Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 71819

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0486]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Health Claims on Food 

Packages

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

an experimental study to assess 

consumer responses to health claims on 

labels of conventional foods. Although 

the focus of the study is on consumer 

responses to health claims, the study 

also looks at their responses to other 

health messages to help enhance the 

external validity of the findings.

DATES: Submit written or electronic 

comments on the collection of 

information by February 8, 2005.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Experimental Study of Health Claims 

on Food Packages

The authority for FDA to collect the 

information derives from the FDA 

Commissioner’s authority, as specified 

in section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 393(d)(2)).

To help consumers reduce their risk 

of disease and improve their health by 

making sound dietary decisions, in the 

Federal Register of November 25, 2003 

(68 FR 66040), FDA issued an advance 

notice of proposed rulemaking 

(ANPRM) to request comments on 

various issues related to health claims 

on conventional food and dietary 

supplement labels. One of the issues 

that FDA has raised in the ANPRM 

relates to whether the wording of a 

health claim needs to refer to the 

substance (a component of food, e.g., 

nutrient) that is the basis of the claim. 

(Hereinafter, the term ‘‘health claim’’

will refer only to a claim meeting the 

standard of significant scientific 

agreement or, put another way, an FDAauthorized claim.) For instance, in the 

example of the calcium-osteoporosis 

claim (‘‘Calcium may reduce the risk of 

osteoporosis’’), FDA requires that the 

substance that is the basis of the claim 

(i.e., calcium) be included in the 

wording of the claim (21 CFR 101.72). 

The requirement of including the 

substance in a health claim was 

motivated by FDA’s experience that 

most substances that are the subject of 

an authorized health claim are 

substances that can be found in a 

number of foods (e.g., calcium) or 

spread throughout the food supply (e.g., 

saturated fat). Therefore, FDA has 

provided for health claims that include 

reference to the common substance to 

assist consumers in their understanding 

of the nature of the diet-health 

relationship, and more importantly so 

that consumers recognize that they can 

construct healthy diets by using a 

variety of foods that contain the 

substance.

FDA requests comments on the 

usefulness of statements that expressly 

include the particular component of 

food (e.g., nutrient) that is the basis for 

the claim (e.g., ‘‘Calcium-rich foods, 

such as yogurt, may reduce the risk of 

osteoporosis’’) versus ‘‘food-specific’’

claims that do not include the food 

component (e.g., ‘‘Yogurt may reduce 

the risk of osteoporosis’’ (68 FR 66040 

at 66047). How consumers respond to 

the two kinds of statements can suggest 

how the explicit mention of a food 

component in a claim affects dietary 

choices, which in turn informs any 

policy initiative(s) that FDA may 

undertake in the future to provide 

information to consumers to help them 

make informed food choices. FDA, 

however, lacks sufficient empirical 

evidence to understand how consumers 

are likely to react to the two different 

kinds of health claims, has not received 

any such evidence in comments on the 

ANPRM, and is not aware of any 

existent evidence.

The purpose of the proposed 

collection of information is to help 

enhance FDA’s understanding of 

consumer responses to health claims 

and inform any policy initiative(s) that 

FDA may undertake in the future to 

provide consumers information to help 

them make informed food choices. The 

information will be used to assess what 

differences, if any, the inclusion of the 

food component in a health claim makes 

in consumer recognition of the food 

component underlying a diet-disease 

relationship; consumer recognition that, 

in addition to the food product that 

carries the claim, there are other foods 

from which they can obtain the food 

component; and consumer perceptions 

of, and attitudes toward, a food.

The proposed collection of 

information is a controlled randomized 

experimental study. The study will use 

a 6 x 3 x 2 within-subjects design (6 

front-panel health-claims/health 

messages x 3 diet-disease relationships 

x 2 prior knowledge) with participants 

randomly assigned to experimental 

conditions. The term ‘‘health message’’

refers to nutrient content claims, 

71820 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 

structure/function claims, and dietary 

guidance statements. Prior knowledge of 

foods, components of food (e.g., 

nutrients), and risks will be measured 

and not manipulated; prior knowledge 

will serve as covariates in the analysis. 

There are two independent variables, 

type of front-panel health-claim/health 

message and type of diet-disease 

relationship. Health-claim/healthmessage conditions include the 

following items:

1. A ‘‘food-specific’’ health claim, e.g., 

‘‘Yogurt may reduce the risk of 

osteoporosis;’’

2. A ‘‘nutrient-specific’’ health claim, 

e.g., ‘‘Calcium-rich foods, such as 

yogurt, may reduce the risk of 

osteoporosis;’’

3. A nutrient content claim, e.g., ‘‘A 

good source of calcium;’’

4. A structure/function claim, e.g., 

‘‘Helps promote bone health;’’

5. A dietary guidance statement, e.g., 

‘‘Dairy products may reduce the risk of 

osteoporosis;’’ and

6. No health claim/health message.

Claims on food labels must be truthful 

and nonmisleading as required under 

sections 403(a)(1) and 201(n) of the act.

Health messages other than the two 

health claims are included solely for 

methodological purposes. The ‘‘no 

health claim/health message’’ condition 

is included to examine what consumers 

already know about nutrients or food 

sources, even when neither of them is 

mentioned on a label. Health messages 

are frequently found on food product 

packages and provide consumers 

various amounts of information about 

food products and their relationships to 

health. Whether consumer responses to 

these health messages are consistent 

with their responses to the two health 

claims will help generalize the findings. 

An examination of response differences 

between health messages that mention 

(e.g., a nutrient content claim) or do not 

mention (e.g., a structure/function 

claim) a nutrient or food source, and 

between these health messages and the 

two health claims in question can help 

validate any effects observed between 

the two health claims. This validation 

will in turn enhance the external 

validity of the findings between the 

‘‘food-specific’’ and ‘‘nutrient-specific’’

health claims. We emphasize, however, 

that the inclusion of examples of 

structure/function claims, nutrient 

content claims, and dietary guidance 

statements does not in any way suggest 

or imply any new, impending, or change 

in regulatory actions regarding these 

messages.

The study proposes to include the 

following three examples of diet-disease 

relationships: (1) Yogurt-calciumosteoporosis, (2) orange juicepotassium-hypertension, and (3) olive 

oil-monounsaturated fatty acid-heart 

disease. The study includes these three 

relationships solely for the purpose of 

covering varying levels of consumer 

familiarity with the foods, nutrients, 

and risks, so the study findings may be 

more useful than if only one dietdisease relationship were examined. We 

reiterate that the choices do not in any 

way suggest or imply any new, 

impending, or change in regulatory 

actions regarding the use of these health 

claims/health messages or the scientific 

basis of these relationships. In total, the 

study will examine 18 experimental 

conditions (6 front-panel health-claim/

health message conditions x 3 dietdisease relationships), each condition is 

a combination of a front-panel condition 

and a diet-disease relationship.

The planned universe of this 

experimental study is 

noninstitutionalized adults 18 and older 

who reside in households with 

telephones in the contiguous United 

States and within a 10-mile radius of 

each of six selected mall interview 

facilities in various locations. The study 

will use a two-phase data collection 

methodology. Phase 1 is a random-digit 

dialing telephone interview, using the 

GENESYS sampling system, to recruit 

participants and to ask about prior 

knowledge as well as demographic 

characteristics. Phase 2 is a computerassisted, self-administered interview 

(CASAI) to elicit responses to 

experimental conditions. A contractor 

will administer the CASAI at mall 

interview facilities separately from the 

telephone interview and on a different 

date after the telephone interview of the 

same participants. An understanding of 

the influences of prior knowledge on 

consumer responses will help reveal 

factors associated with differential 

responses and extend the usefulness of 

the findings to similar messages about 

other diet-disease relationships. It is 

necessary to collect prior knowledge 

information before and separately from 

collecting responses to health claims 

and health messages to minimize 

demand and confounding effects 

between prior knowledge and message 

responses. Hence, the study proposes to 

obtain prior knowledge in the telephone 

interview. To minimize unnecessary 

confounding by external factors, it is 

essential that all participants are able to 

look at the stimuli (i.e., labels) and 

stimuli are presented consistently and 

uniformly to all participants. The 

CASAI offers the advantage of 

consistent and uniform presentation of 

label images.

Target sample size of the study is 

1,060 participants who complete both 

the telephone interview and the CASAI. 

Participants will be randomly assigned 

to the same 2 of the 18 experimental 

conditions in both the telephone 

interview and the CASAI. Each of the 

two conditions includes a different dietdisease relationship and a different 

front-panel condition. Presentation 

order of the conditions will be counterbalanced within the sample. All front 

panels will be full-color and patterned 

after existing labels in the market. Both 

the front and back panels of a label will 

be available during the CASAI. Back 

panel information (e.g., nutrient 

contents) will be kept constant between 

front-panel conditions for a given food 

product.

The following key information is to be 

collected:

• Responses to the experimental 

conditions such as perceived health 

benefits, substances related to the 

benefits, other food sources that may 

offer the same benefits;

• Prior knowledge of diet-disease 

relationships;

• Food purchase and consumption 

experience; 

• Interest in food and food purchase 

decisions;

• Use of dietary supplements, special 

diets, and health status; and

• Demographic characteristics.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity 

No. of

Respondents

Annual

Frequency per 

Response

Total Annual

Responses

Hours

per Response Total Hours 

Pretest 27 1 27 2.4 65

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Notices 71821

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Activity 

No. of

Respondents

Annual

Frequency per 

Response

Total Annual

Responses

Hours

per Response Total Hours 

Screener 4,500 1 4,500 0.02 90

Interview 1,060 1 1,060 2.4 2,544

Total 2,699

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA’s 

experience with previous consumer 

studies. Prior to the administration of 

the experiment, the agency plans to 

conduct a pretest of the final 

questionnaires to minimize potential 

problems in administration of the 

interviews. The pretest will be 

conducted in up to three waves, each 

with nine participants. The agency will 

use a screener to select an eligible adult 

in each household to participate in the 

study. Each pretest, as well as actual 

interview, is expected to last no more 

than a total of 2.4 hours (10 minutes for 

the telephone interview, 15 minutes for 

the CASAI, and 2 hours for traveling 

time to and from the CASAI location).

The anticipated sample size per 

condition is approximately 120. This 

sample size is expected to identify small 

to medium effects with a power of 0.8 

and at the .05 significance level.

Dated: December 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27119 Filed 12–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0478]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information.’’ This guidance document 

describes a means by which an 

implantable radiofrequency transponder 

system for patient identification and 

health information may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

final rule to classify the implantable 

radiofrequency transponder system for 

patient identification and health 

information into class II (special 

controls). This guidance document is 

immediately in effect as the special 

control for the device, but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information’’

to the Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance.

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT: Gail 

Gantt, Center for Devices and 

Radiological Health (HFZ–480), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1287.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying the implantable 

radiofrequency transponder system for 

patient identification and health 

information into class II (special 

controls) under section 513(f)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for the Implantable 

Radiofrequency Transponder System for 

Patient Identification and Health 

Information device.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act (21 U.S.C. 360(k)) for 

a device that has not previously been 

classified may, within 30 days after 

receiving an order classifying the device 

in class III under section 513(f)(1) of the 

act, request FDA to classify the device 

under the criteria set forth in section 

513(a)(1) of the act. FDA shall, within 

60 days of receiving such a request, 

classify the device by written order. 

This classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document.