81_FR_8175 81 FR 8143 - Airworthiness Directives; B-N Group Ltd. Airplanes

81 FR 8143 - Airworthiness Directives; B-N Group Ltd. Airplanes

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 81, Issue 32 (February 18, 2016)

Page Range8143-8146
FR Document2016-03307

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.

Federal Register, Volume 81 Issue 32 (Thursday, February 18, 2016)
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Rules and Regulations]
[Pages 8143-8146]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03307]


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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 http://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: 
[email protected]; Internet: http://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 http://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: 
[email protected].

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:  http://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 http://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: [email protected]. 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: http://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: [email protected]; Internet: http://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 http://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: http://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



                                                            Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations                                        8143

                                           compliance time after the effective date of             (n) Material Incorporated by Reference                another country to identify and correct
                                           this AD.                                                   (1) The Director of the Federal Register           an unsafe condition on an aviation
                                             (2) Where Boeing Alert Service Bulletin               approved the incorporation by reference               product. The MCAI describes the unsafe
                                           747–53A2499, Revision 3, dated July 15,                 (IBR) of the service information listed in this       condition as damage of the cable sliding
                                           2014, specifies to contact Boeing for repair            paragraph under 5 U.S.C. 552(a) and 1 CFR
                                           instructions: Before further flight, repair                                                                   end assembly and installation of the
                                                                                                   part 51.                                              incorrect end fitting on engine control
                                           using a method approved in accordance with                 (2) You must use this service information
                                           the procedures specified in paragraph (l) of                                                                  cable assemblies. We are issuing this AD
                                                                                                   as applicable to do the actions required by
                                           this AD.
                                                                                                   this AD, unless the AD specifies otherwise.
                                                                                                                                                         to require actions to address the unsafe
                                           (k) Credit for Previous Actions                            (i) Boeing Alert Service Bulletin 747–             condition on these products.
                                                                                                   53A2499, Revision 3, dated July 15, 2014.             DATES: This AD is effective March 24,
                                             Actions done before the effective date of
                                           this AD using the service information                      (ii) Reserved.                                     2016.
                                           identified in paragraph (k)(1) or (k)(2) of this           (3) For service information identified in             The Director of the Federal Register
                                           AD are acceptable for compliance with the               this AD, contact Boeing Commercial                    approved the incorporation by reference
                                           corresponding requirements of paragraphs (g)            Airplanes, Attention: Data & Services                 of a certain publication listed in the AD
                                           and (h) of this AD.                                     Management, P.O. Box 3707, MC 2H–65,                  as of March 24, 2016.
                                             (1) Boeing Alert Service Bulletin 747–                Seattle, WA 98124–2207; telephone 206–                   The Director of the Federal Register
                                           53A2499, Revision 1, dated October 30, 2008,            544–5000, extension 1; fax 206–766–5680;              approved the incorporation by reference
                                           which is not incorporated by reference in this          Internet https://www.myboeingfleet.com.
                                                                                                                                                         of a certain other publication listed in
                                           AD.                                                        (4) You may view this service information
                                                                                                   at FAA, Transport Airplane Directorate, 1601          this AD as of April 1, 2014 (79 FR
                                             (2) Boeing Alert Service Bulletin 747–                                                                      10340, February 25, 2014).
                                           53A2499, Revision 2, dated August 12, 2010,             Lind Avenue SW., Renton, WA. For
                                           which was incorporated by reference in AD               information on the availability of this               ADDRESSES: You may examine the AD
                                           2010–26–10, Amendment 39–16549 (75 FR                   material at the FAA, call 425–227–1221.               docket on the Internet at http://
                                           81427, December 28, 2010).                                 (5) You may view this service information          www.regulations.gov by searching for
                                                                                                   that is incorporated by reference at the              and locating Docket No. FAA–2015–
                                           (l) Alternative Methods of Compliance                   National Archives and Records
                                           (AMOCs)                                                                                                       4803; or in person at the Docket
                                                                                                   Administration (NARA). For information on             Management Facility, U.S. Department
                                              (1) The Manager, Seattle Aircraft                    the availability of this material at NARA, call
                                                                                                   202–741–6030, or go to: http://
                                                                                                                                                         of Transportation, Docket Operations,
                                           Certification Office (ACO), FAA, has the
                                           authority to approve AMOCs for this AD, if              www.archives.gov/federal-register/cfr/ibr-            M–30, West Building Ground Floor,
                                           requested using the procedures found in 14              locations.html.                                       Room W12–140, 1200 New Jersey
                                           CFR 39.19. In accordance with 14 CFR 39.19,                                                                   Avenue SE., Washington, DC 20590.
                                                                                                      Issued in Renton, Washington, on February             For service information identified in
                                           send your request to your principal inspector           7, 2016.
                                           or local Flight Standards District Office, as                                                                 this final rule, contact Britten-Norman
                                           appropriate. If sending information directly            Michael Kaszycki,                                     Aircraft Limited, Commodore House,
                                           to the manager of the ACO, send it to the               Acting Manager, Transport Airplane                    Mountbatten Business Centre, Millbrook
                                           attention of the person identified in                   Directorate, Aircraft Certification Service.          Road East, Southampton SO15 1HY,
                                           paragraph (m)(1) of this AD. Information may            [FR Doc. 2016–03219 Filed 2–17–16; 8:45 am]           United Kingdom; telephone: +44 20
                                           be emailed to: 9-ANM-Seattle-ACO-AMOC-
                                           Requests@faa.gov.
                                                                                                   BILLING CODE 4910–13–P                                3371 4000; fax: +44 20 3371 4001;
                                              (2) Before using any approved AMOC,                                                                        email: info@bnaircraft.com; Internet:
                                           notify your appropriate principal inspector,                                                                  http://www.britten-norman.com/
                                           or lacking a principal inspector, the manager           DEPARTMENT OF TRANSPORTATION                          customer-support/. You may view this
                                           of the local flight standards district office/                                                                referenced service information at the
                                           certificate holding district office.                    Federal Aviation Administration
                                                                                                                                                         FAA, Small Airplane Directorate, 901
                                              (3) An AMOC that provides an acceptable                                                                    Locust, Kansas City, Missouri 64106.
                                           level of safety may be used for any repair,             14 CFR Part 39
                                                                                                                                                         For information on the availability of
                                           modification, or alteration required by this
                                           AD if it is approved by the Boeing
                                                                                                   [Docket No. FAA–2015–4803; Directorate                this material at the FAA, call (816) 329–
                                                                                                   Identifier 2015–CE–034–AD; Amendment                  4148. It is also available on the Internet
                                           Commercial Airplanes Organization
                                                                                                   39–18399; AD 2016–04–05]                              at http://www.regulations.gov by
                                           Designation Authorization (ODA) that has
                                           been authorized by the Manager, Seattle                 RIN 2120–AA64                                         searching for Docket No. FAA–2015–
                                           ACO, to make those findings. To be                                                                            4803.
                                           approved, the repair method, modification               Airworthiness Directives; B–N Group                   FOR FURTHER INFORMATION CONTACT:
                                           deviation, or alteration deviation must meet            Ltd. Airplanes
                                           the certification basis of the airplane and the                                                               Raymond Johnston, Aerospace Engineer,
                                           approval must specifically refer to this AD.            AGENCY:  Federal Aviation                             FAA, Small Airplane Directorate, 901
                                              (4) AMOCs approved for AD 2010–26–10,                Administration (FAA), Department of                   Locust, Room 301, Kansas City,
                                           Amendment 39–16549 (75 FR 81427,                        Transportation (DOT).                                 Missouri 64106; telephone: (816) 329–
                                           December 28, 2010), are approved as AMOCs                                                                     4159; fax: (816) 329–3047; email:
                                           for the corresponding provisions of                     ACTION: Final rule.
                                                                                                                                                         raymond.johnston@faa.gov.
                                           paragraphs (g) and (h) this AD.
                                                                                                   SUMMARY:   We are superseding an                      SUPPLEMENTARY INFORMATION:
                                           (m) Related Information                                 airworthiness directive (AD) 2014–03–
                                             (1) For more information about this AD,               18 for B–N Group Ltd. Models BN–2,                    Discussion
                                           contact Nathan Weigand, Aerospace                       BN–2A, BN–2A–2, BN–2A–3, BN–2A–6,                       We issued a notice of proposed
                                           Engineer, Airframe Branch, ANM–120S,                    BN–2A–8, BN–2A–9, BN–2A–20, BN–                       rulemaking (NPRM) to amend 14 CFR
                                           FAA, Seattle Aircraft Certification Office,             2A–21, BN–2A–26, BN–2A–27, BN–2B–                     part 39 by adding an AD that would
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                                           1601 Lind Avenue SW., Renton, WA 98057–                 20, BN–2B–21, BN–2B–26, BN–2B–27,                     apply to B–N Group Ltd. Models BN–2,
                                           3356; phone: 425–917–6428; fax: 425–917–
                                           6590; email: nathan.p.weigand@faa.gov.
                                                                                                   BN2A MK. III, BN2A MK. III–2, and                     BN–2A, BN–2A–2, BN–2A–3, BN–2A–6,
                                             (2) Service information identified in this            BN2A MK. III–3 airplanes. This AD                     BN–2A–8, BN–2A–9, BN–2A–20, BN–
                                           AD that is not incorporated by reference is             results from mandatory continuing                     2A–21, BN–2A–26, BN–2A–27, BN–2B–
                                           available at the addresses specified in                 airworthiness information (MCAI)                      20, BN–2B–21, BN–2B–26, BN–2B–27,
                                           paragraphs (n)(3) and (n)(4) of this AD.                issued by an aviation authority of                    BN2A MK. III, BN2A MK. III–2, and


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                                           8144             Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations

                                           BN2A MK. III–3 airplanes. The NPRM                      changes. We have determined that these                that is likely to exist or develop on
                                           was published in the Federal Register                   minor changes:                                        products identified in this rulemaking
                                           on October 29, 2015 (80 FR 66482), and                    • Are consistent with the intent that               action.
                                           proposed to supersede AD 2014–03–18,                    was proposed in the NPRM (80 FR
                                                                                                                                                         Regulatory Findings
                                           Amendment 39–17755 (79 FR 10340;                        66482, October 29, 2015) for correcting
                                           February 25, 2014).                                     the unsafe condition; and                               We determined that this AD will not
                                             The NPRM proposed to correct an                         • Do not add any additional burden                  have federalism implications under
                                           unsafe condition for the specified                      upon the public than was already                      Executive Order 13132. This AD will
                                           products and was based on mandatory                     proposed in the NPRM (80 FR 66482,                    not have a substantial direct effect on
                                           continuing airworthiness information                    October 29, 2015).                                    the States, on the relationship between
                                           (MCAI) originated by an aviation                                                                              the national government and the States,
                                                                                                   Related Service Information Under 1                   or on the distribution of power and
                                           authority of another country. The MCAI                  CFR Part 51
                                           states that:                                                                                                  responsibilities among the various
                                                                                                      We reviewed Britten-Norman Aircraft                levels of government.
                                              Britten-Norman Aircraft Limited was made
                                                                                                   Limited Service Bulletin No. SB 334,                    For the reasons discussed above, I
                                           aware of two occurrences where a failure of
                                           engine control cable assemblies has caused              Issue 1, dated August 30, 2013; and                   certify this AD:
                                           engine control difficulties. In both reported           Britten-Norman Aircraft Limited Service                 (1) Is not a ‘‘significant regulatory
                                           cases, the cable sliding end assemblies were            Bulletin No. SB 334, Issue 2, dated July              action’’ under Executive Order 12866,
                                           in poor condition and in both cases, an                 17, 2015. The service information                       (2) Is not a ‘‘significant rule’’ under
                                           incorrect end-fitting was installed, which              describes procedures for inspection and               the DOT Regulatory Policies and
                                           may have contributed to the failures.                   replacement if necessary of the engine                Procedures (44 FR 11034, February 26,
                                              This condition, if not detected and                  control cable assemblies. This service                1979),
                                           corrected, could result in reduced engine               information is reasonably available                     (3) Will not affect intrastate aviation
                                           control, possibly resulting in reduced control                                                                in Alaska, and
                                           of the aeroplane.
                                                                                                   because the interested parties have
                                                                                                   access to it through their normal course                (4) Will not have a significant
                                              To address this potential unsafe condition,                                                                economic impact, positive or negative,
                                           Britten-Norman Aircraft issued Service                  of business or by the means identified
                                                                                                   in the ADDRESSES section of this final                on a substantial number of small entities
                                           Bulletin (SB) 334 to provide inspection
                                           instructions, and EASA issued AD 2013–                  rule.                                                 under the criteria of the Regulatory
                                           0215 to require a one-time inspection and                                                                     Flexibility Act.
                                           functional test of the engine control cables            Costs of Compliance
                                                                                                                                                         Examining the AD Docket
                                           and, depending on findings, replacement of                We estimate that this AD will affect
                                           the cables.                                             96 products of U.S. registry. We also                   You may examine the AD docket on
                                              Subsequently, as it was found that BN2               estimate that it would take about 1                   the Internet at http://
                                           ‘‘Islander’’ aeroplanes were mistakenly
                                                                                                   work-hour per product to comply with                  www.regulations.gov by searching for
                                           omitted from the AD applicability, EASA                                                                       and locating Docket No. FAA–2015–
                                           issued AD 2013–0263, retaining the                      the basic requirements of this proposed
                                                                                                   AD. The average labor rate is $85 per                 4803; or in person at the Docket
                                           requirements of EASA AD 2013–0215, which                                                                      Management Facility between 9 a.m.
                                           was superseded, and extending the                       work-hour.
                                                                                                     Based on these figures, we estimate                 and 5 p.m., Monday through Friday,
                                           applicability to BN2 aeroplanes.
                                              Since EASA AD 2013–0263 was issued, it               the cost of this AD on U.S. operators to              except Federal holidays. The AD docket
                                           was found that certain parts, specific to               be $8,160 or $85 per product.                         contains the NPRM, the regulatory
                                           BN2A ‘‘Trislander’’ aeroplanes only, were                 In addition, we estimate that any                   evaluation, any comments received, and
                                           inadvertently not included in SB 334 and, as            necessary follow-on actions would take                other information. The street address for
                                           a consequence, not required by AD 2013–                 about 10 work-hours and require parts                 the Docket Office (telephone (800) 647–
                                           0263 to be inspected.                                   costing $6,000, for a cost of $6,850 per              5527) is in the ADDRESSES section.
                                              Prompted by these findings, Britten-                                                                       Comments will be available in the AD
                                           Norman revised SB 334 (now at issue 2) to
                                                                                                   product. We have no way of
                                                                                                   determining the number of products                    docket shortly after receipt.
                                           include the missing parts.
                                              For the reason described above, this AD              that may need these actions.                          List of Subjects in 14 CFR Part 39
                                           retains the requirements of EASA AD 2013–               Authority for This Rulemaking                           Air transportation, Aircraft, Aviation
                                           0263, which is superseded, and adds
                                           inspection requirements for the additional                 Title 49 of the United States Code                 safety, Incorporation by reference,
                                           parts.                                                  specifies the FAA’s authority to issue                Safety.
                                           The MCAI can be found in the AD                         rules on aviation safety. Subtitle I,                 Adoption of the Amendment
                                           docket on the Internet at: http://                      section 106, describes the authority of
                                                                                                                                                           Accordingly, under the authority
                                           www.regulations.gov/                                    the FAA Administrator. ‘‘Subtitle VII:
                                                                                                                                                         delegated to me by the Administrator,
                                           #!documentDetail;D=FAA-2015-4803-                       Aviation Programs,’’ describes in more
                                                                                                                                                         the FAA amends 14 CFR part 39 as
                                           0001.                                                   detail the scope of the Agency’s
                                                                                                                                                         follows:
                                                                                                   authority.
                                           Comments                                                   We are issuing this rulemaking under               PART 39—AIRWORTHINESS
                                             We gave the public the opportunity to                 the authority described in ‘‘Subtitle VII,            DIRECTIVES
                                           participate in developing this AD. We                   Part A, Subpart III, Section 44701:
                                           received no comments on the NPRM or                     General requirements.’’ Under that                    ■ 1. The authority citation for part 39
                                           on the determination of the cost to the                 section, Congress charges the FAA with                continues to read as follows:
                                                                                                   promoting safe flight of civil aircraft in
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                                           public.                                                                                                           Authority: 49 U.S.C. 106(g), 40113, 44701.
                                                                                                   air commerce by prescribing regulations
                                           Conclusion                                              for practices, methods, and procedures                § 39.13    [Amended]
                                             We reviewed the relevant data and                     the Administrator finds necessary for                 ■ 2. The FAA amends § 39.13 by
                                           determined that air safety and the                      safety in air commerce. This regulation               removing Amendment 39–17755 (79 FR
                                           public interest require adopting the AD                 is within the scope of that authority                 10340; February 25, 2014) and adding
                                           as proposed except for minor editorial                  because it addresses an unsafe condition              the following new AD:


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                                                            Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations                                             8145

                                           2016–04–05 B–N Group Ltd.: Amendment                    Norman Aircraft Limited Service Bulletin No.          FAA, has the authority to approve AMOCs
                                               39–18399; Docket No. FAA–2015–4803;                 SB 334, Issue 2, dated July 17, 2015.                 for this AD, if requested using the procedures
                                               Directorate Identifier 2015–CE–034–AD.                 (3) For all airplanes except the Trislander        found in 14 CFR 39.19. Send information to
                                                                                                   Models BN2A MK. III, BN2A MK. III–2, and              ATTN: Raymond Johnston, Aerospace
                                           (a) Effective Date                                      BN2A MK. III–3: If no discrepancies are               Engineer, FAA, Small Airplane Directorate,
                                              This airworthiness directive (AD) becomes            found during the inspection required in               901 Locust, Room 301, Kansas City, Missouri
                                           effective March 24, 2016.                               paragraph (f)(1) of this AD, before further           64106; telephone: (816) 329–4159; fax: (816)
                                                                                                   flight, inspect the control linkages for proper       329–3047; email: raymond.johnston@faa.gov.
                                           (b) Affected ADs                                        adjustment and make any necessary changes             Before using any approved AMOC on any
                                             This AD supersedes AD 2014–03–18,                     following Britten-Norman Aircraft Limited             airplane to which the AMOC applies, notify
                                           Amendment 39–17755 (79 FR 10340;                        Service Bulletin No. SB 334, Issue 1, dated           your appropriate principal inspector (PI) in
                                           February 25, 2014) (‘‘AD 2014–03–18’’).                 August 30, 2013; or Britten-Norman Aircraft           the FAA Flight Standards District Office
                                                                                                   Limited Service Bulletin No. SB 334, Issue 2,         (FSDO), or lacking a PI, your local FSDO.
                                           (c) Applicability
                                                                                                   dated July 17, 2015.                                     (2) Airworthy Product: For any requirement
                                              This AD applies to B–N Group Ltd. Models                (4) For the Trislander Models BN2A MK.             in this AD to obtain corrective actions from
                                           BN–2, BN–2A, BN–2A–2, BN–2A–3, BN–2A–                   III, BN2A MK. III–2, and BN2A MK. III–3               a manufacturer or other source, use these
                                           6, BN–2A–8, BN–2A–9, BN–2A–20, BN–2A–                   airplanes: If no discrepancies are found              actions if they are FAA-approved. Corrective
                                           21, BN–2A–26, BN–2A–27, BN–2B–20, BN–                   during the inspection required in paragraph           actions are considered FAA-approved if they
                                           2B–21, BN–2B–26, BN–2B–27, BN2A MK. III,                (f)(2) of this AD, before further flight, inspect     are approved by the State of Design Authority
                                           BN2A MK. III–2, and BN2A MK. III–3                      the control linkages for proper adjustment            (or their delegated agent). You are required
                                           airplanes, all serial numbers, certificated in          and make any necessary changes following              to assure the product is airworthy before it
                                           any category.                                           Britten-Norman Aircraft Limited Service               is returned to service.
                                                                                                   Bulletin No. SB 334, Issue 2, dated July 17,
                                           (d) Subject
                                                                                                   2015.                                                 (h) Related Information
                                             Air Transport Association of America                     (5) For all airplanes except the Trislander          Refer to MCAI European Aviation Safety
                                           (ATA) Code 76: Engine Controls.                         Models BN2A MK. III, BN2A MK. III–2, and              Agency (EASA) AD No.: 2015–0184, dated
                                                                                                   BN2A MK. III–3: If any discrepancies are              September 1, 2015; for related information.
                                           (e) Reason
                                                                                                   found during the inspection required in
                                              This AD was prompted by mandatory                                                                          The MCAI can be found in the AD docket on
                                                                                                   paragraph (f)(1) of this AD and/or the control
                                           continuing airworthiness information (MCAI)                                                                   the Internet at: http://www.regulations.gov/
                                                                                                   linkages cannot be properly adjusted as
                                           originated by an aviation authority of another                                                                #!documentDetail;D=FAA-2015-4803-0001.
                                                                                                   specified in paragraph (f)(3) of this AD,
                                           country to identify and correct an unsafe               before further flight, replace the engine             (i) Material Incorporated by Reference
                                           condition on an aviation product. The MCAI              control cable assembly with a serviceable
                                           describes the unsafe condition as possible                                                                       (1) The Director of the Federal Register
                                                                                                   unit following Britten-Norman Aircraft                approved the incorporation by reference
                                           damage of the cable sliding end assembly and            Limited Service Bulletin No. SB 334, Issue 1,
                                           installation of the incorrect end fitting on                                                                  (IBR) of the service information listed in this
                                                                                                   dated August 30, 2013; or Britten-Norman              paragraph under 5 U.S.C. 552(a) and 1 CFR
                                           engine control cable assemblies. We are                 Aircraft Limited Service Bulletin No. SB 334,
                                           issuing this proposed AD to detect and                                                                        part 51.
                                                                                                   Issue 2, dated July 17, 2015.
                                           correct damage of the cable sliding end                                                                          (2) You must use this service information
                                                                                                      (6) For the Trislander Models BN2A MK.
                                           assembly (cracking, distortion, corrosion) and                                                                as applicable to do the actions required by
                                                                                                   III, BN2A MK. III–2, and BN2A MK. III–3
                                           incorrect end fittings on the engine control                                                                  this AD, unless the AD specifies otherwise.
                                                                                                   airplanes: If any discrepancies are found
                                           assemblies, which could lead to reduced                                                                          (3) The following service information was
                                                                                                   during the inspection required in paragraph
                                           engine control with consequent loss of                                                                        approved for IBR on March 24, 2016 (the
                                                                                                   (f)(2) of this AD and/or the control linkages
                                           control, and to incorporate revised service                                                                   effective date of this AD).
                                                                                                   cannot be properly adjusted as specified in
                                           information with updated information on                                                                          (i) Britten-Norman Aircraft Limited Service
                                                                                                   paragraph (f)(4) of this AD, before further
                                           applicability and on the identity of parts to                                                                 Bulletin No. SB 334, Issue 2, dated July 17,
                                                                                                   flight, replace the engine control cable
                                           be inspected on some airplanes.                                                                               2015.
                                                                                                   assembly with a serviceable unit following
                                                                                                   Britten-Norman Aircraft Limited Service                  (ii) Reserved.
                                           (f) Actions and Compliance                                                                                       (4) The following service information was
                                                                                                   Bulletin No. SB 334, Issue 2, dated July 17,
                                              Unless already done, do the actions in               2015.                                                 approved for IBR on April 1, 2014 (79 FR
                                           paragraphs (f)(1) through (f)(6) of this AD:               (7) For all airplanes except the Trislander        10340; February 25, 2014).
                                              (1) For all airplanes except the Trislander          Models BN2A MK. III, BN2A MK. III–2, and                 (i) Britten-Norman Aircraft Limited Service
                                           Models BN2A MK. III, BN2A MK. III–2, and                BN2A MK. III–3: After April 1, 2014 (the              Bulletin No. SB 334, Issue 1, dated August
                                           BN2A MK. III–3: Within the next 6 months                effective date retained from AD 2014–03–18),          30, 2013.
                                           after April 1, 2014 (the effective date retained        do not install on any airplane engine control            (ii) Reserved.
                                           from AD 2014–03–18), do a one-time                      cable assemblies, P/N 137835, P/N 172449–                (5) For Britten-Norman service information
                                           inspection of the engine control cable                  1, P/N 172450, and P/N 172451, unless they            identified in this AD, contact Britten-Norman
                                           assemblies, part number (P/N) 137835, P/N               are new or have been inspected as required            Aircraft Limited, Commodore House,
                                           172449–1, P/N 172450, and P/N 172451, and               in paragraphs (f)(1) and (f)(3) of this AD and        Mountbatten Business Centre, Millbrook
                                           surrounding areas for damage (cracking,                 found free of any discrepancies and have              Road East, Southampton SO15 1HY, United
                                           distortion, corrosion); for the correct cable           proper adjustment.                                    Kingdom; telephone: +44 20 3371 4000; fax:
                                           end-fitting; and to assure the wire locking is             (8) For the Trislander Models BN2A MK.             +44 20 3371 4001; email: info@
                                           intact following Britten-Norman Aircraft                III, BN2A MK. III–2, and BN2A MK. III–3               bnaircraft.com; Internet: http://www.britten-
                                           Limited Service Bulletin No. SB 334, Issue 1,           airplanes: After March 24, 2016 (the effective        norman.com/customer-support/.
                                           dated August 30, 2013; or Britten-Norman                date of this AD), do not install on any                  (6) You may view this service information
                                           Aircraft Limited Service Bulletin No. SB 334,           airplane engine control cable assemblies P/N          at FAA, Small Airplane Directorate, 901
                                           Issue 2, dated July 17, 2015.                           80468 and/or P/N NB–45–2883, unless they              Locust, Kansas City, Missouri 64106. For
                                              (2) For the Trislander Models BN2A MK.               are new or have been inspected as required            information on the availability of this
                                           III, BN2A MK. III–2, and BN2A MK. III–3                 in paragraphs (f)(2) and (f)(4) of this AD and        material at the FAA, call 816–329–4148. In
                                           airplanes: Within the next 3 months after               found free of any discrepancies and have              addition, you can access this service
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                                           March 24, 2016 (the effective date of this              proper adjustment.                                    information on the Internet at http://
                                           AD), do a one-time inspection of the engine                                                                   www.regulations.gov by searching for and
                                           control cable assemblies, P/N 80468 and                 (g) Other FAA AD Provisions                           locating Docket No. FAA–2015–4803.
                                           P/N NB–45–2883, and surrounding areas for                  The following provisions also apply to this           (7) You may view this service information
                                           damage (cracking, distortion, corrosion); for           AD:                                                   that is incorporated by reference at the
                                           the correct cable end-fitting; and to assure the           (1) Alternative Methods of Compliance              National Archives and Records
                                           wire locking is intact following Britten-               (AMOCs): The Manager, Standards Office,               Administration (NARA). For information on



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                                           8146             Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations

                                           the availability of this material at NARA, call         144), among other amendments,                         III device may respond to the call for
                                           202–741–6030, or go to: http://                         established a comprehensive system for                PMAs by filing a PMA or a notice of
                                           www.archives.gov/federal-register/cfr/ibr-              the regulation of medical devices                     completion of a PDP. In practice, the
                                           locations.html.                                         intended for human use. Section 513 of                option of filing a notice of completion
                                             Issued in Kansas City, Missouri, on                   the FD&C Act (21 U.S.C. 360c)                         of a PDP has rarely been used. For
                                           February 10, 2016.                                      established three categories (classes) of             simplicity, although the PDP option
                                           Pat Mullen,                                             devices, reflecting the regulatory                    remains available to manufacturers in
                                           Acting Manager, Small Airplane Directorate,             controls needed to provide reasonable                 response to a final order under section
                                           Aircraft Certification Service.                         assurance of their safety and                         515(b) of the FD&C Act, this document
                                           [FR Doc. 2016–03307 Filed 2–17–16; 8:45 am]             effectiveness. The three categories of                will refer only to the requirement for the
                                           BILLING CODE 4910–13–P                                  devices are class I (general controls),               filing of, and obtaining approval of, a
                                                                                                   class II (special controls), and class III            PMA.
                                                                                                   (premarket approval).                                    On July 9, 2012, FDASIA was enacted.
                                           DEPARTMENT OF HEALTH AND                                   Under section 513(d) of the FD&C Act,              Section 608(a) of FDASIA amended
                                           HUMAN SERVICES                                          devices that were in commercial                       section 513(e) of the FD&C Act,
                                                                                                   distribution before the enactment of the              changing the process for reclassifying a
                                           Food and Drug Administration                            1976 amendments, May 28, 1976                         device from rulemaking to an
                                                                                                   (generally referred to as preamendments               administrative order. Section 608(b) of
                                           21 CFR Part 888                                         devices), are classified after FDA has: (1)           FDASIA amended section 515(b) of the
                                                                                                   Received a recommendation from a                      FD&C Act, changing the process for
                                           [Docket No. FDA–2011–N–0661]                            device classification panel (an FDA                   requiring premarket approval for a
                                                                                                   advisory committee); (2) published the                preamendments class III device from
                                           Effective Date of Requirement for
                                                                                                   panel’s recommendation for comment,                   rulemaking to an administrative order.
                                           Premarket Approval for Total Metal-on-                                                                           FDA is requiring PMAs for total
                                                                                                   along with a proposed regulation
                                           Metal Semi-Constrained Hip Joint                                                                              metal-on-metal (MoM) semi-constrained
                                                                                                   classifying the device; and (3) published
                                           Systems                                                 a final regulation classifying the device.            hip joint systems (heretofore referenced
                                           AGENCY:    Food and Drug Administration,                FDA has classified most                               as ‘‘MoM hips’’), which include the
                                           HHS.                                                    preamendments devices under these                     following two specific preamendments
                                           ACTION:   Final order.                                  procedures.                                           class III devices: Hip joint metal/metal
                                                                                                      Devices that were not in commercial                semi-constrained, with a cemented
                                           SUMMARY:   The Food and Drug                            distribution prior to May 28, 1976                    acetabular component, prosthesis; and
                                           Administration (FDA) is issuing a final                 (generally referred to as                             hip joint metal/metal semi-constrained,
                                           order to require the filing of a premarket              postamendments devices), are                          with an uncemented acetabular
                                           approval application (PMA) or a notice                  automatically classified by section                   component, prosthesis.
                                           of completion of a product development                  513(f) of the FD&C Act into class III                    Section 515(b)(1) of the FD&C Act sets
                                           protocol (PDP) for the hip joint metal/                 without any FDA rulemaking process.                   forth the process for issuing a final
                                           metal semi-constrained, with a                          Those devices remain in class III and                 order. Specifically, prior to the issuance
                                           cemented acetabular component,                          require premarket approval unless, and                of a final order requiring premarket
                                           prosthesis; and hip joint metal/metal                   until, the device is reclassified into class          approval for a preamendments class III
                                           semi-constrained, with an uncemented                    I or II or FDA issues an order finding the            device, the following must occur: (1)
                                           acetabular component, prosthesis.                       device to be substantially equivalent, in             Publication of a proposed order in the
                                                                                                   accordance with section 513(i) of the                 Federal Register; (2) a meeting of a
                                           DATES: This order is effective on
                                                                                                   FD&C Act, to a predicate device that                  device classification panel described in
                                           February 18, 2016.                                                                                            section 513(b) of the FD&C Act; and (3)
                                                                                                   does not require premarket approval.
                                           FOR FURTHER INFORMATION CONTACT:                        The Agency determines whether new                     consideration of comments from all
                                           Sergio M. de del Castillo, Center for                   devices are substantially equivalent to               affected stakeholders, including
                                           Devices and Radiological Health, 10903                  predicate devices by means of                         patients, payors, and providers. FDA
                                           New Hampshire Ave., Bldg. 66, Rm.                       premarket notification procedures in                  published a proposed order to require
                                           1538, Silver Spring, MD 20993, 301–                     section 510(k) of the FD&C Act (21                    PMAs for MoM hips in the Federal
                                           796–6419.                                               U.S.C. 360(k)) and 21 CFR part 807.                   Register of January 18, 2013 (78 FR
                                           SUPPLEMENTARY INFORMATION:                                 A preamendments device that has                    4094), and convened a meeting of a
                                                                                                   been classified into class III and devices            device classification panel for MoM
                                           I. Background—Regulatory Authorities
                                                                                                   found substantially equivalent by means               hips as discussed in the proposed order
                                              The Federal Food, Drug, and Cosmetic                 of premarket notification (510(k))                    and in this document.
                                           Act (the FD&C Act), as amended by the                   procedures to such a preamendments                       Section 515(b)(3) of the FD&C Act
                                           Medical Device Amendments of 1976                       device or to a device within that type                provides that FDA shall, after the close
                                           (the 1976 amendments) (Pub. L. 94–                      (both the preamendments and                           of the comment period on the proposed
                                           295), the Safe Medical Devices Act of                   substantially equivalent devices are                  order, consideration of any comments
                                           1990 (Pub. L. 101–629), the Food and                    referred to as preamendments class III                received, and a meeting of a device
                                           Drug Administration Modernization Act                   devices) may be marketed without                      classification panel described in section
                                           of 1997 (Pub. L. 105–115), the Medical                  submission of a PMA until FDA issues                  513(b) of the FD&C Act, issue a final
                                           Device User Fee and Modernization Act                   a final order under section 515(b) of the             order to require premarket approval or
                                           of 2002 (Pub. L. 107–250), the Medical                  FD&C Act (21 U.S.C. 360e(b)) requiring                publish a document terminating the
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                                           Devices Technical Corrections Act (Pub.                 premarket approval. Section 515(b)(1) of              proceeding together with the reasons for
                                           L. 108–214), the Food and Drug                          the FD&C Act directs FDA to issue an                  such termination.
                                           Administration Amendments Act of                        order requiring premarket approval for a                 A preamendments class III device
                                           2007 (Pub. L. 110–85), and the Food and                 preamendments class III device.                       may be commercially distributed
                                           Drug Administration Safety and                             Although, under the FD&C Act, the                  without a PMA until 90 days after FDA
                                           Innovation Act (FDASIA) (Pub. L. 112–                   manufacturer of a preamendments class                 issues a final order (a final rule issued


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Document Created: 2016-02-18 07:46:50
Document Modified: 2016-02-18 07:46:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis AD is effective March 24, 2016.
ContactRaymond Johnston, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047; email: [email protected]
FR Citation81 FR 8143 
RIN Number2120-AA64
CFR AssociatedAir Transportation; Aircraft; Aviation Safety; Incorporation by Reference and Safety

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