Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3621

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

18, 2000.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–1597 Filed 1–21–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 99–NE–40–AD]

RIN 2120–AA64

Airworthiness Directives; CFM

International CFM56–2, –2A, –2B, –3,

–3B, –3C, –5, –5B, –5C Series Turbofan

Engines

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 CFM

International (CFMI) CFM56–2, –2A,

–2B, –3, –3B, –3C, –5, –5B, –5C series

turbofan engines. This proposal would

require initial and repetitive visual

inspections of the fuel pump filter cover

helicoil inserts and bolts for damage,

and, if necessary, repair or replacement

with serviceable parts. This proposal

also would require the installation of

new fuel pumps that incorporate an

improved filter cover retention design

(D-bolts) as terminating action to the

inspections. This proposal is prompted

by reports that fuel pump filter cover

helicoil inserts have loosened or pulled

out. The actions specified by the

proposed AD are intended to prevent

fuel leakage from between the fuel

pump filter cover and gear housing,

which could result in an engine fire and

damage to the airplane.

DATES: Comments must be received by

February 23, 2000.

ADDRESSES: Submit comments to the

Federal Aviation Administration (FAA),

New England Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 99–NE–40–AD, 12 New

England Executive Park, Burlington, MA

01803–5299. Comments may also be

sent via the Internet using the following

address: ‘‘9-ane-adcomment@faa.gov’’.

Comments sent via the Internet must

contain the docket number in the

subject line. Comments may be

inspected at this location between 8:00

a.m. and 4:30 p.m., Monday through

Friday, except Federal holidays.

The service information referenced in

the proposed rule may be obtained from

CFM International, Technical

Publications Department, 1 Neumann

Way, Cincinnati, OH 45215; telephone

(513) 552–2981, fax (513) 552–2816.

This information may be examined at

the FAA, New England Region, Office of

the Regional Counsel, 12 New England

Executive Park, Burlington, MA.

FOR FURTHER INFORMATION CONTACT:

James Rosa, Aerospace Engineer, Engine

Certification Office, FAA, Engine and

Propeller Directorate, 12 New England

Executive Park, Burlington, MA 01803–

5299; telephone (781) 238–7152, fax

(781) 238–7199.

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

should identify the Rules Docket

number and be submitted 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 99-NE–40–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, New England Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 99–NE–40–AD, 12 New

England Executive Park, Burlington, MA

01803–5299.

Discussion

The Federal Aviation Administration

(FAA) has received reports of fuel

leakage from between the fuel pump

filter cover and gear housing on CFM

International (CFMI) CFM56–2, –2A,

–2B, –3, –3B, –3C, –5, –5B, –5C series

turbofan engines.

Investigation

The investigation revealed that fuel

pump filter cover helicoil inserts have

loosened or pulled out. The FAA has

identified excessive torque during the

installation of fuel filter cover bolts as

the cause.

Improved Filter Cover

The manufacturer has introduced an

improved filter cover retention design

using a captured D-bolt and special

locking nut that reduces the potential

for filter cover bolt over torque damage

and loss of bolted joint strength.

Unsafe Condition

This condition, if not corrected, could

result in fuel leakage from between the

fuel pump filter cover and gear housing,

which could result in an engine fire and

damage to the airplane.

Service Information

The FAA has reviewed and approved

the technical contents of the following

CFMI Service Bulletins (SBs), that

describe procedures for visual

inspections of inserts and bolts for

damage, and provide criteria for

rejection of hardware and necessary

replacement with serviceable parts:

CFM56–2 SB 73–110, Revision 2, dated

April 29, 1999; CFM56

The FAA has also reviewed and

approved the technical contents of the

following CFMI SBs, that describe

procedures for removal and replacement

of fuel pumps (D-bolt fix): CFM56–2 SB

73–-A113, dated August 17, 1999;

CFM56–2A SB 73–A058, dated August

17, 1999; CFM56–2B SB 73–A079, dated

August 17, 1999; CFM56–3/3B/3C SB

73-A129, dated August 17, 1999;

CFM56–5 SB 73–A143, dated June 18,

1999; CFM56–5B SB 73–A062, dated

June 18, 1999; CFM56–5C SB 73–A078,

dated June 21, 1999.

Differences Between Service Bulletins

and This AD

The referenced SBs describe a onetime inspection. This AD requires

repetitive inspections at every filter

change.

Proposed Inspections and Repair or

Replacement

Since an unsafe condition has been

identified that is likely to exist or

3622 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules

develop on other products of this same

type design, the proposed AD would

require initial and repetitive visual

inspections of helicoil inserts and bolts

for damage defined in the applicable

SBs. The inspections would be required

at each fuel filter replacement. If the

damage equals or exceeds the reject

criteria, this AD would require, prior to

further flight, removing the damaged

hardware from service and replacement

with serviceable parts, or repairing the

damaged hardware.

Terminating Action

This AD would also require the

installation of new fuel pumps that

incorporate an improved filter cover

retention design (D-bolts) as a

terminating action to the inspections.

The actions would be required to be

accomplished in accordance with the

SBs described previously.

Economic Analysis

There are approximately 8,781

engines of the affected design in the

worldwide fleet. The FAA estimates that

4,063 engines installed on aircraft of

U.S. registry would be affected by this

proposed AD, that it would take

approximately 0.3 work hours per

engine to accomplish the proposed

inspections and 3 work hours per

engine to accomplish the proposed Dbolt installation, and that the average

labor rate is $60 per work hour. The

FAA therefore estimates the total cost to

US operators of this proposed rule is

$73,134 for one inspection and

$4,958,658 for hardware/D-bolt

installation.

Regulatory Impact

This proposal does not have

federalism implications, as defined in

Executive Order No. 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 proposal.

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:

CFM International: Docket No. 99–NE–40–

AD.

Applicability: CFM International (CFMI)

CFM56–2, –2A, –2B, –3, –3B, –3C, –5, –5B,

–5C series turbofan engines, installed on but

not limited to McDonnell Douglas DC–8

series, Boeing 737 series, Airbus Industrie

A319, A320, A321, and A340 series, and

Boeing E–3, E–6, and KC–135 (military)

series airplanes.

Note 1: This airworthiness directive (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 (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 fuel leakage from between the

fuel pump filter cover and gear housing,

which could result in an engine fire and

damage to the airplane, accomplish the

following:

Inspections

(a) Perform initial and repetitive visual

inspections of fuel pump filter cover helicoil

inserts and bolts for damage, as follows:

(1) Initially inspect at the next fuel filter

replacement, but not to exceed 200 cycles-inservice (CIS) after either the effective date of

this AD or the last inspection, whichever

occurs first, in accordance with section 2.,

Accomplishment Instructions, of the

applicable CFMI Service Bulletins (SBs)

listed in paragraph (a)(4) of this AD.

(2) Thereafter, inspect at each fuel filter

replacement in accordance with section 2.,

Accomplishment Instructions, of the

applicable CFMI SBs listed in paragraph

(a)(4) of this AD.

Replacement or Repair

(3) If damage equals or exceeds the reject

criteria stated in section 2., Accomplishment

Instructions, of the SBs listed in paragraph

(a)(4) of this AD, prior to further flight

remove the fuel pump from service and

replace with serviceable part, or repair the

helicoil, in accordance with section 2.,

Accomplishment Instructions, of the SBs

listed in paragraphs (a)(4) or (b), as

applicable, of this AD.

Applicable Inspection SBs

(4) Inspect, and replace, if necessary, in

accordance with the following CFMI SBs, as

applicable:

• CFM56–2 SB 73–110, Revision 2, dated

April 29, 1999.

• CFM56–2A SB 73–055, Revision 1, dated

April 29, 1999.

• CFM56–2B SB 73–076, Revision 1, dated

April 29, 1999.

• CFM56–3/3B/3C SB 73–126, Revision 1,

dated April 29, 1999.

• CFM56–5 SB 73–136, Revision 2, dated

April 29, 1999.

• CFM56–5B SB 73–056, Revision 2, dated

April 29, 1999.

• CFM56–5C SB 73–073, Revision 2, dated

April 29, 1999.

Terminating Action

(b) Remove and replace the fuel pump at

the next engine, gearbox, or fuel pump shop

visit, but not later than 5 years from the

effective date of this AD, in accordance with

section 2., Accomplishment Instructions, of

the following CFMI SBs, as applicable:

• CFM56–2 SB 73–A113, dated August 17,

1999.

• CFM56–2A SB 73–A058, dated August

17, 1999.

• CFM56–2B SB 73–A079, dated August

17, 1999.

• CFM56–3/3B/3C SB 73–A129, dated

August 17, 1999.

• CFM56–5 SB 73–A143, dated June 18,

1999.

• CFM56–5B SB 73–A062, dated June 18,

1999.

• CFM56–5C SB 73–A078, dated June 21,

1999.

Installation of a new fuel pump with a new

filter cover attachment in accordance with

this paragraph constitutes terminating action

to the inspections required by paragraph (a)

of this AD.

Definitions

(c) For the purpose of this AD, a

serviceable part is defined as a part with gear

housing helicoil inserts that meet the

inspection requirements of the applicable

CFMI SBs listed in paragraph (a)(4) of this

AD. A serviceable part is also defined as a

part that has been modified in accordance

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3623

1The request was made in a January 3, 2000 letter

jointly signed by the American Farm Bureau

Federation, the American Soybean Association, the

National Association of Wheat Growers, the

National Cattlemen’s Beef Association, the National

Corn Grower’s Association, the National Farmers

Union, and the National Pork Producers Council.

with the applicable CFMI SB listed in

paragraph (b) of this AD.

Alternate Methods of Compliance

(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, Engine

Certification Office (ECO). Operators shall

submit their request through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, ECO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the ECO.

Ferry Flights

(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 inspection requirements

of this AD can be accomplished.

Issued in Burlington, Massachusetts, on

January 14, 2000.

David A. Downey,

Assistant Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 00–1641 Filed 1–21–00; 8:45 am]

BILLING CODE 4910–13–U

COMMODITY FUTURES TRADING

COMMISSION

17 CFR Part 1

RIN 3038–AB50

Proposed Revision of the

Commission’s Procedures for the

Review of Contract Market Rules

AGENCY: Commodity Futures Trading

Commission.

ACTION: Extension of comment period.

SUMMARY: On November 26, 1999, the

Commodity Futures Trading

Commission (‘‘Commission’’) published

in the Federal Register a request for

public comment on a proposal to revise

its procedures for the review of contract

market rules and rule amendments (64

FR 66428). The original comment period

expires January 25, 2000. By letter dated

January 3, 2000, seven agricultural

organizations requested a thirty day

extension of the comment period to

permit the membership of each

organization to fully consider the

implications of the proposed

procedures.1

The Commission has determined to

extend the comment period for thirty

days in order to insure that an adequate

opportunity is provided for submission

of meaningful comments.

EFFECTIVE DATE: Written comments must

be received on or before February 24,

2000.

ADDRESSES: Comments on the proposal

should be sent to Jean A. Webb,

Secretary, Commodity Futures Trading

Commission, Three Lafayette Center,

1155 21st Street, NW, Washington, DC

20581. Comments may be sent by

facsimile transmission to (202) 418–

5521, or by e-mail to secretary @cftc.gov.

Reference should be made to

‘‘Procedure for the Review of Contract

Market Rules’’.

FOR FURTHER INFORMATION CONTACT:

David P. Van Wagner, Associate

Director, Division of Trading and

Markets, Commodity Futures Trading

Commission, Three Lafayette Centre,

1155 21st Street, NW, Washington, DC

20581. Telephone Number: (202) 418–

5490. Facsimile Number: (202) 418–

5536. Electronic Mail: tm@cftc.gov.

Issued in Washington, D.C. on January 18,

2000 by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 00–1568 Filed 1–21–00; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 99N–3088]

RIN 0910–AB33

Marketing Exclusivity and Patent

Provisions for Certain Antibiotic Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing

regulations to exempt marketing

applications for certain antibiotic drug

products from regulatory provisions

governing marketing exclusivity and

patents. The proposal would apply to

marketing applications for drug

products containing an antibiotic drug

that was the subject of a marketing

application received by FDA before

November 21, 1997, the effective date of

the Food and Drug Administration

Modernization Act of 1997

(Modernization Act). This action is

intended to bring the agency’s

regulations into conformance with

certain transitional provisions of the

Modernization Act. FDA is including in

the proposed regulation a list of the

active moieties of antibiotic drugs that

were the subjects of marketing

applications received by FDA before

November 21, 1997.

DATES: Written comments by April 24,

2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. The Modernization Act

On November 21, 1997, the President

signed the Modernization Act (Public

Law 105–115). Section 125(b) of the

Modernization Act repealed section 507

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 357 (1996)).

Section 507 was the section of the act

under which the agency certified

antibiotic drugs. Section 125(b) of the

Modernization Act also made

conforming amendments to the act.

In the Federal Register of May 12,

1998 (63 FR 26066), and January 5, 1999

(64 FR 396), the agency issued

conforming amendments to its

regulations to remove provisions

governing certification of antibiotic

drugs (21 CFR parts 430 to 460) and to

make other changes needed to reflect

the repeal of section 507 of the act.

Section 125(d)(1) of the

Modernization Act provides that

marketing applications for antibiotic

drugs that were approved under former

section 507 of the act will be considered

to have been submitted and approved

under the new drug application (NDA)

submission and approval provisions

found at section 505(b) and (c) of the act

(21 U.S.C. 355(b) and (c)). If the

marketing application was an approved

abbreviated antibiotic drug application,

it will be considered to have been

submitted and approved under the

abbreviated new drug application

(ANDA) provisions found in section

505(j) of the act.

The Modernization Act also exempts

certain antibiotic-related drug marketing

applications from the marketing

exclusivity and patent provisions found