{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry.\" The guidance provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of retroviral vector-based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The guidance supersedes the document entitled \"Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,\" dated November 2006. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and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/2020/01/30/2020-01700.html","cfr_references":[],"citation":"85 FR 5448","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-1999-D-0081"],"dockets":[],"document_number":"2020-01700","effective_on":null,"end_page":5450,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/01/30/2020-01700.xml","html_url":"https://www.federalregister.gov/documents/2020/01/30/2020-01700/testing-of-retroviral-vector-based-human-gene-therapy-products-for-replication-competent-retrovirus","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-01700?publication_date=2020-01-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-01-30/2020-01700/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":421,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-01-30/pdf/2020-01700.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-01700.pdf?1580305539","publication_date":"2020-01-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/01/30/2020-01700.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 30 Martineau et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0083"},{"title":"Reference 28 Scholler et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0081"},{"title":"Reference 27 Mohanal et al 2016 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0080"},{"title":"Reference 24  Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events November 2006 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0077"},{"title":"Reference 21 Rowe et al 1970 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0074"},{"title":"Reference 20 Bassin et al 1971 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0073"},{"title":"Reference 19 Farley et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0072"},{"title":"Reference 7 Vanin et al 1994 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0060"},{"title":"Reference 5 Gunter et al 1993 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0058"},{"title":"Reference 1 Donahue et al 1992 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry","document_id":"FDA-1999-D-0081-0054"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1999-D-0081","supporting_documents_count":65,"docket_id":"FDA-1999-D-0081","regulation_id_number":null,"title":"Testing for Replication Competent Retrovirus in Retroviral","checked_regulationsdotgov_at":"2020-02-02T04:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5448,"subtype":null,"title":"Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry; Availability","toc_doc":"Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":85}