Document ID: FDA-2010-N-0499-0001
Agency: fda
Document Type: Notice
Title: Agreement To Support Global Capacity for the Surveillance and Monitoring of Counterfeit/Falsified Medicines, etc.
Posted Date: 2010-10-13T04:00Z

[Federal Register: October 13, 2010 (Volume 75, Number 197)]
[Notices]               
[Page 62837-62838]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13oc10-66]                         

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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]
BILLING CODE 4160-01-P