[Federal Register: February 6, 2006 (Volume 71, Number 24)]
[Notices]
[Page 6079-6081]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe06-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0036]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Possible Footnotes and Cueing
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 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 reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on
[[Page 6080]]
an experimental study of possible footnotes and cueing schemes intended
to help consumers understand and apply quantitative trans fat
information they might see on the Nutrition Facts Panel of a food
product. The experimental study will estimate the communication
effectiveness of quantitative trans fat information in terms of its
ability to help consumers make heart-healthy product decisions in
realistic label usage situations for a range of products.
DATES: Submit written or electronic comments on the collection of
information by April 7, 2006.
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.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(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: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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 reinstatement 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 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 Cueing Schemes to Help
Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition
Facts Panel (OMB Control Number 0910-0532)--Reinstatement
FDA is requesting OMB approval of an experimental study of possible
footnotes and cueing schemes intended to help consumers interpret
quantitative trans fat information on the Nutrition Facts Panel of a
food product. The purpose of the experimental study is 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 41434), FDA issued
a final rule requiring disclosure on the Nutrition Facts Panel of
quantitative trans fat information on a separate line without any
accompanying footnote. At the same time, the agency issued 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,'' (68 FR 41507) which requested comments about possible
footnotes to help consumers better understand trans fat declarations on
the product label. The agency sought comments about whether it should
consider requiring statements about trans fat, either alone or in
combination with saturated fat and cholesterol, as a footnote on the
Nutrition Facts Panel to enhance consumers' understanding about such
cholesterol-raising lipids and how to use information on the label to
make healthy food choices. Comments received in response to the notice
contained suggested footnotes and cueing schemes. The proposed
experimental study will evaluate the ability of several possible
footnotes and cueing schemes to help consumers make heart-healthy food
choices. The results of the experimental study will 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 use information gathered from Internet
panel samples to evaluate how consumers understand and respond to
possible footnote and cueing schemes. The distinctive features of
Internet panels for the purpose of the experimental 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 cueing 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. The study will be conducted from a sample drawn from a large,
nationally representative consumer panel with 800,000 households. The
sample size and population pool are adequate to ensure that results can
be generalized.
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 derived from
fully crossing 7 possible footnotes/cueing schemes, 3 product types,
and 2 prior knowledge conditions.
FDA will use the information from the experimental 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
experimental study will be used to estimate consumer comprehension and
the behavioral impact of various footnotes and cueing schemes intended
to help consumers better understand quantitative trans fat information.
The experimental study data will be collected using participants of
an Internet panel of approximately 600,000 people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this collection of information as
follows:
[[Page 6081]]
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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Internet survey 3,240 1 3,240 .25 810
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Total 810
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed in this document.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1522 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S