{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled \"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry.\" The guidance document informs members of the medical and scientific community and other interested persons notice that, at this time, we intend to exercise enforcement discretion with respect to the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies under limited circumstances described in the guidance. The guidance announced in this notice finalizes the draft guidance entitled \"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies\" dated March 2016, and supersedes the guidance entitled \"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies\" dated July 2013.","action":"Notice of availability.","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/2022/11/29/2022-26000.html","cfr_references":[],"citation":"87 FR 73313","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 29, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0811"],"dockets":[{"supporting_documents":[{"title":"Attachment 2 Roman, M. Micro-Biome Restorative Therapy: Successful treatment of Dogs and Cats with Fecal Transplants  re: Comment from Margo Roman","document_id":"FDA-2013-D-0811-0070"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-11-29","updated_at":"2023-02-27T19:54:28.462-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-0811-0153","allow_late_comments":null,"id":"FDA-2013-D-0811-0153","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2013-D-0811","title":"Guidance for Industry:  Enforcement Policy Regarding IND Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability"}],"document_number":"2022-26000","effective_on":null,"end_page":73314,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/11/29/2022-26000.xml","html_url":"https://www.federalregister.gov/documents/2022/11/29/2022-26000/enforcement-policy-regarding-investigational-new-drug-requirements-for-use-of-fecal-microbiota-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-26000?publication_date=2022-11-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-11-29/2022-26000/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":942,"last_updated":"2026-09-22 00:15:09 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-29/pdf/2022-26000.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-26000.pdf?1669650503","publication_date":"2022-11-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/11/29/2022-26000.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 2 Roman, M. Micro-Biome Restorative Therapy: Successful treatment of Dogs and Cats with Fecal Transplants  re: Comment from Margo Roman","document_id":"FDA-2013-D-0811-0070"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0811","supporting_documents_count":1,"docket_id":"FDA-2013-D-0811","document_id":"FDA-2013-D-0811-0153","regulation_id_number":null,"title":"Guidance for Industry:  Enforcement Policy Regarding IND Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability","checked_regulationsdotgov_at":"2023-02-28T00:54:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":73313,"subtype":null,"title":"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry; Availability","toc_doc":"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}