Information Collection

Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80

IC 5820 under ICR 200207-0910-006 · 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⚠️ Notice: This information collection may be referencing outdated material.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:	Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA-3500				No	No
Form	FDA-3500A				No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,397	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	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	10,959	0	10,941	18
Annual IC Time Burden (Hours)	287,574	0	-57,540	345,114
Annual IC Cost Burden (Dollars)	1,416,000	1,416,000	0	0

Documents for IC

Title	Document	Date Uploaded

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