Information Collection

Current Good Manufacturing Practice (CGMP), Quality System (QS) Regulation (Final Rule)

IC 5713 under ICR 199806-0910-005 · 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⚠️ Notice: This information collection may be referencing outdated material.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 (Final Rule)	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

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 7,237	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	7,237	7,237
Annual IC Time Burden (Hours)	3,903,169	3,903,169
Annual IC Cost Burden (Dollars)	28,261,704,000	28,261,704,000

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.