{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled \"Generic Drug User Fee Amendments (GDUFA) of 2017.\" At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.","action":"Notice of public meeting; request for comments.","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/2020/06/26/2020-13749.html","cfr_references":[],"citation":"85 FR 38378","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public meeting will be held on July 21, 2020, from 8:30 a.m. to 3:30 p.m., and will take place virtually and will be held by webcast only. Submit either electronic or written comments on this public meeting by August 20, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1459"],"dockets":[],"document_number":"2020-13749","effective_on":null,"end_page":38380,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/06/26/2020-13749.xml","html_url":"https://www.federalregister.gov/documents/2020/06/26/2020-13749/generic-drug-user-fee-amendments-public-meeting-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-13749?publication_date=2020-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-06-26/2020-13749/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":895,"last_updated":"2026-04-04 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-06-26/pdf/2020-13749.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-13749.pdf?1593089122","publication_date":"2020-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/06/26/2020-13749.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":15,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1459","supporting_documents_count":0,"docket_id":"FDA-2020-N-1459","document_id":"FDA-2020-N-1459-0001","regulation_id_number":null,"title":"Generic Drug User Fee Amendments; Public Meeting; Request for Comments","checked_regulationsdotgov_at":"2020-08-24T02:30:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38378,"subtype":null,"title":"Generic Drug User Fee Amendments; Public Meeting; Request for Comments","toc_doc":"Generic Drug User Fee Amendments","toc_subject":"Meetings:\n","topics":[],"type":"Notice","volume":85}