
[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
