Experimental Studies of Nutrition Symbols on Food Packages

Forms and Documents

Document Name	Status
0655 83-C justification 5-18-2010.doc Justification for No Material/Nonsubstantive Change	2010-05-18
FOP Study - 0910-0655 - Memo to OMB May 17 2010.pdf Supplementary Document	2010-05-18
symbol STUDY 1 appendices 021210 clean.doc Supplementary Document	2010-02-12
symbol experiment Study 1 eye tracking invitation Appendix E.doc Supplementary Document	2009-12-09
symbol experiment Study 1 reminder appendix K.doc Supplementary Document	2009-12-09
symbol experiment study 1 symbols.doc Supplementary Document	2009-12-09
symbol STUDY 2 appendices 021210 clean.doc Supplementary Document	2010-02-12
symbol experiment study 2 pretest and survey invitation (Appendix F).doc Supplementary Document	2009-12-09
symbol experiment study 2 reminder email (Appendix L).doc Supplementary Document	2009-12-09
symbol STUDY 2 appendices 021210 clean.doc Supplementary Document	2010-02-12
symbol experiment study 2 reminder email (Appendix L).doc Supplementary Document	2009-12-09
symbol experiment study 2 pretest and survey invitation (Appendix F).doc Supplementary Document	2009-12-09
symbol STUDY 1 appendices 021210 clean.doc Supplementary Document	2010-02-12
symbol experiment Study 1 eye tracking invitation Appendix E.doc Supplementary Document	2009-12-09
symbol experiment Study 1 reminder appendix K.doc Supplementary Document	2009-12-09
symbol experiment study 1 symbols.doc Supplementary Document	2009-12-09
FDA Nutrition Symbols ICR SS A 011910 rev'd to include added burden hours 5-18-2010.doc Supporting Statement A	2010-05-18

IC Document Collections

IC ID	Document Title	Status
193020	Pretest invitation, Pretest, Survey invitation, Survey (Study 1) Other-cognitive interview screener	New
191570	Cognitive Interview, Pretest, and Survey (Study 2) Other-cognitive interview screener	Modified
191569	Cognitive Interview, Pretest, and Survey (Study 1) Other-cognitive interview screener	Modified

ICR Details

OMB Control No: 0910-0655	ICR Reference No: 201005-0910-012
Status: Historical Active	Previous ICR Reference No: 201002-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Studies of Nutrition Symbols on Food Packages
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/24/2010
	Date Received in OIRA: 05/24/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	01/31/2013	01/31/2013
Responses	52,528	0	42,128
Time Burden (Hours)	4,523	0	3,613
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Cognitive Interview, Pretest, and Survey (Study 1)
Cognitive Interview, Pretest, and Survey (Study 2)
Pretest invitation, Pretest, Survey invitation, Survey (Study 1)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	52,528	42,128	0	10,400	0	0
Annual Time Burden (Hours)	4,523	3,613	0	910	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $600,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 05/24/2010

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