[Federal Register: July 1, 2008 (Volume 73, Number 127)]
[Notices]
[Page 37466-37469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy08-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Innovative Food Defense Projects; New Limited Competition
Cooperative Agreement U13; Request for Application Number: RFA-FDA-08-
010
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing
the availability of grant funds for the support of innovative food
defense projects. These grants are available to State, local, and
tribal levels and must have national implication or application that
can enhance Federal, State, and local food regulatory programs and are
likely to impact preparedness, response and/or recovery. FDA
anticipates providing approximately $240,000 in direct plus indirect
costs in support of this program in fiscal year 2008. It is anticipated
that 6 awards will be made for up to $40,000 per award/per year for up
to 1 year.
DATES: The application receipt date is July 30, 2008.
I. Background/Funding Opportunity Description
Food defense is a term used to describe activities associated with
protecting the nation's food supply from intentional contamination. FDA
(agency) has adopted 3 broad strategies that encompass its food defense
activities:
(1) Awareness: Prevention/Preparedness: Increase awareness among
Federal, state, local, and tribal governments and the private sector to
better understand where the greatest vulnerabilities lie and develop
effective protection/mitigation strategies to shield the food supply
from intentional contamination; (2) Response: Develop the capacity for
a rapid coordinated response to a foodborne terrorist attack; and (3)
Recovery: Develop the capacity for a rapid coordinated recovery from a
foodborne terrorist attack.
In the aftermath of 9/11, the agency utilized an approach known as
Operational Risk Management (ORM). ORM involves a determination of
which combinations of foods and agents, and where on the farm-to-table
continuum, constitute the highest risks of being targeted for attack
that may result in a large number of causalities. It is recognized that
any food could potentially be contaminated and thus zero-risk foods do
not exist. However, based on ORM analysis it was discovered that
higher-risk foods do share several common vulnerability factors: Large
batch size, which implies a large number of servings; short shelf life,
which implies rapid turnaround at retail and rapid consumption; uniform
mixing, which would maximize the potential number of contaminated
units; and accessibility of a so-called critical node, defined as a
process or activity in the farm-to-table chain during which the agent
could be added and go undetected.
Currently, there is a joint program led by FDA, U.S. Department of
Agriculture, Federal Bureau of Investigations, and the Department of
Homeland Security, in collaboration with private industry and the
states known as the Strategic Partnership Program Agroterrorism (SPPA)
Initiative. The SPPA was launched in July 2005 and through industry and
state volunteers vulnerability assessments are conducted locally in
different states on a variety of food commodities in coordination with
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Federal partners. These assessments not only address a specific food
commodity but also facilitate interactions between the Federal, state
and local officials that would be involved in a response to a
deliberate attack on the food supply.
Reports summarizing the results from the first 2 years of SPPA
Assessments have been released. The report demonstrates trends seen in
processing and agriculturally based commodities and also discusses
potential mitigation strategies and research gaps that were identified.
The full reports can be viewed at the Center for Food Safety and
Nutrition (CFSAN) Web site at http://www.cfsan.fda.gov/fooddefense.
As we continue to move forward in meeting our food defense goals by
increasing preparedness, developing response plans, and ensuring we
have the tools to facilitate recovery, we must also integrate these
approaches into our existing food safety infrastructure. The overlap
between food safety (unintentional contamination) and food defense
(intentional contamination) is extensive and the pool of resources
available is often the same. Food safety and food defense are ongoing
issues and it is critical that these programs be integrated to the
maximum extent possible in order to ensure the most efficient use of
resources as well as optimizing response to an event. FDA is committed
to this approach in order to make optimal use of both human and
financial resources to protect public health. As a result, FDA and
State field forces may weave components of food defense awareness and
education into food safety inspections. FDA encourages other
stakeholders to consider the possibilities of incorporating food
defense ideas into their food safety related programs.
FDA has relied on the States in assisting with these activities
through formal contracts, partnership agreements, and other
arrangements. Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the demands on both the agency
and the States have increased. Procedures need to be reviewed and
innovative changes need to be made. These changes should increase
effectiveness and efficiency and conserve resources. CFSAN will
continue to support food defense programs by providing high quality,
science-based work that result in maximizing consumer protection. FDA
believes that these grants will be able to generate significant
innovative projects and products that will benefit State and local
governments, FDA, the industry, and the general public in the areas of
food defense just as past awards have benefited all stakeholders in
food safety. It is anticipated that innovative food defense programs
and concepts that are developed at the State and local levels could
enhance programs that are developed at the Federal level. To view past
innovative food safety awards that have been generated out of this work
you can view the ORA Web site at http://www.fda.gov/ora/fed_state/
Innovative_Grants.html.
A. Project Emphasis
The specific goal of this program is to generate products that
complement, develop, or improve State and local food defense programs
and that these could be applied to food defense programs nationwide.
Examples of food defense projects are: The ALERT Food Defense Awareness
Initiative, Food Defense Surveillance Assignments, Food Emergency
Response Network (FERN: federal and state laboratories), and SPPA
Initiative. Applications that address food defense projects and fulfill
the following specific project objectives will be considered for
funding.
Each application must address only one project. Applicants may
apply for more than one project area, but must submit a separate
application for each project. If an applicant should receive a fundable
score on more than one topic area only the application with the highest
score will be awarded. These grants are not to be used to fund or
conduct food inspections for food safety regulatory agencies. No more
than 10 percent of the total award can be used to conduct food safety/
food defense exercises. Food safety agencies may subcontract up to 25
percent of the award to educational institutions for assistance with
development of food defense awareness education projects and materials
and training.
There are three key project areas identified for this effort:
1. Innovative Food Defense Plan Integration
One key project area is the development of innovative template food
defense plans and associated programs that could be integrated with
established food safety programs, including continuous improvement
plans for the protection of various food establishments in order to
improve food defense effectiveness and efficiency. Innovative food
defense programs and methodology projects must demonstrate an effect on
factors that contribute to awareness, preparedness, early response, and
recovery in all, or a segment of, food industry programs. For example,
projects could address key elements from the ALERT Initiative. This
initiative details five key points that the food industry can use to
decrease the risk of intentional food contamination. The ALERT
initiative is derived from the FDA Food Security Guidance documents
written for specific segments of the food industry. These proposals
should focus on providing efficient and effective food defense
awareness communications and/or have an effect on factors that
contribute to a potential intentional food contamination. Information
relative to the ALERT initiative can be found at http://
www.cfsan.fda.gov/fooddefense.
2. Education and Awareness Information Dissemination
Another key project area is the development of innovative food
defense awareness education projects and materials for State and local
food safety and food defense regulatory officials that foster
consistency and uniform application of State and local food
regulations. These education projects and/or materials must be
reproducible by other State and local food safety regulatory agencies.
These projects may incorporate concurrent education of both State and
local food safety and food defense regulatory agencies and the food
industry and must be consistent with the ALERT Initiative messages.
3. Innovative Food Defense Training
FDA recognizes that there are a number of new technologies and
methods for distance learning and training that may be applicable to
the food industry and relevant stakeholders in relation to food
defense. FDA also recognizes that Federal, state, and local officials
should be able to identify, in a general sense, potential risks, in
relation to food defense in food industry establishments. They should
also be able to encourage food defense awareness in the employees and
management of food industry establishments. Innovative food defense
training efforts are needed so that all stakeholders will have an
increased awareness of the threat of intentional contamination of the
U.S. food supply. Relevant stakeholders should also understand their
unique responsibilities in reducing the risk of intentional
contamination of the food supply. Innovative food defense training must
also be consistent with the ALERT initiative messages.
II. Award Information
Mechanism of Support
The U13--Support of Scientific Conferences will be used to support
this program. Under the U13 Mechanism,
[[Page 37468]]
the Project Director/Principal Investigator (PD/PI) retains the primary
responsibility and dominant role for planning, directing, and executing
the proposed project, with FDA staff being substantially involved as a
partner with the PD/PI.
III. Eligibility Information
A. Eligible Applications
This grant program is only available to State, local, and tribal
government food regulatory agencies. (See single point of contact
(SPOC) requirements stated in section IV.D of this document).
B. Cost Sharing or Matching
None.
C. Other
These grants are available to State, local, and tribal levels and
must have national implication or application that can enhance Federal,
State, and local food regulatory programs and are likely to impact
preparedness, response and/or recovery. At the discretion of FDA,
successful project formats will be made available to interested
Federal, State, local, and tribal food safety regulatory agencies. Only
one grant will be awarded per State per year. States are urged to
collaborate between agencies to submit a single application.
FDA reserves a royalty-free, nonexclusive, and irrevocable license
to reproduce, publish or otherwise use, and to authorize others to use,
for Federal Government purposes: (1) The copyright in any work
developed under a grant, subgrant or contract under a grant or subgrant
and (2) any rights of copyright to which a grantee, subgrantee, or a
contractor purchases ownership with grant support (45 CFR 92.34).
IV. Application and Submission
A. Application Information
In order to apply electronically, the applicant must have a Data
Universal Number System number and register in the Central Contractor
Registration database. Please note: You must be registered with a
username and password obtained from a Credential Provider to apply for
opportunities. (See the following Web site: http://www.grants.gov/
applicants/get_registered.jsp).\1\
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\1\ FDA has verified the non-FDA Web site addresses throughout
this document, but we are not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.
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If you experience technical difficulties with your online
submission you should contact either Marc Pitts, Grants Management
Specialist, Office of Acquisitions & Grants Services, Division of
Acquisition Support and Grants, Food and Drug Administration, 5630
Fishers Lane, Rockville, MD 20857, 301-827-7162,
Marc.Pitts@fda.hhs.gov, the Grants.gov Customer Support Center by e-
mail at support@grants.gov, or the Customer Support Center by telephone
at 1-800-518-4726.
B. Content and Form of Application Submission
FDA is accepting the application for this program electronically by
the Internet at: Grants.gov. Applicants must apply electronically by
visiting the Web site http://www.grants.gov and following instructions
under ``APPLY FOR GRANTS.'' The required application PHS 424, which is
part of the PHS 5161-1 form, can be completed and submitted online by
selecting Step 1: ``Download a Grant Application Package'' then by
entering the funding opportunity number ``RFA-FD-08-010''. The
``Selected Grant Applications For Download'' page will provide you with
the Additional Resources download for Adobe Reader and PureEdge Viewer
as well as the download to the ``Instructions & Application hyperlink.
The face page of the application should indicate ``Innovative Food
Defense Grant Program RFA-FD-08-010.''
Information collection requirements requested on SF 424/PHS Form
5161-1 were approved and issued under the Office of Management and
Budget Circular A-102.
C. Submission Dates and Times
The application receipt date for 2008 is July 30, 2008.
Applications will be accepted from 8 a.m. to 4:30 p.m. Eastern Time,
Monday through Friday, until the established receipt date.
Applications must be submitted electronically and must be received
by the close of business on the established receipt date.
No addendum material will be accepted after the established receipt
date.
D. Intergovernmental Review
Intergovernmental review applicants are limited to one State
government agency per State. Applications submitted under this program
are subject to the requirements of Executive Order 12372.
The regulations issued under Executive Order 12372 also apply to
this program and are implemented through the Department of Health and
Human Services regulations at 45 CFR part 100. Executive Order 12372
sets up a system for State and local government review of applications
for Federal financial assistance. Applicants (other than federally
recognized Indian tribal governments) should contact the State's SPOC
as early as possible to alert them to the prospective application(s)
and to receive any necessary instructions on the State's review
process. A current listing of SPOCs is included in the application kit.
The SPOC should send any State review process recommendations to the
FDA Grants Management Office contact listed in section VI of this
document. The due date for the State process recommendations is no
later than 60 days after the deadline date for the receipt of
applications. FDA does not guarantee availability to accommodate or
explain SPOC comments that are received after the 60 day cut-off. A
current listing of SPOCs can be found at http://www.whitehouse.gov/omb/
grants/spoc.html.
E. Funding Restrictions
Nonallowable costs include, but are not limited to: (1) Purchase of
equipment; (2) transportation costs exceeding coach class fares; (3)
entertainment; (4) tips; (5) bar charges; (6) personal telephone calls;
(7) laundry charges; (8) travel or expenses other than local mileage
for local participants; (9) organization dues; (10) honoraria or other
payments for the purpose of conferring distinction or communicating
respect, esteem or admiration; (11) alterations or renovations; and
(12) travel or per diem costs for Federal employees.
V. Award Administration Information
A. Award Notices/Administrative and National Policy Requirements
Support for this program will be in the form of a grant. These
grants will be subject to all policies and requirements that govern the
project grant programs of FDA, including the provisions of 42 CFR part
52 and 45 CFR parts 74 and 92. These grants are subject to the A-87
cost principles.
B. Reporting Requirements
A final Program Progress Report and a final Financial Status Report
(SF-269) are required within 90 days of the expiration date of the
project period as noted on the Notice of Grant Award. In addition, the
grantee must file an invention statement and disposition of equipment
statement within 90 days after the end date of the project period as
noted on the notice of the cooperative agreement award. An original and
two
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copies of each report shall be submitted to FDA's Grants Management
Office (see section VI of this document).
A Mid-Year Progress Report is also required no later than 90 days
after the close of the budget period. The Mid-Year Progress Report
should cover 6 months of activity.
Program monitoring of recipients will be conducted on an ongoing
basis and written reports will be reviewed and evaluated at least semi-
annually by the project officer. Project monitoring may also be in the
form of telephone conversations between the project officer/grants
management specialist and the principal investigator.
When multiple years are involved, awardees will be required to
submit the PHS Non-Competing Grant Progress Report (PHS 2590) http://
grants.nih.gov/grants/funding/2590/2590.htm annually and financial
statements as required in the Department of Health and Human Services
Grants Policy Statement. Reports must be submitted two months prior to
the next budget period start date. The Progress Report should include a
report of the previous meeting supported by the current grant, as well
as a full description of the next planned meeting.
VI. Agency Contacts
We encourage your inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into two areas: Scientific/research and financial or
grants management issues:
A. Scientific/Research Contacts
Regarding the programmatic issues of this notice: Jennifer Gabb,
Division of Federal-State Relations, Office of Regulatory Affairs (HFC-
150), Food and Drug Administration, 5600 Fishers Lane, rm. 12-07,
Rockville, MD 20857, 301-827-2899, e-mail: jennifer.gabb@fda.hhs.gov,
or access the Internet at http://www.fda.gov/ora/fed_state/
default.htm.
For general Food Defense program information: Don Kautter, Center
for Food Safety and Applied Nutrition (HFS-007), 5100 Paint Branch, rm.
3B019, College Park, MD, 20740, 301-436-1629, e-mail:
donald.kautter@fda.hhs.gov, or access the Internet at: http://
www.cfsan.fda.gov/~dms/defterr.html.
B. Financial or Grants Management Contacts
Regarding the administrative and financial management issues of
this notice: Marc Pitts, Office of Acquisitions & Grants Services,
Grants Acquisition and Assistance Team (HFA-500), Food and Drug
Administration, rm. 2104, 5630 Fishers Lane, Rockville, MD 20857; e-
mail: marc.pitts@fda.hhs.gov.
Dated: June 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14876 Filed 6-30-08; 8:45 am]
BILLING CODE 4160-01-S