{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled \"Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.\" The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled \"Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),\" dated April 2008.","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/2016/09/16/2016-22353.html","cfr_references":[],"citation":"81 FR 63766","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-3399"],"dockets":[],"document_number":"2016-22353","effective_on":null,"end_page":63767,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/09/16/2016-22353.xml","html_url":"https://www.federalregister.gov/documents/2016/09/16/2016-22353/recommendations-for-microbial-vectors-used-for-gene-therapy-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-22353?publication_date=2016-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-09-16/2016-22353/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":335,"last_updated":"2026-09-22 20:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/2016-22353.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-22353.pdf?1473943588","publication_date":"2016-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/09/16/2016-22353.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 14 Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA  BE Studies 2012 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0017"},{"title":"Reference 13  International Conference on Harmonisation Guidance  E8 General Considerations for Clinical Trials 1997  62 FR 66113 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0016"},{"title":"Reference 12 Guidance for Industry Design and Analysis of Shedding Studies for Virus or Bacteria Based Gene Therapy and Oncolytic Products 2015 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0015"},{"title":"Reference 11 Guidance for Industry Preclinical Assessment of Investigational Cellular and Gene Therapy Products 2013 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0014"},{"title":"Reference 10 Guidance for Industry CGMP for Phase 1 Investigational Drugs 2008 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0013"},{"title":"Reference 9  Guidance for Industry Determining the Need for and Content of Environmental Assessments for Gene Therapies Vectored Vaccines and Related Recombinant Viral or Microbial Products 2015 re Recommendations for Microbial Vectors used for Gene Thera","document_id":"FDA-2015-D-3399-0012"},{"title":"Reference 8 Guideline for the Determination of Residual Moisture in Dried Biological Products1990 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0011"},{"title":"Reference 7 Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics 1999 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0010"},{"title":"Reference 6 International Conference on Harmonisation Q5C  Guideline for Industry Quality of Biotechnological Products Stability Testing of Biotechnological Biological Products 1996 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guid","document_id":"FDA-2015-D-3399-0009"},{"title":"Reference 5 G Nebe von Caron et al. Analysis of Bacterial Function by Multi Color Fluorescence Flow Cytometry and Single Cell Sorting. J Microb. Methods  2000 re Recommendations for Microbial Vectors used for Gene Therapy Draft Guidance for Industry","document_id":"FDA-2015-D-3399-0008"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-3399","supporting_documents_count":15,"docket_id":"FDA-2015-D-3399","regulation_id_number":null,"title":"Recommendations for Microbial Vectors used for Gene Therapy","checked_regulationsdotgov_at":"2016-10-06T06:00:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63766,"subtype":null,"title":"Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability","toc_doc":"Recommendations for Microbial Vectors Used for Gene Therapy","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}