Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Automatic, Mechanical, and Electronic Equipment Removed 0 0 0
Batch Production and Control Records Removed 0 0 0
Changes in Master Production and Control Records or Other Records Removed 0 0 0
Compliant Files Removed 0 0 0
Component, Drug, Product Container, Closure, and Labeling Records Removed 0 0 0
Components and Drug Product Containers or Closures Removed 0 0 0
Computer or Related Systems Removed 0 0 0
Consultants Removed 0 0 0
Discrepancies in Drug Product Production and Control Records Removed 0 0 0
Distribution Records Removed 0 0 0
Equipment Cleaning and Maintenance Removed 0 0 0
Equipment Cleaning and Use Log Removed 0 0 0
Equipment Identification Removed 0 0 0
Expiration Dating Removed 0 0 0
Filters Removed 0 0 0
Labeling and Packaging Facilities Removed 0 0 0
Labeling and Packaging Material Removed 0 0 0
Laboratory Animals Removed 0 0 0
Laboratory Controls Removed 0 0 0
Laboratory Records Removed 0 0 0
Master Production and Control Records Removed 0 0 0
Procedures for Notification of Regulatory Actions Removed 0 0 0
Production and Process Controls Removed 0 0 0
Production, Control, and Distribution Records Removed 0 0 0
Recordkeeping CGMP for Finished Pharmaceuticals Modified 979492 654820 0
Recordkeeping CGMP for Medical Gases, Containers, and Closures Modified 641094 396988 0 Other-Agency Guidance
Returned Drug Products Removed 0 0 0
Stability Testing Removed 0 0 0
Tamper Evident-Packaging Removed 0 0 0
Tamper-Evident Packaging Removed 0 0 0
Test Methodology Removed 0 0 0
Total burden requested under this ICR: 1620586 1051808 0  
To view an IC, click on IC Title