{"abstract":"The Food and Drug Administration (FDA) is announcing the following public workshop entitled \"Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests.\" The purpose of this workshop is to obtain feedback on two FDA draft guidances, \"Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases\" and \"Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics\" that describes new approaches to regulate NGS-based tests.","action":"Notice of public workshop; request for comments.","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/2016/08/22/2016-19939.html","cfr_references":[],"citation":"81 FR 56656","comment_url":null,"comments_close_on":"2016-10-06","correction_of":null,"corrections":[],"dates":"The public workshop will be held on September 23, 2016, from 9 a.m.to 3 p.m. Submit either electronic or written comments on the public workshop by October 6, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-2473"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":2,"comment_start_date":"2016-08-22","updated_at":"2023-02-28T19:32:51.381-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-2473-0001","allow_late_comments":null,"id":"FDA-2016-N-2473-0001","comment_end_date":"2016-10-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-N-2473","title":"Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments"}],"document_number":"2016-19939","effective_on":null,"end_page":56658,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/22/2016-19939.xml","html_url":"https://www.federalregister.gov/documents/2016/08/22/2016-19939/adapting-regulatory-oversight-of-next-generation-sequencing-based-tests-public-workshop-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-19939?publication_date=2016-08-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-22/2016-19939/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":571,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-22/pdf/2016-19939.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-19939.pdf?1471610763","publication_date":"2016-08-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/22/2016-19939.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-2473","supporting_documents_count":0,"docket_id":"FDA-2016-N-2473","document_id":"FDA-2016-N-2473-0001","regulation_id_number":null,"title":"Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T00:32:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56656,"subtype":null,"title":"Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments","toc_doc":"Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":81}