[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Notices]
[Pages 39512-39514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support a National Center for Food 
Safety and Technology; Notice of Intent to Renew a Cooperative 
Agreement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intention to accept and consider a single source application for the 
award of a cooperative agreement in fiscal year 1999. An estimated 
amount of $2 million per year, with an additional 4 years of support, 
is available to the Illinois Institute of Technology (IIT) to support 
the National Center for Food Safety and Technology (NCFST), which is 
located on IIT's Moffett Campus in Summit-Argo, IL. Competition is 
limited to IIT because IIT has the unique capability to bring together 
diverse perspectives on food safety; IIT has access to the exceptional 
combination of scientific expertise, pilot plants, and research 
facilities necessary to focus those perspectives on cooperative food 
safety programs; and IIT has underway a cooperative food safety 
research program and an academic degree program in food safety. This is 
the first American effort to join the resources of government, 
academia, and industry in a consortium to study issues of food safety.

DATES: Submit applications by August 23, 1999. If this date falls on a 
weekend, it will be extended to Monday; if this date falls on a 
holiday, it will be extended to the following workday.

ADDRESSES: An application is available from and should be submitted to: 
Maura C. Stephanos (address below). Applications hand carried or 
commercially delivered should be addressed to Maura C. Stephanos, 5630 
Fishers Lane, rm. 2129, Rockville, MD 20852, FAX 301-827-7106, e-mail 
address: [email protected].

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice contact: Maura C. Stephanos, Senior Grants Management 
Specialist, Office of Regulatory Affairs Support and Assistance 
Management Branch (HFA-520), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7183.
    Regarding the programmatic aspects contact: Karen L. Carson, Center 
for Food Safety and Applied Nutrition (HFS-22), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-5140, FAX 
202-205-4525, e-mail address: [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept 
and consider a single source application from IIT for a cooperative 
agreement 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.
    IIT's application for this award will undergo dual peer review. An 
external review committee of experts in food science research will 
review and evaluate the application based on its scientific merit. A 
second level review will be conducted by the National Advisory 
Environmental Health Science Council.

I. 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 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. Applications received were competitively reviewed by a 
panel of non-FDA food scientists, and the award approved by the 
National Advisory Environmental Health Science Council in September 
1988.
    In the Federal Register of September 10, 1991 (56 FR 46189) and in 
the Federal Register of May 12, 1994 (59 FR 24703), 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, and September 26, 
1994, respectively, following competitive review of the application by 
a panel of non-FDA food scientists. The award was approved by the 
National Advisory Environmental Health Science Council in September 
1991 and in September 1994, respectively.
    Under the cooperative agreement, IIT has established and staffed 
the NCFST at IIT's Moffett Campus in Summit-Argo, IL. Other 
participants in this effort are the IIT Research Institute; the Food 
Science Department of the University of Illinois, Urbana-Champaign; 
FDA; and industry. The 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, the 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 the NCFST positioned the Center as a focal point of FDA's 
participation in research and risk assessment associated with the 
President's Food Safety Initiative (FSI). Specifically, the work at 
NCFST focuses on development of preventive technologies targeted to 
reduce or eliminate microbial contamination of foods that results in 
foodborne illness. The work at the NCFST complements and feeds into FSI 
risk assessment and other activities at the Joint Institute for Food 
Safety and Applied Nutrition at the University of Maryland.

II. Mechanism of Support

A. Award Instrument

    Support for this program, if granted, will be in the form of a 
cooperative agreement. In 1999, FDA is providing $2 million for this 
award. The award will be subject to all policies and requirements that 
govern the research grant programs of the Public Health Service (PHS), 
including the provisions of 42 CFR part 52, 45 CFR part 74, and the PHS 
Grants Policy Statement.

B. Length of Support

    The length of support will be 1 year with the possibility of an 
additional 4 years of noncompetitive support. Continuation, beyond the 
first year, will be based upon performance during the preceding year 
and the availability of Federal fiscal year appropriations.

[[Page 39513]]

III. 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 the 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 biotechnology laboratory, 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 operate 
simultaneously 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 can also accommodate 
biotechnology scaleup and downstream processing and purification 
research. 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--academia, government, and industry--have 
brought their unique perspectives to focus on contemporary issues of 
food safety. The 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. The 
NCFST recently convened a meeting of national experts in aseptic 
processing of foods containing small particles to identify research 
required to establish the safety of the process and gain its approval 
in the United States. This process is used in other countries and has 
the advantages of providing consumers with shelf-stable, fresher 
tasting products. As a result of the research conducted by industry in 
response to the plan developed at NCFST, an aseptic process was 
approved by FDA. The NCFST has become a center of cutting edge 
technologies, such as high pressure processing, pulsed electric field 
processing, electrical resistance processing, and ultra violet 
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 for 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.
    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) 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 specific investigational techniques to be applied 
to the 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 8 years at IIT. 
The program will produce 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 endproducts, 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 
and University of Illinois are gaining hands-on experience in food 
safety by participating in the cooperative food safety research 
program. Several Masters of Science degrees, which included research 
conducted on cooperative projects, have been granted in disciplines 
such as engineering by IIT since the inception of the 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 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.

IV. Reporting Requirements

    Program progress reports and financial status reports will be 
required annually, based on date of award. These reports will be due 
within 30 days after the end of the budget period. A final program 
progress report and financial status report will be due 90 days after 
expiration of the project period of the cooperative agreement.

 V. 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

[[Page 39514]]

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, coauthorship of publications.

    Dated: July 15, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-18689 Filed 7-21-99; 8:45 am]
BILLING CODE 4160-01-F