{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled \"Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception\" dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.","action":"Request for comment on draft guidance.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2014/10/23/2014-25217.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"79 FR 63348","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 22, 2014","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1584"],"dockets":[],"document_number":"2014-25217","effective_on":null,"end_page":63349,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/23/2014-25217.xml","html_url":"https://www.federalregister.gov/documents/2014/10/23/2014-25217/same-surgical-procedure-exception-questions-and-answers-regarding-the-scope-of-the-exception-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-25217?publication_date=2014-10-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-23/2014-25217/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":387,"last_updated":"2026-07-27 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-23/pdf/2014-25217.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-25217.pdf?1413991334","publication_date":"2014-10-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/23/2014-25217.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":"2015-01-12T19:46:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63348,"subtype":null,"title":"Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability","toc_doc":"Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception","toc_subject":"Guidance:","topics":[],"type":"Proposed Rule","volume":79}