{"abstract":"The Food and Drug Administration (FDA or Agency) is seeking public comment on the Clinical Data Summary Report Pilot program as part of the Agency's continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision- making process. The Agency is also seeking public feedback on a new integrated review template for the documentation of new drug marketing applications developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on both of these efforts and on how FDA might continue supporting our stakeholders' needs related to the clarity and transparency of drug approval decisions.","action":"Notice; 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/2019/06/27/2019-13751.html","cfr_references":[],"citation":"84 FR 30733","comment_url":null,"comments_close_on":"2019-08-26","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the notice by August 26, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-2012"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":21,"comment_start_date":"2019-06-27","updated_at":"2023-02-28T14:12:28.977-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-2012-0001","allow_late_comments":null,"id":"FDA-2019-N-2012-0001","comment_end_date":"2019-08-27","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-N-2012","title":"New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication"}],"document_number":"2019-13751","effective_on":null,"end_page":30736,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/06/27/2019-13751.xml","html_url":"https://www.federalregister.gov/documents/2019/06/27/2019-13751/new-drugs-regulatory-program-modernization-improving-approval-package-documentation-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-13751?publication_date=2019-06-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-06-27/2019-13751/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":4160,"last_updated":"2026-04-11 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-06-27/pdf/2019-13751.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-13751.pdf?1561553124","publication_date":"2019-06-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/06/27/2019-13751.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":21,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-2012","supporting_documents_count":0,"docket_id":"FDA-2019-N-2012","document_id":"FDA-2019-N-2012-0001","regulation_id_number":null,"title":"New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication","checked_regulationsdotgov_at":"2023-02-28T19:12:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30733,"subtype":null,"title":"New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication","toc_doc":"Improving Approval Package Documentation and Communication","toc_subject":"New Drugs Regulatory Program Modernization:","topics":[],"type":"Notice","volume":84}