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HHS/CDC | RIN: 0920-AA71 | Publication ID: Fall 2024 |
Title: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins | |
Abstract:
The Bioterrorism Preparedness Act requires that the Department of Health and Human Services (HHS) Secretary review and republish the list of select agents and toxins on at least a biennial basis. CDC published an Advanced Notice of Proposed Rulemaking in 2020 to allow the public an additional opportunity to comment on potential changes to HHS’s list of select agents. Further, CDC’s standard practice is to send email notices called SA-Grams to the regulated entities and Responsible Officials regarding changes and alerts concerning the Select Agent Program as well as announcements of opportunities to provide comment on proposed rules. HHS will finalize the January 2024 proposed rule in two separate rulemakings: One final rule will focus on changes to the select agents and toxins list. The second final rule will focus on administrative and programmatic changes. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 42 CFR 73 | |
Legal Authority: Pub. L. 107-188 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal, Local, State |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Daniel A Singer Acting Director, Division of Regulatory Science and Compliance Department of Health and Human Services Centers for Disease Control and Prevention 1600 Clifton Road NE, H21-4, Atlanta, GA 30329 Phone:404 718-2000 Email: lrsat@cdc.gov |