{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium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 2014. This draft guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion regarding the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, provided the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for use of the FMT products, the stool is obtained from a donor known to either the patient or the licensed health care provider treating the patient, and the donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product to treat his or her patient. This draft guidance, when finalized, is intended to supersede the guidance document entitled \"Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal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,\" dated July 2013 (July 2013 Guidance).","action":"Notice.","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/2014/02/26/2014-04095.html","cfr_references":[],"citation":"79 FR 10814","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 March 28, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0811"],"dockets":[],"document_number":"2014-04095","effective_on":null,"end_page":10815,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/26/2014-04095.xml","html_url":"https://www.federalregister.gov/documents/2014/02/26/2014-04095/guidance-for-industry-enforcement-policy-regarding-investigational-new-drug-requirements-for-use-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-04095?publication_date=2014-02-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-26/2014-04095/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":674,"last_updated":"2026-10-24 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-26/pdf/2014-04095.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-04095.pdf?1393336464","publication_date":"2014-02-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/26/2014-04095.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-21T05:00:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10814,"subtype":null,"title":"Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; 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 for Industry:","topics":[],"type":"Notice","volume":79}