[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37466-37469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14876]


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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,

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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, 
[email protected], the Grants.gov Customer Support Center by e-
mail at [email protected], 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: [email protected], 
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: 
[email protected], 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: [email protected].

    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