{"abstract":"The Food and Drug Administration (FDA) is withdrawing the interim final rule that it published on February 4, 2002. The interim final rule amended the regulations for records and reports concerning experiences with approved new animal drugs. FDA invited interested parties to comment on the interim final rule. As a result of those comments, this final rule more clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs). In addition, the final rule revises the timing and content of certain reports to enhance their usefulness. This regulation will provide for protection of public and animal health and reduce unnecessary recordkeeping and reporting requirements.","action":"Withdrawal of interim final rule and issuance of 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/2003/03/31/03-7475.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"211","title":21},{"chapter":null,"citation_url":null,"part":"226","title":21},{"chapter":null,"citation_url":null,"part":"510","title":21},{"chapter":null,"citation_url":null,"part":"514","title":21}],"citation":"68 FR 15355","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 30, 2003. The interim final rule published on February 4, 2002 (67 FR 5046), is withdrawn as of March 31, 2003.","disposition_notes":null,"docket_ids":["Docket No. 88N-0038"],"dockets":[{"supporting_documents":[{"title":"Supporting Statement","document_id":"FDA-1988-N-0018-0005"},{"title":"Supporting Statement","document_id":"FDA-1988-N-0018-0004"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-07-30T14:56:30.754-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1988-N-0018-0002","allow_late_comments":false,"id":"FDA-1988-N-0018-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-1988-N-0018","title":"Records & Reports concerning experience w/ new animal drugs"}],"document_number":"03-7475","effective_on":"2003-06-30","end_page":15369,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/03/31/03-7475.xml","html_url":"https://www.federalregister.gov/documents/2003/03/31/03-7475/records-and-reports-concerning-experience-with-approved-new-animal-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-7475?publication_date=2003-03-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-03-31/03-7475/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":368,"last_updated":"2026-10-22 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-03-31/pdf/03-7475.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-03-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/03/31/03-7475.txt","regulation_id_number_info":{"0910-AC42":{"issue":"200210","html_url":"https://www.federalregister.gov/regulations/0910-AC42/records-and-reports-concerning-experience-with-approved-new-animal-drugs","title":"Records and Reports Concerning Experience With Approved New Animal Drugs","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200210&RIN=0910-AC42&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AC42"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Supporting Statement","document_id":"FDA-1988-N-0018-0005"},{"title":"Supporting Statement","document_id":"FDA-1988-N-0018-0004"}],"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-1988-N-0018","supporting_documents_count":2,"docket_id":"FDA-1988-N-0018","document_id":"FDA-1988-N-0018-0002","regulation_id_number":null,"title":"Records & Reports concerning experience w/ new animal drugs","checked_regulationsdotgov_at":"2026-07-31T21:55:04Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":15355,"subtype":null,"title":"Records and Reports Concerning Experience With Approved New Animal Drugs","toc_doc":"Approved new animal drugs; adverse experiences; reporting and recordkeeping requirements","toc_subject":"Animal drugs, feeds, and related products:","topics":["Administrative practice and procedure","Animal drugs","Confidential business information","Drugs","Labeling","Laboratories","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":68}