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
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
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  
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