[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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