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.
Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules 2193

(2) Section 1.35 ‘‘Cents-off,’’ or other

savings representations (21 CFR 1.35), is

obsolete. The agency is not aware of its

use.

(3) Section 2.5 Imminent hazard to

the public health (21 CFR 2.5), describes

the criteria that the Commissioner of

Food and Drugs would use in

determining whether an imminent

hazard exists. FDA issued this

regulation on July 1, 1971 (36 FR

12516). FDA proposed to revoke § 2.5 on

August 21, 1979 (44 FR 48983), in

conjunction with broader rulemaking

proceedings that would have

established by regulation, among other

things, certain criteria for the Secretary

of Health and Human Services’ (the

Secretary’s) determination of imminent

hazard. The 1979 proposed rulemaking

was withdrawn on January 20, 1994 (59

FR 3042). However, the principle upon

which FDA based its proposed

withdrawal of § 2.5 in 1979 is still valid,

namely, that it is ‘‘potentially confusing

to have criteria for FDA’s

recommendations to the Secretary

separate from the criteria for the

Secretary’s decision.’’ (44 FR 48983 at

48985). The criteria used by the

Secretary were established in 1977 in

the Secretary’s decision declaring

phenformin hydrochloride an imminent

hazard. This decision was upheld in

Forsham v. Califano, 442 F.Supp. 203

(D.D.C. 1977). The agency is proposing

to revoke § 2.5 because it is potentially

confusing and no longer necessary.

(4) 21 CFR part 10, subpart C—

Electronic Media Coverage of Public

Administrative Proceedings; Guideline

on Policy and Procedures is intended to

clarify and explain FDA’s policy on the

presence and operation of electronic

recording equipment at public

proceedings. This is a statement of

policy and need not be codified. This

information is available to those

presiding over such proceedings

through appropriate agency publications

(e.g., ‘‘Policy and Guidance Handbook

for FDA Advisory Committee

Members’’) and from the staff in FDA’s

Office of Public Affairs.

(5) Section 50.21 Effective date (21

CFR 50.21), states that the informed

consent requirements in part 50 ‘‘apply

to all human subjects entering a clinical

investigation that commences on or after

July 27, 1981.’’ FDA proposes to revoke

this provision because it is no longer

necessary. The agency is unaware of any

continuing clinical investigations that

were begun before July 27, 1981, to

warrant retaining this provision.

(6) 21 CFR part 50, subpart C—

Protections Pertaining to Clinical

Investigations Involving Prisoners as

Subjects describes restrictions on

clinical investigations involving

prisoners, including special

requirements for institutional review

boards reviewing clinical investigations

involving prisoners. On July 7, 1981 (46

FR 35085), the agency stayed the

effective date of the subpart C

regulations. Because the agency has

never made the subpart C regulations

effective, it now proposes to revoke

subpart C.

II. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The proposed rule, if finalized,

would simply eliminate certain

regulatory provisions that the agency

has not used or that have become

obsolete. Consequently, the proposed

rule would not impose any additional

regulatory burdens on small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8), that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Request for Comments

Interested persons may, on or before

April 24, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects

21 CFR Part 1

Cosmetics, Drugs, Exports, Food

labeling, Imports, Labeling, Reporting

and recordkeeping requirements.

21 CFR Part 2

Administrative practice and

procedure, Cosmetics, Devices, Drugs,

Foods.

21 CFR Part 10

Administrative practice and

procedure, News media.

21 CFR Part 50

Human research subjects, Prisoners,

Reporting and recordkeeping

requirements, Safety.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 1, 2, 10, and 50 be

amended as follows:

PART 1—GENERAL ENFORCEMENT

REGULATIONS

1. The authority citation for 21 CFR

part 1 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 403, 502, 505, 512,

602, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 343, 352, 355,

360b, 362, 371); sec. 215 of the Public Health

Service Act (42 U.S.C. 216).

§ 1.31 [Removed]

2. Section 1.31 Package size savings is

removed from subpart B.

§ 1.35 [Removed]

3. Section 1.35 ‘‘Cents-off,’’ or other

savings representations is removed from

subpart B.

PART 2—GENERAL ADMINISTRATIVE

RULINGS AND DECISIONS

4. The authority citation for 21 CFR

part 2 continues to read as follows:

Authority: Secs. 201, 301, 305, 402, 408,

409, 501, 502, 505, 507, 512, 601, 701, 702,

704 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 335, 342, 346a, 348,

351, 352, 355, 357, 360b, 361, 371, 372, 374);

15 U.S.C. 402, 409.

§ 2.5 [Removed]

5. Section 2.5 Imminent hazard to the

public health is removed from subpart

A.
2194 Federal Register / Vol. 61, No. 17 / Thursday, January 25, 1996 / Proposed Rules

1The 1983 Amendments did not amend the

definition of net earnings from self-employment

under section 1402(a) of the Code or the timing of

the tax on self-employment income under section

1401 of the Code. Accordingly, the special timing

rule under section 3121(v)(2) does not apply to

nonqualified deferred compensation that

constitutes net earnings from self-employment.

PART 10—ADMINISTRATIVE

PRACTICES AND PROCEDURES

6. The authority citation for 21 CFR

part 10 continues to read as follows:

Authority: Secs. 201–903 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321–394); 21 U.S.C. 41–50, 141–149, 467f,

679, 821, 1034; secs. 2, 351, 354, 361 of the

Public Health Service Act (42 U.S.C. 201,

262, 263b, 264); secs. 2–12 of the Fair

Packaging and Labeling Act (15 U.S.C. 1451–

1461); 5 U.S.C. 551–558, 701–721; 28 U.S.C.

2112.

Subpart C [Removed]

7. Subpart C consisting of §§ 10.200

through 10.206 is removed.

PART 50—PROTECTION OF HUMAN

SUBJECTS

8. The authority citation for 21 CFR

part 50 continues to read as follows:

Authority: Secs. 201, 406, 408, 409, 502,

503, 505, 506, 507, 510, 513–516, 518–520,

701, 721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 346, 346a, 348,

352, 353, 355, 356, 357, 360, 360c–360f,

360h–360j, 371, 379e, 381); secs. 215, 301,

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 262, 263b–263n).

§ 50.3 [Amended]

9. Section 50.3 Definitions is amended

by removing paragraph (j), and

redesignating paragraphs (k), (l), and (m)

as paragraphs (j), (k), and (l),

respectively.

§ 50.21 [Removed]

10. Section 50.21 Effective date is

removed from subpart B.

Subpart C [Removed]

11. Subpart C consisting of §§ 50.40

through 50.48 is removed.

Dated: January 18, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1142 Filed 1–24–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 31

[EE–142–87]

RIN 1545–AF97

FICA Taxation of Amounts Under

Employee Benefit Plans

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: This document contains

proposed regulations under section

3121(v)(2) of the Internal Revenue Code

of 1986, relating to when amounts

deferred under or paid from certain

nonqualified deferred compensation

plans are taken into account as ‘‘wages’’

for purposes of the employment taxes

imposed by the Federal Insurance

Contributions Act (FICA). The

regulations provide guidance to

taxpayers who must comply with

section 3121(v)(2), which was added to

the Code by section 324 of the Social

Security Amendments of 1983.

DATES: Written comments and requests

for a public hearing must be received by

April 24, 1996.

ADDRESSES: Send submissions to:

CC:DOM:CORP:R (EE–142–87), room

5228, Internal Revenue Service, P.O.

Box 7604, Ben Franklin Station,

Washington, DC 20044. In the

alternative, submissions may be hand

delivered between the hours of 8 a.m.

and 5 p.m. to: CC:DOM:CORP:R (EE–

142–87), Courier’s Desk, Internal

Revenue Service, 1111 Constitution

Avenue, NW, Washington, DC.

FOR FURTHER INFORMATION CONTACT:

David N. Pardys, (202) 622–4606 (not a

toll-free number), concerning the

regulations, and Michael Slaughter,

(202) 622–7190 (not a toll-free number),

concerning submissions.

SUPPLEMENTARY INFORMATION:

Background

This document contains proposed

amendments to the Employment Tax

Regulations (26 CFR part 31) under

section 3121(v)(2) of the Internal

Revenue Code of 1986 (the ‘‘Code’’)

relating to the employment tax

treatment of amounts deferred under or

paid from certain nonqualified deferred

compensation plans. These amendments

are proposed to reflect the statutory

changes made by section 324 of the

Social Security Amendments of 1983

(the ‘‘1983 Amendments’’), which

added section 3121(v)(2) to the Code,

and section 2662(f)(2) of the Deficit

Reduction Act of 1984 (DEFRA), which

amended section 324 of the 1983

Amendments.

Explanation of Provisions

Sections 3101 and 3111 of the Code

impose FICA tax on employees and

employers, respectively. FICA tax

consists of the Old-Age, Survivors, and

Disability Insurance (OASDI) tax and

the Hospital Insurance (HI) tax, and

generally is computed as a percentage of

wages (as defined in section 3121(a))

with respect to employment. Subject to

specific exceptions, section 3121(a)

defines ‘‘wages’’ as all remuneration for

employment. Existing regulations

(§ 31.3121(a)-2(a)) provide that FICA tax

is imposed at the time the remuneration

is actually or constructively paid.

Prior to the 1983 Amendments,

benefits under a nonqualified deferred

compensation plan generally were

wages subject to FICA tax at the time

they were actually or constructively

paid, unless certain retirement-related

exclusions applied. These exceptions

(former section 3121(a)(2)(A), (a)(3), and

(a)(13)(A)(iii)) were repealed by the

1983 Amendments. Thus, under the

1983 Amendments, which generally

apply to remuneration paid after

December 31, 1983, ‘‘retirement’’

payments are no longer excluded from

wages. Instead, the 1983 Amendments

added section 3121(v)(2), which

provides a special timing rule for wages

(within the meaning of section 3121(a))

that constitute an amount deferred

under a nonqualified deferred

compensation plan.1

Under section 3121(v)(2)(A), any

‘‘amount deferred’’ under a nonqualified

deferred compensation plan must be

taken into account as wages for FICA

purposes as of the later of (1) when the

services are performed, or (2) when

there is no substantial risk of forfeiture

of the rights to such amount. This

special timing rule may result in

imposition of FICA tax before the

benefit payments under the plan begin,

thus accelerating the imposition of FICA

tax on benefits under a nonqualified

deferred compensation plan.

Section 3121(v)(2)(B) provides a

special exclusion (the ‘‘nonduplication

rule’’) that prevents double taxation.

Once an amount deferred under a

nonqualified deferred compensation

plan is ‘‘taken into account’’ as wages

under the special timing rule, the

nonduplication rule provides that

neither that amount nor the ‘‘income

attributable to that amount’’ is again

treated as FICA wages. Thus, benefit

payments under a nonqualified deferred

compensation plan are not subject to

FICA tax when actually or

constructively paid (i.e., under the

general timing rule for wage inclusion)

if the benefit payments consist of

amounts deferred under the plan that

were previously taken into account as

FICA wages under the special timing

rule plus the attributable income.