{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for Huntington's disease and Parkinson's disease. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of Huntington's disease and Parkinson's disease on daily life and patient views on treatment approaches. Although these are both neurological diseases, since they are quite distinct, FDA will structure this public meeting into two distinct sessions. The morning session, scheduled from 9 a.m. to 1 p.m., will be devoted to hearing patient perspectives on the impact of Huntington's disease on daily life and their views on currently available treatment approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m., will be devoted to obtaining patient perspectives on the impact of Parkinson's disease on daily life and patient views on currently available treatment approaches.","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/2015/07/17/2015-17556.html","cfr_references":[],"citation":"80 FR 42503","comment_url":null,"comments_close_on":"2015-11-23","correction_of":null,"corrections":[],"dates":"The public meeting will be held on September 22, 2015, from 9 a.m. to 5 p.m. Registration to attend the meeting must be received by September 14, 2015 (see SUPPLEMENTARY INFORMATION for instructions). Register here to attend the meeting: https:// pfddhuntingtonparkinson.eventbrite.com. Submit electronic or written comments to the public docket by November 23, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0967"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":139,"comment_start_date":"2015-07-17","updated_at":"2023-03-01T00:04:37.055-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2012-N-0967-0747","allow_late_comments":null,"id":"FDA-2012-N-0967-0747","comment_end_date":"2015-11-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2012-N-0967","title":"PDUFA V Patient-Focused Drug Development; Public Meeting and Request for Comments"}],"document_number":"2015-17556","effective_on":null,"end_page":42505,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/07/17/2015-17556.xml","html_url":"https://www.federalregister.gov/documents/2015/07/17/2015-17556/public-meeting-on-patient-focused-drug-development-for-huntingtons-and-parkinsons-diseases","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-17556?publication_date=2015-07-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-07-17/2015-17556/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2314,"last_updated":"2026-10-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-07-17/pdf/2015-17556.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-17556.pdf?1437050807","publication_date":"2015-07-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/07/17/2015-17556.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":139,"agency_id":"FDA","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","document_id":"FDA-2012-N-0967-0747","regulation_id_number":null,"title":"PDUFA V Patient-Focused Drug Development; Public Meeting and Request for Comments","checked_regulationsdotgov_at":"2023-03-01T05:04:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42503,"subtype":null,"title":"Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases","toc_doc":"Patient-Focused Drug Development for Huntington's and Parkinson's Diseases","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":80}