Information Collection

Adverse Event Reporting -- 314.80(c)(2)

IC 188676 under ICR 201810-0910-005 · OMB 0910-0230.

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Information Collection (IC) Details

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IC Title:	Adverse Event Reporting -- 314.80(c)(2)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.80(c)(2)

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: 810	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	13,924	-71	13,995
Annual IC Time Burden (Hours)	835,434	-4,266	839,700
Annual IC Cost Burden (Dollars)	0	-23,026	23,026

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