THIS IS THE BIG DEAL PART - Hand Sanitizers Manufacturers for PHE will start to incur fees for FY 2025:
Consistent with the Department of Health and Human Services’ (HHS) Notice published on January 12, 2021, and FDA’s OMUFA fee rate notices for FYs 2021-2023, FDA will not assess OMUFA facility fees for FY 2024 upon those firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE. However, the agency is highlighting in its March 29, 2024 Federal Register Notice titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2024” the following information for stakeholders in the interest of transparency regarding the agency’s planning for assessment of OMUFA facility fees for FY 2025;
Accordingly, as the PHE expired on May 11, 2023, those facilities that “continue to manufacture” solely hand sanitizer products as of December 31, 2024 will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025. Conversely, if such facilities cease manufacturing hand sanitizer products and delist and deregister to reflect that before 12:00 am EST on December 31, 2024, they will not be identified as an OTC monograph drug facility and will not be considered fee liable for purposes of FY 2025 OMUFA facility fees.
FY 2024 Facility User Fee Rates
Monograph Drug Facility (MDF) Facility Fee
$ 34,166
Contract Manufacturing Organization (CMO) Facility Fee
$ 22,777
Today, the U.S. Food and Drug Administration announced the over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) facility fee rates for fiscal year (FY) 2024 in a Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2024.” Refer to the Federal Register notice here: https://lnkd.in/eTkAt5fr
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