{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.\" The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Driving is a complex activity involving a wide range of cognitive, perceptual, and motor activities. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. This draft guidance recommends using a systematic effort to identify drugs that increase the risk of MVAs as a critical component of assessing drug risk and designing strategies to reduce this risk.","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/2015/01/16/2015-00596.html","cfr_references":[],"citation":"80 FR 2432","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 17, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-2300"],"dockets":[],"document_number":"2015-00596","effective_on":null,"end_page":2433,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/01/16/2015-00596.xml","html_url":"https://www.federalregister.gov/documents/2015/01/16/2015-00596/evaluating-drug-effects-on-the-ability-to-operate-a-motor-vehicle-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-00596?publication_date=2015-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-01-16/2015-00596/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":639,"last_updated":"2026-10-23 14:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-01-16/pdf/2015-00596.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-00596.pdf?1421331299","publication_date":"2015-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/01/16/2015-00596.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-2014-D-2300","supporting_documents_count":0,"docket_id":"FDA-2014-D-2300","regulation_id_number":null,"title":"Evaluating Drug Effects on the Ability to Operate a Motor Vehicle","checked_regulationsdotgov_at":"2015-03-18T05:00:34Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2432,"subtype":null,"title":"Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Draft Guidance for Industry; Availability","toc_doc":"Evaluating Drug Effects on the Ability to Operate a Motor Vehicle","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}