Airworthiness Directives; Dassault Aviation Airplanes, 1595-1598 [2016-31871]
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Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations
(g) Inspection of Fluid Level and Nitrogen
Pressure in HR
Within the compliance time defined in
table 1 to paragraph (g) of this AD, as
applicable, inspect the HR fluid level and
nitrogen pressure of each hydraulic circuit,
in accordance with the instructions of
paragraph 4.2.2.1 of Airbus Alert Operators
Transmission (AOT) A29L005–16, Revision
01, dated June 28, 2016. Repeat the
inspection thereafter at intervals not to
exceed 1,600 flight hours.
TABLE 1 TO PARAGRAPH (g) OF THIS
AD—INITIAL INSPECTION COMPLIANCE TIME
Compliance Time
(A or B, whichever occurs later)
A ...........
B ...........
Before accumulating 1,600 flight
hours since first flight of the airplane.
Within 1,000 flight hours or 3
months, whichever occurs first
after the effective date of this
AD.
(h) Corrective Action
If, during any inspection required by
paragraph (g) of this AD, any unacceptable
pressure or fluid level is identified, before
further flight, do the actions in paragraphs
(h)(1) and (h)(2) of this AD, as applicable, for
each unacceptable pressure or fluid level that
is discovered. Accomplishment of these
actions on an airplane does not constitute
terminating action for the repetitive
inspections as required by paragraph (g) of
this AD for that airplane.
(1) Add or remove hydraulic fluid, as
applicable, in accordance with the
instructions of paragraph 4.2.2.2 of Airbus
Alert Operators Transmission (AOT)
A29L005–16, Revision 01, dated June 28,
2016.
(2) Add or remove nitrogen gas, as
applicable, in accordance with the
instructions of paragraph 4.2.2.2 of Airbus
AOT A29L005–16, Revision 01, dated June
28, 2016.
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(i) Servicing Hydraulic Reservoir
Concurrent with the initial inspection
specified in paragraph (g) of this AD, revise
the maintenance or inspection program, as
applicable, to incorporate the hydraulic
reservoir servicing actions specified in
paragraph 4.2.2.2 of Airbus AOT A29L005–
16, Revision 01, dated June 28, 2016.
(j) No Alternative Actions and Intervals
After accomplishing the revision required
by paragraph (i) of this AD, no alternative
actions (e.g., inspections) and intervals may
be used unless the actions and intervals are
approved as an alternative method of
compliance (AMOC) in accordance with the
procedures specified in paragraph (l)(1) of
this AD.
(k) Credit for Previous Actions
This paragraph provides credit for actions
required by paragraphs (g) and (h) of this AD,
if those actions were performed before the
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effective date of this AD using Airbus
AOTA29L005–16, dated January 28, 2016.
(l) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, 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 Branch, send it to ATTN:
Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1138; fax 425–227–1149.
Information may be emailed to: 9–ANM–116–
AMOC–REQUESTS@faa.gov. 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.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
the European Aviation Safety Agency
(EASA); or Airbus’s EASA Design
Organization Approval (DOA). If approved by
the DOA, the approval must include the
DOA-authorized signature.
(m) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA AD
2016–0107, dated June 7, 2016, for related
information. This MCAI may be found in the
AD docket on the Internet at https://
www.regulations.gov by searching for and
locating Docket No. FAA–2016–9117.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (n)(3) and (n)(4) of this AD.
(n) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) Airbus Alert Operators Transmission
(AOT) A29L005–16, Revision 01, dated June
28, 2016.
(ii) Reserved.
(3) For service information identified in
this AD, contact Airbus SAS, Airworthiness
Office—EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone: +33
5 61 93 36 96; fax: +33 5 61 93 45 80; email:
airworthiness.A330–A340@airbus.com;
Internet: https://www.airbus.com.
(4) You may view this service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
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1595
information on the availability of this
material at the FAA, call 425–227–1221.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on
December 23, 2016.
Thomas Groves,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2016–31868 Filed 1–5–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2016–7420; Directorate
Identifier 2015–NM–017–AD; Amendment
39–18774; AD 2017–01–07]
RIN 2120–AA64
Airworthiness Directives; Dassault
Aviation Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
We are adopting a new
airworthiness directive (AD) for all
Dassault Aviation Model FAN JET
FALCON airplanes; Model FAN JET
FALCON SERIES C, D, E, F, and G
airplanes; Model MYSTERE-FALCON
200 airplanes; Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20–
F5 airplanes; and MYSTERE-FALCON
50 airplanes. This AD was prompted by
a report that, during approach for
landing, the main entry door detached
from an airplane. This AD requires a
functional test or check of the main
entry door closure and warning system,
and applicable door closing inspections,
adjustments, operational tests, and
corrective actions if necessary. We are
issuing this AD to address the unsafe
condition on these products.
DATES: This AD is effective February 10,
2017.
The Director of the Federal Register
approved the incorporation by reference
of certain publications listed in this AD
as of February 10, 2017.
ADDRESSES: For service information
identified in this final rule, contact
Dassault Falcon Jet Corporation,
Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone 201–
440–6700; Internet https://
SUMMARY:
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www.dassaultfalcon.com. You may
view this referenced service information
at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the
availability of this material at the FAA,
call 425 227–1221. It is also available on
the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2016–
7420.
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–2016–
7420; or in person at the Docket
Management Facility between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this AD, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Office (telephone 800–647–
5527) is Docket Management Facility,
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: Tom
Rodriguez, Aerospace Engineer,
International Branch, ANM–116,
Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA
98057–3356; telephone 425–227–1137;
fax 425–227–1149.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would
apply to all Dassault Aviation Model
FAN JET FALCON airplanes; Model
FAN JET FALCON SERIES C, D, E, F,
and G airplanes; Model MYSTEREFALCON 200 airplanes; Model
MYSTERE-FALCON 20–C5, 20–D5, 20–
E5, and 20–F5 airplanes; and
MYSTERE–FALCON 50 airplanes. The
NPRM published in the Federal
Register on July 1, 2016 (81 FR 43120).
The European Aviation Safety Agency
(EASA), which is the Technical Agent
for the Member States of the European
Union, has issued EASA Airworthiness
Directive 2015–0007, dated January 15,
2015 (referred to after this as the
Mandatory Continuing Airworthiness
Information, or ‘‘the MCAI’’), to correct
an unsafe condition for all Dassault
Aviation Model FAN JET FALCON
airplanes; Model FAN JET FALCON
SERIES C, D, E, F, and G airplanes;
Model MYSTERE-FALCON 200
airplanes; Model MYSTERE-FALCON
20–C5, 20–D5, 20–E5, and 20–F5
airplanes; and MYSTERE-FALCON 50
airplanes. The MCAI states:
`
During approach for landing, a MystereFalcon 20–X5 lost the main entrance door
[MED] at an altitude of 7,000 feet. The flight
crew maintained control of the aeroplane to
land uneventfully. The results of the
preliminary technical investigations
concluded that the cause of this event could
be either a broken cable, or an unlocked
safety catch, associated with one or two
deficient micro switches.
This condition, if not detected and
corrected, could lead to in-flight opening
and/or detachment of the Crew/Passenger
door, possibly resulting in loss of control of
the aeroplane, and/or injury to persons on
the ground.
To address this potential unsafe condition,
Dassault Aviation issued Service Bulletins
(SB) F20–789, F200–133 and MF50–531,
providing instructions for inspection/
adjustment, as well as an operational test of
the Crew/Passenger door closure.
For the reasons described above, this
[EASA] AD requires a one-time
accomplishment of a functional test/check of
the MED closure/warning system. It also
requires [a general visual] inspection and
operational test of the Crew/Passenger door
[including the control and latching
mechanisms] and, depending on findings,
applicable corrective actions.
Corrective actions include adjusting
the telescopic rod bolts on the door
until the clearance between the lower
part of the door and the fuselage is
within the specified tolerances. The
corrective actions for the control and
latching mechanisms include adjusting
components and replacing damaged
components (including pull latches,
microswitches, pulleys, and cables).
Signs of damage include cracks,
corrosion, wear, and distortion. You
may examine the MCAI in the AD
docket on the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2016–
7420.
Comments
We gave the public the opportunity to
participate in developing this AD. We
received no comments on the NPRM or
on the determination of the cost to the
public.
Conclusion
We reviewed the relevant data and
determined that air safety and the
public interest require adopting this AD
as proposed except for minor editorial
changes. We have determined that these
minor changes:
• Are consistent with the intent that
was proposed in the NPRM for
correcting the unsafe condition; and
• Do not add any additional burden
upon the public than was already
proposed in the NPRM.
Related Service Information Under 1
CFR Part 51
Dassault Aviation issued the
following service information.
• Dassault Service Bulletin F20–789,
also referred to as 789, dated December
9, 2014.
• Dassault Service Bulletin F50–531,
also referred to as 531, dated December
9, 2014.
• Dassault Service Bulletin F200–133,
also referred to as 133, dated December
9, 2014.
The service information describes
procedures for inspections, adjustments,
and operational tests of certain doors
and corrective actions. These
documents are distinct since they apply
to different airplane models. 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.
Costs of Compliance
We estimate that this AD affects 392
airplanes of U.S. registry.
We estimate the following costs to
comply with this AD:
ESTIMATED COSTS
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Action
Labor cost
4 work-hours × $85 per hour = $340 .............
Inspections/adjustments/operational tests.
We have received no definitive data
that will enable us to provide cost
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estimates for the on-condition actions
specified in this AD.
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Cost per
product
Parts cost
$0
Cost on U.S.
operators
$340
$133,280
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
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rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs,’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in ‘‘Subtitle VII,
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We determined that this AD will not
have federalism implications under
Executive Order 13132. This AD will
not have a substantial direct effect on
the States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in
Alaska; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
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■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
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2017–01–07 Dassault Aviation:
Amendment 39–18774; Docket No.
FAA–2016–7420; Directorate Identifier
2015–NM–017–AD.
1597
(h) Main Entry/Passenger/Crew Door Closing
Inspections, Adjustments, and Operational
Tests and Corrective Actions
Air Transport Association (ATA) of
America Code 52, Doors.
Within 330 flight hours or 13 months,
whichever occurs first after the effective date
of this AD, unless already done: Do the
applicable door closing inspections,
adjustments, and operational tests, and do all
applicable corrective actions, in accordance
with the Accomplishment Instructions of the
applicable service information identified in
paragraph (h)(1), (h)(2), or (h)(3) of this AD.
Do all applicable corrective actions before
further flight.
(1) For Model FAN JET FALCON airplanes;
Model FAN JET FALCON SERIES C, D, E, F,
and G airplanes; and Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20–F5
airplanes: Dassault Service Bulletin F20–789,
also referred to as 789, dated December 9,
2014.
(2) For Model MYSTERE-FALCON 200
airplanes: Dassault Service Bulletin F200–
133, also referred to as 133, dated December
9, 2014.
(3) For Model MYSTERE-FALCON 50
airplanes: Dassault Service Bulletin F50–531,
also referred to as 531, dated December 9,
2014.
(e) Reason
(i) Other FAA AD Provisions
This AD was prompted by a report that,
during approach for landing, the main entry
door detached from an airplane. We are
issuing this AD to detect and correct
defective crew/passenger doors. Such a
condition could result in the in-flight
opening or detachment of the crew/passenger
door, which could result in loss of control of
the airplane and injury to persons on the
ground.
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, 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 Branch, send it to ATTN:
Tom Rodriguez, Aerospace Engineer,
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1137; fax 425–227–1149.
Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. 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.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
the EASA; or Dassault Aviation’s EASA
DOA. If approved by the DOA, the approval
must include the DOA-authorized signature.
(a) Effective Date
This AD is effective February 10, 2017.
(b) Affected ADs
None.
(c) Applicability
This AD applies to the Dassault Aviation
airplanes, certificated in any category,
identified in paragraphs (c)(1) through (c)(5)
of this AD, all airplanes.
(1) Model FAN JET FALCON airplanes.
(2) Model FAN JET FALCON SERIES C, D,
E, F, and G airplanes.
(3) Model MYSTERE–FALCON 200
airplanes.
(4) Model MYSTERE–FALCON 20–C5, 20–
D5, 20–E5, and 20–F5 airplanes.
(5) Model MYSTERE–FALCON 50
airplanes.
(d) Subject
(f) Compliance
Comply with this AD within the
compliance times specified.
(g) Main Entry/Passenger/Crew Door Check
or Functional Test
Within 65 days after the effective date of
this AD, unless done within 6 months before
the effective date of this AD, do the
applicable functional test or door lock check
specified in paragraph (g)(1), (g)(2), or (g)(3)
of this AD, and do all applicable corrective
actions, using a method approved by the
Manager, International Branch, ANM–116,
Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or
Dassault Aviation’s EASA Design
Organization Approval (DOA). Do all
applicable corrective actions before further
flight.
(1) For Model FAN JET FALCON airplanes;
Model FAN JET FALCON SERIES C, D, E, F,
and G airplanes; and Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20–F5
airplanes: A functional test of the passenger/
crew door warning system.
(2) For Model MYSTERE-FALCON 200
airplanes: A check of the door locking
indicator system.
(3) For Model MYSTERE-FALCON 50
airplanes: A check of the door lock
indication.
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(j) Related Information
Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2015–0007, dated
January 15, 2015, for related information.
This MCAI may be found in the AD docket
on the Internet at https://www.regulations.gov
by searching for and locating Docket No.
FAA–2016–7420.
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(k) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) Dassault Service Bulletin F20–789, also
referred to as 789, dated December 9, 2014.
(ii) Dassault Service Bulletin F50–531, also
referred to as 531, dated December 9, 2014.
(iii) Dassault Service Bulletin F200–133,
also referred to as 133, dated December 9,
2014.
(3) For service information identified in
this AD, contact Dassault Falcon Jet
Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606;
telephone 201–440–6700; Internet https://
www.dassaultfalcon.com.
(4) You may view this service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on
December 23, 2016.
Thomas Groves,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2016–31871 Filed 1–5–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA–2014–N–0297]
Obstetrical and Gynecological
Devices; Reclassification of Surgical
Instrumentation for Use With
Urogynecologic Surgical Mesh
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or the Agency) is
reclassifying surgical instrumentation
for use with urogynecologic surgical
mesh from class I (general controls)
exempt from premarket notification to
class II (special controls) and subject to
premarket notification, and identifying
them as ‘‘specialized surgical
instrumentation for use with
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SUMMARY:
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urogynecologic surgical mesh.’’ FDA is
designating special controls that are
necessary to provide a reasonable
assurance of safety and effectiveness of
the device. FDA is reclassifying this
device on its own initiative based on
new information.
DATES: This order is effective January 6,
2017. See further discussion in section
V, ‘‘Implementation Strategy.’’
FOR FURTHER INFORMATION CONTACT:
Sharon Andrews, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. G110,
Silver Spring, MD 20993, 301–796–
6529, Sharon.Andrews@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et
seq.), as amended, established a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Devices that were in commercial
distribution before the enactment of the
1976 amendments on May 28, 1976, are
generally referred to as preamendments
devices. Under section 513(d) of the
FD&C Act, preamendments devices are
classified after FDA has: (1) Received a
recommendation from a device
classification panel (an FDA advisory
committee); (2) published the panel’s
recommendation for comment, along
with a proposed regulation classifying
the device; and (3) published a final
regulation classifying the device. FDA
has classified most preamendments
devices under these procedures.
Devices that were not in commercial
distribution prior to May 28, 1976, are
generally referred to as postamendments
devices. Postamendments devices are
automatically classified into class III
without any FDA rulemaking process
(section 513(f) of the FD&C Act).
Postamendments devices remain in
class III and require premarket approval
unless, and until, the device is
reclassified into class I or II or FDA
issues an order finding the device to be
substantially equivalent, under section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
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procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and 21 CFR
part 807.
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144) was
enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C
Act, changing the mechanism for
reclassifying a device from rulemaking
to an administrative order.
Section 513(e) of the FD&C Act
provides that FDA may, by
administrative order, reclassify a device
based upon ‘‘new information.’’ FDA
can initiate a reclassification under
section 513(e) of the FD&C Act or an
interested person may petition FDA to
reclassify a device. The term ‘‘new
information,’’ as used in section 513(e)
of the FD&C Act, includes information
developed as a result of a reevaluation
of the data before the Agency when the
device was originally classified, as well
as information not presented, not
available, or not developed at that time.
(See, e.g., Holland-Rantos Co. v. United
States Department of Health, Education,
and Welfare, 587 F.2d 1173, 1174 n.1
(D.C. Cir. 1978); Upjohn v. Finch, 422
F.2d 944 (6th Cir. 1970); Bell v.
Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously
before the Agency is an appropriate
basis for subsequent action where the
reevaluation is made in light of newly
available authority (see Bell, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F.Supp.
382, 388–391 (D.D.C. 1991)), or in light
of changes in ‘‘medical science’’
(Upjohn, 422 F.2d at 951). Whether data
before the Agency are old or new data,
the ‘‘new information’’ to support
reclassification under section 513(e)
must be ‘‘valid scientific evidence,’’ as
defined in section 513(a)(3) of the FD&C
Act and § 860.7(c)(2) (21 CFR
860.7(c)(2)). (See, e.g., Gen. Medical Co.
v. FDA, 770 F.2d 214 (D.C. Cir. 1985);
Contact Lens Mfrs. Assoc. v. FDA, 766
F.2d 592 (D.C. Cir. 1985), cert. denied,
474 U.S. 1062 (1986).) To be considered
in the reclassification process, the
‘‘valid scientific evidence’’ upon which
the Agency relies must be publicly
available. Publicly available information
excludes trade secret and/or
confidential commercial information,
e.g., the contents of a pending premarket
approval application (PMA). (See
section 520(c) of the FD&C Act (21
U.S.C. 360j(c)).)
The process for issuing a final
reclassification order is specified in
section 513(e)(1) of the FD&C Act. Prior
to the issuance of a final order
reclassifying a device, the following
must occur: (1) Publication of a
proposed order in the Federal Register;
E:\FR\FM\06JAR1.SGM
06JAR1
Agencies
[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Rules and Regulations]
[Pages 1595-1598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31871]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2016-7420; Directorate Identifier 2015-NM-017-AD;
Amendment 39-18774; AD 2017-01-07]
RIN 2120-AA64
Airworthiness Directives; Dassault Aviation Airplanes
AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are adopting a new airworthiness directive (AD) for all
Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON
SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes;
Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes; and
MYSTERE-FALCON 50 airplanes. This AD was prompted by a report that,
during approach for landing, the main entry door detached from an
airplane. This AD requires a functional test or check of the main entry
door closure and warning system, and applicable door closing
inspections, adjustments, operational tests, and corrective actions if
necessary. We are issuing this AD to address the unsafe condition on
these products.
DATES: This AD is effective February 10, 2017.
The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 10,
2017.
ADDRESSES: For service information identified in this final rule,
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606; telephone 201-440-6700; Internet
https://
[[Page 1596]]
www.dassaultfalcon.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call 425 227-1221. It is also available on the
Internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2016-7420.
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-2016-
7420; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, 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: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137;
fax 425-227-1149.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Dassault Aviation Model
FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G
airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTERE-FALCON 20-
C5, 20-D5, 20-E5, and 20-F5 airplanes; and MYSTERE-FALCON 50 airplanes.
The NPRM published in the Federal Register on July 1, 2016 (81 FR
43120).
The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0007, dated January 15, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Dassault Aviation
Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F,
and G airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTERE-
FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes; and MYSTERE-FALCON 50
airplanes. The MCAI states:
During approach for landing, a Myst[egrave]re-Falcon 20-X5 lost
the main entrance door [MED] at an altitude of 7,000 feet. The
flight crew maintained control of the aeroplane to land
uneventfully. The results of the preliminary technical
investigations concluded that the cause of this event could be
either a broken cable, or an unlocked safety catch, associated with
one or two deficient micro switches.
This condition, if not detected and corrected, could lead to in-
flight opening and/or detachment of the Crew/Passenger door,
possibly resulting in loss of control of the aeroplane, and/or
injury to persons on the ground.
To address this potential unsafe condition, Dassault Aviation
issued Service Bulletins (SB) F20-789, F200-133 and MF50-531,
providing instructions for inspection/adjustment, as well as an
operational test of the Crew/Passenger door closure.
For the reasons described above, this [EASA] AD requires a one-
time accomplishment of a functional test/check of the MED closure/
warning system. It also requires [a general visual] inspection and
operational test of the Crew/Passenger door [including the control
and latching mechanisms] and, depending on findings, applicable
corrective actions.
Corrective actions include adjusting the telescopic rod bolts on
the door until the clearance between the lower part of the door and the
fuselage is within the specified tolerances. The corrective actions for
the control and latching mechanisms include adjusting components and
replacing damaged components (including pull latches, microswitches,
pulleys, and cables). Signs of damage include cracks, corrosion, wear,
and distortion. You may examine the MCAI in the AD docket on the
Internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2016-7420.
Comments
We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.
Conclusion
We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
Do not add any additional burden upon the public than was
already proposed in the NPRM.
Related Service Information Under 1 CFR Part 51
Dassault Aviation issued the following service information.
Dassault Service Bulletin F20-789, also referred to as
789, dated December 9, 2014.
Dassault Service Bulletin F50-531, also referred to as
531, dated December 9, 2014.
Dassault Service Bulletin F200-133, also referred to as
133, dated December 9, 2014.
The service information describes procedures for inspections,
adjustments, and operational tests of certain doors and corrective
actions. These documents are distinct since they apply to different
airplane models. 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.
Costs of Compliance
We estimate that this AD affects 392 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
Estimated Costs
----------------------------------------------------------------------------------------------------------------
Cost per Cost on U.S.
Action Labor cost Parts cost product operators
----------------------------------------------------------------------------------------------------------------
Inspections/adjustments/operational 4 work-hours x $85 per $0 $340 $133,280
tests. hour = $340.
----------------------------------------------------------------------------------------------------------------
We have received no definitive data that will enable us to provide
cost estimates for the on-condition actions specified in this AD.
Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to
issue
[[Page 1597]]
rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
Regulatory Findings
We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a ``significant regulatory action'' under Executive Order
12866;
2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:
PART 39--AIRWORTHINESS DIRECTIVES
0
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
0
2. The FAA amends Sec. 39.13 by adding the following new airworthiness
directive (AD):
2017-01-07 Dassault Aviation: Amendment 39-18774; Docket No. FAA-
2016-7420; Directorate Identifier 2015-NM-017-AD.
(a) Effective Date
This AD is effective February 10, 2017.
(b) Affected ADs
None.
(c) Applicability
This AD applies to the Dassault Aviation airplanes, certificated
in any category, identified in paragraphs (c)(1) through (c)(5) of
this AD, all airplanes.
(1) Model FAN JET FALCON airplanes.
(2) Model FAN JET FALCON SERIES C, D, E, F, and G airplanes.
(3) Model MYSTERE-FALCON 200 airplanes.
(4) Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5
airplanes.
(5) Model MYSTERE-FALCON 50 airplanes.
(d) Subject
Air Transport Association (ATA) of America Code 52, Doors.
(e) Reason
This AD was prompted by a report that, during approach for
landing, the main entry door detached from an airplane. We are
issuing this AD to detect and correct defective crew/passenger
doors. Such a condition could result in the in-flight opening or
detachment of the crew/passenger door, which could result in loss of
control of the airplane and injury to persons on the ground.
(f) Compliance
Comply with this AD within the compliance times specified.
(g) Main Entry/Passenger/Crew Door Check or Functional Test
Within 65 days after the effective date of this AD, unless done
within 6 months before the effective date of this AD, do the
applicable functional test or door lock check specified in paragraph
(g)(1), (g)(2), or (g)(3) of this AD, and do all applicable
corrective actions, using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA); or Dassault
Aviation's EASA Design Organization Approval (DOA). Do all
applicable corrective actions before further flight.
(1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON
SERIES C, D, E, F, and G airplanes; and Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes: A functional test of the
passenger/crew door warning system.
(2) For Model MYSTERE-FALCON 200 airplanes: A check of the door
locking indicator system.
(3) For Model MYSTERE-FALCON 50 airplanes: A check of the door
lock indication.
(h) Main Entry/Passenger/Crew Door Closing Inspections, Adjustments,
and Operational Tests and Corrective Actions
Within 330 flight hours or 13 months, whichever occurs first
after the effective date of this AD, unless already done: Do the
applicable door closing inspections, adjustments, and operational
tests, and do all applicable corrective actions, in accordance with
the Accomplishment Instructions of the applicable service
information identified in paragraph (h)(1), (h)(2), or (h)(3) of
this AD. Do all applicable corrective actions before further flight.
(1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON
SERIES C, D, E, F, and G airplanes; and Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes: Dassault Service Bulletin F20-
789, also referred to as 789, dated December 9, 2014.
(2) For Model MYSTERE-FALCON 200 airplanes: Dassault Service
Bulletin F200-133, also referred to as 133, dated December 9, 2014.
(3) For Model MYSTERE-FALCON 50 airplanes: Dassault Service
Bulletin F50-531, also referred to as 531, dated December 9, 2014.
(i) Other FAA AD Provisions
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone 425-227-1137; fax 425-227-1149. Information
may be emailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. 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.
(2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Dassault Aviation's EASA DOA. If approved by the DOA, the
approval must include the DOA-authorized signature.
(j) Related Information
Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Airworthiness Directive 2015-0007, dated January 15, 2015, for
related information. This MCAI may be found in the AD docket on the
Internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2016-7420.
[[Page 1598]]
(k) Material Incorporated by Reference
(1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
(i) Dassault Service Bulletin F20-789, also referred to as 789,
dated December 9, 2014.
(ii) Dassault Service Bulletin F50-531, also referred to as 531,
dated December 9, 2014.
(iii) Dassault Service Bulletin F200-133, also referred to as
133, dated December 9, 2014.
(3) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone 201-440-6700; Internet https://www.dassaultfalcon.com.
(4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
(5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
Issued in Renton, Washington, on December 23, 2016.
Thomas Groves,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-31871 Filed 1-5-17; 8:45 am]
BILLING CODE 4910-13-P