{"abstract":"The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice 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/2015/08/03/2015-18914.html","cfr_references":[],"citation":"80 FR 46028","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":"2015-18914","effective_on":null,"end_page":46032,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/03/2015-18914.xml","html_url":"https://www.federalregister.gov/documents/2015/08/03/2015-18914/prescription-drug-user-fee-rates-for-fiscal-year-2016","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-18914?publication_date=2015-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-03/2015-18914/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":7736,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18914.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-18914.pdf?1438346774","publication_date":"2015-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/03/2015-18914.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":"2015-08-23T06:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46028,"subtype":null,"title":"Prescription Drug User Fee Rates for Fiscal Year 2016","toc_doc":"Prescription Drug User Fee Rates for Fiscal Year 2016","toc_subject":null,"topics":[],"type":"Notice","volume":80}