{"abstract":"The Food and Drug Administration (FDA) is announcing a public meeting and 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 patient perspective on the disease severity and the currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for the patient-focused drug development initiative and the criteria used for nomination. The public is invited to comment on this preliminary list through a public docket and at a public meeting where FDA will provide an overview of the patient-focused drug development initiative with discussion of the nominated disease areas.","action":"Notice of public meeting; 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/2012/09/24/2012-23454.html","cfr_references":[],"citation":"77 FR 58849","comment_url":null,"comments_close_on":"2012-11-01","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by November 1, 2012. The public meeting will be held on October 25, 2012, from 9 a.m. to 12:30 p.m. Registration to attend the meeting must be received by October 18, 2012. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0967"],"dockets":[],"document_number":"2012-23454","effective_on":null,"end_page":58851,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/09/24/2012-23454.xml","html_url":"https://www.federalregister.gov/documents/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-23454?publication_date=2012-09-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-09-24/2012-23454/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":6023,"last_updated":"2026-10-22 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-24/pdf/2012-23454.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-23454.pdf?1348231869","publication_date":"2012-09-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/09/24/2012-23454.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":"2012-11-03T05:01:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":58849,"subtype":null,"title":"Prescription Drug User Fee Act Patient-Focused Drug Development; Public Meeting and Request for Comments","toc_doc":"Prescription Drug User Fee Act Patient-Focused Drug Development","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":77}