18774 Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices

proposed collection of information; (c)

ways to enhance the quality, utility and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Projects: Comparative

Analysis of Caregiving Patterns for

Disabled Elders with Long-Term

Insurance—New—The Assistant

Secretary for Planning and Evaluation

(ASPE) is participating in a survey

which will compare the usage of formal

and informal caregiving services

between the disabled elderly with longterm care insurance policies and the

disabled elderly in the general

population. Respondents: Individuals or

households—Burden Information for the

Home Care Instrument—Number of

respondents: 700; Average time per

response: 1.5 hours; Burden for Home

Care Instrument: 1,050 hours—Burden

Information for the Nursing Home

Instrument—Number of respondents:

350; Average time per response: 1.5

hours; Burden for Nursing Home

Instrument: 525 hours—Burden

Information for the Informal Caregiver

Telephone Survey: Number of

respondents: 700; Average time per

response: 20 minutes; Burden for

Informal Caregiver Telephone Survey:

233 hours—Burden Information for the

Policy Holder Screening Instrument—

Number of respondents: 1500; Average

time per response: 7 minutes; Burden

for Policy Holder Screening Instrument:

175 hours—Total Burden: 1983. hours.

Send comments to Cynthia Agens

Bauer, OS Reports Clearance Officer,

Room 503H, Humphrey Building, 200

Independence Avenue SW.,

Washington, DC 20201. Written

comments should be received within 60

days of this notice.

Dennis P. Williams,

Deputy Assistant Secretary, Budget.

[FR Doc. 97–9883 Filed 4–16–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0086]

Food Labeling: Draft Guidance on Diet

Plans

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing draft

guidance to the marketers of food plans

that are represented as a total diet and

that have been formulated so that the

dietary intake of various nutrients by

those who participate in the plan is

controlled. The agency hopes that this

guidance, if finalized, will help to

minimize any problems that may

develop should firms proceed to market

with these plans.

DATES: Written comments by July 1,

1997.

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:

Christine J. Lewis, Center for Food

Safety and Applied Nutrition (HFS–

451), Food and Drug Administration,

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

202–205–4168.

SUPPLEMENTARY INFORMATION: FDA is

aware that there is interest in the food

industry in offering a food plan in

which most of the food in the diet is

purchased through the plan. The foods

sold in these plans would be formulated

so that the total diet of those who

comply with the plan provides

controlled levels of such nutrients as fat,

saturated fat, cholesterol, and sodium.

FDA applauds innovative efforts to

help consumers maintain healthy

dietary practices. The agency notes that

one of the main purposes of the

Nutrition Labeling and Education Act

(the 1990 amendments) was to

encourage such practices, and, thus,

such plans can be seen, at least

conceptually, as consistent with that

statute. The agency also recognizes that

diets can be structured to be useful in

the management of certain chronic

conditions. The agency has no desire to

do anything that would discourage

efforts to achieve these innovative goals.

While these plans have the potential

to be useful, they also have the potential

to create a number of significant

concerns under the Federal Food, Drug,

and Cosmetic Act (the act). The

purveyors of such programs will need to

take care to ensure that, in presenting

these programs to the American

consumer, they do not run afoul of any

of the provisions of the act. Given this

need for care, FDA has concluded that

it would be useful to companies that

either have decided, or who may decide,

to offer such programs, and that it

would help to prevent regulatory

problems, if the agency outlined the

statutory concerns that it can foresee

could be created by these programs. The

agency is also setting out its thoughts on

these concerns. The agency would

welcome comments on these

preliminary views from interested

persons. The major concerns that FDA

has at least preliminarily identified

follow.

A. Health Claims

Under section 403(r)(1)(B) of the act

(21 U.S.C. 343(r)(1)(B)) and 21 CFR

101.14(a)(1), a health claim is:

* * * any claim made on the label or in

labeling of a food, including a dietary

supplement, that expressly or by implication,

including ‘‘third party’’ references, written

statements (e.g., a brand name including a

term such as ‘‘heart’’), symbols (e.g., a heart

symbol), or vignettes, characterizes the

relationship of any substance to a disease or

health-related condition. Implied health

claims include those statements, symbols,

vignettes, or other forms of communication

that suggest, within the context in which

they are presented, that a relationship exists

between the presence or level of a substance

in the food and a disease or health-related

condition.

Thus, for a claim to be a health claim,

one of the essential elements is that it

be, expressly or by implication, about a

particular substance and not about the

total diet. The agency points out that, in

adopting the health claim final rule, it

said that:

* * * phrases on labeling such as ‘‘eat a

variety of foods to lllll,’’ ‘‘eat a variety

of fresh fruits and vegetables to lllll,’’

or ‘‘follow the food pyramid to lllll,’’

without any reference, either express or

implied, to a substance that might be in the

foods, would not satisfy this element. The

latter types of claims would not be subject to

regulation as health claims.

(58 FR 2478 at 2480, January 6, 1993).

The agency thus recognizes that claims

about the effects of a diet plan,

depending on how the claim is made,

would arguably not be subject to

regulation as a health claim.

FDA advises that it will carefully

scrutinize any claims that are made for

a diet plan to determine whether they

are health claims. For example, a claim

that the diet has been designed to

provide high levels of vitamin A to

reduce the risk of cancer would be a

health claim because the statement links

the two basic components of a health

claim, a food substance and a disease or

health-related condition. Any claims

that are made that are health claims

must be made in accordance with FDA’s

authorizing regulations, or they will

misbrand the products under section

403(r)(1)(B) of the act.

B. Nutrient Content Claims

A claim that expressly or by

implication characterizes the level of a

nutrient in a food is a nutrient content
Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices 18775

claim (21 CFR 101.13(b)). Such claims

must be made in accordance with FDA’s

regulations defining the claim (section

403(r)(1)(A) of the act). FDA cautions

that care must be taken in how claims

are made about diet plans to ensure that

the foods in the plan are not represented

as having lower, or higher, nutrient

levels than they actually contain. For

example, a claim that a plan has been

formulated to provide low fat foods, as

compared to a claim that the plan has

been formulated to provide a diet that

is low in fat, would imply that the foods

in the plan are low fat. Thus, every food

in the plan would have to meet the

definition for ‘‘low fat’’ in 21 CFR

101.62(b)(2) to avoid being misbranded.

C. Foods for Special Dietary Use

Foods that purport or are represented

as to be used to supply a special dietary

need that exists by reason of a physical,

physiological, pathological, or other

condition are foods for special dietary

use under section 411(c)(3)(A) of the act

(21 U.S.C. 350(c)(3)(A)). There is a

substantial possibility that a diet plan

may be represented in a way that

subjects the foods in the plan to

regulation as foods for special dietary

use. For example, a claim that the diet

plan provides a modified diet,

formulated for those who must restrict

their sodium intake, would present the

foods in the plan as foods for special

dietary use. Under section 403(j) of the

act, FDA has authority to require, on the

label of such foods, information

concerning their dietary properties that

it finds necessary to fully inform

purchasers about their value for special

dietary use.

FDA advises that, if these diet plans

appear on the market, FDA will

carefully scrutinize the labeling and

advertising for such plans to see

whether it is necessary for the agency to

invoke its authority under section 403(j)

of the act.

D. False or Misleading Claims

Under section 403(a)(1) of the act,

food is deemed to be misbranded if its

labeling is false or misleading in any

particular. FDA would expect that any

firm that markets a diet plan will have

evidence about the effects of following

the plan, and that that evidence would

establish that any claims that are made

about that plan and the food that makes

up the plan are truthful and not

misleading. FDA also would expect that

the firm will share that evidence with

FDA. For example, if there is a claim

that a plan has been clinically proven to

have a certain effect, FDA will expect

that at least one properly designed

clinical study has been done with the

particular diet plan, that the results of

the study or studies fully support the

claims that are made, and that the

results of the studies will be shared with

FDA.

E. Drug Claims

FDA is concerned that claims made

about a diet plan could evidence an

intent that the plan is to be used as a

drug. Under section 201(g)(1)(B) of the

act (21 U.S.C. 321(g)(1)(B)), articles

intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of

disease in humans or other animals are

deemed to be drugs. Thus, for example,

a claim that a diet plan is a ‘‘therapeutic

diet’’ could subject the plan to

regulation under the provisions of the

act that apply to drugs and, in

particular, new drugs. FDA therefore

cautions that manufacturers who decide

to market diet plans with claims that

subject the plans to regulation as drugs

must be prepared to satisfy the

applicable statutory requirements.

F. Meat and Poultry Products

FDA advises that diet plans that

include meat or poultry products are

also subject to regulation by the Food

Safety and Inspection Service of the

U.S. Department of Agriculture, under

the Meat Inspection Act and the Poultry

Products Inspection Act.

G. Conclusion

In conclusion, FDA advises that this

document’s discussion of the regulatory

requirements that apply to diet plans is

not intended to discourage such plans.

It is intended to ensure that

manufacturers who decide to go forward

with such plans do so with an

understanding of the act and FDA’s

regulations. The agency hopes that, by

laying out its concerns and

expectations, it will help to minimize

the problems that will develop should

firms proceed to market with these

plans and thus to maximize the

likelihood that consumers will fully

appreciate the benefits that they offer.

This draft guidance represents the

agency’s current thinking on food plans

that are marketed as a total diet. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, on or before

July 1, 1997 submit to the Dockets

Management Branch (address above)

written comments on this draft

guidance. 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.

Dated: April 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–9876 Filed 4–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0152]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; OXILANTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

OXILANTM and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and