Recordkeeping - AER and Records During Pandemic (COOP planning; documenting conditions and high absenteeism; documenting AER process)

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

Document Name Document Type
0230 Postmarketing Adverse Event Reporting for Medical Products Dietary Supplements During a Pandemic.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Recordkeeping - AER and Records During Pandemic (COOP planning; documenting conditions and high absenteeism; documenting AER process)	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-Agency Guidance			0230 Postmarketing Adverse Event Reporting for Medical Products Dietary Supplements During a Pandemic.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 350	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	800	-350	1,150
Annual IC Time Burden (Hours)	10,600	-2,800	13,400
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.