Serious adverse event reports for dietary supplements

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0635 can be found here:

Documents and Forms

Document Name Document Type
21 USC 379aa.doc Other-Statute
Guidance-DS AER 30-day 8-21-08 oc2008209.doc Other-guidance document

Information Collection (IC) Details

IC Title:	Serious adverse event reports for dietary supplements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statute			21 USC 379aa.doc		Yes	No	Paper Only
Other-guidance document			Guidance-DS AER 30-day 8-21-08 oc2008209.doc		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 480	Number of Respondents for Small Entity: 384

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	8,160	7,498	662
Annual IC Time Burden (Hours)	16,320	14,996	1,324
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.