{"abstract":"On March 20, 2019, the U.S. Food and Drug Administration approved a new drug application for SUNOSI, a drug product consisting of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) tablets for oral use. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place solriamfetol in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing solriamfetol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.","action":"Interim final rule, with request for comments.","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2019/06/17/2019-12723.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1308,"title":21}],"citation":"84 FR 27943","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2019-12723"],"dates":"The effective date of this rulemaking is June 17, 2019. Interested persons may file written comments on this rulemaking in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before July 17, 2019. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.","disposition_notes":null,"docket_ids":["Docket No. DEA-504"],"dockets":[{"supporting_documents":[{"title":"HHS Letter for Solriamfetol","document_id":"DEA-2019-0006-0003"},{"title":"Solriamfetol DEA 8 Factor","document_id":"DEA-2019-0006-0002"}],"agency_name":"DEA","documents":[{"comment_count":1,"comment_start_date":"2019-06-17","updated_at":"2023-03-01T14:42:23.996-05:00","comment_url":"https://www.regulations.gov/commenton/DEA-2019-0006-0001","allow_late_comments":null,"id":"DEA-2019-0006-0001","comment_end_date":"2019-07-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"DEA-2019-0006","title":"Schedules of Controlled Substances:  Placement of Solriamfetol in Schedule IV"}],"document_number":"2019-12723","effective_on":"2019-06-17","end_page":27947,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/06/17/2019-12723.xml","html_url":"https://www.federalregister.gov/documents/2019/06/17/2019-12723/schedules-of-controlled-substances-placement-of-solriamfetol-in-schedule-iv","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-12723?publication_date=2019-06-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-06-17/2019-12723/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":2180,"last_updated":"2026-06-27 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-06-17/pdf/2019-12723.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-12723.pdf?1560516326","publication_date":"2019-06-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/06/17/2019-12723.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"HHS Letter for Solriamfetol","document_id":"DEA-2019-0006-0003"},{"title":"Solriamfetol DEA 8 Factor","document_id":"DEA-2019-0006-0002"}],"comments_count":1,"agency_id":"DEA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=DEA-2019-0006","supporting_documents_count":2,"docket_id":"DEA-2019-0006","document_id":"DEA-2019-0006-0001","regulation_id_number":null,"title":"Schedules of Controlled Substances:  Placement of Solriamfetol in Schedule IV","checked_regulationsdotgov_at":"2023-03-01T19:42:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27943,"subtype":null,"title":"Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV","toc_doc":"Placement of Solriamfetol in Schedule IV","toc_subject":"Schedules of Controlled Substances:","topics":["Administrative practice and procedure","Drug traffic control","Reporting and recordkeeping requirements"],"type":"Rule","volume":84}