Reporting - AER under 314.80 (marketing applications) - quarterly reports

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

Document Name Document Type
0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf Other-Agency Guidance
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf Other-Agency Guidance

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: Modified

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 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.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: 682	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	838,000	823,798	14,202
Annual IC Time Burden (Hours)	50,280,000	49,427,880	852,120
Annual IC Cost Burden (Dollars)	5,000	5,000	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.