Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Requirement for Maintenance of Complaint Files for Type A Medicated Articles for Two Years Modified 650 325 0
Requirement for Maintenance of Distribution Records for Each Shipment for Type A Medicated Articles for Two Years Modified 16900 4225 0
Requirement for Maintenance of Master-Formula and Batch Production Records for Type A Medicated Articles Modified 16900 29575 0
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 Modified 16900 12675 0
Requires Maintenance of Records for Packaging and Labeling of Type A Medicated Articles Modified 16900 12675 0
Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards Modified 16900 29575 0
Total burden requested under this ICR: 85150 89050 0  
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