Dietary supplement adverse events records

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⚠️ Notice: This information collection may be referencing outdated material.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

Information Collection (IC) Details

IC Title:	Dietary supplement adverse events records	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,600	Number of Respondents for Small Entity: 1,280

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	118,400	118,234	166
Annual IC Time Burden (Hours)	59,200	59,034	166
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.