Study; Consumer Responses to Nutrition Facts Labels w/Various Footnote Formats and Declaration of Added Sugars

Forms and Documents

Document Name	Status
Added Sugars Study SS Part B.doc Supporting Statement B	2013-06-06
Experimental Study Consumer Responses to Nutrition Facts Labels Supporting Statement Part A Revised.doc Supporting Statement A	2014-01-29

IC Document Collections

IC ID	Document Title	Status
207262	Survey Other-Test Stimuli	New
207261	Survey Invitation Other-Survey Invitation	New
207260	Pretest Other-Pretest	New
207259	Pretest Invitation Other-Pretest Invitation	New
207258	Cognitive Interview Other-Cognitive Interview Instrument	New
207257	Cognitive interview screener Other-Cognitive Interview Screener	New

ICR Details

OMB Control No: 0910-0764	ICR Reference No: 201306-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 19748
Title: Study; Consumer Responses to Nutrition Facts Labels w/Various Footnote Formats and Declaration of Added Sugars
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/18/2014
	Date Received in OIRA: 06/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	36 Months From Approved
Responses	51,231	0	0
Time Burden (Hours)	3,906	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR is a one-time data collection consisting of a research study whose overall objective is to examine consumer reactions to two main categories of potential modifications to the Nutrition Facts label: (1) replacement of the existing information in the Nutrition Facts footnote area with statements related to percent Daily Values and how to use them; and (2) insertion of a separate declaration for added sugars below the declaration for sugars. Respondents will be asked to submit information via a web-based survey, including respondents' identification of the more healthful product in a pair of products, respondents' evaluations about a food product's nutritional attributes and overall healthfulness, and respondents' perceptions of various label formats' understandability, helpfulness, usefulness, and believability. The study is part of the agency's continuing effort to provide consumers with information to assist them in making informed dietary choices and constructing healthful diets. The agency is interested in using this study to inform future consumer education related to understanding and using Nutrition Facts labels.

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Authorizing Statute(s): None

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
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 32120	05/31/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 32394	05/30/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Survey
Cognitive interview screener
Cognitive Interview
Pretest Invitation
Pretest
Survey Invitation

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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	51,231	0	0	51,231	0	0
Annual Time Burden (Hours)	3,906	0	0	3,906	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection request for an experimental study.

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Annual Cost to Federal Government: $200,000

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]? No

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: 06/10/2013

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