Information Collection

Reporting; Manufacturer Reporting-- 803.50 through 803.53

IC 6116 under ICR 202412-0910-004 · OMB 0910-0437.

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Information Collection (IC) Details

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IC Title:	Reporting; Manufacturer Reporting-- 803.50 through 803.53	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 4 21 CFR 803

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-MDR Webpage					Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,871	Number of Respondents for Small Entity: 150

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

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	2,320,393	863,509	1,456,884
Annual IC Time Burden (Hours)	232,039	86,351	145,688
Annual IC Cost Burden (Dollars)	18,710	18,710	0

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