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

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). 

(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. 

(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: http://

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 

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: info@bnaircraft.com; 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: 

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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8144 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. 

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 

■ 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 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 BrittenNorman 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: 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: info@

bnaircraft.com; Internet: http://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 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 


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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 

202–741–6030, or go to: http://

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. 

SUMMARY: 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: 

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– 

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 

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 


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