Food Labeling: Notification Procedures for Statements on Dietary Supplements

Forms and Documents

Document Name	Status
SS-0910-0331.doc Supporting Statement A	2010-01-27

IC Document Collections

IC ID	Document Title	Status
5918	Food Labeling: Notification Procedures for Statements on Dietary Supplements	Modified

ICR Details

OMB Control No: 0910-0331	ICR Reference No: 201001-0910-013
Status: Historical Active	Previous ICR Reference No: 200612-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Labeling: Notification Procedures for Statements on Dietary Supplements
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: 03/29/2010
	Date Received in OIRA: 01/29/2010
Terms of Clearance: This collection is approved in accordance with 5 CFR 1320, however, upon resubmission, FDA must provide a written explanation of the steps it has taken to enable electronic reporting of this information and an estimate of when electronic submission will be possible.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	36 Months From Approved	03/31/2010
Responses	2,200	0	2,500
Time Burden (Hours)	1,650	0	1,875
Cost Burden (Dollars)	0	0	0

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Abstract: The reporting requirements of this regulation implement the Dietary Supplement Health and Education Act. The subject regulation establishes reporting procedures necessary to inform FDA when dietary supplement manufacturers are making statements of nutritional support on their labels or in their labeling.

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Authorizing Statute(s): US Code: 21 USC 343(r)(6) 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 26406	06/02/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4079	01/26/2010
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
Food Labeling: Notification Procedures for Statements on Dietary Supplements

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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	2,200	2,500	0	0	-300	0
Annual Time Burden (Hours)	1,650	1,875	0	0	-225	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $17,326

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)? 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: 01/29/2010

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