{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders.","action":"Notice of pilot project, 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/2015/10/06/2015-25349.html","cfr_references":[],"citation":"80 FR 60391","comment_url":null,"comments_close_on":"2015-10-06","correction_of":null,"corrections":[],"dates":"Submit requests to participate in the REMS SPL pilot from October 6, 2015 to December 7, 2015. See the \"Participation\" section for instructions on how to submit a request to participate. The pilot will proceed for 4 months, from October 6, 2015 to February 3, 2016. This pilot may be extended as resources and needs allow.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-3402"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2015-10-06","updated_at":"2023-02-28T23:54:39.505-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-3402-0001","allow_late_comments":null,"id":"FDA-2015-N-3402-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-N-3402","title":"Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format"}],"document_number":"2015-25349","effective_on":null,"end_page":60393,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/06/2015-25349.xml","html_url":"https://www.federalregister.gov/documents/2015/10/06/2015-25349/electronic-submission-of-final-approved-risk-evaluation-and-mitigation-strategies-and-summary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-25349?publication_date=2015-10-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-06/2015-25349/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1907,"last_updated":"2026-09-20 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/2015-25349.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-25349.pdf?1444049161","publication_date":"2015-10-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/06/2015-25349.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2015-N-3402","supporting_documents_count":0,"docket_id":"FDA-2015-N-3402","document_id":"FDA-2015-N-3402-0001","regulation_id_number":null,"title":"Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format","checked_regulationsdotgov_at":"2023-03-01T04:54:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60391,"subtype":null,"title":"Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project","toc_doc":"Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project","toc_subject":null,"topics":[],"type":"Notice","volume":80}