{"abstract":"The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the \"340B Drug Pricing Program\" or the \"340B Program.\" This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.","action":"Notice of proposed rulemaking.","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/2016/08/12/2016-18969.html","cfr_references":[{"chapter":null,"citation_url":null,"part":10,"title":42}],"citation":"81 FR 53381","comment_url":null,"comments_close_on":"2016-10-11","correction_of":null,"corrections":[],"dates":"Submit written comments on or before October 11, 2016.","disposition_notes":null,"docket_ids":[],"dockets":[{"supporting_documents":[],"agency_name":"HHS","documents":[{"comment_count":0,"comment_start_date":"2016-08-12","updated_at":"2023-03-01T03:50:10.532-05:00","comment_url":"https://www.regulations.gov/commenton/HHS-OS-2022-0008-0484","allow_late_comments":null,"id":"HHS-OS-2022-0008-0484","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"HHS-OS-2022-0008","title":"HHS 2022 Archive"},{"supporting_documents":[],"agency_name":"HRSA","documents":[{"comment_count":31,"comment_start_date":"2016-08-12","updated_at":"2023-03-01T03:50:10.071-05:00","comment_url":"https://www.regulations.gov/commenton/HRSA-2016-0002-0001","allow_late_comments":null,"id":"HRSA-2016-0002-0001","comment_end_date":"2016-10-12","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"HRSA-2016-0002","title":"340B Drug Pricing Program; Administrative Dispute Resolution"}],"document_number":"2016-18969","effective_on":null,"end_page":53388,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/12/2016-18969.xml","html_url":"https://www.federalregister.gov/documents/2016/08/12/2016-18969/340b-drug-pricing-program-administrative-dispute-resolution","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-18969?publication_date=2016-08-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-12/2016-18969/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":3082,"last_updated":"2026-08-24 14:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-12/pdf/2016-18969.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-18969.pdf?1470919536","publication_date":"2016-08-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/12/2016-18969.txt","regulation_id_number_info":{"0906-AA90":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0906-AA90/340b-drug-pricing-program-administrative-dispute-resolution-process","title":"340B Drug Pricing Program; Administrative Dispute Resolution Process","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0906-AA90&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0906-AA90"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0906-AA90/340b-drug-pricing-program-administrative-dispute-resolution-process","title":"340B Drug Pricing Program; Administrative Dispute Resolution Process"},"comments_count":31,"agency_id":"HRSA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HRSA-2016-0002","supporting_documents_count":0,"docket_id":"HRSA-2016-0002","document_id":"HRSA-2016-0002-0001","regulation_id_number":"0906-AA90","title":"340B Drug Pricing Program; Administrative Dispute Resolution","checked_regulationsdotgov_at":"2023-03-01T08:50:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":53381,"subtype":null,"title":"340B Drug Pricing Program; Administrative Dispute Resolution","toc_doc":"340B Drug Pricing Program","toc_subject":"Administrative Dispute Resolutions:","topics":["Biologics","Business and industry","Diseases","Drugs","Health","Health care","Health facilities","Hospitals"],"type":"Proposed Rule","volume":81}