Federal Register #2026-15342

FDA Announces FY 2027 Outsourcing Facility and Third-Party Certification Program Fee Rates

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, announces fiscal year 2027 fee rates for outsourcing facilities that compound human drugs and for third-party certification bodies under the Food Safety Modernization Act (FSMA). - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No OEMs or commercial vendors are involved; this is a regulatory fee notice, not a procurement of products or services. - Products/Services and Fees: - Qualified Small Business Establishment Fee: $7,142 for outsourcing facilities qualifying as small businesses - Non-Small Business Establishment Fee: $22,074 for non-small businesses - Reinspection Fee: $21,427 for each reinspection of an outsourcing facility - Third-Party Certification Program User Fee: Annual and application fees for accreditation and certification bodies under FSMA - Notable Requirements: - Eligibility criteria for small business fee reductions and waivers - Payment procedures and deadlines for outsourcing facilities and certification bodies - Fees are set for the full fiscal year 2027 - No procurement of goods or services is solicited; this is a regulatory announcement establishing fee rates.

Description

The Food and Drug Administration (FDA) announces the fiscal year 2027 rates for establishment and reinspection fees for entities compounding human drugs and registering as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act. The fees include a small business establishment fee of $7,142, a non-small business establishment fee of $22,074, and a reinspection fee of $21,427. The document details how these fees were calculated and outlines payment procedures for outsourcing facilities. These fees are effective from October 1, 2026, through September 30, 2027.

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