Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Annual reports of holder of orphan drug designation Modified 450 1350 0
Changes in ownership of orphan drug designation Modified 43 215 0
Common European Medicines Agency/Food and Drug Administration Application Form New 150 6750 0 Form and Instruction Form 3671
Deficiency letters and granting orphan-drug designation New 10 20 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 450 67500 0
Permanent resident agent for foreign sponsor Modified 65 130 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: 1176 76255 0  
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