{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document 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of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry.\" The draft guidance document provides members of the medical and scientific community and other interested persons with notice that, when finalized, we intend to exercise enforcement discretion under limited conditions, regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies. The draft guidance replaces the draft guidance of the same title dated March 2014 and, when finalized, is intended to supersede the document of the same title, dated July 2013.","action":"Notice of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/2016/03/01/2016-04372.html","cfr_references":[],"citation":"81 FR 10632","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 31, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0811"],"dockets":[],"document_number":"2016-04372","effective_on":null,"end_page":10633,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/01/2016-04372.xml","html_url":"https://www.federalregister.gov/documents/2016/03/01/2016-04372/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/2016-04372?publication_date=2016-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-01/2016-04372/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4341,"last_updated":"2026-08-24 22:15:11 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-01/pdf/2016-04372.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-04372.pdf?1456753572","publication_date":"2016-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/01/2016-04372.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_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","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":"2016-06-01T12:00:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10632,"subtype":null,"title":"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry; Availability","toc_doc":"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}