{"abstract":"The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2016.","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/2015/08/03/2015-18915.html","cfr_references":[],"citation":"80 FR 46015","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0007"],"dockets":[],"document_number":"2015-18915","effective_on":null,"end_page":46019,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/03/2015-18915.xml","html_url":"https://www.federalregister.gov/documents/2015/08/03/2015-18915/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-18915?publication_date=2015-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-03/2015-18915/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":13469,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18915.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-18915.pdf?1438346775","publication_date":"2015-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/03/2015-18915.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-2015-N-0007","supporting_documents_count":0,"docket_id":"FDA-2015-N-0007","regulation_id_number":null,"title":"Prescription Drug User Fee Act IV-Drug Safety","checked_regulationsdotgov_at":"2015-08-23T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46015,"subtype":null,"title":"Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016","toc_doc":"Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016","toc_subject":"Generic Drug User Fee:","topics":[],"type":"Notice","volume":80}