[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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