Recordkeeping CGMP APIs

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

OMB: 0910-0139

IC ID: 248022

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Recordkeeping CGMP APIs
 
No Unchanged
 
Mandatory
 
21 CFR 1270 21 CFR 225; 226 21 CFR 210; 211 21 CFR 600 through 680  (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Health Consumer Health and Safety

 

1,260 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 322,560 0 0 0 0 322,560
Annual IC Time Burden (Hours) 264,499 0 0 0 0 264,499
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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