Information Collection

Reporting; Manufacturer Reporting-- 803.50 through 803.53

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

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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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

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 %

table that charts list of burden
	Approved	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

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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