[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
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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]
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