30620 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

the requirement for identifying the

solvent used for dry extracts, no firms

will provide information concerning the

identity of the solvent. FDA estimates

that firms will provide the ratio of the

starting materials to the volume of the

solvents used in the production of

liquid extracts only when it is in their

best interest and that this will occur no

more than 10 percent of the time. The

other revisions to the regulations should

also help reduce the amount of time that

a firm must spend to provide the

required information. All of the

information required by this final rule to

be disclosed on the label of dietary

supplements that contain liquid extracts

is information that a firm would be

expected to have in the normal course

of its business of producing dietary

supplements. Firms should know or

have readily available to them

information on the amount of the extract

by volume or weight that is present in

the dietary supplement and the identity

of the solvent. The hour burden

estimates in Table 1 of this document

are for the information collection

provisions established by regulation and

do not include those that stem solely

from the act or the DSHEA.

Although the statement of identity,

nutrition, and ingredient labeling

regulations for dietary supplements in

§ 101.36 were approved following

publication of the September 1997 final

rule (OMB control number 0910–0351),

FDA has resubmitted them to OMB for

approval of the revised requirements for

label disclosure of extract ingredients in

this final rule. Prior to the effective date

of the regulations, FDA will publish a

notice in the Federal Register

announcing OMB’s decision to approve,

modify, or disapprove the revised

requirements. An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.36 is amended by

revising paragraphs (b)(3)(ii)(B),

(b)(3)(ii)(C), and (b)(3)(iii) to read as

follows:

§ 101.36 Nutrition labeling of dietary

supplements.

* * * * *

(b) * * *

(3) * * *

(ii) * * *

(B) For any dietary ingredient that is

a liquid extract from which the solvent

has not been removed, the quantity

listed shall be the volume or weight of

the total extract. Information on the

condition of the starting material shall

be indicated when it is fresh and may

be indicated when it is dried.

Information may be included on the

concentration of the dietary ingredient

and the solvent used, e.g., ‘‘fresh

dandelion root extract, x (y:z) in 70%

ethanol,’’ where x is the number of

milliliters (mL) or mg of the entire

extract, y is the weight of the starting

material and z is the volume (mL) of

solvent. Where the solvent has been

partially removed (not to dryness), the

final concentration, when indicated,

shall be stated (e.g., if the original

extract was 1:5 and 50 percent of the

solvent was removed, then the final

concentration shall be stated as 1:2.5).

Where the name of the solvent used is

not included in the nutrition label, it is

required to be listed in the ingredient

statement in accordance with § 101.4(g).

(C) For a dietary ingredient that is an

extract from which the solvent has been

removed, the weight of the ingredient

shall be the weight of the dried extract.

(iii) The constituents of a dietary

ingredient described in paragraph

(b)(3)(i) of this section may be listed

indented under the dietary ingredient

and followed by their quantitative

amounts by weight per serving, except

that dietary ingredients described in

paragraph (b)(2) of this section shall be

listed in accordance with that section.

When the constituents of a dietary

ingredient described in paragraph

(b)(3)(i) of this section are listed, all

other dietary ingredients shall be

declared in a column; however, the

constituents themselves may be

declared in a column or in a linear

display.

* * * * *

Dated: May 29, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–14915 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 98N–0294]

Beverages: Bottled Water; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of May 11, 1998 (63 FR 25764).

The document lifted the stay of the

effective date for the allowable levels in

the bottled water quality standard for

nine chemical contaminants, i.e.,

antimony, beryllium, cyanide, nickel,

thallium, diquat, endothall, glyphosate,

and 2,3,7,8–TCDD (dioxin), that was

imposed in a final rule published on

March 26, 1996. The document was

published with some errors under the

‘‘DATES’’ section. This document

corrects those errors.

DATES: The regulation published at 63

FR 25764 is effective February 2, 1999.

Submit written comments by July 27,

1998. If no timely significant adverse

comments are received, the agency will

publish a document in the Federal

Register no later than August 6, 1998,

confirming the effective date of the

direct final rule. If timely significant

adverse comments are received, the

agency will publish a document of

significant adverse comment in the

Federal Register withdrawing this

direct final rule no later than August 6,

1998.

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:

Henry Kim, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–260–0631.

SUPPLEMENTARY INFORMATION: FDA

published a direct final rule in the

Federal Register of May 11, 1998 (63 FR

25764), lifting the stay of the effective

date for the allowable levels in the

bottled water standard for nine chemical

contaminants. As published, the dates

section is incorrect.

In FR Doc. 98–12381, beginning on

page 25764 in the Federal Register of

Monday, May 11, 1998, the following

correction is made:

1. On page 25764, beginning in the

second column, the ‘‘DATES’’ section is
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30621

corrected to read as follows: ‘‘DATES:

The regulation published at 63 FR

25764 is effective February 2, 1999.

Submit written comments by July 27,

1998. If no timely significant adverse

comments are received, the agency will

publish a document in the Federal

Register no later than August 6, 1998,

confirming the effective date of the

direct final rule. If timely significant

adverse comments are received, the

agency will publish a document of

significant adverse comment in the

Federal Register withdrawing this

direct final rule no later than August 6,

1998.’’

Dated: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14718 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 602

[TD 8769]

RIN 1545–AV26

Permitted Elimination of Preretirement

Optional Forms of Benefit

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations that permit an amendment

to a qualified plan or other employee

pension benefit plan that eliminates

plan provisions for benefit distributions

before retirement but after age 701⁄2.

These regulations affect employers that

maintain qualified plans and other

employee pension benefit plans, plan

administrators of these plans and

participants in these plans.

EFFECTIVE DATE: These regulations are

effective June 5, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas Foley, (202) 622–6050 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collection of information

contained in these final regulations has

been reviewed and approved by the

Office of Management and Budget in

accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

3507(d)) under the control number

1545–1545. The collection of

information in these final regulations is

in § 1.411(d)–4. Responses to this

collection of information are required in

order to obtain a benefit. Specifically,

this information is required for a

taxpayer who wants to amend a

qualified plan to eliminate certain

preretirement optional forms of benefit.

This information will be used to

determine whether taxpayers have

amended a qualified plan.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a valid control

number.

The estimated average burden per

recordkeeper for master and prototype

plan employers is 10 minutes. The

estimated average burden per

recordkeeper for master and prototype

plan sponsors is 30 minutes. The

estimated average burden per

recordkeeper for employers with

individually designed plans is 30

minutes.

Comments concerning the accuracy of

this burden estimate and suggestions for

reducing this burden should be sent to

the Internal Revenue Service, Attn: IRS

Clearance Officer, T:FS:FP, Washington,

D.C. 20224, and to the Office of

Management and Budget, Attn: Desk

Officer for the Department of the

Treasury, Office of Information and

Regulatory Affairs, Washington, D.C.

20503.

Books or records relating to a

collection of information must be

retained as long as their contents may

become material in the administration

of any internal revenue law. Generally,

tax returns and tax return information

are confidential, as required by 26

U.S.C. 6103.

Background

This document contains amendments

to the Income Tax Regulations (26 CFR

part 1) under section 411(d) of the

Internal Revenue Code of 1986. The

final regulations permit taxpayers to

amend qualified plans to eliminate plan

provisions for benefit distributions

before retirement but after age 701⁄2, if

certain conditions are satisfied.

Section 411(d)(6) generally provides

that a plan will not be treated as

satisfying the requirements of section

411 if the accrued benefit of a

participant is decreased by a plan

amendment. Under section 411(d)(6)(B),

a plan amendment that eliminates an

optional form of benefit will be treated

as reducing accrued benefits to the

extent that the amendment applies to

benefits accrued as of the later of the

adoption date or the effective date of the

amendment. However, section

411(d)(6)(B) also permits the Secretary

to provide in regulations that this rule

will not apply to an amendment that

eliminates an optional form of benefit.

Section 401(a)(9) provides that, in

order for a plan to be qualified under

section 401(a), distributions from the

plan must commence no later than the

‘‘required beginning date.’’ Prior to

1997, section 401(a)(9)(C) generally

provided that the required beginning

date is April 1 following the calendar

year in which the employee attains age

701⁄2. Consequently, in order to satisfy

section 401(a)(9), qualified plans, other

than certain church and governmental

plans, have provided for distributions to

commence no later than April 1

following the calendar year that an

employee attains age 701⁄2. These

distributions commence without regard

to whether the employee has retired

from employment with the employer

maintaining the plan.

Section 1404 of the Small Business

Job Protection Act of 1996, Public Law

104–188 (SBJPA), amended the

definition of required beginning date

that applies to an employee who is not

a 5-percent owner. Section

401(a)(9)(C)(i), as amended, provides

that, in the case of such an employee,

the required beginning date is April 1 of

the calendar year following the later of

the calendar year in which the

employee attains age 701⁄2 or the

calendar year in which the employee

retires. Accordingly, except in the case

of 5-percent owners, a plan is no longer

required to provide for distributions that

commence prior to retirement in order

to satisfy section 401(a)(9).

The right to commence benefit

distributions in any form at a particular

time is an optional form of benefit

within the meaning of section

411(d)(6)(B) and § 1.411(d)–4, Q&A–

1(b). In enacting section 1404 of the

SBJPA, Congress did not alter the

application of section 411(d)(6). Thus,

except to the extent authorized by

regulations, a plan amendment that

eliminates the right to commence

preretirement benefit distributions in a

plan after age 701⁄2 (or restricts the right

by adding an additional condition)

violates section 411(d)(6) if the

amendment applies to benefits accrued

as of the later of the adoption or

effective date of the amendment.

On July 2, 1997, a notice of proposed

rulemaking under section 411(d)(6) was

published in the Federal Register (62

FR 35752). The proposed regulations

would allow amendment of qualified

plans to eliminate the right to

commence preretirement benefit

distributions after age 701⁄2, as required

under section 401(a)(9) before its

amendment by the SBJPA. On October