{"abstract":"The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.","action":"Notice.","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/2013/05/02/2013-10379.html","cfr_references":[],"citation":"78 FR 25749","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The XML-enabled Adobe PDF form, Form FDA 3331--Automated, will be available for piloting between May 1, 2013, and January 1, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0294"],"dockets":[],"document_number":"2013-10379","effective_on":null,"end_page":25749,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/02/2013-10379.xml","html_url":"https://www.federalregister.gov/documents/2013/05/02/2013-10379/submission-of-new-drug-applicationabbreviated-new-drug-application-field-alert-reports-notice-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-10379?publication_date=2013-05-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-02/2013-10379/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1493,"last_updated":"2026-07-28 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-02/pdf/2013-10379.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-10379.pdf?1367429232","publication_date":"2013-05-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/02/2013-10379.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-2013-N-0294","supporting_documents_count":0,"docket_id":"FDA-2013-N-0294","regulation_id_number":null,"title":"Submission of NDA/ANDA Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program","checked_regulationsdotgov_at":"2013-05-26T05:01:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25749,"subtype":null,"title":"Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program","toc_doc":"Automated Form Pilot Program","toc_subject":"Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports:","topics":[],"type":"Notice","volume":78}