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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual reports of holder of orphan drug designation
Modified
1652
4956
0
Changes in ownership of orphan drug designation
Modified
43
215
0
Insufficient quantities of orphan drugs
Modified
3
45
0
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Modified
428
64200
0
Form and Instruction
FDA3671
Common EMEA/FDA Application for Orphan Medicinal Product Designation
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
Removed
0
0
0
Form and Instruction
FDA 3671
COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
Permanent resident agent for foreign sponsor
Modified
55
110
0
Written recommendations; content and format of a request, the providing of; refusal to provide
Modified
2
200
0
Total burden requested under this ICR:
2183
69726
0
To view an IC, click on IC Title