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 is listed under ICR 202309-0910-005.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
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	Information collection
(CBER) Submissions related to expanded access and treatment of an intermediate-size patient population	Information collection
(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	Information collection
(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population	Information collection
(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All Historical Document Collections

Historical document collections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

OMB Details

Expanded Access to Investigational Drugs for Treatment Use Submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
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.