[Federal Register Volume 59, Number 91 (Thursday, May 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11595]
[[Page Unknown]]
[Federal Register: May 12, 1994]
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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 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 60501. Competition is limited to IIT because IIT has: the
unique capability of bringing together diverse perspectives on food
safety; access to the exceptional combination of scientific expertise,
pilot plants, and research facilities necessary to focus those
perspectives on cooperative food safety programs; and a cooperative
food safety research program and an academic degree program in food
safety underway.
ADDRESSES:
An application is available from and should be submitted to: Maura
Stephanos, State Contracts and Assistance Agreements Branch (HFA-520),
Food and Drug Administration, Park Bldg., rm. 3-40, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-6170.
Applications hand-carried or commercially delivered should be
addressed to the Park Bldg., rm. 3-40, 12420 Parklawn Dr., Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of
this notice: Maura Stephanos (address above).
Regarding the programmatic aspects: Karen Carson, Center for Food
Safety and Applied Nutrition (HFS-22), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5140.
SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept
and consider a single source application from IIT for a cooperative
agreement to support 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 that such
agreements will provide to the public.
IIT's application 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 joins 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 was approved by the
National Advisory Environmental Health Science Council in September,
1988.
In the Federal Register of September 10, 1991 (56 FR 46189), FDA
published a notice of its intention to limit consideration for the
award of a cooperative agreement to IIT to support NCFST. FDA awarded
the cooperative agreement to IIT on September 30, 1991, 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.
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. 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 programs focused on food safety 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.
II. Mechanism of Support
A. Award Instrument
Support for this program, if granted, will be in the form of a
cooperative agreement. In 1994, FDA is providing $2,000,000 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 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.
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 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 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 plant 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 biotechnology research facility, funded by the State of
Illinois, for scale-up and downstream processing and purification
research. Other facilities include 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
recently convened a meeting of its members to identify and discuss the
mechanisms and safety aspects of new food processing and packaging
technologies that are either now moving into the food manufacturing
industry or are expected to be introduced soon, including laser
heating, high voltage pulse processing and high pressure processing,
and cold sterilization techniques. Ongoing research on recycling
plastics for food contact use was initiated from a planning meeting
that brought together NCFST participants with expertise and knowledge
about plastics recycling, including representatives of government,
academia, and industry, to discuss the status of recycling research in
the U.S. industry and regulatory perspectives. The cooperative research
that was generated by this meeting has recently been expanded to
include recycling of paperboard for fatty and aqueous foods, which is a
use that is not currently provided for by Federal regulations. This
type of research fills existing gaps in knowledge and expertise
associated with recycled packaging materials in a time when many States
are mandating the recycling of packaging materials, and answers
questions about safety and use of these materials.
In addition to research on recycled materials for food container
use, the cooperative research program in progress investigates safety
aspects of biotechnological and fermentation techniques, validation of
critical controls in computerized and automated processing lines, and
formation of potentially detrimental compounds during high-temperature
processing. 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 can use the information in the design of HACCP programs,
which prevent food safety hazards before they occur and enhance the
safety of the final product, for use in their plants.
An academic degree program in food safety science, which is not
part of the cooperative agreement, has been underway for 3 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, these graduates will evaluate the adequacy of processing
and packaging parameters to produce safe endproducts, as well as manage
regulatory and information programs designed to enhance the safety of
the food supply and consumer knowledge about the food supply. Graduate
students from IIT and the University of Illinois can gain 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 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
that can 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 effects that food safety
knowledge and expertise are having. 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 ensuring 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 coproject officers who
will actively monitor the FDA-supported program under this award.
2. FDA will 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 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.
VI. Use of the Metric System
In order to be eligible for this FDA grant program, applications
must be in compliance with the Metric Conversion Act of 1975 (as
amended by the Omnibus Trade and Competitiveness Act of 1988) which
requires that the metric system be used in all Federal procurements,
grants, and business-related activities. Therefore, all applications
submitted under this notice which contain measurement-sensitive
information and/or data, must reflect such data using the metric
system. During this period of transition, both metric and inch-pound
units will be used simultaneously to express measurements. Examples of
measurements that should now be reflected in metrics include: (1)
Travel (if applicable) in kilometers (km); (2) office or laboratory
space (if applicable) in square meters (m2); (3) audio/visual
(film) (if applicable) in millimeters (mm); and (4) publications (if
applicable) in centimeters (cm). Applications found not to be in
compliance will be returned to the applicant without consideration.
Written requests for exemption from the requirement will be considered
on a case-by-case basis. If additional costs are incurred due to
implementation of this requirement, such costs may be considered as
allowable if bonafide supporting justification is presented. The grants
management officer will determine the allowability of such costs.
VII. Smoke-Free Workplace
PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
Dated: May 4, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-11595 Filed 5-11-94; 8:45 am]
BILLING CODE 4160-01-F
