[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55793-55795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Cooperative Agreement to Support the Foodborne Disease Burden 
Epidemiology Reference Group of the World Health Organization (U18)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[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: 
[email protected].
    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: [email protected].
    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.

[[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: [email protected].

    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