Federal Register #2604280115

Onshoring Agreements for Reduced Tariffs on Patented Pharmaceuticals

The Bureau of Industry and Security (BIS) within the Department of Commerce is seeking applications from pharmaceutical manufacturers for company-specific onshoring agreements to reduce Section 232 tariffs on patented pharmaceuticals and their ingredients. - Government Buyer: - Department of Commerce, Bureau of Industry and Security, Office of Strategic Industries and Economic Security - Eligible Applicants: - Pharmaceutical manufacturers producing patented pharmaceuticals and associated ingredients - Products/Services Requested: - Patented pharmaceutical products and associated pharmaceutical ingredients (no specific brands or part numbers listed) - Sodium nitrite (noted for countervailing duty review, not as a primary procurement target) - Key Requirements: - Submission of detailed onshoring plans, investment commitments, and production milestones - Comprehensive documentation including product details (HTSUS codes, brand names, active ingredients, manufacturing locations) - Periodic audited reports and certifications - Compliance with federal oversight, monitoring, and confidentiality provisions - Potential Most Favored Nation pricing agreements with the Department of Health and Human Services - Notable Details: - Open to all qualifying pharmaceutical manufacturers; no specific OEMs or brands named - Agreements are subject to approval, monitoring, and enforcement by the Department of Commerce - Program aims to increase domestic pharmaceutical manufacturing for national security

Description

This notice announces the procedures for companies manufacturing pharmaceutical products to apply for company-specific agreements with the Department of Commerce to onshore manufacturing of pharmaceutical products and their ingredients. Companies entering into such agreements are eligible for a reduced Section 232 duty rate on imports of their pharmaceutical products and associated ingredients. Applications must be submitted electronically within 30 days of publication, by June 12, 2026. The notice details the application process, documentation requirements, and enforcement provisions for these onshoring agreements.

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