Information Collection

Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation

IC 5715 under ICR 201611-0910-002 · OMB 0910-0073.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0073 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 820.186 21 CFR 820.198 21 CFR 820.200 21 CFR 820.20 21 CFR 820.22 21 CFR 820.25 21 CFR 820.30 21 CFR 820.40 21 CFR 820.50 21 CFR 820.50 21 CFR 820.60 21 CFR 820.65 21 CFR 820.70 21 CFR 820..72 21 CFR 820.75 21 CFR 820.80 21 CFR 820.86 21 CFR 820.90 21 CFR 820.100 21 CFR 820.120 21 CFR 820.130 21 CFR 820.140 21 CFR 820.160 21 CFR 820.150 21 CFR 820.170 21 CFR 820.180 21 CFR 820.181 21 CFR 820.184

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: 24,738	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	24,738	-1,248	25,986
Annual IC Time Burden (Hours)	8,608,824	-434,304	9,043,128
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.