Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)

Orphan Drug Products

OMB: 0910-0167

IC ID: 182669

Information Collection (IC) Details

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Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3671 COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION Final version of Common EMEA-FDA Application Form for Orphan Medicinal Product designationFINAL FORM.doc No No Paper Only

Health Consumer Health and Safety

 

40 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 40 0 40 0 0 0
Annual IC Time Burden (Hours) 1,280 0 1,280 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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