{"abstract":"The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.","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"},{"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/2013/06/12/2013-13930.html","cfr_references":[{"chapter":null,"citation_url":null,"part":316,"title":21}],"citation":"78 FR 35117","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 12, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0583"],"dockets":[],"document_number":"2013-13930","effective_on":"2013-08-12","end_page":35135,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/12/2013-13930.xml","html_url":"https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-13930?publication_date=2013-06-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-12/2013-13930/mods.xml","not_received_for_publication":null,"page_length":19,"page_views":{"count":10751,"last_updated":"2026-07-27 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-12/pdf/2013-13930.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-13930.pdf?1370955547","publication_date":"2013-06-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/12/2013-13930.txt","regulation_id_number_info":{"0910-AG72":{"issue":"201110","html_url":"https://www.federalregister.gov/regulations/0910-AG72/orphan-drug-regulations-","title":"Orphan Drug Regulations ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201110&RIN=0910-AG72&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AG72"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0583","supporting_documents_count":0,"docket_id":"FDA-2011-N-0583","regulation_id_number":null,"title":"Orphan Drug Regulations","checked_regulationsdotgov_at":"2013-07-02T08:23:42Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":35117,"subtype":null,"title":"Orphan Drug Regulations","toc_doc":"Orphan Drug Regulations","toc_subject":null,"topics":["Administrative practice and procedure","Drugs","Investigations","Medical research","Reporting and recordkeeping requirements"],"type":"Rule","volume":78}