Common European Medicines Agency/Food and Drug Administration Application Form

Orphan Products Development; Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation and FDA Orphan Drug Designation Request Form

OMB: 0910-0167

IC ID: 212826

Information Collection (IC) Details

View Information Collection (IC)

Common European Medicines Agency/Food and Drug Administration Application Form
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction Form 3671 Common EMEA/FDA Application for Orphan Medicinal Product Designation 0167_Form 3671.pdf Yes Yes Fillable Fileable Signable
Form and Instruction Form 4035 FDA Application for Orphan Medicinal Product Designation 0167_FDA-4035.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

496 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 620 0 0 470 0 150
Annual IC Time Burden (Hours) 19,840 0 0 13,090 0 6,750
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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