{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the selection of disease areas to be addressed during fiscal years (FYs) 2016-2017of its Patient-Focused Drug Development Initiative. This initiative is being conducted to fulfill FDA's performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides a more systematic approach under PDUFA V for obtaining the patients' perspective on disease severity and currently available treatments for a set of disease areas. FDA selected these disease areas based on a careful consideration of the public comments received after publication of a preliminary list of disease areas in the Federal Register on October 8, 2014.","action":"Notice of availability.","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/2015/07/02/2015-16359.html","cfr_references":[],"citation":"80 FR 38216","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0967"],"dockets":[],"document_number":"2015-16359","effective_on":null,"end_page":38217,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/07/02/2015-16359.xml","html_url":"https://www.federalregister.gov/documents/2015/07/02/2015-16359/prescription-drug-user-fee-act-patient-focused-drug-development-announcement-of-disease-areas-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-16359?publication_date=2015-07-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-07-02/2015-16359/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":931,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-07-02/pdf/2015-16359.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-16359.pdf?1435754827","publication_date":"2015-07-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/07/02/2015-16359.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-2012-N-0967","supporting_documents_count":0,"docket_id":"FDA-2012-N-0967","regulation_id_number":null,"title":"PDUFA V Patient-Focused Drug Development; Public Meeting and Request for Comments","checked_regulationsdotgov_at":"2015-07-22T06:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38216,"subtype":null,"title":"Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2016-2017","toc_doc":"Prescription Drug User Fee Act Patient-Focused Drug Development","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":80}