

Start Further Info FOR FURTHER INFORMATION CONTACT: In this document, FDA is announcing fiscal year (FY) 2022 rates for GDUFA II fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs) drug master files (DMFs) generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities and generic drug applicant program user fees. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, Health and Human Services (HHS). Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of
#Federal register 2017 domestic segment fee rate pdf#
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