Federal Register #FDA-2026-N-7757

FDA and ONC Request Public Comment on Disclosure, Recordkeeping, and TEFCA Monitoring Requirements

This opportunity involves a request for public comment from the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health IT (ONC), both under the Department of Health and Human Services (HHS). - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of the National Coordinator for Health IT (ONC) - OEMs and Vendors: - No specific OEMs or vendors are mentioned; this is not a procurement for products or services. - Products/Services Requested: - Third-party disclosure and recordkeeping requirements for reportable food incidents - Notification to immediate previous sources and subsequent recipients of reportable food - Maintenance of records for two years as required by section 417 of the Federal Food, Drug, and Cosmetic Act - Routine customer feedback collection for TEFCA monitoring activities involving Qualified Health Information Networks (QHINs) - Unique or Notable Requirements: - The FDA seeks to extend information collection requirements to improve rapid identification and tracking of reportable food for public health protection - ONC requests clearance for ongoing feedback collection to monitor TEFCA activities - No procurement of goods or services; the notice is strictly for public comment on information collection and monitoring practices

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to third-party disclosure and recordkeeping requirements for reportable food, as mandated by the Paperwork Reduction Act of 1995. This involves notifications to immediate previous sources and subsequent recipients of reportable food and maintaining records for two years. The purpose is to enable FDA to quickly identify and track reportable food to protect public health. Comments are due by October 16, 2026.

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