Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Forms and Documents

Document Name	Status
0635 Supporting Statement 2016.pdf Supporting Statement A	2016-02-16

IC Document Collections

IC ID	Document Title	Status
202999	Follow-up reports of new medical information Other-Guidance	Modified
186733	Dietary supplement adverse events records Other-Statute	Modified
186732	Serious adverse event reports for dietary supplements Other-Statute	Modified

ICR Details

OMB Control No: 0910-0635	ICR Reference No: 201602-0910-006
Status: Historical Active	Previous ICR Reference No: 201205-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Adverse Event Reporting and Recordkeeping for 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: 03/21/2016
	Date Received in OIRA: 02/18/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	03/31/2016
Responses	129,404	0	128,600
Time Burden (Hours)	69,394	0	77,560
Cost Burden (Dollars)	0	0	0

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Abstract: For Dietary Supplements, FDA requires the manufacturer, packer, or distributor whose name appears on the label to report all serious adverse event reports associated with the use of a dietary supplement via the MedWatch form. FDA is issuing guidance to describe the minimum data elements for serious adverse event reports for dietary supplements; how, when, and where to submit a serious adverse event report for a dietary supplement; and records maintenance and access for serious and non-serious adverse event reports and related documents.

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Authorizing Statute(s): US Code: 21 USC 379aa 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:
	80 FR 63797	10/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 3438	01/21/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Serious adverse event reports for dietary supplements
Dietary supplement adverse events records
Follow-up reports of new medical information

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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	129,404	128,600	0	0	804	0
Annual Time Burden (Hours)	69,394	77,560	0	0	-8,166	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This information collection reflects agency adjustments as described in Q15 of the Supporting Statement.

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Annual Cost to Federal Government: $19,399,380

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: 02/18/2016

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