52292 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 

Subject 

(d) Air Transport Association (ATA) of 

America Code 57: Wings. 

Reason 

(e) The mandatory continuing 

airworthiness information (MCAI) states: 

Several cases of aileron terminal quadrant 

support brackets that were manufactured 

using sheet metal have been found cracked 

on DHC–8 Series 300 aircraft. Investigation 

revealed that the failure of the support 

bracket was due to fatigue. Failure of the 

aileron terminal quadrant support bracket 

could result in an adverse reduction of 

aircraft roll control. 

These conditions could result in loss of 

control of the airplane. 

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) For airplanes with an aileron terminal 

quadrant support bracket having part number 

(P/N) 85711569: At the applicable times 

specified in paragraph (g)(1) or (g)(2) of this 

AD, install a new aileron input quadrant 

support bracket by incorporating MODSUM 

8Q101250, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 8–57–43, Revision B, dated 

October 7, 2009. 

(1) For airplanes that have accumulated 

30,000 total flight hours or more as of the 

effective date of this AD: Within 3,000 flight 

hours after the effective date of this AD. 

(2) For airplanes that have accumulated 

less than 30,000 total flight hours as of the 

effective date of this AD: Before the 

accumulation of 33,000 total flight cycles or 

within 6,000 flight hours after the effective 

date of this AD, whichever occurs first. 

(h) Doing the installation by incorporating 

MODSUM 8Q101250 is also acceptable for 

compliance with the requirements of 

paragraph (g) of this AD if done before the 

effective date of this AD in accordance with 

Bombardier Service Bulletin 8–57–43, dated 

August 9, 2002; or Bombardier Service 

Bulletin 8–57–43, Revision A, dated January 

17, 2003. 

FAA AD Differences 

Note 1: 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, New York Aircraft 

Certification Office (ACO), ANE–170, 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: 

Program Manager, Continuing Operational 

Safety, FAA, New York ACO, 1600 Stewart 

Avenue, Suite 410, Westbury, New York, 

11590; telephone 516–228–7300; fax 516– 

794–5531. Before using any approved AMOC 

on any airplane to which the AMOC applies, 

notify your principal maintenance inspector 

(PMI) or principal avionics inspector (PAI), 

as appropriate, or lacking a principal 

inspector, your local Flight Standards 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 Canadian Airworthiness 

Directive CF–2009–45, dated December 11, 

2009; and Bombardier Service Bulletin 8–57– 

43, Revision B, dated October 7, 2009; for 

related information. 

Issued in Renton, Washington, on August 

18, 2010. 

Jeffrey E. Duven, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2010–21064 Filed 8–24–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–0845; Directorate 

Identifier 2010–CE–044–AD] 

RIN 2120–AA64 

Airworthiness Directives; Diamond 

Aircraft Industries GmbH Models DA 

40 and DA 40F Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for all 

Diamond Aircraft Industries GmbH 

Models DA 40 and DA 40F airplanes. 

This proposed AD would change the 

emergency open doors procedure by 

incorporation of a temporary revision 

into the FAA-approved airplane flight 

manual for all airplanes. This proposed 

AD would also require replacement of 

the passenger door retaining bracket 

with an improved design retaining 

bracket for certain airplanes. This 

proposed AD results from several 

reports of the rear passenger door 

departing the airplane in flight. We are 

proposing this AD to change the 

emergency open doors procedure and 

retrofit the rear passenger door retaining 

bracket, which if not corrected could 

result in the rear passenger door 

departing the airplane in flight. 

DATES: We must receive comments on 

this proposed AD by October 12, 2010. 

ADDRESSES: Use one of the following 

addresses to comment on this proposed 

AD: 

• Federal eRulemaking Portal: Go to 

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

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

For service information identified in 

this proposed AD, contact Diamond 

Aircraft Industries GmbH, N.A. OttoStra+e 5, A–2700 Wiener Neustadt, 

Austria, telephone: +43 2622 26700; fax: 

+43 2622 26780; e-mail: 

office@diamond-air.at; Internet: http:// 

www.diamond-air.at. 

FOR FURTHER INFORMATION CONTACT: 

Mike Kiesov, Aerospace Engineer, FAA, 

Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4144; fax: (816) 

329–4090; e-mail: mike.kiesov@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments 

regarding this proposed AD. Send your 

comments to an address listed under the 

ADDRESSES section. Include the docket 

number, ‘‘FAA–2010–0845; Directorate 

Identifier 2010–CE–044–AD’’ at the 

beginning 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:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 52293 

substantive verbal contact we receive 

concerning this proposed AD. 

Discussion 

We have received information from 

Diamond Aircraft Industries GmbH that 

the Models DA 40 and DA 40F airplanes 

have had an estimated 31 rear passenger 

doors depart the airplane while in flight. 

They also estimate an additional 18 

doors have been replaced because of 

damage to the hinge, primarily due to 

wind gust conditions while the airplane 

is parked. Diamond Aircraft Industries 

GmbH conducted a structural test to 

determine the root cause of the door 

opening in flight. The test concluded 

that the locking mechanism provided 

adequate strength to react the loads in 

flight. They determined that the root 

cause was the crew not properly 

securing the rear passenger door prior to 

flight. 

Models DA 40 and DA 40F airplanes 

do have a secondary safety latch design 

feature. The initial intended design 

function of this latch was to hold the 

rear passenger door in the ‘‘near closed’’ 

position while on the ground, protecting 

the door from wind gusts. However, the 

original retainer bracket might not hold 

the door in this ‘‘near closed’’ position 

while in flight. Diamond Aircraft 

Industries GmbH has designed an 

improved retainer bracket to prevent the 

passenger rear door fully opening in 

flight. In addition, they have revised the 

emergency door open procedure. 

This condition, if not corrected, could 

result in the rear passenger door 

departing the airplane in flight. 

Relevant Service Information 

We have reviewed Diamond Aircraft 

Industries GmbH Mandatory Service 

Bulletin NO. MSB 40–070/NO. MSB 

D4–079/NO. MSB F4–024, dated April 

30, 2010; and Diamond Aircraft 

Industries GmbH Work Instruction WI– 

MSB 40–070/WI–MSB D4–079/WI–MSB 

F4–024, dated April 30, 2010. 

The service information describes 

procedures for replacement of the 

passenger door retaining bracket with an 

improved design retaining bracket. 

FAA’s Determination and Requirements 

of the Proposed AD 

We are proposing this AD because we 

evaluated all information and 

determined the unsafe condition 

described previously is likely to exist or 

develop on other products of the same 

type design. This proposed AD would 

require a retrofit of the rear passenger 

door retaining bracket for certain 

airplanes. This proposed AD would also 

change the emergency open doors 

procedure by incorporation of a 

temporary revision into the FAAapproved airplane flight manual for all 

airplanes. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 699 airplanes in the U.S. 

registry. 

We estimate the following costs to do 

the proposed revision to the airplane 

flight manual: 

Labor cost Parts cost 

Total cost 

per 

airplane 

Total cost 

on U.S. 

operators 

.5 work-hour × $85 per hour = $42.50 ...................................................... Not Applicable ................................. $42.50 $29,707.50 

We estimate the following costs to do 

the proposed retrofit of the passenger 

door retaining bracket. We estimate that 

this would affect 428 airplanes in the 

U.S. registry: 

Labor cost Parts cost 

Total cost 

per 

airplane 

Total cost 

on U.S. 

operators 

2 work-hours × $85 per hour = $170.00 ..................................................................................... $75.00 $245.00 $104,860.00 

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. 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 and placed it in the 

AD docket. 

Examining the AD Docket 

You may examine the AD docket that 

contains the proposed AD, the 

regulatory evaluation, any comments 

received, and other information on the 

Internet at http://www.regulations.gov; 

or in person at the Docket Management 

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

Monday through Friday, except Federal 

holidays. The Docket Office (telephone 

(800) 647–5527) is located at the street 

address stated in the ADDRESSES section. 

Comments will be available in the AD 

docket shortly after receipt. 


srobinson on DSKHWCL6B1PROD with PROPOSALS
52294 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

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 AD: 

Diamond Aircraft Industries GmbH: Docket 

No. FAA–2010–0845; Directorate 

Identifier 2010–CE–044–AD. 

Comments Due Date 

(a) We must receive comments on this 

airworthiness directive (AD) action by 

October 12, 2010. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Diamond Aircraft 

Industries GmbH Models DA 40 and DA 40F 

airplanes, all serial numbers (S/N), that are 

certificated in any category. 

Subject 

(d) Air Transport Association of America 

(ATA) Code 52: Doors. 

Unsafe Condition 

(e) This AD results from several reports of 

the rear passenger door departing the 

airplane in flight. We are proposing this AD 

to change the emergency open doors 

procedure and retrofit the rear passenger 

door retaining bracket, which if not corrected 

could result in the rear passenger door 

departing the airplane in flight. 

Compliance 

(f) To address this problem, you must do 

the following, unless already done: 

Actions Compliance Procedures 

(1) For all serial numbers: Incorporate Diamond 

Aircraft Temporary Revision TR–MA ̈ M 40– 

428, page 3–37b, dated April 30, 2010, into 

the FAA-approved airplane flight manual.

Within 6 months after the effective date of this 

AD.

Follow Diamond Aircraft Temporary Revision 

TR–MA ̈ M 40–428, Cover Page, dated April 

30, 2010. 

(2) For Model DA 40, S/N 40.006 through 

40.009, 40.011 through 40.081, 40.084, and 

40.201 through 40.749; and Model DA 40F 

S/N 40.FC001 through 40.FC009: Replace 

the rear passenger door retaining bracket 

with an improved design retaining bracket.

Within 6 months after the effective date of this 

AD.

Follow Diamond Aircraft Industries GmbH 

Mandatory Service Bulletin NO. MSB 40– 

070/NO. MSB D4–079/NO. MSB F4–024, 

dated April 30, 2010; and Diamond Aircraft 

Industries GmbH Work Instruction WI–MSB 

40–070/WI–MSB D4–079/WI–MSB F4–024, 

dated April 30, 2010. 

Alternative Methods of Compliance 

(AMOCs) 

(g) The Manager, Small 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: Mike Kiesov, 

Aerospace Engineer, FAA, Small Airplane 

Directorate, 901 Locust, Room 301, Kansas 

City, Missouri 64106; telephone: (816) 329– 

4144; fax: (816) 329–4090; e-mail: 

mike.kiesov@faa.gov. Before using any 

approved AMOC on any airplane to which 

the AMOC applies, notify your appropriate 

principal inspector (PI) in the FAA Flight 

Standards District Office (FSDO), or lacking 

a PI, your local FSDO. 

Related Information 

(h) To get copies of the service information 

referenced in this AD, contact Diamond 

Aircraft Industries GmbH, N.A. Otto-Stra+e 5, 

A–2700 Wiener Neustadt, Austria, telephone: 

+43 2622 26700; fax: +43 2622 26780; e-mail: 

office@diamond-air.at; Internet: http:// 

www.diamond-air.at. To view the AD docket, 

go to U.S. Department of Transportation, 

Docket Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 New 

Jersey Avenue, SE., Washington, DC 20590, 

or on the Internet at http:// 

www.regulations.gov. 

Issued in Kansas City, Missouri, on August 

18, 2010. 

John R. Colomy, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–21068 Filed 8–24–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 870, 884 and 892 

[Docket No. FDA–2010–N–0412] 

RIN 0910–AG51 

Effective Date of Requirement for 

Premarket Approval for Four Class III 

Preamendments Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the following four 

class III preamendments devices: 

Ventricular bypass (assist) device; 

pacemaker repair or replacement 

material; female condom; and 

transilluminator for breast evaluation. 

The agency is also summarizing its 

proposed findings regarding the degree 

of risk of illness or injury designed to 

be eliminated or reduced by requiring 

the devices to meet the statute’s 

approval requirements and the benefits 

to the public from the use of the 

devices. In addition, FDA is announcing 

the opportunity for interested persons to 

request that the agency change the 

classification of any of the 

aforementioned devices based on new 

information. This action implements 

certain statutory requirements. 

DATES: Submit written or electronic 

comments by November 23, 2010. 

Submit requests for a change in 

classification by September 9, 2010. 

FDA intends that, if a final rule based 

on this proposed rule is issued, anyone 

who wishes to continue to market the 

device will need to submit a PMA 

within 90 days of the effective date of 

the final rule. Please see section XIII of 

this document for the effective date of 

any final rule that may publish based on 

this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0412 and/or RIN number 0910–AG51, 

by any of the following methods: 

Electronic Submissions 


srobinson on DSKHWCL6B1PROD with PROPOSALS