Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 / Proposed Rules 32771

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–NM–70–AD]

RIN 2120–AA64

Airworthiness Directives; de Havilland

Model DHC–8–100, –200, and –300

Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

revise an existing airworthiness

directive (AD), applicable to certain de

Havilland Model DHC–8–100, –200, and

–300 series airplanes, that currently

requires modification of the attitude and

heading reference systems (AHRS). That

AD was prompted by a report of loss of

power to both AHRS’s during flight due

to a faulty terminal block to which the

signal ground for the AHRS’s is

connected. The actions specified by that

AD are intended to prevent

simultaneous power loss to both

AHRS’s, which could result in reduced

controllability of the airplane. This

action would reduce the applicability of

the existing AD.

DATES: Comments must be received by

July 16, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 98–NM–

70–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

Bombardier, Inc., Bombardier Regional

Aircraft Division, Garratt Boulevard,

Downsview, Ontario M3K 1Y5, Canada.

This information may be examined at

the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW.,

Renton, Washington; or at the FAA,

Engine and Propeller Directorate, New

York Aircraft Certification Office, 10

Fifth Street, Third Floor, Valley Stream,

New York.

FOR FURTHER INFORMATION CONTACT:

Luciano Castracane, Aerospace

Engineer, Systems and Equipment

Branch, ANE–172, FAA, New York

Aircraft Certification Office, Engine and

Propeller Directorate, 10 Fifth Street,

Third Floor, Valley Stream, New York

11581; telephone (516) 256–7535; fax

(516) 568–2716.

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–70–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–70–AD, 1601 Lind Avenue,

SW., Renton, Washington 98055–4056.

Discussion

On September 19, 1997, the FAA

issued AD 97–20–10, amendment 39–

10147 (62 FR 50861, September 29,

1997), applicable to certain de

Havilland Model DHC–8–100, –200, and

–300 series airplanes, to require

modification of the attitude and heading

reference systems (AHRS). That action

was prompted by a report of loss of

power to both AHRS’s during flight due

to a faulty terminal block to which the

signal ground for the AHRS’s are

connected. The requirements of that AD

are intended to prevent simultaneous

power loss to both AHRS’s, which could

result in reduced controllability of the

airplane.

Actions Since Issuance of Previous Rule

Since issuance of that AD, the

Transport Canada Aviation (TCA),

which is the airworthiness authority for

Canada, has issued Canadian

airworthiness directive CF–97–01R2,

dated August 13, 1997. This revision

supersedes Canadian airworthiness

directive CF–97–01R1, dated February

3, 1997, which was referenced in AD

97–20–10 as the parallel Canadian

airworthiness directive for AD 97–20–

10. The only change effected by CF–97–

01R2 is to reduce the list of affected

airplanes to serial numbers 3 through

472 inclusive. The effectivity listing of

CF–97–01R2 limits accomplishment of

the modification of the AHRS to those

airplanes on which the modification

was not accomplished in production.

FAA’s Conclusions

This airplane model is manufactured

in Canada 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,

TCA has kept the FAA informed of the

situation described above. The FAA has

examined the findings of the TCA,

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 revise

AD 97–20–10 to continue to require

modification of the AHRS. The

proposed AD also would reduce the

applicability of that AD to airplanes

having serial numbers 3 through 472

inclusive.

Cost Impact

The FAA estimates that 167 de

Havilland Model DHC–8–100, –200, and

–300 series airplanes of U.S. registry

would be affected by this proposed AD,

that it would take approximately 4 work

hours per airplane to accomplish the

proposed actions, and that the average

labor rate is $60 per work hour.

Required parts would cost

approximately $10 per airplane. Based

on these figures, the cost impact of the

proposed AD on U.S. operators is

estimated to be $41,750, or $250 per

airplane.
32772 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 / Proposed Rules

The cost impact figure discussed

above is 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

removing amendment 39–10147 (62 FR

50861, September 29, 1997), and by

adding a new airworthiness directive

(AD), to read as follows:

De Havilland, Inc.: Docket 98–NM–70–AD.

Revises AD 97–20–10, Amendment 39–

10147.

Applicability: Model DHC–8–100, –200,

and –300 series airplanes, serial numbers 3

through 472 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 simultaneous power loss to

both attitude and heading reference systems

(AHRS), which could result in reduced

controllability of the airplane, accomplish

the following:

(a) Within 400 hours time-in-service after

November 3, 1997 (the effective date of AD

97–20–10, amendment 39–10147), modify

the AHRS’s, in accordance with Bombardier

Alert Service Bulletin S.B. A8–34–117,

Revision ‘C’, dated February 14, 1997.

(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, New York

Aircraft Certification Office (ACO), FAA,

Engine and Propeller Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, New York ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the New York ACO.

(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.

Note 3: The subject of this AD is addressed

in Canadian airworthiness directive CF–97–

01R2, dated August 13, 1997.

Issued in Renton, Washington, on June 9,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–15885 Filed 6–15–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 98N–0361]

Administrative Practices and

Procedures; Internal Agency Review of

Decisions; Companion Document to

Direct Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the regulations governing the

review of agency decisions by inserting

a statement that sponsors, applicants, or

manufacturers of drugs (including

biologics) or devices may request review

of a scientific controversy by an

appropriate scientific advisory panel, or

an advisory committee. The agency is

taking this action to clarify the

availability of review of scientific

controversies by such advisory panels or

committees. This proposed rule is a

companion document to a direct final

rule published elsewhere in this issue of

the Federal Register. If FDA receives

any significant adverse comment, the

direct final rule will be withdrawn, and

the comments will be considered in the

development of a final rule using usual

notice and comment rulemaking based

on this proposed rule.

DATES: Comments must be received on

or before 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.

FOR FURTHER INFORMATION CONTACT:

Suzanne M. O’Shea, Office of the Chief

Mediator and Ombudsman (HF–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3390.

SUPPLEMENTARY INFORMATION:

I. Discussion

On November 21, 1997, President

Clinton signed into law the Food and

Drug Administration Modernization Act

of 1997 (FDAMA) (Pub. L. 105–115).

Section 404 of FDAMA amends the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 301 et seq.) by

adding a new provision, Dispute

Resolution (section 562 of the act (21

U.S.C. 360bbb-1)). Under the dispute

resolution provision, FDA is to

determine the existence of procedures