OMB control number

Expanded Access to Investigational Drugs for Treatment Use

OMB 0910-0814 · HHS/FDA.

OMB 0910-0814

This ICR collects information from licensed physicians who submit requests for expanded access to investigational drugs on behalf of individual patients. We are revising Form FDA 3926, which requires the completion of certain data fields. Applicable regulations are found in 21 CFR 312, subpart I - Expanded Access to Investigational Drugs for Treatment Use.

The latest form for Expanded Access to Investigational Drugs for Treatment Use expires 2026-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3926 (CBER) Submissions related to emergency use of an investigational new drug Form
Form FDA 3926 (CBER) Submissions related to expanded access and treatment of an individual patient Form
Form FDA 3926 (CDER) Submissions related to emergency use of an investigational new drug Form
0814 Individual Patient Access SSA 2023 to revise form REV.docx Supporting Statement A
(CBER) Submissions related to a treatment IND or treatment protocol
(CBER) Submissions related to expanded access and treatment of an intermediate-size patient population
(CBER) Submissions related to emergency use of an investigational new drug Form
(CBER) Submissions related to expanded access and treatment of an individual patient Form
(CDER) Submissions related to a treatment IND or treatment protocol
(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population
(CDER) Submissions related to emergency use of an investigational new drug Form
Expanded Access to Investigational Drugs for Treatment Use Submissions Other-eSubmitter Screenshots

All Historical Document Collections

202309-0910-005 Approved without change	Revision of a currently approved collection	2023-09-07
202203-0910-005 Approved without change	Revision of a currently approved collection	2022-04-29
202106-0910-011 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-06-22
202009-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-09-09
201903-0910-003 Approved without change	Extension without change of a currently approved collection	2019-04-23
201706-0910-002 Approved with change	No material or nonsubstantive change to a currently approved collection	2017-06-06
201603-0910-009 Approved with change	New collection (Request for a new OMB Control Number)	2016-03-24

OMB Details

Expanded Access to Investigational Drugs for Treatment Use Submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3926

Individual Patient Expanded Access Investigational New Drug Application (IND)

Fillable Fileable

Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.