Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards

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

OMB: 0910-0154

IC ID: 197520

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Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards CVM
 
No Removed
 
Mandatory
 
21 CFR 226.58

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 0 0 -16,900 0 0 16,900
Annual IC Time Burden (Hours) 0 0 -29,575 0 0 29,575
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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