Information Collection

Voluntary Adverse Event Report via the SRP

IC 192360 under ICR 201301-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
Form 3800 Safety Reporting Portal Voluntary Adverse Event Report via the SRP	Form
RFR proposed SRP modifications_12April12.doc	Other-Table of Changes to Registry
3800 Safety Reporting Portal CTP SRP Report Wireframes 11192012.pdf	Form

IC Title:

Voluntary Adverse Event Report 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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3800				Yes	Yes	Fillable Fileable
Other-Table of Changes to Registry					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: 757

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	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

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.

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