Daily Rules, Proposed Rules, and Notices of the Federal Government


Single Source Cooperative Agreement Award for World Health Organization

AGENCY: Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR).
ACTION: Statutory Authority:Sections 301 and 319L of the Public Health Service Act, (42 U.S.C. 241 and 247d-7e).

Estimated Amount of Award:$400,000.

Project Period:Sept. 30, 2012 to Sept. 29, 2013.

SUMMARY: 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 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).

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.

Single Source 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. haveagreed 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.

Additional Information:The agency program contact is Richard J. Hatchett, MD, who can be contacted by phone at (202) 260-0150 or via email

Dated: September 12, 2012. Nicole Lurie, Assistant Secretary for Preparedness and Response.