Information Collection

Add Adverse Event Reporting Plan to COOP

IC 198613 under ICR 202006-0910-014 · OMB 0910-0701.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0701 AER Pandemic GFI 2020.pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

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-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: 5,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 80 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	5,000	5,000
Annual IC Time Burden (Hours)	250,000	250,000
Annual IC Cost Burden (Dollars)	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.