Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)

FDA Adverse Event and Products Experience Reports; Electronic Submissions

⚠️ Notice: This information collection may be referencing outdated material.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

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Mandatory Adverse Event Reporting via ESG (Gateway-to-Gateway transmission)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 310; 314; 329; 514 21 CFR 600; 803; 1271 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3,007,000	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	3,007,000	3,007,000
Annual IC Time Burden (Hours)	1,804,200	1,804,200
Annual IC Cost Burden (Dollars)	141,084,984	141,084,984

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.