{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Controlled Correspondence Related to Generic Drug Development.\" This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry entitled \"Controlled Correspondence Related to Generic Drug Development\" issued in December 2020.","action":"Notice of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/2022/12/22/2022-27827.html","cfr_references":[],"citation":"87 FR 78691","comment_url":null,"comments_close_on":"2023-02-21","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 21, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2014-D-1167"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-02-27T18:09:50.536-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-1167-0024","allow_late_comments":null,"id":"FDA-2014-D-1167-0024","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-D-1167","title":"Controlled Correspondence Related to Generic Drug Development"}],"document_number":"2022-27827","effective_on":null,"end_page":78693,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/12/22/2022-27827.xml","html_url":"https://www.federalregister.gov/documents/2022/12/22/2022-27827/controlled-correspondence-related-to-generic-drug-development-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-27827?publication_date=2022-12-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-12-22/2022-27827/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":797,"last_updated":"2026-10-25 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-22/pdf/2022-27827.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-27827.pdf?1671630330","publication_date":"2022-12-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/12/22/2022-27827.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-2014-D-1167","supporting_documents_count":0,"docket_id":"FDA-2014-D-1167","document_id":"FDA-2014-D-1167-0024","regulation_id_number":null,"title":"Controlled Correspondence Related to Generic Drug Development","checked_regulationsdotgov_at":"2023-02-27T23:09:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78691,"subtype":null,"title":"Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability","toc_doc":"Controlled Correspondence Related to Generic Drug Development","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}