(CBER) Submissions related to expanded access and treatment of an individual patient

Expanded Access to Investigational Drugs for Treatment Use

OMB: 0910-0814

IC ID: 253121

Information Collection (IC) Details

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(CBER) Submissions related to expanded access and treatment of an individual patient
 
No Removed
 
Required to Obtain or Retain Benefits
 
21 CFR 312

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3926 Individual Patient Expanded Access Investigational Form FDA 3926.pdf Yes Yes Fillable Fileable
Instruction FDA-3926_instructions.pdf Yes No Printable Only
Other-eSubmitter Screenshots eSubmitter Screenshots.pdf Yes No Fillable Fileable Signable
Other-Agency Guidance 0814_Guidance.pdf Yes No Printable Only

Health Consumer Health and Safety

 

118 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 0 0 0 -154 0 154
Annual IC Time Burden (Hours) 0 0 0 -1,232 0 1,232
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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