{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System\" dated June 2013. The draft guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution. The guidance document is intended to assist manufacturers obtain a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements. The draft guidance, when finalized, is intended to supersede the guidance entitled \"Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications\" dated October 2009.","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/2013/06/17/2013-14097.html","cfr_references":[],"citation":"78 FR 36196","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-D-0157"],"dockets":[],"document_number":"2013-14097","effective_on":null,"end_page":36197,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/17/2013-14097.xml","html_url":"https://www.federalregister.gov/documents/2013/06/17/2013-14097/draft-guidance-for-industry-biologics-license-applications-for-minimally-manipulated-unrelated","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-14097?publication_date=2013-06-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-17/2013-14097/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":218,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-17/pdf/2013-14097.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-14097.pdf?1371214486","publication_date":"2013-06-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/17/2013-14097.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-08-04T05:00:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36196,"subtype":null,"title":"Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability","toc_doc":"Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood, etc.","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}