{"abstract":"The Food and Drug Administration (FDA) is announcing a meeting entitled \"Regulatory New Drug Review: Solutions for Study Data Exchange Standards\" the purpose of which is to solicit input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. FDA also seeks input from stakeholders and other members of the public on this topic and a set of premeeting questions discussed below.","action":"Announcement of 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/2012/08/14/2012-19748.html","cfr_references":[{"chapter":0,"citation_url":null,"part":null,"title":21}],"citation":"77 FR 48491","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The meeting will be held on November 5, 2012, from 10 a.m. to 4 p.m.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0780"],"dockets":[],"document_number":"2012-19748","effective_on":null,"end_page":48492,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/08/14/2012-19748.xml","html_url":"https://www.federalregister.gov/documents/2012/08/14/2012-19748/regulatory-new-drug-review-solutions-for-study-data-exchange-standards-notice-of-meeting-request-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-19748?publication_date=2012-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-08-14/2012-19748/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1634,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-08-14/pdf/2012-19748.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-19748.pdf?1344862545","publication_date":"2012-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/08/14/2012-19748.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0780","supporting_documents_count":0,"docket_id":"FDA-2012-N-0780","regulation_id_number":null,"title":"Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting; Request for Comments","checked_regulationsdotgov_at":"2012-10-07T05:00:55Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48491,"subtype":null,"title":"Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting; Request for Comments","toc_doc":"Solutions for Study Data Exchange Standards; Meeting; Request for Comments","toc_subject":"Regulatory New Drug Review: ","topics":[],"type":"Proposed Rule","volume":77}