Information Collection

Adverse Drug Event Recordkeeping -- 314.80(i)

IC 188678 under ICR 201207-0910-003 · OMB 0910-0230.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0230 can be found here:

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Information Collection (IC) Details

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IC Title:	Adverse Drug Event Recordkeeping -- 314.80(i)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 301

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 665	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	399,998	-2	400,000
Annual IC Time Burden (Hours)	6,399,968	-32	6,400,000
Annual IC Cost Burden (Dollars)	22,000	40	21,960

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