(CBER) Submissions related to emergency use of an investigational new drug

Expanded Access to Investigational Drugs for Treatment Use

OMB: 0910-0814

IC ID: 253122

Information Collection (IC) Details

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(CBER) Submissions related to emergency use of an investigational new drug
 
No New
 
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 Yes Fillable Fileable Signable
Other-Agency Guidance 0814_Guidance.pdf Yes No Printable Only

Health Consumer Health and Safety

 

1,591 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 6,704 0 0 6,704 0 0
Annual IC Time Burden (Hours) 107,264 0 0 107,264 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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