{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to specify the deadline and content for submission of an annual summary of investigational drugs supplied under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act) and the uses for which the investigational drugs were supplied. This final rule implements a provision in the Right to Try Act that requires sponsors and manufacturers who provide an \"eligible investigational drug\" under the provisions of the Right to Try Act to submit to FDA an annual summary of such use, and directs FDA to specify by regulation the deadline of submission.","action":"Final rule.","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/2022/09/14/2022-19737.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"300","title":21}],"citation":"87 FR 56269","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 14, 2022. For additional information on the effective and compliance dates, see section V of this document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-5553"],"dockets":[{"supporting_documents":[{"title":"RIGHT TO TRY REPORTING REQUIREMENT: ANNUAL SUMMARY FORM re: Annual Summary Reporting Requirements Under the Right to Try Act","document_id":"FDA-2019-N-5553-0026"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-09-14","updated_at":"2023-02-27T21:20:36.036-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-5553-0024","allow_late_comments":null,"id":"FDA-2019-N-5553-0024","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2019-N-5553","title":"Annual Summary Reporting Requirements Under the Right to Try Act"}],"document_number":"2022-19737","effective_on":"2022-11-14","end_page":56277,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/14/2022-19737.xml","html_url":"https://www.federalregister.gov/documents/2022/09/14/2022-19737/annual-summary-reporting-requirements-under-the-right-to-try-act","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-19737?publication_date=2022-09-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-14/2022-19737/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":5383,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-14/pdf/2022-19737.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-19737.pdf?1663073118","publication_date":"2022-09-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/14/2022-19737.txt","regulation_id_number_info":{"0910-AI36":{"issue":"202204","html_url":"https://www.federalregister.gov/regulations/0910-AI36/annual-summary-reporting-requirements-under-the-right-to-try-act","title":"Annual Summary Reporting Requirements Under the Right to Try Act","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&RIN=0910-AI36&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI36"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"RIGHT TO TRY REPORTING REQUIREMENT: ANNUAL SUMMARY FORM re: Annual Summary Reporting Requirements Under the Right to Try Act","document_id":"FDA-2019-N-5553-0026"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-5553","supporting_documents_count":1,"docket_id":"FDA-2019-N-5553","document_id":"FDA-2019-N-5553-0024","regulation_id_number":null,"title":"Annual Summary Reporting Requirements Under the Right to Try Act","checked_regulationsdotgov_at":"2023-02-28T02:20:35Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":56269,"subtype":null,"title":"Annual Summary Reporting Requirements Under the Right to Try Act","toc_doc":"Annual Summary Reporting Requirements under the Right to Try Act","toc_subject":null,"topics":["Drugs","Prescription drugs"],"type":"Rule","volume":87}