Content and format of a request for orphan-drug designation

Orphan Drug Regulations

OMB: 0910-0702

IC ID: 199797

Documents and Forms
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Content and format of a request for orphan-drug designation
 
No Modified
 
Mandatory
 
21 CFR 316.20(b)(2)

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

Health Immunization Management

 

20 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 20 0 20 0 0 0
Annual IC Time Burden (Hours) 4 0 4 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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