Information Collection

Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance

IC 217571 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
503B Adverse Event Reporting Guidance.docx Other-Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance	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:

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 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	55	55
Annual IC Time Burden (Hours)	61	61
Annual IC Cost Burden (Dollars)	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.