[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6079-6081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1522]


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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://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