{"abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining the patient perspective on disease severity and currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for consideration in patient-focused drug development meetings during fiscal years (FYs) 2016-2017. The public is invited to comment on this preliminary list through a public docket.","action":"Request for comments.","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/2014/10/08/2014-23965.html","cfr_references":[],"citation":"79 FR 60857","comment_url":null,"comments_close_on":"2014-12-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by December 5, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0967"],"dockets":[],"document_number":"2014-23965","effective_on":null,"end_page":60859,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/08/2014-23965.xml","html_url":"https://www.federalregister.gov/documents/2014/10/08/2014-23965/prescription-drug-user-fee-act-patient-focused-drug-development-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-23965?publication_date=2014-10-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-08/2014-23965/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":4043,"last_updated":"2026-10-24 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-08/pdf/2014-23965.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-23965.pdf?1412685849","publication_date":"2014-10-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/08/2014-23965.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":"2015-01-12T19:44:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60857,"subtype":null,"title":"Prescription Drug User Fee Act Patient-Focused Drug Development; Request for Comments","toc_doc":"Prescription Drug User Fee Act Patient-Focused Drug Development","toc_subject":null,"topics":[],"type":"Notice","volume":79}