Experimental Study of Nutrition Facts Label Formats

Forms and Documents

Document Name	Status
SS- Part B-Nutrition Facts Label format.doc Supporting Statement B	2010-11-18
Nutrition Facts Label Appendix F - Reminder E-Mail.doc Supplementary Document	2010-11-18
Nutrition Facts Label- Appendix E - Food Label Profiles.doc Supplementary Document	2010-11-18
Nutrition Facts Label - Appendix D - Food Label Mock-up.doc Supplementary Document	2010-11-18
Nutrition Facts Label- Appendix B - Mail Invitation.doc Supplementary Document	2010-11-18
SS - Part A - Nutrition Fact Label Format #2.doc Supporting Statement A	2010-12-03

IC Document Collections

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

ICR Details

OMB Control No: 0910-0682	ICR Reference No: 201012-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Nutrition Facts Label Formats
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 without change	Conclusion Date: 04/25/2011
	Date Received in OIRA: 12/16/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	36 Months From Approved
Responses	61,258	0	0
Time Burden (Hours)	4,241	0	0
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
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 59553	11/18/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 70266	11/17/2010
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
Cognitive Interview Screener
Cognitive Interview
Pretest
Experiment Invitation
Experiment
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	0	0	61,258	0	0
Annual Time Burden (Hours)	4,241	0	0	4,241	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 collection.

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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: 12/16/2010

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