29500 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

The FAA estimates that 19 receivers

in the U.S. registry would be affected by

the proposed AD, that it would take

approximately 2 workhours per receiver

to accomplish the proposed action, and

that the average labor rate is

approximately $60 an hour. The

manufacturer is not charging the owner/

operator for exchanging the navigation

receiver unit and is allowing 2

workhours of labor to be claimed by the

owners/operators to accomplish the

proposed action. Based on these figures,

there is no cost impact of the proposed

AD on U.S. operators. The FAA has no

way of determining if any of the affected

airplanes have the navigation receiver

with Modification 20 installed.

The compliance time of this AD is

presented in calendar time instead of

hours time-in-service (TIS). The FAA

has determined that a calendar time

compliance is the most desirable

method because of the wide range of

fleet usage. Therefore, to ensure that the

above-referenced condition is detected

and corrected on all airplanes within a

reasonable period of time without

inadvertently grounding any airplanes, a

compliance schedule based upon

calendar time instead of hours TIS is

required.

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 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:

AlliedSignal Inc.: Docket No. 95–CE–91–AD.

Applicability: VHF Navigation Receivers

with the following model, part numbers,

computer software, and modifications that do

not have Modification 20 installed on but not

limited to Learjet Model 31A, Fokker Model

F27–50, and British Aerospace Model ATP

airplanes, certificated in any category.

Model King part No.

Software

ID

Modification

VN–411B ........................................................................................................................................................ 066–1101–00 06 18 and 19.

VN–411B ........................................................................................................................................................ 066–1101–31 00 00 and 19.

VN–411B ........................................................................................................................................................ 066–1101–40 00 00 and 19.

VN–411B ........................................................................................................................................................ 066–1101–50 00 00 and 19.

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 (d) 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: Requried within the next 90

calendar days after the effective date of this

AD or upon replacement or repair of any

affected AlliedSignal VHF Navigation

Receiver, whichever occurs first, unless

already accomplished.

To prevent VHF navigation receiver

interference from FM radio station broadcast

frequencies, which could cause distortion of

the navigation audio and deflection of the

desired flight path of the airplane during

landing operations, possibly resulting in loss

of the airplane, accomplish the following:

(a) Remove any navigation receiver that

does not have Modification 20 installed and

return the unit to an AlliedSignal Bendix/

King service center in accordance with

AlliedSignal Bendix/King Service Bulletin

(SB) VN 411B–20, dated January 1996.

(b) Replace the navigation receiver with

one that has Modification 20 installed by an

AlliedSignal Bendix/King service center in

accordance with AlliedSignal Bendix/King

SB VN 411B–20, dated January 1996.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) An Alternative method of compliance

or adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Wichita Aircraft

Certification Office, 1801 Airport Road,

Room 100, Mid-Continent Airport, Wichita,

Kansas 67209. The request shall be

forwarded through an appropriate FAA

Maintenance Inspector, who may add

comments and then send it to the Manager,

Wichita 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 Wichita Aircraft

Certification Office.

(e) All persons affected by this directive

may obtain copies of the document referred

to herein upon request to AlliedSignal,

General Aviation Avionics, 400 North Rogers

Road, Olathe, Kansas 66062–1212; or may

examine this document at the FAA, Central

Region, Office of the Assistant Chief Counsel,

Room 1558, 601 E. 12th Street, Kansas City,

Missouri 64106.

Issued in Kansas City, Missouri, on June 4,

1996.

Henry A. Armstrong,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 96–14693 Filed 6–10–96; 8:45 am]

BILLING CODE 4910–13–P
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules 29501

14 CFR Part 39

[Docket No. 95–CE–85–AD]

RIN 2120–AA64

Airworthiness Directives: Pilatus

Aircraft Ltd., Model PC–6 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 Pilatus

Aircraft Ltd. (Pilatus) Model PC–6

airplanes. The proposed action would

require inspecting for loose or sheared

rivets in the hinge brackets on the

horizontal stabilizer and inspecting for

incorrect spacing tolerance of the hinge

brackets. If the rivets are found loose or

sheared, the proposed AD would require

replacing the rivets and also repositioning the hinge brackets, if found

incorrectly spaced. Several reports of

rivets shearing on the hinge brackets

prompted the proposed action. The

actions specified in this proposed AD

are intended to prevent structural

failure of the hinge bracket on the

horizontal stabilizer, which could result

in partial or complete loss of control of

the horizontal stabilizer and loss of

control of the airplane.

DATES: Comments must be received on

or before August 14, 1996.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Assistant Chief Counsel,

Attention: Rules Docket No. 95–CE–85–

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

Pilatus Aircraft Ltd., CH–6370 Stans,

Switzerland. This information also may

be examined at the Rules Docket at the

address above.

FOR FURTHER INFORMATION CONTACT: Mr.

Roman T. Gabrys, Project Officer, Small

Airplane Directorate, Aircraft

Certification Service, FAA, 1201

Walnut, suite 900, Kansas City, Missouri

64106; telephone (816) 426–6932;

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–85–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

Assistant Chief Counsel, Attention:

Rules Docket No. 95–CE–85–AD, Room

1558, 601 E. 12th Street, Kansas City,

Missouri 64106.

Discussion

The Federal Office for Civil Aviation

(FOCA), which is the airworthiness

authority for Switzerland, recently

notified the FAA that an unsafe

condition may exist on certain Pilatus

Model PC–6 airplanes. The FOCA has

received several reports of sheared or

loose rivets in the hinge bracket that

attaches the horizontal stabilizer to the

fuselage. Investigation reveals that preloads in the hinge bracket flanges may

exist due to tightness of the fit of the

spacer, or in certain instances, the hinge

bracket is not positioned or spaced

correctly. This condition can

substantially affect the load carrying

capability of these brackets, thus

causing the rivets to shear or loosen,

which could lead to structural failure of

the horizontal stabilizer.

Pilatus Aircraft Ltd. has issued service

bulletin (SB) PC–6 165, dated February

7, 1994, which specifies procedures for

inspecting for sheared or loose rivets,

replacing any sheared or loose rivets

with new rivets, and checking the

spacing tolerance of the hinge brackets.

FOCA classified this service bulletin

as mandatory and has issued

airworthiness directive (AD) HB 94–086,

dated June 4, 1994, in order to ensure

the continued airworthiness of these

airplanes in Switzerland.

This airplane model is manufactured

in Switzerland and is type certificated

for operation in the United States under

the provisions of § 21.29 of the Federal

Aviation Regulations (14 CFR 21.29)

and the applicable bilateral

airworthiness agreement between

Switzerland and the United States.

Pursuant to this bilateral airworthiness

agreement, the Switzerland FOCA has

kept the FAA informed of the situation

described above. The FAA has

examined the findings of the

Switzerland FOCA, 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.

After examining the circumstances

and reviewing all available information

related to the incidents described above,

the FAA has determined that AD action

should be taken to prevent a reduction

in the structural integrity of the hinge

bracket and tailplane, which could

result in partial or complete loss of

control of the horizontal stabilizer and

loss of control of the airplane.

Since an unsafe condition has been

identified that is likely to exist or

develop in other Pilatus Model PC–6

airplanes of the same type design

registered in the United States, the

proposed AD would require the

following:

—Inspecting the hinge brackets attached

to the fuselage for loose or sheared

rivets,

—Inspecting the hinge brackets for

correct spacing tolerance and

positioning,

—Removing the brackets and adjusting

any incorrect spacing or positioning,

and

—Replacing any loose or sheared rivets

with new rivets.

The FAA estimates that one airplane

in the U.S. registry would be affected by

the proposed AD, that it would take less

than 1 workhour per airplane to

accomplish the proposed actions, and

that the average labor rate is

approximately $60 an hour. Based on

these figures, the total cost impact of the

proposed AD for the only U.S. operator

is estimated to be $60. This is the cost

of the inspection only and does not

include the cost for replacing any loose

rivets, if found. This figure is based on

the assumption that the affected owner/
29502 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

operator of the affected airplane has not

performed the inspection or

modification.

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 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive

(AD) to read as follows:

Pilatus Aircraft Ltd.: Docket No. 95–CE–85–

AD.

Applicability: Model PC–6 Airplanes

(serial numbers 825 through 892).

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 (e) 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 within the next 75

hours time-in-service (TIS), after the effective

date of this AD, unless already accomplished.

Note 2: The compliance time required in

this AD takes precedence over the

compliance time in Pilatus Service Bulletin

PC–6 165, dated February 7, 1994.

To prevent structural failure of the hinge

bracket on the horizontal stabilizer, which

could result in partial or complete loss of

control of the horizontal stabilizer and loss

of control of the airplane, accomplish the

following:

(a) Inspect the hinge brackets on the

horizontal stabilizer for sheared or loose

rivets in accordance with paragraph 2.A. in

the ACCOMPLISHMENT INSTRUCTIONS

section of Pilatus Service Bulletin (SB) PC–

6 165, dated February 7, 1994.

(b) Inspect the spacing tolerance of the

hinge bracket in accordance with paragraph

2.C. in the ACCOMPLISHMENT

INSTRUCTIONS section of Pilatus SB PC–6

165, dated February 7, 1994.

(c) If there are loose or sheared rivets or if

the bracket spacing is out of the spacing

tolerance, prior to further flight, modify the

position and space tolerance of the hinge

brackets and replace any loose or sheared

rivets in accordance with paragraph 2.D. in

the ACCOMPLISHMENT INSTRUCTIONS

section of Pilatus SB PC–6 165, dated

February 7, 1994.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviations Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(e) 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. 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 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(f) All persons affected by this directive

may obtain copies of the document referred

to herein upon request to Pilatus Aircraft

Ltd., CH–6370 Stans, Switzerland; or may

examine this document at the FAA, Central

Region, Office of the Assistant Chief Counsel,

Room 1558, 601 E. 12th Street, Kansas City,

Missouri.

Issued in Kansas City, Missouri on June 4,

1996.

Henry A. Armstrong,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 96–14694 Filed 6–10–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 200, 250, and 310

[Docket No. 96N–0183]

RIN 0910–AA53

Consolidation of Drug Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

consolidate a list of drugs, previously

determined by rulemaking to be new

drugs, into one section. This document

would also remove the sections now

providing for these drugs, except for

certain information in the regulations

that FDA considers to be necessary. This

action, which will make the regulations

more concise and efficient, is being

taken in response to the President’s

regulatory reinvention initiative

(REGO).

DATES: Written comments by August 26,

1996. FDA proposes that any final rule

based on this proposal become effective

2 weeks 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:

Mary E. Catchings, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–7), 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION:

I. Introduction

On March 4, 1995, President Clinton

issued a memorandum titled

‘‘Regulatory Reinvention Initiative.’’

This memorandum, part of the reform of

the Federal regulatory system, directed

heads of departments and agencies to

undertake a page-by-page review of their

existing regulations and to eliminate or

modify those that are outdated or

otherwise in need of reform. FDA has

conducted a comprehensive review of