Mandatory Adverse Event Reporting via the SRP (other than RFR reports)

FDA Adverse Event and Products Experience Reports; Electronic Submissions

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0645 can be found here:

Documents and Forms

Document Name Document Type
0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013.pdf Other-(Screen shots for CVM collecti
0645 IC2 Mandatory DSR Wireframes.pdf Other-eForm Submission

Information Collection (IC) Details

IC Title:	Mandatory Adverse Event Reporting via the SRP (other than RFR reports)	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-(Screen shots for CVM collection)			0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013.pdf		Yes	No	Paper Only
Other-eForm Submission			0645 IC2 Mandatory DSR Wireframes.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: 3,360	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,360	2,724	636
Annual IC Time Burden (Hours)	3,360	2,724	636
Annual IC Cost Burden (Dollars)	157,647	157,647	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.