29362 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive

(AD) to read as follows:

Pilatus Aircraft LTD.: Docket No. 98–CE–30–

AD.

Applicability: Model PC–7 airplanes, serial

numbers MSN 001 through MSN 609,

certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (d) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated in the

body of this AD, unless already

accomplished.

To prevent main landing gear (MLG) or

nose landing gear (NLG) failure caused by

deterioration of a MLG or NLG leg seal unit,

which could result in damage to the airplane

or airplane controllability problems during

takeoff, landing, or taxi operations,

accomplish the following:

(a) Within the next 100 hours time-inservice after the effective date of this AD,

replace the seal unit on both MLG legs and

the NLG leg in accordance with the

ACCOMPLISHMENT INSTRUCTIONS

section of Pilatus Service Bulletin No. 32–

018, dated March 6, 1998.

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

person may install a MLG leg or NLG leg that

does not have an improved seal unit installed

in accordance with the ACCOMPLISHMENT

INSTRUCTIONS section of Pilatus Service

Bulletin No. 32–018, dated March 6, 1998.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Small Airplane

Directorate, 1201 Walnut, suite 900, Kansas

City, Missouri 64106. The request shall be

forwarded through an appropriate FAA

Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(e) Questions or technical information

related to Pilatus Service Bulletin No. 32–

018, dated March 6, 1998, should be directed

to Pilatus Aircraft Ltd., Customer Liaison

Manager, CH–6371 Stans, Switzerland;

telephone: +41 41 619 6509; facsimile: +41

41 610 3351. This service information may be

examined at the FAA, Central Region, Office

of the Regional Counsel, Room 1558, 601 E.

12th Street, Kansas City, Missouri 64106.

Note 3: The subject of this AD is addressed

in Swiss AD HB 98–069, dated March 23,

1998.

Issued in Kansas City, Missouri, on May

21, 1998.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 98–14192 Filed 5–28–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–CE–03–AD]

RIN 2120–AA64

Airworthiness Directives; British

Aerospace Model B.121 Series 1, 2,

and 3 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Supplemental notice of

proposed rulemaking (NPRM);

Reopening of the comment period.

SUMMARY: This document proposes to

revise an earlier proposed airworthiness

directive (AD) that would have required

the following on certain British

Aerospace Model B.121 Series 1, 2, and

3 airplanes: installing an inspection

opening in the area of the main spar

web, repetitively inspecting the area at

the main spar web for cracks and the

area of the wing to fuselage attach bolt

holes for corrosion, and repairing or

replacing any cracked or corroded part.

The proposed AD was the result of

mandatory continuing airworthiness

information (MCAI) issued by the

airworthiness authority for the United

Kingdom. Since issuing the NPRM,

British Aerospace has developed

additional service information to that

referenced in the previous proposal to

include the installation of nuts of

improved design at the wing to fuselage

main-spar attachment fittings and the

deletion of the inspection of the area of

the wing to fuselage attach bolt holes for

corrosion. The improved design nuts

provide better torque retention than the

nuts originally installed. The Federal

Aviation Administration (FAA) has

determined that the above-referenced

changes in the revised service

information should be incorporated into

the NPRM, and that the comment period

for the proposal should be reopened and

the public should have additional time

to comment. The actions specified by

the proposed AD are intended to

prevent structural failure of the main

spar web area caused by fatigue cracking

or separation of the wing caused by

loose nuts at the wing to fuselage mainspar attachment fittings, which could

result in loss of control of the airplane.

DATES: Comments must be received on

or before July 3, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Regional Counsel,

Attention: Rules Docket No. 98–CE–03–

AD, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106. Comments

may be inspected at this location

between 8 a.m. and 4 p.m., Monday

through Friday, holidays excepted.

Service information that applies to the

proposed AD may be obtained from

British Aerospace (Operations) Limited,

British Aerospace Regional Aircraft,

Prestwick International Airport,

Ayrshire, KA9 2RW, Scotland;

telephone: (01292) 479888; facsimile:

(01292) 479703. This information also

may be examined at the Rules Docket at

the address above.

FOR FURTHER INFORMATION CONTACT: Mr.

Roger Chudy, Aerospace Engineer,

Small Airplane Directorate, Aircraft

Certification Service, 1201 Walnut, suite

900, Kansas City, Missouri 64106;

telephone: (816) 426–6932; facsimile:

(816) 426–2169

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications

should identify the Rules Docket

number and be submitted in triplicate to

the address specified above. All

communications received on or before

the closing date for comments, specified

above, will be considered before taking

action on the proposed rule. The

proposals contained in this notice may

be changed in light of the comments

received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this
Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules 29363

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 98–CE–03–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of Supplemental NPRM’s

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Central Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 98–CE–03–AD, Room 1558,

601 E. 12th Street, Kansas City, Missouri

64106.

Discussion

A proposal to amend part 39 of the

Federal Aviation Regulations (14 CFR

part 39) to include an AD that would

apply to certain British Aerospace

Model B.121 Series 1, 2, and 3 airplanes

was published in the Federal Register

as a notice of proposed rulemaking

(NPRM) on March 16, 1998 (63 FR

12708). The NPRM proposed to require

installing an inspection opening in the

area of the main spar web, repetitively

inspecting the area at the main spar web

for cracks and the area of the wing to

fuselage attach bolt holes for corrosion,

and repairing or replacing any cracked

or corroded part. Accomplishment of

the proposed inspections would be

required in accordance with British

Aerospace PUP Mandatory Service

Bulletin No. B121/102, Revision No. 1,

Issued April 16, 1997. If necessary, the

proposed repair or replacement would

be required in accordance with a

scheme obtained from the manufacturer

through the FAA, Small Airplane

Directorate.

The NPRM was the result of

mandatory continuing airworthiness

information (MCAI) issued by the

airworthiness authority for the United

Kingdom.

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were received on the

proposed rule or the FAA’s

determination of the cost to the public.

Events Since Issuance of the NPRM

Since issuance of the NPRM, British

Aerospace has developed additional

service information to that referenced in

the previous proposal to include the

installation of nuts of improved design

at the wing to fuselage main-spar

attachment fittings and the deletion of

the inspection at the area of the wing to

fuselage attach bolt holes for corrosion.

The improved design nuts provide

better torque retention than the ones

originally installed.

In addition, British Aerospace has reexamined the service history and

evaluated reports from the field and has

changed the compliance time (that is

referenced in the service information)

for the inspection opening installation

and the initial eddy current inspection

to upon the accumulation of 2,000

flying hours.

To incorporate the above changes,

British Aerospace has issued the

following service bulletins, which

supersede British Aerospace PUP

Mandatory Service Bulletin No. B121/

102, Revision No. 1, Issued April 16,

1997:

—British Aerospace PUP Mandatory

Service Bulletin No. B121/106, dated

January 12, 1998, which specifies

procedures for replacing the nuts

(with improved design nuts) at the

wing to fuselage main-spar

attachment fittings; and

—British Aerospace PUP Mandatory

Service Bulletin No. B121/105, dated

January 12, 1998, which specifies

procedures for installing an

inspection opening in the area of the

main spar web, and inspecting the

area at the main spar web for cracks.

These procedures are basically the

same as contained in British

Aerospace PUP Mandatory Service

Bulletin No. B121/102, Revision No.

1, Issued April 16, 1997.

The FAA’s Determination

After examining all information

related to the subject described in this

document, the FAA has determined

that:

—Improved design nuts should be

installed at the wing to fuselage mainspar attachment fittings;

—The improved service information

should be incorporated into the

proposed AD;

—The compliance time of the proposed

inspection opening installation and

initial eddy current inspection should

be changed to coincide with the

service information referenced above;

and

—AD action should be taken to

incorporate these changes to prevent

structural failure of the main spar web

area caused by fatigue cracking or

separation of the wing caused by

loose nuts at the wing to fuselage

main-spar attachment fittings, which

could result in loss of control of the

airplane.

The Supplemental NPRM

Since installing improved design nuts

at the wing to fuselage main-spar

attachment fittings proposes actions that

go beyond the scope of what was

already proposed, the FAA is reopening

the comment period to allow the public

additional time to comment on this

proposed action.

Cost Impact

The FAA estimates that 2 airplanes in

the U.S. registry would be affected by

the proposed AD; that it would take

approximately 37 workhours per

airplane to accomplish the proposed

initial inspection, inspection opening

installation, and improved design nut

installations; that the average labor rate

is approximately $60 an hour. There is

no cost for the parts to accomplish the

proposed replacements. Based on these

figures, the total cost impact of the

proposed AD on U.S. operators is

estimated to be $4,440, or $2,220 per

airplane. These figures only take into

account the cost of the proposed initial

inspections, inspection opening

installation, and improved design nut

installations; and do not take into

account the cost of repetitive

inspections. The FAA has no way of

determining the number of repetitive

inspections each owner/operator of the

affected airplanes will incur.

Regulatory Impact

The regulations proposed herein

would not have substantial direct effects

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. Therefore,

in accordance with Executive Order

12612, it is determined that this

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (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); and (3) if

promulgated, 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. A copy of the draft

regulatory evaluation prepared for this

action has been placed in the Rules

Docket. A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.
29364 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend 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

(AD) to read as follows:

British Aerospace (Operations) Limited:

Docket No. 98–CE–03–AD.

Applicability: Model B.121 Series 1, 2, and

3 airplanes, all serial numbers, certificated in

any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (f) of this AD. The

request should include an assessment of the

effect of the modification, alteration, or repair

on the unsafe condition addressed by this

AD; and, if the unsafe condition has not been

eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated in the

body of this AD, unless already

accomplished.

To prevent structural failure of the main

spar web area caused by fatigue cracking or

separation of the wing caused by loose nuts

at the wing to fuselage main-spar attachment

fittings, which could result in loss of control

of the airplane, accomplish the following:

(a) Within the next 100 hours time-inservice (TIS) after the effective date of this

AD, replace the nuts (with improved design

nuts) at the wing to fuselage main-spar

attachment fittings in accordance with

British Aerospace PUP Mandatory Service

Bulletin No. B121/106, dated January 12,

1998.

(b) Upon accumulating 2,000 hours TIS on

the main spar or within the next 50 hours

TIS, whichever occurs later, install an

inspection opening and inspect, using eddy

current methods, the area at the main spar

web for cracks in accordance with the

ACCOMPLISHMENT INSTRUCTIONS

section of British Aerospace PUP Mandatory

Service Bulletin No. B121/105, dated January

12, 1998.

Note 2: Accomplishing the installation

inspection opening and initial eddy current

inspection required by this AD in accordance

with British Aerospace PUP Mandatory

Service Bulletin No. B121/102, Revision No.

1, Issued April 16, 1997, is considered

‘‘already accomplished’’ for the requirements

of paragraph (b) of this AD.

(c) Within 800 hours TIS after the initial

inspection required by paragraph (b) of this

AD, and thereafter at intervals not to exceed

800 hours TIS, reinspect the area of the main

spar web as specified in paragraph (b) of this

AD.

(d) If any cracks are found during any

inspection required by this AD, prior to

further flight, accomplish the following:

(1) Obtain a repair or replacement scheme

from the manufacturer through the FAA,

Small Airplane Directorate, at the address

specified in paragraph (e) of this AD; and

(2) Incorporate this scheme and continue to

repetitively inspect as required by paragraph

(c) of this AD, unless specified differently in

the instructions to the repair or replacement

scheme.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(f) An alternative method of compliance or

adjustment of the initial or repetitive

compliance times that provides an equivalent

level of safety may be approved by the

Manager, Small Airplane Directorate, Aircraft

Certification Service, 1201 Walnut, suite 900,

Kansas City, Missouri 64106. The request

shall be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(g) Questions or technical information

related to the service information referenced

in this document should be directed to

British Aerospace (Operations) Limited,

British Aerospace Regional Aircraft,

Prestwick International Airport, Ayrshire,

KA9 2RW, Scotland; telephone: (01292)

479888; facsimile: (01292) 479703. This

service information may be examined at the

FAA, Central Region, Office of the Regional

Counsel, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106.

Note 4: The subject of this AD is addressed

in British AD 005–01–98, not dated.

Issued in Kansas City, Missouri, on May

21, 1998.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 98–14189 Filed 5–28–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

Quality System Inspection Technique

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following public meeting: ‘‘Quality

System Inspection Technique.’’ The goal

of the meeting is to obtain views and

opinions from interested parties

concerning a proposed new technique

for conducting quality system

inspections. This proposed technique

could eventually replace the technique

presently used when FDA conducts

quality systems (good manufacturing

practices) inspections of medical device

manufacturers. The proposed ‘‘Quality

System Inspection Technique’’ was

developed by a group composed of the

Center for Devices and Radiological

Health (CDRH) and Office of Regulatory

Affairs staff, familiar with the Quality

Systems Regulation and present

inspectional processes, with input from

the medical device industry. This

meeting is part of the CDRH’s ongoing

reengineering effort to develop an

inspection program covering the Quality

System Regulation that results in more

focused and efficient inspections.

DATES: The public meeting will be held

on Thursday, June 18, 1998, from 8:30

a.m. to 5 p.m.

ADDRESSES: The public meeting will be

held at 5600 Fishers Lane, conference

rooms D and E, third floor, Rockville,

MD 20857.

FOR FURTHER INFORMATION CONTACT:

For information regarding the

meeting: Timothy R. Wells, Center

for Devices and Radiological Health

(HFZ–332), 2094 Gaither Rd.,

Rockville, MD 20859, 301–594–

4616, FAX 301–594–4638, e-mail

trw@cdrh.fda.gov.

For information regarding registration

or requests for oral presentations:

Georgia A. Layloff, Food and Drug

Administration, St. Louis Branch

Office, 12 Sunnen Dr., suite 122, St.

Louis, MO 63143, 314–645–1167,

ext. 121, FAX 314–645–2969, e-mail

glayloff@ora.fda.gov.

SUPPLEMENTARY INFORMATION: The draft

entitled ‘‘Quality System Inspection

Technique’’ is posted for comment on

the CDRH’s World Wide Web (www)

home page. The draft document may be