Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63267

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 39–8997 (59 FR

41235, August 11, 1994), and by adding

a new airworthiness directive (AD),

amendment 39–10219, to read as

follows:

97–24–12 British Aerospace: Amendment

39–10219. Docket : 96–NM–187–AD.

Supersedes AD 94–17–02, Amendment

39–8997.

Applicability: All Model BAC 1–11 200

and 400 series 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 (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 failure of the thrust reverser

control cables, which may lead to the

inability of the thrust reverser to deploy and/

or an uncommanded thrust reverser

deployment while the airplane is in flight,

accomplish the following:

(a) Within 100 hours time-in-service or 30

days after the effective date of this AD,

whichever occurs first, perform an inspection

to determine the tension of the control cables

of the thrust reverser, in accordance with

British Aerospace, Alert Service Bulletin 76–

A–PM6031, dated January 18, 1995. If the

tension of any control cable is outside the

limits specified in the alert service bulletin,

prior to further flight, correct the tension of

that cable in accordance with the alert

service bulletin. Thereafter, repeat the

inspection at intervals not to exceed 2,400

hours time-in-service or 12 months,

whichever occurs first.

(b) Within 100 hours time-in-service or 30

days after the effective date of this AD,

whichever occurs first, perform an inspection

to detect breakage, damage, wear, or signs of

corrosion (swelling) of the control cable of

the thrust reverser, in accordance with

British Aerospace Alert Service Bulletin 76–

A–PM6031, dated January 18, 1995.

(1) If no discrepancy is found, prior to

further flight, lubricate the cables in

accordance with the alert service bulletin.

Thereafter, repeat the inspection at intervals

not to exceed 2,400 hours time-in-service or

12 months, whichever occurs first.

(2) If any control cable is damaged, is worn

beyond the limits specified in the alert

service bulletin, is corroded, or has a broken

wire, prior to further flight, replace the

discrepant cable with a serviceable cable, and

lubricate the cables in accordance with the

alert service bulletin. Thereafter, repeat the

inspection at intervals not to exceed 2400

hours time-in-service or 12 months after the

effective date of this AD, whichever occurs

first.

(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,

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.

(d) 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.

(e) The actions shall be done in accordance

with British Aerospace Alert Service Bulletin

76–A–PM6031, dated January 18, 1995. This

incorporation by reference was approved by

the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR

part 51. Copies may be obtained from British

Aerospace (Operations) Ltd., trading as

British Aerospace Airbus Ltd., P.O. Box 77,

Bristol BS99 7AR, England. Copies may be

inspected at the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(f) This amendment becomes effective on

January 2, 1998.

Issued in Renton, Washington, on

November 19, 1997.

Stewart R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–31028 Filed 11–26–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–NM–126–AD; Amendment

39–10221; AD 97–24–14]

RIN 2120–AA64

Airworthiness Directives; Saab Model

SAAB 2000 Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment adopts a

new airworthiness directive (AD),

applicable to certain Saab Model SAAB

2000 series airplanes, that requires

inspection of the two-way check valve

on the engine fire extinguishing system

for discrepancies, and corrective action,

if necessary. This amendment is

prompted by issuance of mandatory

continued airworthiness information by

a foreign civil airworthiness authority.

The actions specified by this AD are

intended to prevent discrepancies of the

check valve, which could result in

improper functioning of the engine fire

extinguishing system.

DATES: Effective January 2, 1998.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of January 2,

1998.

ADDRESSES: The service information

referenced in this AD may be obtained

from Saab Aircraft AB, SAAB Aircraft

Product Support, S–581.88, Linko ̈ping,

Sweden. This information may be

examined at the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, Rules Docket,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT:

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: A

proposal to amend part 39 of the Federal

Aviation Regulations (14 CFR part 39) to

include an airworthiness directive (AD)

that is applicable to certain Saab Model

SAAB 2000 series airplanes was

published in the Federal Register on

September 23, 1997 (62 FR 49634). That

action proposed to require inspection of

the two-way check valve on the engine

fire extinguishing system for
63268 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

discrepancies, and corrective action, if

necessary.

Comments

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were submitted in response

to the proposal or the FAA’s

determination of the cost to the public.

Conclusion

The FAA has determined that air

safety and the public interest require the

adoption of the rule as proposed.

Cost Impact

The FAA estimates that 3 Model

SAAB 2000 series airplanes of U.S.

registry will be affected by this AD, that

it will take approximately 4 work hours

per airplane to accomplish the required

actions, and that the average labor rate

is $60 per work hour. Based on these

figures, the cost impact of the AD on

U.S. operators is estimated to be $720,

or $240 per airplane. The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the 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 adopted herein will

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 final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

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 DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

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 from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

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 the following new airworthiness

directive:

97–24–14 Saab Aircraft AB: Amendment

39–10221. Docket 97–NM–126–AD.

Applicability: Model SAAB 2000 airplanes,

having serial numbers –002 through –043

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 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: Required as indicated, unless

accomplished previously.

To prevent discrepancies of the check

valve, which could result in improper

functioning of the engine fire extinguishing

system, accomplish the following:

(a) Within 2 months after the effective date

of this AD, perform an inspection of the twoway check valve on the engine fire

extinguishing system for discrepancies, in

accordance with Saab Service Bulletin 2000–

26–010, dated July 5, 1996. If any

discrepancy is found, prior to further flight,

install a new two-way check valve in

accordance with the service bulletin.

(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,

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.

(c) 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.

(d) The actions shall be done in accordance

with Saab Service Bulletin 2000–26–010,

dated July 5, 1996. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from Saab Aircraft AB, SAAB

Aircraft Product Support, S–581.88,

Linko ̈ping, Sweden. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 3: The subject of this AD is addressed

in Swedish airworthiness directive SAD No.

1–099, dated July 8, 1996.

(e) This amendment becomes effective on

January 2, 1998.

Issued in Renton, Washington, on

November 19, 1997.

Stewart R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–31030 Filed 11–26–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 85N–0214]

Policy on 180-Day Marketing

Exclusivity for Drugs Marketed Under

Abbreviated New Drug Applications;

Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Clarification.

SUMMARY: The Center for Drug

Evaluation and Research (CDER) of the

Food and Drug Administration (FDA) is

publishing this document to clarify the

status of its practices governing 180

days of marketing exclusivity for generic

drugs and the approval of abbreviated

new drug applications (ANDA’s) subject

to patent litigation. This document is

being published due to recent court

decisions interpreting provisions of the

Drug Price Competition and Patent

Term Restoration Act of 1984 (Pub. L.

98–417) (the 1984 amendments).

FOR FURTHER INFORMATION CONTACT: Jerry

Phillips, Center for Drug Evaluation and