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

###### Food and Drug Administration

          - [Docket No. FDA-2010-N-0466]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

      ( print page 55794)    

# SUMMARY:

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2010 (FY10) to the World Health Organization (WHO). One of the primary goals of the WHO is to provide for timely collaboration on multinational cooperative activities.

# DATES:

Important dates are as follows:

1. The application due date is September 16, 2010.

2. The anticipated start date is September 2010.

3. The opening date is September 16, 2010.

4. The expiration date is September 30, 2010.

# FOR FURTHER INFORMATION CONTACT:

*Center Contact*: Salvatore Evola, Center for Food Safety and Applied Nutrition (HFS-300), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2164, e-mail:                         *evola.salvatore@fda.hhs.gov*.                    

*Grants Management Contact*: Kimberly Pendleton, Division of Acquisition Support and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, 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 refer to the full FOA located at                         *http://www.fda.gov/​Food/​NewsEvents/​ucm176500.htm*.                    

# SUPPLEMENTARY INFORMATION:

## I. Funding Opportunity Description

Catalog of Federal Domestic Assistance Number: 93.103

### A. Background

This funding opportunity is a single source application for the award of a cooperative agreement to the WHO to support the Initiative to Estimate the Global Burden of Foodborne Diseases—Foodborne Disease Burden Epidemiology Reference Group (FERG). This cooperative agreement ensures FDA's participation and leadership in important international risk assessment and public health efforts involving microbiological and chemical hazards. Competition is limited to WHO because it is the parent organization of FERG.

### B. Research Objectives

The WHO's FERG comprises over 30 internationally renowned experts in a broad range of disciplines relevant to global foodborne disease epidemiology.

FERG consists of the following groups:
    - a Core (or Steering) Group to coordinate and oversee the scientific work;
    - four different Thematic Task Forces advancing the work in specific areas: Infectious diseases, chemicals and toxins, source attribution, and country burden of disease protocols; and
    - external resource advisers who are invited on an ad hoc basis to provide specific expertise.

FERG is charged with the following tasks:
    - assemble, appraise, and report on the current, the projected, and the averted burden of foodborne disease estimates;
    - conduct epidemiological reviews for mortality, morbidity, and disability in each of the major foodborne diseases;
    - provide models for the estimation of foodborne disease burden where data are lacking;
    - develop cause attribution models to estimate the proportion of diseases that are foodborne; and, most importantly,
    - use the FERG models to develop user-friendly tools for burden of foodborne disease studies at country level.

In addition, FERG aims to estimate the global human health burden (expressed in Disability-Adjusted Life Years (DALYs)) of foodborne disease. FERG will initially focus on microbial, parasitic, zoonotic, and chemical contamination of food with an emphasis on diseases whose incidence and severity is thought to be high, and on pathogens and chemicals that are most likely to contaminate food and which have a high degree of preventability.

FERG is supported by the WHO Secretariat, comprising nine WHO Departments as well as international organizations (such as FAO, United Nations Environment Programme etc.) with an interest in foodborne disease burden estimation.

This agreement will strengthen and allow WHO to continue its work in important international risk assessment and public health efforts. This agreement will also assist FDA in future assessments of the potential hazards, risks, and public health impact of foodborne disease. WHO is an umbrella organization that provides for timely international collaboration on multinational cooperative activities. The evaluations that are produced by WHO expert groups are based on sound science that contributes to improved public health and food safety worldwide. The following activities are to be supported by this cooperative agreement: (1) Schedule, plan, and conduct appropriate work groups, consultations, and committee meetings; (2) identify advisers, and prepare written working papers summarizing the data on foodborne contaminants under consideration; and (3) prepare written working papers and technical documents for the FAO/WHO Expert Consultations related to contaminants (microbiological and chemical) in food.

### C. Eligibility Information

                    Competition is limited to WHO because it has unique expertise and capacity found nowhere else. As part of the implementation of the WHO Global Strategy for Food Safety, WHO launched the Initiative to Estimate the Global Burden of Foodborne Diseases from all major causes (of microbiological, parasitic, and chemical origin) and in 2007 established FERG to estimate the global health burden of foodborne disease (and to express the estimate in DALYs) (                    *http://www.who.int/​foodsafety/​foodborne_​disease/​ferg*). (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the                     **Federal Register**                    .) FERG is a multisectoral and multidisciplinary group of global experts in foodborne diseases and representatives from numerous UN and other international agencies as well as National bodies (including the U.S. agencies FDA, United States Department of Agriculture and Centers for Disease Control and Prevention, among others). FERG operates through several Task Forces in the area of parasitic diseases, enteric diseases, chemicals and toxins, and source attribution (the latter aims to provide evidence that links burden of disease to specific food commodities, where possible). While FERG is reviewing all existing scientific evidence, including surveillance data, the full picture of the global health burden of foodborne disease can only be established if national level estimates of the health burden of foodborne disease are collected. FERG therefore launched the Country Studies Task Force which aims to strengthen the capacity of countries to undertake national burden of foodborne disease assessments, and provides countries with tools with which to conduct these studies and continue to monitor disease burden in the long-term. A further strength of such data lies in its ability to assist countries to detect important food safety threats early and to make and apply food safety policies and interventions based on sound scientific evidence pertinent to that country. WHO aims to conduct such studies in all six regions over the coming years.                          ( print page 55795)    

## II. Award Information/Funds Available

### A. Award Amount

The estimated amount of support in FY10 will be up to $100,000 total costs (direct plus indirect costs), with the possibility of 2 additional years of support for a total (over 3 years) of up to $300,000, subject to the availability of funds.

### B. Length of Support

The award will provide 1 year of support, with the possibility of 2 additional years of support, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations. 

## III. Paper Application, Registration, and Submission Information

                    To submit a paper application in response to this FOA, applicants should first review the full announcement located at                     *http://www.fda.gov*. Persons interested in applying for a grant may obtain an application at                     *http://grants.nih.gov/​grants/​forms.htm*. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the                     **Federal Register**                    .) For all paper application submissions, the following steps are required:                
    - Step 1: Obtain a Dun and Bradstreet (DUNS) Number
    - Step 2: Register With Central Contractor Registration
    - Step 3: Register With Electronic Research Administration (eRA) Commons

                    Steps 1 and 2, in detail, can be found at                     *http://www07.grants.gov/​applicants/​organization_​registration.jsp*. Step 3, in detail, can be found at                     *https://commons.era.nih.gov/​commons/​registration/​registrationInstructions.jsp*. After you have followed these steps, submit paper applications to: Kimberly Pendleton, Division of Acquisition Support and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, e-mail:                     *Kimberly.Pendleton@fda.hhs.gov*.                

Dated: September 9, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-22863 Filed 9-13-10; 8:45 am]

BILLING CODE 4160-01-S