7710 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Rules and Regulations

shall be governed by the provisions of

§ 330.10 of this part.

* * * * *

3. Section 330.7 is amended by

revising paragraph (c) to read as follows:

§ 330.7 Joint ownership accounts.

* * * * *

(c) Qualifying joint accounts. (1) A

joint deposit account shall be deemed to

be a qualifying joint account, for

purposes of this section, only if:

(i) All co-owners of the funds in the

account are natural persons; and

(ii) Each co-owner has personally

signed a deposit account signature card;

and

(iii) Each co-owner possesses

withdrawal rights on the same basis.

(2) The requirement of paragraph

(c)(1)(ii) of this section shall not apply

to certificates of deposit, to any deposit

obligation evidenced by a negotiable

instrument, or to any account

maintained by an agent, nominee,

guardian, custodian or conservator on

behalf of two or more persons.

(3) All deposit accounts that satisfy

the criteria in paragraph (c)(1) of this

section, and those accounts that come

within the exception provided for in

paragraph (c)(2) of this section, shall be

deemed to be jointly owned provided

that, in accordance with the provisions

of § 330.4(a) of this part, the FDIC

determines that the deposit account

records of the insured depository

institution are clear and unambiguous

as to the ownership of the accounts. If

the deposit account records are

ambiguous or unclear as to the manner

in which the deposit accounts are

owned, then the FDIC may, in its sole

discretion, consider evidence other than

the deposit account records of the

insured depository institution for the

purpose of establishing the manner in

which the funds are owned. The

signatures of two or more persons on the

deposit account signature card or the

names of two or more persons on a

certificate of deposit or other deposit

instrument shall be conclusive evidence

that the account is a joint account

unless the deposit records as a whole

are ambiguous and some other evidence

indicates, to the satisfaction of the FDIC,

that there is a contrary ownership

capacity.

* * * * *

4. The heading of § 330.10 is revised

to read as follows:

§ 330.10 Accounts held by a depository

institution as the trustee of an irrevocable

trust.

5. Section 330.11 is amended by

adding a new paragraph (d) to read as

follows:

§ 330.11 Irrevocable trust accounts.

* * * * *

(d) Commingled accounts of

bankruptcy trustees. Whenever a

bankruptcy trustee appointed under

Title 11 of the United States Code

commingles the funds of various

bankruptcy estates in the same account

at an insured depository institution, the

funds of each Title 11 bankruptcy estate

will be added together and insured for

up to $100,000, separately from the

funds of any other such estate.

6. Section 330.12 is amended by

revising the heading and introductory

text of paragraph (g), redesignating

paragraphs (g)(1), (g)(2) and (g)(3) as

paragraphs (g)(2), (g)(3) and (g)(4),

respectively, and adding new

paragraphs (g)(1) and (h) to read as

follows:

§ 330.12 Retirement and other employee

benefit plan accounts.

* * * * *

(g) Definitions of ‘‘depositor’’,

‘‘employee benefit plan’’, ‘‘employee

organizations’’ and ‘‘non-contingent

interest’’. Except as otherwise indicated

in this section, for purposes of this

section:

(1) The term depositor means the

person(s) administering or managing an

employee benefit plan.

* * * * *

(h) Disclosure of capital status—(1)

Disclosure upon request. An insured

depository institution shall, upon

request, provide a clear and

conspicuous written notice to any

depositor of employee benefit plan

funds of the institution’s leverage ratio,

Tier 1 risk-based capital ratio, total riskbased capital ratio and prompt

corrective action (PCA) capital category,

as defined in the regulations of the

institution’s primary federal regulator,

and whether, in the depository

institution’s judgment, employee benefit

plan deposits made with the institution,

at the time the information is requested,

would be eligible for ‘‘pass-through’’

insurance coverage under paragraphs (a)

and (b) of this section. Such notice shall

be provided within five business days

after receipt of the request for

disclosure.

(2) Disclosure upon opening of an

account. (i) An insured depository

institution shall, upon the opening of

any account comprised of employee

benefit plan funds, provide a clear and

conspicuous written notice to the

depositor consisting of: an accurate

explanation of the requirements for

pass-through deposit insurance coverage

provided in paragraphs (a) and (b) of

this section; the institution’s PCA

capital category; and a determination of

whether or not, in the depository

institution’s judgment, the funds being

deposited are eligible for ‘‘passthrough’’ insurance coverage.

(ii) An insured depository institution

shall provide the notice required in

paragraph (h)(2)(i) of this section to

depositors who have employee benefit

plan deposits with the insured

depository institution on July 1, 1995

that, at the time such deposits were

placed with the insured depository

institution, were not eligible for passthrough insurance coverage under

paragraphs (a) and (b) of this section.

The notice shall be provided to the

applicable depositors within ten

business days after July 1, 1995.

(3) Disclosure when ‘‘pass-through’’

coverage is no longer available.

Whenever new, rolled-over or renewed

employee benefit plan deposits placed

with an insured depository institution

would no longer be eligible for ‘‘passthrough’’ insurance coverage, the

institution shall provide a clear and

conspicuous written notice to all

existing depositors of employee benefit

plan funds of its new PCA capital

category, if applicable, and that new,

rolled-over or renewed deposits of

employee benefit plan funds made after

the applicable date shall not be eligible

for ‘‘pass-through’’ insurance coverage

under paragraphs (a) and (b) of this

section. Such written notice shall be

provided within 10 business days after

the institution receives notice or is

deemed to have notice that it is no

longer permitted to accept brokered

deposits under section 29 of the Act and

the institution no longer meets the

requirements in paragraph (b) of this

section.

(4) Definition of ‘‘employee benefit

plan’’. For purposes of this paragraph,

the term employee benefit plan has the

same meaning as provided under

paragraph (g)(2) of this section but also

includes any eligible deferred

compensation plans described in

section 457 of the Internal Revenue

Code of 1986 (26 U.S.C. 457).

By order of the Board of Directors.

Dated at Washington, D.C., this 31st day of

January, 1995.

Federal Deposit Insurance Corporation.

Robert E. Feldman,

Acting Executive Secretary.

[FR Doc. 95–3178 Filed 2–8–95; 8:45 am]

BILLING CODE 6714–01–P
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Rules and Regulations 7711

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95N–0025]

Food Labeling; General Requirements

for Nutrition Labeling of Dietary

Supplements; General Requirements

for Nutrient Content Claims for Dietary

Supplements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of intent.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that, given the need to modify its

regulations on nutrition labeling and

nutrient content claims for dietary

supplements to respond to the 1994

Dietary Supplement Health and

Education Act (the 1994 DSHEA), it

does not intend to enforce those

regulations until after December 31,

1996. FDA is issuing this notice of

intent in response to inquiries from the

dietary supplement industry.

FOR FURTHER INFORMATION CONTACT:

Virginia L. Wilkening, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Background

The Nutrition Labeling and Education

Act (the 1990 amendments) was enacted

on November 8, 1990. This law

amended the Federal Food, Drug, and

Cosmetic Act (the act) to require that

virtually all foods, including

conventional foods and dietary

supplements, bear nutrition labeling

(section 403(q) of the act (21 U.S.C.

343(q)), and that if they bear claims

about the level of nutrients that they

contain, those claims be made in

accordance with definitions adopted by

FDA (see section 403(r) of the act). The

1990 amendments required that FDA

issue proposed rules implementing

these provisions within 12 months from

the date of their enactment and final

rules within 24 months (sections 2(b)

and 3(b) of the 1990 amendments). The

final rules were to be effective 6 months

after they were issued, although FDA

was authorized to delay application of

the rules for up to 1 year if it found that

compliance with the nutrition labeling

and nutrient content claim provisions

would cause undue economic hardship

(section 10(a) of the 1990 amendments).

FDA issued proposed rules on

November 27, 1991 (see 56 FR 60366

and 60421). On October 29, 1992,

however, shortly before the final rules

were to be issued, the Dietary

Supplement Act of 1992 (the 1992 DS

act) (Title II of Pub. L. 102–571) was

enacted. This law took dietary

supplements out of the rulemaking

schedule that had been established

under the 1990 amendments. It

provided that FDA issue new proposals

on the nutrition labeling of, and nutrient

content claims for, dietary supplements

by June 15, 1993, and that the agency

issue final rules by December 31, 1993.

However, the provisions of the 1990

amendments that made the final rules

effective 6 months after issuance, and

that gave FDA discretion to delay their

applicability for 1 year, continued to

apply to dietary supplements.

Consistent with the 1990 amendments

and the 1992 DS act, on June 18, 1993

(58 FR 33715 and 33731), FDA issued

proposed rules on the nutrition labeling

and nutrient content claims for dietary

supplements. On January 4, 1994 (59 FR

354 and 378), FDA issued the final

rules. As stated above, under the 1990

amendments, these final rules were to

be effective 6 months from December

31, 1993, or on July 1, 1994. However,

in conjunction with the publication of

the final rules, FDA made a finding that

requiring compliance by that date

would cause dietary supplement

manufacturers undue economic

hardship (59 FR 350, January 4, 1994).

Therefore, FDA stated that these

manufacturers need not comply with

the final rules on nutrition labeling and

nutrient content claims until July 1,

1995.

Having completed these rulemakings,

FDA anticipated that dietary

supplement firms would begin taking

steps to come into compliance with the

new rules, and dietary supplement

manufacturers have apparently done so.

For example, in 1994, a number of

dietary supplement trade associations

held conferences about the new rules,

and FDA received inquiries from a

number of firms about what steps are

required.

In October 1994, however, a

significant ambiguity was introduced

into the regulation of the labeling of

dietary supplements. At that time, the

1994 DSHEA (Pub. L. 103–417) was

enacted. This new law amended both

the nutrition labeling and nutrient

content claim provisions of the act (see

sections 7(b) and (c) of the 1994

DSHEA). It made limited changes in

how nutrition information is to be

presented in the labeling of dietary

supplements, although it made

implementation of these changes subject

to regulations adopted by the Secretary

of Health and Human Services (and, by

delegation, FDA) (section 403(q)(5)(F) of

the act). It also limited in one respect

the nutrient content claims for dietary

supplements that must be defined by

regulation by FDA (section 403(r)(2)(F)

of the act).

With respect to the effective date of

these amendments and to the other

labeling provisions enacted as part of

the new law, the 1994 DSHEA stated

that dietary supplements may be labeled

in accordance with its provisions after

its date of enactment, and that they

must be labeled in compliance with its

provisions after December 31, 1996

(section 7(e) of the 1994 DSHEA). The

new law was silent, however, with

respect to its effect on the July 1, 1995,

applicability date established under the

1990 amendments and the 1992 DS act

for FDA’s regulations on the nutrition

labeling and nutrient content claim

requirements for dietary supplements.

II. Statement

In the wake of the new law, FDA has

received inquiries from the dietary

supplement industry about how the

agency intends to enforce the law. One

trade association wrote that its members

are making efforts to comply with the

July 1, 1995, effective date established

under the 1990 amendments and the

1992 DS act, but that, as a practical

matter, that effective date should not be

enforced to allow the process of

implementing the 1994 DSHEA to

proceed in a reasonable fashion. The

trade association cautioned that if FDA

did not follow such a course, companies

would be put in the untenable position

of needing to relabel in July 1995, only

to relabel again by the end of 1996 (Ref.

1).

FDA believes that it is appropriate, in

response to these inquiries, to issue a

statement on how it intends to enforce

its nutrition labeling and nutrient

content claim regulations with respect

to dietary supplements in light of the

passage of the 1994 DSHEA (Ref. 2). In

formulating this statement, FDA has

carefully considered Congress’ goals in

passing the 1994 DSHEA and the 1990

amendments, as well as the needs of the

companies that are required to label

their products in accordance with the

act and of consumers to whom the

information in question is to be

provided.

In the 1990 amendments, Congress

required that food labels bear

information that will help consumers to

maintain healthy dietary practices and

established timeframes for the

implementation of the legislation to
7712 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Rules and Regulations

ensure that it would be given effect

without undue delay. In the 1994

DSHEA, Congress, while embracing

most of what FDA has done under the

1990 amendments with respect to

dietary supplements, sought to provide

for the inclusion of additional

information on the nutrition label and to

provide additional flexibility in how

that information is presented. The

dietary supplement industry is left

facing an applicability date for FDA’s

nutrition labeling and nutrient content

claim regulations for dietary

supplements of July 1, 1995, without

complete guidance on how the nutrition

label is ultimately to be presented on

these products. As for consumers, they

are currently provided with nutrition

information on many, but by no means

all, dietary supplements, but that

information is not being presented in a

form that is consistent with the

‘‘Nutrition Facts’’ panel that appears on

conventional foods.

Having considered these factors, FDA

advises that, while the nutrition labeling

and nutrient content claim regulations

implementing the 1990 amendments for

dietary supplements will go into effect

on July 1, 1995, it does not intend to

enforce those regulations until it has

modified them to reflect the 1994

DSHEA, and until after dietary

supplement manufacturers are required

to label their products in accordance

with the 1994 DSHEA; that is, not until

after December 31, 1996.

FDA considers this course of action

appropriate for several reasons. First,

FDA recognizes the merit in the dietary

supplement industry’s argument that it

should not be required to relabel its

products until it has a full

understanding of what its alternatives

and obligations are. Enforcing the

nutrition labeling and nutrient content

claims regulations on July 1, 1995,

would require dietary supplement

manufacturers to choose between

relabeling their products twice, the first

time to come into compliance and the

second to take advantage of the

flexibility provided by the new law, or

foregoing that flexibility. To force

dietary supplement manufacturers to

make such a choice would be a result

that the agency does not believe

Congress contemplated or would have

intended in enacting the 1994 DSHEA.

The 1994 DSHEA provides for

flexibility in the dietary ingredients that

can be included in the ‘‘Nutrition Facts’’

box and in the presentation of

ingredient information. FDA, pursuant

to the 1994 DSHEA, is at work on

regulations that define this flexibility.

FDA agrees that industry should have

an opportunity to take advantage of this

flexibility without being forced to

relabel twice to do so. FDA

acknowledges that it will not be

possible for the agency to have its

regulations in place, nor for the industry

to have adequate time to design its

labeling in accordance with these

regulations, by July of this year. Thus,

the interests of industry and the policies

embodied in the 1994 DSHEA will be

advanced if FDA declines to enforce the

nutrition labeling and nutrient content

claim regulations that apply to dietary

supplements until after December 31,

1996, when they will be fully modified

to reflect the 1994 DSHEA.

While the purposes of the 1990

amendments will not be as clearly

advanced by such a course of action,

they will also not be contravened.

Implementation of the 1994 DSHEA will

move FDA forward toward its goal of

full implementation of the 1990

amendments. Moreover, while Congress

sought to rule out undue delay in

implementation of the 1990

amendments, a delay caused by

implementation of another law enacted

by Congress can hardly be considered

‘‘undue.’’

Finally, it is true that consumers face

an additional delay before dietary

supplements bear nutrition information

that is as consistent as possible, both in

content and presentation, with that on

other foods, and until there is full

compliance by dietary supplements

with the nutrient content claim

provisions of the act. These facts are

mitigated, however, by the fact that

there is information listing nutrients

and their levels on many dietary

supplements, and that many dietary

supplements do not bear nutrient

content claims.

Thus, having fully considered these

factors, the agency advises that it does

not intend to enforce the nutrition

labeling and nutrient content claims

regulations that apply to dietary

supplements until after December 31,

1996. The agency is at work developing

a proposal that implements the labeling

provisions of the 1994 DSHEA and

expects to publish it in the near future.

III. References

The following references have been

placed on display in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, and may be seen by interested

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

Monday through Friday.

1. Cordaro, John, President, Council for

Responsible Nutrition, letter to David A.

Kessler, Commissioner, FDA, December 7,

1994.

2. Shank, Fred, R., Director, Center for

Food Safety and Applied Nutrition, FDA,

letter to John B. Cordaro, President, Council

for Responsible Nutrition, January 30, 1995.

Dated: February 6, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–3294 Filed 2–8–95; 8:45 am]

BILLING CODE 4160–01–F

AGENCY FOR INTERNATIONAL

DEVELOPMENT

22 CFR Part 226

Administration of Assistance Awards

to U.S. Non-Governmental

Organizations

AGENCY: Agency for International

Development (USAID).

ACTION: Correction to interim final rule.

SUMMARY: This document contains a

correction to the interim final rule

which was published Thursday, January

19, 1995 (60 FR 3743). The rule relates

to the administration of assistance

awards to U.S. Non-Governmental

Organizations.

EFFECTIVE DATE: February 9, 1995.

FOR FURTHER INFORMATION CONTACT:

Diana Joan Esposito, Office of

Procurement, Procurement Policy and

Evaluation (M/OP/P), USAID, SA–14

Rm. 1600I, 320 21st Street, Washington,

DC 20523. Telephone 703 875–1529,

Fax 703–875–1243.

SUPPLEMENTARY INFORMATION:

Background

On January 19, 1995, USAID issued

an interim final rule at 22 CFR part 226

which implemented Office of

Management and Budget (OMB)

Circular A–110.

Need for Correction

As published, the preamble refers to

a change that was not implemented in

the interim final rule.

Correction of Publication

Accordingly, the publication on

January 19, 1995 of the interim final

rule, is corrected as follows:

Preamble [Corrected]

On page 3744, in the first column, at

the paragraph beginning ‘‘Section

226.22(l) is revised to provide * * *’’ is

corrected to read: ‘‘Section 226.22(l) is

revised to provide that USAID may

authorize recipients to retain all interest

earned in accordance with USAID’s

statutory authority.’’ The statement in

the preamble that interest earned will be

remitted to USAID has been deleted.