Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules 2189

protected surfaces of the wing, or when

unusual lateral trim requirements or

autopilot trim warnings are encountered.

Note: The autopilot may mask tactile cues

that indicate adverse changes in handling

characteristics. Therefore, the pilot should

consider not using the autopilot when any

ice is visible on the airplane.

• All icing detection lights must be

operative prior to flight into icing conditions

at night. This supersedes any relief provided

by the Master Minimum Equipment List

(MMEL).’’

(2) Revise the FAA-approved AFM by

incorporating the following into the Normal

Procedures Section of the AFM. This may be

accomplished by inserting a copy of this AD

in the AFM.

‘‘WARNING

If ice is observed forming aft of the

protected surfaces of the wing, or if unusual

lateral trim requirements or autopilot trim

warnings are encountered:

• If the flaps are extended, do not retract

them until the airframe is clear of ice.

• The flight crew should reduce the angleofattack by increasing speed as much as the

airplane configuration and weather allow,

without exceeding design maneuvering

speed.

• If the autopilot is engaged, hold the

control wheel firmly and disengage the

autopilot. Do not re-engage the autopilot

until the airframe is clear of ice.

• Exit the icing area immediately by

changing altitude or course.

• Report these weather conditions to Air

Traffic Control.

CAUTION

Severe icing comprises environmental

conditions outside of those for which the

airplane is certificated. Flight in freezing

rain, freezing drizzle, or mixed icing

conditions (supercooled liquid water and ice

crystals) may result in extreme ice build-up

on protected surfaces exceeding the

capability of the ice protection system, or

may result in ice forming aft of the protected

surfaces. This ice may not be shed using the

ice protection systems, and may seriously

degrade the performance and controllability

of the airplane.

THE FOLLOWING SHALL BE USED TO

IDENTIFY FREEZING RAIN/FREEZING

DRIZZLE ICING CONDITIONS:

• Unusually extensive ice accreted on the

airframe in areas not normally observed to

collect ice.

• Accumulation of ice on the upper

surface (for low-wing airplanes) or lower

surface (for highwing airplanes) of the wing

aft of the protected area.

• Accumulation of ice on the propeller

spinner farther back than normally observed.

THE FOLLOWING MAY BE USED TO

IDENTIFY POSSIBLE FREEZING RAIN/

FREEZING DRIZZLE CONDITIONS:

• Visible rain at temperatures below +5

degrees Celsius [outside air temperature

(OAT)].

• Droplets that splash or splatter on impact

at temperatures below +5 degrees Celsius

OAT.

PROCEDURES FOR EXITING THE

FREEZING RAIN/FREEZING DRIZZLE

ENVIRONMENT:

These procedures are applicable to all

flight phases from takeoff to landing. Monitor

the outside air temperature. While severe

icing may form at temperatures as cold as -18

degrees Celsius, increased vigilance is

warranted at temperatures around freezing

with visible moisture present. If the visual

cues specified in the AFM for identifying

possible freezing rain or freezing drizzle

conditions are observed, accomplish the

following:

• Exit the freezing rain or freezing drizzle

severe icing conditions immediately to avoid

extended exposure to flight conditions

outside of those for which the airplane has

been certificated for operation. Asking for

priority to leave the area is fully justified

under these conditions.

• Avoid abrupt and excessive

maneuvering that may exacerbate control

difficulties.

• Do not engage the autopilot. The

autopilot may mask unusual control system

forces.

• If the autopilot is engaged, hold the

control wheel firmly and disengage the

autopilot.

• If an unusual roll response or

uncommanded control movement is

observed, reduce the angle-ofattack by

increasing airspeed or rolling wings level (if

in a turn), and apply additional power, if

needed.

• Avoid extending flaps during extended

operation in icing conditions. Operation with

flaps extended can result in a reduced wing

angle-ofattack, with ice forming on the upper

surface further aft on the wing than normal,

possibly aft of the protected area.

• Report these weather conditions to Air

Traffic Control.’’

(b) Incorporating the AFM revisions, as

required by this AD, may be performed by

the owner/operator holding at least a private

pilot certificate as authorized by section 43.7

of the Federal Aviation Regulations (14 CFR

43.7), and must be entered into the aircraft

records showing compliance with this AD in

accordance with section 43.11 of the Federal

Aviation Regulations (14 CFR 43.11).

(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, Brussels Aircraft

Certification Office (ACO), Europe, Africa,

Middle East office, FAA, c/o American

Embassy, B–1000 Brussels, Belgium. The

request should be forwarded through an

appropriate FAA Maintenance Inspector,

who may add comments and then send it to

the Manager, Brussels ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Brussels ACO.

(d) All persons affected by this directive

may examine information related to this AD

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 January

19, 1996.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 96–1223 Filed 1–24–96; 8:45 am]

BILLING CODE 4910–13–U

14 CFR Part 39

[Docket No. 96–CE–06–AD]

Airworthiness Directives; Fairchild

Aircraft SA226 and SA227 Series

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 all Fairchild

Aircraft SA226 and SA227 series

airplanes. This proposal would require

revising the Airplane Flight Manual

(AFM) to specify procedures that would

prohibit flight in freezing rain or

freezing drizzle conditions (as

determined by certain visual cues), limit

or prohibit the use of various flight

control devices, and provide the flight

crew with recognition cues for, and

procedures for exiting from, severe icing

conditions. This proposal is prompted

by results of a review of the

requirements for certification of the

airplane in icing conditions, new

information on the icing environment,

and icing data provided currently to the

flight crews. The actions specified by

the proposed AD are intended to

minimize the potential hazards

associated with operating the airplane

in freezing rain or freezing drizzle

conditions by providing more clearly

defined procedures and limitations

associated with such conditions.

DATES: Comments must be received on

or before March 7, 1996.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Assistant Chief Counsel,

Attention: Rules Docket No. 96–CE–06–

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.

Information that relates to the

proposed AD may be examined at the

Rules Docket at the address above.

FOR FURTHER INFORMATION CONTACT: Mr.

Ronald L. Filler, Flight Test Pilot, FAA,

Airplane Certification Office, 2601

Meacham Boulevard, Fort Worth, Texas
2190 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules

76193–0150; telephone (817) 222–5132;

facsimile (817) 222–5960.

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. 96–CE–06–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. 96–CE–06–AD, Room

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

Missouri 64106.

Discussion

In October 1994, a transport category

airplane was involved in an accident in

which severe icing conditions (believed

to be composed of freezing drizzle size

droplets) were reported in the area.

Although the National Transportation

Safety Board (NTSB) has not yet made

a finding of probable cause of the

accident, loss of control of the airplane

may have occurred because ice

accretion on the upper surface of the

wing aft of the area protected by the ice

protection system caused airflow

separation, which resulted in the

ailerons being forced to a right-wingdown control position. There also is

concern that the autopilot, which was

engaged, may have masked the unusual

control forces generated by the ice

accumulation. On the accident aircraft,

these conditions, if not corrected, could

result in a roll upset from which the

flight crew may be unable to recover.

The atmospheric conditions (freezing

drizzle) that may have contributed to

the accident are outside the icing

envelope specified in Appendix C of

part 25 of the Federal Aviation

Regulations (14 CFR part 25) for

certification of any airplane. Section

23.1419 of the Federal Aviation

Regulations (14 CFR 23.1419) crossreferences Appendix C of part 25 of the

Federal Aviation Regulations (14 CFR

part 25). Freezing rain is an atmospheric

condition that also is outside the icing

envelope. Such icing conditions are not

defined in Appendix C of part 25 of the

Federal Aviation Regulations (14 CFR

part 25) for certification of any airplane,

and the FAA has not required that

airplanes be shown to be capable of

operating safely in those icing

conditions.

The FAA finds that flight crews are

not currently provided with adequate

information necessary to determine

when the airplane is operating in icing

conditions for which the airplane is not

certificated or what action to take when

such conditions are encountered.

Therefore, the FAA has determined that

flight crews must be provided with such

information and must be made aware of

certain visual cues that may indicate the

airplane is operating in atmospheric

conditions that are outside the icing

envelope.

Since such information is not

available to flight crews, and no

airplane is certificated for operation in

freezing drizzle conditions, the FAA

finds that the potentially unsafe

condition (described previously as

control difficulties following operation

of the airplane in icing conditions

outside of the icing envelope) is not

limited to airplanes having the same

type design as that of the accident

airplane.

The FAA recognizes that the flight

crew of any airplane that is certificated

for flight in icing conditions may not

have adequate information concerning

flight in icing conditions outside the

icing envelope. However, the FAA finds

that the specified unsafe condition must

be addressed as a higher priority on

airplanes that are turbopropellerpowered and have unpowered control

systems. Many of these airplanes carry

passengers in regularly scheduled

revenue service in the United States.

Since turbopropeller-powered airplanes

are more likely to operate at low

altitudes and to make more frequent

landings, they are more likely to

encounter icing conditions that are

outside the icing envelope.

Additionally, the flight crew of an

airplane having an unpowered roll

control system must rely solely on

physical strength to counteract roll

control anomalies, whereas a roll

control anomaly that occurs on an

airplane having a powered roll control

system need not be offset directly by the

flight crew.

Subsequent to the accident, the FAA,

in conjunction with certain foreign

airworthiness authorities and airplane

manufacturers, conducted reviews of

certain transport and small category

airplanes to determine if any airplanes

might experience control difficulty

should a ridge of ice form aft of the

deicing boots and forward of the

ailerons. The review focused on

turbopropeller-powered airplanes

having unpowered roll control systems,

since those airplanes are similar in

design to the accident airplane and

because they are frequently exposed to

icing conditions.

During the reviews of these airplanes,

an artificial ice shape was used in the

demonstration of roll control

characteristics. This ice shape was

chosen as representative of a shape that

might form if an airplane were operated

in freezing drizzle. Results of these

reviews revealed that certain airplanes

demonstrated acceptable roll control

forces. However, the dynamics of ice

accretion in freezing drizzle are not well

understood, and the FAA recognizes

that such airplanes could develop ice

shapes other than those tested during

the review. Upon further review, the

FAA may consider additional

rulemaking.

Following examination of all relevant

information, the FAA has determined

that certain limitations and procedures

should be included in the FAAapproved Airplane Flight Manual

(AFM) for the affected airplanes, as

follows:

• Fairchild Aircraft SA226 and

SA227 series airplanes must be

prohibited from flight in freezing rain or

freezing drizzle conditions (as

determined by certain visual cues); and

• flight crews must be provided with

information that would minimize the

potential hazards associated with

operating the airplane in freezing rain or

freezing drizzle conditions.

The FAA has determined that such

limitations and procedures currently are

not defined adequately in the AFM for

these airplanes.
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules 2191

Explanation of the Provisions of the

Proposed AD

Since an unsafe condition has been

identified that is likely to exist on

airplanes of the same type design, the

proposed AD would require revising the

Limitations Section of the AFM to

specify procedures that would:

• prohibit flight in freezing rain or

freezing drizzle conditions (as

determined by certain visual cues);

• prohibit use of the autopilot when

ice is formed aft of the protected

surfaces of the wing, or when an

unusual lateral trim condition exists;

and

• require that all icing detection

lights be operative prior to flight into

icing conditions at night.

The prohibition on flight in freezing

rain or freezing drizzle is not intended

to prohibit purely inadvertent

encounters with the specified

atmospheric conditions. However, pilots

should make all reasonable efforts to

avoid such encounters and must

immediately exit the conditions if they

are encountered.

This proposed AD also would require

revising the Normal Procedures Section

of the AFM to specify procedures that

would:

• limit the use of the flaps and

prohibit the use of the autopilot when

ice is observed forming aft of the

protected surfaces of the wing, or if

unusual lateral trim requirements or

autopilot trim warnings are

encountered; and

• provide the flight crew with

recognition cues for, and procedures for

exiting from, severe icing conditions.

Cost Impact

The FAA estimates that 779 airplanes

in the U.S. registry would be affected by

the proposed AD, that it would take

approximately 1 workhour per airplane

to accomplish the proposed action, and

that the average labor rate is

approximately $60 an hour. Since an

owner/operator who holds at least a

private pilot’s certificate as authorized

by sections 43.7 and 43.11 of the

Federal Aviation Regulations (14 CFR

43.7 and 43.11) can accomplish the

proposed action, the only cost impact

upon the public is the time it would

take the affected airplane owner/

operators to incorporate the proposed

AFM revisions.

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 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:

Fairchild Aircraft: Docket No. 96–CE–06–

AD.

Applicability: Models SA226–T, SA226–

T(B), SA226–AT, SA226–TC, SA227–TT,

SA227–AT, SA227–AC, SA227–BC, SA227–

CC, and SA227–DC airplanes (all serial

numbers), 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 indicataed,

unless already accomplished.

To minimize the potential hazards

associated with operating the airplane in

freezing rain or freezing drizzle icing

conditions by providing more clearly defined

procedures and limitations associated with

such conditions, accomplish the following:

(a) Within 30 days after the effective date

of this AD, accomplish the requirements of

paragraphs (a)(1) and (a)(2) of this AD.

Note 2: Operators must initiate action to

notify and ensure that flight crewmembers

are apprised of this change.

(1) Revise the FAA-approved Airplane

Flight Manual (AFM) by incorporating the

following into the Limitations Section of the

AFM. This may be accomplished by inserting

a copy of this AD in the AFM.

• Flight in meteorological conditions

described as freezing rain or freezing drizzle,

as determined by the following visual cues,

is prohibited:

—Unusually extensive ice accreted on the

airframe in areas not normally observed to

collect ice.

—Accumulation of ice on the upper surface

(for low-wing airplanes) or lower surface

(for high-wing airplanes) of the wing aft of

the protected area.

—Accumulation of ice on the propeller

spinner farther back than normally

observed.

If the airplane encounters conditions that

are determined to contain freezing rain or

freezing drizzle, the pilot must immediately

exit the freezing rain or freezing drizzle

conditions by changing altitude or course.

Note: The prohibition on flight in freezing

rain or freezing drizzle is not intended to

prohibit purely inadvertent encounters with

the specified meteorological conditions.

However, pilots should make all reasonable

efforts to avoid such encounters and must

immediately exit the conditions if they are

encountered.

• Use of the autopilot is prohibited when

any ice is observed forming aft of the

protected surfaces of the wing, or when

unusual lateral trim requirements or

autopilot trim warnings are encountered.

Note: The autopilot may mask tactile cues

that indicate adverse changes in handling

characteristics. Therefore, the pilot should

consider not using the autopilot when any

ice is visible on the airplane.

• All icing detection lights must be

operative prior to flight into icing conditions

at night. This supersedes any relief provided

by the Master Minimum Equipment List

(MMEL).’’

(2) Revise the FAA-approved AFM by

incorporating the following into the Normal

Procedures Section of the AFM. This may be

accomplished by inserting a copy of this AD

in the AFM.

‘‘WARNING

‘‘If ice is observed forming aft of the

protected surfaces of the wing, or if unusual

lateral trim requirements or autopilot trim

warnings are encountered:
2192 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules

• If the flaps are extended, do not retract

them until the airframe is clear of ice.

• The flight crew should reduce the angleof-attack by increasing speed as much as the

airplane configuration and weather allow,

without exceeding design maneuvering

speed.

• If the autopilot is engaged, hold the

control wheel firmly and disengage the

autopilot. Do not re-engage the autopilot

until the airframe is clear of ice.

• Exit the icing area immediately by

changing altitude or course.

• Report these weather conditions to Air

Traffic Control.

CAUTION

Severe icing comprises environmental

conditions outside of those for which the

airplane is certificated. Flight in freezing

rain, freezing drizzle, or mixed icing

conditions (supercooled liquid water and ice

crystals) may result in extreme ice build-up

on protected surfaces exceeding the

capability of the ice protection system, or

may result in ice forming aft of the protected

surfaces. This ice may not be shed using the

ice protection systems, and may seriously

degrade the performance and controllability

of the airplane.

THE FOLLOWING SHALL BE USED TO

IDENTIFY FREEZING RAIN/FREEZING

DRIZZLE ICING CONDITIONS:

• Unusually extensive ice accreted on the

airframe in areas not normally observed to

collect ice.

• Accumulation of ice on the upper

surface (for low-wing airplanes) or lower

surface (for highwing airplanes) of the wing

aft of the protected area.

• Accumulation of ice on the propeller

spinner farther back than normally observed.

THE FOLLOWING MAY BE USED TO

IDENTIFY POSSIBLE FREEZING RAIN/

FREEZING DRIZZLE CONDITIONS:

• Visible rain at temperatures below +5

degrees Celsius [outside air temperature

(OAT)].

• Droplets that splash or splatter on impact

at temperatures below +5 degrees Celsius

OAT.

PROCEDURES FOR EXITING THE

FREEZING RAIN/FREEZING DRIZZLE

ENVIRONMENT:

These procedures are applicable to all

flight phases from takeoff to landing. Monitor

the outside air temperature. While severe

icing may form at temperatures as cold as

¥18 degrees Celsius, increased vigilance is

warranted at temperatures around freezing

with visible moisture present. If the visual

cues specified in the AFM for identifying

possible freezing rain or freezing drizzle

conditions are observed, accomplish the

following:

• Exit the freezing rain or freezing drizzle

severe icing conditions immediately to avoid

extended exposure to flight conditions

outside of those for which the airplane has

been certificated for operation. Asking for

priority to leave the area is fully justified

under these conditions.

• Avoid abrupt and excessive

maneuvering that may exacerbate control

difficulties.

• Do not engage the autopilot. The

autopilot may mask unusual control system

forces.

• If the autopilot is engaged, hold the

control wheel firmly and disengage the

autopilot.

• If an unusual roll response or

uncommanded control movement is

observed, reduce the angle-of-attack by

increasing airspeed or rolling wings level (if

in a turn), and apply additional power, if

needed.

• Avoid extending flaps during extended

operation in icing conditions. Operation with

flaps extended can result in a reduced wing

angle-of-attack, with ice forming on the

upper surface further aft on the wing than

normal, possibly aft of the protected area.

• Report these weather conditions to Air

Traffic Control.’’

(b) Incorporating the AFM revisions, as

required by this AD, may be performed by

the owner/operator holding at least a private

pilot certificate as authorized by section 43.7

of the Federal Aviation Regulations (14 CFR

43.7), and must be entered into the aircraft

records showing compliance with this AD in

accordance with section 43.11 of the Federal

Aviation Regulations (14 CFR 43.11).

(c) An alternative method of compliance or

adjustment of the compliance times that

provides an equivalent level of safety may be

approved by the Manager, Fort Worth

Airplane Certification Office (ACO), FAA,

2601 Meacham Boulevard, Fort Worth, Texas

76137–0150. The request shall be forwarded

through an appropriate FAA Maintenance

Inspector, who may add comments and then

send it to the Manager, Fort Worth ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Fort Worth ACO.

(d) All persons affected by this directive

may examine information related to this AD

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 January

19, 1996.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 96–1217 Filed 1–24–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 2, 10, and 50

[Docket No. 95N–0340]

RIN 0910–AA54

Revocation of Certain Regulations;

General

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revoke certain regulations that are

obsolete or no longer necessary to

achieve public health goals. These

regulations have been identified for

revocation as the result of a page-bypage review of the agency’s regulations.

This regulatory review is in response to

the Administration’s ‘‘Reinventing

Government’’ initiative which seeks to

streamline government to ease the

burden on regulated industry and

consumers.

DATES: Written comments by April 24,

1996.

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:

Regarding the regulations mentioned

in this document: Philip L. Chao,

Policy Development and

Coordination Staff (HF–23), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3380.

Regarding general information on

FDA’s ‘‘reinventing initiative’’: Lisa

M. Helmanis, Regulations Policy

Management Staff (HF–26), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–3480.

SUPPLEMENTARY INFORMATION: On March

4, 1995, President Clinton announced

plans for reforming the Federal

regulatory system as part of his

‘‘Reinventing Government’’ initiative. In

his March 4 directive, the President

ordered all Federal agencies to conduct

a page-by-page review of their

regulations and to ‘‘eliminate or revise

those that are outdated or otherwise in

need of reform.’’ This proposal, which

would revoke certain obsolete and

unnecessary regulations, represents

FDA’s continuing effort to implement

the President’s plan. In previous issues

of the Federal Register, FDA proposed

revoking or revising other regulations,

and the agency expects to issue future

reinvention proposals in upcoming

issues.

The following is a section-by-section

analysis of the regulations that FDA is

proposing to revoke. These regulations

are listed numerically as they appear in

Code of Federal Regulations (CFR).

I. Section-by-Section Analysis

(1) Section 1.31 Package size saving

(21 CFR 1.31), addressing economy size

packaging is obsolete. The agency is not

aware of its use.