{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Nonclinical Evaluation of Endocrine-Related Drug Toxicity.\" The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled \"Endocrine Disruption Potential of Drugs: Nonclinical Evaluation\" issued on September 20, 2013.","action":"Notice.","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/2015/09/09/2015-22683.html","cfr_references":[],"citation":"80 FR 54295","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1039"],"dockets":[],"document_number":"2015-22683","effective_on":null,"end_page":54296,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/09/09/2015-22683.xml","html_url":"https://www.federalregister.gov/documents/2015/09/09/2015-22683/nonclinical-evaluation-of-endocrine-related-drug-toxicity-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-22683?publication_date=2015-09-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-09-09/2015-22683/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":303,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-09-09/pdf/2015-22683.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-22683.pdf?1441716402","publication_date":"2015-09-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/09/09/2015-22683.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-1039","supporting_documents_count":0,"docket_id":"FDA-2013-D-1039","regulation_id_number":null,"title":"Endocrine Disruption Potential of Drugs: Nonclinical Evaluation","checked_regulationsdotgov_at":"2015-09-29T06:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54295,"subtype":null,"title":"Nonclinical Evaluation of Endocrine-Related Drug Toxicity; Guidance for Industry; Availability","toc_doc":"Nonclinical Evaluation of Endocrine-Related Drug Toxicity","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}