{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"ANDA Submissions--Content and Format of Abbreviated New Drug Applications.\" The guidance document is intended to assist applicants in preparing complete and high-quality original abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug, and Cosmetic Act. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application.","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/2014/06/12/2014-13641.html","cfr_references":[],"citation":"79 FR 33758","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 11, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0725"],"dockets":[],"document_number":"2014-13641","effective_on":null,"end_page":33759,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/12/2014-13641.xml","html_url":"https://www.federalregister.gov/documents/2014/06/12/2014-13641/draft-guidance-for-industry-on-abbreviated-new-drug-application-submissions-content-and-format-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-13641?publication_date=2014-06-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-12/2014-13641/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1428,"last_updated":"2026-08-24 14:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-12/pdf/2014-13641.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-13641.pdf?1402491877","publication_date":"2014-06-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/12/2014-13641.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-2014-D-0725","supporting_documents_count":0,"docket_id":"FDA-2014-D-0725","regulation_id_number":null,"title":"Draft Guidance for Industry on ANDA Submissions; Content and Format of Abbreviated New Drug Applications; Availability","checked_regulationsdotgov_at":"2014-08-12T12:00:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33758,"subtype":null,"title":"Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability","toc_doc":"Content and Format of Abbreviated New Drug Applications","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":79}