[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Page 63799-63801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0507]

Agency Emergency Processing Request Under OMB Review; 
Experimental Study of Trans Fat Claims on Foods

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 trans fat claims on foods to 
evaluate the effects of various possible disclosure requirements to 
help consumers

[[Page 63800]]

understand and apply trans fat claims that they might see on food 
products. The study is intended to estimate the communication 
effectiveness of these disclosure requirements in realistic label usage 
situations for a range of products that may bear trans fat claims.

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 needed 
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 
possible accompanying disclosure requirements for trans fat nutrient 
content claims. Delays in resolving this issue will undercut the 
effectiveness of these 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 
    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.

An Experimental Study of Trans Fat Claims on Foods

    FDA is requesting OMB approval of an experimental study of trans 
fat claims on food products to help FDA's Center for Food Safety and 
Applied Nutrition formulate decisions and policies affecting labeling 
requirements for trans fat claims on foods. 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.'' The 
document announced that the agency was seeking information about 
possible disclosure requirements to accompany nutrient content claims 
about trans fatty acids to help consumers make heart-healthy food 
choices. The proposed study is intended to evaluate the ability of 
several such disclosure requirements to enable consumer heart-healthy 
food choices in order to provide empirical support for possible policy 
decisions about the need for such disclosures 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 claims on products with differing 
fatty acid profiles and possible disclosure requirements with those 
claims. The distinctive features of Internet panel and shopping mall 
methodologies for the purpose of this 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 disclosure statements label statements while controlling for 
individual differences. 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 also 
    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 1 of the 126 experimental conditions consisting of 
fully crossing 7 footnote disclosure conditions, 3 product types, 3 
fatty acid profiles and 2 prior knowledge conditions.
    Respondents will provide background information and respond to 
package labels that contain the variations of label statements to be 
tested. Key measures for the study are product perception questions 
about the labeled food product (expected health benefits, perceived 
nutrition ratings).
    FDA will use the information from the study to evaluate regulatory 
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 
by the agency to assess likely consumer responses to various disclosure 
requirements for nutrient content claims.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
 Type of                        Annual Frequency        Total Annual
  Survey   No. of Respondents     per Response           Responses        Hours per Response      Total Hours
Internet       2,520                   1                 2,520                     .4             1,008
Total      ..................  ..................  .....................  ..................      1,008
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

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    We anticipate that all statistical tests will collapse across the 
three product categories. We estimate that 20 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 

    Dated: November 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28194 Filed 11-7-03; 8:45 am]