[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Page 57108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

AGENCY: Office of the Assistant Secretary for Preparedness and 
Response, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: The U.S. Department of Health and Human Services (HHS), Office 
of the Assistant Secretary for Preparedness and Response (ASPR) intends 
to fund an unsolicited proposal submitted by the World Health 
Organization (WHO) to support work towards establishing a regulatory 
pathway at WHO for prequalification of medical countermeasures to be 
deployed internationally in an emergency, which includes supporting WHO 
and potential recipient countries to build regulatory capacity for the 
import, registration, and emergency use of medical countermeasures. The 
goals of this Cooperative Agreement are to: (1) Using smallpox vaccines 
as a case study, complete product review and prequalification of 
smallpox vaccines included in or pledged to the WHO Smallpox Vaccine 
Emergency Stockpile for emergency use; (2) Establish general regulatory 
pathways for emergency use authorization and/or a process for emergency 
prequalification of emergency medical countermeasures and; (3) Support 
potential recipient WHO member states in building capacities for the 
import, registration, and emergency use of medical countermeasures.
    This Cooperative Agreement directly supports several federal 
initiatives focused on strengthening national and international health 
security, including HHS's ongoing work within the Global Health 
Security Initiative (GHSI) to develop an operational framework for the 
international deployment of medical countermeasures which contemplates 
the legal, regulatory, and logistical issues to be considered during 
such a deployment as noted in the 2013 GHSI Ministerial communique.\1\ 
Additionally, it supports Objective 9 of the Global Health Security 
Agenda \2\ which calls for improving global access to medical and non-
medical countermeasures during health emergencies and the improvement 
of international deployment capabilities. It also aligns with the HHS 
Global Health Strategy priority to ``develop policy frameworks, 
agreements and operational plans to facilitate HHS decision-making in 
response to both single and multiple international requests for 
emergency assistance, including for the deployment of medical 
countermeasures and HHS personnel.'' \3\
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    \1\ 2013 Global Health Security Initiative Ministerial Meeting 
Communique [online]. Available from: http://www.ghsi.ca/english/statements.asp.
    \2\ The Global Health Security Agenda. Available from: http://www.globalhealth.gov/global-health-topics/global-health-security/ghsagenda.html.
    \3\ HHS Global Health Strategy Objectives [online]. Available 
from: http://www.globalhealth.gov/global-programs-and-initiatives/global-health-strategy/strategy-objectives/.
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    Period of Performance: October 1, 2014 to September 29, 2017.

FOR FURTHER INFORMATION CONTACT: Please submit an inquiry via the ASPR 
Division of Grants Management at [email protected].

SUPPLEMENTARY INFORMATION: The Division of International Health 
Security within the Office of Policy and Planning in ASPR is the 
program office for this award.
    Procedures for Providing Public Input: All written comments must be 
submitted no later than 15 days after posting of this announcement. 
Please submit comments to [email protected].

    Authority:  301 42 U.S.C. 241.

    Dated: September 18, 2014.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2014-22773 Filed 9-23-14; 8:45 am]
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