{"abstract":"The Food and Drug Administration (FDA or the Agency is announcing the availability of a summary report of a public workshop that was held on April 16, 2018, entitled \"Evaluating Inclusion and Exclusion Criteria in Clinical Trials.\" The FDA Reauthorization Act of 2017 (FDARA) requires that the Agency convene a public workshop to discuss clinical trial eligibility criteria to inform a guidance on this subject and to publish a report summarizing the topics discussed within 90 days of the public workshop. This summary report fulfills FDA's mandate under FDARA.","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/2018/08/23/2018-18232.html","cfr_references":[],"citation":"83 FR 42666","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-2776"],"dockets":[],"document_number":"2018-18232","effective_on":null,"end_page":42667,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/08/23/2018-18232.xml","html_url":"https://www.federalregister.gov/documents/2018/08/23/2018-18232/evaluating-inclusion-and-exclusion-criteria-in-clinical-trials-workshop-report-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-18232?publication_date=2018-08-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-08-23/2018-18232/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":581,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-08-23/pdf/2018-18232.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-18232.pdf?1534941938","publication_date":"2018-08-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/08/23/2018-18232.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-2776","supporting_documents_count":0,"docket_id":"FDA-2018-D-2776","regulation_id_number":null,"title":"Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report, Availability","checked_regulationsdotgov_at":"2018-09-12T10:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42666,"subtype":null,"title":"Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report; Availability","toc_doc":"Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report","toc_subject":null,"topics":[],"type":"Notice","volume":83}