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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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:

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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 %

table that charts list of burden
	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

table that charts IC Documents
Title	Document	Date Uploaded
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.