Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages

Forms and Documents

Document Name	Status
ICR Whole Grain Study (Part B).doc Supporting Statement B	2012-11-15
test graphics.pdf Supplementary Document	2012-11-15
ICR Whole Grain Study (Part A).doc Supporting Statement A	2013-08-15

IC Document Collections

IC ID	Document Title	Status
204882	Survey Other-Survey	New
204881	Survey Invitation Other-Survey Instrument	New
204880	Pretest Other-Survey Instrument	New
204879	Pretest Invitation Other-Survey Instrument	New
204878	Cognitive Interview Other-Survey Instrument	New
204877	Cognitive Interview Screener Other-Survey Instrument	New

ICR Details

OMB Control No: 0910-0747	ICR Reference No: 201211-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages
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: 09/05/2013
	Date Received in OIRA: 11/19/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2015	18 Months From Approved
Responses	9,909	0	0
Time Burden (Hours)	1,050	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA conducts research and educational and public information programs relating to food safety pursuant to its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 393 (b)(2), to protect the public health by ensuring that foods are "safe, wholesome, sanitary, and properly labeled," and in section 903(d)(2)(C) (21 U.S.C. 393 (d)(2)(C)), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act. FDA helps consumers make informed dietary decisions by regulating nutrition information in food labeling, initiating its own consumer education activities, and collaborating with public and private entities in conveying nutrition information to consumers. These activities are aimed at influencing consumer awareness, understanding, and behaviors related to diet and nutrition and ultimately health outcomes of the Nation. The Nutrition Labeling and Education Act (NLEA), which amended the Food, Drug and Cosmetic Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. There are three different types of claims that the food industry can voluntarily use on food labels. Although they are regulated differently, they all must be truthful and not misleading. FDA is proposing to conduct an experimental study to quantitatively assess consumer reactions to different whole grain statements. The purpose of the study is to help enhance FDA's understanding of consumer comprehension and perceptions of food labels that use whole grains labeling statements. The study is part of the agency's continuing effort to enable consumers to make informed dietary choices and construct healthful diets. The results of the study will be used for informing possible measures that the agency may take to help consumers make such choices.

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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:
	76 FR 30725	05/26/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 11547	02/27/2012
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 Invitation
Survey
Cognitive Interview Screener
Cognitive Interview
Pretest Invitation
Pretest

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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	9,909	0	0	9,909	0	0
Annual Time Burden (Hours)	1,050	0	0	1,050	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 for the purpose of data collection.

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Annual Cost to Federal Government: $300,000

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: 11/19/2012

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