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Dear Colleague,
This message is in reference to the March 29, 2024, Food and Drug Administration Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024”. The fiscal year (FY) 2024 Over-the-Counter (OTC) monograph drug facility fees are due today, June 3, 2024. If you are a qualifying owner of an OTC monograph drug facility, as described in sections 744M and 744L of the Federal Food, Drug, and Cosmetic Act, please visit FDA’s payment portal and submit your payment. For more information on fee-qualifying OTC monograph drug facilities as well as fee payment options and procedures, please visit the aforementioned FRN. For more information on the OTC monograph user fee program (or OMUFA), please visit our OMUFA User Fee website.
If you have submitted your FY 2024 OMUFA facility user fee prior to this message, thank you for your attention to this matter and no further action is required at this time. If you have any questions regarding this message, please contact the OMUFA User Fee Team at CDERCollections@fda.hhs.gov.
Respectfully,
Division of User Fee Management
Office of Management
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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