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MOU number: 225-96-8001

Memorandum of Understanding

Between
The Food and Drug Administration

and

University of Maryland
College Park, Maryland

I. PURPOSE

The Food and Drug Administration (hereinafter referred to as FDA) and the University of Maryland wish to conduct collaborative research dealing with mission-related activities of the two organizations. This will be done through a newly created Joint Institute for Food Safety and Applied Nutrition (hereinafter referred to as JIFSAN), which will conduct multidisciplinary research. This Memorandum of Understanding (MOU) describes the general terms to which the parties agree regarding the Institute, the collaborative research, and related matters.

II. BACKGROUND

FDA is charged with the enforcement of the Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting the public health associated with foods, drugs, veterinary products, medical devices, and radiological products. To accomplish its mission, FDA must continually strive to keep its scientists abreast of the latest developments in scientific research. Its regulatory program must often rely upon the consultation of others.

FDA is the lead United States regulatory agency responsible for assuring the safety of the nation’s food supply and the safety of cosmetics; and CFSAN scientists apply the latest scientific knowledge to the development of policies and programs to achieve this goal.

FDA/Center for Food Safety and Applied Nutrition’s (hereinafter referred to as CFSAN) primary mission related to food is to develop and implement regulatory and research initiatives and programs which promote and protect the public health and economic interest by ensuring that the nation’s food supply is safe, nutritious, wholesome, and honestly labeled.

CFSAN and its association with the Joint Institute will gain in national and international recognition in the areas of food safety and applied nutrition.

The University of Maryland is the Washington region’s most comprehensive research institution with numerous academic programs relevant to FDA’s mission, including food science, agriculture, life sciences, 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, the international community and the world.

The benefits to be achieved in establishing a definitive relationship between FDA and the University of Maryland are substantial, e.g., collaborations with internationally known scientists with established reputations; access to domestic and international network for foods; access to domestic and foreign information; sharing of specialized scientific equipment (Mass Spectrometry, Nuclear Magnetic Resonance, Fourier Transform Infrared Instruments); network to other public health agencies (CDC and NIH); nearby state-of-the-art animal research facilities; and opportunities for staff development.

Collaborative research will provide opportunities for undergraduate and graduate education in the form of internships, cooperative education, research opportunities, and public service; provide opportunities for the professional and technical development of FDA staff; and expand outreach and educational programs for industry and the public through the use of innovative technology.

The collaborative activities will involve faculty and students from departments and interdisciplinary units (such as the Survey Research Center, Institute for Advance Computer Studies, and Institute for Philosophy and Public Policy) in certain colleges, including the College of Agriculture and Natural Resources, College of Behavioral and Social Sciences, College of Computer, Mathematical, and Physical Sciences, College of Engineering, College of Life Sciences and School of Public Affairs.

2. Provide assistance to University of Maryland in curriculum development in areas of mutual interest and expertise of the parties.

3. Explore opportunities to provide funding support, through appropriate funding mechanisms, for the Director and operations of the Director’s office at JIFSAN.

4. Provide qualified personnel to participate in the University of Maryland’s instructional program.

5. Make FDA facilities and scientific equipment available to University of Maryland including necessary training and guidance. Such use is not to interfere with the primary mission of either party.

B. University of Maryland agrees to:

1. Appoint a Director for the Joint Institute for Food Safety and Applied Nutrition who will be responsible for administering the Institute in accordance with the mission, policies, and plans established by the executive committee. The University and FDA will cooperate in a national search to jointly recruit and select the director, who will be qualified for a full faculty appointment in the University. The Associate Provost for Research and Dean of the Graduate School, in consultation with the appropriate academic college deans, will oversee the Institute’s Director on behalf of the executive committee (see item C.2 below) and will report regularly on activities.

2. Provide access for appropriate FDA employees to the resources of university libraries, including the principal library, the Theodore R. McKeldin Library (humanities, social sciences, and life sciences), and its specialized branch libraries, such as the Engineering and Physical Sciences Library and the Charles E. White Memorial Library (chemistry, biochemistry, and microbiology).

3. Provide adjunct and research faculty appointments for FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives with the College of Agriculture and Natural Resources, the College of Life Sciences, and other colleges as appropriate, and provide that such appointments comply with University polices on appointment of faculty.

4. Provide full faculty appointments for individuals jointly recruited by University of Maryland and FDA in accordance with university policies on recruitment, selection and appointment of faculty. Such appointees may be located in university facilities; the salaries and expenses of such appointees will be shared by the University and FDA.

5. Graduate students trained under the auspices of JIFSAN will have competitive access to all assistantships and fellowships administered by the relevant participating academic units.

6. The recovery of indirect costs shall be in accordance with the rates and conditions stated in the Rate Agreement between the University of Maryland and the Federal Government as issued by the Department of Health and Human Services, Division of Cost Allocation and Liaison.

7. Make University of Maryland facilities and scientific equipment available to FDA including necessary training and guidance. Such use is not to interfere with the primary mission of either party.

8. Provide access to the University of Maryland Faculty Club for selected FDA staff.

9. Provide access to shuttle bus service between the University campus and the College Park/University of Maryland Metro Rail Station.

C. It is Mutually Agreed:

1. University of Maryland and the FDA will establish JIFSAN which will be an interdisciplinary research unit. JIFSAN will conduct research, risk assessment, policy studies and related activities to promote the efficacy and effectiveness of regulation in food safety and applied nutrition. Its activities may include the formation of strategic alliances and industrial partnerships with private industry and other state and federal government agencies to support research and development; educational outreach; and policy dissemination. FDA will provide office space for the Director JIFSAN.

2. The University of Maryland and FDA will designate representatives to an executive committee (including the deans of the College of Agriculture and Natural Resources, the College of Life Sciences, and such other university colleges as appropriate, the FDA Deputy Commissioner for Operations, the Director, CFSAN, the Deputy Director for Programs, CFSAN, and other FDA representatives, as appropriate); the Associate Provost for Research and Dean of the Graduate School will serve as presiding officer. The executive committee will develop a mission statement, strategic plan and annual operating budget for JIFSAN; coordinate an ongoing survey of the existing relevant research resources at University and FDA, and determine the effective and efficient use of these resources in support of the Institute. The executive committee will be responsible for the ongoing monitoring and implementation of the strategic plan (including the use of jointly allocated resources).

3. The University and FDA will collaborate as appropriate in the development of specialized core research facilities, such as mass spectrometry, nuclear magnetic resonance, electron microscopy, electron-spin resonance spectroscopy, automated nucleic acid analysis, and protein chemistry.

4. The University and FDA will provide opportunities for graduate and undergraduate students through specialized educational programs, field experiences, academic training activities, internships and independent studies in order to enhance the involvement of students in research and policy development and to prepare them for careers in public service.

5. The University and FDA will collaborate in the development of special seminars, workshops, colloquiums and forums, and lecture series for the purpose of providing and enhancing continuing education opportunities for FDA staff, the university faculty, and the broader scientific community. The University of Maryland in consultation with FDA will develop mechanisms for receiving donations for supporting such programs.

6. The University of Maryland and FDA will engage in collaborative research activities with faculty and students in relevant academic departments of the University (such as Chemistry and Biochemistry, Nutrition and Food Sciences, Agriculture and Resource Economics, Microbiology and Molecular and Cell Biology, Economics, and Computer Science); and graduate programs (such as Nutrition, Food Sciences, Chemical Physics and Survey Methodology).

7. The University and FDA will collaborate in furthering the scientific basis for public policy formulation, evaluation, modeling, and risk assessment in the four major areas of FDA’s food program to include:

a. food security (related to pathogens, contaminants, and toxins);
b. regulatory science (related to the premarket review process, postmarket compliance and enforcement strategies, international standards and competence, and educational research);
c. nutrition and clinical studies (related to nutrient quality, safety, and labeling); and
d. food industry intelligence and consumer behavior.

D. ADDITIONALLY IT IS AGREED THAT:

1. Rights to any inventions resulting from collaborative research will be determined based on current U.S. Government patent regulations.

2. Upon termination, property contributions, if any, will be returned to the contributing party unless the other party purchases the contributed property at current market value.

3. The FDA and the University of Maryland will follow each other’s security procedures and policies regarding access to and use of facilities, review jointly the results of the program on an annual basis, and evaluate its accomplishments and progress. Appropriate changes can be instituted upon concurrence of both parties.

4. It is recognized that from time to time FDA and the University of Maryland will be sharing in both expenses and efforts in research projects and from time to time this will require compensation of either party by the other. As research projects are developed, the details of how costs are to be shared will be agreed to in advance.

5. It is also recognized that, if FDA personnel teach courses during Government time and the third parties receiving the instruction are paying tuition to the University of Maryland, then the Government will receive some form of compensation. The details of the above understanding will be reflected in an Addendum to this Agreement.

6. This agreement may be amended any time upon mutual agreement between the parties in writing.

IV. NAMES AND ADDRESSES OF PARTICIPATING PARTIES

A. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

B. University of Maryland
College Park, Maryland 20742

V. LIAISON OFFICERS

A. Liaison Officer (s) for FDA:

Fred R. Shank, Ph.D., Director, Center for Food
Safety and Applied Nutrition

James L. Tidmore, Director, Office of Facilities,
Acquisitions and Central Services

B. Liaison Officer (s) for University of Maryland:

To be determined

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and will continue in effect for ten (10) years and may be renewed upon mutual agreement of the parties.

VI. The foregoing represents the broad outline of the parties’ present intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and the University. This Memorandum of Understanding and all associated agreements will be subject to availability of funds, applicable federal and state laws, and to university policies.

This agreement is being entered into under authority contained in 42 U.S.C. Section 301 and 1702, Public Health Service Act.

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