{"abstract":"The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the \"340B Drug Pricing Program\" or the \"340B Program.\" This notice proposes guidance for covered entities enrolled in the 340B Program and drug manufacturers that are required by section 340B of the PHSA to make their drugs available to covered entities under the 340B Program. When finalized after consideration of public comments solicited by this notice, the guidance is intended to assist 340B covered entities and drug manufacturers in complying with the statute.","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":"Health Resources and Services Administration","name":"Health Resources and Services Administration","id":222,"url":"https://www.federalregister.gov/agencies/health-resources-and-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/222","parent_id":221,"slug":"health-resources-and-services-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/08/28/2015-21246.html","cfr_references":[],"citation":"80 FR 52300","comment_url":null,"comments_close_on":"2015-10-27","correction_of":null,"corrections":[],"dates":"Submit comments on or before October 27, 2015.","disposition_notes":null,"docket_ids":[],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":1273,"comment_start_date":"2015-08-31","updated_at":"2023-02-28T23:59:33.182-05:00","comment_url":"https://www.regulations.gov/commenton/HRSA-2015-0002-0001","allow_late_comments":null,"id":"HRSA-2015-0002-0001","comment_end_date":"2015-10-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"HRSA-2015-0002","title":"340B Drug Pricing Program"}],"document_number":"2015-21246","effective_on":null,"end_page":52324,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/28/2015-21246.xml","html_url":"https://www.federalregister.gov/documents/2015/08/28/2015-21246/340b-drug-pricing-program-omnibus-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-21246?publication_date=2015-08-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-28/2015-21246/mods.xml","not_received_for_publication":null,"page_length":25,"page_views":{"count":46927,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/2015-21246.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-21246.pdf?1440679529","publication_date":"2015-08-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/28/2015-21246.txt","regulation_id_number_info":{"0906-AB08":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0906-AB08/340b-program-omnibus-guidelines","title":"340B Program Omnibus Guidelines","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0906-AB08&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0906-AB08"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0906-AB08/340b-program-omnibus-guidelines","title":"340B Program Omnibus Guidelines"},"comments_count":1273,"agency_id":"HRSA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HRSA-2015-0002","supporting_documents_count":0,"docket_id":"HRSA-2015-0002","document_id":"HRSA-2015-0002-0001","regulation_id_number":"0906-AB08","title":"340B Drug Pricing Program","checked_regulationsdotgov_at":"2023-03-01T04:59:32Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":52300,"subtype":null,"title":"340B Drug Pricing Program Omnibus Guidance","toc_doc":"340B Drug Pricing Program Omnibus","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}