Notify FDA When Normal Reporting is Not Feasible

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance

Documents and Forms

Document Name Document Type
0701 AER Pandemic GFI 2020.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Notify FDA When Normal Reporting is Not Feasible	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

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			0701 AER Pandemic GFI 2020.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 500	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 80 %

	Approved	Previously Approved
Annual Number of Responses for this IC	500	500
Annual IC Time Burden (Hours)	4,000	4,000
Annual IC Cost Burden (Dollars)	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.