{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.\" This guidance finalizes the draft guidance entitled \"Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics\" issued on February 20, 2020.","action":"Notice of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/2023/06/05/2023-11898.html","cfr_references":[],"citation":"88 FR 36589","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 5, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-5607"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-06-05","updated_at":"2023-06-05T16:56:31.909-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-5607-0013","allow_late_comments":null,"id":"FDA-2019-D-5607-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-5607","title":"Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry; Availability"}],"document_number":"2023-11898","effective_on":null,"end_page":36590,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/06/05/2023-11898.xml","html_url":"https://www.federalregister.gov/documents/2023/06/05/2023-11898/nonclinical-evaluation-of-the-immunotoxic-potential-of-pharmaceuticals-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-11898?publication_date=2023-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-06-05/2023-11898/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":502,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-05/pdf/2023-11898.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11898.pdf?1685709930","publication_date":"2023-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/06/05/2023-11898.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-2019-D-5607","supporting_documents_count":0,"docket_id":"FDA-2019-D-5607","document_id":"FDA-2019-D-5607-0013","regulation_id_number":null,"title":"Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-06-06T17:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36589,"subtype":null,"title":"Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals; Guidance for Industry; Availability","toc_doc":"Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}