Back to: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
Presenter
LCDR Yajun (Jason) Tu, PharmD, PhD, BCSCP
Program Management Officer
Division of User Fee Management (DUFM)
Policy and Operations Branch (POB)
Office of Management (OM)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Abstract
Lieutenant Commander Jason Tu details OTC Monograph Order Requests (OMORs), administrative requests to change OTC monograph conditions, categorized as Tier 1 or Tier 2 with varying fees. OMOR fees are generally due upon submission and are not included in the OMUFA target revenue, which is set at $36,467,000 for FY 2025 and is based on facility fees. The FY 2025 fee rates are MDF ($37,556), CMO ($25,037), Tier 1 OMOR ($559,777), and Tier 2 OMOR ($111,955). The presentation outlines the payment process and stressed the serious consequences of non-payment, including being placed on a public arrears list, products being deemed misbranded, denial of OMORs/meetings, and the accrual of interest and penalties. Refunds for overpayments or errors require a written request within 180 days.