[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37817-37819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0010]


Cooperative Agreement With the World Health Organization 
Department of Food Safety and Zoonoses in Support of Strategies That 
Address Food Safety Problems That Align Domestically and Globally (U01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of a sole source 
cooperative agreement with the World Health Organization (WHO). The 
goal of the Food and Drug Administration, Office of the Commissioner 
and the Office of International Programs, Center for Food Safety and 
Nutrition, and the Center for Veterinary Medicine is to contribute to 
the knowledge base of the current state of food safety globally, 
including challenges, risks and emerging trends, through an integrated 
information system based on WHO's existing network efforts.

DATES: Important dates are as follows
    1. The application due date is July 20, 2011.
    2. The anticipated start date is September, 2011.
    3. The opening date is the date the notice is published in the 
Federal Register.
    4. The expiration date is July 21, 2011.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: For 
programmatic questions and concerns contact: Katherine Bond, Office of 
International Programs, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-8318; e-mail: 
[email protected].
    For financial and administrative questions and concerns contact: 
Gladys M. Bohler, Office of Acquistion and Grant Services, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1078 (HFA 500), Rockville, 
MD 20857, 301-827-7175; 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/InternationalPrograms/CapacityBuilding/default.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    RFA-FD-11-021,
    93.103: 93.103.

A. Background

    WHO has responsibility for the provision of technical cooperation 
to its 193 Member States (national governments) in the area of food 
safety and zoonotic diseases. Among the focus areas are: Surveillance 
for food borne disease; identification of food contamination; 
management of mechanisms for information sharing; and systems for 
emergency response, including outbreak investigations and governments' 
food product recalls which may potentially have a global impact or 
cross national boundaries, and which may fall within the requirements 
of the International Health Regulations. WHO's technical support 
complements a paradigm shift that is emerging around the globe; a shift 
from a focus on food safety interventions at

[[Page 37818]]

ports-of-entry toward an approach that emphasizes preventive, risk-
based efforts. This shift entails increasing accountability of entities 
along the supply chain that grow, harvest, manufacture, process, store, 
transport, distribute, and/or import foods for ensuring the safety of 
their products, while at the same time strengthening national 
authorities' capacity and systems to be able to regulate these products 
efficiently and effectively. Along with the Food and Agriculture 
Organization of the United Nations (FAO), WHO also has a responsibility 
in relation to harmonizing international science-based food safety 
standards (e.g., as one of the founding institutions and technical 
advisory bodies to the Codex Alimentarius Commission (Codex)). Codex 
was founded in 1963 to develop food standards, guidelines, and other 
related texts, such as codes of practice, under the Joint FAO/WHO Food 
Standards Programme. Currently, 185 Member States, including the United 
States through FDA and other U.S. Government agency technical and 
scientific experts, actively participate in Codex.
    The goal of the Food and Drug Administration, Office of the 
Commissioner and the Office of International Programs, Center for Food 
Safety and Nutrition, and the Center for Veterinary Medicine is to 
contribute to the knowledge base of the current state of food safety 
globally, including challenges, risks and emerging trends, through an 
integrated information system based on WHO's existing network efforts, 
such as the Global Foodborne Infections Network (GFN), International 
Food Safety Authorities Network (INFOSAN), Global Environment 
Monitoring System for Food (GEMS/Food), Global Early Warning Systems 
for Animal Diseases Including Zoonoses (GLEWS), and the Initiative to 
Estimate the Global Burden of Foodborne Diseases (FERG), as well as 
programs currently under development, such as the Global Laboratory 
Directory (GLaD); enable the sharing of scientific findings and data 
through expert meetings and technical consultations; enhance capacity 
at international and national levels in such areas of laboratory 
analyses, surveillance, and risk assessment/risk management, including 
through the Advisory Group on Integrated Surveillance of Antimicrobial 
Resistance (AGISAR); contribute to the scientific, standard-setting 
work of the Codex Alimentarius Commission (Codex) through scientific 
advisory groups including the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA), the Joint FAO/WHO Meetings on Pesticide Residues 
(JMPR), the FAO/WHO Joint Meetings on Microbiological Risk Assessment 
(JEMRA), and the Joint FAO/WHO Expert Meetings on Nutrition (JEMNU) 
currently in development phase; and enable participation of Member 
States through the Codex Trust Fund.
    A significant outcome of the 63rd World Health Assembly in May 2010 
was a consensus resolution on advancing food safety initiatives, which, 
among other items, acknowledged the continuing need for closer 
collaboration between the health sector and other sectors, and 
increased action on food safety at the international and national 
levels, across the full length of the food-production chain, in order 
to reduce significantly the incidence of food borne disease. This 
resolution also closed a ten year gap in WHO governance dialogue on 
global food safety challenges, providing all Member States with a 
general pathway for global collaboration and enforcing the 
Secretariat's role in technical cooperation.
    In support of the resolution's implementation, FDA awarded two 
cooperative agreements in fiscal year (FY) 2010 to WHO's Department of 
Food Safety and Zooonses (FOS) to: (1) support the development of a 
plan that delineates a global integrated information system to better 
report and utilize information and data that are timely, accurate, and 
comparable; and, through such data, increase understanding of risk 
factors and safety standards relative to public health outcomes; and 
(2) support WHO's Advisory Group on Integrated Surveillance for 
Antimicrobial Resistance (AGISAR), which is part of WHO's effort to 
minimize the public health impact of antimicrobial resistance 
associated with the use of antimicrobials in food animals.
    For nearly 30 years, FDA, through the Center for Food Safety and 
Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), 
has participated with WHO's International Programme on Chemical Safety 
(IPCS) in a Cooperative Agreement that supported WHO's work in 
international risk assessment and its standard-setting activities for 
food ingredients, contaminants, and veterinary drug residues in food, 
including the Joint FAO/WHO Expert Committee on Food Additives (JECFA). 
JECFA contributes internationally-recognized science-based risk 
assessments of food additives, contaminants, and residues of veterinary 
drug reside in food. This Cooperative Agreement has also supported 
Joint FAO/WHO Expert Consultations on risk assessments for emerging or 
cross-cutting issues (e.g., the use of active chlorine species in food 
processing, bisphenol-A). The evaluations that are produced by JECFA 
and the Expert Consultations provide a sound scientific basis for 
Codex's standard-setting activities that contribute to improved public 
health and food safety worldwide.
    The 63rd Health Assembly also called the continuation of 
sustainable preventive measures through food safety education programs 
such as the FIVE KEYS to safer food developed by WHO in collaboration 
with FDA. The WHO Five Keys to Safer Food global message and training 
materials for consumers in the home are now recognized as an 
international source for conducting national food safety education 
programs. In 2008, a joint Food and Agriculture Organization (FAO)/WHO 
Expert Meeting on the microbiological hazards in fresh leafy vegetables 
and herbs also acknowledged the success of the FIVE KEYS to safe food 
as it reviewed the scientific data and made recommendations for 
limiting the risks associated with microbial contamination of these 
products. An important recommendation from the meeting was the 
suggestion that WHO develop training and educational materials based on 
the FIVE KEYS TO SAFER FOOD concept. As a result, WHO, working together 
with FDA, developed FIVE KEYS to Growing Safer Fruits and Vegetables: 
Promoting Health by Decreasing Microbial Contamination, a training 
program designed for educating rural workers who grow fresh fruits and 
vegetables for themselves, their families and for sale in local 
markets.
    Many of the network ``building blocks'' to address elements of 
preventive risk-base approaches to food safety reside within WHO. For 
example:
     The International Networks of Food Safety Authorities 
(INFOSAN), a joint FAO/WHO program consisting of 177 Member States, 
which aims to promote the rapid exchange of information during food 
safety related events, promote partnership and collaboration between 
countries, and help countries to strengthen their capacity to manage 
food safety risks;
     The Global Foodborne Infections Network (GFN), a network 
of over 1,500 individuals from 700 institutions in 177 countries, that 
provide human resource expertise to promote integrated, laboratory-
based surveillance and intersectoral collaboration in human

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health, veterinary, and food-related disciplines;
     The Global Early Warning Systems for Animal Diseases 
Including Zoonoses (GLEWS), a joint system that coordinates alert 
mechanisms of the WHO, the FAO, and the World Organization for Animal 
Health (OIE) to assist in prediction, prevention, and control of 
zoonotic disease threats;
     The Global Laboratory Directory (GLaD), a support system 
for building, connecting, and sustaining laboratory and surveillance 
networks (currently in development phase);
     The Global Environment Monitoring System for Food (GEMS/
Food), a program, which focuses on data collection and training related 
to dietary exposure of chemical hazards and involves a network of WHO 
Collaborating Center and national institutions from around the globe;
     The Foodborne Disease Burden Epidemiology Reference Group 
(FERG), established to provide guidance to WHO on the burden of 
foodborne disease to countries, with an anticipated publication of 
Global Report within the next several years;
     JECFA, the Joint FAO/WHO Meetings on Pesticide Residues 
(JMPR), the Joint FAO/WHO Meetings on Microbiological Risk Assessment 
(JEMRA), and the Joint FAO/WHO Expert Meetings on Nutrition (JEMNU) 
currently in development phase, that serve as technical advisory bodies 
to Codex;
     The management of the Codex Trust Fund; and
     The FIVE KEYS to safer food training materials developed 
to educate food handlers in safe food handling practices.

B. Research Objectives

The Funding Opportunity
    The Cooperative Agreement announced in this FOA represents the 
continuation of a long-standing collaboration between WHO and FDA in 
support of strategies and approaches that align well domestically and 
globally to address food safety problems. Relevant strategies include: 
(1) Efforts to strengthen data and information systems so they are 
comparable, comprehensive, and robust, thereby allowing for better 
decision-making for all Member States; (2) enhanced capacity around the 
globe to improve detection of and response to food safety threats 
through preventive controls, data, information, surveillance systems, 
and risk-based approaches; and (3) global harmonization of science-
based standards and adoption or adaption of international standards by 
national authorities.
    This Cooperative Agreement is expected to support the following 
types of collaboration:
     Contribute to the knowledge base of the current state of 
food safety globally, including challenges, risks, and emerging trends, 
through an integrated information system based on WHO's existing 
network efforts, such as the GFN, INFOSAN, GEMS/Food, GLEWS, and FERG, 
as well as programs currently under development, such as GLaD;
     Enable the sharing of scientific findings and data through 
expert meetings and technical consultations;
     Enhance capacity at international and national levels in 
such areas of laboratory analyses, surveillance, and risk assessment/
risk management, including through AGISAR;
     Contribute to the scientific, standard-setting work of 
Codex through scientific advisory groups including JECFA, JMPR, JEMRA, 
and JEMNU currently in development phase; and
     Enable participation of Member States through the Codex 
Trust Fund.
    Inherent in the cooperative agreement award is substantive 
involvement by the awarding agency. Accordingly, FDA will be actively 
engaged in the programmatic activities of the entire project funded by 
this cooperative agreement, including but not limited, to the following 
items:
     FDA will appoint a project officer who will actively 
monitor the FDA-supported program under this award and work closely and 
collaboratively with a core group of experts. This core group of 
technical experts (CG/TE) from CFSAN, CVM, the Office of Regulatory 
Affairs (ORA) and relevant offices of the Office of the Commissioner 
(OC) will provide technical guidance and advice, as appropriate, to WHO 
in the implementation of this cooperative agreement. Support can be 
from various sources including in-kind participation.
     Appropriate participation of FDA in multinational advisory 
group(s) that are working to address food safety regulatory systems, 
the development and implementation of science-based standards and 
norms, and strengthening the existing capacity of Member States in the 
area of food safety and preventive controls.

C. Eligibility Information

    The World Health Organization (WHO) Department of Food Safety and 
Zoonoses (FOS). Competition is limited to WHO because, as the only 
global health organization with a well-established trusted presence and 
high-level access to appropriate regulatory authorities in its 193 
Member Countries and Territories and with its ability to coordinate 
programs at both the regional and international levels, it is uniquely 
qualified to further the food safety objectives of this cooperative 
agreement. This ability to advance the objectives of this cooperative 
agreement through Member-State participation and intersectoral action 
is requisite for the success of this program.

II. Award Information/Funds Available

A. Award Amount

    The total funding available is up to $260,000 (total costs 
including indirect costs) in fiscal year 2011 in support of this 
project. One award will be made.

B. Length of Support

    Funding will be provided for 1 year, with the possibility of up to 
4 additional years of support, contingent upon successful performance 
and the availability of funds.

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/InternationalPrograms/CapacityBuilding/default.htm. Persons 
interested in applying for a grant may obtain an application http://grants2.nih.gov/grants/funding/phs398/phs398.html.
    For all paper application submissions, the following steps are 
required:
     Step 1: Obtain a Dun and Bradstreet Data Universal 
Numbering System (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: Gladys M. Bohler (See the FOR INFORMATION 
AND ADDITIONAL REQUIREMENTS CONTACT section of this document.).

    Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16120 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P