{"abstract":"The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA 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 the Food and Drug Administration (FDA or Agency) is announcing fiscal year (FY) 2018 rates for GDUFA 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/2017/08/29/2017-18377.html","cfr_references":[],"citation":"82 FR 41026","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":"2017-18377","effective_on":null,"end_page":41029,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/08/29/2017-18377.xml","html_url":"https://www.federalregister.gov/documents/2017/08/29/2017-18377/generic-drug-user-fee-rates-for-fiscal-year-2018","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-18377?publication_date=2017-08-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-08-29/2017-18377/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":11728,"last_updated":"2026-10-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-08-29/pdf/2017-18377.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-18377.pdf?1503924380","publication_date":"2017-08-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/08/29/2017-18377.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0007","supporting_documents_count":0,"docket_id":"FDA-2016-N-0007","regulation_id_number":null,"title":"Prescription Drug User Fee Act IV-Drug Safety","checked_regulationsdotgov_at":"2017-09-18T06:00:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41026,"subtype":null,"title":"Generic Drug User Fee Rates for Fiscal Year 2018","toc_doc":"Generic Drug User Fee Rates for Fiscal Year 2018","toc_subject":null,"topics":[],"type":"Notice","volume":82}