Granting orphan-drug designation

Orphan Drug Regulations

OMB: 0910-0702

IC ID: 199798

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Granting orphan-drug designation
 
No Modified
 
Mandatory
 
21 CFR 316.24(a)

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

Health Immunization Management

 

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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 10 0 10 0 0 0
Annual IC Time Burden (Hours) 60 0 60 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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