Federal Register #FDA-2026-N-3240

FDA requests public comment on information collection for prescription drug importation programs

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public comment on its proposed information collection for prescription drug importation programs. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Request for public input on information collection related to prescription drug importation - Supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act - Scope: - Procedures for importation program sponsors - Criteria for FDA review and authorization - Requirements for eligible prescription drugs and entities involved in importation - Notable Details: - No specific OEMs, vendors, products, or purchase quantities are requested - The opportunity is for information collection, not procurement of goods or services - Unique Requirements: - Focus on regulatory compliance, public health, and safety - Input sought from stakeholders on information collection processes

Description

The Food and Drug Administration (FDA) is requesting comments on a proposed collection of information related to the importation of prescription drugs. This collection supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act and applicable regulations, which aim to reduce the cost of covered products to American consumers without additional risk to public health and safety. The regulations set forth procedures for importation program sponsors, criteria for FDA review and authorization, and requirements for eligible prescription drugs and entities involved in importation. Comments are due by September 28, 2026.

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