{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.","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/2020/07/29/2020-15441.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"514","title":21}],"citation":"85 FR 45505","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 28, 2020. For the applicable compliance date, please see section V, \"Effective and Compliance Dates\" in SUPPLEMENTARY INFORMATION.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-6381"],"dockets":[],"document_number":"2020-15441","effective_on":"2020-08-28","end_page":45513,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/29/2020-15441.xml","html_url":"https://www.federalregister.gov/documents/2020/07/29/2020-15441/postmarketing-safety-reports-for-approved-new-animal-drugs-electronic-submission-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-15441?publication_date=2020-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-29/2020-15441/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":952,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-29/pdf/2020-15441.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15441.pdf?1595940313","publication_date":"2020-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/29/2020-15441.txt","regulation_id_number_info":{"0910-AH51":{"issue":"202004","html_url":"https://www.federalregister.gov/regulations/0910-AH51/postmarketing-safety-reports-for-approved-new-animal-drugs-electronic-submission-requirements","title":"Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AH51&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH51"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FDA tab C - Postmarket Safety Reports for NAD - RIA (OMB final 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0015"},{"title":"FDA tab C - Postmarket Safety Reports for NAD - Final Rule (2018-333) (OMB final 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0014"},{"title":"FDA tab B - Postmarket Safety Reports for NAD - RIA (OMB redline compare 3-18-20 to 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0013"},{"title":"FDA tab B - Postmarket Safety Reports for NAD - Final Rule (OMB redline compare 3-18-20 and 6-11-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0012"},{"title":"FDA tab A - Postmarket Safety Reports for NAD - RIA (OMB preliminary 3-18-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0011"},{"title":"FDA tab A - Postmarket Safety Reports for NAD - Final Rule (2018-333) (OMB preliminary 3-18-20) RE Memorandum to DMS - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)","document_id":"FDA-2017-N-6381-0010"}],"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-N-6381","supporting_documents_count":6,"docket_id":"FDA-2017-N-6381","document_id":"FDA-2017-N-6381-0005","regulation_id_number":null,"title":"Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements","checked_regulationsdotgov_at":"2020-09-02T00:30:08Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":45505,"subtype":null,"title":"Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements","toc_doc":"Postmarketing Safety Reports for Approved New Animal Drugs","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Confidential business information","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}