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 


jstallworth on DSKBBY8HB2PROD with RULES