{"abstract":"The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is amending its regulations governing new animal drug applications to further define the term ``adequate and well-controlled studies.'' The purpose of this final rule is to further define ``adequate and well controlled'' to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions.","action":"Final rule.","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/1998/03/05/98-5675.html","cfr_references":[{"chapter":null,"citation_url":null,"part":514,"title":21}],"citation":"63 FR 10765","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The regulations are effective on April 6, 1998.","disposition_notes":null,"docket_ids":["Docket No. 97N-0141"],"dockets":[],"document_number":"98-5675","effective_on":"1998-04-06","end_page":10772,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/03/05/98-5675/adequate-and-well-controlled-studies-for-investigational-use-and-approval-of-new-animal-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-5675?publication_date=1998-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-03-05/98-5675/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":54,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-03-05/pdf/98-5675.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/03/05/98-5675.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T01:24:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10765,"subtype":null,"title":"Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":63}