{"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 functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. 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 functional GI disorders on daily life and patient views on 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/2015/02/11/2015-02804.html","cfr_references":[],"citation":"80 FR 7616","comment_url":null,"comments_close_on":"2015-07-13","correction_of":null,"corrections":[],"dates":"The public meeting will be held on May 11, 2015, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by May 1, 2015 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments to the public docket by July 13, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0244"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":46,"comment_start_date":"2015-02-11","updated_at":"2023-02-28T17:05:43.300-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-0244-0001","allow_late_comments":null,"id":"FDA-2015-N-0244-0001","comment_end_date":"2015-07-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-N-0244","title":"Patient-Focused Drug Development for Functional Gastrointestinal Disorders"}],"document_number":"2015-02804","effective_on":null,"end_page":7617,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/11/2015-02804.xml","html_url":"https://www.federalregister.gov/documents/2015/02/11/2015-02804/patient-focused-drug-development-for-functional-gastrointestinal-disorders-public-meeting-request","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-02804?publication_date=2015-02-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-11/2015-02804/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1448,"last_updated":"2026-07-27 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02804.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-02804.pdf?1423576476","publication_date":"2015-02-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/11/2015-02804.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":46,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0244","supporting_documents_count":0,"docket_id":"FDA-2015-N-0244","document_id":"FDA-2015-N-0244-0001","regulation_id_number":null,"title":"Patient-Focused Drug Development for Functional Gastrointestinal Disorders","checked_regulationsdotgov_at":"2023-02-28T22:05:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7616,"subtype":null,"title":"Patient-Focused Drug Development for Functional Gastrointestinal Disorders; Public Meeting; Request for Comments","toc_doc":"Patient-Focused Drug Development for Functional Gastrointestinal Disorders","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":80}