Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Forms and Documents

Document Name	Status
0642 Supporting Statement 2013.doc Supporting Statement A	2013-02-14

IC Document Collections

IC ID	Document Title	Status
188226	Introductory Statement for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act Other-guidance document	Modified
188225	Contact information for Dietary Supplements and Non-Prescription Drugs Other-guidance document	Modified

ICR Details

OMB Control No: 0910-0642	ICR Reference No: 201210-0910-005
Status: Historical Active	Previous ICR Reference No: 200903-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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 with change	Conclusion Date: 02/18/2013
	Date Received in OIRA: 10/31/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	02/28/2013
Responses	11,120	0	111,200
Time Burden (Hours)	2,224	0	444,800
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from dietary supplement and non-prescription drug manufacturers and distributers seeking to introduce these products into interstate commerce under the FFDCA. Respondents provide the agency with proposed labeling for their products as required under the applicable statutes and FDA clears the labeling to ensure compliance so the products can be marketed. Products that do not comply with the applicable labeling regulations may be misbranded and subject to enforcement action.

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Authorizing Statute(s): PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
  

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 35687	06/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 50699	08/22/2012
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
Introductory Statement for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Contact information for Dietary Supplements and Non-Prescription Drugs

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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	11,120	111,200	0	0	-100,080	0
Annual Time Burden (Hours)	2,224	444,800	0	0	-442,576	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: FDA is requesting to extend approval of the ICR, for which there is a decrease in burden. The burden change is due to an adjustment based on the agency's determination that the number of disclosures per respondent, the total annual number of disclosures, the average burden per disclosure, and the total annual hour burden have decreased.

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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]? 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: 10/31/2012

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