{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document 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,\" dated October 2009. In this draft guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This draft guidance provides advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor- investigators) to assist in the submission of an IND for certain HPC- Cs, when such HPC-Cs are not licensed in accordance with certain FDA regulations, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. This draft guidance document is applicable only to HPC-Cs intended for hematopoietic reconstitution in patients with the clinical indications listed in the guidance entitled \"Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications\" (HPC-C licensure guidance), published elsewhere in this issue of the Federal Register. FDA is also announcing that it no longer intends to exercise enforcement discretion with respect to the IND and biologics license application (BLA) requirements for minimally manipulated, unrelated allogeneic hematopoietic stem/progenitor cell products and the phase-in implementation period for IND and license application requirements will end as of October 20, 2011.","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/E9-25136.html","cfr_references":[],"citation":"74 FR 53751","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 electronic or written comments on the draft guidance by January 19, 2010.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0490"],"dockets":[],"document_number":"E9-25136","effective_on":null,"end_page":53752,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/20/E9-25136.xml","html_url":"https://www.federalregister.gov/documents/2009/10/20/E9-25136/draft-guidance-for-industry-and-food-and-drug-administration-staff-investigational-new-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-25136?publication_date=2009-10-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-20/E9-25136/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":34,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-20/pdf/E9-25136.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/E9-25136.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-2009-D-0490","supporting_documents_count":337941,"docket_id":"FDA-2009-D-0490","regulation_id_number":null,"title":"Draft 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; Availability","checked_regulationsdotgov_at":"2009-10-23T17:28:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53751,"subtype":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability","toc_doc":"Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood, etc.","toc_subject":"Draft Guidance for Industry and Food and Drug Administration Staff:","topics":[],"type":"Notice","volume":74}