Experimental Study of Trans Fat Claims on Foods

Forms and Documents

Document Name	Status
0533 ss part B 12-7-06.doc Supporting Statement B	0000-00-00
0533 CoverMemotoOMB 2006.doc Supplementary Document	0000-00-00
0533 Attachment E Academic Peer Reviewers.doc Supplementary Document	0000-00-00
0533 Attachment C Panel Claims.doc Supplementary Document	0000-00-00
0533 Attachment B Product Profiles.doc Supplementary Document	0000-00-00
0533 Attachment D Trans Fat Info Sheet.doc Supplementary Document	0000-00-00
0533 Attachment A 21 USC393.doc Supplementary Document	0000-00-00
0533 ss clean .doc Supporting Statement A	2007-06-26

IC Document Collections

IC ID	Document Title	Status
6251	Experimental Study of Trans Fat Claims on Foods Other-Other	Modified

ICR Details

OMB Control No: 0910-0533	ICR Reference No: 200702-0910-012
Status: Historical Active	Previous ICR Reference No: 200311-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Trans Fat Claims on Foods
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/28/2007
	Date Received in OIRA: 02/22/2007
Terms of Clearance: If changes to the questionnaire and related materials are made after pre-testing, FDA shall submit the final versions for OMB approval via ROCIS. The study design is appropriate for the purpose of the study identified in the supporting statement. However, in describing the data collected and results of the analysis, FDA will clearly acknowledge that the data does not provide nationally representative estimates of consumer attitudes, knowledge, behaviors, etc.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	36 Months From Approved
Responses	2,920	0	0
Time Burden (Hours)	730	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: An experimental study of the effectiveness of various possible interpretational aids to help consumers understand and apply nutrient content claims about trans fat that may appear on food labels.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FFDCA
  

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:
	71 FR 6076	02/06/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 75554	12/15/2006
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Experimental Study of Trans Fat Claims on Foods

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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	2,920	0	0	2,919	0	1
Annual Time Burden (Hours)	730	0	0	90	0	640
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 collection of information was discontinued in 2004. FDA is now ready to conduct the study and is reinstating this information collection.

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Annual Cost to Federal Government: $205,669

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 02/22/2007

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