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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
744
2232
0
Changes in ownership of orphan drug designation
Modified
63
315
0
Common European Medicines Agency/Food and Drug Administration Application Form
Modified
620
19840
0
Form and Instruction
Form 3671
Common EMEA/FDA Application for Orphan Medicinal Product Designation
Form and Instruction
Form 4035
FDA Application for Orphan Medicinal Product Designation
Deficiency letters and granting orphan-drug designation
Modified
20
40
0
Insufficient quantities of orphan drugs
Modified
6
90
0
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Modified
620
83700
0
Permanent resident agent for foreign sponsor
Modified
70
140
0
Written recommendations; content and format of a request, the providing of; refusal to provide
Modified
1
50
0
Total burden requested under this ICR:
2144
106407
0
To view an IC, click on IC Title