{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.\" The document provides guidance regarding the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and other chronic uses.","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/2018/08/06/2018-16726.html","cfr_references":[],"citation":"83 FR 38315","comment_url":null,"comments_close_on":"2018-10-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-2583"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2018-08-06","updated_at":"2023-03-01T03:00:02.809-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-2583-0001","allow_late_comments":null,"id":"FDA-2018-D-2583-0001","comment_end_date":"2018-10-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-2583","title":"Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability "}],"document_number":"2018-16726","effective_on":null,"end_page":38316,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/08/06/2018-16726.xml","html_url":"https://www.federalregister.gov/documents/2018/08/06/2018-16726/nonclinical-testing-of-orally-inhaled-nicotine-containing-drug-products-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-16726?publication_date=2018-08-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-08-06/2018-16726/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":332,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-08-06/pdf/2018-16726.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-16726.pdf?1533300322","publication_date":"2018-08-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/08/06/2018-16726.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-2583","supporting_documents_count":0,"docket_id":"FDA-2018-D-2583","document_id":"FDA-2018-D-2583-0001","regulation_id_number":null,"title":"Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T08:00:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38315,"subtype":null,"title":"Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability","toc_doc":"Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}