Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations 45309

PART 543—INCORPORATION,

ORGANIZATION, AND CONVERSION

OF FEDERAL MUTUAL

ASSOCIATIONS

1. The authority citation for part 543

continues to read as follows:

Authority: 12 U.S.C. 1462, 1462a, 1463,

1464, 1467a, 2901 et seq.

2. Section 543.8 is amended by

revising the heading and paragraph (a)

to read as follows:

§ 543.8 Conversion of depository

institutions to Federal mutual charter.

(a) With the approval of the OTS, any

depository institution, as defined in

§ 552.13 of this chapter, that is in

mutual form, may convert into a Federal

mutual savings association, provided

that:

(1) The depository institution, upon

conversion, will have its deposits

insured by the Federal Deposit

Insurance Corporation;

(2) The depository institution, in

accomplishing the conversion, complies

with all applicable state and federal

statutes and regulations, and OTS

policies, and obtains all necessary

regulatory and member approvals; and

(3) The resulting Federal mutual

association conforms, within the time

prescribed by the OTS, to the

requirements of section 5(c) of the Home

Owners’ Loan Act.

* * * * *

3. Section 543.9 is amended by

revising paragraph (a) and the

introductory text of paragraph (c) to

read as follows:

§ 543.9 Application for conversion to

Federal mutual charter.

(a) Filing. Any depository institution

that proposes to convert to a Federal

mutual association as provided in

§ 543.8 shall, after approval by its board

of directors, file in accordance with

§ 516.1 of this chapter an application on

forms obtained from the OTS. The

applicant shall submit any financial

statements or other information the OTS

may require.

* * * * *

(c) Action on application. The OTS

will consider such application and any

information submitted with the

application, and may approve the

application in accordance with section

5(e) of the Home Owners’ Loan Act and

§ 543.2(g)(1). Converting depository

institutions that have been in existence

less than three years will be subject to

all approval criteria and other

requirements applicable to de novo

Federal associations. Approval of an

application and issuance by the OTS of

a charter will be subject to:

* * * * *

Dated: August 19, 1997.

By the Office of Thrift Supervision.

Nicolas P. Retsinas,

Director.

[FR Doc. 97–22798 Filed 8–26–97; 8:45 am]

BILLING CODE 6720–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 96–ANE–40; Amendment 39–

10112; AD 97–18–02]

RIN 2120–AA64

Airworthiness Directives; Hartzell

Propeller Inc. ( )HC–( )(2,3)(X,V)( )–( )

Series and HA–A2V20–1B Series

Propellers With Aluminum Blades

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment supersedes

four existing airworthiness directives

(ADs), applicable to Hartzell Propeller

Inc. ( )HC–( )(2,3)(X,V)( )–( ) series

propellers with aluminum blades, that

currently require inspections for cracks

in blade shanks and clamps. This

amendment requires initial and

repetitive dye penetrant and eddy

current inspections of the blade and an

optical comparator inspection of the

blade retention area, and, if necessary,

replacement with serviceable parts. In

addition, this AD requires initial and

repetitive visual and magnetic particle

inspection of the blade clamp, dye

penetrant inspection of the blade

internal bearing bore, and, if necessary,

replacement with serviceable parts.

Also, for all HC–(1,4,5,8)(2,3)(X,V)( )–( )

steel hub propellers, this AD requires an

additional initial and repetitive visual

and magnetic particle inspection of the

hub and, if necessary, replacement with

serviceable parts. This amendment is

prompted by reports of cracked blades,

blade clamps, and hubs and reports of

blade separations. The actions specified

by this AD are intended to prevent blade

separation due to cracked blades, hubs,

or blade clamps, which can result in

loss of control of the airplane.

DATES: Effective September 11, 1997.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of September

11, 1997.

Comments for inclusion in the Rules

Docket must be received on or before

October 27, 1997.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), New England

Region, Office of the Assistant Chief

Counsel, Attention: Rules Docket No.

96–ANE–40, 12 New England Executive

Park, Burlington, MA 01803–5299.

Comments may also be sent via the

Internet using the following address: ‘‘9-

ad-engineprop@faa.dot.gov’’. Comments

sent via the Internet must contain the

docket number in the subject line.

The service information referenced in

this AD may be obtained from Hartzell

Propeller Inc., One Propeller Place,

Piqua, OH 45356–2634, ATTN: Product

Support; telephone (937) 778–4200, fax

(937) 778–4321. This information may

be examined at the FAA, New England

Region, Office of the Assistant Chief

Counsel, Burlington, MA; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Tomaso DiPaolo, Aerospace Engineer,

Chicago Aircraft Certification Office,

FAA, Small Airplane Directorate, 2300

East Devon Ave., Des Plaines, IL 60018;

telephone (847) 294–7031, fax (847)

294–7834.

SUPPLEMENTARY INFORMATION: The

Federal Aviation Administration (FAA)

issued airworthiness directive (AD) 68–

13–02, Amendment 39–614 (33 FR

9252, June 22, 1968), applicable to

Hartzell Propeller Inc. Model PHC–

A3VF–4/V8433–2R and –4R propellers,

to require repetitive inspections for

cracks in blade shanks at intervals not

to exceed 400 hours Time in Service

(TIS). That action was prompted by

reports of cracks in blade shanks. That

condition, if not corrected, could result

in loss of a blade due to blade shank

cracks, which could result in loss of

aircraft control.

The FAA issued AD 68–19–04,

Amendment 39–868 (34 FR 18296,

November 15, 1969), applicable to

Hartzell Propeller Inc. Model HC–A2XF,

HC–12X20, HC–82VF, BHC–A2XF, HC–

13X20, HC–82VK, HC–A2XK, HC–

D3X20, HC–82VL, HC–A2XL, HC–

82X20, HC–83XF, HC–A3XK, HC–82XF,

HC–83XK, HC–A3VK, HC–82XG, HC–

83X20, HC–82XK, and HC–82KL

propellers, with 8433, V8433, 8833, and

V8833 blades, to require repetitive

inspections for cracks in blade shanks at

intervals not to exceed 1,000 hours TIS.

That action was prompted by reports of

cracks in blade shanks. That condition,

if not corrected, could result in loss of

a blade due to blade shank cracks,
45310 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations

which could result in loss of aircraft

control.

The FAA issued AD 75–17–34,

Amendment 39–2337 (40 FR 33433,

August 8, 1975), applicable to Hartzell

Propeller Inc. Model EHC–A3VF–2B/

V7636D propellers installed on

Teledyne Continental Motors Model IO–

520–E series engines and on the

deHavilland Heron D.H. 114 Series

aircraft in accordance with STC

SA1685WE, to require repetitive

inspections for cracks in blade shanks

and clamps at intervals not to exceed

1,000 hours TIS. That action was

prompted by reports of cracks in blade

shanks and clamps. That condition, if

not corrected, could result in loss of a

blade due to blade shank and clamp

cracks, which could result in loss of

aircraft control.

The FAA issued AD 77–14–07,

Amendment 39–2955 (42 FR 35638, July

11, 1977), applicable to Hartzell

Propeller Inc. Model EHC–A3VF–2B/

V7636N propellers installed on

Teledyne Continental Motors Model IO–

520–E series engines and on the

deHavilland Heron D.H. 114 Series

aircraft in accordance with STC

SA1685WE, to require repetitive

inspections for cracks in certain blade

clamps at intervals not to exceed 32

hours TIS, repetitive inspections for

cracks in blade shanks at intervals not

to exceed 400 hours TIS, and, as

necessary, rework or replace blades at

intervals not to exceed 1,200 hours TIS.

That action was prompted by reports of

cracks in blade shanks and clamps. That

condition, if not corrected, could result

in loss of a blade due to blade shank and

clamp cracks, which could result in loss

of aircraft control.

Since the issuance of those ADs, the

FAA has received reports of:

(1) 37 cracked blades in the past three

years, including two blade separations

with one resulting in a fatal accident;

(2) 4 cracked blade clamps, including

one blade separation;

(3) 5 blade separations from hub

fatigue cracks (only found in HC–8( )( )

series hubs).

The investigations into these

occurrences revealed fatigue cracks in

the following parts/areas:

(1) blade internal bearing bore

(corrosion at origin) and blade retention

radius;

(2) steel hub blade clamps; and

(3) steel hub blade retention radius

(only found in HC–8( )( ) series hubs).

Additionally, the FAA has determined

that the HC–(1,4,5,8)(2,3)(X,V)( )–( )

Series steel hub propellers have similar

loading and load paths to the failed HC–

8( )( ) series propellers and may develop

fatigue cracks.

The FAA has reviewed and approved

the technical contents of Hartzell

Propeller Inc. Service Bulletin (SB) No.

HC–SB–61–217, Revision 1, dated July

11, 1997, that describes procedures for

fluorescent dye penetrant and eddy

current inspections of the blade and an

optical comparator inspection of the

blade retention area, and, if necessary,

replacement with serviceable parts. In

addition, this SB describes procedures

for visual and magnetic particle

inspection of the blade clamp, dye

penetrant inspection of the blade

internal bearing bore and, if necessary,

replacement with serviceable parts. For

all HC–(1,4,5,8)(2,3)(X,V)( )–( ) steel hub

propellers, this SB describes an

additional visual and magnetic particle

inspection of the hub, and, if necessary,

replacement with serviceable parts.

Since an unsafe condition has been

identified that is likely to exist or

develop on other propellers of this same

type design, this AD supersedes ADs

68–13–02, 68–19–04, 75–17–34, and 77–

14–07 to require initial and repetitive

fluorescent dye penetrant and eddy

current inspections of the blade and an

optical comparator inspection of the

blade retention area, and, if necessary,

replacement with serviceable parts. In

addition, this AD requires an initial and

repetitive visual and magnetic particle

inspection of the blade clamp, dye

penetrant inspection of the blade

internal bearing bore and, if necessary,

replacement with serviceable parts.

Also, for all HC–(1,4,5,8)(2,3)(X,V)( )–( )

steel hub propellers, this AD requires an

additional initial and repetitive visual

and magnetic particle inspection of the

hub and, if necessary, replacement with

serviceable parts. Finally, this AD adds

a reporting requirement to obtain

additional data and determine if

adjustment can be made to the repetitive

inspection intervals, with possible

relief. The actions are required to be

accomplished in accordance with the

SB described previously.

Since a situation exists that requires

the immediate adoption of this

regulation, it is found that notice and

opportunity for prior public comment

hereon are impracticable, and that good

cause exists for making this amendment

effective in less than 30 days.

Comments Invited

Although this action is in the form of

a final rule that involves requirements

affecting flight safety and, thus, was not

preceded by notice and an opportunity

for public comment, comments are

invited on this rule. Interested persons

are invited to comment on this 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

under the caption ADDRESSES. All

communications received on or before

the closing date for comments will be

considered, and this rule may be

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the 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 AD

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 96–ANE–40.’’ The

postcard will be date stamped and

returned to the commenter.

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.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and is not a ‘‘significant regulatory

action’’ under Executive Order 12866. It

has been determined further that this

action involves an emergency regulation

under DOT Regulatory Policies and

Procedures (44 FR 11034, February 26,

1979). If it is determined that this

emergency regulation otherwise would

be significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.
Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations 45311

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 USC 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing amendment 39–614 (33 FR

9252, June 22, 1968), 39–868 (33 FR

12961, September 13, 1968), 39–868 (34

FR 18296, November 15, 1969), 39–2337

(40 FR 33433, August 8, 1975), and 39–

2955 (42 FR 35638, July 11, 1977), and

by adding a new airworthiness

directive, Amendment 39–10112, to

read as follows:

97–18–02 Hartzell Propeller Inc.:

Amendment 39–10112. Docket 96–ANE–

40. Supersedes AD 68–13–02,

Amendment 39–614; AD 68–19–04,

Amendment 39–868; AD 75–17–34,

Amendment 39–2337; AD 77–14–07,

Amendment 39–2955.

Applicability: Hartzell Propeller Inc. ()HC–

()(2,3)(X,V)()–() series and HA-A2V20–1B

series propellers with aluminum blades.

These propellers are installed on but not

limited to the following aircraft:

Manufacturer Aircraft Model

Aero Commander (Twin Commander)

500 AERO COMMANDER

500A AERO COMMANDER

500B, 500S, 500U AERO COMMANDER

520 AERO COMMANDER

560 AERO COMMANDER

560A, 560E AERO COMM.

680, 680E, 720 AERO COMM.

680F, FP, FL, FLR AERO COMMANDER

B1 (CALLAIR)

Aeromere

FALCO F.8.L

Aeronautica Macchi

AL60–F5

AM–3

Bauger

SAIL PLANE

Beech

35 SERIES BONANZA

35–C33 DEBONAIR

35–C33A, E33A, F33A

50 SERIES TWIN BONANZA

58P, 58TC BARON

95–55, 95–A55, 95–B55 BARON

65, A65, 65–(B)80, 65–A80, 70

A65–8200, 70

Bellanca

14–13

14–19

14–19–2

14–19–3

7GCA, 7GCB, 7GCC

DW–1 EAGLE

Camair

480

Cessna

170

170A

172 SKYHAWK

175

180, A, B, C, D, E, F, G, H

182, A, B, C, D, E

182F, G, H, J, K, L, M

210, A, B, C, 5, 5A

310, 310A

310B, 310C

310D, E, F, G, H, E310H

320, 320–1 SKYKNIGHT

320A, 320B

402 BUSINESSLINER

411

WREN 460

WREN 460H, J, K, L, M

deHavilland

DH104 DOVE

DH114 HERON

Dornier

DO27Q–6

DO28A–1

DO28B–1

Fuji

T–3, LM–2

GAF—Gov’t. Aircraft Factories

N22B, N24A, N22S, N22C

Goodyear (Loral)

GA22A GOODYEAR BLIMP

GZ19, 19A GOODYEAR BLIMP

Great Lakes

2T–1A–2

Grumman

G44, G44A WIDGEON

G21C, D GOOSE

Helio

H–391 COURIER

H–391B COURIER

H–395A COURIER

Luscombe

11

11A

Mooney

M20

Multitech (Temco)

D16 TWIN NAVION

D16A TWIN NAVION

Nardi

FN–333

Navion

NAVION B

NAVION, NAVION A

Pacific Aerospace (Fletcher)

FU–24, FU–24A

Piaggio

P–149D

P136–L1 ROYAL GULL

P136–L2 ROYAL GULL

P149D

P166 ROYAL GULL

Pilatus

PC–3

PC–6; PC–6–H1, –H2 PORTER

Piper

PA–E23–250 AZTEC

PA14 FAMILY CRUISER

PA18(A)(S)–150 SUPER CUB

PA18A–150 SUPER CUB

PA22–150, PA22S–150

TRIPACER

PA23 SERIES APACHE

PA23–160 APACHE

PA23–235 AZTEC

PA23–250 AZTEC

PA24–250 COMANCHE

PA24–400 COMANCHE

PA24S COMANCHE

PA28 CHEROKEE

PA28–140 CHEROKEE

Prop Jets Inc.

200

200A,B,C

Republic (STOL Amphibian)

RC3 SEABEE

Scottish Aviation (BAE)

B.206 SERIES 2 BEAGLE

Stinson

L–5

108, –1, –2, –3

108–2–3

Sud Aviation (SOCATA)

GY.80–150 GARDAN

GY.80–160 GARDAN HORIZON

Swift

GC–1B

Taylorcraft

20

Texas Bullet

205

Windecker

EAGLE

Note 1: The above is not a complete list of

aircraft which may contain the affected

Hartzell Propeller Inc. ()HC–()(2,3)(X,V)()–()

series and HA–A2V20–1B series propellers

with aluminum blades because of installation

approvals made by, for example,

Supplemental Type Certificate or field

approval under FAA Form 337 ‘‘Major Repair

and Alteration.’’ It is the responsibility of the

owner, operator, and person returning the

aircraft to service to determine if an aircraft

has an affected propeller.

Note 2: The parenthesis that appear in the

propeller models indicate the presence or

absence of additional letter(s) which vary the

basic propeller hub model designation. This

airworthiness directive is applicable

regardless of whether these letters are present

or absent on the propeller hub model

designation.

Note 3: This AD applies to each propeller

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

propellers 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 (g) 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 blade separation due to cracked

blades, hubs, or blade clamps, which can

result in loss of control of the airplane,

accomplish the following:
45312 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations

(a) On Hartzell propeller models with hub

models ()HC–(1,4,5,8)(2,3)(X,V)()–() perform

initial and repetitive inspections and, if

necessary, replace with serviceable parts in

accordance with Hartzell Propeller Inc.

Service Bulletin (SB) No. HC–SB–61–217,

Revision 1, dated July 11, 1997, as follows:

(1) Initially perform a fluorescent dye

penetrant and eddy current inspection of the

blade, an optical comparator inspection of

the blade retention area, a dye penetrant

inspection of the blade internal bearing bore,

and a visual and magnetic particle inspection

of the blade clamp and of the hub. The initial

inspection is required within the following:

(i) 1,000 hours time since new (TSN) for

propellers with less than 900 hours TSN on

the effective date of this AD, provided that

the initial inspections are performed within

60 calendar months TSN or 24 calendar

months after the effective date of this AD,

whichever calendar time occurs later, or

(ii) 100 hours time in service (TIS) for

propellers with 900 or more hours TSN, or

unknown TSN, on the effective date of this

AD, provided that the initial inspections are

performed within 24 calendar months after

the effective date of this AD.

(2) Thereafter, perform repetitive

fluorescent dye penetrant and eddy current

inspection of the blade, an optical

comparator inspection of the blade retention

area, and a visual and magnetic particle

inspection of the blade clamp. The repetitive

inspection is required at intervals not to

exceed 500 hours TIS or 60 calendar months,

whichever occurs first, since last inspection.

(3) Thereafter, perform a repetitive visual

and magnetic particle inspection of the hub.

This repetitive hub inspection is required at

intervals not to exceed 250 hours TIS or 60

calendar months, whichever occurs first,

since last inspection.

(4) Thereafter, perform a repetitive dye

penetrant inspection of the blade internal

bearing bore. This repetitive blade internal

bearing bore inspection is required at

intervals not to exceed 60 calendar months

since last inspection.

(b) On Hartzell propeller models with hub

models ( )HC–(A,D)(2,3)(X,V) ( )–( ), and

HA–A2V20–1B, except HC–A3VF–7( ),

perform initial and repetitive inspections

and, if necessary, replace with serviceable

parts in accordance with Hartzell SB No. HC–

SB–61–217, Revision 1, dated July 11, 1997,

as follows:

(1) Initially perform a fluorescent dye

penetrant and eddy current inspection of the

blade, an optical comparator inspection of

the blade retention area, a visual and

magnetic particle inspection of the blade

clamp, and a dye penetrant inspection of the

blade internal bearing bore. The initial

inspection is required within the following:

(i) 1,000 hours TSN for propellers with less

than 800 hours TSN on the effective date of

this AD, provided that the initial inspections

are performed within 60 calendar months

TSN or 24 calendar months after the effective

date of this AD, whichever calendar time

occurs later, or

(ii) 200 hours TIS for propellers with 800

or more hours TSN, or unknown TSN, on the

effective date of this AD, provided that the

initial inspections are performed within 24

calendar months after the effective date of

this AD.

(2) Thereafter, perform repetitive

fluorescent dye penetrant and eddy current

inspection of the blade, an optical

comparator inspection of the blade retention

area, and a visual and magnetic particle

inspection of the blade clamp. The repetitive

inspection is required at intervals not to

exceed 500 hours TIS or 60 calendar months,

whichever occurs first, since last inspection.

(3) Thereafter, perform repetitive dye

penetrant inspections of the blade internal

bearing bore. This repetitive blade internal

bearing bore inspection is required at

intervals not to exceed 60 calendar months

since last inspection.

(c) On Hartzell propeller models with hub

models HC–A3VF–7( ) perform initial and

repetitive inspections and, if necessary,

replace with serviceable parts in accordance

with Hartzell SB No. HC–SB–61–217,

revision 1, dated July 11, 1997, as follows:

(1) Initially perform a fluorescent dye

penetrant and eddy current inspection of the

blade, an optical comparator inspection of

the blade retention area, a visual and

magnetic particle inspection of the blade

clamp, and a dye penetrant inspection of the

blade internal bearing bore. The initial

inspection is required within the following:

(i) 3,000 hours TSN for propellers that have

never been overhauled and have less than

2,500 hours TSN on the effective date of this

AD, provided that the initial inspections are

performed within 60 calendar months TSN or

24 calendar months after the effective date of

this AD, whichever calendar time occurs

later, or

(ii) 3,000 hours TIS since last overhaul for

propellers that have been overhauled but

have less than 2,500 hours TIS since last

overhaul on the effective date of this AD,

provided that the initial inspections are

performed within 60 calendar months TIS

since last overhaul or 24 calendar months

after the effective date of this AD, whichever

calendar time occurs later, or

(iii) 500 hours TIS, for propellers that have

never been overhauled and have 2,500 or

more hours TSN on the effective date of this

AD, or propellers which have been

overhauled and have 2,500 or more hours TIS

since last overhaul on the effective date of

this AD, or propellers with unknown TSN,

provided that the initial inspections are

performed within 24 calendar months after

the effective date of this AD.

(2) Thereafter, perform repetitive

fluorescent dye penetrant and eddy current

inspection of the blade, an optical

comparator inspection of the blade retention

area, and a visual and magnetic particle

inspection of the blade clamp. The repetitive

inspection is required at intervals not to

exceed 3000 hours TIS or 60 calendar

months, whichever occurs first, since last

inspection.

(3) Thereafter, perform repetitive dye

penetrant inspections of the blade internal

bearing bore. This repetitive blade internal

bearing bore inspection is required at

intervals not to exceed 60 calendar months

since last inspection.

(d) The initial inspection of the internal

blade bearing bore required by paragraphs

(a)(1), (b)(1), or (c)(1) of this AD need not be

accomplished again if previously

accomplished in accordance with page 4 of

Hartzell SB No. HC–SB–61–217, Revision 1,

dated July 11, 1997.

(e) If not previously accomplished, shot

peen the propeller blade shank area during

the initial inspection required by paragraphs

(a)(1), (b)(1), or (c)(1), as appropriate, and

perform the shot peening in accordance with

Hartzell SB No. HC–SB–61–217, Revision 1,

dated July 11, 1997. Re-shot peening of the

propeller blade shank area during the

repetitive inspections required by paragraphs

(a)(2), (b)(2), or (c)(2), as appropriate, is

required only if the propeller blade shank

area has been repaired or has excessive wear

or damage in accordance with Hartzell SB

No. HC–SB–61–217, Revision 1, dated July

11, 1997.

(f) Report inspection results to the

Manager, Chicago Aircraft Certification

Office, FAA, Small Airplane Directorate,

2300 East Devon Ave., Des Plaines, IL 60018,

within 15 working days of the inspection.

Reporting requirements have been approved

by the Office of Management and Budget

(OMB) and assigned OMB control number

2120–0056.

(g) 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, Chicago

Aircraft Certification Office. The request

should be forwarded through an appropriate

FAA Maintenance Inspector, who may add

comments and then send it to the Manager,

Chicago Aircraft Certification Office.

Note 4: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the Chicago

Aircraft Certification Office.

(h) 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 aircraft to

a location where the requirements of this AD

can be accomplished.

(i) The actions required by this AD shall be

done in accordance with the following

Hartzell Propeller Inc. SB:

Document No. Revision Pages Date

HC–SB–61–217 ............................................................................................................................ 1 1–16 July 11, 1997.

Total pages: 16.
Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Rules and Regulations 45313

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 Hartzell Propeller Inc., One Propeller

Place, Piqua, OH 45356–2634, ATTN:

Product Support; telephone (937) 778–4200,

fax (937) 778–4321. Copies may be inspected

at the FAA, New England Region, Office of

the Assistant Chief Counsel, 12 New England

Executive Park, Burlington, MA; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(j) This amendment becomes effective on

September 11, 1997.

Issued in Burlington, Massachusetts, on

August 15, 1997.

James C. Jones,

Assistant Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 97–22677 Filed 8–26–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 89N–0474]

RIN 0910–AA25

Specific Requirements on Content and

Format of Labeling for Human

Prescription Drugs; Addition of

‘‘Geriatric Use’’ Subsection in the

Labeling

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing the content and

format of labeling for human

prescription drug products, including

biological products, to include

information pertinent to the appropriate

use of drugs in the elderly (persons aged

65 years and over) and to facilitate

access to this information by

establishing a ‘‘Geriatric use’’ subsection

in the labeling. The final rule is one of

several measures FDA has taken in

response to the special concerns

associated with prescription drug use in

elderly patients. FDA believes that

improving access to information that is

important to the elderly will facilitate

the safe and effective use of prescription

drugs in older populations.

DATES: This final rule becomes effective

on August 27, 1998. Submit written

comments on the collection of

information provisions by October 27,

1997. See section IV of this document

for the implementation dates of this

final rule for drug classes and drug

products.

ADDRESSES: Submit written comments

on the information collection

requirements to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Thomas C. Kuchenberg, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5621.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November

1, 1990 (55 FR 46134), FDA proposed to

amend its prescription drug labeling

regulations (§ 201.57) to establish in the

‘‘Precautions’’ section a subsection on

the use of drugs in elderly or geriatric

patients (aged 65 years and over). The

final rule requires, in a new ‘‘Geriatric

use’’ subsection of prescription drug

labeling, that sponsors describe

available information pertinent to the

appropriate use of drugs in elderly

patients. In cases where none of the

provisions of the ‘‘Geriatric use’’

subsection are applicable, FDA may

permit omission of the subsection or

approve an accurate and appropriate

alternate statement.

The final rule recognizes the special

concerns associated with the geriatric

use of prescription drugs and

acknowledges the need to communicate

important information so that drugs can

be used safely and effectively in older

patients. The medical community has

become increasingly aware that

prescription drugs can produce effects

in elderly patients that are significantly

different from those produced in

younger patients. Although both young

and old patients can exhibit a range of

responses to drug therapy, factors

contributing to different responses are

comparatively more common among the

elderly. For example, elderly patients

are more likely to have impaired

mechanisms of drug excretion (e.g.,

decreased kidney function), to be on

other medications that can interact with

a newly prescribed drug, or to have

another medical condition that can

affect drug therapy.

Geriatric labeling information is of

increasing importance because of the

growing proportion of the population

that is over 65 years of age, and the

significant use of medications by this

age group. People over age 65 constitute

only 12 percent of the U.S. population,

but they consume over 30 percent of the

prescription drug products sold in this

country. The elderly are expected to

constitute 22 percent of the U.S.

population by the year 2030.

The final rule is one of several actions

taken by FDA to promote safe and

effective prescription drug use in the

elderly. FDA has encouraged sponsors

to include more elderly subjects,

especially those over 75 years of age, in

clinical studies. In the Federal Register

of March 5, 1990 (55 FR 7777), FDA

announced the availability of a

guideline entitled ‘‘Guideline for the

Study of Drugs Likely to be Used in the

Elderly.’’ The guideline emphasizes

FDA’s recommendation that drugs

should be studied in the full range of

patients who will receive them,

including the elderly, and that efforts

should be made to discover differences

in pharmacokinetics related to age, or to

conditions associated with age (e.g.,

decreased renal function, concomitant

drugs, concomitant illness), and that

clinical data should be analyzed to see

whether the drug has different effects,

favorable or unfavorable, in the old and

young. The guideline provides detailed

advice on how to evaluate new drugs in

older patients and is intended to

encourage routine and thorough

evaluation of the effects of drugs in

elderly populations so that sufficient

information can be provided to

physicians. The guideline did not call

for, or anticipate, an increase in the

number of patients or the number of

clinical studies needed to evaluate a

new therapy. Patients over 65 years of

age already represented a significant

portion of study subjects in most cases,

based on several FDA surveys. The

principal new steps called for were to

not exclude the very old, to analyze the

data already collected, and to obtain

modest additional pharmacokinetic

data. Only in special cases (e.g., drugs

especially targeted for older patients or

where age-related differences or

problems are anticipated) were separate

studies in the elderly recommended.

In the Federal Register of August 2,

1994 (59 FR 39398), FDA published a

guideline regarding the use of drugs in

geriatric populations entitled ‘‘Studies

in Support of Special Populations:

Geriatrics.’’ The guideline was prepared

by the Efficacy Expert Working Group of

the International Conference on

Harmonisation (ICH) of Technical

Requirements for Registration of

Pharmaceuticals for Human Use, which

is concerned with the harmonization of

technical requirements among the

European Union, Japan, and the United

States. The guideline reflects sound

scientific principles for testing drugs in

geriatric populations and for submitting