{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"REMS Logic Model: A Framework to Link Program Design With Assessment.\" The guidance describes FDA's risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants of new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) incorporate REMS assessment planning into the design of a REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS.","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/2024/05/07/2024-09928.html","cfr_references":[],"citation":"89 FR 38161","comment_url":null,"comments_close_on":"2024-08-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-1032"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2024-05-07","updated_at":"2024-09-03T16:58:08.433-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-1032-0001","allow_late_comments":false,"id":"FDA-2024-D-1032-0001","comment_end_date":"2024-08-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-1032","title":"REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry; Availability"}],"document_number":"2024-09928","effective_on":null,"end_page":38163,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/05/07/2024-09928.xml","html_url":"https://www.federalregister.gov/documents/2024/05/07/2024-09928/risk-evaluation-and-mitigation-strategy-logic-model-a-framework-to-link-program-design-with","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-09928?publication_date=2024-05-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-05-07/2024-09928/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":968,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-07/pdf/2024-09928.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09928.pdf?1715000171","publication_date":"2024-05-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/05/07/2024-09928.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-D-1032","supporting_documents_count":0,"docket_id":"FDA-2024-D-1032","document_id":"FDA-2024-D-1032-0001","regulation_id_number":null,"title":"REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-08-08T01:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38161,"subtype":null,"title":"Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry; Availability","toc_doc":"Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}