70718 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 

• If the WHEEL N/W STRG FAULT ECAM 

caution appears, without the L/G SHOCK 

ABSORBER FAULT ECAM caution: 

—No specific crew action is requested by the 

WHEEL N/W STRG FAULT ECAM caution 

procedure. 

—Refer to the ECAM STATUS. 

Note 1: When a statement identical to that 

in paragraph (h) of this AD has been included 

in the general revisions of the AFM, the 

general revisions may be inserted into the 

AFM, and the copy of this AD may be 

removed from the AFM. 

(i) For airplanes that are not specified in 

paragraph (g) of this AD: At the times 

specified in paragraphs (i)(1) and (i)(2) of this 

AD, perform a boroscope inspection of the 

NLG upper support (backplate) to detect 

ruptured (completely broken) anti-rotation 

lugs, in accordance with Airbus Technical 

Note 957.1901/05, dated October 18, 2005; 

and check the NLG strut inflation pressure 

and adjust as applicable before further flight, 

according to a method approved by either the 

Manager, International Branch, ANM–116, 

Transport Airplane Directorate, FAA; or the 

Direction Ge ́ne ́rale de l’Aviation Civile 

(DGAC) (or its delegated agent). Chapter 12, 

Subject 12–14–32 of the Airbus A318/A319/ 

A320/A321 Aircraft Maintenance Manual 

(AMM), as revised by Airbus A318/A319/ 

A320/A321 AMM Temporary Revision (TR) 

12–001, dated November 13, 2005, is one 

approved method. 

(1) Within 100 flight cycles following an 

electronic centralized aircraft monitoring 

(ECAM) caution ‘‘L/G SHOCK ABSORBER 

FAULT’’ associated with at least one of the 

centralized fault display system (CFDS) 

messages listed in paragraphs (i)(1)(i), 

(i)(1)(ii), and (i)(1)(iii) of this AD. 

(i) ‘‘N L/G EXT PROX SNSR 24GA TGT 

POS.’’

(ii) ‘‘N L/G EXT PROX SNSR 25GA TGT 

POS.’’

(iii) ‘‘N L/G SHOCK ABSORBER FAULT 

2526GM.’’

(2) Within 90 days after the effective date 

of this AD unless accomplished previously in 

accordance with paragraph (i)(1) of this AD. 

(j) If any ruptured (completely broken) 

upper support anti-rotation lugs are found 

during the inspections required by paragraph 

(i) of this AD, before further flight, replace 

the NLG with a serviceable NLG according to 

a method approved by either the Manager, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA; or the DGAC (or 

its delegated agent). Chapter 32 of the Airbus 

A318/A319/A320/A321 AMM is one 

approved method. If any other damage to the 

upper support lugs is found, before further 

flight, check whether the NLG wheels can be 

turned by hand without the compression of 

the shock absorber (i.e., without climbing the 

centering cam with the aircraft NLG on jacks) 

and the nose wheel steering disconnected 

from the electrical box 5GC. If the wheels can 

be turned, before further flight, replace the 

NLG with a serviceable NLG according to a 

method approved by either the Manager, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA; or the DGAC (or 

its delegated agent). Chapter 32 of the Airbus 

A318/A319/A320/A321 AMM is one 

approved method. If the wheels cannot be 

turned, within 100 flight cycles accomplish 

corrective actions (which could include 

replacement or continuing inspections) in 

accordance with a method approved by the 

Manager, International Branch, ANM–116, 

Transport Airplane Directorate, FAA. 

Alternative Methods of Compliance 

(AMOCs) 

(k)(1) 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. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Related Information 

(l) None. 

Material Incorporated by Reference 

(m) You must use Airbus Technical Note 

957.1901/05, dated October 18, 2005, to 

perform the actions that are required by this 

AD, unless the AD specifies otherwise. (The 

document number of the Airbus technical 

note is only specified on page 1 of the 

document.) 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 Airbus, 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France, 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 

November 16, 2005. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 05–23154 Filed 11–22–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2005–23085; Directorate 

Identifier 2005–SW–25–AD; Amendment 39–

14385; AD 2005–24–05] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Vertol Model 107–II Helicopters 

AGENCY: Federal Aviation 

Administration, DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: This amendment adopts a 

new airworthiness directive (AD) for 

Boeing Vertol (Boeing) Model 107–II 

helicopters. This action requires a visual 

and magnetic particle inspection of the 

quill shaft. This amendment is 

prompted by the discovery of cracks in 

a quill shaft during a routine inspection. 

The actions specified in this AD are 

intended to detect a fatigue crack in a 

quill shaft and prevent separation of the 

quill shaft between the aft transmission 

and the mix box assembly, loss of rotor 

synchronization, and subsequent loss of 

control of the helicopter. 

DATES: Effective December 8, 2005. 

Comments for inclusion in the Rules 

Docket must be received on or before 

January 23, 2006. 

ADDRESSES: Use one of the following 

addresses to submit comments on this 

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; 

• Fax: (202) 493–2251; or 

• 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. 

You may get the service information 

identified in this AD from The Boeing 

Company, c/o Service Engineering, MC 

P01–10, P.O. Box 16858, Philadelphia, 

PA 19142–3227. 

Examining the Docket 

You may examine the docket that 

contains the AD, any comments, and 

other information on the Internet at 

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

Docket Management System (DMS) 

Docket Offices 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 the ADDRESSES

section. Comments will be available in 

the AD docket shortly after the DMS 

receives them. 

FOR FURTHER INFORMATION CONTACT: 

George Duckett, Aviation Safety 

Engineer, FAA, New York Aircraft 

Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 70719 

Certification Office, Airframe and 

Propulsion Branch, 1600 Stewart Ave., 

suite 410, Westbury, New York 11590, 

telephone (516) 228–7325, fax (516) 

794–5531. 

SUPPLEMENTARY INFORMATION: This 

amendment adopts a new AD for Boeing 

Model 107–II helicopters. This action 

requires a visual and magnetic particle 

inspection of the quill shaft. This 

amendment is prompted by the 

discovery of cracks in a quill shaft 

during a routine 700-hour TIS clutch 

replacement in which a magnetic 

particle inspection of the quill shaft was 

done. Investigation shows that cracking 

on the ends of the spline teeth of the 

quill shaft, around the pinhole, occurs 

due to a wear step in the mating pinion 

gear splines. These cracked spline teeth 

can provide stress concentrations that 

may lead to fatigue cracks. This 

condition, if not corrected, could result 

in separation of the quill shaft between 

the aft transmission and the mix box 

assembly, loss of rotor synchronization, 

and subsequent loss of control of the 

helicopter. 

We have reviewed Boeing Service 

Bulletin No. 107–63–1005, Revision 1, 

dated April 27, 2005, which describes 

procedures for inspections of quill 

shafts, part number (P/N) 107D2067, all 

dash numbers. The service bulletin also 

specifies rejecting any quill shaft with 

chipped or cracked teeth or any quill 

shaft with a crack and, although not 

required by this AD, specifies measuring 

and recording wear in the spline of the 

mating pinion gear, P/N 107D2215. 

Also, Boeing recommends replacing 

unairworthy quill shafts with airworthy 

quill shafts, P/N 107D2067–5. These 

part-numbered quill shafts have been 

improved with a shot-peen process. 

However, in this AD, we are only 

requiring that you replace any 

unairworthy quill shaft with an 

airworthy quill shaft with any approved 

P/N. 

This AD is an interim action which 

covers initial inspections of the quill 

shaft. We plan to follow this AD with a 

superseding Notice of Proposed 

Rulemaking (NPRM) containing longer 

term requirements. The NPRM will 

propose adding the pinion gear wear 

measurements specified in the service 

bulletin and will propose adding 

recurring inspections of the quill shaft. 

Also, because we still have not 

determined the cause of the wear steps 

in the mating pinion gear splines, we 

may consider further rulemaking when 

the cause is ultimately determined. 

This unsafe condition is likely to exist 

or develop on other helicopters of the 

same type design. Therefore, this AD is 

being issued to detect a fatigue crack in 

a quill shaft and prevent separation of 

the quill shaft between the aft 

transmission and the mix box assembly, 

loss of rotor synchronization, and 

subsequent loss of control of the 

helicopter. This AD requires the 

following for a helicopter with a quill 

shaft, P/N 107D2067, and a pinion gear, 

P/N 107D2215, installed: 

• Remove the aft transmission 

assembly, separate the mix box 

assembly from the aft transmission, and 

remove the quill shaft from the pinion 

gear assembly; 

• Visually inspect the external spline 

of the quill shaft for a chipped or 

cracked tooth around the pinhole; and 

• Magnetic particle inspect the quill 

shaft for a crack. 

• Replace any quill shaft that has a 

crack or a chipped or cracked tooth with 

an airworthy quill shaft before further 

flight. 

If the pinion gear has 700 or more hours 

TIS, comply within 50 hours TIS, unless 

accomplished within the previous 350 

hours TIS. If the pinion gear has less 

than 700 hours TIS, comply on or before 

reaching 750 hours TIS. 

The short compliance time involved 

is required because these high-usage 

helicopters can quickly develop pinion 

gear wear that could lead to cracks in 

the quill shaft and adversely affect the 

structural integrity and controllability of 

the helicopter. Therefore, the actions 

described previously are required 

within 50 hours TIS, a short time period 

of about 2 weeks based on the high 

usage rate of these model helicopters, 

and this AD must be issued 

immediately. 

Since a situation exists that requires 

the immediate adoption of this 

regulation, it is found that notice and 

opportunity for prior public comment 

hereon are impracticable, and that good 

cause exists for making this amendment 

effective in less than 30 days. 

We estimate that this AD will affect 7 

helicopters. We estimate that each 

helicopter inspection will take about 17 

work hours at an average labor rate of 

$65 per work hour. Required parts will 

cost $2,500 for each quill shaft. Based 

on these figures, we estimate the total 

cost impact of the AD on U.S. operators 

to be $10,235, assuming one quill shaft 

is replaced on the fleet. 

Comments Invited 

This AD is a final rule that involves 

requirements that affect flight safety and 

was not preceded by notice and an 

opportunity for public comment; 

however, we invite you to submit any 

written data, views, or arguments 

regarding this AD. Send your comments 

to an address listed under ADDRESSES. 

Include ‘‘Docket No. FAA–2005–23085; 

Directorate Identifier 2005–SW–25–AD’’

at the beginning of your comments. We 

specifically invite comments on the 

overall regulatory, economic, 

environmental, and energy aspects of 

the AD. We will consider all comments 

received by the closing date and may 

amend the 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 AD. Using the 

search function of our docket web site, 

you can find and read the comments to 

any of our dockets, including the name 

of the individual who sent the 

comment. 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. 

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 the 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 an economic evaluation 

of the estimated costs to comply with 

this AD. See the DMS to examine the 

economic evaluation. 

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 

70720 Federal Register / Vol. 70, No. 225 / Wednesday, November 23, 2005 / Rules and Regulations 

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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me by the Administrator, 

the Federal Aviation Administration 

amends part 39 of the Federal Aviation 

Regulations (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. Section 39.13 is amended by adding 

a new airworthiness directive to read as 

follows: 

2005–24–05 Boeing Vertol (Boeing): 

Amendment 39–14385. Docket No. 

FAA–2005–23085; Directorate Identifier 

2005–SW–25–AD. 

Applicability: Model 107–II helicopters, all 

serial numbers, with a quill shaft, part 

number (P/N) 107D2067, all dash numbers, 

and a spiral bevel pinion gear (pinion gear), 

P/N 107D2215, installed, certificated in any 

category. 

Compliance: Required as indicated. 

To detect a fatigue crack in a quill shaft to 

prevent separation of the quill shaft between 

the aft transmission and the mix box 

assembly, loss of rotor synchronization, and 

subsequent loss of control of the helicopter, 

accomplish the following: 

(a) For a helicopter with a pinion gear 

installed with the following hours time-inservice (TIS): 

Pinion gear hours TIS Compliance time 

700 or more hours TIS ............................................................................. Within 50 hours TIS, unless accomplished within the previous 350 

hours TIS. 

Less than 700 hours TIS .......................................................................... On or before reaching 750 hours TIS. 

(1) Remove the aft transmission assembly, 

separate the mix box assembly from the aft 

transmission, and remove the quill shaft from 

the pinion gear assembly; 

(2) Visually inspect the external spline of 

the quill shaft for a chipped or cracked tooth 

around the pinhole; and 

(3) Magnetic particle inspect the quill shaft 

for a crack. 

(b) Before further flight, replace any quill 

shaft that has a crack or a chipped or cracked 

tooth with an airworthy quill shaft. 

Note 1: Boeing Service Bulletin No. 107–

63–1005, Revision 1, dated April 27, 2005, 

pertains to the subject of this AD. 

Note 2: Replacement quill shafts 

manufactured by Kawasaki Heavy Industries 

(KHI) for use on their Model KV107–II 

helicopters must be approved by the 

geographic Aircraft Certification Office 

(ACO) on a case-by-case basis for installation 

on a Boeing Model 107–II helicopter. 

(c) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Contact the Manager, New York ACO, 

Engine and Propeller Directorate, FAA, for 

information about previously approved 

alternative methods of compliance. 

(d) Special flight permits will not be 

issued. 

(e) This amendment becomes effective on 

December 8, 2005. 

Issued in Fort Worth, Texas, on November 

16, 2005. 

Scott A. Horn, 

Acting Manager, Rotorcraft Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–23156 Filed 11–22–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 312 

[Docket No. 2000N–1663] 

RIN 0910–AA61 

Investigational New Drugs: Export 

Requirements for Unapproved New 

Drug Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations on the exportation of 

investigational new drugs, including 

biological products. The final rule 

describes four different mechanisms for 

exporting an investigational new drug 

product. These provisions implement 

changes in FDA’s export authority 

resulting from the FDA Export Reform 

and Enhancement Act of 1996 and also 

simplify the existing requirements for 

exports of investigational new drugs. 

DATES: This rule is effective December 

23, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Philip L. Chao, Office of Policy and 

Planning (HF–23), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–0587. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 19, 

2002 (67 FR 41642), we (FDA) 

published a proposed rule to describe 

various options for exporting an 

investigational new drug, including a 

biological product. We issued the 

proposed rule to implement statutory 

changes resulting from the FDA Export 

Reform and Enhancement Act of 1996 

(Pub. L. 104–134, as amended by Pub. 

L. 104–180) and to modify a pre-existing 

regulatory program for exporting 

investigational new drugs. 

Under current § 312.110(b) (21 CFR 

312.110(b)), any person who intends to 

export an unapproved new drug product 

for use in a clinical investigation must 

have either an investigational new drug 

application (IND) or submit a written 

request to us (FDA). The written request 

must provide sufficient information 

about the drug to satisfy us that the drug 

is appropriate for investigational use in 

humans, that the drug will be used for 

investigational purposes only, and that 

the drug may be legally used by the 

consignee in the importing country for 

the proposed investigational use (see 

§ 312.110(b)(2)(i)). The request must 

also specify the quantity of the drug to 

be shipped and the frequency of 

expected shipments (id.). If we 

authorize exportation of the drug, we 

notify the government of the importing 

country (id.). Similar procedures exist 

for export requests made by foreign 

governments (see § 312.110(b)(2)(ii)). 

Section 312.110(b)(3) states that the 

requirements in paragraph (b) apply 

only where the drug is to be used for the 

purpose of a clinical investigation. 

Section 312.110(b)(4) states that the 

requirements in paragraph (b) do not 

apply to the exports of new drugs 

approved or authorized for export under