{"abstract":"On January 19, 2017, the Environmental Protection Agency (EPA), acting in concert with other agencies, promulgated revisions to the \"Common Rule.\" EPA's codification of these revisions is in 40 CFR part 26, subpart A. These revisions went into effect on July 19, 2018, and compliance with the new provisions was required beginning on January 21, 2019. In addition to the core protections found in the Common Rule, EPA has promulgated regulations that are specific to research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes. The revisions to the Common Rule create discrepancies within some of these EPA-specific regulations. This final rule harmonizes the EPA-specific regulations with revisions to the Common Rule in order to resolve those discrepancies.","action":"Final rule.","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2019/07/23/2019-15665.html","cfr_references":[{"chapter":null,"citation_url":null,"part":26,"title":40}],"citation":"84 FR 35315","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective on September 23, 2019.","disposition_notes":null,"docket_ids":["EPA-HQ-ORD-2018-0280","FRL-9996-48-ORD"],"dockets":[],"document_number":"2019-15665","effective_on":"2019-09-23","end_page":35324,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/07/23/2019-15665.xml","html_url":"https://www.federalregister.gov/documents/2019/07/23/2019-15665/protection-of-human-research-subjects","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-15665?publication_date=2019-07-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-07-23/2019-15665/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":950,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-07-23/pdf/2019-15665.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-15665.pdf?1563799525","publication_date":"2019-07-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/07/23/2019-15665.txt","regulation_id_number_info":{"2080-AA13":{"issue":"201904","html_url":"https://www.federalregister.gov/regulations/2080-AA13/harmonize-40-cfr-part-26-subparts-c-d-and-k-with-subpart-a-the-common-rule-","title":"Harmonize 40 CFR Part 26 Subparts C, D, and K with Subpart A (the Common Rule)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=2080-AA13&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["2080-AA13"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FIFRA SAP Review Waiver of Draft Final Rule","document_id":"EPA-HQ-ORD-2018-0280-0020"},{"title":"USDA Response to Notification","document_id":"EPA-HQ-ORD-2018-0280-0019"},{"title":"Revised NPRM Per OMB Comments","document_id":"EPA-HQ-ORD-2018-0280-0008"},{"title":"EPA Response to OMB Comments 2","document_id":"EPA-HQ-ORD-2018-0280-0007"},{"title":"EPA Response to OMB Comments 1","document_id":"EPA-HQ-ORD-2018-0280-0006"},{"title":"NPRM for OMB Review","document_id":"EPA-HQ-ORD-2018-0280-0005"},{"title":"FIFRA  Scientific Advisory  Panel Review Waiver 6-4-18","document_id":"EPA-HQ-ORD-2018-0280-0004"},{"title":"USDA  Response to Notification","document_id":"EPA-HQ-ORD-2018-0280-0002"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/2080-AA13/harmonize-40-cfr-part-26-subparts-c-d-and-k-with-subpart-a-the-common-rule-","title":"Harmonize 40 CFR Part 26 Subparts C, D, and K with Subpart A (the Common Rule)"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=EPA-HQ-ORD-2018-0280","supporting_documents_count":8,"docket_id":"EPA-HQ-ORD-2018-0280","regulation_id_number":"2080-AA13","title":"Harmonize EPA Regulations with Common Rule Revisions","checked_regulationsdotgov_at":"2019-07-25T03:30:08Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":35315,"subtype":null,"title":"Protection of Human Research Subjects","toc_doc":"Protection of Human Research Subjects","toc_subject":null,"topics":["Administrative practice and procedure","Environmental protection","Pesticides and pests"],"type":"Rule","volume":84}