Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Annual reports of holder of orphan drug designation Removed 0 0 0
Changes in ownership of orphan drug designation Removed 0 0 0
Common European Medicines Agency/Food and Drug Administration Application Form Removed 0 0 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 Removed 0 0 0
Insufficient quantities of orphan drugs Removed 0 0 0
Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests Modified 4577 123673 0 Other-Guidance
Form and Instruction FDA 4035 FDA Orphan Drug Designation Request Form
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation Removed 0 0 0
Permanent resident agent for foreign sponsor Removed 0 0 0
Total burden requested under this ICR: 4577 123673 0  
To view an IC, click on IC Title