[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36875-36878]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn08-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0360]
Cooperative Agreement to Establish and Support the Western Center
for Food Safety (U01)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a Request
for Application (RFA) Number RFA-FD-08-004 and its intention to receive
and consider a new sole source application for the award of a
cooperative agreement in fiscal year 2008 (FY 2008) to establish and
support the Western Center for Food Safety (WCFS). The WCFS will be
located at the Western Institute for Food Safety and Security (WIFSS)
on the University of California, Davis (UCD) campus in Davis, CA.
FOR FURTHER INFORMATION CONTACT:
Scientific/Programmatic Contact: Steven Gendel, Center for Food
Safety and Applied Nutrition (HFS-006), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2290, e-mail:
steven.gendel@fda.hhs.gov.
Financial or Grants Management Contact: Gladys M. Bohler, Division
of Acquisition Support and Grants (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-7168, FAX: 301-827-7101, e-mail: gladys.melendez-
bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
A. Background
FDA intends to establish a cooperative agreement to create the WCFS
to address these issues through the development of approaches and data
critical to understanding the risks associated with the interface
between production agriculture and food protection. Such knowledge is
critical to the development of scientifically validated ``best
practices'' for mitigating those risks at the production (versus
processing) level. In establishing this cooperative agreement, FDA
recognizes the importance of agricultural practices in the Western
states, an increasingly important food producing region for fruits,
vegetables, specialty crops, and dairy products; and a key point of
entry for imported foods. The development of an integrated
collaborative food protection research/education/outreach program in
this region will benefit both consumers and producers nationwide.
B. Program Research Goals
A proposal is being solicited to establish and operate a
collaborative center that is designed to meet the objectives of the
RFA. The proposal should include information on both the structure and
administration of the center and the approaches that will be used to
establish robust and sustainable regional, national, and international
research and outreach collaborations (including collaborations with the
agency's other Centers of Excellence; other Centers at UCD, such as the
Center for Produce Safety; and other components of the University of
California system), as well as strategies for cultivating additional
base support for the center.
[[Page 36876]]
1. Concept
FDA faces an increasing number of critical and complex food
protection and public health challenges. FDA believes that these
challenges can be addressed most efficiently by expanding the available
science base through collaborative partnerships. Collaborative
partnerships stimulate the integration of applied research, education,
and outreach programs to enhance food protection and public health and
address new and emerging issues. Collaborative partnerships provide
opportunities to leverage resources and to stimulate interest among
academics in solving pressing national food protection challenges.
Accordingly, access to scientists and facilities associated with
agriculture within the Western United States increases FDA's
understanding of the unique challenges and practices that must be
considered when developing risk management measures that are pertinent
to agricultural production in this region.
2. Project Emphasis
The collaborative partnership with WCFS will focus on the interface
between food protection and the agricultural production of commodities
such as produce and dairy foods. This will include studies in areas
such as pre- and post-harvest practices and environmental contamination
(both from point sources and from distributed sources, e.g.,
perchlorate in ground water) for both domestic and imported
commodities. WCFS will address ``real-world'' problems (such as the
development of technologies and practices for food safety-related
sampling of fresh produce or the impact of field practices on
subsequent processing) and develop knowledge leading to practical
solutions and approaches that are both feasible and protective of
public health. WCFS will also generate and analyze data needed to
provide a scientific basis for optimizing the interactions between
potentially competing national concerns, e.g., safety of food
production environments versus the protection of wildlife habitats in
agricultural communities. The education and outreach components of the
partnership will ensure that this knowledge is available for, and
useful to, all stakeholders.
3. Summary of Objectives
The cooperative research, education, and outreach programs
developed through the WCFS will address scientific issues related to
the interface between food protection and agriculture for commodities
such as produce, dairy foods, and seafood. These programs will include
partnerships with academia, industry, non-governmental organizations,
and international organizations. These partnerships will also promote
and sustain collaborative domestic and international outreach and
education.
The objectives of this cooperative agreement are to:
1. Carry out multidisciplinary applied research projects that
address ``real world'' issues related to food protection, agricultural
practices, and the impact of agricultural practices on subsequent food
processing associated with FDA-regulated products;
2. Develop and implement outreach and communication programs with
stakeholders to identify research needs and to facilitate utilization
of the knowledge produced by the research program; and
3. Develop and implement education programs that address food
protection problems and increase awareness of the role of science in
food protection.
II. Award Information
A. Award Instrument/Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the
cooperative agreement award mechanism (U01). Support will be in the
form of a cooperative agreement. Accordingly, FDA will have substantial
involvement in the program activities of the project. FDA will support
the collaboration covered by this notice under the authority of section
301 of the Public Health Service (PHS) Act (42 U.S.C. 241).
B. Award Amount and Length of Support
The estimated amount of support in FY 2008 will be for up to $1.5
million (direct plus indirect costs), with the possibility of 4
additional years of support for up to $2.6 million, subject to the
availability of funds. This award will improve public health by
creating an applied research, education, and outreach program related
to the interface between food protection (i.e., food safety and food
defense) and agriculture.
C. Funding Plan
The estimated amount of support in FY 2008 will be for up to $1.5
million (direct plus indirect costs), with the possibility of 4
additional years of support for up to $2.6 million, subject to the
availability of funds.
D. Delineation of Substantive Involvement
A cooperative agreement involves substantial FDA programmatic
involvement with the awardees is anticipated during the performance of
the activities. Under the cooperative agreement, FDA's purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership
role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the awardees for
the project as a whole, although specific tasks and activities may be
shared among the awardees and FDA. Additional information on the role
and responsibility of the grantee and FDA can be found in the full text
announcement of the FOA posted on FDA's Center for Food Safety and
Applied Nutrition (CFSAN) Web site: http://www.cfsan.fda.gov/list.html.
III. Eligibility Information
A. Eligible Institutions/Organizations
Competition is limited to the University of California. FDA
believes that establishing the WCFS at WIFSS is appropriate because
WIFSS is uniquely qualified to fulfill the objectives of the proposed
cooperative agreement. It is an established partnership between
academia, state and Federal agencies, and private industry focused on
enhancing food protection using a variety of approaches that include
basic and applied research; communication and connectivity with public
and private partners; outreach programs that extend from farm to fork;
and modern information management. WIFSS's location at the UCD
facilitates interaction with numerous Centers and Departments within
the School of Veterinary Medicine, School of Medicine, College of
Agricultural and Environmental Sciences, and College of Engineering.
The existing administrative structure at WIFSS can be readily leveraged
for developing new food protection programs and fostering new
partnerships. Existing collaborations with agricultural producers will
promote the conduct of on-farm, pre-, and post-harvest food protection
research. Such field-scale research is critical both for understanding
how agricultural practice impacts food safety and for ensuring that new
technologies are practical and effective.
Collaboration between the public and the private sectors has proven
to be an efficient means for both FDA and
[[Page 36877]]
academia to remain current with scientific and technical advances
associated with FDA-regulated products (e.g., foods, animal drugs and
feed additives). The degree to which FDA nurtures, develops, and builds
on these collaborations directly affects FDA's ability to enhance
public health. The information and expertise that will be obtained
through this partnership between FDA and WIFSS can be leveraged by all
segments of the food protection and nutrition community, as well as by
public health organizations, other Federal agencies, and academic
institutions in the performance of their roles.
B. Cost Sharing
This cooperative agreement program requires that the applicant
substantially share in the project costs if an award is made,
including, but not limited to, partial salary support for
administrative staff and in-kind support (e.g., faculty salaries and
facilities costs).
IV. Application and Submission
A. Form and Content of Applications
Applications must be prepared using the most current PHS 398
research grant application instructions and forms. Applications must
have a Dun and Bradstreet Data Universal Numbering System (DUNS) number
as the universal identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling 866-
705-5711 or through the Web site at http://www.dnb.com/us/.\1\ The DUNS
number should be entered on line 11 of the face page of the PHS 398
form.
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\1\ (FDA has verified the 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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The PHS 398 application instructions are available at http://
grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Applicants must use the currently approved version of the PHS
398. For further assistance, contact Gladys M. Bohler, 301-827-7168, e-
mail: gladys.melendez-bohler@fda.hhs.gov. Hearing Impaired--
Telecommunications for the hearing impaired are available at: TTY 301-
451-0088.
B. Address to Submit Application
Applications must be prepared using the forms found in the PHS 398
instructions for preparing a non-modular research grant application.
Submit a signed, typewritten original of the paper application,
including the checklist, three signed photocopies, and appendix
material in one package to: Gladys M. Bohler, Grants Management
Specialist, Division of Acquisition Support and Grants (HFA-500), Food
and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD
20857, 301-827-7168, e-mail: gladys.melendez-bohler@fda.hhs.
C. Key Dates
The application is due within 30 days after publication of the
Funding Opportunity Announcement in the Federal Register. On-time
submission requires that the application be successfully submitted to
http://www.grants.gov no later than 5 p.m. local time (of the applicant
institution/organization).
D. Other Submission Requirements
The total project period for an application submitted in response
to this funding opportunity may not exceed 5 years.
Applicant may submit only one application. Resubmission
applications are not permitted in response to this FOA. Renewal
applications are not permitted in response to this FOA.
Consent forms, assent forms, and any other information given to a
subject are part of the grant application and must be provided, even if
in a draft form. The applicant is referred to the Department of Health
and Human Services (HHS) regulations at 45 CFR 46.116 and 21 CFR 50.25
for details.
Awardee(s) must agree to the ``Cooperative Agreement Terms and
Conditions of Award'' in section VI.2.A. of the full text of the FOA
posted on the CFSAN Web site: (http://www.cfsan.fda.gov).
V. Application Review
Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by FDA, CFSAN, and in accordance with FDA peer
review procedures, using the review criteria stated in the following
paragraph.
As part of the scientific peer review, a responsive complete
application will: (1) Undergo a review process to determine their
scientific and technical merit; (2) be assigned a priority score; (3)
receive a written critique; and (4) receive a second level of review by
the National Institutes of Health, National Cancer Institute National
Cancer Advisory Board.
VI. Award Administrative Information
A. Reporting
Substantive involvement by the awarding agency is inherent in the
cooperative agreement award. Accordingly, FDA will have substantial
involvement in the program funded by the cooperative agreement.
Substantive involvement includes, but is not limited to, the following:
1. FDA will have prior approval of the appointment of all key
administrative and scientific personnel proposed by the grantee.
2. FDA will be directly involved in the guidance and development of
the program.
3. FDA scientists will participate, with the grantee, in
determining and carrying out scientific and technical activities.
Collaboration will also include data analysis, interpretation of
findings and, where appropriate, co-authorship of publications.
4. The original and two copies of the annual Financial Status
Report (FSR) (SF-269) must be sent to FDA's Grants Management
Specialist within 90 days of each budget period end date.
5. A final progress report, invention statement, and Financial
Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated and/or at
the end of the project period.
B. Administrative Requirements
This agreement will be subject to all policies and requirements
that govern the research grant programs of the PHS, including
provisions of 42 CFR part 52 and 45 CFR Parts 74 and 92. All grants are
subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement (GPS),
dated January 2007, which supersedes in its entirety the PHS GPS, dated
April 1, 1994, and addendum dated January 24, 1995.
An award is subject to the requirements of the HHS GPS that are
applicable based on the recipient type and the purpose of this award.
This includes any requirements in Parts I and II of the HHS GPS
(available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) that
apply to an award.
Although consistent with the HHS GPS, any applicable statutory or
regulatory requirements, including 45 CFR parts 74 or 92, directly
apply to this award apart from any coverage in the HHS GPS.
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C. Other Information
Awardees will be required to submit the Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements, as
required in the HHS GPS.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14749 Filed 6-27-08; 8:45 am]
BILLING CODE 4160-01-S
Sole Source Cooperative Agreement Program Entitled
"Cooperative Agreement to Establish and Support the Western Center for Food Safety" June 30, 2008