Dear Colleague,
This message is in reference to the March 18, 2026, Food and Drug Administration Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026. ” The fiscal year (FY) 2026 Over-the-Counter (OTC) monograph drug facility user fees are due today, June 1, 2026. 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 to 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 drug user fee program (OMUFA), please visit our OMUFA user fee website.
FDA issued FY 2026 OMUFA facility user fee invoices on April 20, 2026.
If you have submitted your FY 2026 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 Staff at CDERCollections@fda.hhs.gov.
Respectfully,
Division of User Fee Management
On detail to Office of Operations | Office of Finance, Budget, and Acquisitions
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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