[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Notices]
[Pages 49757-49758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19854]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notification of an Expansion to the Cooperative Agreement Award 
to the World Health Organization

AGENCY: Biomedical Advanced Research and Development Authority (BARDA), 
Assistant Secretary for Preparedness and Response (ASPR), Department of 
Health and Human Services (HHS).

ACTION: Notification of an expansion to the Cooperative Agreement Award 
to the World Health Organization for a grant titled: ``Smallpox 
Research Oversight Activities: WHO Advisory Committee on Variola Virus 
Research''

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

    Statutory Authority:  Sections 301 and 319L of the Public Health 
Service Act, (42 U.S.C. 241 and 247d-7e)

    Estimated Amount of Award: $175,000 USD.
    Project Period: September 30, 2012 to September 29, 2013.

SUMMARY: A natural re-emergence of smallpox is not deemed possible, but 
if it were to occur as a result of a terrorist or deliberate event, it 
would be a potentially devastating threat to public health worldwide 
and would constitute a public health emergency of international concern 
(PHEIC) under the International Health Regulations (IHR) (2005). A case 
of smallpox detected by a member state requires notification to World 
Health Organization (WHO) as soon as possible, and any confirmed 
smallpox case would generate an

[[Page 49758]]

immediate global public health response.
    WHO must rely on fast and reliable laboratory diagnostic capacity 
worldwide to be able to identify a re-emergence of smallpox, 
particularly in countries where systemic orthopoxvirus infections such 
as monkeypox, vaccinia virus infection or cowpox, and other non-pox 
viral rash illnesses, such as chicken pox, may cause clinical 
diagnostic confusion.
    Over the past 10 years, clinical virology laboratory diagnostics 
has been evolving and increasingly relies on molecular techniques. This 
is also true with laboratory diagnoses of poxvirus infections. Precise 
and consistent identification of orthopoxviruses, in particular variola 
viruses, is now achievable using such molecular techniques as real-time 
Polymerase Chain Reaction (PCR), unlike earlier techniques that may 
have relied on direct virus isolation and identification.
    WHO must be alerted when there is a potential or actual smallpox 
infection. Early detection and confirmation of smallpox cannot rely 
solely on the two WHO Collaborating Centres for smallpox and other 
poxvirus infections. In order to facilitate and support a prompt and 
effective response to mitigate the spread of the disease, these two 
Centres should be supported by a worldwide network of reliable 
laboratories able to perform PCR and real-time PCR diagnostics enabling 
initial detection and identification of smallpox events.
    Additionally, the U.S. Government supports the development of other 
medical products, including vaccines and drugs, for use within the U.S. 
upon verification of a smallpox case. The U.S. Government, through the 
Office of the Assistant Secretary for Preparedness and Response (ASPR), 
has successfully developed vaccine products, and is actively engaged in 
the development of several drug candidates for smallpox therapies, 
which require access to the Variola virus to satisfy regulatory 
requirements for product approvals.
    Justification: WHO is the only eligible applicant; it is the only 
organization that is allowed by international agreements to address the 
issues outlined in this proposal. WHO is the directing and coordinating 
authority for health within the United Nations (U.N.) system. It is 
responsible for providing leadership on global health matters, shaping 
the health research agenda, setting norms and standards, articulating 
evidence-based policy options, providing technical support to 
countries, and monitoring and assessing health trends. In the 21st 
century, health is a shared responsibility, involving equitable access 
to essential care and collective defense against transnational threats. 
States Parties to the U.N. have agreed to international standards on 
reporting public health incidents of concern under IHR (2005). 
Additionally, a majority of States Parties have also agreed to specific 
work-frames for pathogens such as smallpox under the Biological Weapons 
Convention.
    Since May 1999, when the 52nd World Health Assembly (WHA) resolved 
to postpone the destruction of the Variola virus to allow for essential 
research (WHA 52.10), WHO has been charged with convening a group of 
experts to advise on the need for continuing such research, to review 
proposals for research involving viable Variola virus, to review the 
progress of such research, and to report to the WHA each year. The need 
to support the activities described in this project has not changed. In 
fact, WHO Member States continue to exert pressure for the WHO 
Secretariat to carry out this work.
    The WHO Advisory Committee on Variola Virus Research (ACVVR) was 
established in 1999 to determine what essential research, if any, must 
be carried out with live Variola virus. The ACVVR monitored the 
research progress in order to reach global consensus on the timing for 
the destruction of existing Variola virus stocks. In 2007, the WHA 
requested the ACVVR undertake a thorough review of the approved 
research program with a report presented in 2010. The results were 
presented at the 64th WHA meeting in May of 2011. The ACVVR continues 
to serve a critically important function for global public health, and 
to oversee research requested specifically by the U.S. to complete its 
national strategic goals. This includes convening a group of experts, 
the Advisory Committee on Variola Virus Research (ACVVR), to advise on 
the need for continuing such research, to review proposals for research 
involving viable Variola virus, and to review the progress of such 
research.
    Additional Information: The agency program contact is George Korch, 
who can be contacted by phone at (202) 690-5760 or via email at 
[email protected].

    Dated: August 12, 2013.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2013-19854 Filed 8-14-13; 8:45 am]
BILLING CODE 4150-37-P