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
Form and Instruction Form 4035
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