[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