{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled \"Providing Regulatory Submissions in Alternate Electronic Format.\" Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document (eCTD) format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this draft guidance to describe the alternate electronic format sponsors or applicants should use for submissions covered under such exemptions and waivers.","action":"Notice of availability.","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/2020/03/11/2020-04994.html","cfr_references":[],"citation":"85 FR 14202","comment_url":null,"comments_close_on":"2020-05-11","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by May 11, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-0420"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-03-11","updated_at":"2023-02-28T13:43:16.445-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-0420-0001","allow_late_comments":null,"id":"FDA-2020-D-0420-0001","comment_end_date":"2020-05-12","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-0420","title":"Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability"}],"document_number":"2020-04994","effective_on":null,"end_page":14203,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/11/2020-04994.xml","html_url":"https://www.federalregister.gov/documents/2020/03/11/2020-04994/providing-regulatory-submissions-in-alternate-electronic-format-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-04994?publication_date=2020-03-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-11/2020-04994/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":727,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/2020-04994.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04994.pdf?1583844329","publication_date":"2020-03-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/11/2020-04994.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-0420","supporting_documents_count":0,"docket_id":"FDA-2020-D-0420","document_id":"FDA-2020-D-0420-0001","regulation_id_number":null,"title":"Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T18:43:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14202,"subtype":null,"title":"Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}