{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled \"FY 2022 Generic Drug Science and Research Initiatives Workshop.\" The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.","action":"Notice of public workshop; 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/2022/02/16/2022-03368.html","cfr_references":[],"citation":"87 FR 8843","comment_url":null,"comments_close_on":"2022-06-10","correction_of":null,"corrections":[],"dates":"The public workshop will be held on May 9, 2022, and May 10, 2022, from 8:30 a.m. to 4:30 p.m. Eastern Time. Submit either electronic or written comments on this public workshop by June 10, 2022. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-6644"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2022-02-16","updated_at":"2023-02-28T12:27:36.972-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-N-6644-0028","allow_late_comments":null,"id":"FDA-2017-N-6644-0028","comment_end_date":"2022-06-11","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-N-6644","title":"Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop"}],"document_number":"2022-03368","effective_on":null,"end_page":8845,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/16/2022-03368.xml","html_url":"https://www.federalregister.gov/documents/2022/02/16/2022-03368/fiscal-year-2022-generic-drug-science-and-research-initiatives-workshop-public-workshop-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-03368?publication_date=2022-02-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-16/2022-03368/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":569,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-16/pdf/2022-03368.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-03368.pdf?1644932741","publication_date":"2022-02-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/16/2022-03368.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-6644","supporting_documents_count":0,"docket_id":"FDA-2017-N-6644","document_id":"FDA-2017-N-6644-0028","regulation_id_number":null,"title":"Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop","checked_regulationsdotgov_at":"2023-02-28T17:27:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8843,"subtype":null,"title":"Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments","toc_doc":"Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop","toc_subject":"Meetings:\n","topics":[],"type":"Notice","volume":87}