[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46824-46825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Justification for a Single Source Cooperative Agreement Award for 
the World Health Organization

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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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 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 rely on

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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 
(unlike earlier techniques that may have relied on direct virus 
isolation and identification).
    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.
    Period of Performance: September 30, 2014 to September 29, 2015.

FOR FURTHER INFORMATION CONTACT: The agency program contact is Julie 
Schafer, who can be contacted by phone at 202-205-1435or via email at 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to Sections 42 U.S.C. 241 and 247d-
7e (Sections 301 and 319L of the Public Health Service Act); ASPR's 
Office of Biomedical Advanced Research and Development Authority 
(BARDA) is the program office for this award.
    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 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 the development of new 
antiviral agents, safer vaccines, and better diagnostics, thus 
strengthening our national security.
    Estimated amount of award: up to $662,500 USD.

HHS/ASPR/BARDA: $225,000
DOD: $250,000 (funds pending)
HHS/NIH/NIAID: $50,000
HHS/CDC: $87,500
HHS/OGA: $50,000

    Procedures for Providing Public Input: All written comments must be 
received no later than 15 days after the posting of this announcement. 
Please submit comments via [email protected].

    Date: August 4, 2014.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2014-18836 Filed 8-8-14; 8:45 am]
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