Back to: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
🔔 Note: Stop playback at 30:05 to complete this lesson.
Presenters
LCDR Tramara Dam, PharmD, MBA, BCSCP, GWCPM
Senior 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)
US Food & Drug Administration (FDA)
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)
US Food & Drug Administration (FDA)
Abstract
This presentation provides an overview of the OTC Monograph Drug User Fee (OMUFA) program, established by the CARES Act. OMUFA authorizes the FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and requesters of OTC monograph order requests (OMORs). These fees help support the FDA’s regulatory activities, including facility inspections and submission reviews, ultimately aiming to facilitate public access to innovative OTC monograph drugs. Key fee types include annual facility fees for Monograph Drug Facilities (MDFs) and Contract Manufacturing Organizations (CMOs), and OMOR fees, categorized as Tier One or Tier Two. Facilities must accurately register within the Electronic Drug Registration and Listing System (eDRLS) to determine their fee liability; for example, the FY 2024 facility fee is based on activity from January 1, 2023, through December 31, 2023. The presentation also details the fee payment process, penalties for non-payment (such as products being deemed misbranded and OMORs not accepted), and criteria for refund eligibility. Specific exemptions from OMUFA fees are discussed, including certain hand sanitizer manufacturers during the COVID-19 public health emergency.