Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16921 

(c) Applicability 

This AD applies to Bombardier, Inc. Model 

DHC–8–400, –401, and –402 airplanes, 

certificated in any category, serial numbers 

4001 through 4361 inclusive. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 52: Doors. 

(e) Reason 

This AD was prompted by a report of the 

inability to open the airstair door while on 

the ground, because the airstair door seal did 

not deflate, which prevented the airstair door 

from opening. We are issuing this AD to 

prevent the airstair door seal from not 

deflating, which could result in the airstair 

door not opening and could impede 

evacuation in the event of an emergency. 

(f) Compliance 

You are responsible for having the actions 

required by this AD performed within the 

compliance times specified, unless the 

actions have already been done. 

(g) Actions 

Within 6,000 flight hours after the effective 

date of this AD: Incorporate ModSum 4– 

126513, Seal System Shut Off Valve Control 

Logic Change, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–52–69, Revision C, dated 

June 28, 2011. 

(h) Credit for Previous Actions 

This paragraph provides credit for the 

actions required by paragraph (g) of this AD, 

if the actions were performed before the 

effective date of this AD using Bombardier 

Service Bulletin 84–52–69, dated January 28, 

2011; Revision A, dated April 26, 2011; or 

Revision B, dated May 9, 2011. 

(i) Other FAA AD Provisions 

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. In accordance with 14 CFR 

39.19, send your request to your principal 

inspector or local Flight Standards District 

Office, as appropriate. If sending information 

directly to the ACO, send it 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, 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. 

(j) Related Information 

Refer to MCAI Canadian Airworthiness 

Directive CF–2011–15, dated June 20, 2011; 

and Bombardier Service Bulletin 84–52–69, 

Revision C, dated June 28, 2011; for related 

information. 

(k) Material Incorporated by Reference 

(1) You must use the following service 

information to do the actions required by this 

AD, unless the AD specifies otherwise. The 

Director of the Federal Register approved the 

incorporation by reference (IBR) of the 

following service information under 5 U.S.C. 

552(a) and 1 CFR part 51: 

(i) Bombardier Service Bulletin 84–52–69, 

Revision C, dated June 28, 2011. 

(2) For service information identified in 

this AD, contact Bombardier, Inc., Q-Series 

Technical Help Desk, 123 Garratt Boulevard, 

Toronto, Ontario M3K 1Y5, Canada; 

telephone 416–375–4000; fax 416–375–4539; 

email thd.qseries@aero.bombardier.com; 

Internet http://www.bombardier.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 an NARA facility, 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 March 9, 

2012. 

Ali Bahrami 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–6530 Filed 3–22–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2011–1194; Directorate 

Identifier 2011–NE–36–AD; Amendment 39– 

16999; AD 2012–06–18] 

RIN 2120–AA64 

Airworthiness Directives; Pratt & 

Whitney Division Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for all Pratt 

& Whitney PW4050, PW4052, PW4056, 

PW4060, PW4060A, PW4060C, 

PW4062, PW4062A, PW4152, PW4156, 

PW4156A, PW4158, PW4160, PW4460, 

PW4462, and PW4650 turbofan engines, 

including models with any dash number 

suffix. This AD was prompted by 

reports of five engine in-flight 

shutdowns and seven unplanned engine 

removals. This AD requires inspections, 

cleaning, and engine modifications to 

address coking in the No. 4 bearing 

compartment and in the oil pressure 

and scavenge tubes. We are issuing this 

AD to prevent an engine fire, a fractured 

fan drive shaft, and damage to the 

airplane. 

DATES: This AD is effective April 27, 

2012. 

ADDRESSES: For service information 

identified in this AD, contact Pratt & 

Whitney, 400 Main St., East Hartford, 

CT 06108; phone: 860–565–8770; fax: 

860–565–4503. You may review copies 

of the referenced service information at 

the FAA, Engine & Propeller Directorate, 

12 New England Executive Park, 

Burlington, MA. For information on the 

availability of this material at the FAA, 

call 781–238–7125. 

Examining the AD Docket 

You may examine the AD docket 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 AD 

docket contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The address for the 

Docket Office (phone: 800–647–5527) is 

Document Management Facility, U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE., Washington, 

DC 20590. 

FOR FURTHER INFORMATION CONTACT: 

James Gray, Aerospace Engineer, Engine 

& Propeller Directorate, FAA, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7742; fax: 781– 

238–7199; email: james.e.gray@faa.gov. 

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 published in the Federal 

Register on November 23, 2011 (76 FR 

72353). That NPRM proposed to require 

inspections, cleaning, and engine 

modifications to address coking in the 

No. 4 bearing compartment and oil 

pressure and scavenge tubes. 


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16922 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

Comments 

We gave the public the opportunity to 

participate in developing this AD. The 

following presents the comments 

received on the proposal and the FAA’s 

response to each comment. 

Request To Not Call Out Specific 

Instructions 

Delta Airlines requested that we do 

not call out specific instructions to 

inspect, clean, and install the 

modifications, because operators have 

developed their own maintenance 

practices that are adequate, but may not 

align 100% with the Service Bulletin 

(SB) instructions. 

We agree. We changed the AD to not 

incorporate by reference the SBs, and to 

list them only as related information, 

without calling out any specific revision 

numbers of them. 

Request To Recognize Compliance by 

Accomplishing SBs Before the Effective 

Date of the AD 

Federal Express, United Parcel 

Service, and United Airlines requested 

that we recognize that their compliance 

by accomplishing earlier versions of 

Pratt & Whitney SB No. PW4ENG 72– 

472 and SB No. PW4ENG 79–76 before 

the effective date of the AD is 

terminating action to the AD. The 

commenters stated that many engines 

have already had the modifications 

accomplished but to earlier versions of 

the SBs. 

We agree. Because we no longer 

incorporate the SBs by reference, if the 

requirements of the AD have already 

been done either by the current revision 

or an earlier revision of SB No. 

PW4ENG 72–472, SB No. PW4ENG 79– 

76, and Alert SB No. A72–436, or other 

methods, techniques, or practices 

acceptable to the Administrator, then no 

further action is required. We have also 

changed the applicability to limit the 

AD to only those engines that have not 

already made the modifications. 

Update to the List of Affected Engine 

Models 

Since we issued the NPRM (76 FR 

72353, November 23, 2011), we 

determined that we need to update the 

list of affected engine models, to reflect 

the models listed in the title block of the 

type certificate data sheet. Engine 

models PW4060C, PW4062, PW4062A, 

PW4650, and PW4160 have been added 

in this AD. The affected engine models 

in operation, as listed in the NPRM, 

have not changed in this AD. 

Conclusion 

We reviewed the relevant data, 

considered the comments received, and 

determined that air safety and the 

public interest require adopting the AD 

with the changes described previously. 

We also determined that these changes 

will not increase the economic burden 

on any operator or increase the scope of 

the AD. 

Costs of Compliance 

We estimate that this AD will affect 

44 turbofan engines installed on 

airplanes of U.S. registry. We estimate 

that it will take 8 work-hours per engine 

to perform an inspection and cleaning of 

the No. 4 bearing compartment; 7 workhours per engine to perform the 

modification to stop buildup of coking 

in the No. 4 bearing compartment; and 

33.7 work-hours per engine to perform 

the rerouting of the No. 4 bearing 

pressure and scavenge tubes. The 

average labor rate is $85 per work-hour. 

Required parts will cost about $69,322 

per engine. Based on these figures, we 

estimate the total cost of the AD to U.S. 

operators to be $3,232,306. 

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 

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), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) 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. 

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 airworthiness 

directive (AD): 

2012–06–18 Pratt & Whitney Division: 

Amendment 39–16999; Docket No. 

FAA–2011–1194; Directorate Identifier 

2011–NE–36–AD. 

(a) Effective Date 

This AD is effective April 27, 2012. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all Pratt & Whitney 

PW4050, PW4052, PW4056, PW4060, 

PW4060A, PW4060C, PW4062, PW4062A, 

PW4152, PW4156, PW4156A, PW4158, 

PW4160, PW4460, PW4462, and PW4650 

turbofan engines, including models with any 

dash number suffix, that have not 

incorporated Pratt & Whitney Alert Service 

Bulletin (ASB) No. PW4ENG–A72–436; 

Service Bulletin (SB) No. PW4ENG–79–76; 

and SB No. PW4ENG–72–472. 

(d) Unsafe Condition 

This AD was prompted by reports of five 

engine in-flight shutdowns and seven 

unplanned engine removals due to clogging 

of No. 4 bearing compartment oil pressure 

and scavenge tubes. We are issuing this AD 

to prevent an engine fire, a fractured fan 

drive shaft, and damage to the airplane. 

(e) Compliance 

(1) If you have incorporated Pratt & 

Whitney ASB No. PW4ENG–A72–436; SB 

No. PW4ENG–79–76; and SB No. PW4ENG– 

72–472, then no further action is required. 

(2) Comply with this AD within the 

compliance times specified, unless already 

done. 


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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16923 

(f) Inspection and Cleaning of No. 4 Bearing 

Compartment for Coking 

(1) Within 1,000 cycles-in-service (CIS) 

after the effective date of this AD, inspect and 

clean the No. 4 bearing compartment. 

(2) Thereafter, within every additional 

1,000 CIS, re-inspect and clean the No. 4 

bearing compartment. 

(g) Modification To Stop Buildup of Coking 

in the No. 4 Bearing Compartment, and 

Rerouting of the No. 4 Bearing Pressure and 

Scavenge Tubes 

At the next engine shop visit, but not to 

exceed 5 years after the effective date of this 

AD, do the following: 

(1) Replace the No. 4 bearing packing 

transfer tube assembly; 

(2) Replace the No. 4 bearing internal 

scavenge tube assembly; 

(3) Remove the No. 4 bearing shield, and 

the No. 4 bearing shield option; and 

(4) Install the new No. 4 bearing shield 

options. 

(5) Modify the turbine exhaust case to 

relocate the No. 4 bearing pressure and 

scavenge tube ports to below the engine 

centerline; 

(6) Replace the internal No. 4 bearing 

pressure and scavenge tubes; 

(7) Modify or replace the turbine case 

cooling brackets to support the new No. 4 

bearing pressure and scavenge tubes; 

(8) Replace the turbine case manifolds as 

necessary; and 

(9) Install the new brackets and clamps to 

support the new routing configuration. 

(h) Terminating Action to the Repetitive 

Inspections and Cleaning 

Performing the modifications specified in 

paragraphs (g)(1) through (g)(9) of this AD is 

terminating action for the repetitive 

inspections and cleanings specified in 

paragraph (f)(2) of this AD. 

(i) Definition of Shop Visit 

For the purpose of this AD, a shop visit is 

when the engine is inducted into the shop for 

any maintenance involving the separation of 

pairs of major mating engine flanges (lettered 

flanges). However, the separation of engine 

flanges solely for the purposes of transporting 

the engine without subsequent engine 

maintenance is not an engine shop visit. 

(j) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

may approve AMOCs for this AD. Use the 

procedures found in 14 CFR 39.19 to make 

your request. 

(k) Related Information 

(1) For more information about this AD, 

contact James Gray, Aerospace Engineer, 

Engine & Propeller Directorate, FAA, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7742; fax: 781–238– 

7199; email: james.e.gray@faa.gov. 

(2) Pratt & Whitney ASB No. PW4ENG– 

A72–436; SB No. PW4ENG–79–76; and SB 

No. PW4ENG–72–472, pertain to the subject 

of this AD. 

(3) For service information identified in 

this AD, contact Pratt & Whitney, 400 Main 

St., East Hartford, CT 06108; phone: 860– 

565–8770; fax: 860–565–4503. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

(l) Material Incorporated by Reference 

None. 

Issued in Burlington. Massachusetts, on 

March 19, 2012. 

Peter A. White, 

Manager, Engine & Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–6996 Filed 3–22–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 20 

[Docket No. FDA–2012–N–0205] 

Agreements and Memoranda of 

Understanding Between the Food and 

Drug Administration and Other 

Departments, Agencies, and 

Organizations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: This direct final rule makes 

technical changes that will update a 

requirement that many of our written 

agreements and memoranda of 

understanding (MOUs) with other 

departments, Agencies, and 

organizations be published in the 

Federal Register. Because we already 

post and will continue to post our 

ongoing agreements and MOUs with 

other departments, Agencies, and 

organizations on our Web site upon 

their completion, this requirement is no 

longer necessary. This direct final rule, 

accordingly, eliminates it. We are 

making these technical changes to 

conserve Agency time and resources, 

reduce government paperwork, and 

eliminate unnecessary Federal Register 

printing costs while continuing to afford 

public access to these documents. We 

are proceeding in accordance with our 

direct final rule procedures. 

We are publishing a companion 

proposed rule under our usual 

procedure for notice-and-comment 

rulemaking to provide a procedural 

framework to finalize the rule in the 

event we receive any significant adverse 

comments and withdraw this direct 

final rule. The companion proposed rule 

and this direct final rule are 

substantively identical. 

DATES: This rule is effective August 6, 

2012. Submit either electronic or 

written comments on or before June 6, 

2012. If we receive no significant 

adverse comments within the specified 

comment period, we will 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 

timely significant adverse comments are 

received, the Agency will publish a 

document in the Federal Register 

withdrawing this direct final rule before 

its effective date. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0205, 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. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–0205 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, 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.regulations.gov and insert the 

docket number, 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: 

Daniel W. Sigelman, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4706, FAX: 301–847–8616, 

email: daniel.sigelman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 3, 

1974 (39 FR 35697), we announced that 

copies of all our MOUs transacted with 


srobinson on DSK4SPTVN1PROD with RULES