{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria.\" The draft guidance document provides blood establishments that collect blood and blood components with FDA's revised recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The guidance recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species (spp.), the causative agents of malaria. The draft guidance, when finalized, is intended to supersede the document entitled \"Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria,\" dated December 2022.","action":"Notice of availability.","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/2025/01/16/2025-01028.html","cfr_references":[],"citation":"90 FR 4750","comment_url":null,"comments_close_on":"2025-03-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 17, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2000-D-0187"],"dockets":[{"supporting_documents":[{"title":"Reference 23 Malaria Surveillance United States 2016 MMWR","document_id":"FDA-2000-D-0187-0070"},{"title":"Reference 19 - Israelyan N","document_id":"FDA-2000-D-0187-0066"},{"title":"Reference 18 - Khan J","document_id":"FDA-2000-D-0187-0065"},{"title":"Reference 17 - Dike A","document_id":"FDA-2000-D-0187-0064"},{"title":"Reference 16 - Neiderhauer C","document_id":"FDA-2000-D-0187-0063"},{"title":"Reference 15 - Stubbs L","document_id":"FDA-2000-D-0187-0062"},{"title":"Reference 14 - Anand A","document_id":"FDA-2000-D-0187-0061"},{"title":"Reference 12 - Uneke C","document_id":"FDA-2000-D-0187-0059"},{"title":"Malaria Guidance 2024-434","document_id":"FDA-2000-D-0187-0058"},{"title":"Reference 10 - Mungai M","document_id":"FDA-2000-D-0187-0057"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-01-16","updated_at":"2025-01-24T14:55:55.979-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2000-D-0187-0046","allow_late_comments":false,"id":"FDA-2000-D-0187-0046","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":42,"id":"FDA-2000-D-0187","title":"Recommendations for Donor Questioning Regarding Malaria"}],"document_number":"2025-01028","effective_on":null,"end_page":4751,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/16/2025-01028.xml","html_url":"https://www.federalregister.gov/documents/2025/01/16/2025-01028/recommendations-to-reduce-the-risk-of-transfusion-transmitted-malaria-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-01028?publication_date=2025-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-16/2025-01028/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":388,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-16/pdf/2025-01028.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01028.pdf?1736948753","publication_date":"2025-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/16/2025-01028.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 23 Malaria Surveillance United States 2016 MMWR","document_id":"FDA-2000-D-0187-0070"},{"title":"Reference 19 - Israelyan N","document_id":"FDA-2000-D-0187-0066"},{"title":"Reference 18 - Khan J","document_id":"FDA-2000-D-0187-0065"},{"title":"Reference 17 - Dike A","document_id":"FDA-2000-D-0187-0064"},{"title":"Reference 16 - Neiderhauer C","document_id":"FDA-2000-D-0187-0063"},{"title":"Reference 15 - Stubbs L","document_id":"FDA-2000-D-0187-0062"},{"title":"Reference 14 - Anand A","document_id":"FDA-2000-D-0187-0061"},{"title":"Reference 12 - Uneke C","document_id":"FDA-2000-D-0187-0059"},{"title":"Malaria Guidance 2024-434","document_id":"FDA-2000-D-0187-0058"},{"title":"Reference 10 - Mungai M","document_id":"FDA-2000-D-0187-0057"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2000-D-0187","supporting_documents_count":42,"docket_id":"FDA-2000-D-0187","document_id":"FDA-2000-D-0187-0046","regulation_id_number":null,"title":"Recommendations for Donor Questioning Regarding Malaria","checked_regulationsdotgov_at":"2025-01-25T18:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4750,"subtype":null,"title":"Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability","toc_doc":"Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}