[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Page 63801-63802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

                                                     Table 1.--Estimated Annual Reporting Burden \1\
                                                                       Annual Frequency
                 Type of Survey                   No. of Respondents     per Response     Total Annual Responses  Hours per Response      Total Hours
Internet Survey                                         2,520                   1               2,520                        .4             1,004
Total                                             ..................  ..................  ......................  ..................        1,004
\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]