Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards

Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

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Information Collection (IC) Details

IC Title:	Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 226.58

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: 65	Number of Respondents for Small Entity: 49

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

Percentage of Respondents Reporting Electronically: 90 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-16,900	16,900
Annual IC Time Burden (Hours)	-29,575	29,575
Annual IC Cost Burden (Dollars)	0	0

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