{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled \"Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,\" dated October 2009. In this guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This guidance (HPC-C licensure guidance) provides recommendations to manufacturers applying for licensure of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood, for specified indications. Elsewhere in this issue of the Federal Register, FDA is publishing a draft guidance entitled \"Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.\" FDA is also announcing the end of the phased-in implementation period for IND and biologics license application (BLA) requirements for minimally manipulated unrelated allogeneic hematopoietic stem/progenitor cell products. The HPC-C licensure guidance announced in this notice finalizes the draft guidance entitled \"Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies,\" dated December 2006.","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/2009/10/20/E9-25135.html","cfr_references":[],"citation":"74 FR 53753","comment_url":null,"comments_close_on":"2011-10-20","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments on agency guidances at any time. FDA no longer intends to exercise enforcement discretion with respect to IND and BLA requirements for minimally manipulated, unrelated allogeneic hematopoietic stem/progenitor cell products and the phase in implementation period for IND and BLA requirements will end after October 20, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-D-0157"],"dockets":[],"document_number":"E9-25135","effective_on":null,"end_page":53754,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/20/E9-25135.xml","html_url":"https://www.federalregister.gov/documents/2009/10/20/E9-25135/guidance-for-industry-minimally-manipulated-unrelated-allogeneic-placentalumbilical-cord-blood","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-25135?publication_date=2009-10-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-20/E9-25135/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":479,"last_updated":"2026-08-24 22:15:11 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-20/pdf/E9-25135.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-10-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/10/20/E9-25135.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-2006-D-0157","supporting_documents_count":337941,"docket_id":"FDA-2006-D-0157","regulation_id_number":null,"title":"Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies","checked_regulationsdotgov_at":"2009-10-23T17:28:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53753,"subtype":null,"title":"Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability","toc_doc":"Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":74}