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contains regulatory documents having general

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are keyed to and codified in the Code of

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REGISTER issue of each week.

Rules and Regulations Federal Register

55727 

Vol. 71, No. 185 

Monday, September 25, 2006 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2005–22874; Directorate 

Identifier 2005–NM–173–AD; Amendment 

39–14769; AD 2006–19–12] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Model 777–200 and –300 Series 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for certain 

Boeing Model 777–200 and –300 series 

airplanes. This AD requires inspecting 

the lower web of the aft fairing of engine 

struts for any discoloration and doing 

any related investigative and corrective 

action if necessary; inspecting the heat 

shield castings for any damage and 

doing any corrective action if necessary; 

installing gap cover strips; and replacing 

insulation blankets with new insulation 

blankets. This AD results from a report 

that several discolored fairing lower 

webs and some damaged/deteriorated 

insulation blankets were found in the aft 

fairings of engine struts. We are issuing 

this AD to prevent cracking of lower 

webs of the aft fairings, which could 

result in flammable hydraulic fluid 

leaking onto or near an ignition source, 

and possibly result in an uncontrollable 

fire in the engine strut area. 

EFFECTIVE DATE: This AD becomes 

effective October 30, 2006. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in the AD 

as of October 30, 2006. 

ADDRESSES: You may examine the AD 

docket on the Internet at http:// 

dms.dot.gov or in person at the Docket 

Management Facility, U.S. Department 

of Transportation, 400 Seventh Street 

SW., Nassif Building, Room PL–401, 

Washington, DC. 

Contact Boeing Commercial 

Airplanes, P.O. Box 3707, Seattle, 

Washington 98124–2207, for service 

information identified in this AD. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Langsted, Aerospace Engineer, 

Propulsion Branch, ANM–140S, FAA, 

Seattle Aircraft Certification Office, 

1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone 

(425) 917–6500; fax (425) 917–6590. 

SUPPLEMENTARY INFORMATION: 

Examining the Docket 

You may examine the airworthiness 

directive (AD) docket on the Internet at 

http://dms.dot.gov or in person at the 

Docket Management Facility office 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The Docket Management Facility office 

(telephone (800) 647–5227) is located on 

the plaza level of the Nassif Building at 

the street address stated in the 

ADDRESSES section. 

Discussion 

The FAA issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to include an AD that would 

apply to certain Boeing Model 777–200 

and –300 series airplanes. That NPRM 

was published in the Federal Register 

on November 9, 2005 (70 FR 67952). 

That NPRM proposed to require 

inspecting the lower web of the aft 

fairing of engine struts for any 

discoloration and doing any related 

investigative and corrective action if 

necessary; inspecting the heat shield 

castings for any damage and doing any 

corrective action if necessary; installing 

gap cover strips; and replacing 

insulation blankets with new insulation 

blankets. 

Comments 

We provided the public the 

opportunity to participate in the 

development of this AD. We have 

considered the comments received. 

Supportive Comment 

One commenter, Boeing, concurs with 

the contents of the NPRM. 

Request To Address Technical 

Discrepancies in the Service Bulletin 

Continental Airlines (CAL) concurs 

with the intent of the NPRM to mandate 

Boeing Special Attention Service 

Bulletin 777–54–0021, dated June 23, 

2005, in an effort to minimize heat 

damage to the pylon aft fairing. CAL 

noted some technical discrepancies that 

may create problems for the operators if 

Service Bulletin 777–54–0021 is 

mandated as-is. CAL specifically noted 

that, in the procedures given for 

performing an inspection of the lower 

web for heat damage, there are no 

International Annealed Copper 

Standard (IACS) values given to 

determine whether the condition of the 

web material is acceptable for continued 

service. CAL considers a conductivity of 

44 percent of IACS value or less 

acceptable for service. CAL coordinated 

these issues with Boeing for corrective 

action, confirmed that the issues would 

be corrected in the next revision of the 

service bulletin, and agreed to validate 

Service Bulletin 777–54–0021 for 

Boeing. CAL recommends that we either 

defer this rulemaking action until 

Revision 1 of the service bulletin is 

released, or incorporate the corrections 

of these discrepancies within the AD. 

CAL also ‘‘would like to see verbiage in 

the ruling that will allow us to take 

credit’’ for work accomplished on 

airplanes changed as shown in the 

initial release of the service bulletin. 

We agree that the initial release of 

Service Bulletin 777–54–0021 has 

discrepancies that could create 

problems for operators if required as-is. 

Since the NPRM was published, Boeing 

has issued Boeing Special Attention 

Service Bulletin 777–54–0021, Revision 

1, dated March 16, 2006. Revision 1 of 

the service bulletin addresses the 

discrepancies noted by CAL. However, 

Revision 1 of the service bulletin 

recommends that the threshold criteria 

for the heat damage inspection be 42 

percent or less of IACS, not the 44 

percent proposed by CAL. We have 

determined that we will require a 42 

percent threshold in accordance with 

that service bulletin. We also have 

determined that no more work is 

necessary for airplanes modified in 

accordance with the initial release of the 

service bulletin. We have revised 

paragraphs (f) and (g) of this AD to 

reference Revision 1 of the service 

bulletin and have added paragraph (h) 


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55728 Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 

to this AD to allow credit for previously 

accomplished actions in accordance 

with the initial release of the service 

bulletin, provided that the IACS 

threshold used is 42 percent or less. 

Request To Extend Compliance Times 

for Airplanes With Boeing Service 

Bulletin 777–54A0015 Incorporated 

CAL requests that the AD make a 

distinction between affected GE-enginepowered airplanes with and without the 

incorporation of Boeing Service Bulletin 

777–54A0015, Revision 1, dated March 

15, 2002. CAL states that according to 

the information in Service Bulletin 777–

54–0021, reports of discolored lower 

webs and deteriorated thermal blankets 

are all from airplanes that did not have 

Service Bulletin 777–54A0015 

incorporated. CAL notes that Service 

Bulletin 777–54A0015 provides 

instructions to modify the cover plate of 

the Number 1 heat shield segment to 

block the through-flow of hot exhaust 

gas in the heat shield cavity, and replace 

the thermal insulation blankets to 

protect the area above from heat 

damage. CAL states that it incorporated 

these changes on all affected airplanes 

in its fleet between 2002 and 2003. CAL 

requests/recommends that we extend 

the compliance time from 12 months to 

24 months for airplanes that have 

incorporated Service Bulletin 777–

54A0015. 

We do not agree to extend the 

compliance time. The incorporation of 

Service Bulletin 777–54A0015 on GEengine-powered airplanes was intended 

to prevent elevated temperatures from 

the primary exhaust from passing into 

the strut aft fairing cavity through a gap 

between the strut aft fairing heat shield 

cover plate and the aft fairing lower 

web. The incorporation of Service 

Bulletin 777–54–0021, Revision 1, is 

intended to prevent the deterioration of 

new insulation blankets in the strut aft 

fairing. The insulation blankets, located 

on the bottom side of the fairing lower 

web and above the segmented heat 

shield, are used to reduce the 

temperature inside the strut aft fairing. 

Gaps in the segmented heat shield allow 

the engine’s primary exhaust to enter 

the heat shield cavity. The flow path 

blockage provided by Service Bulletin 

777–54A0015 is entirely separate from 

the blockage provided by Service 

Bulletin 777–54–0021, Revision 1. We 

consider these two design changes 

independent and do not agree with 

extending the compliance time for those 

airplanes having incorporated Service 

Bulletin 777–54A0015. We have not 

revised this AD in this regard. 

Clarification of Service Bulletin’s 

Inclusion of Nutplate Inspection 

Service Bulletin 777–54–0021, 

Revision 1, includes in the general 

visual inspection for damage of the heat 

shield casting, a missing or loose 

nutplate as one criterion for damage. We 

consider this additional criterion a 

relieving action. Without the nutplate 

inspection in the general visual 

inspection for damage, a missing 

nutplate would be discovered during reinstallation of the forward-most heat 

shield when fasteners would fail to be 

torqued to the correct torque value. 

Finding missing or loose nutplate(s) 

during the general visual inspection 

provides scheduling and economic 

benefits when compared to the cost of 

discovering missing nutplates after heat 

shield reinstallation. 

Clarification of Additional Available 

Repair Method 

Service Bulletin 777–54–0021, 

Revision 1, also provides more detailed 

repair instructions that may be used for 

repair of conditions found during the 

inspections. We have revised paragraph 

(g) of this AD to allow repair in 

accordance with the repair instructions 

provided by Service Bulletin 777–54–

0021, Revision 1. 

Conclusion 

We have carefully reviewed the 

available data, including the comments 

received, and determined that air safety 

and the public interest require adopting 

the AD with the changes described 

previously. We have determined that 

these changes will neither increase the 

economic burden on any operator nor 

increase the scope of the AD. 

Costs of Compliance 

There are about 294 airplanes of the 

affected design in the worldwide fleet. 

This AD will affect about 72 airplanes 

of U.S. registry. The actions will take 

about 9 to 11 work hours per airplane, 

depending on engine manufacturer 

(configuration), at an average labor rate 

of $65 per work hour. Required parts 

would cost about $15,368 to $16,179 per 

airplane. Based on these figures, the 

estimated cost of the AD for U.S. 

operators is $1,148,616 to $1,216,368, or 

$15,953 to $16,894 per airplane. 

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 have 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 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); 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. 

See the ADDRESSES section for a location 

to examine the regulatory evaluation. 

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 Federal Aviation 

Administration (FAA) amends § 39.13 

by adding the following new 

airworthiness directive (AD): 


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Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55729 

2006–19–12 Boeing: Amendment 39–14769. 

Docket No. FAA–2005–22874; 

Directorate Identifier 2005–NM–173–AD. 

Effective Date 

(a) This AD becomes effective October 30, 

2006. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Boeing Model 777–

200 and –300 series airplanes, certificated in 

any category; as identified in Boeing Special 

Attention Service Bulletin 777–54–0021, 

Revision 1, dated March 16, 2006. 

Unsafe Condition 

(d) This AD results from a report that 

several discolored fairing lower webs and 

some damaged/deteriorated insulation 

blankets were found in the aft fairings of 

engine struts. We are issuing this AD to 

prevent cracking of lower webs of the aft 

fairings, which could result in flammable 

hydraulic fluid leaking onto or near an 

ignition source, and possibly result in an 

uncontrollable fire in the engine strut area. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspection, Installation, and Replacement 

Actions 

(f) Except as provided by paragraph (g) of 

this AD: Within 12 months after the effective 

date of this AD, do the actions specified in 

paragraphs (f)(1), (f)(2), (f)(3), and (f)(4) of 

this AD in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 777–54–

0021, Revision 1, dated March 16, 2006. 

(1) Do a general visual inspection of the 

lower web of the aft fairing for any 

discoloration and do any related investigative 

action. 

(2) Do a general visual inspection of the 

heat shield castings for any damage (crack(s), 

dent(s), gouge(s), warpage, fretting, or 

missing/loose nutplates). 

(3) Install gap cover strips on the heat 

shield pans. 

(4) Replace insulation blankets on the heat 

shield pans with new insulation blankets. 

Repair Instructions 

(g) If any damage, discoloration, heat 

damage, or crack is found during any 

inspection required by this AD: Before 

further flight, do all applicable corrective 

actions in accordance with a method 

approved by the Manager, Seattle Aircraft 

Certification Office (ACO), FAA, or in 

accordance with the Accomplishment 

Instructions of Boeing Special Attention 

Service Bulletin 777–54–0021, Revision 1, 

dated March 16, 2006. 

Previously Accomplished Actions 

(h) Actions done before the effective date 

of this AD in accordance with Boeing Special 

Attention Service Bulletin 777–54–0021, 

dated June 23, 2005, are acceptable for 

compliance with the requirements of 

paragraph (f) of this AD, except where the 

service bulletin does not provide an 

International Annealed Copper Standard 

(ICAS) value for determining the results of 

the inspection for heat damage, the 

maximum acceptable ICAS value is 42 

percent. 

Alternative Methods of Compliance 

(AMOCs) 

(i)(1) The Manager, Seattle ACO, FAA, has 

the authority to approve AMOCs for this AD, 

if requested in accordance with the 

procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with 14 CFR 39.19 on any 

airplane to which the AMOC applies, notify 

the appropriate principal inspector in the 

FAA Flight Standards Certificate Holding 

District Office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the repair must meet the 

certification basis of the airplane, and the 

approval must specifically refer to this AD. 

Material Incorporated by Reference 

(j) You must use Boeing Special Attention 

Service Bulletin 777–54–0021, Revision 1, 

dated March 16, 2006, to perform the actions 

that are required by this AD, unless the AD 

specifies otherwise. The Director of the 

Federal Register approved the incorporation 

by reference of this document in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

Contact Boeing Commercial Airplanes, P.O. 

Box 3707, Seattle, Washington 98124–2207, 

for a copy of this service information. You 

may review copies at the Docket Management 

Facility, U.S. Department of Transportation, 

400 Seventh Street SW., Room PL–401, 

Nassif Building, Washington, DC; on the 

Internet at http://dms.dot.gov; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at the 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 

September 13, 2006. 

Kevin M. Mullin, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 06–8122 Filed 9–22–06; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 807, 868, 870, 872, 874, 

876, 878, 880, 882, 884, 886, and 892 

[Docket No. 2006N–0335] 

Medical Devices; Reprocessed SingleUse Devices; Requirement for 

Submission of Validation Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending certain classification 

regulations for reprocessed single-use 

devices (SUDs) whose exemption from 

premarket notification (510(k)) 

requirements have been terminated and 

other reprocessed SUDs already subject 

to premarket notification for which 

validation data, as specified under the 

Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

are necessary in a 510(k). Elsewhere in 

this issue of the Federal Register, we are 

publishing a companion proposed rule, 

under FDA’s usual procedures for notice 

and comment, to provide a procedural 

framework to finalize the rule in the 

event we receive any significant adverse 

comment and withdraw the direct final 

rule. This action codifies actions taken 

in previous Federal Register notices in 

accordance with MDUFMA. 

DATES: This rule is effective February 7, 

2007. Submit written or electronic 

comments by December 11, 2006. If we 

receive no significant adverse comments 

within the specified comment period, 

we intend to publish a document 

confirming the effective date of the final 

rule in the Federal Register within 30 

days after the comment period on this 

direct final rule ends. If we receive any 

timely significant adverse comment, we 

will withdraw this final rule in part or 

in whole by publication of a document 

in the Federal Register within 30 days 

after the comment period ends. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2006N–0335, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 


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