Select Agents – Notice of Proposed Rulemaking

On October 3, 2011, the Centers for Disease Control (CDC), located within the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 61206) requesting public comment on the appropriateness of the current HHS and Overlap list of select agents and toxins lists.   While this public comment period officially ended on December 2, the comment period has been extended to January 17, 2012.  The CDC is specifically asking for comments related to:

  1.  Whether there are other agents or toxins that should be added to the HHS or Overlap list;
  2.  Whether agents or toxins currently on the HHS or Overlap list should be deleted from the list;
  3. The appropriateness of the proposed tiering of the select agents and toxins list;
  4. Whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents;
  5. Any other aspect of the proposed amendments to the select agent regulations.

The Select Agents and Toxins List can be obtained from the National Select Agent Registry here.  A further list of Excluded Agents can be found here. To submit a comment, please see, and reference your comments by Regulatory Information Number (RIN), 0920-AA34 and the Agency (Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)).  The original Notice of Proposed Rulemaking (NPRM) is published in the Federal Register (76 FR 61206).

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