https://www.leonardocompany.com/en/home. You may view a copy
of the 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 (EASA) AD No. 2019-0149, dated June 24, 2019.
You may view the EASA AD on the internet at https://www.regulations.gov in Docket No. FAA-2020-0649.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 7120, Engine Mount
Section.

(j) 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) Leonardo Helicopters Alert Service Bulletin No. 139-593,
Revision A, dated June 14, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Leonardo S.p.a. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home.
    (4) You may view this service information 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>.
    (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_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 27, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-03660 Filed 2-24-21; 8:45 am]
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