42 CFR Part 73 - SELECT AGENTS AND TOXINS
- § 73.0 Applicability and related requirements.
- § 73.1 Definitions.
- § 73.2 Purpose and scope.
- § 73.3 HHS select agents and toxins.
- § 73.4 Overlap select agents and toxins.
- § 73.5 Exemptions for HHS select agents and toxins.
- § 73.6 Exemptions for overlap select agents and toxins.
- § 73.7 Registration and related security risk assessments.
- § 73.8 Denial, revocation, or suspension of registration.
- § 73.9 Responsible Official.
- § 73.10 Restricting access to select agents and toxins; security risk assessments.
- § 73.11 Security.
- § 73.12 Biosafety.
- § 73.13 Restricted experiments.
- § 73.14 Incident response.
- § 73.15 Training.
- § 73.16 Transfers.
- § 73.17 Records.
- § 73.18 Inspections.
- § 73.19 Notification of theft, loss, or release.
- § 73.20 Administrative review.
- § 73.21 Civil money penalties.
Title 42 published on 06-Feb-2018 04:05
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 73 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-24952 RIN 0920-AA58 Docket No. CDC-2015-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Notice of proposed rulemaking; withdrawal. The proposed rule published on July 16, 2015 (80 FR 42079), is withdrawn as of November 17, 2017. 42 CFR Part 73 The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus strains to the list of HHS select agents and toxins.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-07210 RIN 0920-AA64 CDC Docket No. CDC-2016-0045 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Interim rule; adoption as final and response to public comments. Effective April 12, 2017. 42 CFR Part 73 On September 14, 2016, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published in the Federal Register (81 FR 63138) an interim final rule and request for comments which added Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. CDC received two comments, both of which supported the rule change.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-04799 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Public Health Service 42 CFR Part 73
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-03044 RIN 0920-AA59 Docket No. CDC-2015-0045 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule; delay of effective date. The effective date for the final rule published January 19, 2017, at 82 FR 6278, is delayed until March 21, 2017. 42 CFR Part 73 The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a delay in the effective date of the final rule titled “Possession, Use, and Transfer of Select Agents and Toxins, Biennial Review and Enhanced Biosafety Requirements” that published on January 19, 2017. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making a parallel change in the effective date of their final rule. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled “Regulatory Freeze Pending Review.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-00726 RIN 0920-AA59 Docket No. CDC-2015-0006 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. Effective February 21, 2017. 42 CFR Part 73 In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-22049 RIN 0920-AA64 CDC Docket No. CDC-2016-0045 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Interim final rule and request for comments. Effective date: The interim final rule is effective on October 14, 2016. Public comment period: Written or electronic comments must be submitted by November 14, 2016. Applicability dates: By October 14, 2016, any individual or entity that possesses B. cereus Biovar anthracis must provide notice to the CDC's DSAT regarding their possession of this agent and must secure the agent against theft, loss, release, or unauthorized access; and by March 13, 2017, an individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with 42 CFR part 73 or amend their current registration in accordance with 42 CFR 73.7(h) and meet all of the requirements of select agent regulations (42 CFR part 73). 42 CFR Part 73 The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-00758 RIN 0920-AA59 Docket No. CDC-2015-0006 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Notice of Proposed Rulemaking (NPRM). Submit written or electronic comments by March 21, 2016. 42 CFR Part 73 In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.
GPO FDSys XML | Text type regulations.gov FR Doc. 2015-17435 RIN 0920-AA58 Docket No. CDC-2015-0050 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention Notice of proposed rulemaking and request for comments. Comments should be received on or before September 14, 2015. 42 CFR Part 73 The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.
GPO FDSys XML | Text type regulations.gov FR Doc. 2015-04169 RIN 0920-AA59 Docket No. CDC-2015-0006 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Advance notice of proposed rulemaking and request for comments. Comments should be received on or before April 28, 2015. 42 CFR Part 73 In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A (Department of Health and Human Services) of Title II (Enhancing Controls on Dangerous Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has initiated the review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. We are considering whether to propose amending the HHS list by removing six biological agents.
GPO FDSys XML | Text type regulations.gov FR Doc. 2014-10740 RIN 0920-AA34 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule; technical amendment. Effective Date: May 12, 2014. 42 CFR Part 73 In a final rule that was published in the Federal Register on October 5, 2012, we amended and republished the list of select agents and toxins that have the potential to pose a severe threat to public health and safety; reorganized the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human health (designation of Tier 1); and amended the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response. In that final rule, all of our regulatory language was not precisely aligned with that used by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) in their parallel select agent regulations published on the same day in the Federal Register . This document corrects inconsistencies in language between the HHS/CDC and USDA/APHIS regulations. We are also correcting an improper term used in those sections of the regulations associated with identification of a viral strain or subspecies that is excluded from the requirements of the regulations, modifying the terms used when a select toxin is excluded from the regulations, clarifying those parts of the regulations that deal with temporary exemptions granted during periods of public health or agricultural emergencies, and adding language to specify that individuals not approved for unescorted access to registered space for activities not related to select agents or toxins (e.g., routine cleaning, maintenance, and repairs) would not have to be continuously escorted by an approved individual so long as those non-approved persons would not be able to gain access to select agents or toxins.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-02828 RIN Docket No. CDC-2012-0010 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Request for information; reopening of comment period. Written or electronic comments must be received on or before March 11, 2013. 42 CFR Part 73 With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the re-opening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28784 RIN 0920-AA34 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule; correction. Effective Date: Effective December 4, 2012. 42 CFR Part 73 The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on October 5, 2012 (77 FR 61084). The document updated the list of HHS and overlap biological agents and toxins and designated certain select agents and toxins as Tier 1 agents.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-25377 RIN Docket No. CDC-2012-0010 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Request for information and comment. Electronic or written comments should be received on or before December 17, 2012. 42 CFR Part 73 The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. This information will be considered in a determination of whether such viruses should be listed as HHS select agents, by revising the HHS Select Agent Regulations (42 CFR Part 73).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24389 RIN 0920-AA34 Docket No. CDC-2011-0012 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. Effective Dates: The amendments to §§ 73.1, 73.3 through 73.6, 73.9, 73.10, 73.13, 73.16, 73.17, and 73.20, of Title 42, Code of Federal Regulations are effective December 4, 2012. The remaining provisions to this final rule are effective April 3, 2013. Applicability Dates: By December 4, 2012, all entities that possess SARS, Chapare, and Lujo viruses must provide notice to CDC regarding their possession of these viruses, and by April 3, 2013, all previously unregistered entities must meet all of the requirements of this part. The Final Rule timelines are based on the timelines that worked effectively for the Federal Select Agent Program Interim Final Rules that were published in December 2002. If the regulated community has concerns about the established timeline, they can contact Federal Select Agent Program for technical assistance. Comment Date: Written comments on the new information collection contained in this final rule should be received by October 15, 2012. 42 CFR Part 73 In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United States,” HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as “Tier 1” agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre-access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register , the United States Department of Agriculture (USDA) has made parallel regulatory changes.