[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Pages 61892-61893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25079]



[[Page 61892]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0063]


Agency Information Collection Activities; Proposed Collection; 
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 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on surveys to study consumers' 
understanding of specific label statements for conventional foods and 
dietary supplements and the impact of such labeling on consumer 
practices, knowledge levels, and attitudes. In the Federal Register of 
July 8, 2002 (67 FR 45128), FDA published a notice announcing OMB's 
approval of this collection of information (OMB control number 0910-
0492). Because this was an emergency approval that will expire on 
December 31, 2002, FDA in this notice is following the normal PRA 
clearance procedures by issuing this notice.

DATES: Submit written or electronic comments on the collection of 
information by December 2, 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 Dockets 
Management Branch (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 Schlosburg, Office of 
Information Resources Management (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, including 
each proposed extension of an existing 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: (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 (OMB 
Control Number 910-0492)--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:

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                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                           Annual
         Type of Survey                 No. of         Frequency per     Total Annual       Hours per      Total
                                  [chyph]Respondents  [chyph]Response  [chyph]Responses  [chyph]Response   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 mall intercept               4,000                   1           4,000               .5       2,000
 survey
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 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: September 24, 2002..
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25079 Filed 10-1-02; 8:45 am]
BILLING CODE 4160-01-S