Changes in ownership of orphan drug designation

Orphan Drugs

OMB: 0910-0167

IC ID: 181016

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Information Collection (IC) Details

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Changes in ownership of orphan drug designation
 
No Removed
 
Mandatory
 
21 CFR 316.27

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

Health Consumer Health and Safety

 

63 0
   
Private Sector Businesses or other for-profits
 
   3 %

  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 0 0 0 -63 0 63
Annual IC Time Burden (Hours) 0 0 0 -315 0 315
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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