{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled \"Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry.\" The draft guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. This draft guidance, when finalized, will supersede the guidance entitled, \"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry\" dated April 2020 and updated August 2020.","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/2023/01/30/2023-01796.html","cfr_references":[],"citation":"88 FR 5894","comment_url":null,"comments_close_on":"2023-03-31","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 31, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2015-D-1211"],"dockets":[{"supporting_documents":[{"title":"Reference 42_AABB_Updated Recommendations on Donor Deferral for Use of Antiretroviral Medications for HIV Prevention and Treatment re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0403"},{"title":"Reference 36_FAIR_Conclusions from the For the Assessment of Individualized Risk (FAIR) group re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0397"},{"title":"Reference 33- O Brien - Donor screening question alternatives to men who have sex with men time deferral  Potential (1) re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0394"},{"title":"Reference 7 Van de perre p re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0368"},{"title":"Reference 1 REV. Epstein_et_al-2013-Transfusion re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0362"},{"title":"Reference 18_FDA Blood Products Advisory Committee Meeting_September 14-15 2000","document_id":"FDA-2015-D-1211-0156"},{"title":"Reference 17_FDA Workshop on Donor Suitability 1998","document_id":"FDA-2015-D-1211-0155"},{"title":"Ref 37 - Custer - Transfusion-transmissible infection","document_id":"FDA-2015-D-1211-0111"},{"title":"Attachment 1 Article from CDC \"HIV Among Transgender People\" re: Comment from Rhode Island Blood Center","document_id":"FDA-2015-D-1211-0107"},{"title":"Ref. 41 Smith DK, Herbst JH, Zhang X, Rose CE, Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the united states, J Acquir Immune Defic Syndr 2015 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry","document_id":"FDA-2015-D-1211-0044"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-01-30","updated_at":"2023-02-24T23:09:05.849-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-D-1211-0151","allow_late_comments":null,"id":"FDA-2015-D-1211-0151","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":100,"id":"FDA-2015-D-1211","title":"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products"}],"document_number":"2023-01796","effective_on":null,"end_page":5895,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/01/30/2023-01796.xml","html_url":"https://www.federalregister.gov/documents/2023/01/30/2023-01796/recommendations-for-evaluating-donor-eligibility-using-individual-risk-based-questions-to-reduce-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-01796?publication_date=2023-01-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-01-30/2023-01796/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":656,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-30/pdf/2023-01796.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-01796.pdf?1674827135","publication_date":"2023-01-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/01/30/2023-01796.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 42_AABB_Updated Recommendations on Donor Deferral for Use of Antiretroviral Medications for HIV Prevention and Treatment re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0403"},{"title":"Reference 36_FAIR_Conclusions from the For the Assessment of Individualized Risk (FAIR) group re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0397"},{"title":"Reference 33- O Brien - Donor screening question alternatives to men who have sex with men time deferral  Potential (1) re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0394"},{"title":"Reference 7 Van de perre p re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0368"},{"title":"Reference 1 REV. Epstein_et_al-2013-Transfusion re: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry","document_id":"FDA-2015-D-1211-0362"},{"title":"Reference 18_FDA Blood Products Advisory Committee Meeting_September 14-15 2000","document_id":"FDA-2015-D-1211-0156"},{"title":"Reference 17_FDA Workshop on Donor Suitability 1998","document_id":"FDA-2015-D-1211-0155"},{"title":"Ref 37 - Custer - Transfusion-transmissible infection","document_id":"FDA-2015-D-1211-0111"},{"title":"Attachment 1 Article from CDC \"HIV Among Transgender People\" re: Comment from Rhode Island Blood Center","document_id":"FDA-2015-D-1211-0107"},{"title":"Ref. 41 Smith DK, Herbst JH, Zhang X, Rose CE, Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the united states, J Acquir Immune Defic Syndr 2015 re Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry","document_id":"FDA-2015-D-1211-0044"}],"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-2015-D-1211","supporting_documents_count":100,"docket_id":"FDA-2015-D-1211","document_id":"FDA-2015-D-1211-0151","regulation_id_number":null,"title":"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products","checked_regulationsdotgov_at":"2023-03-01T20:57:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5894,"subtype":null,"title":"Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability","toc_doc":"Evaluating Donor Eligibility using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}