Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
(CBER) Submissions related to a treatment IND or treatment protocol New 15 4500 0
(CBER) Submissions related to emergency use of an investigational new drug New 6704 107264 0 Form FDA 3926
Instruction
Other-eSubmitter Screenshots
Other-Agency Guidance
(CBER) Submissions related to expanded access and treatment of an individual patient New 154 1232 0 Form FDA 3926
Instruction
Other-eSubmitter Screenshots
Other-Agency Guidance
(CBER) Submissions related to expanded access and treatment of an intermediate-size patient population New 28 3360 0
(CDER) Submissions related to a treatment IND or treatment protocol New 140 42000 0
(CDER) Submissions related to emergency use of an investigational new drug New 3542 56672 0 Form FDA 3926
Instruction
Other-eSubmitter Screenshots
Other-Agency Guidance
(CDER) Submissions related to expanded access and treatment of an individual patient New 3010 2258 0 Form Individual Patient Expanded Access Investigational
Instruction
Other-eSubmitter Screenshots
Other-Agency Guidance
(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population New 317 38040 0
Expanded Individual Patient Access Application Submissions Removed 0 0 0 Other-Agency Guidance
Form Form FDA 3926
Instruction
Other-eSubmitter screenshots
Total burden requested under this ICR: 13910 255326 0  
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