Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 1949 

3. Would 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 Federal Aviation Administration 

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 39–14275 (70 FR 

54622, September 16, 2005) and by 

adding a new airworthiness directive, to 

read as follows: 

Turbomeca: Docket No. FAA–2005–22430; 

Directorate Identifier 2005–NE–34–AD. 

Comments Due Date 

(a) The Federal Aviation Administration 

(FAA) must receive comments on this 

airworthiness directive (AD) action by March 

19, 2007. 

Affected ADs 

(b) This AD supersedes AD 2005–19–10, 

Amendment 39–14275. 

Applicability 

(c) This AD applies to Turbomeca Arrius 

2 F turboshaft engines with fuel control units 

(FCUs) not incorporating modification Tf 55. 

These engines are installed on, but not 

limited to, Eurocopter EC120B helicopters. 

Unsafe Condition 

(d) This AD results from the European 

Aviation Safety Agency (EASA) and 

Turbomeca expanding the applicability to the 

full population of FCUs installed on Arrius 

2 F turboshaft engines. FCUs not 

incorporating modification Tf 55 are 

susceptible to having an improperly 

assembled constant delta pressure (delta P) 

diaphragm. We are issuing this AD to prevent 

an uncommanded engine in-flight shutdown 

on a single-engine helicopter, resulting in a 

forced autorotation landing or an accident. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed as 

soon as practicable after the effective date of 

this AD but no later than July 31, 2007, 

unless the actions have already been done. 

(f) Replace all FCUs not incorporating 

modification Tf 55 with FCUs that 

incorporate modification Tf 55. 

Alternative Methods of Compliance 

(g) The Manager, Engine Certification 

Office, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Related Information 

(h) Contact Christopher Spinney, 

Aerospace Engineer, Engine Certification 

Office, FAA, Engine and Propeller 

Directorate, 12 New England Executive Park, 

Burlington, MA 01803; telephone (781) 238–

7175, fax (781) 238–7199; e-mail: 

christopher.spinney@faa.gov for more 

information about this AD. 

(i) EASA AD No. 2006–0237, dated August 

9, 2006, addresses the subject of this AD. 

(j) Turbomeca Mandatory Service Bulletin, 

Update No. 1, dated March 17, 2006, pertains 

to the subject of this AD. 

Issued in Burlington, Massachusetts, on 

January 10, 2007. 

Francis A. Favara, 

Manager, Engine and Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–494 Filed 1–16–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

RIN 2120–AA64 

[Docket No. FAA–2006–25896; Directorate 

Identifier 2006–NE–33–AD] 

Airworthiness Directives; General 

Electric Company CF34–10E Series 

Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to 

supersede an existing airworthiness 

directive (AD) for General Electric 

Company (GE) CF34–10E series turbofan 

engines. That AD currently requires 

removing the fuel inlet strainer from 

main fuel pump (MFP) part number 

(P/N) 2043M12P03, installing a certain 

replacement flange as an interim repair, 

remarking the MFP to P/N 2043M12P04, 

and performing initial and repetitive 

visual inspections of the main fuel filter. 

This proposed AD would require 

removing MFPs, P/N 2043M12P03 and 

2043M12P04 from service and installing 

an improved MFP with a different P/N. 

This proposed AD results from GE 

determining that the cause of MFP fuel 

strainer failure is a design problem with 

the strainer. We are proposing this AD 

to prevent engine in-flight shutdown 

due to MFP malfunctions. 

DATES: We must receive any comments 

on this proposed AD by March 19, 2007. 

ADDRESSES: Use one of the following 

addresses to comment 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–

0001. 

• 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. 

Contact General Electric Company via 

Lockheed Martin Technology Services, 

10525 Chester Road, Suite C, Cincinnati, 

Ohio 45215, telephone (513) 672–8400, 

fax (513) 672–8422, for the service 

information identified in this proposed 

AD. 

FOR FURTHER INFORMATION CONTACT: Tara 

Fitzgerald, Aerospace Engineer, Engine 

Certification Office, FAA, Engine and 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

telephone: (781) 238–7130, fax: (781) 

238–7199. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments 

regarding this proposal. Send your 

comments to an address listed under 

ADDRESSES. Include ‘‘Docket No. FAA–

2006–25896; Directorate Identifier 

2006–NE–33–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 received 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 

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1950 Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 

personnel concerning this proposed AD. 

Using the search function of the DMS 

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 may 

review the DOT’s complete Privacy Act 

Statement in the Federal Register 

published on April 11, 2000 (65 FR 

19477–78) or you may visit http:// 

dms.dot.gov. 

Examining the AD Docket 

You may examine the docket that 

contains the proposal, any comments 

received and any final disposition in 

person at the DMS Docket Office 

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

through Friday, except Federal holidays. 

The Docket Office (telephone (800) 647–

5227) is located on the plaza level of the 

Department of Transportation Nassif 

Building at the street address stated in 

ADDRESSES. Comments will be available 

in the AD docket shortly after the DMS 

receives them. 

Discussion 

On September 21, 2006, we issued AD 

2006–20–06, Amendment 39–14775 (71 

FR 60663, October 16, 2006). That AD 

requires removing the MFP inlet strainer 

from the MFPs, installing a certain 

replacement flange as an interim repair, 

remarking the MFP to P/N 2043M12P04, 

and performing initial and repetitive 

visual inspections of the main fuel filter. 

That AD was the result of three reports 

of release of the tripod support legs on 

the MFP inlet strainer, leading to engine 

in-flight shutdown. That condition, if 

not corrected, could result in engine inflight shutdown due to MFP 

malfunctions. 

Actions Since AD 2006–20–06 Was 

Issued 

Since AD 2006–20–06 was issued, GE 

determined that the cause of MFP fuel 

inlet strainer failure is a design problem 

with the strainers installed in the MFPs. 

GE has introduced MFP P/N 

2043M12P05, which has a more robust 

design fuel inlet strainer. 

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 products of this same 

type design. For that reason, we are 

proposing this AD, which would require 

removing MFPs, P/N 2043M12P03 and 

2043M12P04 from service and installing 

an improved MFP, not later than April 

30, 2007. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 50 CF34–10E series 

turbofan engines installed on airplanes 

of U.S. registry. We also estimate that it 

would take about 3 work-hours per 

engine to perform the proposed actions, 

and that the average labor rate is $80 per 

work-hour. Required parts would cost 

about $4,226 per engine to upgrade the 

MFP to a different P/N to make it 

serviceable. Based on these figures, we 

estimate the total upgrade cost of the 

proposed AD to U.S. operators to be 

$223,300. 

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 

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. Would 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 

Under the authority delegated to me 

by the Administrator, the Federal 

Aviation Administration 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 39–14775 (71 FR 

60663, October 16, 2006) and by adding 

a new airworthiness directive to read as 

follows: 

General Electric Company: Docket No. FAA–

2006–25896; Directorate Identifier 2006–

NE–33–AD. 

Comments Due Date 

(a) The Federal Aviation Administration 

(FAA) must receive comments on this 

airworthiness directive (AD) action by March 

19, 2007. 

Affected ADs 

(b) This AD supersedes AD 2006–20–06, 

Amendment 39–14755. 

Applicability 

(c) This AD applies to General Electric 

Company (GE) CF34–10E2A1, –10E5, 

–10E5A1, –10E6, –10E6A1, and –10E7 

turbofan engines, with main fuel pump 

(MFP) part number (P/N) 2043M12P03 or P/ 

N 2043M12P04, installed. These engines are 

installed on, but not limited to, Embraer ERJ 

190–100–STD, ERJ 190–100–LR, and ERJ 

190–100–IGW airplanes. 

Unsafe Condition 

(d) This AD results from GE determining 

that the cause of MFP fuel strainer failure is 

a design problem with the strainer. We are 

issuing this AD to prevent engine in-flight 

shutdown due to MFP 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. 

MFP Removal and Installation 

(f) Not later than April 30, 2007, remove 

MFPs, P/N 2043M12P03 and 2043M12P04, 

from service and install a serviceable MFP. 

Definition 

(g) For the purpose of this AD, a 

serviceable MFP is one that does not have P/ 

N 2043M12P03 or 2043M12P04. 

Recommended Actions 

(h) We recommend that operators avoid 

performing the actions in this AD on both 

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Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 1951 

engines installed on the same airplane at the 

same time, if at all possible. 

Alternative Methods of Compliance 

(i) The Manager, Engine Certification 

Office, FAA, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Related Information 

(j) GE Service Bulletin No. CF34–10E S/B 

73–0013, dated December 15, 2006, pertains 

to the subject of this AD. 

(k) Contact Tara Fitzgerald, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; telephone (781) 238–7138, fax (781) 

238–7199; e-mail: tara.fitzgerald@faa.gov for 

more information about this AD. 

Issued in Burlington, Massachusetts, on 

January 10, 2007. 

Francis A. Favara, 

Manager, Engine and Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–498 Filed 1–16–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. 2005P–0121] 

Orthopedic Devices; Reclassification 

of Non-Invasive Bone Growth 

Stimulator 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of panel 

recommendation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing for 

public comment the recommendation of 

the Orthopaedic and Rehabilitation 

Devices Panel to deny a petition to 

reclassify the non-invasive bone growth 

stimulator from class III to class II. The 

Panel made this recommendation after 

reviewing the reclassification petition 

submitted by RS Medical Corp., as well 

as consideration of presentations made 

at the Panel meeting by the petitioner, 

FDA, and members of the public. FDA 

is also issuing for public comment its 

findings on the Panel’s 

recommendation. After considering any 

public comments on the Panel’s 

recommendation and FDA’s findings, 

FDA will approve or deny the 

reclassification petition by order in the 

form of a letter to the petitioner. FDA’s 

decision on the reclassification petition 

will be announced in the Federal 

Register. 

DATES: Submit written or electronic 

comments by April 17, 2007. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005P–0121, 

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. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No. 2005P–0121 for this notice. 

All comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michel Janda, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background (Regulatory Authorities) 

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et. seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 (the 

SMDA) (Public Law 101–629), and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Public Law 105–115), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the 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). 

Under section 513 of the act, devices 

that were in commercial distribution 

before May 28, 1976 (the date of 

enactment of the 1976 amendments), 

generally referred to as preamendments 

devices, are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the act into 

class III without any FDA rulemaking 

process. Those devices remain in class 

III and require premarket approval, 

unless and until the device is 

reclassified into class I or II or FDA 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the 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 act 

(21 U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Reclassification of classified 

postamendments devices is governed by 

section 513(f)(3) of the act. This section 

provides that FDA may initiate the 

reclassification of a device classified 

into class III under section 513(f)(1) of 

the act, or the manufacturer or importer 

of a device may petition the Secretary of 

Health and Human Services (the 

Secretary) for the issuance of an order 

classifying the device in class I or class 

II. FDA’s regulations in 21 CFR 860.134 

set forth the procedures for the filing 

and review of a petition for 

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