{"abstract":"The Health Resources and Services Administration administers section 340B of the Public Health Service (PHS) Act, which is referred to as the \"340B Drug Pricing Program\" or the \"340B Program.\" This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution (ADR) process. This final rule revises the 340B administrative dispute resolution process set forth in the Code of Federal Regulations.","action":"Final rule.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/04/19/2024-08262.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"10","title":42}],"citation":"89 FR 28643","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective June 18, 2024.","disposition_notes":null,"docket_ids":["Docket No. 2021-0004"],"dockets":[{"supporting_documents":[],"agency_name":"HHS","documents":[{"comment_count":0,"comment_start_date":"2024-04-19","updated_at":"2024-09-03T16:54:30.988-04:00","comment_url":"https://www.regulations.gov/commenton/HHS-OS-2024-0002-0017","allow_late_comments":false,"id":"HHS-OS-2024-0002-0017","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"HHS-OS-2024-0002","title":"HHS 2024 Publications"},{"supporting_documents":[{"title":"340B Drug Pricing Program; 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Administrative Dispute Resolution","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0906-AB28&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0906-AB28"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"HHS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HHS-OS-2024-0002","supporting_documents_count":0,"docket_id":"HHS-OS-2024-0002","document_id":"HHS-OS-2024-0002-0017","regulation_id_number":null,"title":"HHS 2024 Publications","checked_regulationsdotgov_at":"2024-04-20T16:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":28643,"subtype":null,"title":"340B Drug Pricing Program; Administrative Dispute Resolution Regulation","toc_doc":"Administrative Dispute Resolution Regulation","toc_subject":"340B Drug Pricing Program:\n","topics":["Biologics","Business and industry","Diseases","Drugs","Health","Health care","Health facilities","Hospitals"],"type":"Rule","volume":89}