Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules 66227

(d) * * *

(2) The claim may indicate that

development of cancer depends on

many factors and identify one or more

of the following as risk factors for the

disease: Family history of a specific type

of cancer, cigarette smoking, alcohol

consumption, overweight and obesity,

ultraviolet or ionizing radiation,

exposure to cancer-causing chemicals,

and dietary factors.

(3) The claim may characterize fruits

and vegetables that meet the

requirements described in paragraph

(c)(2)(ii) of this section as foods that are

low in fat and that contain (or are a good

source of) one or more of vitamin A,

vitamin C, or dietary fiber.

* * * * *

(e) * * *

(1) Low fat diets rich in fruits and

vegetables (foods that are low in fat and

may contain dietary fiber, vitamin A

and vitamin C), may reduce the risk of

some types of cancer.

(2) A diet low in fat and high in

certain fruits and vegetables, foods that

are low in fat and that may contain

vitamin A and vitamin C, may reduce

your risk of some cancer.

Dated: December 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31008 Filed 12–20–95; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

21 CFR Part 888

[Docket No. 95N–0176]

Orthopedic Devices: Classification,

Reclassification, and Codification of

Pedicle Screw Spinal Systems;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting

certain statements in the preamble to a

proposed rule that appeared in the

Federal Register of October 4, 1995 (60

FR 51946). The document proposed to

classify certain unclassified

preamendments pedicle screw spinal

systems into class II (special controls),

and to reclassify certain

postamendments pedicle screw spinal

systems from class III (premarket

approval) to class II. The document

states further that FDA is issuing for

public comment the recommendations

of the Orthopedic and Rehabilitation

Devices Panel (the Panel) concerning

the classification/reclassification of

pedicle screw spinal systems, and the

agency’s tentative findings on the

Panel’s recommendations. The

document is being corrected to reflect

an accurate description of the formation,

membership, and activities of the Spinal

Implant Manufacturers Group (SIMG),

and the Scientific Committee, two

separate entities established by the

spinal implant manufacturers and

medical professional societies to collect

and submit to FDA all available valid

scientific data on the performance of

pedicle screw spinal devices.

FOR FURTHER INFORMATION CONTACT:

Mark N. Melkerson, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

In the FR Doc. 95–24686, appearing

on page 51946 in the Federal Register

of Wednesday, October 4, 1995, the

following corrections are made:

1.On page 51947, in the second

column, in the fourth paragraph,

beginning in line 7, the second, third,

and fourth sentences are removed and

the following text is added in their place

to read as follows:

In response, two groups were

founded: The Spinal Implant

Manufacturers Group (SIMG), and the

Scientific Committee. SIMG, founded by

16 medical device manufacturers,

agreed to provide the funding that

would be required to conduct a

nationwide study of pedicle screw

devices. The Scientific Committee was

formed by five professional medical

societies, including the North American

Spine Society, the American Academy

of Orthopedic Surgeons, the Scoliosis

Research Society, the Congress of

Neurosurgeons, and the American

Association of Neurological Surgeons.

The Scientific Committee was formed to

develop and implement a uniform

research protocol to gather clinical

experience from the use of the device.

The Scientific Committee consisted of

four surgeons and two nonvoting SIMG

representatives, a biostatistician, and a

clinical/regulatory affairs professional.

2. On page 51947, in the third

column, in the first paragraph,

beginning in the fifteenth line, the

fourth and fifth sentences are removed

and the following text is added in their

place to read as follows:

At this meeting, the Scientific

Committee presented clinical data from

its nationwide ‘‘Historical Cohort Study

of Pedicle Screw Fixation in Thoracic,

Lumbar, and Sacral Spinal Fusions’’

(Cohort Study). FDA presented a

comprehensive review of the medical

literature, an analysis of the medical

literature, an analysis of the Cohort

study conducted by the Scientific

Committee, and a summary of the

clinical data that had been released by

IDE sponsors.

3. On page 51950, in the first column,

in the fourth paragraph, in the first line,

the abbreviation ‘‘SIMG’’ is corrected to

read ‘‘Scientific Committee’’.

Dated: December 8, 1995.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 95–31047 Filed 12–20–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[INTL–52–86]

RIN 1545–AL99

Statements to Recipients of Dividends

and Patronage Dividends

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Partial withdrawal of a notice of

proposed rulemaking.

SUMMARY: This document withdraws a

portion of the notice of proposed

rulemaking under sections 6042 and

6044 of the Internal Revenue Code that

was published in the Federal Register

on February 29, 1988, as proposed to be

amended on September 27, 1990. The

proposed regulations prescribed rules

for official statements to recipients of

dividends and patronage dividends paid

after December 31, 1983.

DATES: This withdrawal is effective on

December 21, 1995.

FOR FURTHER INFORMATION CONTACT:

Renay France, (202)622–4910 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

On February 29, 1988, the IRS issued

proposed regulations on backup

withholding (INTL–52–86, 53 FR 5991).

The proposed regulations related, in

part, to official statements to recipients

of dividends and patronage dividends

under sections 6042 and 6044,

respectively (proposed §§ 1.6042–5 and

1.6044–6). On September 27, 1990, the

IRS issued additional proposed

regulations on backup withholding (IA–

224–82, 55 FR 39427). Those proposed
66228 Federal Register / Vol. 60, No. 245 / Thursday, December 21, 1995 / Proposed Rules

regulations contained amendments to

the regulations previously proposed

under sections 6042 and 6044.

In the Rules and Regulations section

of this issue of the Federal Register, the

IRS is issuing final regulations relating

to backup withholding that were

proposed in INTL–52–86 and IA- 224–

82. Those final regulations do not

include proposed §§ 1.6042–5 and

1.6044–6. Further, when the IRS issues

additional final regulations that were

proposed under INTL–52–86, those

additional final regulations will not

include proposed §§ 1.6042- 5 and

1.6044–6. Accordingly, this document

withdraws those proposed regulations

sections. See §§ 1.6042–4 and 1.6044–5

of the final regulations for substantive

rules proposed under the withdrawn

sections.

List of Subjects 26 CFR Part 1

Income taxes, Reporting and

recordkeeping requirements.

Withdrawal of Portion of Notice of

Proposed Rulemaking

Accordingly, under the authority of

26 U.S.C. 7805, proposed §§ 1.6042–5

and 1.6044–6 that were published in the

Federal Register on February 29, 1988

(53 FR 5991) and amended in the

Federal Register on September 27, 1990

(55 FR 39427) are withdrawn.

Margaret Milner Richardson,

Commissioner of Internal Revenue

[FR Doc. 95–30735 Filed 12–20–95; 8:45 am]

BILLING CODE 4830–01–U

26 CFR Part 1

[EE–53–95]

RIN 1545–AT95

Requirements for Tax Exempt Section

501(c)(5) Organizations

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of Proposed Rulemaking.

SUMMARY: This document contains

proposed regulations clarifying certain

requirements of section 501(c)(5). The

requirements are being clarified to

provide needed guidance to

organizations as to the requirements an

organization must meet in order to be

exempt from tax as an organization

described in section 501(c)(5).

DATES: Written comments and requests

for a public hearing must be received by

March 20, 1996.

ADDRESSES: Send submissions to:

CC:DOM:CORP:T:R (EE–53–95), room

5228, Internal Revenue Service, POB

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:T:R (EE–53–95),

Courier’s Desk, Internal Revenue

Service, 1111 Constitution Avenue NW.,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Robin Ehrenberg, (202) 622–6080 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Background

This notice of proposed rulemaking

clarifies the scope of the exemption

provided in section 501(c)(5) of the

Internal Revenue Code for labor,

agricultural and horticultural

organizations.

An income tax exemption for labor

organizations was first provided in the

Corporation Excise Tax Act of 1909,

Public Law No. 61–5, 36 Stat. 11, 112–

118, and has been in effect continuously

since that time. A labor organization is

an entity that is organized ‘‘to protect

and promote the interests of labor.’’

Portland Cooperative Labor Temple

Association v. Commissioner, 39 B.T.A.

450 (1939), acq., 1939–1 C.B. 28. The

principal purpose of the organization

must be to better the working conditions

of people engaged in a common pursuit.

See, Treas. Reg. § 1.501(c)(5)–1.

Organizations meeting this requirement

have traditionally engaged in collective

action directed toward the workers’

common objective of improving working

conditions. They include labor unions

that negotiate with employers on behalf

of workers for improved wages, fringe

benefits, hours and similar working

conditions, and certain union-controlled

organizations, like strike funds, that

provide benefits to workers that

enhance the union’s ability to bargain

effectively. See Rev. Rul. 67–7 (1967–1

C.B. 137). They do not include strike

funds that provide income to union

members but are not controlled by

unions. See Rev. Rul. 76–420 (1976–2

C.B. 153). Such an organization will not

pay the strike benefits ‘‘with the

objective of bettering conditions of

employment, but by reason of its

contractual agreements with the

workers.’’

Labor organizations may also meet the

requirements of section 501(c)(5) by

providing benefits that directly improve

working conditions or compensate for

unpredictable hazards that interrupt

work. Examples of such benefits include

operating a dispatch hall to match union

members with work assignments and

providing industry stewards who

represent employees with grievances

against management. See Rev. Rul. 75–

473 (1975–2 C.B. 213); Rev. Rul. 77–5

(1977–1 C.B. 148). On the other hand,

managing saving and investment plans

for workers, including retirement plans,

does not bear directly on working

conditions. See Rev. Rul. 77–46 (1977–

1 C.B. 147). Accordingly, section

501(c)(5) has not been applied to

organizations that manage retirement

savings plans as their principal activity.

Nevertheless, in Morganbesser v.

United States, 984 F.2d 560 (2d Cir.

1993), the court held that a trust

managing a pension benefit plan

pursuant to a collective bargaining

agreement qualified as a labor

organization described in section

501(c)(5). The IRS and the Treasury

Department believe that this decision is

contrary to existing law, and the IRS is

issuing an action on decision reflecting

its view that the Morganbesser court

erred in its holding. These proposed

regulations are a clarification of the

existing legal standard.

Like labor organizations, agricultural

and horticultural organizations must

also better the conditions of those

engaged in a common pursuit in order

to be described in section 501(c)(5). See

§ 1.501(c)(5)–1. There is no authority

indicating that the law is to be

interpreted differently for agricultural

and horticultural organizations than for

labor organizations. Accordingly, the

proposed regulations clarify the law as

it applies to all section 501(c)(5)

organizations.

Certain organizations have taken the

position in refund actions that they are

labor organizations described in section

501(c)(5) even though their principal

activity was to manage retirement

savings plans for workers. In addition,

some such foreign organizations have

claimed exemption from withholding on

dividend, interest and similar income

that they have earned. The IRS will

continue to oppose these claims for

refund and exemption from

withholding.

A health plan is not a retirement

savings plan. Thus, the IRS will

continue to follow Rev. Rul. 62–17

(1962–1 C.B. 87) (regarding a labor

organization providing health benefits)

even in circumstances where a majority

of the organization’s members are

retired. Furthermore, the IRS will

continue to recognize that negotiating

the terms of a retirement plan and other

postretirement benefits and designating

one or more representatives to the board

of a multiemployer pension trust are

proper activities for a labor

organization. The proposed regulations

are not intended to apply to or affect