[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28049-28052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support the Joint Institute for Food 
Safety and Applied Nutrition; Notice of Intent to Establish 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 University of Maryland at 
College Park (UMCP). The cooperative agreement will support the Joint 
Institute for Food Safety and Applied Nutrition (JIFSAN) and a new FDA 
laboratory/office building to be constructed in College Park, MD. 
JIFSAN is to be colocated on the UMCP campus. Competition is limited to 
UMCP because the Food and Drug Administration Revitalization Act 
directed FDA to consolidate the Center for Food Safety and Applied 
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM); and 
related congressional action directed the Centers to be located in 
Prince George's County, MD. The cooperative agreement is intended to 
create a partnership that allows for a more efficient use of research 
resources and thereby enhances the quality of food safety and nutrition 
research.

ADDRESSES: Applications may be obtained from, and should be submitted 
to, Robert L. Robins, Grants Management Officer, Office of Facilities, 
Acquisition and Central Services (HFA-520), Food and Drug 
Administration, Park Bldg., 5600 Fishers Lane, rm. 3-40, Rockville, MD 
20857, 301-443-6170. Applications hand carried or commercially 
delivered should be submitted to Robert L. Robins, Park Bldg., 12420 
Parklawn Dr., rm. 3-40, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice contact: Robert L. Robins (address above).
    Regarding the programmatic aspects contact: Elizabeth M. Calvey, 
CFSAN (HFS-345), Food and Drug Administration, 200 C St., SW., 
Washington, DC 20204, 202-205-4716.
SUPPLEMENTAL INFORMATION:

I. Background

    FDA is announcing its intention to accept and consider a single-
source application from UMCP for a cooperative agreement to support the 
JIFSAN. 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.
    UMCP's application for this award will undergo dual peer review. An 
ad hoc review panel of nonFederal experts (i.e., in areas associated 
with food safety, nutrition, and risk assessment) will review and 
evaluate the application based on its scientific merit. A second level 
review will be conducted by the National Advisory Environmental Health 
Sciences Council.
    JIFSAN was established between FDA and the University of Maryland 
(the University) in April 1996 through a formal memorandum of 
understanding (MOU) to create a partnership that allows for more 
efficient use of research resources and thereby enhances the quality of 
food safety and nutrition research and public health policy. As the 
role of FDA research scientists in regulatory activities increases, it 
is vital that these scientists have ready access to very specialized 
research facilities and expertise (e.g., Center of Biomolecular 
Structure and Organization) in order to expedite regulatory policy and 
decisions (e.g., petition review). As described in the MOU of April 
1996, JIFSAN is to be a jointly administered, multidisciplinary, 
research program. JIFSAN was established as part of FDA's consolidation 
project affecting CFSAN and CVM.
    FDA's consolidation project was authorized through the Food and 
Drug Administration Revitalization Act (Pub. L. 101-635). The Treasury, 
Postal Service and General Government Appropriations Act, 1992 (Pub. L. 
102-141) directed that new construction for the consolidation of FDA 
occur in Montgomery and Prince George's Counties, Maryland. The 
Congressional Conference Report (H. Rept. 102-234, 1991) related to 
this law further specifies that FDA begin consolidating its current 
programs into two campuses:

[[Page 28050]]

 (1) A headquarters campus to include administrative and drug research 
facilities, in Montgomery County, and (2) a food and veterinary 
sciences campus in Prince George's County. To this end, the General 
Services Administration, through its site selection process, purchased 
land in the vicinity of the College Park metro rail station intended as 
the location for consolidation of CFSAN and CVM.
    In the United States, there is no single center for research and 
development of expertise and analytical methodology in food safety and 
applied nutrition. In a January 1997 radio address, the President 
emphasized the need for Government, academia, industry, and consumers 
to work together to improve the safety of the food supply. FDA is in 
the vanguard of this effort, establishing the National Center for Food 
Safety and Technology (NCFST) with the Illinois Institute of Technology 
in 1988, and now, establishing JIFSAN with UMCP. The missions of NCFST 
and JIFSAN are mutually dependent. The focus of NCFST is food 
technology, specifically the effect of innovative food processing and 
packaging technologies on the safety of the food supply. The focus of 
JIFSAN is food safety and nutrition, specifically as related to risk 
analysis, applied microbiology, natural toxins, chemical contaminants, 
and an integrated program of study of food composition and nutrition.

II. Establishment of JIFSAN

A. Concept

    FDA believes that the cooperative research program with UMCP to be 
established at JIFSAN will provide opportunities to leverage resources 
so that important national and international problems in food safety 
and nutrition can be addressed in a timely manner. Further, FDA 
believes that cooperative research through JIFSAN will promote the 
efficient use of the complementary resources (e.g., major 
instrumentation, space, information and computer technologies, etc.) of 
both parties. All research will be related to FDA program requirements 
in food safety and nutrition. Other Federal and State agencies, 
industry, consumer and trade groups, and international organizations 
with mutual interests will have opportunities for collaboration. FDA 
believes that the cooperative research at JIFSAN will enhance the 
agency's food safety and nutrition programs (e.g., risk assessment, 
microbiology, food contaminants including natural toxins, food 
composition, foods for special dietary uses, and advanced studies in 
micronutrients). The agency and UMCP intend to design the collaborative 
effort to:
    (1) Develop a critical mass of scientific expertise necessary to 
address ongoing and increasingly complex key public health issues, to 
provide early warning of emerging problems, to provide support during 
periodic emergencies and crisis situations (e.g., microbial 
contamination of apple juice), and to provide scientific expertise in 
close proximity to FDA administrative offices to expedite regulatory 
policy and decisions (e.g., petition review). (All official regulatory 
activities, however, will be performed by FDA employees only);
    (2) Provide for more efficient use of current resources devoted to 
risk assessment research and related activities (e.g., surveillance, 
modeling, etc.), enhancing the safety of the food supply;
    (3) Develop more effective methods for communicating risk 
associated with both microbial and chemical hazards to the general 
public by going beyond the study of the science to the study of how 
that science is heard and understood (risk communication);
    (4) Share resources to enhance the research infrastructure and 
provide for effective use of increasingly sophisticated scientific 
equipment with high acquisition, installation, and maintenance costs 
and the corresponding expertise of both parties; and
    (5) Establish mechanisms for exchange of technical information and 
scientific concepts between FDA and other sectors of the food safety 
and nutrition community (e.g., other Federal and State agencies, 
industry, academia, consumer and trade groups, and international 
organizations).

B. Project Emphasis

    The purpose of JIFSAN is to develop collaborative partnerships to 
augment and enhance FDA's scientific expertise in food safety and 
nutrition. The collaborative work will supplement FDA scientific 
expertise needed to address increasingly complex problems in such areas 
as risk assessment, food composition analyses, and other food safety 
related areas to include: Food safety related to emerging pathogens, 
contaminants (e.g., industrial chemicals and toxic elements), and 
natural toxins (e.g., mycotoxins); regulatory science supporting the 
review of food ingredients and the development of international 
standards; and nutrition and clinical studies related to nutrient 
quality, safety, labeling, and patterns of consumer behavior. The 
downsizing of FDA's food safety and nutrition program has reduced 
present expertise in some of these areas below critical levels. This 
loss of expertise has required the agency to find other ways of 
expanding its science base, such as establishing JIFSAN, a unique 
partnership between Government and academia.
    JIFSAN will be designed to provide the collaborative environment 
and expertise necessary to conduct advanced research in key areas such 
as risk analysis (risk assessment, risk management, and risk 
communication). Risk analysis requires a multidisciplinary approach. 
The needs of risk analysis are well beyond the core sciences of 
chemistry, microbiology, toxicology, and traditional food science 
concepts of food safety and applied nutrition. Risk analysis must draw 
upon a number of other disciplines, including computer sciences, 
mathematics and statistics, philosophy of science, economics, 
communications, and law. The advancement of risk assessment 
methodologies will ultimately promote efficient and effective risk 
management (e.g., rational regulation of public health policy) and risk 
communication approaches. Conducting advanced research in risk analysis 
will promote the development of risk-based, scientifically supported, 
safety standards that will result in a safer food supply and can be 
used to identify priorities in order to more effectively apply 
available resources.
    This collaborative effort will permit the sharing of complementary 
resources (e.g., major instrumentation, space, and information and 
computer technologies) and create opportunities to leverage the 
shrinking resources of both parties so that important national and 
international issues in food safety and nutrition can be addressed in a 
timely manner. Many of these issues (i.e., emerging pathogens, natural 
toxins, toxic element contamination, fortification policy, safety of 
dietary supplements, etc.) can only be addressed with close cooperation 
of the public and private sectors. Combining CFSAN's major 
instrumentation resources and corresponding expertise with UMCP will 
enhance FDA's access to state-of-the-art instrumentation to conduct 
research at the forefront of food safety and nutrition sciences. The 
direct access to the vast library resources on the College Park campus 
will permit CFSAN to redirect its program from maintaining a classical 
library system to providing on-line data base access to pertinent 
scientific literature. The complementary nature of these shared UMCP 
and FDA facilities will enhance the research infrastructure of both

[[Page 28051]]

institutions and reduce costs by avoiding unnecessary duplication. A 
close working relationship of FDA and University personnel will provide 
enhanced scientific expertise in advanced techniques for the 
characterization of biotechnology products as well as expand the 
current capabilities in research to support regulatory actions and 
respond to emergency situations.

C. Summary

    FDA believes that JIFSAN is a sound investment in the future public 
health of American consumers. It provides an opportunity for extensive 
cooperation with University scientists, and it will stimulate 
collaborative efforts to ensure a safe food supply contributing 
significantly to implementation of the goals for Government, academia, 
industry, and consumers to work together to improve food safety. FDA 
deals with an increasing number of critical and complex food safety 
issues. In order for FDA to respond rapidly in these situations it 
requires that FDA scientists be in close proximity with a source of 
complementary and specialized scientific expertise and facilities to 
expedite regulatory policy and decisions. The MOU between FDA and UMCP 
provides the essential foundation for a vigorous, high quality 
scientific research program to support sound regulatory policy and 
performance.
    The public and FDA will both benefit from the type of collaboration 
possible at JIFSAN. Scientists from each sector would bring a special 
perspective to advancing the knowledge of food safety and nutrition 
sciences. Interaction among those scientists will stimulate creativity 
and innovation. FDA's participation in this venture will promote a 
greater awareness and understanding of regulatory science and practice 
among academic scientists thereby providing economic and program 
benefits to both. In summary, this collaboration between FDA and UMCP 
provides an efficient means of remaining current with scientific and 
technical accomplishments in the areas of food safety and applied 
nutrition. This will ensure that FDA continues to be best positioned to 
carry out its statutory responsibilities, respond rapidly in a crisis 
situation, protect, promote, and enhance the health of the American 
People.

 III. Mechanism of Support

A. Award Instrument

    Support for this program, if granted, will be in the form of a 
cooperative agreement. In 1997, FDA is providing approximately 
$500,000.00 for this award. It is anticipated that funding will 
increase in subsequent years. 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.

IV. Reasons for Single-Source Selection

    FDA believes that there is compelling evidence that UMCP is 
uniquely qualified to fulfill the objectives of the proposed 
cooperative agreement. The University is in close proximity to the 
congressionally directed location of FDA's consolidation of CFSAN and 
CVM in Prince George's County, MD. The University has vast resources, 
which complement and greatly expand FDA's research and scientific 
resources. UMCP is the Washington region's most comprehensive research 
institution with numerous academic programs relevant to FDA's mission 
and the resources to support CFSAN's areas of interest, including: 
Microbiology, chemistry, food science, agriculture, public policy, risk 
assessment, computational science, economics, and survey methodology. 
The University serves as the primary center for graduate study and 
research and provides undergraduate instruction across a broad spectrum 
of academic disciplines. The University extends its vast intellectual 
resources to the community through innovative projects designed to 
serve individuals, governments, and the private sector throughout the 
State of Maryland, the nation, and the international community. In 
1988, the General Assembly of Maryland designated UMCP as the flagship 
institution for the University of Maryland System which consists of 11 
campuses across the State and offers programs at some 200 sites 
worldwide.
    The University is developing four central instrumentation 
facilities to provide effective use of state-of-the-art scientific 
instrumentation with high acquisition, installation, and maintenance 
costs to conduct research at the forefront of science. The central 
facilities will be the Nuclear Magnetic Resonance Laboratory, 
Biological Imaging Laboratory, Electron Microscopy Laboratory, and Mass 
Spectrometry Laboratory. These instrumentation centers will complement 
CFSAN's resources and expertise and facilitate access to these 
resources to meet FDA's food safety and nutrition program needs. In 
addition, the vast library resources on the College Park campus will 
permit FDA direct access to periodicals and books relevant to the 
program, as well as access to the collection of libraries on all 
campuses in the University of Maryland System and use of over 60 
automated reference tools in the libraries.
    Acknowledging the importance of an interdisciplinary approach to 
knowledge, the University maintains organized research units outside 
the usual department structures (i.e., Department of Chemistry and 
Biochemistry and Department of Molecular, Cell, and Microbial Biology, 
etc.). Through participation in collaborative projects, FDA will have 
access to these additional University resources. Several of these 
research units will complement or meet the programmatic needs of FDA. 
These units include the Center for Research in Public Communication 
where cooperative projects related to risk communication studies could 
be developed, the Survey Research Center and the Institute for 
Philosophy and Public Policy, which will promote more efficient 
development and dissemination of public policy, and the Maryland Fire 
and Rescue Institute, which will facilitate the maintenance of 
emergency response readiness credentials of the FDA Safety Staff who 
are responsible for maintaining and ensuring safety and regulatory 
compliance at FDA facilities where collaborative research is conducted.
    Collaboration between the public and the private sector is an 
efficient means for both FDA and the University to remain current with 
scientific and technical accomplishments from a food safety and applied 
nutrition perspective. These collaborative programs will produce 
generic knowledge and expertise to be used by all segments of the food 
safety and nutrition community, as well as by public health 
organizations, other Federal agencies, and academic institutions in the 
performance of their roles. Harmonizing regulatory activities is but 
one example of the need for, and use of, this food safety and nutrition 
knowledge and expertise. The partnership between FDA and UMCP will 
provide both the technical and educational expertise for effective 
creation of technology transfer mechanisms that will facilitate the 
movement of new technology and

[[Page 28052]]

provide fundamental food safety and nutrition information to the public 
and private sector.

V. 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.

VI. 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 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 program and of the 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: May 15, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-13446 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F