Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Rules and Regulations 31857 

(h) Subject 

Joint Aircraft Service Component (JASC) 

Code: Engine Controls, 7600. 

Issued in Fort Worth, Texas, on May 21, 

2014. 

Lance T. Gant, 

Acting Directorate Manager, Rotorcraft 

Directorate, Aircraft Certification Service. 

[FR Doc. 2014–12717 Filed 6–2–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2014–0336; Directorate 

Identifier 2013–SW–063–AD; Amendment 

39–17857; AD 2014–11–07] 

RIN 2120–AA64 

Airworthiness Directives; Agusta S.p.A 

Helicopters (Type Certificate Currently 

Held by AgustaWestland S.p.A) 

(Agusta) 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for Agusta 

Model A109A, A109A II, A109C, 

A109E, A109K2, A109S, AW109SP, 

A119, and AW119 MKII helicopters. 

This AD requires inspecting and 

replacing certain part-numbered main 

rotor swashplate support nuts. This AD 

is prompted by a report of two cracked 

nuts found on an A109S helicopter. 

These actions are intended to detect a 

cracked nut and prevent failure of the 

main rotor system, and subsequent loss 

of control of the helicopter. 

DATES: This AD becomes effective June 

18, 2014. 

We must receive comments on this 

AD by August 4, 2014. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Docket: Go to 

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

online instructions for sending your 

comments electronically. 

• Fax: 202–493–2251. 

• Mail: Send comments to the U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE., Washington, 

DC 20590–0001. 

• Hand Delivery: Deliver to the 

‘‘Mail’’ address between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov or in person at the 

Docket Operations Office between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The AD 

docket contains this AD, the foreign 

authority’s AD, the economic 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations Office (telephone 

800–647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

For service information identified in 

this AD, contact AgustaWestland, 

Product Support Engineering, Via del 

Gregge, 100, 21015 Lonate Pozzolo (VA) 

Italy, ATTN: Maurizio D’Angelo; 

telephone 39–0331–664757; fax 39 

0331–664680; or at http://

www.agustawestland.com/technicalbulletins. You may review the 

referenced service information at the 

FAA, Office of the Regional Counsel, 

Southwest Region, 2601 Meacham 

Blvd., Room 663, Fort Worth, Texas 

76137. 

FOR FURTHER INFORMATION CONTACT: 

Robert Grant, Aviation Safety Engineer, 

Safety Management Group, FAA, 2601 

Meacham Blvd., Fort Worth, Texas 

76137; telephone (817) 222–5110; email 

robert.grant@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety, and 

we did not provide you with notice and 

an opportunity to provide your 

comments prior to it becoming effective. 

However, we invite you to participate in 

this rulemaking by submitting written 

comments, data, or views. We also 

invite comments relating to the 

economic, environmental, energy, or 

federalism impacts that resulted from 

adopting this AD. The most helpful 

comments reference a specific portion of 

the AD, explain the reason for any 

recommended change, and include 

supporting data. To ensure the docket 

does not contain duplicate comments, 

commenters should send only one copy 

of written comments, or if comments are 

filed electronically, commenters should 

submit them only one time. We will file 

in the docket all comments that we 

receive, as well as a report summarizing 

each substantive public contact with 

FAA personnel concerning this 

rulemaking during the comment period. 

We will consider all the comments we 

receive and may conduct additional 

rulemaking based on those comments. 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Union, has issued EASA Emergency AD 

No. 2013–0265–E, dated October 30, 

2013, to correct an unsafe condition for 

Agusta Model A109A, A109A II, A109C, 

A109E, A109K2, A109LUH, A109S, 

AW109SP, A119, and AW119 MKII 

helicopters. EASA advises that during a 

scheduled inspection of the rotating 

control installation, two nuts, part 

number (P/N) MS21042–4, which 

connect the swashplate support to the 

upper case of the main transmission 

were found cracked. EASA states a 

subsequent investigation determined 

that the cracks in the nuts resulted from 

a production deficiency, which caused 

hydrogen embrittlement, at the nut 

manufacturer. EASA also states that this 

condition, if not detected and corrected, 

could lead to failure of the main rotor 

function and subsequent loss of control 

of the helicopter. The EASA Emergency 

AD requires repetitive inspections of 

each nut, P/N MS21042–4, for a crack, 

replacing any nut that has a crack with 

a different part-numbered nut, and, 

within 3 months, replacing each nut 

that does not have a crack with a 

different part-numbered nut. EASA 

Emergency AD 2013–0265–E also 

prohibits installing a nut, P/N 

MS21042–4, to connect the swashplate 

support to the upper case on any 

helicopter. 

FAA’s Determination 

These helicopters have been approved 

by the aviation authority of Italy and are 

approved for operation in the United 

States. Pursuant to our bilateral 

agreement with Italy, EASA, its 

technical representative, has notified us 

of the unsafe condition described in the 

EASA AD. We are issuing this AD 

because we evaluated all information 

provided by EASA and determined the 

unsafe condition exists and is likely to 

exist or develop on other helicopters of 

these same type designs. 

Related Service Information 

Agusta has issued Bollettino Tecnico 

(BT) No. 109–137 for Model A109A, 

A109A II and A109C helicopters; BT 

No. 109EP–131 for Model A109E 

helicopters; BT No. 109K–59 for Model 

A109K2 helicopters; BT No. 109S–056 

for Model A109S helicopters; BT No. 

109SP–070 for Model AW109SP 

helicopters; and BT No. 119–062 for 

Model A119 and AW119 MKII 

helicopters. All of the BTs are Revision 

0 and are dated October 29, 2013. Each 

BT describes procedures for inspecting 


wreier-aviles on DSK5TPTVN1PROD with RULES
31858 Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Rules and Regulations 

the nuts connecting the swashplate 

support to the upper case of the main 

transmission for a crack and for 

replacing each nut, P/N MS21042–4, 

with a nut, P/N NAS1805–4. 

AD Requirements 

This AD requires, within 10 hours 

time-in-service (TIS), inspecting each 

nut, P/N MS21042–4, which connects 

the swashplate support to the upper 

case of the main transmission, for a 

crack. If there is a crack on any nut, or 

within 25 hours TIS if there is not a 

crack, this AD requires replacing each 

nut, P/N MS21042–4, connecting the 

swashplate support to the upper case of 

the main transmission. This AD also 

prohibits installing a nut, P/N 

MS21042–4, connecting the swashplate 

support to the upper case of the main 

transmission on any helicopter. 

Differences Between This AD and the 

EASA 

The EASA AD requires replacing each 

nut, P/N MS21042–4, within 3 months, 

while this AD requires replacing the 

nuts within 25 hours TIS. The EASA AD 

also requires that each of the P/N 

MS21042–4 nuts be replaced with P/N 

NAS1805–4 nuts and this AD does not. 

The EASA AD also requires repetitive 

inspections of the P/N MS21042–4 nuts 

until they can be replaced and this AD 

does not. This AD does not apply to 

Model A109LUH helicopters as they are 

not type-certificated in the U.S. 

Costs of Compliance 

We estimate that this AD affects 222 

helicopters of U.S. Registry. We estimate 

that operators may incur the following 

costs in order to comply with this AD. 

At an average labor rate of $85 per workhour, inspecting the nuts connecting the 

swashplate support to the upper case of 

the main transmission requires about .5 

work-hour, for a cost per helicopter of 

$43, and a total cost to U.S. operators of 

$9,546. Replacing the nuts requires 

about 1 work-hour, and required parts 

cost is minimal, for a cost per helicopter 

of $85 and a total cost to U.S. operators 

of $18,870. 

FAA’s Justification and Determination 

of the Effective Date 

Providing an opportunity for public 

comments before adopting these AD 

requirements would delay 

implementing the safety actions needed 

to correct this known unsafe condition. 

Therefore, we find that the risk to the 

flying public justifies waiving notice 

and comment before adopting this rule 

because the required corrective actions 

must be done within 10 hours TIS and 

25 hours TIS, a very short time period 

based on the average flight-hour 

utilization rate of these helicopters. 

Since an unsafe condition exists that 

requires the immediate adoption of this 

AD, we determined that notice and 

opportunity for public comment before 

issuing this AD are impracticable and 

that good cause exists for making this 

amendment effective in less than 30 

days. 

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, I certify 

that this AD: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska to the extent that it justifies 

making a regulatory distinction; 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. 

We prepared an economic evaluation 

of the estimated costs to comply with 

this AD and placed it in the AD docket. 

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 airworthiness 

directive (AD): 

2014–11–07 Agusta S.p.A Helicopters 

(Type Certificate Currently Held By 

AgustaWestland S.p.A) (Agusta): 

Amendment 39–17857; Docket No. 

FAA–2014–0336; Directorate Identifier 

2013–SW–063–AD. 

(a) Applicability 

This AD applies to Agusta Model A109A, 

A109A II, A109C, A109E, A109K2, A109S, 

AW109SP, A119, and AW119 MKII 

helicopters with a nut, part-number (P/N) 

MS21042–4, connecting the main rotor 

swashplate support to the upper case of the 

main transmission installed, certificated in 

any category. 

(b) Unsafe Condition 

This AD defines the unsafe condition as a 

crack on a nut connecting the main rotor 

swashplate support to the upper case of the 

main transmission. This condition could 

result in failure of the main rotor system and 

subsequent loss of control of the helicopter. 

(c) Effective Date 

This AD becomes effective June 18, 2014. 

(d) Compliance 

You are responsible for performing each 

action required by this AD within the 

specified compliance time unless it has 

already been accomplished prior to that time. 

(e) Required Actions 

(1) Within 10 hours time-in-service (TIS), 

using a light, visually inspect each nut, P/N 

MS21042–4, which connects the swashplate 

support to the upper case of the main 

transmission for a crack. 

(i) If there is a crack, before further flight, 

remove all six nuts, P/N MS21042–4, 

connecting the swashplate support to the 

upper case. 

(ii) If there are no cracks, within 25 hours 

TIS, remove all six nuts, P/N MS21042–4, 

connecting the swashplate support to the 

upper case. 

(2) Do not install a nut, P/N MS21042–4, 

connecting the swashplate support to the 

upper case of the main transmission on any 

helicopter. 

(f) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Group, Rotorcraft Directorate, FAA, may 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Rules and Regulations 31859 

approve AMOCs for this AD. Send your 

proposal to: Robert Grant, Aviation Safety 

Engineer, Safety Management Group, FAA, 

2601 Meacham Blvd., Fort Worth, Texas 

76137; telephone (817) 222–5110; email 

robert.grant@faa.gov. 

(2) For operations conducted under a 14 

CFR part 119 operating certificate or under 

14 CFR part 91, subpart K, we suggest that 

you notify your principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office or 

certificate holding district office, before 

operating any aircraft complying with this 

AD through an AMOC. 

(g) Additional Information 

(1) Agusta Bollettino Tecnico (BT) No. 

109–137 for Model A109A, A109A II and 

A109C helicopters; BT No. 109EP–131 for 

Model A109E helicopters; BT No. 109K–59 

for Model A109K2 helicopters; BT No. 109S– 

056 for Model A109S helicopters; BT No. 

109SP–070 for Model AW109SP helicopters; 

and BT No. 119–062 for Model A119 and 

AW119 MKII helicopters, all Revision 0 and 

dated October 29, 2013, which are not 

incorporated by reference, contain additional 

information about the subject of this AD. For 

service information identified in this AD, 

contact AgustaWestland, Product Support 

Engineering, Via del Gregge, 100, 21015 

Lonate Pozzolo (VA) Italy, ATTN: Maurizio 

D’Angelo; telephone 39–0331–664757; fax 

39–0331–664680; or at http://

www.agustawestland.com/technicalbullettins. You may review a copy of the 

service information at the FAA, Office of the 

Regional Counsel, Southwest Region, 2601 

Meacham Blvd., Room 663, Fort Worth Texas 

76137. 

(2) The subject of this AD is addressed in 

European Aviation Safety Agency (EASA) 

Emergency AD No. 2013–0265–E, dated 

October 30, 2013. You may view the EASA 

AD on the internet at http://

www.regulations.gov in Docket No. FAA– 

2014–0336. 

(h) Subject 

Joint Aircraft Service Component (JASC) 

Code: 6200 Main Rotor System. 

Issued in Fort Worth, Texas, on May 21, 

2014. 

Lance T. Gant, 

Acting Directorate Manager, Rotorcraft 

Directorate, Aircraft Certification Service. 

[FR Doc. 2014–12719 Filed 6–2–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2014–N–0576] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Powered Surgical Instrument for 

Improvement in the Appearance of 

Cellulite 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

powered surgical instrument for 

improvement in the appearance of 

cellulite into class II (special controls). 

The Agency is classifying the device 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of the device. 

DATES: This order is effective July 3, 

2014. The classification was applicable 

on July 12, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Jitendra Virani, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G459, Silver Spring, 

MD 20993–0002, 301–796–6398. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or 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 part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144, July 9, 

2012, 126 Stat. 1054), provides two 

procedures by which a person may 

request FDA to classify a device under 

the criteria set forth in section 513(a)(1) 

(a de novo request). Under the first 

procedure, the person submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified and, 

within 30 days of receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

the person requests a classification 

under section 513(f)(2). Under the 

second procedure, rather than first 

submitting a premarket notification 

under section 510(k) and then a request 

for classification under the first 

procedure, the person determines that 

there is no legally marketed device upon 

which to base a determination of 

substantial equivalence and requests a 

classification under section 513(f)(2) of 

the FD&C Act. If the person submits a 

request to classify the device under this 

second procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. In 

accordance with section 513(f)(1) of the 

FD&C Act, FDA issued an order on 

March 14, 2011, classifying the 

Cabochon System into class III, because 

it was not substantially equivalent to a 

device that was introduced or delivered 

for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, or a device which 

was subsequently reclassified into class 

I or class II. On October 29, 2011, 

Cabochon Aesthetics, Inc., submitted a 

request for classification of the 

Cabochon System under section 

513(f)(2) of the FD&C Act. The 

manufacturer recommended that the 

device be classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 


wreier-aviles on DSK5TPTVN1PROD with RULES