Adverse Drug Event Recordkeeping -- 314.80(i)

Postmarketing Adverse Drug Experience Reporting

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0230 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:	Adverse Drug Event Recordkeeping -- 314.80(i)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.80(i)

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: 352	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	658,240	290,448	367,792
Annual IC Time Burden (Hours)	10,531,840	4,647,168	5,884,672
Annual IC Cost Burden (Dollars)	25,000	4,771	20,229

Documents for IC

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No associated records found

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