Federal Register #FDA-2026-N-8690

FDA Seeks Public Comment on Information Collection for Human Drug Compounding Outsourcing Facility Registration

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public comment on its proposed information collection for the registration of human drug compounding outsourcing facilities. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No Original Equipment Manufacturers (OEMs) or commercial vendors are named or involved - Products/Services Requested: - This is not a procurement; no products or services are being purchased - The notice concerns the collection of information from facilities that compound human drugs and elect to register as outsourcing facilities - Information to be collected includes: - Facility details, unique identifiers, and contact information - Annual drug product reports - Assessment and payment of establishment fees - Requests for small business fee reductions (Form FDA 3908) - Reinspection fees and dispute resolution processes - Registration information must be submitted electronically in Structured Product Labeling (SPL) format unless a waiver is granted - Unique/Notable Requirements: - Focus on regulatory compliance and reporting, not procurement - Estimated annual reporting and recordkeeping burden is provided for public awareness - Public comment is requested on the proposed information collection, not on any acquisition or contract

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees. Facilities that compound drugs may elect to register as outsourcing facilities and must provide annual registration information including facility details and drug product reports. The collection also covers the assessment of establishment fees, small business fee reductions, reinspection fees, and dispute resolution processes. Comments on the information collection must be submitted by October 30, 2026.

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