Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations 65427

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.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends 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 to

read as follows:

2001–25–04 Honeywell International Inc.:

Amendment 39–12557. Docket No. 99–

NE–17–AD.

Applicability

This airworthiness directive (AD) is

applicable to Honeywell International Inc.

(formerly AlliedSignal Inc. and Textron

Lycoming) Models LTS101–6000A–2 and

LTS101–600A–3 turboshaft engines; and

LTP101–600A–1A and LTP101–700A–1A

turboprop engines with fuel controls with the

following part numbers (P/N’s) installed:

TABLE 1.—FUEL CONTROL P/N’S

Engine Model No. Fuel Control P/N

LTS101–600A–2 ....................................................................................... 4–301–098–01, 4–301–098–04, 4–301–098–10, 4–301–098–15.

LTS101–600A–3 ....................................................................................... 4–301–288–01, 4–301–288–04.

LTP101–600A–1A .................................................................................... 4–303–023–01, 4–303–023–02, 4–303–023–03, 4–303–023–04.

LTP101–700A–1A .................................................................................... 4–303–033–01, 4–303–033–02, 4–303–033–04.

These engines are used on, but not limited

to, Aerospatiale AS350 helicopters and Air

Tractor AT–302, Page Thrush, Piaggio P.166–

DL3, and Riley International R421 airplanes.

Note 1: This AD applies to each engine

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

engines 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

Compliance with this AD is required at the

next replacement of the fuel control or within

12 calendar months after the effective date of

this AD, whichever occurs first.

To prevent the engine from reducing the

fuel flow to minimum flow resulting in an

uncommanded power loss:

(a) Remove any fuel control that has one

of the P/N’s listed in Table 1 of this AD, and

replace with a fuel control that does not have

one of the part numbers listed in Table 1 of

this AD.

Alternative Methods of Compliance

(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, Los Angles

Aircraft Certification Office (LAACO).

Operators must submit their request through

an appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, LAACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the LAACO.

Special Flight Permits

(c) Special flight permits may be issued in

accordance §§ 21.197 and 21.199 of the

Federal Aviation Regulations (14 CFR 21.197

and 21.199) to operate the aircraft to a

location where the requirements of this AD

can be accomplished.

Effective Date

(d) This amendment becomes effective on

January 23, 2002.

Issued in Burlington, Massachusetts, on

December 7, 2001.

Jay J. Pardee,

Manager, Engine and Propeller Directorate,

Aircraft Certification Service.

[FR Doc. 01–30951 Filed 12–18–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 99–NE–46–AD; Amendment 39–

12558; AD 2001–25–05]

RIN 2120–AA64

Airworthiness Directives; Rolls-Royce

Corporation (Formerly Allison Engine

Company) AE 3007 Series Turbofan

Engines

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment supersedes

an existing airworthiness directive (AD),

that is applicable to Rolls-Royce

Corporation (formerly Allison Engine

Company) AE 3007 series turbofan

engines. That AD currently requires

removal of certain compressor cone

shafts from service before exceeding

new cyclic life limits and replacement

with serviceable parts. This amendment

requires increasing the cyclic life limit

for certain serial numbers of new

compressor cone shafts, part number (P/

N) 23070729, that are used on

AE3007A1/3 and AE3007A1P engines.

This amendment is prompted by recent

approved changes in engineering and

manufacturing processes for new

compressor cone shafts P/N 23070729.

The actions specified by this AD are

intended to prevent low-cycle fatigue

(LCF) failure of cone shafts, which

could result in an uncontained engine

failure and damage to the airplane.

DATES: Effective date January 23, 2002.

ADDRESSES: The information in this AD

may be examined, by appointment, at

the Federal Aviation Administration

(FAA), New England Region, Office of

the Regional Counsel, 12 New England

Executive Park, Burlington, MA.

FOR FURTHER INFORMATION CONTACT:

Michael Downs, Aerospace Engineer,

Chicago Aircraft Certification Office,

FAA, Small Airplane Directorate, 2300

East Devon Avenue, Des Plaines, IL

60018; telephone: (847) 294–7870, fax:

(847) 294–7834.

SUPPLEMENTARY INFORMATION: A

proposal to amend part 39 of the Federal

Aviation Regulations (14 CFR part 39)

by superseding AD 2000–09–05,

Amendment 39–11714 (65 FR 26121,

May 5, 2000), which is applicable to

Rolls-Royce Corporation (formerly

Allison Engine Company) AE 3007

series turbofan engines was published

65428 Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations

in the Federal Register on May 25, 2001

(66 FR 28850). That action proposed to

require increasing the cyclic life limit

for certain serial numbers of new

compressor cone shafts, part number (P/

N) 23070729, that are used on

AE3007A1/3 and AE3007A1P engines.

Comments

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were received on the

proposal or the FAA’s determination of

the cost to the public. The FAA has

determined that air safety and the

public interest require the adoption of

the rule as proposed.

Economic Analysis

There are approximately 598 RollsRoyce Corporation (formerly Allison

Engine Company) AE 3007 series

turbofan engines of the affected design

in the worldwide fleet. The FAA

estimates that 364 engines installed on

airplanes of U.S. registry will be affected

by this AD, that it will take

approximately 150 work hours per

engine to accomplish the required

actions, and that the average labor rate

is $60 per work hour. Required parts

will cost approximately $3,921 per

engine. Based on these figures, the total

cost impact of the AD on U.S. operators

is estimated to be $4,703,244.

Regulatory Analysis

This final rule does not have

federalism implications, as defined in

Executive Order 13132, because it

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.

Accordingly, the FAA has not consulted

with state authorities prior to

publication of this final rule.

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 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 final evaluation has

been prepared for this action and it 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.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends 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 39–11714 (65 FR

26121, May 5, 2000) and by adding a

new airworthiness directive,

Amendment 39–12558, to read as

follows:

2001–25–05 Rolls-Royce Corporation:

Amendment 39–12558. Docket No. 99–

NE–46–AD. Supersedes AD 2000–09–05,

Amendment 39–11714.

Applicability

This airworthiness directive (AD) is

applicable to Rolls-Royce Corporation

(formerly Allison Engine Company) models

AE 3007A, AE 3007A1, AE 3007A1/1, AE

3007A1/2, AE 3007A1/3, AE 3007A1P, and

AE 3007C turbofan engines, with compressor

cone shafts, part numbers (P/N’s) 23050728

and 23070729, installed. These engines are

installed on but not limited to EMBRAER

EMB–135 and EMB–145 series and Cessna

750 series airplanes.

Note 1: This AD applies to each engine

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

engines 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 (h) 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

Compliance with this AD is required as

indicated, unless already done.

To prevent low-cycle fatigue (LCF) failure

of cone shafts, which could result in an

uncontained engine failure and damage to

the airplane, do the following:

(a) For Rolls-Royce Corporation model AE

3007A engines, remove cone shafts from

service prior to accumulating 9,500 cyclessince-new (CSN) and replace with

serviceable parts.

(b) For Rolls-Royce Corporation model AE

3007C engines, remove cone shafts from

service prior to accumulating 14,500 CSN

and replace with serviceable parts.

(c) For Roll-Royce Corporation models AE

3007A1, AE 3007A1/1, and AE 3007A1/2

engines, remove cone shafts from service

prior to accumulating 7,500 CSN and replace

with serviceable parts.

(d) For Rolls-Royce Corporation model AE

3007A1/3 engines:

(1) With compressor cone shafts P/N

23070729, serial number (SN) MM78599,

MM78615, MM78632, MM78650, MM78651,

MM78652, MM78653, MM78654, MM78655,

MM78656, MM78657, MM78658, MM78659,

MM78660, MM78661, MM78662, MM78663,

MM78665 or higher, remove cone shafts from

service prior to accumulating 9,300 CSN and

replace with serviceable parts.

(2) With compressor cone shafts P/N

23050728, or P/N 23070729 having other

than the S/N’s listed in paragraph (d)(1) of

this AD, remove cone shafts from service

prior to accumulating 3,500 CSN and replace

with serviceable parts.

(e) For Rolls-Royce Corporation AE

3007A1P engines:

(1) With compressor cone shafts P/N

23070729, SN MM78599, MM78615,

MM78632, MM78650, MM78651, MM78652,

MM78653, MM78654, MM78655, MM78656,

MM78657, MM78658, MM78659, MM78660,

MM78661, MM78662, MM78663, MM78665

or higher, remove cone shafts from service

prior to accumulating 7,300 CSN and replace

with serviceable parts.

(2) With compressor cone shafts P/N

23050728, or P/N 23070729 having other

than the SN’s listed in paragraph (e)(1) of this

AD, remove cone shafts from service prior to

accumulating 2,400 CSN and replace with

serviceable parts.

New Life Limits

(f) Paragraphs (a), (b), (c), (d) and (e) of this

AD establish new, lower life limits for cone

shafts, P/N’s 23050728 and 23070729.

(g) Except for the provisions of paragraph

(h) of this AD, no cone shafts, P/Ns 23050728

and 23070729, may remain in service

exceeding the life limits established in

paragraphs (a), (b), (c), (d) and (e) of this AD.

Alternative Methods of Compliance

(h) 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, Chicago

Aircraft Certification Office. Operators must

submit their request through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, Chicago Aircraft Certification

Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the Chicago

Aircraft Certification Office.

Special Flight Permits

(i) Special flight permits may be issued in

accordance §§ 21.197 and 21.199 of the

Federal Aviation Regulations (14 CFR 21.197

and 21.199) to operate the aircraft to a

Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations 65429

location where the requirements of this AD

can be done.

Effective Date

(j) This amendment becomes effective on

January 23, 2002.

Issued in Burlington, Massachusetts, on

December 7, 2001.

Jay J. Pardee,

Manager, Engine and Propeller Directorate,

Aircraft Certification Service.

[FR Doc. 01–30952 Filed 12–18–01; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 98N–0583]

Exports: Notification and

Recordkeeping Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule that establishes the notification and

recordkeeping requirements for persons

exporting human drugs, biological

products, devices, animal drugs, food,

and cosmetics that may not be marketed

or sold in the United States. These

regulations implement recent changes in

the statutory requirements applicable to

certain exports, and also codify

recordkeeping requirements for exports

of products that cannot be marketed or

sold in the United States generally.

DATES: This rule is effective March 19,

2002.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy,

Planning, and Legislation (HF–23), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of April 2,

1999 (64 FR 15994), FDA published a

proposed rule to establish notification

and recordkeeping requirements for

products exported under section 801 or

802 of the Federal Food, Drug, or

Cosmetic Act (the act) (21 U.S.C. 381 or

382, respectively) or section 351 of the

Public Health Service Act (PHS Act) (42

U.S.C. 262), as amended by the FDA

Export Reform and Enhancement Act

(Public Law 104–134, as amended by

Public Law 104–180).

The FDA Export Reform and

Enhancement Act significantly changed

and simplified the export requirements

for unapproved human drugs, biological

products, devices, and animal drugs.

For example, before the law was

enacted, most exports of unapproved

new drugs could only be made to the 21

countries then identified in section 802

of the act, and these exports were

subject to numerous restrictions. The

FDA Export Reform and Enhancement

Act amended section 802 of the act to

allow, among other things, the export of

unapproved new human drugs to any

country in the world if the drug

complies with the laws of the importing

country and has valid marketing

authorization from any of the following

countries: Australia, Canada, Israel,

Japan, New Zealand, Switzerland, South

Africa, and the countries in the

European Union (EU) and the European

Economic Area (EEA) and certain other

requirements are met (see section

802(b)(1)(A) of the act). Currently, the

EU countries are Austria, Belgium,

Denmark, Germany, Greece, Finland,

France, Ireland, Italy, Luxembourg, the

Netherlands, Portugal, Spain, Sweden,

and the United Kingdom. The EEA

countries are the EU countries, Iceland,

Liechtenstein, and Norway. (The list of

countries will expand automatically if

any country accedes to the EU or

becomes a member of the EEA.) This

provision of section 802 of the act also

applies to the export of certain devices

that cannot be sold or marketed in the

United States.

The FDA Export Reform and

Enhancement Act also established

recordkeeping and notification

requirements. Section 802(g) of the act

requires an exporter of a drug or device

under section 802(b)(1)(A) of the act to

provide a ‘‘simple notification’’ to the

agency ‘‘identifying the drug or device

when the exporter first begins to export

such drug or device’’ to any of the 25

countries identified in section

802(b)(1)(A) of the act. For exports to

other, nonlisted countries, section

802(g) of the act requires the exporter to

provide a simple notification

‘‘identifying the drug or device and the

country to which such drug or device is

being exported.’’ This section also

requires persons exporting drugs or

devices under any provision of section

802 of the act to ‘‘maintain records of all

drugs or devices exported and the

countries to which they were exported.’’

Certain aspects of the proposed rule

raised numerous issues. As a result, in

the Federal Register of June 17, 1999

(64 FR 32442), FDA extended the

comment period from June 16, 1999, to

July 16, 1999.

FDA received 18 comments on the

proposed rule. In addition, the agency

received several comments on the

export notification and recordkeeping

discussions in its draft export guidance

document which was published in the

Federal Register on June 12, 1998 (63

FR 32219, FDA docket number 98D–

0307). Drug manufacturers, device

manufacturers, device exporters, and

food, drug, and device trade

associations submitted comments. An

animal drug trade association and a

biological product company also

submitted comments. Because FDA

wrote both the proposed rule and the

guidance document contemporaneously,

the agency considered comments

submitted on the proposed rule and

related comments submitted on the draft

export guidance document when it

prepared this final rule.

II. Comments on the Proposed Rule,

Including Related Comments Submitted

to the Draft Guidance Document

Most comments focused on specific

provisions in the proposed rule.

However, others made general

comments about FDA’s export authority

or the need for any regulations or

addressed other export issues that were

not directly related to the proposed rule.

A description of the comments, and

FDA’s responses, follows.

A. General Comments

(Comment 1) Several comments

claimed that the proposal was contrary

to the letter or intent of the FDA Export

Reform and Enhancement Act because it

would create ‘‘unnecessary,’’

‘‘cumbersome,’’ or ‘‘burdensome’’

requirements that would make it more

difficult or time-consuming to export

products from the United States, place

U.S. firms at a competitive disadvantage

in global markets, force firms to relocate

overseas, or result in lost profits. Some

comments said FDA must withdraw the

proposal, although others said the

agency should significantly revise the

proposal to reduce its requirements.

FDA recognizes that the FDA Export

Reform and Enhancement Act was

designed to facilitate exports of

unapproved products from the United

States and, through the draft guidance

document, proposed rules, and other

contacts with individual firms, the

agency worked to reduce or eliminate

export requirements and facilitate

exports. FDA drafted the proposed rule

to implement the notification and

recordkeeping requirements in section

802 of the act and to establish a single,

consistent agency position regarding the

types of records it would examine to

determine compliance with section