Information Collection

Quality System Regulation Amendments

IC 5715 under ICR 202202-0910-018 · OMB 0910-0073.

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Information Collection (IC) Details

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IC Title:	Quality System Regulation Amendments	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 820

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: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 20,346	Number of Respondents for Small Entity: 0

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	Previously Approved
Annual Number of Responses for this IC	65,462	38,388	27,074
Annual IC Time Burden (Hours)	7,457,136	-1,564,616	9,021,752
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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