Information Collection

Serious adverse event reports for dietary supplements

IC 186732 under ICR 201602-0910-006 · OMB 0910-0635.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
21 USC 379aa.doc	Other-Statute
Guidance-DS AER 30-day 8-21-08 oc2008209.doc	Other-guidance document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of 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: 170

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,890	-5,270	8,160
Annual IC Time Burden (Hours)	5,780	-10,540	16,320
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.