{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #287 entitled \"Raw Data for Safety and Effectiveness Studies.\" This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM's) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.","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/2024/04/29/2024-09139.html","cfr_references":[],"citation":"89 FR 33371","comment_url":null,"comments_close_on":"2024-06-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by June 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-1613"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-04-29","updated_at":"2024-09-03T16:56:00.414-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-1613-0001","allow_late_comments":false,"id":"FDA-2024-D-1613-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-1613","title":"Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability"}],"document_number":"2024-09139","effective_on":null,"end_page":33372,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/04/29/2024-09139.xml","html_url":"https://www.federalregister.gov/documents/2024/04/29/2024-09139/raw-data-for-safety-and-effectiveness-studies-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-09139?publication_date=2024-04-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-04-29/2024-09139/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":344,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-29/pdf/2024-09139.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09139.pdf?1714135541","publication_date":"2024-04-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/04/29/2024-09139.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-1613","supporting_documents_count":0,"docket_id":"FDA-2024-D-1613","document_id":"FDA-2024-D-1613-0001","regulation_id_number":null,"title":"Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-04-30T13:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33371,"subtype":null,"title":"Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability","toc_doc":"Raw Data for Safety and Effectiveness Studies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}