Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars

Forms and Documents

Document Name	Status
NF2 SSB_111215_Updated.doc Supporting Statement B	2011-12-21
NF2 SSA_111215_Updated.doc Supporting Statement A	2012-01-03

IC Document Collections

IC ID	Document Title	Status
200695	Reporting: Survey Other-NF2 Appendices Update	New
200694	Reporting: Survey Invitation Other-NF2 Appendices Update	New
200693	Reporting: Pretest Other-NF2 Appendices Update	New
200692	Reporting: Pretest Invitation Other-NF2 Appendices Update	New
200691	Reporting: Cognitive Interview Other-NF2 Appendices Update	New
200690	Reporting- Cognitive Interview Screener Other-NF2 Appendices Update	New

ICR Details

OMB Control No:	ICR Reference No: 201201-0910-004
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount 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OIRA Conclusion Action: Withdrawn	Conclusion Date: 03/06/2012
	Date Received in OIRA: 01/04/2012
Terms of Clearance: In accordance with 5 CFR 1320, this ICR has been withdrawn at the request of FDA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) regulates the labeling of food products under the Federal Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act (NLEA) of 1990 (Public Law No. 101-535). NLEA specified that most packaged foods must bear nutrition labeling, including certain nutrients and food components that may be added or deleted by regulation as necessary to assist consumers in maintaining healthy dietary practices. This study will among other things, explore how declaring the added sugars content of foods might affect consumers' attention to and understanding of the sugars and calorie contents and other information on the Nutrition Facts label. FDA is contemplating requiring the amount of added sugars to be declared under sugars with a double indention format because added sugars are a component of sugars. This new requirement would be the first time that the mandatory declaration of a nutrient is shown in this format on the Nutrition Facts label. Since added sugars have been linked to obesity, a significant public health problem in the country (Ref. 4), it is important that this new requirement is supported by evidence that consumers can correctly use the information. The Agency is not aware of any existing consumer research that has examined this topic and is therefore interested in using this study to enhance understanding of how consumers would comprehend and use this new information.

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Authorizing Statute(s): PL: Pub.L. 101 - 535 1 Name of Law: null
  

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:
	76 FR 29758	05/23/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 81948	12/29/2011
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
Reporting- Cognitive Interview Screener
Reporting: Cognitive Interview
Reporting: Pretest Invitation
Reporting: Pretest
Reporting: Survey Invitation
Reporting: Survey

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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 collection of information.

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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: 01/04/2012

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