[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: mstepha1@oc.fda.gov.
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: kcarson@bangate.fda.gov.
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
