💰FY 2026 Animal Generic Drug User Fee Rates and Procedures
Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2026 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2026.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The content outlines new fee rates and payment procedures for the Generic New Animal Drug User Fee Program for FY 2026, imposing financial obligations on businesses engaged in this sector. This includes application fees for generic drug submissions and various associated costs, which are crucial for compliance with FDA regulations.