Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Rules and Regulations 47371 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2017–0648; Product 

Identifier 2017–CE–012–AD; Amendment 

39–19070; AD 2017–20–13] 

RIN 2120–AA64 

Airworthiness Directives; PIAGGIO 

AERO INDUSTRIES S.p.A. Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for 

PIAGGIO AERO INDUSTRIES S.p.A. 

Model P–180 airplanes. This AD results 

from 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 disbonding of the upper 

and lower metal skin from the 

honeycomb core on the elevator 

assembly and other flight control 

surfaces. We are issuing this AD to 

require actions to address the unsafe 

condition on these products. 

DATES: This AD is effective November 

16, 2017. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of November 16, 2017. 

ADDRESSES: You may examine the AD 

docket on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2017– 

0638; or in person at Document 

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 AD, contact PIAGGIO AERO 

INDUSTRIES S.p.A—Continued 

Airworthiness, Via Pionieri e Aviatori 

d’Italia snc—16154 Genova, Italy; 

Telephone: +39 010 0998046; Fax: 

None; email: airworthiness@

piaggioaerospace.it; Internet: 

www.piaggioaerospace.it/en/customersupport#care. You may view this 

referenced service information at the 

FAA, Policy and Innovation Division, 

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–2017–0648. 

FOR FURTHER INFORMATION CONTACT: 

Mike Kiesov, Aerospace Engineer, FAA, 

Small Airplane Standards Branch, 901 

Locust, Room 301, Kansas City, 

Missouri 64106; telephone: (816) 329– 

4144; fax: (816) 329–4090; email: 

mike.kiesov@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 certain PIAGGIO AERO 

INDUSTRIES S.p.A. Model P–180 

airplanes. The NPRM was published in 

the Federal Register on June 29, 2017 

(82 FR 29445). 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: 

During a post flight inspection of a right 

hand (RH) elevator assembly, disbonding was 

detected on the upper and lower metal skin 

from the honeycomb core. Subsequent 

investigation identified that a manufacturing 

deficiency caused the detected disbonding 

and that other flight control surfaces could 

potentially be affected by the same 

deficiency. 

This condition, if not detected and 

corrected, could reduce the structural 

stiffness of the flight control surface and 

downgrade its aerodynamic characteristics, 

possibly resulting in reduced control of the 

aeroplane. 

To address this potential unsafe condition, 

Piaggio Aero Industries (PAI) issued Service 

Bulletin (SB) 80–0455 to provide inspection 

instructions. 

For the reasons described above, this 

[EASA] AD requires repetitive inspections of 

the affected flight control assemblies and, 

depending on findings, repair or 

replacement. This [EASA] AD also requires 

reporting of the inspection result to PAI. 

The MCAI can be found in the AD 

docket on the Internet at https://

www.regulations.gov/ 

document?D=FAA-2017-064-0002. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

received no comments on the NPRM or 

on the determination of the cost to the 

public. 

Conclusion 

We reviewed the relevant data and 

determined that air safety and the 

public interest require adopting this AD 

as proposed except for minor editorial 

changes. We have determined that these 

minor changes: 

• Are consistent with the intent that 

was proposed in the NPRM for 

correcting the unsafe condition; and 

• Do not add any additional burden 

upon the public than was already 

proposed in the NPRM. 

Related Service Information Under 1 

CFR Part 51 

We reviewed PIAGGIO AERO 

INDUSTRIES S.p.A. Mandatory Service 

Bulletin N.: 80–0455, dated: January 13, 

2017. This service information describes 

procedures for repetitive inspections to 

verify the structural integrity of the 

flight control 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 AD. 

Costs of Compliance 

We estimate that this AD will affect 

103 products of U.S. registry. We also 

estimate that it will take 9 work-hours 

per product to comply with the basic 

requirements of this 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 $78,795, or $765 per product. 

The scope of damage found in the 

required inspections could vary 

significantly from airplane to airplane. 

We have no way of determining how 

much damage may be found on each 

airplane or the cost to repair damaged 

parts on each airplane. 

In addition, we have no way of 

knowing how many products may need 

replacement as a result of the required 

inspections. The following cost 

estimates were obtained directly from 

the manufacturer and we estimate that 

any necessary follow-on replacement 

actions would cost as follows: 

(i) Control surface repair: 10 workhours for a cost of $850 per product. 

(ii) Left Hand (LH) Forward Wing 

Flap Replacement: 4 work-hours and 

require parts costing $30,079, for a total 

cost of $30,419. 

(iii) Right Hand (RH) Forward Wing 

Flap Replacement: 4 work-hours and 

require parts costing $30,079, for a total 

cost of $30,419. 

(iv) LH Aileron Assembly: 7 workhours and require parts costing $40,715, 

for a total cost of $41,310. 

(v) RH Aileron Assembly: 7 workhours and require parts costing $86,050, 

for a total cost of $86,645. 

(vi) Main Wing LH Inboard Flap 

Assembly: 4 work-hours and require 

parts costing $22,699, for a total cost of 

$23,039. 

(vii) Main Wing RH Inboard Flap 

Assembly: 4 work-hours and require 


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47372 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Rules and Regulations 

parts costing $22,699, for a total cost of 

$23,039. 

(viii) LH Elevator Assembly: 8 workhours and require parts costing $59,917, 

for a total cost of $60,597. 

(ix) RH Elevator Assembly: 8 workhours and require parts costing $59,917, 

for a total cost of $60,597. 

There is an additional 10 work-hours 

that may be required for post-repair or 

post-installation replacement of flight 

control surface adjustments and testing, 

for a total cost of $850. 

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. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to small airplanes and 

domestic business jet transport 

airplanes to the Director of the Policy 

and Innovation Division. 

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–2017– 

0648; 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 adding 

the following new AD: 

2017–20–13 Piaggio Aero Industries S.p.A.: 

Amendment 39–19070; Docket No. 

FAA–2017–0648; Product Identifier 

2017–CE–012–AD. 

(a) Effective Date 

This airworthiness directive (AD) becomes 

effective November 16, 2017. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to PIAGGIO AERO 

INDUSTRIES S.p.A. P–180 airplanes, serial 

numbers 1002, 1004 through 1220, that are: 

(1) Equipped with flight control surfaces 

part numbers (P/Ns) and serial numbers (S/ 

Ns) not listed in table 1 of PIAGGIO AERO 

INDUSTRIES S.p.A. Mandatory Service 

Bulletin N.: 80–0455, dated: January 13, 2017 

(PAI SB No. 80–0455); and 

(2) certificated in any category. 

(d) Subject 

Air Transport Association of America 

(ATA) Code 27: Flight 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 disbonding 

of the upper and lower metal skin from the 

honeycomb core on the elevator assembly 

and other flight control surfaces. We are 

issuing this AD to prevent structural stiffness 

of the flight control surface and the 

downgrade of its aerodynamic 

characteristics, resulting in reduced control. 

(f) Actions and Compliance 

Unless already done, do the actions in 

paragraphs (f)(1) through (8) of this AD. The 

parts affected by this AD are all left hand 

(LH) forward flaps, right hand (RH) forward 

flaps, main wing LH inboard flaps, main 

wing RH inboard flaps, LH ailerons, RH 

ailerons, LH elevators, and RH elevators, 

hereafter referred to as ‘‘affected control 

surface’’ in this AD. 

(1) Within the next 50 hours time-inservice (TIS) after November 16, 2017 (the 

effective date of this AD) or within the next 

200 hours TIS after the last coin tapping 

inspection of the affected control surface 

following PAI Non-Destructive Test Manual 

(NDTM) 180–MAN–0300–01107, Chapter 51– 

00–01; whichever occurs later, do a coin 

tapping inspection of each affected control 

surface. Repetitively thereafter inspect at the 

intervals specified in paragraphs (f)(3)(i) and 

(ii). Follow Part B of the Accomplishment 

Instructions in PAI SB No. 80–0455. 

(i) Do two repetitive inspections at 

intervals not to exceed 200 hours TIS; and 

(ii) Repetitively thereafter inspect at 

intervals not to exceed 600 hours TIS. 

(2) If damage is found during any 

inspection required in paragraph (f)(1) of this 

AD, before further flight, repair or replace as 

necessary each damaged affected control 

surface following Part B and/or C of the 

Accomplishment Instructions in PAI SB No. 

80–0455. 

(3) Within 50 hours TIS after the repair of 

an affected control surface as required by 

paragraph (f)(2) of this AD, do a coin tapping 

inspection of that repaired affected control 

surface. Repetitively thereafter inspect at the 

intervals specified in paragraphs (f)(3)(i) and 

(ii) of this AD. Follow the instructions in PAI 

SB No. 80–0455. 

(i) Do two repetitive inspections at 

intervals not to exceed 200 hours TIS; and 

(ii) Repetitively thereafter inspect at 

intervals not to exceed 600 hours TIS. 

(4) If damage is found during any 

inspection required in paragraph (f)(3) of this 

AD, before further flight, repair or replace as 

necessary each damaged affected control 

surface following the instructions in Part B 

and/or C of the Accomplishment Instructions 

in PAI SB No. 80–0455. 

(5) Repair of an affected control surface, as 

required by paragraph (f)(2) or (4) of this AD, 

does not constitute terminating action for 

repetitive inspections as required by this AD 


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Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Rules and Regulations 47373 

for that affected control surface, unless the 

FAA-approved repair instructions specify 

otherwise. 

(6) Replacement of the affected part on an 

airplane with a part listed in table 1 of PAI 

SB No. 80–0455, constitutes terminating 

action for the repetitive inspections required 

by this AD for that part. 

(7) You may incorporate the actions of PAI 

SB No. 80–0455, into your FAA-approved 

airplane inspection program (AIP) or 

maintenance program (instructions for 

continued airworthiness) to ensure the 

continuing airworthiness of each operated 

airplane. 

(8) After November 16, 2017 (the effective 

date of this AD), you may install on an 

airplane an affected control surface not listed 

in table 1 of PAI SB No. 80–0455, provided 

that before further flight after installation, the 

affected control surface has been inspected as 

specified in this AD and found airworthy. 

(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: Mike Kiesov, Aerospace Engineer, 

FAA, Small Airplane Standards Branch, 901 

Locust, Room 301, Kansas City, Missouri 

64106; telephone: (816) 329–4144; fax: (816) 

329–4090; email: mike.kiesov@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) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, Small Airplane Standards 

Branch, FAA; or the European Aviation 

Safety Agency (EASA). 

(3) Reporting Requirements: For any 

reporting requirement in this AD, a federal 

agency may not conduct or sponsor, and a 

person is not required to respond to, nor 

shall a person be subject to a penalty for 

failure to comply with a collection of 

information subject to the requirements of 

the Paperwork Reduction Act unless that 

collection of information displays a current 

valid OMB Control Number. The OMB 

Control Number for this information 

collection is 2120–0056. Public reporting for 

this collection of information is estimated to 

be approximately 5 minutes per response, 

including the time for reviewing instructions, 

completing and reviewing the collection of 

information. All responses to this collection 

of information are mandatory. Comments 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave. SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No.: 2017–0045, dated 

March 9, 2017 for related information. You 

may examine the MCAI on the Internet at 

https://www.regulations.gov/ 

document?D=FAA-2017-0648-0002. 

(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 this AD specifies otherwise. 

(i) PIAGGIO AERO INDUSTRIES S.p.A. 

Mandatory Service Bulletin (SB) No.: 80– 

0455, dated January 13, 2017. 

(ii) Reserved. 

(3) For PIAGGIO AERO INDUSTRIES 

S.p.A. service information identified in this 

AD, contact PIAGGIO AERO INDUSTRIES 

S.p.A.—Continued Airworthiness, Via 

Pionieri e Aviatori d’Italia snc—16154 

Genova, Italy; Telephone: +39 010 0998046; 

Fax: None; email: airworthiness@

piaggioaerospace.it; Internet: 

www.piaggioaerospace.it/en/customersupport#care. 

(4) You may view this service information 

at the FAA, Policy and Innovation Division, 

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–2017–0648. 

(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 Kansas City, Missouri, on 

September 29, 2017. 

Pat Mullen, 

Acting Deputy Director, Policy & Innovation 

Division, Aircraft Certification Service. 

[FR Doc. 2017–21443 Filed 10–11–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2017–N–1608] 

Medical Devices; Neurological 

Devices; Classification of Cranial 

Motion Measurement Device; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

final order entitled ‘‘Medical Devices; 

Neurological Devices; Classification of 

Cranial Motion Measurement Device’’ 

that appeared in the Federal Register of 

July 28, 2017. The final order was 

published with an incorrect statement 

in the preamble about whether FDA 

planned to exempt the device from 

premarket notification requirements. 

This document corrects that error. 

DATES: Effective October 12, 2017. 

FOR FURTHER INFORMATION CONTACT: Jay 

Gupta, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2611, Silver Spring, 

MD 20993–0002, 301–796–2795, 

jay.gupta@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 28, 2017 (82 FR 

35069), FDA published the final order 

‘‘Medical Devices; Neurological Devices; 

Classification of Cranial Motion 

Measurement Device.’’ The final order 

published with an incorrect statement 

in the preamble about whether FDA 

planned to exempt the device from 

premarket notification requirements 

under section 510(k) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360(k)). 

Correction 

In the Federal Register of July 28, 

2017, in FR Doc. 2017–15895, the 

following correction is made: 

On page 35070, after table 1 in the third 

column, the last paragraph is corrected to 

read as follows: 

‘‘Section 510(m) of the FD&C Act provides 

that FDA may exempt a class II device from 

the premarket notification requirements 

under section 510(k), if FDA determines that 

premarket notification is not necessary to 

provide reasonable assurance of the safety 

and effectiveness of the device. For this type 

of device, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of the safety 

and effectiveness of the device. Therefore, 

this device type is not exempt from 

premarket notification requirements. Persons 

who intend to market this type of device 

must submit to FDA a premarket notification, 

prior to marketing the device, which contains 

information about the cranial motion 

measurement device they intend to market.’’ 

Dated: October 4, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21982 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 


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