Information Collection

MedWatch: The FDA Medical Products Reporting Program

IC 5855 under ICR 199909-0910-001 · OMB 0910-0291.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0291 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	MedWatch: The FDA Medical Products Reporting Program	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-3500A				Yes	Yes
Form	FDA-3500				Yes	Yes

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 22,071	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 5 %

	Approved	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	328,361	29,791	0	298,570
Annual IC Time Burden (Hours)	320,081	31,076	0	289,005
Annual IC Cost Burden (Dollars)	0	0	-6,427,000	6,427,000

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.