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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. FDA-2008-N-0360]

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01)

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing a Request for Application (RFA) Number RFAFD08004 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.

SUMMARY: Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01),

SUPPLEMENTAL 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.
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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 postharvest 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 ``realworld'' problems (such as the development of technologies and practices for food safetyrelated 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, nongovernmental 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 FDAregulated 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 onfarm, pre, and postharvest food protection research. Such fieldscale 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
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academia to remain current with scientific and technical advances associated with FDAregulated 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 inkind 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 7055711 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.
\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.)

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, 3018277168, e mail: gladys.melendezbohler@fda.hhs.gov. Hearing Impaired Telecommunications for the hearing impaired are available at: TTY 301 4510088.

B. Address to Submit Application

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a nonmodular 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 (HFA500), Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 3018277168, email: gladys.melendezbohler@fda.hhs. C. Key Dates

The application is due within 30 days after publication of the Funding Opportunity Announcement in the Federal Register. Ontime 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, coauthorship of publications.

4. The original and two copies of the annual Financial Status Report (FSR) (SF269) 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. [[Page 36878]]

C. Other Information

Awardees will be required to submit the NonCompeting 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. E814749 Filed 62708; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT

Scientific/Programmatic Contact: Steven Gendel, Center for Food Safety and Applied Nutrition (HFS006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 3014362290, email: steven.gendel@fda.hhs.gov.

Financial or Grants Management Contact: Gladys M. Bohler, Division of Acquisition Support and Grants (HFA500), Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301 8277168, FAX: 3018277101, email: gladys.melendez bohler@fda.hhs.gov.