Information Collection

Voluntary Adverse Event Reporting via the SRP

IC 192360 under ICR 201302-0910-006 · OMB 0910-0645.

⚠️ Notice: This information collection may be referencing outdated material.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
CTP SRP Report Wireframes 11192012.pdf Other-Screen Shots for CTP Submissio
0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013.pdf Other-CVM Reporting

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Voluntary Adverse Event Reporting via the SRP	Agency IC Tracking Number:

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-CVM Reporting			0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013.pdf		Yes	No	Printable Only
Other-Screen Shots for CTP Submissions			CTP SRP Report Wireframes 11192012.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,513	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	1,513	-36,052	37,565
Annual IC Time Burden (Hours)	908	-21,631	22,539
Annual IC Cost Burden (Dollars)	0	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.