Recordkeeping CGMP for Finished Pharmaceuticals

Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases

OMB: 0910-0139

IC ID: 37604

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Recordkeeping CGMP for Finished Pharmaceuticals CDER
 
No Modified
 
Mandatory
 
21 CFR 210 21 CFR 211 21 CFR 610.12; 610.13; 610.18 21 CFR 680.2; 680.3

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

Health Public Health Monitoring

 

3,270 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 979,492 0 0 975,132 0 4,360
Annual IC Time Burden (Hours) 654,820 0 0 545,820 0 109,000
Annual IC Cost Burden (Dollars) 0 0 0 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.

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