Voluntary Adverse Event Report via the SRP

Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803

⚠️ Notice: This information collection may be referencing outdated material.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
Form 3800 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

Information Collection (IC) Details

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:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3800	Safety Reporting Portal	CTP SRP Report Wireframes 11192012.pdf		Yes	Yes	Fillable Fileable
Other-Table of Changes to Registry			RFR proposed SRP modifications_12April12.doc		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 %

	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

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.