[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62837-62838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25687]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0499]
Cooperative Agreement To Support Building Global Capacity for the
Surveillance and Monitoring of Counterfeit/Falsified Medicines and
Supply Chain Threats
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to accept and consider a single source application for award
of a cooperative agreement to the World Health Organization (WHO) in
support of building a global surveillance and monitoring system for
combating counterfeit/falsified medicines and risks and breaches in the
supply.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: Program
Contact: Deborah Autor, or Ilisa Bernstein, Office of Compliance,
Center for Drugs Evaluation and Research, Food and Drug Administration,
White Oak Bldg. 51, rm. 5270, 10903 New Hampshire Ave., Silver Spring,
MD 20993, 301-796-3100, e-mail: Deborah.Autor@fda.hhs.gov or
Ilisa.Bernstein@fda.hhs.gov.
Management Contact: Katherine C. Bond, Office of the Commissioner,
[[Page 62838]]
White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring,
MD 20993, 301-796-8318, FAX: 301-595-5058, e-mail:
Katherine.Bond@fda.hhs.gov.
Grants Contact: Kimberly Pendleton, Division of Acquisition and
Grants, Food and Drug Administration, 5630 Fishers Lane (HFA-500), Rm.
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, e-mail:
kimberly.pendleton@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact Kimberly Pendleton.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
[RFA-FD-10-008]
[Catalog of Federal Domestic Assistance Number(s): 93.103
https://www.cfda.gov]
A. Background
The problem of counterfeit/falsified medicines was first addressed
at the international level in 1985 at the Conference of Experts on the
Rational Use of Drugs in Nairobi. The meeting recommended that the WHO
and relevant stakeholders should study the feasibility of setting up a
clearinghouse to collect data and to inform governments about the
nature and extent of counterfeiting. This project represents a
collaborative agreement between WHO and FDA in building global rapid
alert surveillance/monitoring system(s) for combating counterfeit/
falsified medicines and risks in the supply chain security that will
assist in developing the global landscape and identifying areas of
public health risk, including such challenges and threats as diversion,
intentional adulteration, and the increasing complexity and reduced
transparency of the supply chain due to globalization and limited
regulatory capacity (such as in resource-constrained countries and/or
countries where regulatory infrastructure lack robustness).
B. Research Objectives
Support WHO technical cooperation with member states to
attain better data and improve data sharing about the public health
risks surrounding counterfeit/falsified medicine and supply chain
security, through the development of surveillance and monitoring
system(s) of counterfeit/falsified medicines and risks in supply chains
and rapid alert system(s).
This could include a phased-in approach for
implementation, testing and assessment of a system, as well as
subsequent refinements to the system based on assessments the WHO may
consider relevant.
Support WHO's work internally to identify and possibly
adapt current global surveillance/monitoring systems that may exist in
other programs (e.g., those that the industry uses to collect
information on counterfeit/falsified medicines), as well as other
public health areas (e.g., infectious diseases), and may be relevant in
applicability to a surveillance/monitoring system for counterfeit/
falsified medicines and supply chain integrity.
Work with member states strategically over time to
establish the necessary processes, protocols and commitment to collect
and contribute data, share/exchange data routinely and consistently,
and use the data emanating from a surveillance and monitoring system
for counterfeit/falsified medicines and supply chain risks in support
of national, sub-regional and global strategies and decision-making to
prevent and address the incidence of counterfeit/falsified medicines
and risks within supply chains in a sustainable and measurable way.
Recognizing the importance of WHO's Anti-counterfeiting
Programme, support WHO's contribution to the design, development and/or
implementation of a global surveillance/monitoring system to better
address the challenges and risks of counterfeit/falsified medicines and
supply chain integrity.
Promote development of consistent terminology around
counterfeit/falsified medicines to enable comparable data collection
and analyses; standardized methods for data collection; and a
harmonized approach to data analyses in support of populating and
utilizing a global surveillance/monitoring system for counterfeit/
falsified medicines and supply chain security. Work with Member States
for the implementation of these methods at the country-level to enable
successful and sustainable implementation of a global surveillance/
monitoring system to better address counterfeit/falsified medicines and
supply chain integrity.
Recognizing that active commitment, participation and
engagement of national medicine regulatory authorities in any WHO
surveillance/monitoring system for counterfeit/falsified drugs is
essential, WHO will need to work with Member States as appropriate, for
implementation, assessment, and refinement of a surveillance/monitoring
system for counterfeit/falsified drugs and supply chain integrity that
is of utility to national medicine regulatory authorities and other
relevant national government stakeholders.
Promote the development of peer-reviewed published
articles on the growing complexities and threats addressing
counterfeit/falsified medicines and supply chain security with a goal
to initiate dialogue and expand the thinking among policymakers and
experts on ways to address this public health threat with a forward-
look toward sustainable solutions through global collaboration and
evidence-based approaches.
C. Eligibility Information
The following organizations/institutions are eligible to apply: The
World Health Organization.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award of $960,500 (total costs
including indirect costs) in fiscal year (FY) 2010 in support of this
project. Subject to the availability of funds and successful
performance, 3 additional years of support up to $847,500 per year will
be available.
B. Length of Support
The support will be 1 year with the possibility of an additional
three years of noncompetitive support. Continuation beyond the first
year will be based on satisfactory performance during the preceding
year, receipt of a non-competing continuation application and available
Federal FY appropriations.
Dated: October 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25687 Filed 10-12-10; 8:45 am]
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