This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

26742

Vol. 63, No. 93

Thursday, May 14, 1998

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–NM–132–AD]

RIN 2120–AA64

Airworthiness Directives; Airbus Model

A300, A310, and A300–600 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 Airbus Model A300, A310, and

A300–600 series airplanes. This

proposal would require a one-time

operational test and repetitive

functional tests of the free fall control

mechanism of the landing gear, to

ensure proper release of the main

landing gear (MLG), and corrective

action, if necessary. This proposal also

would require eventual modification of

the free fall control mechanism of

landing gear, which constitutes

terminating action for the repetitive

functional tests. This proposal is

prompted by issuance of mandatory

continuing airworthiness information by

a foreign civil airworthiness authority.

The actions specified by the proposed

AD are intended to prevent malfunction

of the free fall control mechanism of the

landing gear, which could result in the

inability to extend the MLG in the event

of failure of the hydraulic extension

system.

DATES: Comments must be received by

June 15, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 98–NM–

132–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.

The service information referenced in

the proposed rule may be obtained from

Airbus Industrie, 1 Rond Point Maurice

Bellonte, 31707 Blagnac Cedex, France.

This information may be examined at

the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW.,

Renton, Washington.

FOR FURTHER INFORMATION CONTACT:

Norman B. Martenson, Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington

98055–4056; telephone (425) 227–2110;

fax (425) 227–1149.

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 98–NM–13–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.

98–NM–132–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.

Discussion

The Direction Ge ́ne ́rale de l’Aviation

Civile (DGAC), which is the

airworthiness authority for France,

recently notified the FAA that an unsafe

condition may exist on certain Airbus

Model A300, A310, and A300–600

series airplanes. The DGAC advises that

during training flights on two Airbus

Model A300 series airplanes, the flight

crew reported difficulty in extending

the main landing gear (MLG) by means

of the free fall control mechanism of the

landing gear. The free fall control

mechanism allows the flight crew to

extend the landing gear in the event of

failure of the hydraulic system that

normally is used to extend the landing

gear. A functional test of the free fall

control mechanism on both airplanes

revealed that this mechanism was rigged

incorrectly, which caused the cockpit

control handle of the free fall control

mechanism to reach its mechanical stop

before the MLG was released for

extension by free fall. Malfunction of

the free fall control mechanism, if not

corrected, could result in the inability to

extend the MLG in the event of failure

of the hydraulic extension system.

Explanation of Relevant Service

Information

The manufacturer has issued Airbus

Industrie All operator Telex (AOT) 32–

14, dated February 3, 1997, and

Revision 01, dated March 13, 1997,

which describe procedures or a onetime operational test and repetitive

functional tests of the free fall control

mechanism of the landing gear, and

corrective action, if necessary.

Procedures for the one-time operational

test of the free fall control mechanism

include inspecting the free fall control

mechanism of the MLG with the landing

gear extended and the weight of the

airplane on the landing gear. Procedures

for the repetitive functional test of the

free fall control mechanism of the

landing gear while the airplane is on

jacks. Corrective actions, if necessary,

including readjusting the telescopic

rods of the MLG uplock of the free fall

control mechanism, or completely

rerigging the free fall control mechanism

by adjusting specified components of

the mechanism. The AOT also

recommends that operators of airplanes
Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 / Proposed Rules 26743

on which installation of Airbus

Modification 04443 is pending need not

accomplish the scheduled operational

test of the free fall control mechanism

of he landing gear.

The manufacturer also has issued

Airbus Industrie Service Bulletins

A300–32–0425, Revision 01; A310–32–

2111, Revision 01; and A300–32–6072,

Revision 01; all dated October 10, 1997.

These service bulletins describe

procedures for modification of the free

fall control mechanism of the landing

gear on Airbus Model A300, A310, and

A300–600 series airplanes. The

Modification includes removing

telescope rods and cranks or crank

assemblies from the MLG part of the free

fall control mechanism of the landing

gear, replacing the telescopic rods with

new parts, and replacing the cranks or

crank assemblies with improved parts.

Accomplishment of the modification

eliminates the need for the repetitive

inspections described previsously.

Accomplishment of the actions

specified in the AOT’s and service

bulletins described previously is

intended to adequately address the

identified unsafe condition. The DGAC

classified the AOT’s and service

bulletins as mandatory and issued

French airworthiness directive 97–113–

322(B)R1, dated December 3, 1997, in

order to assure the continued

airworthiness of these airplanes in

France.

FAA’s Conclusions

These airplane models are

manufactured in France and are type

certificated for operation in the United

States under the provisions of section

21.29 of the Federal Aviation

Regulations (14 CFR 21.29) and the

applicable bilateral airworthiness

agreement. Pursuant to this bilateral

airworthiness agreement, the DGAC has

kept the FAA informed of the situation

described above. The FAA has

examined the findings of the DGAC,

reviewed all available information, and

determined that AD action is necessary

for products of this type design that are

certificated for operation in the United

States.

Explanation of Requirements of

Proposed Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other airplanes of the same

type design registered in the United

States, the proposed AD would require

accomplishment of the actions specified

in the AOT’s and the service bulletins

described previously.

Cost Impact

The FAA estimates that 24 Model

A300 series airplanes, 41 Model, A310

series airplanes, and 61 Model A300–

600 series airplanes of U.S. registry

would be affected by this proposed AD.

It would take approximately 3 work

hours per airplane to accomplish the

proposed operational test, at an average

labor rate of $60 per work hour. Based

on these figures, the cost impact of the

proposed operational test on U.S.

operators is estimated to be $22,680, or

$180 per airplane.

It would take approximately 2 work

hours per airplane to accomplish the

proposed functional test, at an average

labor rate of $60 per work hour. Based

on these figures, the cost impact of the

proposed functional test on U.S.

operators is estimated to be $15,120, or

$120 per airplane, per test cycle.

It would take approximately 26 work

hours per airplane to accomplish the

proposed modification on the Model

A300 and A300–600 series airplanes, at

an average labor rate of $60 per work

hour. Required parts would cost

approximately $2,630 per airplane.

Based on these figures, the cost impact

of the proposed modification on U.S.

operators of Model A300 or A300–600

series airplanes is estimated to be

$356,150, or $4,190 per airplane.

It would take approximately 28 work

hours per airplane to accomplish the

proposed modification on the Model

A310 series airplanes, at an average

labor rate of $60 per work hour.

Required parts would cost

approximately $3,710 per airplane.

Based on these figures, the cost impact

of the proposed modification on U.S.

operators of Model A310 series

airplanes is estimated to be $220,990, or

$5,390 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 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.

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:

Airbus Industrie: Docket 98–NM–132–AD.

Applicability: Model A300, A310, and

A300–600 series airplanes; on which Airbus

Industrie Modification 02781 has been

accomplished, and on which Airbus

Industrie Modification 03433 or 04443 has

not been accomplished; certificated in any

category.

Note: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise 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, unless

accomplished previously.

To prevent malfunction of the free fall

control mechanism of the landing gear,

which could result in the inability to extend

the main landing gear (MLG) in the event of
26744 Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 / Proposed Rules

failure of the hydraulic extension system,

accomplish the following:

(a) Within 600 flight hours after the

effective date of this AD, perform a one-time

operational test of the free fall control

mechanism of the landing gear to ensure

proper release of the MLG for extension by

free fall, in accordance with Airbus Industrie

All Operator Telex (AOT) 32–14, dated

February 3, 1997, or Revision 01, dated

March 13, 1997. If any discrepancy is

detected in the functioning of the free fall

control mechanism of the landing gear, prior

to further flight, readjust the mechanism, and

repeat the operational test in accordance with

the AOT. If any discrepancy is detected in

the second operational test, prior to further

flight, rerig the free fall control mechanism

in accordance with the AOT, and accomplish

the actions required by paragraph (b) of this

AD.

(b) Within 10 months after the effective

date of this AD, perform a functional test of

the free fall control mechanism of the landing

gear to ensure proper release of the MLG for

extension by free fall, in accordance with

AOT 32–14, dated February 3, 1997, or

Revision 01, dated March 13, 1997.

Thereafter, repeat the functional test of the

free fall control mechanism of the landing

gear at intervals not to exceed 12 months,

until the modification required by paragraph

(c) of the AD has been accomplished. During

any test performed in accordance with

paragraph (b) of this AD, if the free fall

control mechanism of the landing gear fails

to fully extend the MLG, prior to further

flight, readjust or rerig the mechanism in

accordance with the AOT.

(c) Within 66 months after the effective

date of this AD, modify the free fall control

mechanism of the landing gear in accordance

with Airbus Industrie Service bulletin A300–

32–0425, Revision 01 (for Model A300 series

airplanes); A310–32–2111, Revision 01 (for

Model A310 series airplanes): or A300–32–

6072, Revision 01 (for Model A300–600

series airplanes); all dated October 10, 1997;

as applicable. Accomplishment of the

modification constitutes terminating action

for the repetitive functional tests required by

paragraph (b) of this AD.

(d) 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.

(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 3: The subject of this AD is addressed

in French airworthiness directive 97–113–

221(B)R1, dated December 3, 1997.

Issued in Renton, Washington, on May 7,

1998.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–12807 Filed 5–13–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 807, and 1271

[Docket No. 97N–484R]

RIN 0910–AB05

Establishment Registration and Listing

for Manufacturers of Human Cellular

and Tissue-Based Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

require manufacturers of certain human

cellular and tissue-based products to

register with the agency and list their

products. In addition, the agency is

proposing to amend the registration and

listing regulations that currently apply

to human cellular and tissue-based

products regulated as drugs, devices,

and/or biological products. This action

is being taken to establish a unified

registration and listing program for

human cellular and tissue-based

products.

DATES: Submit written comments on the

proposed rule by August 12, 1998.

Submit written comments on the

information collection provisions by

June 15, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Submit

written comments on the information

collection provisions to the Office of

Information and Regulatory Affairs,

OMB, New Executive Office Bldg., 725

17th St. NW., Washington, DC 20503,

Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy or Paula S. McKeever,

Center for Biologics Evaluation and

Research (HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

suite 200N, Rockville, MD 20852–1448,

301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Introduction

FDA is putting in place a

comprehensive new system of

regulation for human cellular and

tissue-based products. As a first step

toward accomplishing this goal, the

agency is proposing regulations that will

require establishments that manufacture

those products to register and list their

products with the agency.

A. Background

The term ‘‘human cellular and tissuebased products’’ encompasses an array

of medical products derived from the

human body and used for replacement,

reproductive, or therapeutic purposes.

Skin, tendons, bone, heart valves, and

corneas have long been used as

replacements for damaged or diseased

tissues. Semen, ova, and embryos are

transferred for reproductive purposes.

Currently, some human cellular and

tissue-based products are being

developed for new therapeutic uses. For

example, scientists are studying the use

of manipulated human cells to treat

viral infections, Parkinson’s disease,

and diabetes, among other diseases.

Human cellular and tissue-based

products serve a crucial role in

medicine, and they have the potential

for providing important new therapies.

Yet they also raise public health

concerns. With the development of new

products, and new uses for existing

products, come questions about safety

and effectiveness that need to be

answered through clinical investigation.

Furthermore, all human cellular and

tissue-based products, because they

contain components of the human body,

pose some risk of carrying pathogens

that could cause disease in health-care

personnel, other handlers of tissue,

recipients, and family members or other

close contacts of recipients.

FDA has never had a single regulatory

program for human cellular and tissuebased products. Instead, it has regulated

these products on a case-by-case basis

responding as it determined appropriate

to the particular characteristics of and

concerns raised by each type of product.

Some tissues have been regulated as

medical devices under section 201 of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 321 et seq.).

Corneal lenticules, dura mater, heart

valve allografts, and umbilical cord vein

grafts fall into this category. Other

products have been considered

biological products under section 351 of

the Public Health Service Act (the PHS

Act) (42 U.S.C. 262) and drugs under the

act (hereinafter referred to as biological

drugs). Somatic cell therapy products

and some gene therapy products fall