Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

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Information Collection (IC) Details

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IC Title:	Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 210 21 CFR 211

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,184	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	1,248,727	74,300	1,174,427
Annual IC Time Burden (Hours)	848,625	50,493	798,132
Annual IC Cost Burden (Dollars)	0	0	0

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