Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926

Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926

OMB: 0910-0814

IC ID: 220651

Information Collection (IC) Details

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Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926 CDER
 
No New
 
Mandatory
 
21 CFR 312.310

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE IP EXPANDED ACCESS 3-23-2016.doc Yes Yes Paper Only
Form 3926 Individual Patient Expanded Access Investigational New Drug Application FORM FDA 3926 FORM 3-23-2016.pdf Yes Yes Fillable Printable
Instruction FORM FDA 3926 INSTRUCTIONS 3-23-2016.pdf Yes Yes Paper Only

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

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