Information Collection

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

IC 192362 under ICR 202109-0910-006 · OMB 0910-0645.

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Information Collection (IC) Details

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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 600; 803; 1271 21 CFR 310; 314; 329; 514 (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

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.