{"abstract":"The Federal Food, Drug, and Cosmetic Act (FD&C Act), 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, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2018/07/27/2018-16067.html","cfr_references":[],"citation":"83 FR 35649","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0007"],"dockets":[],"document_number":"2018-16067","effective_on":null,"end_page":35653,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/07/27/2018-16067.xml","html_url":"https://www.federalregister.gov/documents/2018/07/27/2018-16067/generic-drug-user-fee-rates-for-fiscal-year-2019","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-16067?publication_date=2018-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-07-27/2018-16067/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":4960,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-07-27/pdf/2018-16067.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-16067.pdf?1532609125","publication_date":"2018-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/07/27/2018-16067.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2018-08-16T10:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35649,"subtype":null,"title":"Generic Drug User Fee Rates for Fiscal Year 2019","toc_doc":"Generic Drug User Fee Rates for Fiscal Year 2019","toc_subject":null,"topics":[],"type":"Notice","volume":83}