Federal Register #FDA-2026-N-8328

FDA Requests Public Comment on Information Collection for Imports and Electronic Import Entries

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public comment on its proposed collection of information related to imports and electronic import entries. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Scope of Request: - Collection of data elements for importing FDA-regulated articles into the United States - Includes submissions through: - Automated Commercial Environment (ACE) system - Weekly Entry Filing Program (WEF) - Import Trade Auxiliary Communication System (ITACS) - FDA Form 766 (Application for Authorization to Relabel or Recondition Non-compliant Articles) - FDA Form 5054 (New Inquiry Form—Import Compliance Branch) - Purpose: - Review imported products for admissibility - Facilitate communication with importers - Support regulatory requirements - Notable Requirements: - No products or services are being procured - No OEMs or vendors are mentioned - Focus is on information collection and feedback from the public - Submission Details: - Includes instructions for submitting comments and types of information required

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to imports and electronic import entries. This collection supports the required data elements that respondents must submit when importing FDA-regulated articles into the United States. It includes data submissions through the Automated Commercial Environment (ACE) system, the weekly entry filing program (WEF), the Import Trade Auxiliary Communication System (ITACS), and specific forms such as FDA 766 and FDA 5054. The information collected helps FDA review products for admissibility and improve communication with the import trade community. Comments on this collection are due by October 16, 2026.

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