{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products\" dated July 2014. The draft guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development.","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/2014/07/09/2014-15991.html","cfr_references":[],"citation":"79 FR 38908","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 19, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0852"],"dockets":[{"supporting_documents":[{"title":"Reference 5 - Couch et al., The minimal infectious dose of adenovirus type 4; the case for natural transmission by viral aerosol re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic","document_id":"FDA-2014-D-0852-0008"},{"title":"Reference 4 - Health Canada, 2001. Material data safety sheet – infectious agents re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0007"},{"title":"Reference 3 - Schenk-Braat et al., An inventory of shedding data from clinical gene therapy trials re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0006"},{"title":"Reference 2 - Simon et al., Viral infections in paediatric patients receiving conventional cancer chemotherapy re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0005"},{"title":"Reference 1 - ICH Considerations: General principles to address virus and vector shedding re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0004"},{"title":"List of References re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0003"}],"agency_name":null,"documents":[{"comment_count":4,"comment_start_date":"2014-07-09","updated_at":"2023-03-01T13:13:12.882-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-0852-0001","allow_late_comments":null,"id":"FDA-2014-D-0852-0001","comment_end_date":"2014-11-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":6,"id":"FDA-2014-D-0852","title":"Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products"}],"document_number":"2014-15991","effective_on":null,"end_page":38908,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/07/09/2014-15991.xml","html_url":"https://www.federalregister.gov/documents/2014/07/09/2014-15991/draft-guidance-for-industry-design-and-analysis-of-shedding-studies-for-virus-or-bacteria-based-gene","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-15991?publication_date=2014-07-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-07-09/2014-15991/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":360,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-09/pdf/2014-15991.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-15991.pdf?1404823816","publication_date":"2014-07-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/07/09/2014-15991.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 5 - Couch et al., The minimal infectious dose of adenovirus type 4; the case for natural transmission by viral aerosol re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic","document_id":"FDA-2014-D-0852-0008"},{"title":"Reference 4 - Health Canada, 2001. Material data safety sheet – infectious agents re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0007"},{"title":"Reference 3 - Schenk-Braat et al., An inventory of shedding data from clinical gene therapy trials re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0006"},{"title":"Reference 2 - Simon et al., Viral infections in paediatric patients receiving conventional cancer chemotherapy re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0005"},{"title":"Reference 1 - ICH Considerations: General principles to address virus and vector shedding re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0004"},{"title":"List of References re Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","document_id":"FDA-2014-D-0852-0003"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-0852","supporting_documents_count":6,"docket_id":"FDA-2014-D-0852","document_id":"FDA-2014-D-0852-0001","regulation_id_number":null,"title":"Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","checked_regulationsdotgov_at":"2023-03-01T18:13:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38908,"subtype":null,"title":"Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Availability","toc_doc":"Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":79}