Expanded Access to Investigational Drugs for Treatment Use

ICR 202309-0910-005

OMB: 0910-0814

Federal Form Document

ICR Details
0910-0814 202309-0910-005
Received in OIRA 202203-0910-005
Expanded Access to Investigational Drugs for Treatment Use
Revision of a currently approved collection   No
Regular 09/07/2023
  Requested Previously Approved
36 Months From Approved 06/30/2025
13,910 13,910
255,326 255,326
0 0

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.

US Code: 21 USC 360bbb Name of Law: FD&C Act; Expanded Access to Unapproved Therapies and Diagnostics

Not associated with rulemaking

  86 FR 71069 12/14/2021
88 FR 30131 05/10/2023

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 13,910 13,910 0 0 0 0
Annual Time Burden (Hours) 255,326 255,326 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
We have made no changes to the approved burden estimate, however, on our own initiative, and for efficiency of agency operations, we are revising Form FDA 3926 to facilitate the submission of information.

Domini Bean 301 796-5733 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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