Federal Register / Vol. 66, No. 10 / Tuesday, January 16, 2001 / Proposed Rules 3521

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

Special Flight Permits

(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.

Note 5: The subject of this AD is addressed

in Dutch airworthiness directive 1998–042/2,

dated February 29, 2000.

Issued in Renton, Washington, on January

9, 2001.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 01–1236 Filed 1–12–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 2000–NM–303–AD]

RIN 2120–AA64

Airworthiness Directives; Boeing

Model 777–200 Series 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

certain Boeing Model 777–200 series

airplanes. This proposal would require

repetitive detailed visual and ultrasonic

inspections of the lower flange of the

flaperon inboard support to find

cracking, and corrective actions, if

necessary. This proposal also would

require a modification, which would

terminate the repetitive inspections.

This action is necessary to prevent

fracture of the inboard support

structure, which could result in an inflight loss of the inboard flaperon,

structural damage, and consequent

reduced controllability of the airplane.

This action is intended to address the

identified unsafe condition.

DATES: Comments must be received by

March 2, 2001.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 2000–NM–

303–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9 a.m. and 3 p.m.,

Monday through Friday, except Federal

holidays. Comments may be submitted

via fax to (425) 227–1232. Comments

may also be sent via the Internet using

the following address:

9-anm-nprmcomment@faa.gov.

Comments sent via fax or the Internet

must contain ‘‘Docket No. 2000–NM–

303–AD’’ in the subject line and need

not be submitted in triplicate.

Comments sent via the Internet as

attached electronic files must be

formatted in Microsoft Word 97 for

Windows or ASCII text.

The service information referenced in

the proposed rule may be obtained from

Boeing Commercial Airplane Group,

P.O. Box 3707, Seattle, Washington

98124–2207. This information may be

examined at the FAA, Transport

Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington.

FOR FURTHER INFORMATION CONTACT: Stan

Wood, Aerospace Engineer, Airframe

Branch, ANM–120S, FAA, Seattle

Aircraft Certification Office, 1601 Lind

Avenue, SW., Renton, Washington

98055–4056; telephone (425) 227–2772;

fax (425) 227–1181.

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 action may be changed in light

of the comments received.

Submit comments using the following

format:

• Organize comments issue-by-issue.

For example, discuss a request to

change the compliance time and a

request to change the service bulletin

reference as two separate issues.

• For each issue, state what specific

change to the proposed AD is being

requested.

• Include justification (e.g., reasons or

data) for each request.

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 action

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 2000–NM–303–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.

2000–NM–303–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.

Discussion

Flight testing of certain Boeing Model

777–200 series airplanes showed that

high engine thrust conditions during

takeoff cause tremendous cyclic loads

on the support structure of the inboard

flaperon. Based on engineering analysis,

fatigue cracks of the support structure

could develop at approximately 4,000

flight cycles. Such fatigue cracking

could result in fracture of the inboard

support structure, in-flight loss of the

inboard flaperon, significant damage to

the surrounding structure, and

consequent reduced controllability of

the airplane.

Explanation of Relevant Service

Information

The FAA has reviewed and approved

Boeing Alert Service Bulletin 777–

57A0036, dated June 24, 1999, which

describes procedures for detailed visual

and ultrasonic inspections of the lower

flange of the flaperon inboard support to

find cracking, and corrective actions if

cracking is found. The corrective actions

consist of accomplishment of the

terminating action in Part 2 of the

service bulletin. The terminating action

includes, but is not limited to, a high

frequency eddy current inspection to

find cracks of the aft holes that attach

the failsafe strap to the lower flange,

oversizing of the holes if cracks are

found, and installation of a failsafe

strap. Accomplishment of the actions

specified in the service bulletin is

intended to adequately address the

identified unsafe condition.

Explanation of Requirements of

Proposed Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other products of this same

type design, the proposed AD would

require accomplishment of the actions

3522 Federal Register / Vol. 66, No. 10 / Tuesday, January 16, 2001 / Proposed Rules

specified in the service bulletin

described previously, except as

discussed below.

Differences Between Service Bulletin

and This Proposed AD

While the effectivity listing of the

service bulletin includes airplanes

having line numbers (L/N) 2 through 9

inclusive; this proposed AD would

apply to airplanes having L/N’s 1

through 9 inclusive. The FAA has

determined that the subject area on the

airplane with L/N 1 is identical to the

subject areas on the Model 777–200

series airplanes listed in the service

bulletin; so the airplane with L/N 1 is

also subject to the identified unsafe

condition.

Although the service bulletin

specifies that the manufacturer may be

contacted for instructions on repair of

certain conditions, this proposed AD

would require the repair of those

conditions to be accomplished per a

method approved by the FAA, or per

data meeting the type certification basis

of the airplane approved by a Boeing

Company Designated Engineering

Representative who has been authorized

by the FAA to make such findings.

Cost Impact

There are approximately 9 airplanes

of the affected design in the worldwide

fleet.

The FAA estimates that 1 airplane of

U.S. registry would be affected by this

proposed AD.

It would take approximately 3 work

hours per airplane to accomplish the

proposed inspections, at an average

labor rate of $60 per work hour. Based

on these figures, the cost impact of the

inspections proposed by this AD on U.S.

operators is estimated to be $180 per

airplane, per inspection cycle.

It would take approximately 6 work

hours per airplane to accomplish the

proposed terminating action, at an

average labor rate of $60 per work hour.

Required parts would cost

approximately $2,932 per airplane.

Based on these figures, the cost impact

of the terminating action proposed by

this AD on U.S. operators is estimated

to be $3,292 per airplane.

The cost impact figures discussed

above are 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 proposed AD were not adopted. The

cost impact figures discussed in AD

rulemaking actions represent only the

time necessary to perform the specific

actions actually required by the AD.

These figures typically do not include

incidental costs, such as the time

required to gain access and close up,

planning time, or time necessitated by

other administrative actions.

Regulatory Impact

The regulations proposed herein

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. Therefore,

it is determined that this proposal

would not have federalism implications

under Executive Order 13132.

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.

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:

Boeing: Docket 2000–NM–303–AD.

Applicability: Model 777–200 series

airplanes, line numbers (L/N) 1 through 9

inclusive, 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 per

paragraph (c) 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 fracture of the inboard support

structure of the flaperon, which could result

in an in-flight loss of the inboard flaperon,

structural damage, and consequent reduced

controllability of the airplane, accomplish

the following:

Repetitive Inspections

(a) Before the accumulation of 4,000 total

flight cycles, or within 90 days after the

effective date of this AD, whichever occurs

later: Do a detailed visual and an ultrasonic

inspection of the lower flange of the flaperon

inboard support to find cracks per Part 1 of

the Accomplishment Instructions of Boeing

Alert Service Bulletin 777–57A0036, dated

June 24, 1999.

(1) If no cracking is found: Repeat the

applicable inspections thereafter at intervals

not to exceed 300 flight cycles until

accomplishment of the terminating action

specified in paragraph (b) of this AD.

(2) If any cracking is found, before further

flight, do the terminating action required by

paragraph (b) of this AD, except, where the

service bulletin specifies to contact Boeing

for instructions, before further flight, repair

per a method approved by the Manager,

Seattle Aircraft Certification Office (ACO),

FAA; or per data meeting the type

certification basis of the airplane approved

by a Boeing Company Designated

Engineering Representative (DER) who has

been authorized by the Manager, Seattle

ACO, to make such findings. For a repair

method to be approved by the Manager,

Seattle ACO, as required by this paragraph,

the approval letter must specifically

reference this AD.

Terminating Action

(b) On or before the accumulation of 8,000

total flight cycles, or within 1,200 flight

cycles after the effective date of this AD,

whichever occurs later: Do the terminating

action (a high frequency eddy current

inspection to find cracks of the aft holes that

attach the failsafe strap to the lower flange,

oversizing of the holes if cracks are found,

and installation of a failsafe strap), per Part

2 of the Accomplishment Instructions of

Boeing Alert Service Bulletin 777–57A0036,

dated June 24, 1999. Accomplishment of this

paragraph terminates the repetitive

inspections required by paragraph (a) of this

AD.

Alternative Methods of Compliance

(c) 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, Seattle

ACO, FAA. Operators shall submit their

requests through an appropriate FAA

Principal Maintenance Inspector, who may

Federal Register / Vol. 66, No. 10 / Tuesday, January 16, 2001 / Proposed Rules 3523

add comments and then send it to the

Manager, Seattle ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

Special Flight Permit

(d) Special flight permits may be issued per

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.

Issued in Renton, Washington, on January

9, 2001.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 01–1235 Filed 1–12–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 807

[Docket No. 00N–1625]

Medical Devices; Rescission of

Substantially Equivalent Decisions and

Rescission Appeal Procedures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing

regulations under which FDA may

rescind a decision issued under the

Federal Food, Drug, and Cosmetic Act

(the act) that a device is substantially

equivalent to a legally marketed device,

and, therefore, may be marketed. In

addition, under this proposal, a

premarket notification (commonly

known as a ‘‘510(k)’’) holder may

request administrative review of a

proposed rescission action. This

proposed rule is being issued in order

to standardize the procedures for

considering rescissions.

DATES: Submit written comments by

April 16, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1061, 5630 Fishers

Lane, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices

and Radiological Health (HFZ–404),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

The Medical Device Amendments

(Public Law 94–295) (the amendments)

to the act (21 U.S.C. 301 et seq.) were

enacted on May 28, 1976. Among other

things, the amendments directed FDA to

issue regulations classifying all medical

devices into one of three regulatory

control categories. The classification

depends upon the degree of regulation

necessary to provide reasonable

assurance of the safety and effectiveness

of the device.

Under section 513(a)(1)(A) of the act

(21 U.S.C. 360c(a)(1)(A)), class I devices

are subject to a comprehensive set of

regulatory provisions applicable to all

classes of devices, e.g., registration and

listing, prohibitions against adulteration

and misbranding, and good

manufacturing practice requirements. A

class I device is exempt from the

premarket notification requirements of

the act unless it is intended for a use

which is of substantial importance in

preventing impairment of human

health, or the device presents a potential

unreasonable risk of illness or injury

under section 510(l) of the act (21 U.S.C.

360(l)). Class II devices are subject to

special controls as well as general

controls. These special controls may

consist of performance standards,

postmarket surveillance, patient

registries, FDA guidelines, or other

appropriate controls under section

513(a)(1)(B) of the act. Class III devices

require premarket approval (PMA) or a

completed product development

protocol by FDA before they may be

marketed, unless they are class III

devices for which we have not called for

PMA’s under section 515(b) of the act

(21 U.S.C. 360e(b)).

II. Premarket Notification

Requirements

Section 510(k) of the act requires each

person who is required to register and

who proposes to begin the introduction

or delivery for introduction into

interstate commerce for commercial

distribution of a device intended for

human use to submit a 510(k).

Throughout this proposal, we use the

following terms:

1. The ‘‘510(k) submitter.’’—the

person who submitted the 510(k) to the

FDA.

2. The ‘‘510(k) holder’’—the person

who possesses the rights to market the

device that is the subject of a 510(k)

substantial equivalence order. (The

510(k) submitter and the 510(k) holder

may or may not be the same person.)

3. The ‘‘510(k) holder of record’’—the

person whom FDA has on file as being

the 510(k) holder.

The proposed rule adds these

definitions to 21 CFR 807.3.

There may be instances when 510(k)

ownership has changed without FDA’s

knowledge. In the event of a proposed

rescission, FDA would provide notice to

the 510(k) holder of record. FDA would

attempt to notify the holder of record by

registered letter. FDA would also post

notice of a proposed rescission on

FDA’s Center for Devices and

Radiological Health’s (CDRH) home

page on the Internet at http://

www.fda.gov/cdrh/index.html. To

protect the privacy of the 510(k) holder,

only the proposed rescission would be

listed; the factual basis and reasons for

the rescission would not be posted on

CDRH’s home page on the Internet.

Under the 510(k) process, the 510(k)

submitter may claim that its new device

is substantially equivalent to a legally

marketed class I or class II device or to

a preamendments class III device that is

not yet required to be the subject of an

approved premarket approval

application. If, after reviewing the

510(k), the agency determines that the

device is substantially equivalent to the

legally marketed device (as defined in

21 CFR 807.92(a)(3)), the agency will

issue an order permitting the 510(k)

submitter to market its device without

the need for the more rigorous

premarket approval under section 515 of

the act.

The criteria the agency must use to

determine substantial equivalence are in

section 513(i) of the act. Section 513(i)

of the act defines substantial

equivalence to mean that the device has

the same intended use as the predicate

device and that FDA, by order, has

found that the device—(i) has the same

technological characteristics as the

predicate device, or (ii)—(I) has

different technological characteristics

and the information submitted that the

device is substantially equivalent to the

predicate device contains information,

including clinical data if deemed

necessary by FDA, that the device is as

safe and effective as a legally marketed

device, and (II) does not raise different

questions of safety and effectiveness

than the legally marketed device.

The statute allows 510(k) marketing

clearance only for devices that FDA

determines are comparable in safety and

effectiveness to a legally marketed

device. New devices that are not

substantially equivalent must remain in

class III and meet the premarket

approval requirements under section

515 of the act before they can be

marketed, unless the device is

reclassified under section 513(f) of the

act.