{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),\" dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled \"Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),\" dated August 2007.","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/2013/11/05/2013-26397.html","cfr_references":[],"citation":"78 FR 66366","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 February 3, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1213"],"dockets":[],"document_number":"2013-26397","effective_on":null,"end_page":66367,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/05/2013-26397.xml","html_url":"https://www.federalregister.gov/documents/2013/11/05/2013-26397/draft-guidance-for-industry-use-of-donor-screening-tests-to-test-donors-of-human-cells-tissues-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-26397?publication_date=2013-11-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-05/2013-26397/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":125,"last_updated":"2026-07-28 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-05/pdf/2013-26397.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-26397.pdf?1383572980","publication_date":"2013-11-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/05/2013-26397.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-01-05T05:00:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66366,"subtype":null,"title":"Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Availability","toc_doc":"Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":78}