{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing to obtain input on the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection not responsive to standard therapies. FDA will consider scientific data and other information from the public hearing as we continue to consider ways to support the development of FMT to treat C. difficile infection not responsive to standard therapies and the impact of the enforcement policy on such development.","action":"Notification of public hearing; 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/2019/09/11/2019-19643.html","cfr_references":[{"chapter":null,"citation_url":null,"part":15,"title":21}],"citation":"84 FR 47911","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public hearing will be held on November 4, 2019, from 9 a.m. to 4 p.m. The hearing may be extended or may end early, depending on the level of public participation. Persons seeking to present or speak at the public hearing must register by October 8, 2019. Persons seeking to attend but not present at the public hearing must register by October 22, 2019. Section III of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until January 21, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-3631"],"dockets":[],"document_number":"2019-19643","effective_on":null,"end_page":47914,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/09/11/2019-19643.xml","html_url":"https://www.federalregister.gov/documents/2019/09/11/2019-19643/use-of-fecal-microbiota-for-transplantation-to-treat-clostridium-difficile-infection-not-responsive","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-19643?publication_date=2019-09-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-09-11/2019-19643/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":2617,"last_updated":"2026-04-22 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-09-11/pdf/2019-19643.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-19643.pdf?1568119521","publication_date":"2019-09-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/09/11/2019-19643.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-2019-N-3631","supporting_documents_count":0,"docket_id":"FDA-2019-N-3631","regulation_id_number":null,"title":"Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Public Hearing; Request for Comments","checked_regulationsdotgov_at":"2020-01-23T04:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47911,"subtype":null,"title":"Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Public Hearing; Request for Comments","toc_doc":"Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies","toc_subject":"Public Hearing:","topics":[],"type":"Proposed Rule","volume":84}