AER under 314.80 (marketing applications) - quarterly reports

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

Document Name Document Type
0230 GFI Periodic Postmarket Reports in ICH E2C(R2) Format.pdf Other-Agency Guidance
0230 GFI Periodic Postmarket Reports in ICH E2C(R2) Format.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	AER under 314.80 (marketing applications) - quarterly reports	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.80(c)(2)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0230 GFI Periodic Postmarket Reports in ICH E2C(R2) Format.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: 820	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	14,202	14,202
Annual IC Time Burden (Hours)	852,120	852,120
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.