[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Notices]
[Page 63801-63802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no03-46]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0506]
Agency Emergency Processing Request Under Office of Management
and Budget Review; Experimental Study of Possible Footnotes and Cuing
Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure
on the Nutrition Facts Panel
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 is an experimental study of possible footnotes and cuing
schemes to help consumers understand and apply quantitative trans fat
information they might see on the Nutrition Facts panel (NFP) of a food
product. The study is intended to estimate the communication
effectiveness of these disclosure requirements in terms of the ability
to help consumers make heart-healthy product decisions in realistic
label usage situations for a range of products that will disclose
quantitative trans fat information.
DATES: Fax written comments on the collection of information by
December 10, 2003. FDA is requesting approval of this emergency
processing by December 10, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
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: FDA is requesting emergency processing of
this proposed collection of information under section 3507(j) of the
PRA 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. Consumer education activities are
necessary to ensure the successful implementation of the regulation
mandating disclosure of the trans fat amount on food label. Before
these activities can be completed, it is necessary to resolve questions
about accompanying footnotes and cuing schemes. Delays in resolving
this issue will undercut the effectiveness of these education
activities and reduce the value of mandatory trans fat disclosure. For
this reason, the use of normal clearance procedures would be likely to
prevent or disrupt this 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 Possible Footnotes and Cuing Schemes to Help
Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition
Facts Panel (NFP)
FDA is requesting OMB approval of an experimental study of possible
footnotes and cuing schemes to help consumers interpret quantitative
trans fat disclosure on the NFP to help FDA's Center for Food Safety
and Applied Nutrition formulate decisions and policies affecting
labeling requirements for trans fat disclosure. In the Federal Register
of July 11, 2003 (68 FR 41507), FDA published an advance notice of
proposed rulemaking entitled ``Food Labeling: Trans Fatty Acids in
Nutrition Labeling; Consumer Research to Consider Nutrient Content and
Health Claims and Possible Footnote or Disclosure Statements,'' stating
that the agency is seeking information about whether it should consider
statements about trans fat, either alone or in combination with
saturated fat and cholesterol, as a footnote in the Nutrition Facts
panel to enhance consumers' understanding about such cholesterol-
raising lipids and how to use disclosed information on the label to
make healthy food choices. The proposed study is intended to evaluate
the ability of several possible footnotes and cuing schemes to enable
consumer heart-healthy food choices in order to provide empirical
support for possible policy decisions about the need for such
requirements and the appropriate form they should take.
FDA or its contractor will collect and use information gathered
from shopping mall intercept and Internet panel samples to evaluate how
consumers understand and respond to possible footnotes and cuing
schemes. The distinctive features of internet panel and shopping mall
methodologies for the purpose of the study are that they allow for
controlled visual presentation of study materials, experimental
manipulation of study materials, and the random assignment of subjects
to condition. Experimental manipulation of labels and random assignment
to condition makes it possible to estimate the effects of the various
possible footnotes and cuing schemes while controlling for individual
differences between subjects. Random assignment ensures that mean
differences between conditions can be tested using well-known
techniques such as analysis of variance or regression analysis to yield
statistically valid estimates of effect size. By implementing the study
in a large nationally representative consumer panel with 600,000
households or in a geographically diverse set of shopping malls, the
generalizability of the findings to a large fraction of the general
population is ensured.
Participants will be adults, age 18 and older, who are recruited
for a study about foods and food labels. Each participant will be
randomly assigned to one of the 42 experimental conditions consisting
of fully crossing seven
[[Page 63802]]
possible footnotes/cuing schemes, 3 product types, and 2 prior
knowledge conditions.
FDA will use the information from the study to evaluate regulatory
and policy options. The agency often lacks empirical data about how
consumers understand and respond to statements they might see in
product labeling. The information gathered from this study can be used
to estimate consumer comprehension and behavioral impact of various
footnotes and cuing schemes intended to enable better understanding of
quantitative trans fat information.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual Frequency
Type of Survey No. of Respondents per Response Total Annual Responses Hours per Response Total Hours
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Internet Survey 2,520 1 2,520 .4 1,004
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Total .................. .................. ...................... .................. 1,004
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that 60 subjects per cell, 2,520 subjects in all, will
provide adequate power to identify small to medium size effects (i.e.,
r =.15 to .30) for all main effects and first order interactions with
power = (1 - beta) well in excess of .80 at the .05 significance level.
Power for second and third order interactions will necessarily be
smaller, but even for third order interactions, statistical power will
be =.80 at the .10 significance level.
Dated: November 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28195 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S