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.
table that charts list comparision
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)