{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff.\" The draft guidance document provides human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff with recommendations for meeting the criterion of \"minimal manipulation\" as it applies to HCT/Ps. The draft guidance, when finalized, is intended to supersede the document entitled \"Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update\" dated September 2006. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2014/12/23/2014-30011.html","cfr_references":[],"citation":"79 FR 77012","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 23, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1696"],"dockets":[],"document_number":"2014-30011","effective_on":null,"end_page":77013,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/23/2014-30011.xml","html_url":"https://www.federalregister.gov/documents/2014/12/23/2014-30011/minimal-manipulation-of-human-cells-tissues-and-cellular--and-tissue-based-products-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-30011?publication_date=2014-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-23/2014-30011/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1123,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-23/pdf/2014-30011.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-30011.pdf?1419257378","publication_date":"2014-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/23/2014-30011.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-1696","supporting_documents_count":0,"docket_id":"FDA-2014-D-1696","regulation_id_number":null,"title":"Guidance for Industry and Food and Drug Administration Staff Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products","checked_regulationsdotgov_at":"2015-02-24T05:00:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":77012,"subtype":null,"title":"Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}