This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

65768

Vol. 62, No. 241

Tuesday, December 16, 1997

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 95–CE–71–AD]

RIN 2120–AA64

Airworthiness Directives; SOCATAGroupe AEROSPATIALE Models TB10

and TB200 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

adopt a new airworthiness directive

(AD) that would apply to certain

SOCATA-Groupe AEROSPATIALE

(Socata) Models TB10 and TB200

airplanes. The proposed AD would

require inspecting the wing rear

attachment fittings for cracks, replacing

any cracked fitting, and incorporating

wing rear attachment fitting

reinforcement kits. The proposed AD is

the result of mandatory continued

airworthiness information (MCAI)

issued by the airworthiness authority for

France. The actions specified by the

proposed AD are intended to prevent

structural failure of the wing rear

attachment fittings caused by cracks in

this area, which could result in a wing

separating from the airplane with

consequent loss of control of the

airplane.

DATES: Comments must be received on

or before January 11, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Regional Counsel,

Attention: Rules Docket No. 95–CE–71–

AD, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106. Comments

may be inspected at this location

between 8 a.m. and 4 p.m., Monday

through Friday, holidays excepted.

Service information that applies to the

proposed AD may be obtained from the

Socata-Groupe Aerospatiale, Socata

Product Support, Aeroport TarbesOssun-Lourdes, B P 930, 65009 Tarbes

Cedex, France; telephone 62.41.74.26;

facsimile 62.41.74.32; or the Product

Support Manager, Socata-Groupe

Aerospatiale, North Perry Airport, 7501

Pembroke Road, Pembroke Pines,

Florida 33023; telephone (954) 964–

6877; facsimile (954) 964–1668. This

information also may be examined at

the Rules Docket at the address above.

FOR FURTHER INFORMATION CONTACT: Mr.

Karl Schletzbaum, Aerospace Engineer,

FAA, Small Airplane Directorate, 1201

Walnut Street, suite 900, Kansas City,

Missouri 64106; telephone (816) 426–

6934; facsimile (816) 426–2169.

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 that

summarizes 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. 95–CE–71–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, Central Region, Office of the

Regional Counsel, Attention: Rules

Docket No. 95–CE–71–AD, Room 1558,

601 E. 12th Street, Kansas City, Missouri

64106.

Discussion

The Direction Generale de l’Aviation

Civile (DGAC), which is the

airworthiness authority for France,

recently notified the FAA that an unsafe

condition may exist on certain Socata

Models TB10 and TB200 airplanes. The

DGAC reports three incidents of cracks

on the wing rear attachment fittings and

one incident of rear wing attachment

fitting deformation. These conditions, if

not detected and corrected, could result

in a wing separating from the airplane

with consequent loss of control of the

airplane.

Relevant Service Information

Socata has issued Service Bulletin No.

SB 10–082, Amdt. 1, dated April 1996,

which specifies procedures for

inspecting the wing rear attachment

fittings for cracks. Also included in this

service bulletin is reference to wing rear

attachment fitting reinforcement kits

that should be incorporated on the

Socata Models TB10 and TB200

airplanes. The procedures for

incorporating these reinforcement kits

are in the technical instructions

included with each kit.

The DGAC classified this service

bulletin as mandatory and issued

French AD 94–249(A)R1, dated June 19,

1996, in order to assure the continued

airworthiness of these airplanes in

France.

The FAA’s Determination

This airplane model is manufactured

in France 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,

the DGAC has kept the FAA informed

of the situation described above.

The FAA has examined the findings

of the DGAC; reviewed all available

information, including the service

information referenced above; and

determined that AD action is necessary

for products of this type design that are

certificated for operation in the United

States.
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65769

Explanation of the Provisions of the

Proposed AD

Since an unsafe condition has been

identified that is likely to exist or

develop in other Socata Models TB10

and TB200 airplanes of the same type

design registered in the United States,

the FAA is proposing AD action. The

proposed AD would require inspecting

the wing rear attachment fittings for

cracks, replacing any cracked fitting,

and incorporating wing rear attachment

fitting reinforcement kits.

Accomplishment of the proposed

inspections would be in accordance

with Socata Service Bulletin No. SB 10–

082, Amdt. 1, dated April 1996.

Accomplishment of the proposed

reinforcement kits would be in

accordance with the technical

instructions included with each kit.

Differences Between the French AD, the

Service Bulletin, and This Proposed AD

French AD 94–249(A)R1, dated June

19, 1996, and Socata Service Bulletin

No. SB 10–082, Amdt. 1, dated April

1996, both give the owners/operators of

certain Models TB10 and TB200

airplanes the option of accomplishing

one of the following if no cracks are

found during the inspections:

—Incorporating the wing rear

attachment fitting reinforcement kit

No. OPT10 920300; or

—Reinspecting at certain intervals until

cracks are found at which time the

incorporation of a wing rear

attachment fitting reinforcement kit

would be mandatory.

The FAA’s policy is to provide

corrective action that will eliminate the

need for repetitive inspections. The

FAA has determined that long-term

operational safety will be better assured

by design changes that remove the

source of the problem, rather than by

repetitive inspections or other special

procedures.

Because the incorporation of wing

rear attachment fitting reinforcement kit

No. OPT10 920300 on the affected

airplanes eliminates the need for

repetitive inspections, the proposed AD

differs from the service bulletin and

French AD in that it would mandate

incorporation of two of these kits on

each wing.

Cost Impact

The FAA estimates that 71 airplanes

in the U.S. registry would be affected by

the proposed AD.

Accomplishing the actions of the

proposed AD (both the inspection and

incorporation of the reinforcement kits)

would take approximately 11 workhours

per airplane (3 workhours for the

inspection of all four wing rear

attachment fitting areas, and 2

workhours to incorporate the

reinforcement kit at each of the four

wing rear attachment fitting areas), at an

average labor rate of approximately $60

an hour. Parts to accomplish the

proposed AD cost approximately $200

per airplane ($50 per kit × 4 kits). Based

on these figures, the total cost impact of

the proposed initial inspection on U.S.

operators is estimated to be $61,060 or

$860 per airplane.

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 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) 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 has been placed 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

adding a new airworthiness directive

(AD) to read as follows:

Socata-Groupe Aerospatiale: Docket No. 95–

CE–71–AD.

Applicability: Models TB10 and TB200

airplanes, serial numbers 804; 807; 808; 816

through 819; 823 through 1701; 1707 through

1733; and 1737 through 1761, 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 in the

body of this AD, unless already

accomplished.

To prevent structural failure of the rear

wing attachment fittings caused by cracks in

this area, which could result in a wing

separating from the airplane with consequent

loss of control of the airplane, accomplish the

following:

Note 2: The compliance times of this AD

are presented in landings instead of hours

time-in-service (TIS). If the number of

landings is unknown, hours TIS may be used

by multiplying the number of hours TIS by

0.67.

Note 3: The paragraph structure of this AD

is as follows:

Level 1: (a), (b), (c), etc.

Level 2: (1), (2), (3), etc.

Level 3: (i), (ii), (iii), etc.

Level 2 and Level 3 structures are

designations of the Level 1 paragraph they

immediately follow.

(a) Upon accumulating 3,000 landings on

each wing rear attachment fitting (total of

four; two per wing) or within the next 75

landings after the effective date of this AD,

whichever occurs later, inspect the wing rear

attachment fittings for cracks in accordance

with the accomplishment instructions

section of Socata Service Bulletin (SB) No.

SB 10–082, mdt. 1, dated April 1996.

(1) If any fitting is found cracked on the

wing side, prior to further flight, replace the

cracked fitting and incorporate wing rear

attachment fitting reinforcement kit No.

OPT10 920300 in accordance with the

Technical Instruction of Modification, OPT10

9203-57, Wing Rear Attachment Bracket,

dated April 1996.

(2) If any fitting is found cracked on the

fuselage side, prior to further flight,

accomplish the following:

(i) Incorporate wing rear attachment fitting

reinforcement kit No. OPT10 920500 in

accordance with the Technical Instruction of
65770 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules

Modification, OPT10 9205–57, Wing Rear

Attachment Bracket, dated April 1996; and

(ii) Incorporate wing rear attachment fitting

reinforcement kit No. OPT10 920300 in

accordance with the Technical Instruction of

Modification, OPT109203–57, Wing Rear

Attachment Bracket, dated April 1996.

(3) If any fitting is not found cracked, prior

to further flight, incorporate wing rear

attachment fitting reinforcement kit No.

OPT10 920300 in accordance with the

Technical Instruction of Modification,

OPT109203–57, Wing Rear Attachment

Bracket, dated April 1996.

(b) 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.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Small Airplane

Directorate, FAA, 1201 Walnut, suite 900,

Kansas City, Missouri 64106. The request

shall be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Small Airplane Directorate.

Note 4: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(d) All persons affected by this directive

may obtain copies of the documents referred

to herein upon request to Socata—Groupe

Aerospatiale, Socata Product Support,

Aeroport Tarbes-Ossun-Lourdes, B P 930,

65009 Tarbes Cedex, France; or Perry

Airport, 7501 Pembroke Road, Pembroke

Pines, Florida 33023. These documents may

also be examined at the FAA, Central Region,

Office of the Regional Counsel, Room 1558,

601 E. 12th Street, Kansas City, Missouri

64106.

Note 5: The subject of this AD is addressed

in French AD 94–249(A)R1, dated June 19,

1996.

Issued in Kansas City, Missouri, on

December 10, 1997.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 97–32727 Filed 12–15–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 97N–0481]

Gastroenterology-Urology Devices:

Reclassification of the Penile Rigidity

Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

reclassify the penile rigidity implant, a

medical device intended to provide

penile rigidity in men diagnosed as

having erectile dysfunction, from class

III to class II. The special controls

identified in this proposed rule are the

physician and patient labeling,

biocompatibility testing, mechanical

reliability performance testing, clinical

testing, and sterilization requirements

described in FDA’s guidance document

entitled ‘‘Guidance for the Content of

Premarket Notifications for Penile

Rigidity Implants.’’ This reclassification

is being proposed on the agency’s own

initiative based on new information.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments) and the Safe Medical

Devices Act of 1990 (the SMDA).

DATES: Written comments by March 16,

1998. FDA proposes that any final

regulation based on this proposal

become effective 30 days after its date

of publication in the Federal Register.

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: John

H. Baxley, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

The act, as amended by the 1976

amendments (Pub. L. 94–295) and the

SMDA (Pub. L. 101–629), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval). Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as post amendment

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until FDA issues an order

finding the device to be substantially

equivalent, under section 513(i) of the

act, to a predicate device that does not

require premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

offered devices by means of premarket

notification procedures in section 510(k)

of the act (21 U.S.C. 360(k)) and 21 CFR

part 807 of the regulations.

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval. Section 515(b) of

the act describes a two step regulatory

process. A notice of proposed

rulemaking in the Federal Register,

which includes the proposed regulation,

proposed findings of risks and benefits

of the device, an opportunity for the

submission of comments and an

opportunity to request reclassification,

is followed by the final rule which

issues the regulation.

In 1990, the SMDA added section

515(i) to the act. This section requires

FDA to issue an order to manufacturers

of preamendment class III devices for

which no final regulation requiring the

submission of PMA’s has been issued to

submit to the agency a summary of, and

a citation to any information known or

otherwise available to them respecting

such devices, including adverse safety

and effectiveness information which has

not been submitted under section 519 of

the act (21 U.S.C. 360i). Section 519 of

the act requires manufacturers,

importers, distributors and device user

facilities to submit adverse event reports

of certain device-related events. Section

515(i) of the act also directs FDA to

either revise the classification of the

device into class I or class II or require

the device to remain in class III and

establish a schedule for the issuance of

a rule requiring the submission of

PMA’s for those devices remaining in

class III.