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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Orphan Drug Products
Modified
1
15
0
Orphan Drug Products
Modified
30
60
0
Orphan Drug Products
Modified
25
100
0
Orphan Drug Products
Modified
500
1000
0
Orphan Drug Products
Modified
5
650
0
Orphan Drug Products
Modified
342
44460
0
Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)
New
40
1280
0
Form and Instruction
FDA 3671
COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
Total burden requested under this ICR:
943
47565
0
To view an IC, click on IC Title