{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule repealing a regulation that requires an FDA- approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation will mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2019/12/16/2019-27046.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"84 FR 68331","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 15, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-6924"],"dockets":[],"document_number":"2019-27046","effective_on":"2020-01-15","end_page":68334,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/12/16/2019-27046.xml","html_url":"https://www.federalregister.gov/documents/2019/12/16/2019-27046/regulation-requiring-an-approved-new-drug-application-for-drugs-sterilized-by-irradiation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-27046?publication_date=2019-12-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-12-16/2019-27046/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1069,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-12-16/pdf/2019-27046.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-27046.pdf?1576244726","publication_date":"2019-12-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/12/16/2019-27046.txt","regulation_id_number_info":{"0910-AH47":{"issue":"201910","html_url":"https://www.federalregister.gov/regulations/0910-AH47/regulation-requiring-an-approved-new-drug-application-for-drugs-sterilized-by-irradiation","title":"Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH47&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH47"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 8 508 - RIA repeal of regulation requiring an approved NDA for drugs sterilized by irradiation UCM620158","document_id":"FDA-2017-N-6924-0009"},{"title":"Reference 7","document_id":"FDA-2017-N-6924-0008"},{"title":"Reference 6","document_id":"FDA-2017-N-6924-0007"},{"title":"Reference 5","document_id":"FDA-2017-N-6924-0006"},{"title":"Reference 4","document_id":"FDA-2017-N-6924-0005"},{"title":"Reference 3","document_id":"FDA-2017-N-6924-0004"},{"title":"Reference 2","document_id":"FDA-2017-N-6924-0003"},{"title":"Reference 1","document_id":"FDA-2017-N-6924-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-6924","supporting_documents_count":8,"docket_id":"FDA-2017-N-6924","regulation_id_number":null,"title":"Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation","checked_regulationsdotgov_at":"2019-12-18T04:30:09Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":68331,"subtype":null,"title":"Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation","toc_doc":"Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation","toc_subject":null,"topics":["Administrative practice and procedure","Drugs","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":84}