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

ICR 201602-0910-006

OMB: 0910-0635

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-02-16
ICR Details
0910-0635 201602-0910-006
Historical Active 201205-0910-008
HHS/FDA CFSAN
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Extension without change of a currently approved collection   No
Regular
Approved with change 03/21/2016
Retrieve Notice of Action (NOA) 02/18/2016
  Inventory as of this Action Requested Previously Approved
03/31/2019 36 Months From Approved 03/31/2016
129,404 0 128,600
69,394 0 77,560
0 0 0

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.

US Code: 21 USC 379aa Name of Law: FFDCA
  
None

Not associated with rulemaking

  80 FR 63797 10/21/2015
81 FR 3438 01/21/2016
No

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This information collection reflects agency adjustments as described in Q15 of the Supporting Statement.

$19,399,380
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/18/2016


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