Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Automatic, Mechanical, and Electronic Equipment New 43600 21800 0
Batch Production and Control Records New 109000 218000 0
Changes in Master Production and Control Records or Other Records New 8720 8720 0
Compliant Files New 21800 21800 0
Component, Drug, Product Container, Closure, and Labeling Records New 13080 6540 0
Components and Drug Product Containers or Closures New 1090 109 0
Computer or Related Systems New 21800 5450 0
Consultants New 1090 545 0
Discrepancies in Drug Product Production and Control Records New 8720 8720 0
Distribution Records New 109000 27250 0
Equipment Cleaning and Maintenance New 218000 54500 0
Equipment Cleaning and Use Log New 8720 2180 0
Equipment Identification New 1090 273 0
Expiration Dating New 21800 10900 0
Filters New 1090 1090 0
Labeling and Packaging Facilities New 218000 54500 0
Labeling and Packaging Material New 218000 54500 0
Laboratory Animals New 1077 269 0
Laboratory Controls New 8720 8720 0
Laboratory Records New 109000 54500 0
Master Production and Control Records New 43600 87200 0
New Start-up SOPs New 2500 50000 0
Procedures for Notification of Regulatory Actions New 872 872 0
Production and Process Controls New 13080 26160 0
Production, Control, and Distribution Records New 872 218 0
Returned Drug Products New 43600 21800 0
SOP Maintenance Modified 4360 109000 0
Stability Testing New 8720 4360 0
Tamper Evident-Packaging New 35380 17690 0
Tamper-Evident Packaging New 354 177 0
Test Methodology New 4360 4360 0
Total burden requested under this ICR: 1301095 882203 0  
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