{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled \"Determining Whether to Submit an ANDA or a 505(b)(2) Application.\" This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry titled \"Determining Whether to Submit an ANDA or a 505(b)(2) Application\" issued in May 2019 and, when finalized, will replace the 2019 guidance for industry.","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/2026/08/18/2026-16837.html","cfr_references":[],"citation":"91 FR 53418","comment_url":null,"comments_close_on":"2026-10-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 19, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2017-D-5974"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-18","updated_at":"2026-10-20T00:02:33.720-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-5974-0012","allow_late_comments":false,"id":"FDA-2017-D-5974-0012","comment_end_date":"2026-10-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-D-5974","title":"Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability"}],"document_number":"2026-16837","effective_on":null,"end_page":53420,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/18/2026-16837.xml","html_url":"https://www.federalregister.gov/documents/2026/08/18/2026-16837/determining-whether-to-submit-an-anda-or-a-505b2-application-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16837?publication_date=2026-08-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-18/2026-16837/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1180,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-18/pdf/2026-16837.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16837.pdf?1786970728","publication_date":"2026-08-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/18/2026-16837.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-2017-D-5974","supporting_documents_count":0,"docket_id":"FDA-2017-D-5974","document_id":"FDA-2017-D-5974-0012","regulation_id_number":null,"title":"Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-10-20T04:02:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53418,"subtype":null,"title":"Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability","toc_doc":"Determining Whether to Submit an ANDA or a 505(b)(2) Application","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}