{"abstract":"The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act, authorizes FDA to award priority review vouchers to sponsors of a material threat medical countermeasure application that meets certain criteria upon approval of such application. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for MOUNJARO (tirzepatide) injection, approved May 13, 2022, meets the redemption criteria.","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/2022/08/29/2022-18523.html","cfr_references":[],"citation":"87 FR 52790","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-0895"],"dockets":[{"supporting_documents":[{"title":"Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure  Priority Review Voucher","document_id":"FDA-2019-N-0895-0008"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0007"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0006"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0005"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0004"},{"title":"ssuance of Priority Review Voucher; \nMaterial Threat Medical \nCountermeasure Product","document_id":"FDA-2019-N-0895-0003"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0002"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-08-29","updated_at":"2023-02-27T21:21:54.037-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-0895-0008","allow_late_comments":null,"id":"FDA-2019-N-0895-0008","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":8,"id":"FDA-2019-N-0895","title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product"}],"document_number":"2022-18523","effective_on":null,"end_page":52790,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/08/29/2022-18523.xml","html_url":"https://www.federalregister.gov/documents/2022/08/29/2022-18523/notice-of-approval-of-product-under-voucher-material-threat-medical-countermeasure-priority-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-18523?publication_date=2022-08-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-08-29/2022-18523/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":614,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-08-29/pdf/2022-18523.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-18523.pdf?1661517922","publication_date":"2022-08-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/08/29/2022-18523.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure  Priority Review Voucher","document_id":"FDA-2019-N-0895-0008"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0007"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0006"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0005"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0004"},{"title":"ssuance of Priority Review Voucher; \nMaterial Threat Medical \nCountermeasure Product","document_id":"FDA-2019-N-0895-0003"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0002"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0001"}],"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-2019-N-0895","supporting_documents_count":8,"docket_id":"FDA-2019-N-0895","document_id":"FDA-2019-N-0895-0008","regulation_id_number":null,"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","checked_regulationsdotgov_at":"2023-02-28T02:21:53Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52790,"subtype":null,"title":"Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher","toc_doc":"Material Threat Medical Countermeasure Priority Review Voucher","toc_subject":"Approval of Product under Voucher:\n","topics":[],"type":"Notice","volume":87}