{"abstract":"The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Richard M. Fleming (Fleming) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Fleming was convicted of two felonies under Federal law that involved fraud. Additionally, Fleming has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. Fleming failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.","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":"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/2018/09/28/2018-21210.html","cfr_references":[],"citation":"83 FR 49095","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The order is applicable September 28, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0333"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":32,"comment_start_date":"2018-09-28","updated_at":"2023-03-02T00:01:47.430-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-N-0333-0003","allow_late_comments":null,"id":"FDA-2013-N-0333-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-N-0333","title":"Proposal to Debar/Notice of Opportunity for Hearing for Richard M. Fleming"}],"document_number":"2018-21210","effective_on":null,"end_page":49097,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/09/28/2018-21210.xml","html_url":"https://www.federalregister.gov/documents/2018/09/28/2018-21210/richard-m-fleming-denial-of-hearing-final-debarment-order","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-21210?publication_date=2018-09-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-09-28/2018-21210/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":74000,"last_updated":"2026-04-22 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/2018-21210.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-21210.pdf?1538052337","publication_date":"2018-09-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/09/28/2018-21210.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":32,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0333","supporting_documents_count":0,"docket_id":"FDA-2013-N-0333","document_id":"FDA-2013-N-0333-0003","regulation_id_number":null,"title":"Proposal to Debar/Notice of Opportunity for Hearing for Richard M. Fleming","checked_regulationsdotgov_at":"2023-03-03T02:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49095,"subtype":null,"title":"Richard M. Fleming; Denial of Hearing; Final Debarment Order","toc_doc":"Richard M. Fleming","toc_subject":"Debarment Orders:","topics":[],"type":"Notice","volume":83}