Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Proposed Rules 64263

provisions of section 21.29 of the 

Federal Aviation Regulations (14 CFR 

21.29) and the applicable bilateral 

airworthiness agreement. According to 

this bilateral airworthiness agreement, 

the DAC has kept the FAA informed of 

the situation described above. We have 

examined the DAC’s findings, evaluated 

all pertinent information, and 

determined that we need to issue an AD 

for products of this type design that are 

certificated for operation in the United 

States. 

Therefore, we are proposing this AD, 

which would require modifying the 

electrical wiring for the stick pusher 

system. The proposed AD would require 

you to use the service information 

described previously to perform these 

actions. 

Costs of Compliance 

The following table provides the 

estimated costs for U.S. operators to 

comply with this proposed AD.

ESTIMATED COSTS

Action Work

hours 

Average

labor rate

per hour 

Parts Cost per

airplane 

Number

of U.S.-

registered

airplanes 

Fleet cost 

Modification ...................................................................... 2 $65 $7 $137 7 $959

Regulatory Findings 

We have 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 that the 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); 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 proposed AD. 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, 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 adding 

the following new airworthiness 

directive (AD):

Empresa Brasileira de Aeronautica S.A. 

(EMBRAER): Docket No. FAA–2004–

19526; Directorate Identifier 2004–NM–

140–AD. 

Comments Due Date 

(a) The Federal Aviation Administration 

must receive comments on this AD action by 

December 6, 2004.

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to EMBRAER Model 

EMB–135BJ series airplanes, serial numbers 

145462, 145495, 145505, 145528, 145625, 

145637, and 145642; certificated in any 

category. 

Unsafe Condition 

(d) This AD was prompted by a report that 

the stick pushers are not being inhibited 

when the AP/PUSH/TRIM switches are 

activated, which can result in reduced 

controllability of the airplane if there is a 

system malfunction. We are issuing this AD 

to prevent reduced controllability of the 

airplane if the stick pusher system 

malfunctions. 

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. 

Modification of Electrical Wiring 

(f) Within 400 flight hours or 180 calendar 

days after the effective date of this AD, 

whichever is first: Modify the wiring for the 

stick pusher system by accomplishing all of 

the actions specified in the Accomplishment 

Instructions of EMBRAER Service Bulletin 

145LEG–27–0009, dated March 1, 2004. 

Alternative Methods of Compliance 

(AMOCs) 

(g) The Manager, International Branch, 

ANM–116, Transport Airplane Directorate, 

FAA, has the authority to approve AMOCs 

for this AD, if requested in accordance with 

the procedures found in 14 CFR 39.19. 

Related Information 

(h) Brazilian airworthiness directive 2004–

04–02, dated May 6, 2004, also addresses the 

subject of this AD.

Issued in Renton, Washington, on October 

21, 2004. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 04–24632 Filed 11–3–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 39

[Docket No. FAA–2004–19525; Directorate 

Identifier 2004–NM–18–AD] 

RIN 2120–AA64

Airworthiness Directives; Boeing 

Model 777–200, –200ER, and –300 

Series Airplanes

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to adopt a 

new airworthiness directive (AD) for all 

Boeing Model 777–200, –200ER, and 

–300 series airplanes. This proposed AD 

would require inspection of the outer 

cylinder of the main landing gear (MLG) 

to determine the serial number; an 

ultrasonic inspection of the outer 

cylinder of the MLG for cracks if 

necessary; and applicable specified and 

corrective actions if necessary. This 

proposed AD is prompted by reports 

indicating that two outer cylinders were 

found fractured in the weld area. We are 

proposing this AD to detect and correct 

cracks or defects that could result in a 

fracture of the outer cylinder of the 

64264 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Proposed Rules 

MLG, which could lead to collapse of 

the MLG during landing.

DATES: We must receive comments on 

this proposed AD by December 20, 

2004.

ADDRESSES: Use one of the following 

addresses to submit comments on this 

proposed AD. 

• DOT Docket Web site: Go to

http://dms.dot.gov and follow the 

instructions for sending your comments 

electronically. 

• Government-wide rulemaking Web 

site: Go to http://www.regulations.gov

and follow the instructions for sending 

your comments electronically. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street SW., Nassif Building, 

room PL–401, Washington, DC 20590. 

• By fax: (202) 493–2251. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street SW., Washington, 

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

through Friday, except Federal holidays. 

For service information identified in 

this proposed AD, contact Boeing 

Commercial Airplanes, P.O. Box 3707, 

Seattle, Washington 98124–2207. 

You can examine the contents of this 

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., room PL–401, on the plaza level of 

the Nassif Building, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Gary 

Oltman, Aerospace Engineer, Airframe 

Branch, ANM–120S, FAA, Seattle 

Aircraft Certification Office, 1601 Lind 

Avenue, SW., Renton, Washington 

98055–4056; telephone (425) 917–6443; 

fax (425) 917–6590.

SUPPLEMENTARY INFORMATION: 

Docket Management System (DMS) 

The FAA has implemented new 

procedures for maintaining AD dockets 

electronically. As of May 17, 2004, new 

AD actions are posted on DMS and 

assigned a docket number. We track 

each action and assign a corresponding 

directorate identifier. The DMS AD 

docket number is in the form ‘‘Docket 

No. FAA–2004–99999.’’ The Transport 

Airplane Directorate identifier is in the 

form ‘‘Directorate Identifier 2004–NM–

999–AD.’’ Each DMS AD docket also 

lists the directorate identifier (‘‘Old 

Docket Number’’) as a cross-reference 

for searching purposes. 

Comments Invited 

We invite you to submit any written 

relevant data, views, or arguments 

regarding this proposed AD. Send your 

comments to an address listed under 

ADDRESSES. Include ‘‘Docket No. FAA–

2004–19525; Directorate Identifier 

2004–NM–18–AD’’ in the subject line of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of the proposed AD. We will 

consider all comments submitted by the 

closing date and may amend the 

proposed AD in light of those 

comments. 

We will post all comments we 

receive, without change, to http://

dms.dot.gov, including any personal 

information you provide. We will also 

post a report summarizing each 

substantive verbal contact with FAA 

personnel concerning this proposed AD. 

Using the search function of that Web 

site, anyone can find and read the 

comments in any of our dockets, 

including the name of the individual 

who sent the comment (or signed the 

comment on behalf of an association, 

business, labor union, etc.). You can 

review DOT’s complete Privacy Act 

Statement in the Federal Register

published on April 11, 2000 (65 FR 

19477–78), or you can visit http://dms.

dot.gov. 

We are reviewing the writing style we 

currently use in regulatory documents. 

We are interested in your comments on 

whether the style of this document is 

clear, and your suggestions to improve 

the clarity of our communications that 

affect you. You can get more 

information about plain language at 

http://www.faa.gov/language and http://

www.plainlanguage.gov. 

Examining the Docket 

You can examine the 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 DOT 

street address stated in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after the DMS 

receives them.

Discussion 

We have received reports indicating 

that two outer cylinders of the main 

landing gear (MLG) were found 

fractured in the weld area while at the 

supplier, before delivery to Boeing for 

installation on Boeing Model 777–200 

series airplanes. The outer cylinder of 

the MLG is a two-piece design, which is 

welded together on the main barrel. 

Investigation revealed that the fractured 

outer cylinders were cleaned with an 

unapproved cleaning solution before 

welding. The cleaning solution that was 

used contained small amounts of oil 

that may have contaminated the 

bonding surfaces of the weld, which 

could cause cracks or defects in the 

weld. These conditions, if not detected 

and corrected, could result in a fracture 

of the outer cylinder of the MLG, which 

could lead to collapse of the MLG 

during landing. 

Relevant Service Information 

We have reviewed Boeing Alert 

Service Bulletin 777–32A0038, Revision 

1, dated February 19, 2004. The service 

bulletin describes procedures for an 

ultrasonic inspection for cracks or 

defects of the outer cylinder of the MLG, 

applicable specified actions, and 

corrective actions if necessary. 

Applicable specified actions may 

involve jacking up the airplane to 

remove the MLG, and disassembling the 

MLG to remove the outer cylinder for 

the ultrasonic inspection. Corrective 

actions involve replacing the outer 

cylinder of the MLG with a new MLG 

whose part identification numbers are 

not listed in the service bulletin. The 

service bulletin also recommends 

reporting the inspection results to 

Boeing. Accomplishing the actions 

specified in the service information is 

intended to adequately address the 

unsafe condition. 

FAA’s Determination and Requirements 

of the Proposed AD 

We have evaluated all pertinent 

information and identified an unsafe 

condition that is likely to exist or 

develop on other airplanes of this same 

type design. Therefore, we are 

proposing this AD, which would require 

inspection of the outer cylinder of the 

MLG to determine the serial number; an 

ultrasonic inspection of the outer 

cylinder of the MLG for cracks if 

necessary; and applicable specified and 

corrective actions as necessary. The 

proposed AD would require you to use 

the service information described 

previously to perform these actions, 

except as discussed under ‘‘Differences 

Between the Proposed AD and the 

Service Bulletin.’’ The proposed AD 

would also require that operators send 

the results of their ultrasonic inspection 

findings to the FAA only if the 

inspection finds any crack. 

Differences Between the Proposed AD 

and the Service Bulletin 

Unlike the effectivity of the service 

bulletin, this proposed AD would affect 

Boeing Model 777–200ER and –300 

series airplanes in addition to Model 

777–200 series airplanes listed in the 

service bulletin. We have determined 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Proposed Rules 64265

that, because of the potential for the 

affected outer cylinders to be installed 

on all these models, the proposed 

actions must be done on all of these 

airplanes to address the identified 

unsafe condition. 

In addition, we have determined that 

the service bulletin does not completely 

address the rotability of the affected 

parts. Therefore, this proposed AD 

would also require a one-time 

inspection to determine if a suspect 

serial number of an outer cylinder may 

be installed on airplanes other than 

those listed in the effectivity of the 

service bulletin. 

The service bulletin specifies a 

compliance time of 8,000 flight cycles or 

when the outer cylinder is 6 years old, 

whichever occurs first. We have 

determined that a grace period of 4,000 

flight cycles or 750 days after the 

effective date of the AD, whichever 

occurs first, is necessary to prevent 

unnecessary grounding of airplanes that 

are over the threshold specified in the 

service bulletin. 

Operators should note that, although 

the Accomplishment Instructions of the 

referenced service bulletin describe 

procedures for submitting a report of all 

ultrasonic inspection results to the 

manufacturer, this proposed AD would 

require submitting the inspection report 

to the FAA only if the inspection finds 

any crack. We need further information 

on the extent of the quality control (QC) 

problem. When the unsafe condition 

addressed by an AD is likely due to a 

manufacturer’s QC problem, a reporting 

requirement is instrumental in ensuring 

that we can gather as much information 

as possible regarding the extent and 

nature of the QC problem or breakdown, 

especially in cases where such data may 

not be available through other 

established means. This information is 

necessary to ensure that we can apply 

knowledge and lessons learned from 

these inspections to future MLG actions. 

The differences discussed in 

‘‘Differences Between the Proposed AD 

and the Service Bulletin’’ have been 

coordinated with Boeing. 

Costs of Compliance 

This proposed AD would affect about 

463 Model 777 series airplanes 

worldwide. The following table 

provides the estimated costs for U.S. 

operators to comply with this proposed 

AD.

ESTIMATED COSTS

Action Work hours 

Average

labor rate

per hour 

Parts Cost per airplane 

Number of

U.S.-registered

airplanes 

Fleet cost 

Part Number Inspection.1 to 229 (depending 

on which inspection 

method is used).

$65 None ........ $65 to $14,885 ........... 133 ............................. $8,645 to 

$1,979,705. 

Ultrasonic Inspection 

(if necessary).

6 ................................. 65 None ........ $390 per outer cylinder, $780 for both 

outer cylinders on 

the airplane.

Unknown, there may 

be up to 26 affected 

outer cylinders in 

fleet.

$10,140. 

Regulatory Findings 

We have 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 that the 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); 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 proposed AD. 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, 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 adding 

the following new airworthiness 

directive (AD):

Boeing: Docket No. FAA–2004–19525; 

Directorate Identifier 2004–NM–18–AD. 

Comments Due Date 

(a) The Federal Aviation Administration 

(FAA) must receive comments on this AD 

action by December 20, 2004. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to all Boeing Model 

777–200, –200ER, –300 series airplanes; 

certificated in any category. 

Unsafe Condition 

(d) This AD was prompted by reports that 

two outer cylinders of the main landing gear 

(MLG) were found fractured in the weld area. 

We are issuing this AD to detect and correct 

cracks or defects that could result in a 

fracture of the outer cylinder of the MLG, 

which could lead to collapse of the MLG 

during landing. 

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. 

Service Bulletin References 

(f) The term ‘‘the service bulletin,’’ as used 

in this AD, means the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

777–32A0038, Revision 1, dated February 19, 

2004. 

Compliance Time 

(g) Perform the applicable actions specified 

in paragraph (h) of this AD at the later of the 

times specified in paragraphs (g)(1) and (g)(2) 

of this AD. 

(1) Within 4,000 flight cycles or 750 days 

after the effective date of this AD, whichever 

occurs first; or 

(2) Before accumulation of 8,000 total flight 

cycles on the outer cylinder or 72 months on 

the outer cylinder since new, whichever 

occurs first. 

64266 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Proposed Rules 

Part Identification Inspection, Ultrasonic 

Inspection, and Corrective Action 

(h) Inspect the outer cylinder of the MLG 

to determine whether an outer cylinder 

having a serial number (S/N) listed in 

paragraph 1.D., ‘‘Description,’’ of the service 

bulletin is installed. Instead of an inspection 

of the outer cylinder of the MLG, a review 

of airplane maintenance records is acceptable 

if the S/N of the outer cylinder can be 

positively determined from that review.

(1) If no S/N identified in the service 

bulletin is installed, no further action is 

required by this paragraph. 

(2) If any S/N identified in the service 

bulletin is installed, before further flight, do 

an ultrasonic inspection of the outer cylinder 

of the MLG for cracks, all applicable 

specified actions, and any corrective actions 

per the service bulletin. Do any applicable 

corrective action before further flight. 

Reporting a Crack 

(i) Submit a report of any crack is found 

during the inspection required by paragraph 

(h)(2) of this AD to the Manager, Seattle 

Aircraft Certification Office (ACO), FAA, 

1601 Lind Avenue, SW., Renton, 

Washington, at the applicable time specified 

in paragraph (i)(1) or (i)(2) of this AD. The 

report must include the inspection results, a 

description of any discrepancies found, the 

outer cylinder serial number and part 

number, and the number of landings and 

flight hours on the outer cylinder. Under the 

provisions of the Paperwork Reduction Act of 

1980 (44 U.S.C. 3501 et seq.), the Office of 

Management and Budget (OMB) has 

approved the information collection 

requirements contained in this AD and has 

assigned OMB Control Number 2120–0056. 

(1) If the inspection was done after the 

effective date of this AD: Submit the report 

within 10 days after the inspection. 

(2) If the inspection was accomplished 

prior to the effective date of this AD: Submit 

the report within 10 days after the effective 

date of this AD. 

Parts Installation 

(j) As of the effective date of this AD, no 

person may install an outer cylinder having 

a S/N listed in paragraph 1.D., ‘‘Description,’’

of the service bulletin on any airplane unless 

it has been inspected and all specified and 

corrective actions are accomplished in 

accordance with paragraph (h)(2) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(k)(1) The Manager, Seattle Aircraft 

Certification Office (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) An AMOC that provides an acceptable 

level of safety may be used for any action 

required by this AD, if it is approved by a 

Boeing Company Designated Engineering 

Representative who has been authorized by 

the Manager, Seattle ACO, to make those 

findings. For a repair method to be approved, 

the approval must specifically refer to this 

AD.

Issued in Renton, Washington, on October 

21, 2004. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 04–24631 Filed 11–3–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. 2000N–1409]

Medical Devices; Revision of the 

Identification of the Iontophoresis 

Device; Withdrawal

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule; withdrawal.

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

the proposed rule the agency issued in 

the Federal Register of August 22, 2000 

(65 FR 50949) (the August 2000 

proposed rule). In that document, FDA 

proposed to amend the physical 

medicine devices regulations to remove 

the class III (premarket approval) 

iontophoresis device identification. In 

response to the comments received on 

the proposed rule, FDA is withdrawing 

the proposed rule and considering and 

other courses of action. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing an opportunity to submit 

information and comments concerning 

FDA’s intent to initiate a proceeding to 

reclassify those iontophoresis devices 

currently in class III into class II (special 

controls).

DATES: The proposed rule is withdrawn 

on November 4, 2004.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices 

and Radiological Health (HFZ–215), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 

23, 1983 (48 FR 53032), FDA issued a 

final rule classifying the iontophoresis 

device into class II (performance 

standards before the Safe Medical 

Devices Act of 1990 and now special 

controls) and class III (premarket 

approval), depending on its intended 

use. An iontophoresis device is a device 

that is intended to use a direct current 

to introduce ions of soluble salts or 

other drugs into the body and induce 

sweating for diagnostic or other uses. If 

the iontophoresis device is intended for 

use in the diagnosis of cystic fibrosis or 

another intended use and the labeling of 

the drug intended for use with the 

device bears adequate directions for the 

device’s use with that drug, the device 

is categorized as class II. An 

iontophoresis device that is intended to 

introduce ions of soluble salts or other 

drugs into the body for other purposes 

is categorized as class III.

In the August 2000 proposed rule, 

FDA proposed regulations to amend the 

physical medicine devices regulations 

to remove the class III (premarket 

approval) iontophoresis device 

identification. FDA proposed this action 

because it believed that there were no 

preamendments iontophoresis devices 

marketed for uses other than those 

described in the class II identification. 

FDA expected that manufacturers of 

those devices currently in class III 

would be able to relabel their devices to 

meet the class II identification.

II. Withdrawal of the Proposed Rule

FDA received substantial comment in 

response to the August 2000 proposed 

rule. Several comments disagreed with 

FDA’s assertion that no class III 

preamendments iontophoresis devices 

existed. In response to these comments, 

FDA is considering other courses of 

action and is withdrawing the August 

2000 proposed rule.

III. Alternative Action

Elsewhere in this issue of the Federal 

Register, FDA is providing interested 

persons with an opportunity to submit 

new information concerning the safety 

and effectiveness of the iontophoresis 

device. After FDA reviews any 

information that it receives in response 

to this notice, the agency will decide 

whether it should go forward with a 

reclassification of those iontophoresis 

devices currently in class III and 

whether a panel meeting is necessary 

before taking any action.

Dated: October 25, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–24590 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S