Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
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
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