[Federal Register Volume 69, Number 88 (Thursday, May 6, 2004)]
[Notices]
[Pages 25405-25408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support the Illinois Institute of 
Technology's National Center for Food Safety and Technology; Notice of 
Intent to Accept and Consider a Single Source Application; Availability 
of Funds for Fiscal Year 2004

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety 
and Applied Nutrition (CFSAN) is announcing its intent to accept and 
consider a single source application for

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the award of a cooperative agreement to the Illinois Institute of 
Technology (IIT) to support the National Center for Food Safety and 
Technology (NCFST). FDA anticipates providing $2,750,000 (direct and 
indirect costs) in fiscal year 2004 in support of this project. Subject 
to the availability of Federal funds and successful performance, 4 
additional years of support up to $5,000,000 per year (direct and 
indirect) will be available.

DATES: Submit applications by June 7, 2004.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to Maura Stephanos, Division of 
Contracts and Grants Management (HFA-531), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7183. 
If an application is hand-carried or commercially delivered, it should 
be addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 20857, FAX: 
301-827-7101, e-mail: [email protected]. Do not send the application 
to the Center for Scientific Review, National Institutes of Health 
(NIH). An application not received by FDA in time for orderly 
processing will be returned to the applicant without consideration. FDA 
can not receive an application electronically.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects 
contact: Maura Stephanos (see ADDRESSES).
    Regarding the programmatic aspects contact: Donald Zink, Center for 
Food Safety and Applied Nutrition (HFS-300), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 
301-436-1693, FAX: 301-436-2632, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    FDA is announcing its intention to accept and consider a single 
source application from IIT (RFA-FDA-CFSAN-04-1) to support the NCFST. 
FDA's authority to enter into grants and cooperative agreements is set 
out in section 301 of the Public Health Service Act (42 U.S.C. 241). 
FDA's research program is described in the Catalog of Federal Domestic 
Assistance No. 93.103. Before entering into cooperative agreements, FDA 
carefully considers the benefits such agreements will provide to the 
public. This application is not subject to review as governed by 
Executive Order 12372, Intergovernmental Review of Federal Programs (45 
CFR part 100). The cooperative agreement is intended to maintain and 
facilitate the further development of NCFST for the purpose of 
enhancing food safety to the benefit of the public. Specifically, NCFST 
is expected to maintain its collaborative research program involving 
FDA, academia, and the food industry; to continue to focus its research 
and outreach efforts on the safety of food processing and processed 
foods; to continue to maintain its food safety library resources; and 
to maintain and utilize its unique pilot plant resources to support the 
development and validation of new and emerging food processing 
technologies.

II. Background

    In the Federal Register of May 3, 1988 (53 FR 15736), FDA published 
a request for applications for a cooperative agreement to establish a 
National Center for Food Safety and Technology, which would join the 
resources of government, academia, and industry in a consortium to 
study questions of food safety. FDA awarded the cooperative agreement 
to IIT in September 1988. The applications received in response to this 
announcement were competitively reviewed by a panel of non-FDA food 
scientists, and the award to IIT was approved by the National Advisory 
Environmental Health Science Council in September 1988.
    In the Federal Register notices of September 10, 1991 (56 FR 
46189), May 12, 1994 (59 FR 24703), and July 22, 1999 (64 FR 39512), 
FDA published notice of its intention to limit consideration for the 
award of a cooperative agreement to IIT to support the NCFST. FDA 
awarded the cooperative agreement to IIT on September 30, 1991, 
September 26, 1994, and September 27, 1999, respectively, following 
competitive review of the applications by a panel of non-FDA food 
scientists. The award was approved by the National Advisory 
Environmental Health Sciences Council in September 1991, September 
1994, and September 1999, respectively.
    Under the cooperative agreement, NCFST was established by IIT to 
bring together the food safety and technology expertise of academia, 
industry, and FDA for the purpose of enhancing the safety of the food 
supply in the common goal of enhancing and improving the safety of food 
for U.S. consumers. NCFST is structured so that representatives of 
participating organizations play a role in establishing policy and 
administrative procedures, as well as identifying long and short-term 
research needs. With this organizational structure, NCFST is able to 
build cooperative food safety programs on a foundation of knowledge 
about current industrial trends in food processing and packaging 
technologies, regulatory perspectives from public health organizations, 
and fundamental scientific expertise from academia. The structure and 
programs at NCFST positioned the center as a key component of FDA's 
food safety and security program. Specifically, the work at NCFST 
focuses on the development and evaluation of new food processing 
technologies and preventive technologies targeted to reduce or 
eliminate harmful chemical and microbial contamination of foods. Also, 
the center is the focal point for the agency's program on food 
packaging development and evaluation. The work at NCFST complements and 
feed into other activities at the Joint Institute for Food Safety and 
Applied Nutrition at the University of Maryland. NCFST is still unique 
in that CFSAN's Division of Food Processing and Packaging is located at 
the center to facilitate the kind of close relationship between 
academia, government and industry that the project requires. Scientists 
from all three sectors can work together in the labs and pilot plant of 
the center on projects of common interest. Finally, IIT has cultivated 
a base of continuing support from the food industry in the form of 
industry members who contribute financial support to the center and 
provide management direction to the center to ensure that industry 
needs are addressed. There is not another existing center where FDA has 
access to the industry relationships and research resources present at 
NCFST.

III. Delineation of Substantive Involvement

    Substantive involvement by the awarding agency is inherent in the 
cooperative agreement award. Accordingly, FDA will have substantial 
involvement in the program activities of the project funded by the 
cooperative agreement. Substantive involvement includes, but is not 
limited to, the following:
    1. FDA will appoint a project officer or co-project officers who 
will actively monitor the FDA-supported program under this award.
    2. FDA shall have prior approval on the appointment of all key 
administrative and scientific personnel proposed by the grantee.
    3. FDA will be directly involved in the guidance and development of 
the

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program and of the personnel management structure for the program.
    4. FDA scientists will participate, with the grantee, in 
determining and carrying out the methodological approaches to be used. 
Collaboration will also include data analysis, interpretation of 
findings, and, where appropriate, co-authorship of publications.

IV. Availability of Funds

    It is anticipated that FDA will fund this cooperative agreement at 
a level approximately $2,750,000 (direct and indirect costs) for the 
first year. An additional 4 years of support up to approximately 
$5,000,000 (direct and indirect costs) each year will be available, 
depending upon fiscal year appropriations, and successful performance.

V. Reasons for Single Source Selection

    FDA believes that there is compelling evidence that IIT is uniquely 
qualified to fulfill the objectives of the proposed cooperative 
agreement. IIT's Moffett Campus, where NCFST is located, is a unique 
research facility which includes an industrial-size pilot plant and 
smaller pilot plants for food processing and packaging equipment, a 
pathogen containment pilot plant, a packaging laboratory, analytical 
laboratories, offices, containment facilities, classrooms, and support 
facilities which permit research from benchtop to industrial-scale. The 
industrial-size pilot plant is built to accommodate routine food 
processing and packaging research in a commercial atmosphere. The 
physical layout of the facility provides maximum versatility in the use 
and arrangement of equipment of both commercial and pilot size, and in 
the capability to simultaneously operate several different pieces of 
equipment without interference with each other. In addition to 
facilities to conduct routine processing research, there are facilities 
suitable for more complex research, notably a pathogen containment 
pilot plant research facility, funded by the State of Illinois, which 
has been used to study the survival of pathogens in aged cheeses. Other 
facilities include smaller containment facilities in which research 
involving use of components that may be potentially hazardous, such as 
pathogens in pasteurization or modified atmosphere packaging research, 
may be conducted.
    Since 1988, IIT has provided an environment in which scientists 
from diverse backgrounds such as academia, government, and industry, 
have brought their unique perspectives to focus on contemporary issues 
of food safety. NCFST functions as a neutral ground where scientific 
exchange, about generic food safety issues, occurs freely and is 
channeled into the design of cooperative food safety programs. NCFST 
has become a center of cutting edge technologies, such as high pressure 
processing, pulsed electric field processing, electrical resistance 
processing, ultraviolet processing, and high pressure processing. 
Ongoing research on packaging materials is focused on providing more 
alternatives for use with irradiation. A workshop, with participation 
by representatives of government, academia, and industry, was held to 
discuss the use of irradiation as an intervention to prevent microbial 
contamination of foods and the need to alternative packaging materials 
for use with this technology. This led to the development of 
cooperative research on the safety of polymeric packaging materials for 
in-package irradiation. This type of research fills existing gaps in 
knowledge and expertise associated with improving the safety of foods 
at a time when concern about food contamination and resultant illnesses 
is high. Most recently, NCFST has gained expertise in conducting 
research under biosafety level 3 conditions and is in the process of 
renovating a facility to accommodate this type of research.
    This cooperative research will provide fundamental food safety 
information, in the public domain, for use by all segments of the food 
science community in product and process development, regulatory 
activities, academic programs, and consumer programs. A particular use 
of this type of data by both industry and public health agencies is in 
hazard analysis critical control point (HACCP) and other types of 
preventive control programs. Food manufacturers will use the 
information in the design of HACCP programs, for use in their plants, 
which prevent food safety hazards before they occur and enhance the 
safety of the final product. Public health agencies can design 
investigational techniques to meet the needs of HACCP systems used in 
manufacturing plants.
    An academic degree program (which is not part of the cooperative 
agreement) in food safety science has been underway for several years 
at IIT. The program produces graduates with a foundation in food 
science and technology with specialization in food safety. Graduates 
from this program will manage quality control, safety assurance, and 
HACCP programs in industry. They will design equipment and processes 
for use in the production and packaging of safe food products. In the 
public sector, regulatory and other public health organizations, these 
graduates will evaluate the adequacy of processing and packaging 
parameters to produce safe end products and they will manage regulatory 
and information programs enhancing the safety of the food supply and 
consumer knowledge about the food supply. Graduate students from IIT 
are gaining hands-on experience in food safety by participating in the 
cooperative food safety research program. Several masters of science 
degrees that included research conducted on cooperative projects have 
been granted by IIT, in disciplines such as engineering, since the 
inception of NCFST.
    Collaboration between the public and the private sector is an 
efficient means for both to remain current with scientific and 
technical accomplishments from a food safety perspective. These 
collaborative programs will produce generic knowledge and expertise to 
be used by all segments of the food processing and packaging industry, 
as well as by public health organizations, regulatory agencies, and 
academic institutions in the performance of their roles in the food 
science community. The trend toward use of HACCP and other types of 
preventive programs in both the domestic and international food 
industry as a means of assuring safety of products and as a basis for 
harmonizing regulatory activities, is but one example of the need for 
and use of this food safety knowledge and expertise. Technology 
transfer mechanisms, which are developing out of the cooperative food 
safety programs, will facilitate the movement of advanced food 
processing and packaging technologies into the marketplace, while 
assuring the safety of those products.

VI. Submission Requirements

    The original and two copies of the completed grant application form 
PHS 398 (rev. 5/01) with copies of the appendices for each of the 
copies, should be submitted to Maura Stephanos (see ADDRESSES). The 
outside of the mailing package should be labeled ``Response to RFA-FDA-
CFSAN-04-1''. The application will be accepted during normal working 
hours, 8 a.m. to 4:30 p.m., Monday through Friday, on or before (see 
DATES section). Information collection requirements requested on Form 
PHS 398 and the instructions have been submitted by the Public Health 
Service (PHS) to the Office of Management and Budget (OMB) and were 
approved and assigned OMB control number 0925-0001.

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VII. Reporting Requirements

    An annual financial status report (FSR) (SF-269) is required. The 
original and two copies of the report must be submitted to FDA's Grants 
Management Officer within 90 days of the budget period expiration date 
of the agreement. Failure to file an annual FSR in a timely fashion may 
be grounds for suspension or termination of the agreement.
    An annual program progress report is also required. The 
noncompeting continuation application (PHS 2590) will be considered the 
annual program progress report.
    A final program progress report, FSR and invention statement must 
be submitted within 90 days after expiration of the project period of 
the cooperative agreement.

VIII. Review Procedures and Evaluation Criteria

A. Review Procedures

    The application submitted by IIT will first be reviewed by grants 
management and program staff for responsiveness. The requested budget 
must not exceed $2,750,000 (direct and indirect costs) for the first 
year. The application will be considered nonresponsive if it is not in 
compliance with this document. If the application is found to be 
nonresponsive, it will be returned to the applicant without further 
consideration.
    The application submitted by IIT will undergo noncompetitive dual 
peer review. The application will be reviewed for scientific and 
technical merit by an ad hoc panel of experts based upon the applicable 
evaluation criteria. If the application is recommended for approval, it 
will then be presented to the National Advisory Environmental Health 
Sciences Council for their concurrence.

B. Review Criteria

    The application will be reviewed and evaluated according to the 
following criteria:
    1. The application clearly demonstrates an understanding of the 
purpose and objectives of the cooperative agreement regarding a 
collaborative food safety and security program.
    2. The application clearly describes the steps and a proposed 
schedule for planning, implementing, and accomplishing the activities 
to be carried out under the cooperative agreement. The application 
presents a clear plan and schedule of steps to accomplish the goals of 
the cooperative agreement.
    3. The application establishes the applicant's ability to perform 
the responsibilities under the cooperative agreement including the 
availability of appropriate staff and sufficient funding.
    4. The application specifies the manner in which interaction with 
FDA will be maintained throughout the life of the project.
    5. The application specifies how IIT will monitor progress of the 
work under the cooperative agreement and how progress will be reported 
to FDA.
    6. The application shall include a detailed budget that shows the 
following items: (1) Anticipated costs that are allowable and allocable 
to the project; and (2) the sources of funds to meet those needs.

IX. Mechanism of Support

    Support for this project will be in the form of a cooperative 
agreement. This agreement will be subject to all policies and 
requirements that govern the research grant programs of the PHS, 
including the provisions of 42 CFR part 52, 45 CFR part 74, and PHS 
grants policy statement. The regulations issued under Executive Order 
12372 do not apply. The length of support will be 1 year. Cost sharing 
or matching is not a requirement of this program. The NIH modular grant 
program does not apply to this FDA program.

X. Dun and Bradstreet Number Requirement

    Beginning October 1, 2003, applicants will be required to have a 
Dun and Bradstreet Number (DUNS) to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a 9-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, call 1-866-705-5711. Be certain that you identify yourself 
as a Federal grant applicant when you contact Dun and Bradstreet.

XI. Legend

    Unless disclosure is required under the Freedom of Information Act 
as amended (5 U.S.C. 552) as determined by the freedom of information 
officials of the Department of Health and Human Services or by a court, 
data contained in the portions of this application that have been 
specifically identified by page number, paragraph, etc., by the 
applicant as containing restricted information, shall not be used or 
disclosed except for evaluation purposes.

    Dated: April 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10266 Filed 5-5-04; 8:45 am]
BILLING CODE 4160-01-S