{"abstract":"The Food and Drug Administration (FDA or Agency) is denying Marwan Massouh's (Dr. Massouh's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Massouh for 3 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 Dr. Massouh was convicted of a misdemeanor under Federal law for causing the introduction or delivery for introduction into interstate commerce of drugs that were misbranded under the FD&C Act. Additionally, FDA finds that the conduct underlying Dr. Massouh's conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Massouh's debarment, FDA considered the relevant factors listed in the FD&C Act. Dr. Massouh 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/2022/05/11/2022-10096.html","cfr_references":[],"citation":"87 FR 28834","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is applicable May 11, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-1992"],"dockets":[],"document_number":"2022-10096","effective_on":null,"end_page":28836,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/11/2022-10096.xml","html_url":"https://www.federalregister.gov/documents/2022/05/11/2022-10096/marwan-massouh-denial-of-hearing-final-debarment-order","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-10096?publication_date=2022-05-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-11/2022-10096/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2094,"last_updated":"2026-05-21 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-11/pdf/2022-10096.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10096.pdf?1652186803","publication_date":"2022-05-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/11/2022-10096.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-1992","supporting_documents_count":0,"docket_id":"FDA-2018-N-1992","document_id":"FDA-2018-N-1992-0003","regulation_id_number":null,"title":"NOOH proposal to Debar Marwan Massouh","checked_regulationsdotgov_at":"2022-05-12T03:30:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28834,"subtype":null,"title":"Marwan Massouh; Denial of Hearing; Final Debarment Order","toc_doc":"Marwan Massouh","toc_subject":"Final Debarment Order:\n","topics":[],"type":"Notice","volume":87}