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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-N-0496]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) is announcing its intention to accept and consider a single source application to award a cooperative agreement to the World Health Organization (WHO) Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and in support of the WHO Global Foodborne Infections Network (GFN) and to provide guidance to the WHO on a framework for the development of an international network to promote and enhance collaboration on harmonization and data sharing among countries with Antimicrobial Resistance (AMR) surveillance programs.

# FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

*Program Contact*: Patrick McDermott, Division of Animal and Food Microbiology, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Mod II, rm. 1505, Rockville, MD 20855, 301-210-4213, FAX: 301-210-4685, email:                         *Patrick.McDermott@fda.hhs.gov*.                    

*Management Contact*: Katherine C. Bond, Office of International Programs, Office of the Commissioner, FDA, White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8318, FAX: 301-595-5058, email:                         *Katherine.Bond@fda.hhs.gov*.                    

*Grants Contact*: Kimberly Pendleton, Division of Acquisition and Grants, FDA, 5630 Fishers Lane (HFA-500), rm. 2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email:                         *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-10-006]

                    [Catalog of Federal Domestic Assistance Number(s): 93.103                     *https://www.cfda.gov*]                

### A. Background

The Food and Drug Administration (FDA) is announcing its intention to accept and consider a single source application for a cooperative agreement to the WHO GFN. This project represents a collaborative agreement between the WHO and FDA aimed at capacity building in laboratory based surveillance of foodborne pathogens and disease in developing regions to support AGISAR and GFN to enable FDA to realize its goal of developing an international database for human and animal isolates of foodborne pathogens and their susceptibility profiles.

### B. Research Objectives

    - Support WHO capacity building activities with member countries for AMR monitoring (development of AMR training modules for GFN training courses, and hosting of visiting scientist from developing countries).
    - Develop harmonized schemes for monitoring antimicrobial resistance in zoonotic and enteric bacteria to include appropriate sampling.
    - Promote information sharing on AMR (development of a global AMR databank).
    - Provide expert advice to WHO, and promote WHO and FDA collaborative work to advise WHO Member States on containment of AMR with a particular focus to Human Critically Important Antimicrobials. AGISAR should be the core advisory group to review criteria for ranking human and animal antimicrobials to be reviewed by WHO; and FDA's resources could be used in support of AGISAR's participation.
    - Support and advise WHO on selection of sentinel sites to be strategically identified around the globe and designing pilot projects to conduct integrated surveillance of antimicrobial resistance.
    - Promote development of standardized methods for monitoring antimicrobial use and work with member states for the implementation of these methods at the country-level.
    - Promote the development of published articles on the emergence of AMR threats and challenges, and the       ( print page 61502)                          need for AMR surveillance 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 $847,500 (total costs including indirect costs) in fiscal year (FY) 2010 in support of this project. Subject to the availability of funds and successful performance, 2 additional years of support up to $565,000 per year will be available.

### B. Length of Support

The support will be 1 year with the possibility of an additional 2 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: September 29, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-24903 Filed 10-4-10; 8:45 am]

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