[Federal Register: February 21, 2002 (Volume 67, Number 35)]
[Notices]
[Page 8030-8031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe02-72]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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