Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Proposed Rules 951

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise 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 reduced controllability of the

airplane, due to problems associated with the

elevator aileron computer (ELAC),

accomplish the following:

(a) Within 1 year after the effective date of

this AD, replace the ELAC’s having part

numbers (P/N) 3945122307 and/or P/N

C12370AAA01 and located in aft electronics

rack 80VU, with modified ELAC’s having P/

N 3945122502, in accordance with Airbus

Industrie Service Bulletin A320–27–1082,

dated April 25, 1995.

Note 2: Airbus Industrie Service Bulletin

A320–27–1082 references Sextant Service

Bulletins 394512–27–014, dated August 11,

1995 (for airplanes on which Airbus

Industrie modification 24136P3436 has not

been installed); and C12370A–27–001, dated

May 2, 1995 (for airplanes on which Airbus

Industrie modification 24136P3436 has been

installed); as additional sources of procedural

service information for modification of the

ELAC’s.

(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,

Standardization Branch, ANM–113, 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, Standardization

Branch, ANM–113.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Standardization Branch,

ANM–113.

(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.

Issued in Renton, Washington, on

December 31, 1996.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–252 Filed 1–6–97; 8:45 am]

BILLING CODE 4910–13–U

14 CFR Part 39

[Docket No. 96–SW–32–AD]

Airworthiness Directives; Hiller Aircraft

Corporation Model UH–12A, UH–12B,

UH–12C, UH–12D, and UH–12E

Helicopters

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 Hiller

Aircraft Corporation (Hiller) Model UH–

12A, UH–12B, UH–12C, UH–12D, and

UH–12E helicopters, that currently

requires a dye penetrant inspection of

the head of the main rotor outboard

tension-torsion (T–T) bar pin for cracks;

a visual inspection of the outboard T–

T bar pin for proper alignment and an

adjustment, if necessary; and,

installation of shims at the inboard end

of the drag strut. This action would

require the same actions required by the

existing AD, but would allow a

magnetic particle inspection of the T–T

bar pin as an alternative to the currently

required dye penetrant inspection, and

would require reporting the results of

the inspections only if cracks are found,

rather than reporting all results of

inspections as required by the existing

AD. This proposal is prompted by an

FAA analysis of a comment to the

existing AD, and the fact that no cracks

have been reported since the issuance of

the existing AD. The actions specified

by the proposed AD are intended to

prevent cracks in the head area of the

outboard T–T bar pin, which could

result in loss of in-plane stability of the

main rotor blade and subsequent loss of

control of the helicopter.

DATES: Comments must be received by

March 10, 1997.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Office of the

Assistant Chief Counsel, Attention:

Rules Docket No. 96–SW–32–AD, 2601

Meacham Blvd., Room 663, Fort Worth,

Texas 76137. 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

Hiller Aircraft Corporation, 3200 Imjin

Road, Marina, California 93933–5101.

This information may be examined at

the FAA, Office of the Assistant Chief

Counsel, 2601 Meacham Blvd., Room

663, Fort Worth, Texas.

FOR FURTHER INFORMATION CONTACT: Mr.

Charles Matheis, Aerospace Engineer,

FAA, Los Angeles Aircraft Certification

Office, 3960 Paramount Blvd.,

Lakewood, California 90712–4137,

telephone (310) 627–5235, fax (310)

627–5210.

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 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 No. 96–SW32–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, Office of the Assistant Chief

Counsel, Attention: Rules Docket No.

96–SW–32–AD, 2601 Meacham Blvd.,

Room 663, Fort Worth, Texas 76137.

Discussion

On May 25, 1995, the FAA issued AD

95–12–02, Amendment 39–9252 (60 FR

30184) to require for Hiller Model UH–

12A, UH–12B, UH–12C, UH–12D, and

UH–12E helicopters, within 25 hours

time-in-service (TIS) or at the next 100

hour inspection, whichever occurs first,

and thereafter at intervals not to exceed

100 hours TIS: (1) an inspection of the

alignment of the outboard T–T bar pin

and an adjustment, if necessary; and (2)

an inspection for cracks in the head of

the outboard T–T bar pin using a dye
952 Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Proposed Rules

penetrant method. Additionally, that

AD requires, within 25 hours TIS or at

the next 100 hour inspection, whichever

occurs first, the installation of shims

between the inboard end of the drag

strut and the outboard T–T bar pin. That

action was prompted by two accidents

involving failure of the outboard T–T

bar pin on Hiller UH–12E helicopters.

The requirements of that AD are

intended to prevent cracks in the head

area of the outboard T–T bar pin, which

could result in loss of in-plane stability

of the main rotor blade and subsequent

loss of control of the helicopter.

Since the issuance of that AD, the

FAA has received a comment suggesting

that paragraph (b) of the existing AD

should specifically identify the

compliance time for the inspection,

even though the compliance time is

stated in paragraph (a). The FAA agrees

with the commenter, and the wording of

paragraph (b) has been changed to

clarify the inspection compliance time.

Additionally, the same commenter

requested that an alternate method of

compliance for the inspection be

included in paragraph (b) of the existing

AD. The FAA agrees, and paragraph (b)

has been changed to allow the use of a

magnetic particle inspection as well as

a dye penetrant inspection required by

the existing AD. One additional

commenter states that misalignment of

the drag strut fork and the main rotor

blade may be causing cracks. While the

cause of the cracks is uncertain, the

FAA has determined that the recurring

inspections required by this AD should

detect misalignments and cracks that

could lead to failure of the T–T bar pin.

Since an unsafe condition has been

identified that is likely to exist or

develop on other Hiller Model UH–12A,

UH12B, UH–12C, UH–12D, and UH–12E

helicopters of the same type design, the

proposed AD would supersede AD 95–

12–02 to require, within 25 hours TIS or

at the next 100 hour inspection,

whichever occurs first, and thereafter at

intervals not to exceed 100 hours TIS:

(1) an inspection of the alignment of the

outboard T–T bar pin and an

adjustment, if necessary; and (2) an

inspection for cracks in the head of the

outboard T–T bar pin using a dye

penetrant method or a magnetic particle

method. Additionally, the proposed AD

requires, within 25 hours TIS or at the

next 100 hour inspection, whichever

occurs first, the installation of shims

between the inboard end of the drag

strut and the outboard T–T bar pin.

The FAA estimates that 700

helicopters of U.S. registry would be

affected by this proposed AD, that it

would take approximately 2 work hours

per helicopter to accomplish the

proposed actions, and that the average

labor rate is $60 per work hour.

Required parts would cost

approximately $700 per pin. Based on

these figures, the total cost impact of the

proposed AD on U.S. operators is

estimated to be $574,000, assuming one

pin must be replaced on every

helicopter in the fleet.

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 USC 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing Amendment 39–9252 (60 FR

30184, June 8, 1995), and by adding a

new airworthiness directive (AD), to

read as follows:

Hiller Aircraft Corporation: Docket No. 96–

SW–32–AD. Supersedes AD 95–12–02,

Amendment 39–9252.

Applicability: Model UH–12A, UH–12B,

UH–12C, UH–12D, and UH–12E helicopters,

certificated in any category.

Note 1: This AD applies to each helicopter

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

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (e) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To prevent cracks in the head area of the

outboard tension-torsion (T–T) bar pin,

which could result in loss of in-plane

stability of the main rotor blade and

subsequent loss of control of the helicopter,

accomplish the following:

(a) Within 25 hours time-in-service (TIS)

after the effective date of this AD, or at the

next 100 hour inspection, whichever occurs

first, and thereafter at intervals not to exceed

100 hours TIS, inspect the alignment of the

outboard T–T bar pin, part number (P/N)

51452, and adjust the alignment, if necessary,

in accordance with Hiller Aviation Service

Letter (SL) 51–2, dated March 31, 1978.

(b) Within 25 hours TIS after the effective

date of this AD, or at the next 100 hour

inspection, whichever occurs first, and

thereafter at intervals not to exceed 100 hours

TIS, inspect the head of the outboard T–T bar

pin for cracks using a dye penetrant or

magnetic particle inspection method.

(c) If a crack is found as a result of the

inspection required by paragraph (b) of this

AD, report the results within 7 working days

following the inspection to the Manager, Los

Angeles Aircraft Certification Office,

Attention Charles Matheis, ANM–120L, 3960

Paramount Blvd., Lakewood, California

90712–4137. Include the helicopter model

number, serial number, and total TIS of the

outboard T–T bar pin in the report. Reporting

requirements have been approved by the

Office of Management and Budget and

assigned OMB control number 2120–0056.

(d) Within 25 hours TIS after the effective

date of this AD, or at the next 100 hours TIS

inspection, whichever occurs first, install

shims between the inboard end of the drag

strut and the outboard T–T bar pin in

accordance with the Accomplishment

Instructions of Hiller Aviation Service

Bulletin No. 51–9, dated April 8, 1983.

(e) An alternative method of compliance or

adjustment of the compliance time that
Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Proposed Rules 953

provides an acceptable level of safety may be

used if approved by the Manager, Los

Angeles Aircraft Certification Office, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Los Angeles Aircraft

Certification Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Los Angeles Aircraft

Certification Office.

(f) 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 helicopter

to a location where the requirements of this

AD can be accomplished. Issued in Fort

Worth, Texas, on December 30, 1996.

Larry M. Kelly,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–251 Filed 1–6–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 95N–0342]

Export Requirements for Medical

Devices; Reopening of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

60 days the comment period for a

proposed rule that appeared in the

Federal Register of November 27, 1995

(60 FR 58308). The document proposed

to amend FDA’s regulations for

investigational devices to streamline

requirements for persons seeking to

export unapproved medical devices.

FDA is seeking comments on whether

this rulemaking is still needed in light

of recent changes in the export

provisions of the Federal Food, Drug,

and Cosmetic Act (the act).

DATES: Written comments by March 10,

1997.

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:

Philip L. Chao, Office of Policy (HF–23),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20850,

301–827–3380, electronic mail:

PChao@bangate.FDA.gov.

SUPPLEMENTARY INFORMATION:

I. The National Performance Review

and the Proposed Rule on Device

Exports

At present, two statutory provisions

in the act govern the export of devices

that are not approved for marketing in

the United States.

The first provision, in section

801(e)(2) of the act (21 U.S.C. 381(e)(2)),

became law as part of the Medical

Device Amendments Act of 1976 (Pub.

L. 94–295) and required FDA approval

of certain exports of unapproved

devices. The second provision, in

section 802 of the act (21 U.S.C. 382),

was the result of the FDA Export Reform

and Enhancement Act of 1996 (the

Export Act of 1996) (Pub. L. 104–134,

and amended by Pub. L. 104–180).

Before the latter provision became

law, FDA had undertaken a program to

streamline the requirements for the

exportation of unapproved devices

under section 801(e) of the act. In the

Federal Register of November 27, 1995

(60 FR 58308), FDA issued a proposed

rule to simplify the agency’s export

approval process for certain unapproved

devices. The proposed rule was

intended, in part, to respond to

concerns in the device industry that the

statutory requirement of FDA approval

of device exports may undermine a

firm’s ability to compete in international

markets and may represent an

unnecessary regulatory barrier. (It

should be emphasized, however, that

FDA’s approval times for device export

applications have decreased

significantly, from an average of 91 days

per request in 1992 to 10 days in 1995,

and further decreased to 8 days in fiscal

year 1996.)

The proposed rule was also intended

to implement part of the President’s and

Vice-President’s ‘‘National Performance

Review’’ pertaining to the exportation of

unapproved devices (as announced in

an April 1995 report entitled

‘‘Reinventing Drug and Device

Regulations’’). Under the National

Performance Review, the agency would

permit the export of unapproved

devices to certain advanced

industrialized countries without prior

FDA review and approval, provided that

the device complied with the importing

country’s laws. The report also stated

that the Administration would seek the

necessary legislative changes and would

consult Congress on the appropriate list

of advanced industrialized countries.

Furthermore, the report stated that FDA

would initiate administrative changes to

permit exports to countries that are not

on the list of advanced industrialized

countries ‘‘if the exporter has an

investigational device exemption (IDE)

permitting testing on humans in the

United States, the importing country has

given FDA a letter providing blanket

approval for IDE-type devices, and the

device is in compliance with the

importing country’s laws.’’

To implement the administrative

reform aspects of the report, FDA

proposed to amend § 812.18 (21 CFR

812.18) to state that a person who

wishes to export an investigational

device subject to part 812—

Investigational Device Exemptions (21

CFR part 812) must comply with the

requirements in section 801(e)(1) of the

act, but that, for purposes of section

801(e)(2), prior FDA approval would be

unnecessary if the investigational device

to be exported is the subject of an

approved IDE (including nonsignificant

risk devices which, under FDA

regulations, are considered to have an

approved IDE) and ‘‘will be marketed or

used in clinical trials in the foreign

country for the same intended use as

that in the approved IDE and is to be

exported to a country that has expressed

its approval of the importation of

investigational devices’’ that are the

subject of an approved IDE. The

proposed rule also stated that, if the

device is the subject of an approved IDE

and has received a ‘‘CE’’ mark from the

European Union (EU), the device may

be exported to any country in the

European Economic Area (EEA).

Proposed § 812.18(b)(1) also would

have FDA’s Center for Devices and

Radiological Health (CDRH) make

available a list of countries that have

approved the importation of

investigational devices that are the

subjects of approved IDE’s. The list

would be maintained electronically.

Proposed § 812.18(b)(2) would require

prior FDA approval to export an

investigational device if FDA withdrew

approval of the IDE or the sponsor

terminated any or all parts of

investigations because unanticipated

adverse device effects present an

unreasonable risk to subjects.

In the preamble to the proposed rule,

FDA also stated that it would amend the

proposed rule to reflect any legislative

changes (60 FR 58308 at 58309).

Thus, the changes in the proposed

rule would have benefited those

companies wishing to export devices:

(1) That have an approved U.S. IDE; (2)

to countries that have agreed to accept

U.S. IDE products; and (3) whose

intended use is the same as the U.S.

IDE. FDA believed this was as much