{"abstract":"The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is amending its select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS- CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC intends to regulate this agent and to require the regulated entity to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.","action":"Interim 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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/11/17/2021-25204.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"73","title":42}],"citation":"86 FR 64075","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: The interim final rule is effective on November 17, 2021.","disposition_notes":null,"docket_ids":["Docket No. CDC-2021-0119"],"dockets":[],"document_number":"2021-25204","effective_on":"2021-11-17","end_page":64081,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/11/17/2021-25204.xml","html_url":"https://www.federalregister.gov/documents/2021/11/17/2021-25204/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-sars-covsars-cov-2-chimeric","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-25204?publication_date=2021-11-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-11-17/2021-25204/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":3668,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-11-17/pdf/2021-25204.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-25204.pdf?1637010924","publication_date":"2021-11-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/11/17/2021-25204.txt","regulation_id_number_info":{"0920-AA79":{"issue":"202210","html_url":"https://www.federalregister.gov/regulations/0920-AA79/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-sars-cov-sars-cov-2-chimeric-vir","title":"Possession, Use, and Transfer of Select Agents and Toxins; Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0920-AA79&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0920-AA79"],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0920-AA79/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-sars-cov-sars-cov-2-chimeric-vir","title":"Possession, Use, and Transfer of Select Agents and Toxins; Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses"},"comments_count":4,"agency_id":"CDC","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CDC-2021-0119","supporting_documents_count":0,"docket_id":"CDC-2021-0119","document_id":"CDC-2021-0119-0004","regulation_id_number":"0920-AA79","title":"Possession, Use, and Transfer of Select Agents and Toxins – Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the HHS list of Select Agents and Toxins","checked_regulationsdotgov_at":"2022-01-20T04:30:11Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":64075,"subtype":null,"title":"Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins","toc_doc":"Addition of SARSCoV/SARSCoV2 Chimeric Viruses resulting from any deliberate manipulation of SARSCoV2 to incorporate nucleic acids coding for SARSCoV virulence factors to the HHS list of Select Agents and Toxins","toc_subject":"Possession, Use, and Transfer of Select Agents and Toxins:\n","topics":["Biologics","Incorporation by reference","Packaging and containers","Penalties","Reporting and recordkeeping requirements","Transportation"],"type":"Rule","volume":86}