Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 11475 

(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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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 39–11320 (64 FR 

50440; September 17, 1999), and adding 

the following new AD: 

Blanik Limited: Docket No. FAA–2016–4233; 

Directorate Identifier 2016–CE–003–AD. 

(a) Comments Due Date 

We must receive comments by April 18, 

2016. 

(b) Affected ADs 

This AD replaces AD 99–19–33, 

Amendment 39–11320 (64 FR 50440; 

September 17, 1999) (‘‘AD 99–19–33’’). 

(c) Applicability 

This AD applies to BLANIK LIMITED 

Models L–13 Blanik and L–13 AC Blanik 

gliders (type certificate previously by LET 

Aeronautical Works), all serial numbers, 

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 lack of 

distinct color marking of the elevator drive. 

We are issuing this AD to prevent inadvertent 

backward installation of the elevator drive, 

which could cause significant elevator 

deflection changes and lead to loss of control. 

(f) Actions and Compliance 

Unless already done, do the following 

actions in paragraphs (f)(1) and (f)(2) of this 

AD, including all subparagraphs: 

(1) Model L–13 Blanik gliders: 

(i) Within the next 3 calendar months after 

November 8, 1999 (the effective date retained 

from AD 99–19–33), paint the elevator drive 

mechanism using a contrasting color (such as 

red) following the procedures in LET 

Mandatory Bulletin MB No.: L13/082a, dated 

December 10, 1998. 

(ii) As of November 8, 1999 (the effective 

date retained from AD 99–19–33), only 

install an elevator bellcrank that has been 

painted as specified in paragraph (f)(1)(i) of 

this AD and that has been properly oriented 

to make sure it is not being installed 

backward. 

(2) Model L–13 AC Blanik gliders: 

(i) Within the next 3 calendar months after 

the effective date of this AD, paint the 

elevator drive mechanism using a contrasting 

color (such as red) following the procedures 

in LET Mandatory Bulletin MB No.: L13/

082a, dated December 10, 1998. 

(ii) As of the effective date of this AD, only 

install an elevator bellcrank that has been 

painted as specified in paragraph (f)(2)(i) of 

this AD and that has been properly oriented 

to make sure it is not being installed 

backward. 

(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: Jim Rutherford, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 329– 

4090; email: jim.rutherford@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 Civil Aviation Authority AD 

CAA–AD–4–099/98, dated December 30, 

1998, for related information. You may 

examine the MCAI on the Internet at http:// 

www.regulations.gov by searching for and 

locating Docket No. FAA–2016–4233. For 

service information related to this AD, 

contact Blanik Limited, 2nd Floor Beaux 

Lane House, Mercer Street Lower, Dublin 2, 

Republic of Ireland; phone: +420 733 662 

194; email: info@blanik.aero; Internet: http:// 

www.blanik.aero/%EF%BB%BFcustomer_

support. You may review 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. 

Issued in Kansas City, Missouri, on 

February 24, 2016. 

Robert P. Busto, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–04542 Filed 3–3–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2016–4232; Directorate 

Identifier 2015–CE–043–AD] 

RIN 2120–AA64 

Airworthiness Directives; EVECTOR, 

spol. s.r.o. Gliders 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for 

EVECTOR, spol. s.r.o. Model L 13 SEH 

VIVAT and L 13 SDM VIVAT gliders 

(type certificate previously held by 

AEROTECHNIK s.r.o.). This proposed 

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 lack of distinct color 

marking of the elevator drive. We are 

issuing this proposed AD to require 

actions to address the unsafe condition 

on these products. 

DATES: We must receive comments on 

this proposed AD by April 18, 2016. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

For service information identified in 

this proposed AD, contact EVEKTOR, 

spol. s.r.o, Letecka 1008, 686 04 

Kunovice, Czech Republic; phone: +420 


jstallworth on DSK7TPTVN1PROD with PROPOSALS
11476 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 

572 537 428; email: evektor@evektor.cz; 

Internet: http://www.evektor.cz/en/ 

sales-and-support. You may review 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. 

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–2016– 

4232; 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 this proposed AD, 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. 

FOR FURTHER INFORMATION CONTACT: Jim 

Rutherford, Aerospace Engineer, FAA, 

Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 

329–4090; email: 

jim.rutherford@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2016–4232; Directorate Identifier 

2015–CE–043–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http:// 

regulations.gov, including any personal 

information you provide. We will also 

post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

The Civil Aviation Authority, which 

is the aviation authority for the Czech 

Republic, has issued AD CAA–AD–4– 

099/98, dated December 30, 1998 

(referred to after this as ‘‘the MCAI’’), to 

correct an unsafe condition for 

EVECTOR, spol. s.r.o. Models L 13 SEH 

VIVAT and L 13 SDM VIVAT gliders 

and BLANIK LIMITED Models L–13 

Blanik and L–13 AC Blanik gliders and 

was based on mandatory continuing 

airworthiness information originated by 

an aviation authority of another country. 

The MCAI states: 

Colour marking of elevator drive is not 

inspected or re-painted during sailplane 

operation. The elevator drive is asymmetrical 

and improper installation causes significant 

elevator deflection changes. 

A review of records revealed that the 

FAA inadvertently did not address this 

MCAI for the EVECTOR, spol. s.r.o. 

Models L 13 SEH VIVAT and L 13 SDM 

VIVAT gliders and the BLANIK 

LIMITED Model L–13 AC Blanik gliders. 

This proposed AD would address this 

MCAI for the EVECTOR, spol. s.r.o. 

Models L 13 SEH VIVAT and L 13 SDM 

VIVAT gliders and would require 

painting or re-painting the elevator 

drive mechanism a contrasting color to 

prevent the backward installation of the 

elevator drive bellcrank. You may 

examine the MCAI on the Internet at 

http://www.regulations.gov by searching 

for and locating Docket No. FAA–2016– 

4232. 

The FAA will address the BLANIK 

LIMITED Model L–13 AC Blanik gliders 

in another AD action. 

Related Service Information Under 1 

CFR Part 51 

AEROTECHNIK CZ s.r.o. issued 

Mandatory Service Bulletin SEH 13– 

003a, dated December 15, 1998. The 

service information describes 

procedures for painting the left arm of 

the elevator drive. 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 NPRM. 

FAA’s Determination and Requirements 

of the Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with this State of 

Design Authority, they have notified us 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all 

information and determined the unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Costs of Compliance 

We estimate that this proposed AD 

will affect 9 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. Required 

parts would cost about $10 per product. 

Based on these figures, we estimate 

the cost of the proposed AD on U.S. 

operators to be $855, or $95 per product. 

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 proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would 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 proposed regulation: 

(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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 


jstallworth on DSK7TPTVN1PROD with PROPOSALS
Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 11477 

the FAA proposes to amend 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: 

EVECTOR, spol. s.r.o.: Docket No. FAA– 

2016–4232; Directorate Identifier 2015– 

CE–043–AD. 

(a) Comments Due Date 

We must receive comments by April 18, 

2016. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to EVECTOR, spol. s.r.o. 

L 13 SEH VIVAT and L 13 SDM VIVAT 

gliders (type certificate previously held by 

AEROTECHNIK s.r.o.), all serial numbers, 

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 lack of 

distinct color marking of the elevator drive. 

We are issuing this AD to prevent inadvertent 

backward installation of the elevator drive, 

which could cause significant elevator 

deflection changes and lead to loss of control. 

(f) Actions and Compliance 

Unless already done, do the following 

actions in paragraphs (f)(1) and (f)(2) of this 

AD. 

(1) Within the next 3 calendar months after 

the effective date of this AD, paint the 

elevator drive mechanism using a contrasting 

color (such as red) following the procedures 

in AEROTECHNIK CZ s.r.o. issued 

Mandatory Service Bulletin SEH 13–003a, 

dated December 15, 1998. 

(2) As of the effective date of this AD, only 

install an elevator bellcrank that has been 

painted as specified in paragraph (f)(1) of this 

AD and that has been properly oriented to 

make sure it is not being installed backward. 

(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: Jim Rutherford, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 329– 

4090; email: jim.rutherford@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 Civil Aviation Authority AD 

CAA–AD–4–099/98, dated December 30, 

1998, for related information. You may 

examine the MCAI on the Internet at 

http://www.regulations.gov by searching for 

and locating Docket No. FAA–2016–4232. 

For service information related to this AD, 

contact EVEKTOR, spol. s.r.o, Letecka 1008, 

686 04 Kunovice, Czech Republic; phone: 

+420 572 537 428; email: evektor@evektor.cz; 

Internet: http://www.evektor.cz/en/sales-andsupport. You may review 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. 

Issued in Kansas City, Missouri, on 

February 24, 2016. 

Robert P. Busto, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–04573 Filed 3–3–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 820 

[Docket No. FDA–2016–N–0436] 

Refurbishing, Reconditioning, 

Rebuilding, Remarketing, 

Remanufacturing, and Servicing of 

Medical Devices Performed by ThirdParty Entities and Original Equipment 

Manufacturers; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the establishment of a 

docket to receive information and 

comments on the medical device 

industry and healthcare community that 

refurbish, recondition, rebuild, 

remarket, remanufacture, service, and 

repair medical devices (hereafter termed 

‘‘third-party entity or entities’’), 

including radiation-emitting devices 

subject to the electronic product 

radiation control (EPRC) provisions of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). FDA is taking this 

action, in part, because various 

stakeholders have expressed concerns 

about the quality, safety, and continued 

effectiveness of medical devices that 

have been subject to one or more of 

these activities that are performed by 

both original equipment manufacturers 

(OEM) and third parties, including 

health care establishments. We are 

seeking comments from the widest 

range of interested persons, including 

those who are engaged in one or more 

of the activities noted previously or who 

utilize refurbished, reconditioned, 

rebuilt, remarketed, remanufactured, or 

third-party serviced and repaired 

medical devices. 

DATES: Submit either electronic or 

written comments by May 3, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 


jstallworth on DSK7TPTVN1PROD with PROPOSALS