Permanent resident agent for foreign sponsor

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

OMB: 0910-0167

IC ID: 181015

Documents and Forms
Document Name
Document Type
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Information Collection (IC) Details

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Permanent resident agent for foreign sponsor
 
No Modified
 
Mandatory
 
21 CFR 316.22

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

Health Immunization Management

 

55 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 55 0 0 25 0 30
Annual IC Time Burden (Hours) 110 0 0 50 0 60
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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