Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Rules and Regulations 6549 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–0801; Directorate 

Identifier 2010–NM–054–AD; Amendment 

39–16595; AD 2011–03–11] 

RIN 2120–AA64 

Airworthiness Directives; Airbus Model 

A300 B4–600 and A300 B4–600R Series 

Airplanes, Model A300 F4–605R 

Airplanes, and Model A300 C4–605R 

Variant F Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for the 

products listed above. 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: 

A recent Wide spread Fatigue Damage 

(WFD) calculation on A300–600 aeroplanes 

has shown that a reinforcement of the upper 

fuselage circumferential joint at FR (frame) 

58 is necessary to enable the aeroplane to 

reach the Extended Service Goal (ESG). 

The failure of the circumferential joint of 

the upper fuselage could affect the structural 

integrity of the aeroplane. 

* * * * * 

We are issuing this AD to require 

actions to correct the unsafe condition 

on these products. 

DATES: This AD becomes effective 

March 14, 2011. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of March 14, 2011. 

ADDRESSES: You may examine the AD 

docket on the Internet at http:// 

www.regulations.gov or in person at the 

U.S. Department of Transportation, 

Docket Operations, M–30, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC. 

FOR FURTHER INFORMATION CONTACT: Dan 

Rodina, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone 

(425) 227–2125; fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to include an AD that would 

apply to the specified products. That 

NPRM was published in the Federal 

Register on August 23, 2010 (75 FR 

51705). That NPRM proposed to correct 

an unsafe condition for the specified 

products. The MCAI states: 

A recent Wide spread Fatigue Damage 

(WFD) calculation on A300–600 aeroplanes 

has shown that a reinforcement of the upper 

fuselage circumferential joint at FR (frame) 

58 is necessary to enable the aeroplane to 

reach the Extended Service Goal (ESG). 

The failure of the circumferential joint of 

the upper fuselage could affect the structural 

integrity of the aeroplane. 

For the reasons described above, this AD 

requires the reinforcement of the affected 

fuselage frame butt joint. 

You may obtain further information 

by examining the MCAI in the AD 

docket. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

considered the comment received. 

Request To Revise Paragraph (g) of the 

NPRM 

FedEx Express (FedEx) requested that 

we add the following sentence to 

paragraph (g) of the NPRM: 

‘‘Accomplish modification in 

accordance with the thresholds 

specified in [Airbus Mandatory] Service 

Bulletin A300–53–6146, Revision 01, 

[dated June 26, 2009,] paragraph E(2), 

Accomplishment Timescale.’’ FedEx 

stated that the threshold table in that 

service bulletin recommends the 

number of flight cycles for each model 

after which the modification should be 

embodied; if the modification is 

embodied before the recommended 

threshold, additional inspections are 

required according to Airbus 

instructions. FedEx further stated that 

the NPRM stipulates accomplishment 

before 42,500 flight cycles and FedEx 

agrees that following the Airbus 

recommendation for the thresholds will 

avoid extensive inspections similar to 

the Airworthiness Limitations Items 

(ALI) Tasks 53.16.04–01–1 and 

53.16.22–01–1. 

We do not agree to add the quoted 

sentence to the AD because, by doing 

the requirements of this AD at or before 

the compliance time specified in this 

AD, no further inspections are required 

by this AD. However, we have added a 

new Note 1 that states ‘‘In case of earlier 

accomplishment of Airbus Mandatory 

Service Bulletin A300–53–6146, 

Revision 01, dated June 26, 2009, before 

the recommended thresholds contained 

in the Threshold Table in paragraph 

1.E.(2) of Airbus Mandatory Service 

Bulletin A300–53–6146, Revision 01, 

dated June 26, 2009, are reached, the 

operator should contact Airbus to define 

an additional non-mandatory 

appropriate inspection program.’’ We 

have reidentified subsequent notes 

accordingly. 

Further, we have determined that 

accomplishing the actions required by 

this AD terminates ALI Tasks 53.16.04– 

01–1 and 53.16.22–01–1. Therefore, we 

have added a new paragraph (h) to this 

AD to clarify that doing the 

requirements of this AD terminates ALI 

Tasks 53.16.04–01–1 and 53.16.22–01– 

1. We have reidentified subsequent 

paragraphs accordingly. 

Conclusion 

We reviewed the available data, 

including the comment received, and 

determined that air safety and the 

public interest require adopting the AD 

with the changes described previously. 

We determined that these changes will 

not increase the economic burden on 

any operator or increase the scope of the 

AD. 

Differences Between This AD and the 

MCAI or Service Information 

We have reviewed the MCAI and 

related service information and, in 

general, agree with their substance. But 

we might have found it necessary to use 

different words from those in the MCAI 

to ensure the AD is clear for U.S. 

operators and is enforceable. 

In making these changes, we do not 

intend to differ substantively from the 

information provided in the MCAI and 

related service information. 

We might also have required different 

actions in this AD from those in the 

MCAI in order to follow our FAA 

policies. Any such differences are 

highlighted in a Note within the AD. 

Costs of Compliance 

We estimate that this AD will affect 

about 124 products of U.S. registry. We 

also estimate that it will take about 347 

work-hours per product to comply with 

the basic requirements of this AD. The 

average labor rate is $85 per work-hour. 

Required parts will cost about $5,670 

per product. Where the service 

information lists required parts costs 

that are covered under warranty, we 

have assumed that there will be no 

charge for these parts. As we do not 

control warranty coverage for affected 

parties, some parties may incur costs 

higher than estimated here. Based on 

these figures, we estimate the cost of 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
6550 Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Rules and Regulations 

this AD to the U.S. operators to be 

$4,360,460 or $35,165 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 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); and 

3. 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 a regulatory evaluation 

of the estimated costs to comply with 

this AD and placed it in the AD docket. 

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 the NPRM, the regulatory 

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. 

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: 

2011–03–11 Airbus: Amendment 39–16595. 

Docket No. FAA–2010–0801; Directorate 

Identifier 2010–NM–054–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective March 14, 2011. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Airbus Model A300 

B4–601, B4–603, B4–620, and B4–622 

airplanes; Model A300 B4–605R and B4– 

622R airplanes; Model A300 F4–605R 

airplanes on which modification 12699 has 

not been accomplished; and Model A300 C4– 

605R Variant F airplanes; certificated in any 

category; all serial numbers. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 53: Fuselage. 

Reason 

(e) The mandatory continuing 

airworthiness information (MCAI) states: 

A recent Wide spread Fatigue Damage 

(WFD) calculation on A300–600 aeroplanes 

has shown that a reinforcement of the upper 

fuselage circumferential joint at FR (frame) 

58 is necessary to enable the aeroplane to 

reach the Extended Service Goal (ESG). 

The failure of the circumferential joint of 

the upper fuselage could affect the structural 

integrity of the aeroplane. 

* * * * * 

Compliance 

(f) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Actions 

(g) Before the accumulation of 42,500 total 

flight cycles, or within 2,000 flight cycles 

after the effective date of this AD, whichever 

occurs later, reinforce the fuselage butt joint 

at FR 58 in accordance with the 

Accomplishment Instructions of Airbus 

Mandatory Service Bulletin A300–53–6146, 

Revision 01, including Appendix 1, dated 

June 26, 2009. 

(h) Accomplishment of the requirements of 

paragraph (g) of this AD terminates 

Airworthiness Limitations Items (ALI) Tasks 

53.16.04–01–1 and 53.16.22–01–1 for these 

airplanes. 

Note 1: In case of earlier accomplishment 

of Airbus Mandatory Service Bulletin A300– 

53–6146, Revision 01, dated June 26, 2009, 

before the recommended thresholds 

contained in the Threshold Table in 

paragraph 1.E.(2) of Airbus Mandatory 

Service Bulletin A300–53–6146, Revision 01, 

dated June 26, 2009, are reached, the operator 

should contact Airbus to define an additional 

appropriate inspection program. 

FAA AD Differences 

Note 2: This AD differs from the MCAI 

and/or service information as follows: 

No differences. 

Other FAA AD Provisions 

(i) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, 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: Dan Rodina, 

Aerospace Engineer, International Branch, 

ANM–116, Transport Airplane Directorate, 

FAA, 1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone (425) 

227–2125; fax (425) 227–1149. 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. The AMOC approval letter 

must specifically reference this AD. 

(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. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act 

(44 U.S.C. 3501 et seq.), the Office of 

Management and Budget (OMB) has 

approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(j) Refer to MCAI European Aviation Safety 

Agency (EASA) Airworthiness Directive 

2010–0007, dated January 7, 2010; and 

Airbus Mandatory Service Bulletin A300–53– 

6146, Revision 01, including Appendix 1, 

dated June 26, 2009; for related information. 

Material Incorporated by Reference 

(k) You must use Airbus Mandatory 

Service Bulletin A300–53–6146, Revision 01, 

including Appendix 1, dated June 26, 2009, 

to do the actions required by this AD, unless 

the AD specifies otherwise. 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Rules and Regulations 6551 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Airbus SAS—EAW 

(Airworthiness Office), 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France; 

telephone +33 5 61 93 36 96; fax +33 5 61 

93 44 51; e-mail account.airwortheas@airbus.com; Internet http:// 

www.airbus.com. 

(3) You may review copies of the service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, call 

425–227–1221. 

(4) You may also review copies of the 

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/

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on January 

25, 2011. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2011–2433 Filed 2–4–11; 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–2010–D–0645] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of 

Contact Cooling System for Aesthetic 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

contact cooling system for aesthetic use 

into class II (special controls). The 

special control that will apply to the 

device is the guidance document 

entitled ‘‘Guidance for Industry and 

FDA Staff; Class II Special Controls 

Guidance Document: Contact Cooling 

System for Aesthetic Use.’’ The Agency 

is classifying the device into class II 

(special controls) in order to provide 

reasonable assurance of safety and 

effectiveness of the device. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of a 

guidance document that will serve as 

the special control for this device type. 

DATES: Effective Date: March 9, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Richard Felten, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1436, Silver Spring, 

MD 20993, 301–796–6392. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

rulemaking? 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 301 et 

seq.) 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), and the Food and Drug 

Administration Modernization Act (Pub. 

L. 107–250) established a 

comprehensive system for 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, depending on 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). 

FDA refers to devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as postamendments 

devices. Postamendments devices are 

classified automatically by statute 

(section 513(f) of the FD&C Act) into 

class III without any FDA rulemaking 

process. These devices remain in class 

III and require premarket approval 

unless: (1) FDA reclassifies the device 

into class I or II; (2) FDA issues an order 

classifying the device into class I or 

class II in accordance with section 

513(f)(2) of the FD&C Act; or FDA issues 

an order finding the device to be 

substantially equivalent, under section 

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

CFR part 807 of the regulations. 

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

provides that any person who submits a 

premarket notification under section 

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

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device that has not 

previously been classified into class III 

under section 513(f)(1), request FDA to 

classify the device under the criteria set 

forth in section 513(a)(1). FDA will, 

within 60 days of receiving this request, 

classify the device by written order. 

This classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

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

the FD&C Act, FDA issued an order on 

October 7, 2009, classifying the Zeltiq 

Lipolysis System for Aesthetic Use 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 13, 2009, ZeltiqTM Aesthetic, 

Inc., submitted a petition requesting 

classification of the lipolysis system for 

aesthetic use 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 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1). FDA classifies 

devices into class II if general controls 

by themselves are insufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the contact 

cooling system for aesthetic use can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide assurance of the safety and 

effectiveness of the device. 

The device was assigned the generic 

name ‘‘Cooling System for Aesthetic 

Use’’ and it is identified as a cooling 

system for aesthetic use. FDA has 

identified the following risks to health 

associated specifically with this type of 

device and the recommended measures 

to mitigate these risks. 

• Discomfort and pain during and 

following treatment are possible due to 

the application of mechanical or 

vacuum massage at levels in excess of 

those recommended in the labeling. 

These effects and tenderness at the 

treatment site may also occur following 

treatment. Prevention of these effects are 

addressed by adequate bench testing 

demonstrating that the feedback 

controls for temperature/cooling are 

functional and do maintain target 

temperature within the stated value. 

Proper function of mechanical controls 

to insure use of the mechanical or 

vacuum massager within safe limits 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1