{"abstract":"The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled \"Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).\" Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases.","action":"Notice of public workshop.","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/2013/08/14/2013-19684.html","cfr_references":[],"citation":"78 FR 49530","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public workshop will be held on October 21 and 22, 2013, from 8:30 a.m. to 5 p.m.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0001"],"dockets":[],"document_number":"2013-19684","effective_on":null,"end_page":49530,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/14/2013-19684.xml","html_url":"https://www.federalregister.gov/documents/2013/08/14/2013-19684/gastroenterology-regulatory-endpoints-and-the-advancement-of-therapeutics-public-workshop","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-19684?publication_date=2013-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-14/2013-19684/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":845,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-14/pdf/2013-19684.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-19684.pdf?1376398233","publication_date":"2013-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/14/2013-19684.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Transcripts Great Workshop II - Day 2 - FINAL","document_id":"FDA-2013-N-0001-0131"},{"title":"Transcripts Great Workshop II - Day 1 - FINAL","document_id":"FDA-2013-N-0001-0130"},{"title":"FDA ICCR Public Meeting  (May 8 2013) Transcript","document_id":"FDA-2013-N-0001-0129"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0001","supporting_documents_count":3,"docket_id":"FDA-2013-N-0001","regulation_id_number":null,"title":"Advisory Committee, Workshops, and Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc)","checked_regulationsdotgov_at":"2013-09-03T06:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49530,"subtype":null,"title":"Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop","toc_doc":"Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":78}