Information Collection

Voluntary Adverse Event Reporting via the SRP

IC 192360 under ICR 201409-0910-012 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3500A Voluntary Adverse Event Reporting via the SRP	Form
3500A MedWatch FDA FORM 3500A 9-15-14.pdf	Form

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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3500A	MedWatch	FDA FORM 3500A 9-15-14.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: 1,513

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	1,513	1,513
Annual IC Time Burden (Hours)	908	908
Annual IC Cost Burden (Dollars)	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.