{"abstract":"The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.","action":"Final rule; technical amendments.","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/2022/03/29/2022-06395.html","cfr_references":[{"chapter":null,"citation_url":null,"part":510,"title":21},{"chapter":null,"citation_url":null,"part":516,"title":21},{"chapter":null,"citation_url":null,"part":520,"title":21},{"chapter":null,"citation_url":null,"part":522,"title":21},{"chapter":null,"citation_url":null,"part":524,"title":21},{"chapter":null,"citation_url":null,"part":529,"title":21},{"chapter":null,"citation_url":null,"part":556,"title":21},{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"87 FR 17942","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 29, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0002"],"dockets":[],"document_number":"2022-06395","effective_on":"2022-03-29","end_page":17949,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/03/29/2022-06395.xml","html_url":"https://www.federalregister.gov/documents/2022/03/29/2022-06395/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-06395?publication_date=2022-03-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-03-29/2022-06395/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":1594,"last_updated":"2026-04-11 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-03-29/pdf/2022-06395.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-06395.pdf?1648471512","publication_date":"2022-03-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/03/29/2022-06395.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"New Animal Drugs; Withdrawal of Approval of New Animal Drug Application","document_id":"FDA-2021-N-0002-0044"},{"title":"FOI Summary sN 141-063 approved August 19 2021","document_id":"FDA-2021-N-0002-0041"},{"title":"FOI Summary oA 200-708 approved August 2 2021","document_id":"FDA-2021-N-0002-0037"},{"title":"FOI Summary sN 140-269 approved May 25 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0036"},{"title":"FOI Summary oN 141-543 approved June 1 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0035"},{"title":"FOI Summary oA 200-702 approved April 23 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0032"},{"title":"FOI Summary sN 141-452 approved May 18 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0029"},{"title":"FOI Summary sN 128-620 approved June 14 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0028"},{"title":"FOI Summary oA 200-700 approved June 10 2021  RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0027"},{"title":"FOI Summary oA 200-697 approved April 5 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address","document_id":"FDA-2021-N-0002-0026"}],"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-2021-N-0002","supporting_documents_count":45,"docket_id":"FDA-2021-N-0002","document_id":"FDA-2021-N-0002-0045","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2022-03-30T03:30:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17942,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","toc_doc":"Approval of Applications; Change of Sponsor","toc_subject":"New Animal Drugs:\n","topics":["Administrative practice and procedure","Animal drugs","Animal feeds","Confidential business information","Dairy products","Foods","Labeling","Meat and meat products","Reporting and recordkeeping requirements"],"type":"Rule","volume":87}