[Federal Register Volume 67, Number 35 (Thursday, February 21, 2002)]
[Notices]
[Pages 8030-8031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4210]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0063]


Agency Emergency Processing Request Under OMB Review; Consumer 
Surveys on Food and Dietary Supplement Labeling Issues

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information would consist of surveys to study consumers' understanding 
of labeling on conventional foods and dietary supplements as well as 
consumer practices, knowledge levels, and attitudes related to such 
labeling.

DATES: Submit written or electronic comments on the collection of 
information by March 25, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Office 
of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer 
for FDA. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The information is critical 
to the agency's mission of regulating food labeling and is needed prior 
to the expiration of the normal time periods for OMB clearance under 
the PRA regulations (5 CFR part 1320). The U.S. Constitution's first 
amendment impact on regulatory decisions on labeling necessitate prompt 
agency action to ensure that the constitutional rights of regulated 
entities are preserved. For this reason, the use of normal clearance 
procedures would be likely to prevent or disrupt this collection of 
information. Under section 903(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(C)), FDA is authorized to 
conduct research related to food labeling.
    FDA invites comments on: (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.

Consumer Surveys on Food and Dietary Supplement Labeling Issues

    FDA is requesting OMB approval of consumer surveys to help FDA's 
Center for Food Safety and Applied Nutrition formulate decisions and 
policies affecting the labeling of conventional foods and dietary 
supplements. Determining how consumers are likely to interpret various 
kinds of claims, disclaimers, warnings, caution statements, and notice 
statements that might appear in labeling is critical to agency 
decisionmaking under the act and the first amendment. It is often 
necessary to test actual or proposed labeling statements in realistic 
situations with typical consumers to determine what these label 
statements are communicating to consumers.
    FDA or its contractor will collect and use information gathered 
from telephone, mail, shopping mall intercept, and Internet surveys to 
evaluate how consumers understand and respond to existing label 
statements, label statements proposed by industry or consumers, and 
other label statements that are under consideration as part of FDA's 
policy development process. Potential respondents to the surveys will 
be individual consumers either randomly chosen to represent specified 
populations or randomly assigned to experimental treatment conditions 
to control for the effects of individual differences in the population 
on the interpretation of label statements. In all instances, FDA will 
strive to collect a representative sample of individuals from the 
overall population or from relevant population groups, as appropriate. 
FDA's general selection method will use stratification, with random 
sampling within the strata, to achieve representativeness for both 
overall populations and sensitive subpopulations, such as at-risk 
individuals or user segments. In the rare cases where geography is a 
limiting factor, FDA will use population-based cluster sampling to 
limit government expense while preserving the statistical properties of 
the sample.
    Respondents will provide background information and respond to 
package labels that contain the variations of label statements to be 
tested. Measures will include both self-reported comprehension and 
acceptance as well as direct behavioral measures of consumer use and 
understanding of the package labeling.
    FDA will use the information from the surveys in evaluating 
regulatory and policy options with respect to labeling. The agency 
often lacks empirical data about how consumers understand and respond 
to statements they might see in product labeling. The information 
gathered from such surveys can be used to test consumer comprehension 
and behavioral impact of various label statements and formats, and to 
identify the existing distribution of behavior, knowledge, and 
attitudes in the population that provides the context for understanding 
such statements. The surveys will help FDA assess consumer reactions to 
existing and proposed label statements.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                     Annual Frequency    Total Annual      Hours per
                        Type of Survey                          No. of Respondents     per Response        Responses       Response      Total Hours
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Mail questionnaire............................................      1,000                   1             1,000               1          1,000
Telephone survey..............................................      2,000                   1             2,000                .5        1,000
Internet or cable survey......................................      4,000                   1             4,000                .5        2,000

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Total.........................................................                                                                           4,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates are based on the expected number of respondents 
necessary to obtain a statistically significant representation of 
important consumer segments (e.g., users of relevant regulated 
products, at-risk population groups), and the number of labeling 
options that may need to be tested.

    Dated: February 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4210 Filed 2-20-02; 8:45 am]
BILLING CODE 4160-01-S