[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