Experimental Study of Proposed Changes to the Nutrition Facts Label Formats

Forms and Documents

Document Name	Status
Nutrition Facts Label Study Part B.doc Supporting Statement B	2014-09-02
NFL Study Emergency clearance Request signed 7 2 14.pdf Supplementary Document	2014-08-29
Nutrition Facts Label Study.doc Supporting Statement A	2014-08-29

IC Document Collections

IC ID	Document Title	Status
212902	Eye tracking study Other-Survey description	New
212901	Online Study Other-Survey Description	New

ICR Details

OMB Control No: 0910-0774	ICR Reference No: 201408-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Experimental Study of Proposed Changes to the 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: Emergency	Approval Requested By: 09/05/2014
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/04/2014
	Date Received in OIRA: 09/02/2014
Terms of Clearance: Approved with the understanding that results generated from this collection are not intended to be generalizable beyond the participating study population.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	6 Months From Approved
Responses	5,160	0	0
Time Burden (Hours)	1,277	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This proposed survey is intended to help enhance FDA's understanding of consumer reactions to proposed format changes to the Nutrition Facts (NF) label and appropriate implement certain food labeling provisions of the Federal Food, Drug, and Cosmetic Act.

Emergency Justfication: Under normal circumstances, we would follow the notice-and-comment process required by the Paperwork Reduction Act (PRA). At the same time, to align with the publication of the Final Rules expected in March 2015, we have only nine months to complete the proposed study and make results available to the public. Therefore, we are requesting emergency approval so that we may complete the study within this timeframe.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 113 Name of Law: FSMA

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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? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Eye tracking study
Online Study

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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	5,160	0	0	5,160	0	0
Annual Time Burden (Hours)	1,277	0	0	1,277	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 request for purposes of data collection.

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Annual Cost to Federal Government: $460,000

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: 09/02/2014

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