Requirement that Records be Prepared and Maintained for Two Years with Respect to Components (Drug and Non-Drug) Used in the Manufacture of the Medicated Premixes

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

OMB: 0910-0154

IC ID: 5767

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Requirement that Records be Prepared and Maintained for Two Years with Respect to Components (Drug and Non-Drug) Used in the Manufacture of the Medicated Premixes CVM
 
No Modified
 
Mandatory
 
21 CFR 226.42

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

Health Consumer Health and Safety

 

65 49
   
Private Sector Businesses or other for-profits
 
   90 %

  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 16,900 0 0 0 0 16,900
Annual IC Time Burden (Hours) 12,675 0 0 0 0 12,675
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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