Information Collection

Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance

IC 217571 under ICR 201808-0910-004 · OMB 0910-0800.

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Information Collection (IC) Details

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IC Title:	Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 310.305

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: 55	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	Previously Approved
Annual Number of Responses for this IC	55	55
Annual IC Time Burden (Hours)	61	61
Annual IC Cost Burden (Dollars)	0	0

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