federal_register: 2021-06361

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2021-06361 Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 Notice The Food and Drug Administration (FDA or the Agency) is announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. On March 27, 2020, new provisions were added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. FDA refers to the OTC Monograph Drug user fee program as "OMUFA" throughout this document. This notice publishes the OMUFA fee rates for FY 2021. 2021-03-26 2021 3 https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021 https://www.govinfo.gov/content/pkg/FR-2021-03-26/pdf/2021-06361.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. On March 27, 2020, new provisions were added to the Federal Food, Drug, and...  

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