Food Labeling: Trans Fatty Acids in Nutrition Labeling

Forms and Documents

Document Name	Status
0515-Attach C-21 CFR101 36b.doc Supplementary Document	2006-10-27
0515-AttachB-21 CFR 101 9c2.doc Supplementary Document	2006-10-27
0515-AttachA-21 USC 343q.doc Supplementary Document	2006-10-27
0515-CoverMemotoOMB-2006.doc Supplementary Document	2006-10-11
0515-ss-2006.doc Supporting Statement A	2006-11-08

IC Document Collections

IC ID	Document Title	Status
6231	Food Labeling: Trans Fatty Acids in Nutrition Labeling	Modified
46040	Food Labeling: Trans Fatty Acids in Nutrition Labeling	New

ICR Details

OMB Control No: 0910-0515	ICR Reference No: 200611-0910-004
Status: Historical Active	Previous ICR Reference No: 200307-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Labeling: Trans Fatty Acids in Nutrition Labeling
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/18/2007
	Date Received in OIRA: 11/16/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	312,350	0	307,600
Time Burden (Hours)	624,700	0	615,200
Cost Burden (Dollars)	172,375	0	171,700,000

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Abstract: The FDA's regulations require the disclosure on the label or labeling of conventional food products and dietary supplement products of the amount of trans fatty acids contained in the product.

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Authorizing Statute(s): US Code: 21 USC 343 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:
	69 FR 18338	04/11/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 60157	10/12/2006
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
Food Labeling: Trans Fatty Acids in Nutrition Labeling
Food Labeling: Trans Fatty Acids in Nutrition Labeling

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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	312,350	307,600	0	4,750	0	0
Annual Time Burden (Hours)	624,700	615,200	0	9,500	0	0
Annual Cost Burden (Dollars)	172,375	171,700,000	0	-171,527,625	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There is no burden reduction.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 11/13/2006

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