Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods

Forms and Documents

Document Name	Status
Fortified Foods Supporting Statement Part B 6 MAR 2014.doc Supporting Statement B	2014-03-07
Fortified Foods Supporting Statement Part A 6 MAR 2014.doc Supporting Statement A	2014-03-07

IC Document Collections

IC ID	Document Title	Status
208382	Survey Other-Survey	New
208381	Survey Invitation Other-Survey Invitation	New
208380	Pretest Other-Study Sample of Food Packages	New
208379	Pretest Invitation Other-Pretest Invitation	New
208378	Cognitive Interview Other-Cognitive Interview	New
208377	Cognitive Interview Screener Other-Cognitive Interview Screener	New

ICR Details

OMB Control No: 0910-0763	ICR Reference No: 201308-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20353
Title: Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods
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: 03/18/2014
	Date Received in OIRA: 08/26/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	24 Months From Approved
Responses	41,584	0	0
Time Burden (Hours)	3,099	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is proposing a study regarding whether fortification of certain foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet.

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Authorizing Statute(s): PL: Pub.L. 101 - 535 2 Name of Law: NLEA
  

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:
	77 FR 48988	08/12/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52201	08/22/2013
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 Invitation
Pretest
Survey Invitation
Survey

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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	41,584	0	0	41,584	0	0
Annual Time Burden (Hours)	3,099	0	0	3,099	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 for purposes of data 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: 08/26/2013

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