{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.\" This draft guidance provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations. The guidance provides definitions for protocol deviations and important protocol deviations. In addition, the guidance provides a recommended classification system for sponsors to report protocol deviations to FDA in clinical study reports for drugs, biological products, and devices; for investigators to report protocol deviations to sponsors and to IRBs; and for IRBs to evaluate protocol deviations.","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/2024/12/30/2024-31261.html","cfr_references":[],"citation":"89 FR 106510","comment_url":null,"comments_close_on":"2025-02-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 28, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-5016"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-12-30","updated_at":"2024-12-30T13:02:07.621-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-5016-0001","allow_late_comments":false,"id":"FDA-2023-D-5016-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-5016","title":"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability"}],"document_number":"2024-31261","effective_on":null,"end_page":106512,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/12/30/2024-31261.xml","html_url":"https://www.federalregister.gov/documents/2024/12/30/2024-31261/protocol-deviations-for-clinical-investigations-of-drugs-biological-products-and-devices-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31261?publication_date=2024-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-12-30/2024-31261/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1473,"last_updated":"2026-08-26 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31261.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31261.pdf?1735307160","publication_date":"2024-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/12/30/2024-31261.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-2023-D-5016","supporting_documents_count":0,"docket_id":"FDA-2023-D-5016","document_id":"FDA-2023-D-5016-0001","regulation_id_number":null,"title":"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-12-31T17:00:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":106510,"subtype":null,"title":"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability","toc_doc":"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}