Expanded Individual Patient Access Application Submissions

Individual Patient Expanded Access Applications

OMB: 0910-0814

IC ID: 220651

Information Collection (IC) Details

View Information Collection (IC)

Expanded Individual Patient Access Application Submissions CDER
 
No Modified
 
Mandatory
 
21 CFR 312.300-312.320

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0814 Exp Access GFI Updated Oct 2017.pdf Yes Yes Fillable Fileable
Form Form FDA 3926 Individual Patient Expanded Access Investigational New Drug Application 0814_Form FDA 3926_2021.pdf Yes Yes Fillable Fileable
Instruction 0814_Form FDA 3926_Instructional Supplement_2021.pdf Yes Yes Fillable Fileable
Other-eSubmitter screenshots 0814 submission app screenshots SEP 2020.pdf Yes Yes Fillable Fileable

Health Health Care Services

 

790 790
   
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 2,394 0 0 0 0 2,394
Annual IC Time Burden (Hours) 1,796 0 0 0 0 1,796
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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