[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Proposed Rules]
[Pages 50730-50731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73

RIN 0920-AA34


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.

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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)

[[Page 50731]]

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: [email protected].

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: 
(404) 718-2000.

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 Sec.  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.
[FR Doc. 2010-20169 Filed 8-16-10; 8:45 am]
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