Information Collection

Records of Adverse Events, Including Records of Efforts to Obtain the Data Elements for Each Adverse Event Report

IC 217572 under ICR 201507-0910-008 · OMB 0910-0800.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0800 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
503B Adverse Event Reporting Guidance.docx	Other-Guidance

IC Title:

Records of Adverse Events, Including Records of Efforts to Obtain the Data Elements for Each Adverse Event Report

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 310.305

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-Guidance			503B Adverse Event Reporting Guidance.docx		Yes	No	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 55

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	55	55
Annual IC Time Burden (Hours)	880	880
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.