{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled \"Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.\" This document provides guidance to industry and FDA staff on the purpose and content of a use- related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application.","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/2024/07/09/2024-15003.html","cfr_references":[],"citation":"89 FR 56392","comment_url":null,"comments_close_on":"2024-09-09","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 9, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2484"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-07-09","updated_at":"2024-09-03T17:10:58.194-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2484-0001","allow_late_comments":false,"id":"FDA-2024-D-2484-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2484","title":"Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2024-15003","effective_on":null,"end_page":56393,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/07/09/2024-15003.xml","html_url":"https://www.federalregister.gov/documents/2024/07/09/2024-15003/purpose-and-content-of-use-related-risk-analyses-for-drugs-biological-products-and-combination","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-15003?publication_date=2024-07-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-07-09/2024-15003/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":520,"last_updated":"2026-04-04 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-09/pdf/2024-15003.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15003.pdf?1720442729","publication_date":"2024-07-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/07/09/2024-15003.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-2024-D-2484","supporting_documents_count":0,"docket_id":"FDA-2024-D-2484","document_id":"FDA-2024-D-2484-0001","regulation_id_number":null,"title":"Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2024-07-10T13:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56392,"subtype":null,"title":"Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}