{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Information Requests and Discipline Review Letters Under GDUFA.\" This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance finalizes the draft guidance of the same title issued on December 18, 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/01/27/2022-01605.html","cfr_references":[],"citation":"87 FR 4257","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 27, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-6752"],"dockets":[],"document_number":"2022-01605","effective_on":null,"end_page":4258,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/01/27/2022-01605.xml","html_url":"https://www.federalregister.gov/documents/2022/01/27/2022-01605/information-requests-and-discipline-review-letters-under-generic-drug-user-fee-amendments-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-01605?publication_date=2022-01-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-01-27/2022-01605/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":550,"last_updated":"2026-08-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-27/pdf/2022-01605.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01605.pdf?1643204735","publication_date":"2022-01-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/01/27/2022-01605.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-6752","supporting_documents_count":0,"docket_id":"FDA-2017-D-6752","document_id":"FDA-2017-D-6752-0006","regulation_id_number":null,"title":"Information Requests and Discipline Review Letters Under GDUFA","checked_regulationsdotgov_at":"2022-01-28T04:30:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4257,"subtype":null,"title":"Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments; Guidance for Industry; Availability","toc_doc":"Information Requests and Discipline Review Letters under Generic Drug User Fee Amendments","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}