Information Collection

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

IC 192361 under ICR 202109-0910-006 · OMB 0910-0645.

Documents and Forms

Documents and forms in this information collection
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 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
0645 IC2 Mandatory DSR Wireframes.pdf	Other-eForm Submission

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

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-(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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	3,360	3,360
Annual IC Time Burden (Hours)	3,360	3,360
Annual IC Cost Burden (Dollars)	157,647	157,647

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.