Annual reports of holder of orphan drug designation

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: 181017

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Annual reports of holder of orphan drug designation
 
No Modified
 
Mandatory
 
21 CFR 316.30

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

744 0
   
Private Sector Businesses or other for-profits
 
   15 %

  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 744 0 0 294 0 450
Annual IC Time Burden (Hours) 2,232 0 0 882 0 1,350
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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