{"abstract":"The Food and Drug Administration (FDA) is proposing to amend 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":"Proposed 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/2011/10/19/2011-27037.html","cfr_references":[{"chapter":null,"citation_url":null,"part":316,"title":21}],"citation":"76 FR 64868","comment_url":null,"comments_close_on":"2012-01-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by January 17, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 18, 2011 (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0583"],"dockets":[],"document_number":"2011-27037","effective_on":null,"end_page":64879,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/10/19/2011-27037.xml","html_url":"https://www.federalregister.gov/documents/2011/10/19/2011-27037/orphan-drug-regulations","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-27037?publication_date=2011-10-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-10-19/2011-27037/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":2661,"last_updated":"2026-07-26 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-10-19/pdf/2011-27037.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-10-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/10/19/2011-27037.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":"2011-10-24T21:18:16Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":64868,"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":"Proposed Rule","volume":76}