20556 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules

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 is contained in the Rules Docket.

A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

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

removing amendment 39–8348 (57 FR

38432, August 25, 1992), and by adding

a new airworthiness directive (AD), to

read as follows:

Fokker: Docket 98–NM–16-AD. Supersedes

AD 92–18–04, Amendment 39–8348.

Applicability: Model F.28 Mark 1000,

2000, 3000, and 4000 series airplanes;

equipped with Menasco horizontal stabilizer

actuators having part number (P/N)

11100-( ); 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 (e) 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, unless

accomplished previously.

To prevent uncommanded trimming or

failure of the trim system of the horizontal

stabilizer, and consequent reduced

controllability of the airplane, accomplish

the following:

(a) Within 20 days after September 9, 1992

(the effective date of AD 92–18–04,

amendment 39–8348), perform an inspection

of the servo-valve sub-assembly rod-end

bearing and servo-valve sub-assembly for

movement, in accordance with Fokker

Service Bulletin F28/27–180, dated July 3,

1992.

(1) If the servo-valve sub-assembly rod-end

bearing and servo-valve sub-assembly move

freely within the load limits specified in the

service bulletin, reassemble and conduct a

functional test, in accordance with the

service bulletin.

(2) If the servo-valve sub-assembly rod-end

bearing or servo-valve sub-assembly require

higher loads for movement than specified in

the service bulletin, prior to further flight,

remove and replace the horizontal stabilizer

control unit with a serviceable control unit

that has been inspected and found to be

within the load limits of the service bulletin,

or that has been inspected and repaired in

accordance with Chapter 27–42–4 of the

Menasco Overhaul Manual (OHM), as revised

by Temporary Revision Number 3, dated July

10, 1992.

(b) Within 6 months after the effective date

of this AD, perform a one-time inspection to

determine the residual strength of the servovalve sub-assembly of the horizontal

stabilizer actuator, in accordance with Part 1

of the Accomplishment Instructions of

Fokker Service Bulletin F28/27–183, dated

November 21, 1994. If any discrepancy is

found, prior to further flight, replace the

actuator with a new or serviceable actuator

in accordance with the service bulletin.

(c) Within 3 years after the effective date

of this AD, replace the horizontal stabilizer

actuator with an actuator that has been

modified and re-marked in accordance with

Part 2 of the Accomplishment Instructions of

Fokker Service Bulletin F28/27–183, dated

November 21, 1994.

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

person shall install a horizontal stabilizer

control unit on any airplane, unless the

horizontal stabilizer actuator has been

modified and re-marked in accordance with

Part 2 of the Accomplishment Instructions of

Fokker Service Bulletin F28/27–183, dated

November 21, 1994.

(e) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, International Branch,

ANM–116.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(f) 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.

Note 3: The subject of this AD is addressed

in Dutch airworthiness directive 1992–007/

2(A), dated January 31, 1995.

Issued in Renton, Washington, on April 21,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11092 Filed 4–24–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–NM–302–AD]

RIN 2120–AA64

Airworthiness Directives; Gulfstream

Aerospace Corporation Model G–159

(G–I) Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

adoption of a new airworthiness

directive (AD) that is applicable to all

Gulfstream Aerospace Corporation

Model G–159 (G–I) airplanes. This

proposal would require revising the

Airplane Flight Manual (AFM) to

modify the limitation that prohibits

positioning the power levers below the

flight idle stop during flight, and to

provide a statement of the consequences

of positioning the power levers below

the flight idle stop during flight. This

proposal is prompted by incidents and

accidents involving airplanes equipped

with turboprop engines in which the

ground propeller beta range was used

improperly during flight. The actions

specified by the proposed AD are

intended to prevent loss of airplane

controllability, or engine overspeed and

consequent loss of engine power caused

by the power levers being positioned

below the flight idle stop while the

airplane is in flight.

DATES: Comments must be received by

May 27, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 97–NM–

302–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9:00 a.m. and 3:00

p.m., Monday through Friday, except

Federal holidays.

This information may be examined at

the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW.,

Renton, Washington; or at the FAA,
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules 20557

Small Airplane Directorate, Atlanta

Aircraft Certification Office, 1895

Phoenix Boulevard, suite 450, Atlanta,

Georgia.

FOR FURTHER INFORMATION CONTACT:

Wayne A. Shade, Aerospace Engineer,

Airframe and Propulsion Branch, ACE–

117A, FAA, Small Airplane Directorate,

Atlanta Aircraft Certification Office,

1895 Phoenix Boulevard, suite 450,

Atlanta, Georgia 30349; telephone (770)

703–7337; fax (770) 703–6097.

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 shall

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

summarizing each FAA-public contact

concerned with the substance of this

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 Number 97–NM–302–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of NPRMs

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Transport Airplane Directorate,

ANM–114, Attention: Rules Docket No.

97–NM–302–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.

Discussion

In recent years, the FAA has received

reports of 14 incidents and/or accidents

involving intentional or inadvertent

operation of the propellers in the

ground beta range during flight on

airplanes equipped with turboprop

engines. (For the purposes of this

proposal, beta is defined as the range of

propeller operation intended for use

during taxi, ground idle, or reverse

operations, as controlled by the power

lever settings aft of the flight idle stop.)

Five of the fourteen in-flight beta

occurrences were classified as

accidents. In each of these five cases,

operation of the propellers in the beta

range occurred during flight. Operation

of the propellers in the beta range

during flight could result in loss of

airplane controllability, or engine

overspeed with consequent loss of

engine power.

Communication between the FAA and

the public during a meeting held on

June 11–12, 1996, in Seattle,

Washington, revealed a lack of

consistency of the information on inflight beta operation contained in the

FAA-approved Airplane Flight Manual

(AFM) for airplanes that are not

certificated for in-flight operation with

the power levers below the flight idle

stop. (Airplanes that are certificated for

this type of operation are not affected by

the above-referenced conditions.)

FAA’s Determinations

The FAA has examined the

circumstances and reviewed all

available information related to the

incidents and accidents described

previously. The FAA finds that the

Limitations Section of the AFM’s for

certain airplanes must be revised to

prohibit positioning the power levers

below the flight idle stop while the

airplane is in flight, and to provide a

statement of the consequences of

positioning the power levers below the

flight idle stop. The FAA has

determined that the affected airplanes

include those that are equipped with

turboprop engines and that are not

certificated for in-flight operation with

the power levers below the flight idle

stop. Since turbopropeller-powered

Gulfstream Aerospace Corporation

Model G–159 (G–I) airplanes meet these

criteria, the FAA finds that the AFM’s

for these airplanes must be revised to

include the limitation and statement of

consequences described previously.

Explanation of the Requirements of the

Proposed AD

Since an unsafe condition has been

identified that is likely to exist or

develop in other turbopropellerpowered Gulfstream Aerospace

Corporation Model G–159 (G–I)

airplanes of the same type design, the

proposed AD would require revising the

Limitations Section of the AFM to

modify the limitation that prohibits the

positioning of the power levers below

the flight idle stop while the airplane is

in flight, and to add a statement of the

consequences of positioning the power

levers below the flight idle stop while

the airplane is in flight.

Interim Action

This is considered interim action

until final action is identified, at which

time the FAA may consider further

rulemaking.

Cost Impact

There are approximately 143

Gulfstream Model G–159 (G–I) airplanes

of the affected design in the worldwide

fleet. The FAA estimates that 63

airplanes of U.S. registry would be

affected by this proposed AD, that it

would take approximately 1 work hour

per airplane to accomplish the proposed

actions, and that the average labor rate

is $60 per work hour. Based on these

figures, the cost impact of the proposed

AD on U.S. operators is estimated to be

$3,780, or $60 per airplane.

The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the proposed requirements of this AD

action, and that no operator would

accomplish those actions in the future if

this AD were not adopted.

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 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) 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 is contained in the Rules Docket.

A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.
20558 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules

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 the following new airworthiness

directive:

Gulfstream Aerospace Corporation

(Formerly Grumman): Docket 97–NM–

302–AD.

Applicability: All Model G–159 (G–I)

airplanes, 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 (b) 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, unless

accomplished previously.

To prevent loss of airplane controllability,

or engine overspeed and consequent loss of

engine power, caused by the power levers

being positioned below the flight idle stop

while the airplane is in flight, accomplish the

following:

(a) For turbopropeller-powered Gulfstream

Model G–159 (G–1) airplanes: Within 30 days

after the effective date of this AD, revise the

Limitations Section of the FAA-approved

Airplane Flight Manual (AFM) to include the

following statements. This action may be

accomplished by inserting a copy of this AD

into the AFM.

‘‘Positioning of the propeller flight fine

pitch lock selector to the ground interlock

position in flight is PROHIBITED. Such

positioning may lead to loss of airplane

control.’’

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, FAA, Small

Airplane Directorate, Atlanta Aircraft

Certification Office (ACO). Operators shall

submit their requests through an appropriate

FAA Principal Operations Inspector, who

may add comments and then send it to the

Manager, Atlanta ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Atlanta ACO.

(c) Special flight permits may be issued in

accordance with §§ 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.

Issued in Renton, Washington, on April 21,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11102 Filed 4–24–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N–0168]

Medical Devices; 30–Day Notices and

135–Day PMA Supplement Review;

Companion Document to Direct Final

Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations governing the

submission and review of premarket

approval application (PMA)

supplements to allow for the submission

of a 30-day notice for modifications to

manufacturing procedures or methods

of manufacture. Amendments are being

made to implement revisions to the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA). This proposed rule is

a companion document to the direct

final rule published elsewhere in this

issue of the Federal Register.

DATES: Submit written comments on or

before July 13, 1998. Submit written

comments on the information collection

requirements on or before June 26, 1998.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186.

SUPPLEMENTARY INFORMATION:

I. Background

This proposed rule is a companion

document to the direct final rule

published elsewhere in this issue of the

Federal Register. This proposed rule is

substantively identical to its companion

direct final rule. The proposed rule will

provide the procedural framework to

finalize the rule in the event the

companion direct final rule receives any

significant adverse comment and is

withdrawn. The comment period for

this companion proposed rule runs

concurrently with that for the direct

final rule. All comments on this

proposed rule will also be considered as

comments on the companion direct final

rule. FDA is publishing the direct final

rule because the rule contains

noncontroversial changes, and FDA

anticipates that it will receive no

significant adverse comments. If no

significant comment is received in

response to the direct final rule, no

further action will be taken related to

this proposed rule. Instead, FDA will

publish a confirmation notice within 30

days after the comment period ends

confirming that the direct final rule will

go into effect on September 9, 1998.

Because this rule makes

noncontroversial changes to an existing

regulation in order to implement

changes required by FDAMA, FDA

believes that publication of a direct final

rule is appropriate. Additional

information about FDA’s direct final

rulemaking procedures is set forth in a

guidance published in the Federal

Register of November 21, 1997 (62 FR

62466).

If FDA receives a significant adverse

comment regarding this rule, FDA will

publish a document withdrawing the

direct final rule within 30 days after the

comment period ends and will proceed

to respond to all of the comments

received under this companion rule

using usual notice-and-comment

procedures. The comment period for

this companion proposed rule runs

concurrently with the direct final rule’s

comment period. Any comments

received under this companion

proposed rule will also be considered

comments regarding the direct final

rule.

A significant adverse comment is

defined as a comment that explains why

the rule would be inappropriate,

including challenges to the rule’s

underlying premise or approach, or

would be ineffective or unacceptable

without a change. In determining

whether a significant adverse comment

is sufficient to terminate a direct final

rulemaking, FDA will consider whether