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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
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
To view an IC, click on IC Title