{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Platform Technology Designation Program for Drug Development.\" The purpose of this draft guidance is to provide details about the implementation of the Platform Technology Designation Program established by the PREVENT Pandemics Act. This draft guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss the planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This draft guidance, when finalized, will represent the current thinking of FDA.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/05/29/2024-11686.html","cfr_references":[],"citation":"89 FR 46406","comment_url":null,"comments_close_on":"2024-07-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 29, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by July 29, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-1829"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-05-29T10:56:47.161-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-1829-0001","allow_late_comments":null,"id":"FDA-2024-D-1829-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-1829","title":"Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request"}],"document_number":"2024-11686","effective_on":null,"end_page":46408,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/05/29/2024-11686.xml","html_url":"https://www.federalregister.gov/documents/2024/05/29/2024-11686/platform-technology-designation-program-draft-guidance-for-industry-availability-agency-information","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-11686?publication_date=2024-05-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-05-29/2024-11686/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2836,"last_updated":"2026-10-22 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-29/pdf/2024-11686.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-11686.pdf?1716900318","publication_date":"2024-05-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/05/29/2024-11686.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-2024-D-1829","supporting_documents_count":0,"docket_id":"FDA-2024-D-1829","document_id":"FDA-2024-D-1829-0001","regulation_id_number":null,"title":"Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","checked_regulationsdotgov_at":"2024-07-18T13:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46406,"subtype":null,"title":"Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Platform Technology Designation Program","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":89}