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Agenda
Reg Review
ICR
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