{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled \"Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria\" dated June 2012. The draft guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. This guidance replaces the draft guidance entitled \"Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria\" dated June 2000. The draft guidance, when finalized, will supersede the FDA memorandum to all registered blood establishments entitled \"Recommendations for Deferral of Donors for Malaria Risk\" dated July 26, 1994. The recommendations contained in the draft guidance are not applicable to donors of Source Plasma.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2012/07/06/2012-16528.html","cfr_references":[],"citation":"77 FR 40068","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 4, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2000-D-0187 Formerly Docket No. 2000D-1267"],"dockets":[],"document_number":"2012-16528","effective_on":null,"end_page":40069,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/07/06/2012-16528.xml","html_url":"https://www.federalregister.gov/documents/2012/07/06/2012-16528/draft-guidance-for-industry-recommendations-for-donor-questioning-deferral-reentry-and-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-16528?publication_date=2012-07-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-07-06/2012-16528/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":198,"last_updated":"2026-10-24 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/2012-16528.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-16528.pdf?1341492609","publication_date":"2012-07-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/07/06/2012-16528.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_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","regulation_id_number":null,"title":"Recommendations for Donor Questioning Regarding Malaria","checked_regulationsdotgov_at":"2012-09-06T05:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40068,"subtype":null,"title":"Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria; Availability","toc_doc":"Donor Questioning, Deferral, Reentry, etc. to Reduce Risk of Transfusion-Transmitted Malaria","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":77}