40856 Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 / Proposed Rules

Note 4: The subject of this AD is addressed

in German airworthiness directive 1998–137,

dated March 26, 1998.

Issued in Renton, Washington, on July 24,

1998.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–20435 Filed 7–30–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–NM–339–AD]

RIN 2120–AA64

Airworthiness Directives; British

Aerospace (Jetstream) Model 4101

Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

supersedure of an existing airworthiness

directive (AD), applicable to all British

Aerospace (Jetstream) Model 4101

airplanes, that currently requires

repetitive functional testing of the main

entrance door, cleaning and lubricating

of the ‘‘speed’’ lock and ‘‘G’’ lock

systems, and repair, if necessary. This

action would add a requirement for

replacement of the ‘‘G’’ lock rollers with

new, improved ‘‘G’’ lock rollers. 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 inability of the

main entrance door to open, which

could delay or impede passengers

exiting the airplane, or rescue personnel

from entering the airplane during an

emergency.

DATES: Comments must be received by

August 31, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 97–NM–

339–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

AI(R) American Support, Inc., 13850

Mclearen Road, Herndon, Virginia

20171. 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 97–NM–339–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–339–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.

Discussion

On September 3, 1997, the FAA

issued AD 97–19–02, amendment 39–

10122 (62 FR 47362, September 9,

1997), applicable to all British

Aerospace (Jetstream) Model 4101

airplanes, to require repetitive

functional testing of the main entrance

door, cleaning and lubricating of the

‘‘speed’’ lock and ‘‘G’’ lock systems, and

repair, if necessary. That action was

prompted by reports of flightcrews and

ground crews being unable to open the

main entrance door. The requirements

of that AD are intended to prevent

inability of the main entrance door to

open, which could delay or impede

passengers exiting the airplane, or

rescue personnel from entering the

airplane during an emergency.

Actions Since Issuance of Previous Rule

In the preamble to AD 97–19–02, the

FAA specified that the actions required

by that AD were considered ‘‘interim

action’’ and that once a modification is

developed, approved, and available, the

FAA may consider additional

rulemaking action. The manufacturer

now has developed such a modification,

and the FAA has determined that

further rulemaking action is indeed

necessary; this proposed AD follows

from that determination.

Explanation of Relevant Service

Information

British Aerospace Regional Aircraft

has issued Jetstream Alert Service

Bulletins J41–A–52–059, dated

September 12, 1997, and Revision 2,

dated January 23, 1998, which describe

procedures for replacement of the ‘‘G’’

lock rollers with rollers having

increased diameters. The installation of

‘‘G’’ lock rollers with increased

diameters provides a means to prevent

jamming of the main entrance door by

increasing the mechanism clearance

when the door handle is operated. The

Civil Aviation Authority (CAA), which

is the airworthiness authority for the

United Kingdom, classified these alert

service bulletins as mandatory and

issued British airworthiness directive

001–09–97 in order to assure the

continued airworthiness of these

airplanes in the United Kingdom.

FAA’s Conclusions

This airplane model is manufactured

in the United Kingdom and is 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 CAA has

kept the FAA informed of the situation

described above. The FAA has

examined the findings of the CAA,

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.
Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 / Proposed Rules 40857

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

supersede AD 97–19–02 to continue to

require repetitive functional testing of

the main entrance door, cleaning and

lubricating of the ‘‘speed’’ lock and ‘‘G’’

lock systems, and repair, if necessary.

The proposed AD would add a

requirement for replacement of the ‘‘G’’

lock rollers with new, improved ‘‘G’’

lock rollers. The actions would be

required to be accomplished in

accordance with the alert service

bulletins described previously.

Cost Impact

There are approximately 57 airplanes

of U.S. registry that would be affected

by this proposed AD.

The actions that are currently

required by AD 97–19–02 take

approximately 1 work hour per airplane

to accomplish, at an average labor rate

of $60 per work hour. Based on these

figures, the cost impact of the currently

required actions on U.S. operators is

estimated to be $3,420, or $60 per

airplane, per functional test cycle.

The new actions that are proposed in

this AD action would take

approximately 3 work hours per

airplane to accomplish, at an average

labor rate of $60 per work hour.

Required parts would be provided by

the manufacturer at no cost to the

operator. Based on these figures, the

cost impact of the proposed

requirements of this AD on U.S.

operators is estimated to be $10,260, or

$180 per airplane.

The cost impact figures discussed

above are based on assumptions that no

operator has yet accomplished any of

the current or 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

removing amendment 39–10122 (62 FR

47362, September 9, 1997), and by

adding a new airworthiness directive

(AD), to read as follows:

British Aerospace Regional Aircraft

[Formerly Jetstream Aircraft Limited;

British Aerospace (Commercial Aircraft)

Limited]: Docket 97–NM–339–AD.

Supersedes AD 97–19–02, Amendment

39–10122.

Applicability: All Jetstream Model 4101

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 (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 inability of the main entrance

door to open, which could delay or impede

passengers exiting the airplane, or rescue

personnel from entering the airplane during

an emergency, accomplish the following:

Restatement of Requirements of AD 97–

19–02, Amendment 39–10122:

(a) Within 30 days after September 24,

1997 (the effective date of AD 97–19–02,

amendment 39–10122), perform a functional

test to verify proper operation of the main

entrance door (including the ‘‘G’’ lock

system) and the ‘‘speed’’ lock system of the

main entrance door, in accordance with

Section 52–10–05 of BAe Jetstream Series

4101 Maintenance Manual (MM).

(1) If the ‘‘speed’’ lock and the ‘‘G’’ lock

function satisfactorily: Within 60 days after

September 24, 1997, perform the actions

specified in paragraphs (a)(1)(i) and (a)(1)(ii)

of this AD.

(i) Clean (remove existing contaminants

and lubricant) and re-lubricate (with a dry

lubricant) the ‘‘speed’’ lock and main

entrance door ‘‘G’’ lock systems in

accordance with Jetstream Service Bulletin

J41–52–058, dated July 14, 1997. And,

(ii) Following accomplishment of

paragraph (a)(1)(i) of this AD, and prior to

further flight, repeat the functional test

specified in paragraph (a) of this AD.

(A) If the ‘‘G’’ lock and the ‘‘speed’’ lock

function satisfactorily in the functional test

required by paragraph (a)(1)(ii) of this AD,

accomplish the requirements of paragraph (b)

of this AD.

(B) If the ‘‘G’’ lock and the ‘‘speed’’ lock

do not function satisfactorily in the

functional test required by paragraph

(a)(1)(ii) of this AD: Prior to further flight,

repair the ‘‘G’’ lock and the ‘‘speed’’ lock in

accordance with a method approved by the

Manager, International Branch, ANM–116,

FAA, Transport Airplane Directorate.

(2) If either the ‘‘speed’’ lock and/or the

‘‘G’’ lock do not function correctly: Prior to

further flight, perform the actions specified

in paragraphs (a)(2)(i) and (a)(2)(ii) of this

AD.

(i) Clean (remove existing contaminants

and lubricant) and re-lubricate (with a dry

lubricant) the main entrance door ‘‘speed’’

lock and ‘‘G’’ lock systems in accordance

with Jetstream Service Bulletin J41–52–058,

dated July 14, 1997. And,

(ii) Following accomplishment of

paragraph (a)(2)(i) of this AD, and prior to

further flight, repeat the functional test of the

main entrance door (including the ‘‘G’’ lock

system) and the ‘‘speed’’ lock system, in

accordance with the MM.

(A) If the ‘‘G’’ lock and ‘‘speed’’ lock

function satisfactorily in the functional test

required by paragraph (a)(2) of this AD,

accomplish the requirements of paragraph (b)

of this AD.

(B) If the ‘‘G’’ lock and ‘‘speed’’ lock do not

function satisfactorily in the functional tests

required by paragraph (a)(2) of this AD: Prior

to further flight, repair the ‘‘G’’ lock and

‘‘speed’’ lock in accordance with a method

approved by the Manager, International

Branch, ANM–116.

(b) Perform the actions specified in

paragraphs (b)(1) and (b)(2) of this AD within

1,500 hours time-in-service following

accomplishment of the initial functional test
40858 Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 / Proposed Rules

of the main entrance door required by

paragraph (a) of this AD. Repeat the actions

specified in paragraphs (b)(1) and (b)(2) of

this AD, thereafter, at intervals not to exceed

1,500 hours time-in-service.

(1) Clean (remove contaminants and dry

lubricant) and re-lubricate (with dry

lubricant) the main entrance door ‘‘speed’’

lock and ‘‘G’’ lock systems in accordance

with Jetstream Service Bulletin J41–52–058,

dated July 14, 1997.

(2) Following accomplishment of

paragraph (b)(1) of this AD and prior to

further flight, perform a functional test of the

main entrance door (including the ‘‘G’’ lock

system) and the ‘‘speed’’ lock system, in

accordance with the MM. If the ‘‘G’’ lock or

‘‘speed’’ lock system do not perform

satisfactorily: Prior to further flight, repair

the ‘‘G’’ lock or ‘‘speed’’ lock system in

accordance with a method approved by the

Manager, International Branch, ANM–116.

New Requirements of This AD:

(c) Within 60 days after the effective date

of this AD, replace the ‘‘G’’ lock rollers on

the main entrance door with new, improved

‘‘G’’ lock rollers in accordance with Jetstream

Alert Service Bulletin J41–A–52–059, dated

September 12, 1997, or Revision 2, dated

January 23, 1998.

(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. 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 British airworthiness directive 001–09–97.

Issued in Renton, Washington, on July 24,

1998.

S. R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–20430 Filed 7–30–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 3, 5, 10, 20, 207, 310, 312,

316, 600, 601, 607, 610, 640, and 660

[Docket No. 98N–0144]

RIN 0910–AB29

Biological Products Regulated Under

Section 351 of the Public Health

Services Act; Implementation of

Biologics License; Elimination of

Establishment License and Product

License

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the biologics regulations to

eliminate references to establishment

licenses and product licenses for all

products regulated under the Public

Health Service Act (PHS Act). In lieu of

filing an establishment license

application (ELA) and product license

application (PLA) in order to market a

biological product in interstate

commerce, a manufacturer would file a

single biologics license application

(BLA) with the agency. Upon approval

of the BLA, a manufacturer would

receive a biologics license to market the

product in interstate commerce. This

action is part of FDA’s continuing effort

to achieve the objectives of the

President’s ‘‘Reinventing Government’’

initiatives and is intended to reduce

unnecessary burdens for industry

without diminishing public health

protection. This action also proposes

regulations to implement certain

sections of the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: Submit written comments by

October 14, 1998. Submit written

comments on the information collection

requirements by August 31, 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 requirements to the Office of

Management and Budget (OMB), New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION:

I. Background

Currently, most manufacturers

requesting approval to market a

biological product in interstate

commerce must submit a PLA and an

ELA to FDA. FDA’s Center for Biologics

Evaluation and Research (CBER)

currently requires manufacturers to use

one of three ELA forms and 1 of 16 PLA

forms for each biological product (see

the Federal Register of July 8, 1997 (62

FR 36558)). Upon approval of the ELA

and PLA, the agency issues a product

license and an establishment license to

the manufacturer. As discussed in the

next three paragraphs, FDA has

reviewed its process of licensing

biological products and has already

taken a number of actions to reduce the

regulatory burdens imposed by the

licensing process and to make the

licensing process more consistent with

the process for the approval of new

drugs.

Manufacturers of certain biological

products are already required to submit

a BLA and obtain FDA approval of the

BLA before the product may be

introduced into interstate commerce. In

the Federal Register of May 14, 1996 (61

FR 24227), FDA issued a final rule to

amend the biologics regulations by

eliminating the ELA requirement for

specified biotechnology and synthetic

biological products licensed under

section 351 of the PHS Act (42 U.S.C.

262 et seq.). The specified

biotechnology and synthetic biological

products are: (1) Therapeutic

deoxyribonucleic acid (DNA) plasmid

products; (2) therapeutic synthetic

peptide products of 40 or fewer amino

acids; (3) monoclonal antibody products

for in vivo use; and (4) therapeutic

recombinant DNA-derived products.

This provision applies only to those

products that FDA determines pursuant

to principles articulated in the

‘‘Intercenter Agreement Between the

Center for Drug Evaluation and Research

and the Center for Biologics Evaluation

and Research’’ (effective on October 31,

1991) to be subject to licensure under

Section 351 of the PHS Act. Thus, upon

approval, manufacturers of the specified

biotechnology and synthetic biological

products receive a single biologics

license instead of a product license and

an establishment license (see § 601.2(c)

(21 CFR 601.2(c))).

In the Federal Register of July 8, 1997

(62 FR 36558), FDA announced the

availability of a revised FDA Form 356h.

FDA Form 356h was revised as a

‘‘Reinventing Government’’ initiative to