{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled \"Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.\" The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.","action":"Notification 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/2017/11/17/2017-24839.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"82 FR 54289","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 17, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1584"],"dockets":[],"document_number":"2017-24839","effective_on":null,"end_page":54290,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/11/17/2017-24839.xml","html_url":"https://www.federalregister.gov/documents/2017/11/17/2017-24839/same-surgical-procedure-exception-questions-and-answers-regarding-the-scope-of-the-exception","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-24839?publication_date=2017-11-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-11-17/2017-24839/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":769,"last_updated":"2026-08-26 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-11-17/pdf/2017-24839.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-24839.pdf?1510839930","publication_date":"2017-11-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/11/17/2017-24839.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-2014-D-1584","supporting_documents_count":0,"docket_id":"FDA-2014-D-1584","regulation_id_number":null,"title":"Same Surgical Procedure Exception under 21 CFR 1271.15(b):  Questions and Answers Regarding the Scope of the Exception","checked_regulationsdotgov_at":"2017-12-07T06:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54289,"subtype":null,"title":"Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability","toc_doc":"Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception","toc_subject":"Guidance:","topics":[],"type":"Rule","volume":82}