[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Notices]
[Page 63799-63801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no03-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
information.
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
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 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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Type of Annual Frequency Total Annual
Survey No. of Respondents per Response Responses Hours per Response Total Hours
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Internet 2,520 1 2,520 .4 1,008
survey
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Total .................. .................. ..................... .................. 1,008
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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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
level.
Dated: November 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28194 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S