2010-20169. Public Health Security and Bioterrorism Preparedness and Response Act of 2002: Biennial Review and Republication of the Select Agent and Toxin List

AGENCY:

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

ACTION:

Extension of public comment period.

SUMMARY:

On July 21, 2010, the Department of Health and Human Services (HHS) published an Advanced Notice of Proposed Rulemaking (ANPRM) requesting public comment on the current HHS list of select agents and toxins. This document is extending the comment period for that ANPRM in order to align the comment period with the comment period of a related document published by the Animal and Plant Health Inspection Service (APHIS) in the Department of Agriculture (USDA).

DATES:

Written comments in response to the Advanced Notice of Proposed Rulemaking published on July 21, 2010 (75 FR 42363) must be received on or before August 30, 2010. Comments received after August 30, 2010 will be considered to the extent possible.

ADDRESSES:

Comments in response to the Advanced Notice of Proposed Rulemaking (75 FR 42363) should be marked “Comments on the changes to the list of select agents and toxins” and mailed to: Centers for Disease Control and Prevention, Division of Select Agents and Toxins, 1600 Clifton Road, NE., MS A-46, Atlanta, Georgia 30333. Comments may be e-mailed to: [e-mail].

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 July 21, 2010, the Department of Health and Human Services (HHS) published an Advanced Notice of Proposed Rulemaking (ANPRM) in the Federal Register (75 FR 42363) requesting public comment on the current HHS list of select agents and toxins. The purpose of the ANPRM is to seek public comment on (1) the appropriateness of the current HHS list of select agents and toxins, (2) whether there are other agents or toxins that should be added to the HHS list, (3) whether agents or toxins currently on the HHS list should be deleted from the list, (4) whether the HHS select agent list should be tiered based on the relative bioterrorism risk of each agent or toxin, and (5) whether the security requirements for agents in the highest tier should be further stratified based on type of use or other factors. The comment period was scheduled to end on August 22, 2010.

On July 29, 2010, the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA) published an Advanced Notice of Proposed Rulemaking (ANPRM in the Federal Register (75 FR 44724) requesting public comment on the USDA/APHIS list of select agents and toxins. The comment period for the USDA/APHIS ANPRM is scheduled to close on August 30, 2010. Since the select agents and toxins listed in § 73.4 (Overlap select agents and toxins) are those regulated by both HHS/CDC and USDA/APHIS, HHS/CDC is extending the comment period for its ANPRM to August 30, 2010 to coincide with that of USDA/APHIS.

After the close of the comment period, we will carefully consider all comments received and plan to publish another notice in the Federal Register either proposing that the select agent and toxin list remain the same, or that specific biological agents or toxins be added to or deleted from the list. If appropriate, we will also propose any changes to the Select Agent regulations (42 CFR part 73) to implement a tiering and/or stratification schema along with any corresponding amendments to the current security requirements in the Select Agent regulations that might be required for higher-risk agents and toxins.

Dated: August 10, 2010.

Kathleen Sebelius,

Secretary, Department of Health and Human Services.