[Federal Register Volume 67, Number 246 (Monday, December 23, 2002)]
[Notices]
[Pages 78234-78235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0063]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; 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 the 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments on the collection of information by 
January 22, 2003.

ADDRESSES: 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: 
Stuart Shapiro, Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Consumer Surveys on Food and Dietary Supplement Labeling Issues--(OMB 
Control Number 0910-0492)--Extension

    FDA is requesting an extension of the 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 Federal Food, Drug, and 
Cosmetic 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, or 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, taking 
into account 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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                         No. of        Annual Frequency     Total Annual        Hours per
 Type of  Survey      Respondents        per Response        Responses           Response         Total  Hours
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Mail                           1,000                  1              1,000                1                1,000
 questionnaire
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Telephone survey               2,000                  1              2,000                 .5              1,000
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Internet or mail               4,000                  1              4,000                 .5              2,000
 intercept survey
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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 assume that as many as one mail survey project, one 
telephone survey project, and two Internet or mall intercept survey 
projects may be done on an annual basis. Estimates are based on the 
expected number of respondents necessary to obtain a statistically 
significant representation of important

[[Page 78235]]

consumer segments (e.g., users of relevant regulated products or at-
risk population groups) and the number of labeling options that may 
need to be tested.

    Dated: December 16, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32160 Filed 12-20-02; 8:45 am]
BILLING CODE 4160-01-S