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

Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

⚠️ Notice: This information collection may be referencing outdated material.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

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.