Airworthiness Directives; B-N Group Ltd. Airplanes, 8143-8146 [2016-03307]
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations
compliance time after the effective date of
this AD.
(2) Where Boeing Alert Service Bulletin
747–53A2499, Revision 3, dated July 15,
2014, specifies to contact Boeing for repair
instructions: Before further flight, repair
using a method approved in accordance with
the procedures specified in paragraph (l) of
this AD.
(k) Credit for Previous Actions
Actions done before the effective date of
this AD using the service information
identified in paragraph (k)(1) or (k)(2) of this
AD are acceptable for compliance with the
corresponding requirements of paragraphs (g)
and (h) of this AD.
(1) Boeing Alert Service Bulletin 747–
53A2499, Revision 1, dated October 30, 2008,
which is not incorporated by reference in this
AD.
(2) Boeing Alert Service Bulletin 747–
53A2499, Revision 2, dated August 12, 2010,
which was incorporated by reference in AD
2010–26–10, Amendment 39–16549 (75 FR
81427, December 28, 2010).
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(l) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in
paragraph (m)(1) of this AD. Information may
be emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by the Boeing
Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Seattle
ACO, to make those findings. To be
approved, the repair method, modification
deviation, or alteration deviation must meet
the certification basis of the airplane and the
approval must specifically refer to this AD.
(4) AMOCs approved for AD 2010–26–10,
Amendment 39–16549 (75 FR 81427,
December 28, 2010), are approved as AMOCs
for the corresponding provisions of
paragraphs (g) and (h) this AD.
(m) Related Information
(1) For more information about this AD,
contact Nathan Weigand, Aerospace
Engineer, Airframe Branch, ANM–120S,
FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, WA 98057–
3356; phone: 425–917–6428; fax: 425–917–
6590; email: nathan.p.weigand@faa.gov.
(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.
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(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 the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 747–
53A2499, Revision 3, dated July 15, 2014.
(ii) Reserved.
(3) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H–65,
Seattle, WA 98124–2207; telephone 206–
544–5000, extension 1; fax 206–766–5680;
Internet https://www.myboeingfleet.com.
(4) You may view this service information
at 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 February
7, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2016–03219 Filed 2–17–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2015–4803; Directorate
Identifier 2015–CE–034–AD; Amendment
39–18399; AD 2016–04–05]
RIN 2120–AA64
Airworthiness Directives; B–N Group
Ltd. Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
AGENCY:
We are superseding an
airworthiness directive (AD) 2014–03–
18 for B–N Group Ltd. Models BN–2,
BN–2A, BN–2A–2, BN–2A–3, BN–2A–6,
BN–2A–8, BN–2A–9, BN–2A–20, BN–
2A–21, BN–2A–26, BN–2A–27, BN–2B–
20, BN–2B–21, BN–2B–26, BN–2B–27,
BN2A MK. III, BN2A MK. III–2, and
BN2A MK. III–3 airplanes. This AD
results from mandatory continuing
airworthiness information (MCAI)
issued by an aviation authority of
SUMMARY:
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8143
another country to identify and correct
an unsafe condition on an aviation
product. The MCAI describes the unsafe
condition as damage of the cable sliding
end assembly and installation of the
incorrect end fitting on engine control
cable assemblies. We are issuing this AD
to require actions to address the unsafe
condition on these products.
DATES: This AD is effective March 24,
2016.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in the AD
as of March 24, 2016.
The Director of the Federal Register
approved the incorporation by reference
of a certain other publication listed in
this AD as of April 1, 2014 (79 FR
10340, February 25, 2014).
ADDRESSES: You may examine the AD
docket on the Internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2015–
4803; or in person at the 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 service information identified in
this final rule, contact Britten-Norman
Aircraft Limited, Commodore House,
Mountbatten Business Centre, Millbrook
Road East, Southampton SO15 1HY,
United Kingdom; telephone: +44 20
3371 4000; fax: +44 20 3371 4001;
email: info@bnaircraft.com; Internet:
https://www.britten-norman.com/
customer-support/. You may view this
referenced service information at the
FAA, Small Airplane Directorate, 901
Locust, Kansas City, Missouri 64106.
For information on the availability of
this material at the FAA, call (816) 329–
4148. It is also available on the Internet
at https://www.regulations.gov by
searching for Docket No. FAA–2015–
4803.
FOR FURTHER INFORMATION CONTACT:
Raymond Johnston, Aerospace Engineer,
FAA, Small Airplane Directorate, 901
Locust, Room 301, Kansas City,
Missouri 64106; telephone: (816) 329–
4159; fax: (816) 329–3047; email:
raymond.johnston@faa.gov.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would
apply to B–N Group Ltd. Models BN–2,
BN–2A, BN–2A–2, BN–2A–3, BN–2A–6,
BN–2A–8, BN–2A–9, BN–2A–20, BN–
2A–21, BN–2A–26, BN–2A–27, BN–2B–
20, BN–2B–21, BN–2B–26, BN–2B–27,
BN2A MK. III, BN2A MK. III–2, and
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations
BN2A MK. III–3 airplanes. The NPRM
was published in the Federal Register
on October 29, 2015 (80 FR 66482), and
proposed to supersede AD 2014–03–18,
Amendment 39–17755 (79 FR 10340;
February 25, 2014).
The NPRM proposed to correct an
unsafe condition for the specified
products and was based on mandatory
continuing airworthiness information
(MCAI) originated by an aviation
authority of another country. The MCAI
states that:
Britten-Norman Aircraft Limited was made
aware of two occurrences where a failure of
engine control cable assemblies has caused
engine control difficulties. In both reported
cases, the cable sliding end assemblies were
in poor condition and in both cases, an
incorrect end-fitting was installed, which
may have contributed to the failures.
This condition, if not detected and
corrected, could result in reduced engine
control, possibly resulting in reduced control
of the aeroplane.
To address this potential unsafe condition,
Britten-Norman Aircraft issued Service
Bulletin (SB) 334 to provide inspection
instructions, and EASA issued AD 2013–
0215 to require a one-time inspection and
functional test of the engine control cables
and, depending on findings, replacement of
the cables.
Subsequently, as it was found that BN2
‘‘Islander’’ aeroplanes were mistakenly
omitted from the AD applicability, EASA
issued AD 2013–0263, retaining the
requirements of EASA AD 2013–0215, which
was superseded, and extending the
applicability to BN2 aeroplanes.
Since EASA AD 2013–0263 was issued, it
was found that certain parts, specific to
BN2A ‘‘Trislander’’ aeroplanes only, were
inadvertently not included in SB 334 and, as
a consequence, not required by AD 2013–
0263 to be inspected.
Prompted by these findings, BrittenNorman revised SB 334 (now at issue 2) to
include the missing parts.
For the reason described above, this AD
retains the requirements of EASA AD 2013–
0263, which is superseded, and adds
inspection requirements for the additional
parts.
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The MCAI can be found in the AD
docket on the Internet at: https://
www.regulations.gov/
#!documentDetail;D=FAA-2015-48030001.
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 the AD
as proposed except for minor editorial
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14:29 Feb 17, 2016
Jkt 238001
changes. We have determined that these
minor changes:
• Are consistent with the intent that
was proposed in the NPRM (80 FR
66482, October 29, 2015) for correcting
the unsafe condition; and
• Do not add any additional burden
upon the public than was already
proposed in the NPRM (80 FR 66482,
October 29, 2015).
Related Service Information Under 1
CFR Part 51
We reviewed Britten-Norman Aircraft
Limited Service Bulletin No. SB 334,
Issue 1, dated August 30, 2013; and
Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 2, dated July
17, 2015. The service information
describes procedures for inspection and
replacement if necessary of the engine
control cable assemblies. This service
information is reasonably available
because the interested parties have
access to it through their normal course
of business or by the means identified
in the ADDRESSES section of this final
rule.
Costs of Compliance
We estimate that this AD will affect
96 products of U.S. registry. We also
estimate that it would take about 1
work-hour per product to comply with
the basic requirements of this proposed
AD. The average labor rate is $85 per
work-hour.
Based on these figures, we estimate
the cost of this AD on U.S. operators to
be $8,160 or $85 per product.
In addition, we estimate that any
necessary follow-on actions would take
about 10 work-hours and require parts
costing $6,000, for a cost of $6,850 per
product. We have no way of
determining the number of products
that may need these actions.
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs,’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in ‘‘Subtitle VII,
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
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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 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.
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–2015–
4803; 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 the NPRM, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Office (telephone (800) 647–
5527) is in the ADDRESSES section.
Comments will be available in the AD
docket shortly after receipt.
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:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by
removing Amendment 39–17755 (79 FR
10340; February 25, 2014) and adding
the following new AD:
■
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations
2016–04–05 B–N Group Ltd.: Amendment
39–18399; Docket No. FAA–2015–4803;
Directorate Identifier 2015–CE–034–AD.
(a) Effective Date
This airworthiness directive (AD) becomes
effective March 24, 2016.
(b) Affected ADs
This AD supersedes AD 2014–03–18,
Amendment 39–17755 (79 FR 10340;
February 25, 2014) (‘‘AD 2014–03–18’’).
(c) Applicability
This AD applies to B–N Group Ltd. Models
BN–2, BN–2A, BN–2A–2, BN–2A–3, BN–2A–
6, BN–2A–8, BN–2A–9, BN–2A–20, BN–2A–
21, BN–2A–26, BN–2A–27, BN–2B–20, BN–
2B–21, BN–2B–26, BN–2B–27, BN2A MK. III,
BN2A MK. III–2, and BN2A MK. III–3
airplanes, all serial numbers, certificated in
any category.
(d) Subject
Air Transport Association of America
(ATA) Code 76: Engine Controls.
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(e) Reason
This AD was prompted by mandatory
continuing airworthiness information (MCAI)
originated by an aviation authority of another
country to identify and correct an unsafe
condition on an aviation product. The MCAI
describes the unsafe condition as possible
damage of the cable sliding end assembly and
installation of the incorrect end fitting on
engine control cable assemblies. We are
issuing this proposed AD to detect and
correct damage of the cable sliding end
assembly (cracking, distortion, corrosion) and
incorrect end fittings on the engine control
assemblies, which could lead to reduced
engine control with consequent loss of
control, and to incorporate revised service
information with updated information on
applicability and on the identity of parts to
be inspected on some airplanes.
(f) Actions and Compliance
Unless already done, do the actions in
paragraphs (f)(1) through (f)(6) of this AD:
(1) For all airplanes except the Trislander
Models BN2A MK. III, BN2A MK. III–2, and
BN2A MK. III–3: Within the next 6 months
after April 1, 2014 (the effective date retained
from AD 2014–03–18), do a one-time
inspection of the engine control cable
assemblies, part number (P/N) 137835, P/N
172449–1, P/N 172450, and P/N 172451, and
surrounding areas for damage (cracking,
distortion, corrosion); for the correct cable
end-fitting; and to assure the wire locking is
intact following Britten-Norman Aircraft
Limited Service Bulletin No. SB 334, Issue 1,
dated August 30, 2013; or Britten-Norman
Aircraft Limited Service Bulletin No. SB 334,
Issue 2, dated July 17, 2015.
(2) For the Trislander Models BN2A MK.
III, BN2A MK. III–2, and BN2A MK. III–3
airplanes: Within the next 3 months after
March 24, 2016 (the effective date of this
AD), do a one-time inspection of the engine
control cable assemblies, P/N 80468 and
P/N NB–45–2883, and surrounding areas for
damage (cracking, distortion, corrosion); for
the correct cable end-fitting; and to assure the
wire locking is intact following Britten-
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14:29 Feb 17, 2016
Jkt 238001
Norman Aircraft Limited Service Bulletin No.
SB 334, Issue 2, dated July 17, 2015.
(3) For all airplanes except the Trislander
Models BN2A MK. III, BN2A MK. III–2, and
BN2A MK. III–3: If no discrepancies are
found during the inspection required in
paragraph (f)(1) of this AD, before further
flight, inspect the control linkages for proper
adjustment and make any necessary changes
following Britten-Norman Aircraft Limited
Service Bulletin No. SB 334, Issue 1, dated
August 30, 2013; or Britten-Norman Aircraft
Limited Service Bulletin No. SB 334, Issue 2,
dated July 17, 2015.
(4) For the Trislander Models BN2A MK.
III, BN2A MK. III–2, and BN2A MK. III–3
airplanes: If no discrepancies are found
during the inspection required in paragraph
(f)(2) of this AD, before further flight, inspect
the control linkages for proper adjustment
and make any necessary changes following
Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 2, dated July 17,
2015.
(5) For all airplanes except the Trislander
Models BN2A MK. III, BN2A MK. III–2, and
BN2A MK. III–3: If any discrepancies are
found during the inspection required in
paragraph (f)(1) of this AD and/or the control
linkages cannot be properly adjusted as
specified in paragraph (f)(3) of this AD,
before further flight, replace the engine
control cable assembly with a serviceable
unit following Britten-Norman Aircraft
Limited Service Bulletin No. SB 334, Issue 1,
dated August 30, 2013; or Britten-Norman
Aircraft Limited Service Bulletin No. SB 334,
Issue 2, dated July 17, 2015.
(6) For the Trislander Models BN2A MK.
III, BN2A MK. III–2, and BN2A MK. III–3
airplanes: If any discrepancies are found
during the inspection required in paragraph
(f)(2) of this AD and/or the control linkages
cannot be properly adjusted as specified in
paragraph (f)(4) of this AD, before further
flight, replace the engine control cable
assembly with a serviceable unit following
Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 2, dated July 17,
2015.
(7) For all airplanes except the Trislander
Models BN2A MK. III, BN2A MK. III–2, and
BN2A MK. III–3: After April 1, 2014 (the
effective date retained from AD 2014–03–18),
do not install on any airplane engine control
cable assemblies, P/N 137835, P/N 172449–
1, P/N 172450, and P/N 172451, unless they
are new or have been inspected as required
in paragraphs (f)(1) and (f)(3) of this AD and
found free of any discrepancies and have
proper adjustment.
(8) For the Trislander Models BN2A MK.
III, BN2A MK. III–2, and BN2A MK. III–3
airplanes: After March 24, 2016 (the effective
date of this AD), do not install on any
airplane engine control cable assemblies P/N
80468 and/or P/N NB–45–2883, unless they
are new or have been inspected as required
in paragraphs (f)(2) and (f)(4) of this AD and
found free of any discrepancies and have
proper adjustment.
(g) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, Standards Office,
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8145
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to
ATTN: Raymond Johnston, Aerospace
Engineer, FAA, Small Airplane Directorate,
901 Locust, Room 301, Kansas City, Missouri
64106; telephone: (816) 329–4159; fax: (816)
329–3047; email: raymond.johnston@faa.gov.
Before using any approved AMOC on any
airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in
the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(h) Related Information
Refer to MCAI European Aviation Safety
Agency (EASA) AD No.: 2015–0184, dated
September 1, 2015; for related information.
The MCAI can be found in the AD docket on
the Internet at: https://www.regulations.gov/
#!documentDetail;D=FAA-2015-4803-0001.
(i) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(3) The following service information was
approved for IBR on March 24, 2016 (the
effective date of this AD).
(i) Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 2, dated July 17,
2015.
(ii) Reserved.
(4) The following service information was
approved for IBR on April 1, 2014 (79 FR
10340; February 25, 2014).
(i) Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 1, dated August
30, 2013.
(ii) Reserved.
(5) For Britten-Norman service information
identified in this AD, contact Britten-Norman
Aircraft Limited, Commodore House,
Mountbatten Business Centre, Millbrook
Road East, Southampton SO15 1HY, United
Kingdom; telephone: +44 20 3371 4000; fax:
+44 20 3371 4001; email: info@
bnaircraft.com; Internet: https://www.brittennorman.com/customer-support/.
(6) You may view this service information
at FAA, Small Airplane Directorate, 901
Locust, Kansas City, Missouri 64106. For
information on the availability of this
material at the FAA, call 816–329–4148. In
addition, you can access this service
information on the Internet at https://
www.regulations.gov by searching for and
locating Docket No. FAA–2015–4803.
(7) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
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the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Kansas City, Missouri, on
February 10, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2016–03307 Filed 2–17–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2011–N–0661]
Effective Date of Requirement for
Premarket Approval for Total Metal-onMetal Semi-Constrained Hip Joint
Systems
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is issuing a final
order to require the filing of a premarket
approval application (PMA) or a notice
of completion of a product development
protocol (PDP) for the hip joint metal/
metal semi-constrained, with a
cemented acetabular component,
prosthesis; and hip joint metal/metal
semi-constrained, with an uncemented
acetabular component, prosthesis.
DATES: This order is effective on
February 18, 2016.
FOR FURTHER INFORMATION CONTACT:
Sergio M. de del Castillo, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, Rm.
1538, Silver Spring, MD 20993, 301–
796–6419.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115), the Medical
Device User Fee and Modernization Act
of 2002 (Pub. L. 107–250), the Medical
Devices Technical Corrections Act (Pub.
L. 108–214), the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), and the Food and
Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
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14:29 Feb 17, 2016
Jkt 238001
144), among other amendments,
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).
Under section 513(d) of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as 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
(generally referred to as
postamendments devices), are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those 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, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has
been classified into class III and devices
found substantially equivalent by means
of premarket notification (510(k))
procedures to such a preamendments
device or to a device within that type
(both the preamendments and
substantially equivalent devices are
referred to as preamendments class III
devices) may be marketed without
submission of a PMA until FDA issues
a final order under section 515(b) of the
FD&C Act (21 U.S.C. 360e(b)) requiring
premarket approval. Section 515(b)(1) of
the FD&C Act directs FDA to issue an
order requiring premarket approval for a
preamendments class III device.
Although, under the FD&C Act, the
manufacturer of a preamendments class
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
III device may respond to the call for
PMAs by filing a PMA or a notice of
completion of a PDP. In practice, the
option of filing a notice of completion
of a PDP has rarely been used. For
simplicity, although the PDP option
remains available to manufacturers in
response to a final order under section
515(b) of the FD&C Act, this document
will refer only to the requirement for the
filing of, and obtaining approval of, a
PMA.
On July 9, 2012, FDASIA was enacted.
Section 608(a) of FDASIA amended
section 513(e) of the FD&C Act,
changing the process for reclassifying a
device from rulemaking to an
administrative order. Section 608(b) of
FDASIA amended section 515(b) of the
FD&C Act, changing the process for
requiring premarket approval for a
preamendments class III device from
rulemaking to an administrative order.
FDA is requiring PMAs for total
metal-on-metal (MoM) semi-constrained
hip joint systems (heretofore referenced
as ‘‘MoM hips’’), which include the
following two specific preamendments
class III devices: Hip joint metal/metal
semi-constrained, with a cemented
acetabular component, prosthesis; and
hip joint metal/metal semi-constrained,
with an uncemented acetabular
component, prosthesis.
Section 515(b)(1) of the FD&C Act sets
forth the process for issuing a final
order. Specifically, prior to the issuance
of a final order requiring premarket
approval for a preamendments class III
device, the following must occur: (1)
Publication of a proposed order in the
Federal Register; (2) a meeting of a
device classification panel described in
section 513(b) of the FD&C Act; and (3)
consideration of comments from all
affected stakeholders, including
patients, payors, and providers. FDA
published a proposed order to require
PMAs for MoM hips in the Federal
Register of January 18, 2013 (78 FR
4094), and convened a meeting of a
device classification panel for MoM
hips as discussed in the proposed order
and in this document.
Section 515(b)(3) of the FD&C Act
provides that FDA shall, after the close
of the comment period on the proposed
order, consideration of any comments
received, and a meeting of a device
classification panel described in section
513(b) of the FD&C Act, issue a final
order to require premarket approval or
publish a document terminating the
proceeding together with the reasons for
such termination.
A preamendments class III device
may be commercially distributed
without a PMA until 90 days after FDA
issues a final order (a final rule issued
E:\FR\FM\18FER1.SGM
18FER1
Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Rules and Regulations]
[Pages 8143-8146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03307]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2015-4803; Directorate Identifier 2015-CE-034-AD;
Amendment 39-18399; AD 2016-04-05]
RIN 2120-AA64
Airworthiness Directives; B-N Group Ltd. Airplanes
AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are superseding an airworthiness directive (AD) 2014-03-18
for B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-
2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-
21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-
3 airplanes. This AD results from mandatory continuing airworthiness
information (MCAI) issued by an aviation authority of another country
to identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as damage of the cable sliding end
assembly and installation of the incorrect end fitting on engine
control cable assemblies. We are issuing this AD to require actions to
address the unsafe condition on these products.
DATES: This AD is effective March 24, 2016.
The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 24,
2016.
The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of April
1, 2014 (79 FR 10340, February 25, 2014).
ADDRESSES: You may examine the AD docket on the Internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4803; or in person at the 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 service information identified in this final rule, contact
Britten-Norman Aircraft Limited, Commodore House, Mountbatten Business
Centre, Millbrook Road East, Southampton SO15 1HY, United Kingdom;
telephone: +44 20 3371 4000; fax: +44 20 3371 4001; email:
info@bnaircraft.com; Internet: https://www.britten-norman.com/customer-support/. You may view this referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148. It is also available on the Internet at https://www.regulations.gov by searching for Docket No. FAA-2015-4803.
FOR FURTHER INFORMATION CONTACT: Raymond Johnston, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047; email:
raymond.johnston@faa.gov.
SUPPLEMENTARY INFORMATION:
Discussion
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to B-N Group Ltd. Models BN-2,
BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21,
BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK.
III, BN2A MK. III-2, and
[[Page 8144]]
BN2A MK. III-3 airplanes. The NPRM was published in the Federal
Register on October 29, 2015 (80 FR 66482), and proposed to supersede
AD 2014-03-18, Amendment 39-17755 (79 FR 10340; February 25, 2014).
The NPRM proposed to correct an unsafe condition for the specified
products and was based on mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country. The MCAI states that:
Britten-Norman Aircraft Limited was made aware of two
occurrences where a failure of engine control cable assemblies has
caused engine control difficulties. In both reported cases, the
cable sliding end assemblies were in poor condition and in both
cases, an incorrect end-fitting was installed, which may have
contributed to the failures.
This condition, if not detected and corrected, could result in
reduced engine control, possibly resulting in reduced control of the
aeroplane.
To address this potential unsafe condition, Britten-Norman
Aircraft issued Service Bulletin (SB) 334 to provide inspection
instructions, and EASA issued AD 2013-0215 to require a one-time
inspection and functional test of the engine control cables and,
depending on findings, replacement of the cables.
Subsequently, as it was found that BN2 ``Islander'' aeroplanes
were mistakenly omitted from the AD applicability, EASA issued AD
2013-0263, retaining the requirements of EASA AD 2013-0215, which
was superseded, and extending the applicability to BN2 aeroplanes.
Since EASA AD 2013-0263 was issued, it was found that certain
parts, specific to BN2A ``Trislander'' aeroplanes only, were
inadvertently not included in SB 334 and, as a consequence, not
required by AD 2013-0263 to be inspected.
Prompted by these findings, Britten-Norman revised SB 334 (now
at issue 2) to include the missing parts.
For the reason described above, this AD retains the requirements
of EASA AD 2013-0263, which is superseded, and adds inspection
requirements for the additional parts.
The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/#!documentDetail;D=FAA-2015-4803-0001.
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 the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
Are consistent with the intent that was proposed in the
NPRM (80 FR 66482, October 29, 2015) for correcting the unsafe
condition; and
Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 66482, October 29, 2015).
Related Service Information Under 1 CFR Part 51
We reviewed Britten-Norman Aircraft Limited Service Bulletin No. SB
334, Issue 1, dated August 30, 2013; and Britten-Norman Aircraft
Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015. The
service information describes procedures for inspection and replacement
if necessary of the engine control cable assemblies. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this final rule.
Costs of Compliance
We estimate that this AD will affect 96 products of U.S. registry.
We also estimate that it would take about 1 work-hour per product to
comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of this AD on U.S.
operators to be $8,160 or $85 per product.
In addition, we estimate that any necessary follow-on actions would
take about 10 work-hours and require parts costing $6,000, for a cost
of $6,850 per product. We have no way of determining the number of
products that may need these actions.
Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
Regulatory Findings
We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a ``significant regulatory action'' under Executive
Order 12866,
(2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
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-2015-
4803; 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 the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone (800) 647-5527) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.
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 removing Amendment 39-17755 (79 FR
10340; February 25, 2014) and adding the following new AD:
[[Page 8145]]
2016-04-05 B-N Group Ltd.: Amendment 39-18399; Docket No. FAA-2015-
4803; Directorate Identifier 2015-CE-034-AD.
(a) Effective Date
This airworthiness directive (AD) becomes effective March 24,
2016.
(b) Affected ADs
This AD supersedes AD 2014-03-18, Amendment 39-17755 (79 FR
10340; February 25, 2014) (``AD 2014-03-18'').
(c) Applicability
This AD applies to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2,
BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26,
BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A
MK. III-2, and BN2A MK. III-3 airplanes, all serial numbers,
certificated in any category.
(d) Subject
Air Transport Association of America (ATA) Code 76: Engine
Controls.
(e) Reason
This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as possible damage
of the cable sliding end assembly and installation of the incorrect
end fitting on engine control cable assemblies. We are issuing this
proposed AD to detect and correct damage of the cable sliding end
assembly (cracking, distortion, corrosion) and incorrect end
fittings on the engine control assemblies, which could lead to
reduced engine control with consequent loss of control, and to
incorporate revised service information with updated information on
applicability and on the identity of parts to be inspected on some
airplanes.
(f) Actions and Compliance
Unless already done, do the actions in paragraphs (f)(1) through
(f)(6) of this AD:
(1) For all airplanes except the Trislander Models BN2A MK. III,
BN2A MK. III-2, and BN2A MK. III-3: Within the next 6 months after
April 1, 2014 (the effective date retained from AD 2014-03-18), do a
one-time inspection of the engine control cable assemblies, part
number (P/N) 137835, P/N 172449-1, P/N 172450, and P/N 172451, and
surrounding areas for damage (cracking, distortion, corrosion); for
the correct cable end-fitting; and to assure the wire locking is
intact following Britten-Norman Aircraft Limited Service Bulletin
No. SB 334, Issue 1, dated August 30, 2013; or Britten-Norman
Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July
17, 2015.
(2) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and
BN2A MK. III-3 airplanes: Within the next 3 months after March 24,
2016 (the effective date of this AD), do a one-time inspection of
the engine control cable assemblies, P/N 80468 and P/N NB-45-2883,
and surrounding areas for damage (cracking, distortion, corrosion);
for the correct cable end-fitting; and to assure the wire locking is
intact following Britten-Norman Aircraft Limited Service Bulletin
No. SB 334, Issue 2, dated July 17, 2015.
(3) For all airplanes except the Trislander Models BN2A MK. III,
BN2A MK. III-2, and BN2A MK. III-3: If no discrepancies are found
during the inspection required in paragraph (f)(1) of this AD,
before further flight, inspect the control linkages for proper
adjustment and make any necessary changes following Britten-Norman
Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August
30, 2013; or Britten-Norman Aircraft Limited Service Bulletin No. SB
334, Issue 2, dated July 17, 2015.
(4) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and
BN2A MK. III-3 airplanes: If no discrepancies are found during the
inspection required in paragraph (f)(2) of this AD, before further
flight, inspect the control linkages for proper adjustment and make
any necessary changes following Britten-Norman Aircraft Limited
Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.
(5) For all airplanes except the Trislander Models BN2A MK. III,
BN2A MK. III-2, and BN2A MK. III-3: If any discrepancies are found
during the inspection required in paragraph (f)(1) of this AD and/or
the control linkages cannot be properly adjusted as specified in
paragraph (f)(3) of this AD, before further flight, replace the
engine control cable assembly with a serviceable unit following
Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue
1, dated August 30, 2013; or Britten-Norman Aircraft Limited Service
Bulletin No. SB 334, Issue 2, dated July 17, 2015.
(6) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and
BN2A MK. III-3 airplanes: If any discrepancies are found during the
inspection required in paragraph (f)(2) of this AD and/or the
control linkages cannot be properly adjusted as specified in
paragraph (f)(4) of this AD, before further flight, replace the
engine control cable assembly with a serviceable unit following
Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue
2, dated July 17, 2015.
(7) For all airplanes except the Trislander Models BN2A MK. III,
BN2A MK. III-2, and BN2A MK. III-3: After April 1, 2014 (the
effective date retained from AD 2014-03-18), do not install on any
airplane engine control cable assemblies, P/N 137835, P/N 172449-1,
P/N 172450, and P/N 172451, unless they are new or have been
inspected as required in paragraphs (f)(1) and (f)(3) of this AD and
found free of any discrepancies and have proper adjustment.
(8) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and
BN2A MK. III-3 airplanes: After March 24, 2016 (the effective date
of this AD), do not install on any airplane engine control cable
assemblies P/N 80468 and/or P/N NB-45-2883, unless they are new or
have been inspected as required in paragraphs (f)(2) and (f)(4) of
this AD and found free of any discrepancies and have proper
adjustment.
(g) Other FAA AD Provisions
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Raymond Johnston, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047;
email: raymond.johnston@faa.gov. Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
(2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
(h) Related Information
Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2015-0184, dated September 1, 2015; for related information. The
MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/#!documentDetail;D=FAA-2015-4803-0001.
(i) Material Incorporated by Reference
(1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
(3) The following service information was approved for IBR on
March 24, 2016 (the effective date of this AD).
(i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334,
Issue 2, dated July 17, 2015.
(ii) Reserved.
(4) The following service information was approved for IBR on
April 1, 2014 (79 FR 10340; February 25, 2014).
(i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334,
Issue 1, dated August 30, 2013.
(ii) Reserved.
(5) For Britten-Norman service information identified in this
AD, contact Britten-Norman Aircraft Limited, Commodore House,
Mountbatten Business Centre, Millbrook Road East, Southampton SO15
1HY, United Kingdom; telephone: +44 20 3371 4000; fax: +44 20 3371
4001; email: info@bnaircraft.com; Internet: https://www.britten-norman.com/customer-support/.
(6) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
816-329-4148. In addition, you can access this service information
on the Internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2015-4803.
(7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on
[[Page 8146]]
the availability of this material at NARA, call 202-741-6030, or go
to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
Issued in Kansas City, Missouri, on February 10, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-03307 Filed 2-17-16; 8:45 am]
BILLING CODE 4910-13-P