Experimental Study of Nutrition Facts Label Formats

Forms and Documents

Document Name	Status
NFP Mod SS Part B updated clean 7 27 11.doc Supporting Statement B	2011-07-27
Justification Memo.- 0910-0682.doc Justification for No Material/Nonsubstantive Change	2011-07-28
0910-0682 screen shots.pdf Supplementary Document	2011-07-27
Appendix E - Food Label Profiles updated 7 27 11.doc Supplementary Document	2011-07-27
Appendix D - Final NFP labels 7 27 11.ppt Supplementary Document	2011-07-27
Appendix C - Questionnaire final clean copy 7 27 11.doc Supplementary Document	2011-07-27
NFP mod SS Part A updated final clean 7 27 11.doc Supporting Statement A	2011-07-27

IC Document Collections

IC ID	Document Title	Status
195728	Experiment Other-Web-based survey	Modified
195727	Experiment Invitation Other-Web based survey	Modified
195726	Pretest Other-Web based survey	Modified
195725	Pretest Invitation Other-Web base survey	Modified
195724	Cognitive Interview Other-Web base survey	Modified
195723	Cognitive Interview Screener Other-Web based survey	Modified

ICR Details

OMB Control No: 0910-0682	ICR Reference No: 201107-0910-012
Status: Historical Active	Previous ICR Reference No: 201012-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Nutrition Facts Label Formats
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 without change	Conclusion Date: 07/28/2011
	Date Received in OIRA: 07/28/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	04/30/2013	04/30/2013
Responses	61,258	0	61,258
Time Burden (Hours)	4,241	0	4,241
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is proposing to conduct an experimental study to quantitatively assess consumer reactions to potential options for modifying the Nutrition Facts Label format. The purpose of this study is to help enhance FDA`s understanding of consumer comprehension and acceptance of modifications to the Nutrition Facts label format. The study is part of the Agency`s continuing effort to enable consumers to make informed dietary choices and construct healthful diets. FDA conducts consumer research under its broad statutory authority, set forth in section 903(b)(2)(A) of the Federal Food and Drug cosmetic Act (the Act)(21 U.S.C.393(b)(2)(A).

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Authorizing Statute(s): US Code: 21 USC 392(d)(2)(C) 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

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
Pretest
Experiment Invitation
Experiment
Cognitive Interview Screener
Cognitive Interview
Pretest 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	61,258	61,258	0	0	0	0
Annual Time Burden (Hours)	4,241	4,241	0	0	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: $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: 07/28/2011

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