Federal Register #FDA-2026-N-7426

FDA Requests Public Comment on Information Collection for Expanded Access to Investigational Drugs

This opportunity is a request for public comment from the Food and Drug Administration (FDA) regarding information collection for expanded access to investigational drugs for treatment use. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - FDA seeks feedback on its proposed collection of information supporting regulations for expanded access to investigational drugs, biologics, and approved drugs for treatment use when no satisfactory alternatives exist. - Scope: - Covers information collection for individual patient requests, intermediate-size patient populations, and treatment protocols. - Involves use of Form FDA 3926 and Form FDA 1571 for submissions. - Notable Details: - No specific OEMs, vendors, or commercial products are involved. - The request is focused on regulatory information collection, not procurement of goods or services. - Stakeholders include licensed physicians and other parties involved in expanded access requests. - No products or services are being procured as part of this notice.

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to expanded access to investigational drugs for treatment use. This collection supports regulations governing the use of investigational new drugs, biologics, and approved drugs when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The expanded access program facilitates availability of such products to patients with serious diseases or conditions when no comparable or satisfactory alternative therapy exists. Comments on this information collection must be submitted by September 28, 2026.

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