FDA shall submit
the final versions of the study instruments and related material
after consideration of relevant additional information (including
cognitive testing and pre-testing results) for OMB approval before
initiating the full study. As stated in the supporting statement,
the study design is appropriate for the purpose of the study, but
in describing the results, FDA will clearly acknowledge that the
data does not provide nationally representative estimates of
consumer attitudes, knowledge, behaviors, etc.
Inventory as of this Action
Requested
Previously Approved
01/31/2013
36 Months From Approved
42,128
0
0
3,613
0
0
0
0
0
With the increased interest in
healthier foods, U.S. food processors and retailers have been
adding nutrition information, particularly nutrition quality icons
(e.g., Smart Choices Program) and selected nutrient level
disclosures (e.g., Guideline Daily Amounts), in addition to other
labeling statements (e.g., nutrient content claims), to the front
of packages (FOP). This type of nutrition labeling schemes is seen
in other countries (e.g., United Kingdom, Sweden, and Australia) as
well. FDA believes the proliferation of these nutrition labeling
schemes in the domestic market and the various nutrition criteria
they use necessitate the agency's exercising the responsibility
that Congress gave it to, among other things, carefully examine
consumer understanding and use of the various schemes to evaluate
how well they impart useful nutrition information to U.S. consumers
and whether certain schemes or types of schemes are better ways to
impart the information. The agency held a public hearing in
September 2007 and completed a focus group study in April 2008 to
obtain comments and information about many consumer issues related
to FOP nutrition labeling schemes. We are also aware of recent
consumer research conducted by foreign governments,
non-governmental organizations and academics. The existing
information, however, does not fill many of the gaps in our
understanding of the impacts of FOP nutrition labeling schemes on
U.S. consumers. Most importantly, there is a lack of publicly
available quantitative consumer research on the relative
effectiveness of existing and alternative labeling schemes in
helping U.S. consumers make better dietary decisions. Therefore,
the agency is proposing to conduct two experimental studies to
assess quantitatively consumer reactions to various FOP nutrition
labeling schemes. The studies will be a critical input to ensure
the usefulness of FOP nutrition information provided to U.S.
consumers.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
symbol STUDY 2 appendices 011910.doc
FDA Nutrition Symbols ICR SS B 011910.docx
Cognitive Interview, Pretest, and Survey (Study 2)