2011-32361. Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Proposed rule; reopening of comment period.

SUMMARY:

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 including whether there are other agents or toxins that should be added to the HHS or Overlap list or whether agents or toxins currently on the HHS or Overlap list should be deleted from the list; the appropriateness of the proposed tiering of the select agents and toxins list; whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents; and any other aspect of the proposed amendments to the select agent regulations. The comment period closed on December 2, 2011. Since we would like to allow interested persons additional time to prepare and submit comments, we are reopening the comment period for the NPRM.

DATES:

Written comments must be received on or before January 17, 2012.

ADDRESSES:

You may submit comments, identified by Regulatory Information Number (RIN), 0920-AA34 in the heading of this document by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Centers for Disease Control and Prevention, Select Agent Program, 1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 30333, Attn: RIN 0920-AA34.

Instructions: All submissions received must include the agency name and RIN for this rulemaking. All relevant comments received will be posted without change to http://www.regulations.gov,, including any personal information provided.

Docket Access: For access to the docket to read background documents or comments received or to download an electronic version of the NPRM, go to http://www.regulations.gov. Comments will be available for public inspection Monday through Friday, except for legal holidays, from 9 a.m. until 5 p.m. at 1600 Clifton Road NE., Atlanta, GA 30333. Please call ahead to 1-866-694-4867 and ask for a representative in the Division of Select Agents and Toxins to schedule your visit. Our general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet as they are received and without change.

FOR FURTHER INFORMATION CONTACT:

Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS A-46, Atlanta, Georgia 30333. Telephone: [phone].

SUPPLEMENTARY INFORMATION:

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 (1) The appropriateness of the current HHS and Overlap list of select agents and toxins including whether there are other agents or toxins that should be added to the HHS or Overlap list or whether agents or toxins currently on the HHS or Overlap list should be deleted from the list; (2) the appropriateness of the proposed tiering of the select agents and toxins list; (3) whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents; and (4) any other aspect of the proposed amendments to the select agent regulations. The comment period closed on December 2, 2011. Since we would like to allow interested persons additional time to prepare and submit comments, we are reopening the comment period for its NPRM. We will also consider all comments we receive between December 2, 2011 and the date of this notice.

Dated: December 13, 2011.

Kathleen Sebelius,

Secretary.