[Federal Register Volume 74, Number 159 (Wednesday, August 19, 2009)]
[Proposed Rules]
[Pages 41829-41831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19737]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

42 CFR Part 73

RIN 0920-AA32


Possession, Use, and Transfer of Select Agents and Toxins--
Chapare virus

AGENCY: Department of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: We are proposing to add Chapare virus to the list of HHS 
select agents and toxins. We are proposing this action because Chapare 
virus has been phylogenetically identified as a Clade B arenavirus and 
is closely related to other currently regulated South American 
arenaviruses that cause haemorrhagic fever, particularly Sabia virus.

DATES: Written comments must be received on or before October 19, 2009.

ADDRESSES: Comments on the proposed change to the list of HHS select 
agents and toxins should be marked ``Comments on Chapare virus'' and 
mailed to: Centers for Disease Control and Prevention, Select Agent 
Program, 1600 Clifton Road, NE., Mailstop 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., Mailstop A-46, Atlanta, GA 30333. Telephone: 
(404) 718-2000.

SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Act) authorizes the 
Secretary to regulate the possession, use, and transfer of select 
agents and toxins that have the potential to pose a severe threat to 
public health and safety. These regulations are set forth at 42 CFR 
part 73.
    Criteria used to determine whether a select agent or toxin should 
be included under the provisions of these regulations are based on:

[[Page 41830]]

     The effect on human health as a result of exposure to the 
agent or toxin,
     The degree of contagiousness of the agent or toxin,
     The methods by which the agent or toxin is transferred to 
humans,
     The availability and effectiveness of pharmacotherapies 
and immunizations to treat and prevent any illness resulting from 
infection by the agent or toxin, and
     Any other criteria, including the needs of children and 
other vulnerable populations that the HHS Secretary considers 
appropriate.
    Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list.
    After consulting with subject matter experts from CDC, the National 
Institutes of Health (NIH), the Food and Drug Administration (FDA), the 
United States Department of Agriculture (USDA)/Animal and Plant Health 
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), 
USDA/CVB (Center for Veterinary Biologics), and the Department of 
Defense (DOD)/United States Army Medical Research Institute for 
Infectious Diseases (USAMRIID) and review of relevant published 
studies, (including Delgado S, Erickson BR, Agudo R, Blair PJ, Vallejo 
E, et al. Chapare Virus, a newly Discovered Arenavirus Isolated from a 
Fatal Hemorrhagic Fever Case in Bolivia. PLoS Pathog 4(4): e1000047, 
April 2008. Available at http://www.plospathogens.org), we believe the 
Chapare virus should be added to the list of HHS select agents and 
toxins.
    The select agents and toxins that were first listed in part 73 
included ``South American Haemorrhagic Fever viruses (Junin, Machupo, 
Sabia, Flexal, Guanarito).'' South American arenaviruses are rodent-
borne viruses, some of which can be associated with large haemorrhagic 
fever outbreaks, and untreated case fatalities can be in excess of 30 
percent. CDC prepared the list of select agents and toxins for a notice 
of intent to issue regulations after receiving extensive input from a 
group of scientists from 21 Federal government entities. Some public 
comments on the notice objected to the inclusion of certain other 
viruses. For example, one commenter indicated that monkeypox virus is 
not easily transmissible to humans and has not been demonstrated to 
result in high levels of mortality. CDC included monkeypox on the final 
rule list, however, in part because it has similarities with smallpox 
virus in that monkeypox has a similar clinical presentation. No 
commenters objected to the listing of South American haemorrhagic fever 
viruses.
    In December 2003 and January 2004, a small number of South American 
haemorrhagic fever cases were reported in rural Bolivia. Specimens were 
available from one fatal case, which had a clinical course that 
included fever, headache, arthralgia, myalgia, and vomiting with 
subsequent deterioration and multiple haemorrhagic signs. Isolated 
virus from two patient serum samples were tested for genetic similarity 
with other Clade B arenaviruses known to cause haemorrhagic fever. The 
complete genome analysis showed that the virus identified was a 
distinct new virus, subsequently named Chapare. Chapare virus was found 
to be most closely related to Sabia virus (causative agent for 
Brazilian haemorrhagic fever).
    We will consider comments that are received within 60 days of 
publication of this notice in the Federal Register. After the comment 
period closes, we will publish another document in the Federal 
Register. The document will include a discussion of any comments we 
receive and any amendments that will be made to the rule as a result of 
the comments.
    If the proposed change is made, we would also consider whether the 
effective date for the regulation of the possession, use, and transfer 
of this agent should be phased in over a period of time greater than a 
30-day effective date. We recognize that entities that currently 
possess an agent that would become regulated as a result of this 
proposed amendment to the regulations may need time to come into full 
compliance with the requirements of the regulations. In order to 
accommodate these entities, we are proposing that the Responsible 
Official at all unregistered entities must submit registration 
paperwork to include the new agent(s) and any new laboratory areas, as 
required in 42 CFR part 73 by 30 days after the effective date and all 
previously unregistered entities must be in full compliance with the 
regulations by 180 days after the effective date to minimize the 
disruption of research.

Regulatory Analyses

Paperwork Reduction Act

    This proposed rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and has been reviewed by the Office 
of Management and Budget.
    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an 
agency to review regulations to assess their impact on small entities 
unless the agency determines that a rule is not expected to have a 
significant impact on a substantial number of small entities.
    Entities most likely to be affected by this rule are laboratories 
and other institutions conducting research and related activities that 
involve the use of an agent that would become regulated as a result of 
this proposed amendment. Even though we believe the impact of these 
changes is expected to be minimal, we will consider comments on the 
impact of this proposed rule to determine if there will be a 
significant impact on small businesses.

Unfunded Mandates

    The Unfunded Mandates Reform Act at 2 U.S.C. 1532 requires that 
agencies prepare an assessment of anticipated costs and benefits before 
developing any rule that may result in expenditure by State, local, or 
tribal governments, in the aggregate, or by the private sector of $100 
million or more (adjusted for inflation) in any given year. This 
proposed rule is not expected to result in any one-year expenditure 
that would exceed this amount.

Executive Order 12988

    This Notice of Proposed Rulemaking has been reviewed under 
Executive Order 12988, Civil Justice Reform. This rule: (1) Would 
preempt all State and local laws and regulations that are inconsistent 
with this rule; (2) would have no retroactive effect; and (3) would not 
require administrative proceedings before parties may file suit in 
court challenging this rule.

Executive Order 13132

    This Notice of Proposed Rulemaking has been reviewed under 
Executive Order 13132, Federalism. The notice does not propose any 
regulation that would preempt State, local, and Indian tribe 
requirements, or that would have any substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.

[[Page 41831]]

List of Subjects in 42 CFR Part 73

    Biologics, Incorporation by reference, Packaging and containers, 
Penalties, Reporting and recordkeeping requirements, Transportation.

    Dated: August 5, 2009.
Kathleen Sebelius,
Secretary.
    For the reasons stated in the preamble, we are proposing to amend 
42 CFR part 73 as follows:

PART 73--SELECT AGENTS AND TOXINS

    1. The authority citation for part 73 continues to read as follows:

    Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of 
Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
    2. Amend Sec.  73.3 by revising the entry for ``South American 
Haemorrhagic Fever viruses'' in paragraph (b) and the reference to it 
in paragraph (f)(3)(i) to read as follows:


Sec.  73.3  HHS select agents and toxins.

* * * * *
    (b) * * *
    South American Haemorrhagic Fever viruses (Chapare, Junin, Machupo, 
Sabia, Flexal, Guanarito)
* * * * *
    (f) * * *
    (3) * * *
    (i) * * * South American Haemorrhagic Fever viruses (Chapare, 
Junin, Machupo, Sabia, Flexal, Guanarito) * * *.
* * * * *


Sec.  73.5  [Amended]

    3. Amend paragraph (a)(3)(i) of Sec.  73.5 by removing the phrase 
``South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, 
Flexal, Guanarito)'' and adding in its place ``South American 
Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, 
Guanarito)''.


Sec.  73.9  [Amended]

    4. Amend paragraph (c)(1) of Sec.  73.9 by removing the phrase 
``South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, 
Flexal, Guanarito)'' and adding in its place ``South American 
Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, 
Guanarito)''.

[FR Doc. E9-19737 Filed 8-18-09; 8:45 am]
BILLING CODE 4160-17-P