Information Collection

Recordkeeping CGMP for Finished Pharmaceuticals

IC 37604 under ICR 202309-0910-010 · OMB 0910-0139.

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Information Collection (IC) Details

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IC Title:

Recordkeeping CGMP for Finished Pharmaceuticals

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600 through 680 21 CFR 210; 211 21 CFR 225; 22 21 CFR 1271 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

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Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 3,270

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	977,730	977,730
Annual IC Time Burden (Hours)	625,747	625,747
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.