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MOU 225-03-8002

Memorandum of Understanding

Between
The United States Food and Drug Administration

and

Virginia Polytechnic Institute and State University

 

The United States Food and Drug Administration (FDA) and the Virginia Polytechnic Institute and State University (Tech) have a shared interest in scientific progress through an exchange of scientific capital in the diverse fields of science and medicine that directly and indirectly affect human and animal health. Both institutions also endorse scientific training for academicians and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning will grow.

 

This Memorandum of Understanding (MOU) establishes terms of collaboration between FDA and Tech to support these shared interests that can proceed through a variety of programs such as sabbaticals, postdoctoral fellowships, and student internships. The MOU also includes the Virginia Tech Center for Food and Nutrition Policy (VT-CFNP), which is a chartered research and education center of Tech. VT-CFNP is nonprofit, dedicated to advancing rational, science-based food and nutrition policy. Their trademark is Ceres® which signifies the center's outreach and public service activities that include an email service of analyses (CeresNet), conferences, roundtables, seminars, and lectures. These provide a venue for stakeholders to debate current food and nutrition policy issues having impact in the United States and throughout the world. The VT-CFNP publishes high-quality, scholarly proceedings and executive summaries commemorating these deliberations that are marketed through its website, scientific conferences, and other appropriate venues.

 

I. FDA relationship with Tech

For the programs listed below, FDA will provide the following:

• Laboratory and/or office space as needed.

• Openness and proactive efforts in collaborative research efforts with Tech faculty, students, and staff.

• Based on available resources, willingness to participate in graduate courses and seminars at Tech.

• Continuing and frequent communication with faculty and staff.

• Openness and welcome to faculty, staff, and students wishing to visit FDA laboratories.

• Promulgation and communication of this collaborative effort through web pages, informal conversations with colleagues, faculty and students. In addition to above, FDA will provide Tech personnel the following:

 

Sabbatical Program:

• Opportunities to apply for a sabbatical with the agency with terms of the sabbatical to be negotiated between the individual and the agency.

• Opportunities to apply for salary support, where appropriate, through a variety of funding mechanisms. Request for salary support must coincide with the current federal fiscal year.

• Opportunity to attend a variety of didactic courses.

 

FDA Service Fellowship Program:

• Opportunity to compete for appointments. For those who receive appointments, research training and mentoring of the Fellow will be the responsibility of the appointing office.

 

Tech Graduate Student Internship Program:

• Tech will select the graduate student and FDA will approve the student applying mutually agreeable criteria.

• With concurrence of both parties on a research project, FDA, as appropriate, will offer office support, laboratory support, and supplies.

• The student will have the opportunity to apply for salary support from the FDA through a variety of mechanisms including Internship Programs, the Student Career Experience Program, and other work-study programs by working with the appropriate FDA Center Director.

• Consistent with Tech and FDA rules and regulations, and negotiated on a case-by-case basis, FDA mentors can, where appropriate, serve on thesis committees, attend examination and committee meetings, and participate in other aspects of the student's educational program at Tech.

• As appropriate, openness and welcome to students wishing to rotate through FDA laboratories, as well as an opportunity to obtain short-term training in related areas.

 

Education and Instruction:

• FDA, when available, will be instructors as part of Tech distance learning.

• FDA, when available, will participate in VT-CFNP's summer education programs.

 

General Appointments:

• Opportunity to submit resumes to apply for Special Government Employee (SGE) appointments.

 

II. FDA's relationship with the Center for Food and Nutrition Policy (CFNP)

Collaborative Research:

• Collaborative research in statistical analyses and other areas of opportunity will be handled in accordance with federal law (e.g., Freedom of Information and Privacy Act) and Agency policy governing the sharing, disclosing and consultation on Agency data. This is required to ensure the protection of proprietary information whether it is pre- or post-marketing. When federal and Agency laws are met, any collaborative research in statistical analyses will be handled through appropriate federal documents such as Cooperative Research and Development Agreements (CRADAs).

• FDA, when available, will participate in VT-CFNP Roundtables in food and nutrition policy.

 

Outreach:

• FDA, when available, will participate in lecture series sponsored by VT-CFNP. These lectures are ideal networking opportunities for students (and others) who wish to understand the science and policy problems and solutions. The tone for the seminars and ensuing discussion period is collegial, informal, and informative.

 

III. Tech's relationship with FDA:

For the programs listed below, Tech will provide FDA the following:

• Laboratory and/or office space as needed and as available in accordance with the resources, rules, laws and policies of Tech.

• Openness and proactive efforts in establishing collaborative research efforts with FDA scientists and staff.

• Continuing and frequent communication with FDA scientists and staff.

• Openness and welcome to FDA scientists and staff wishing to visit relevant Tech laboratories and participate in relevant programs.

• Promulgation and communication of this collaborative effort through web pages, informal conversations with colleagues, faculty and students.

• In addition to above, Tech will provide FDA personnel the following:

 

Sabbatical Program at Tech:

• Opportunities to apply for a sabbatical with Tech. Terms of the sabbatical will be negotiated between the individual and the appropriate University unit.

• Opportunity to attend and/or participate in a variety of courses at the graduate level.

 

FDA Service Fellowship Program:

• Opportunities to apply for funding through internal and external mechanisms for additional research support for collaborative research efforts between Tech and FDA laboratories, subject to the policies and practices of Tech and FDA.

 

Tech Graduate Students:

• The basic formal educational structure be adhered to by students within any of its programs. It is understood that all students will meet all requirements for courses and degree programs as set up by the appropriate department or program at Tech.

• Stipend support, health insurance coverage, and/or tuition support in the form of teaching assistantships, campus fellowships, or other mechanisms, where appropriate are based on available resources, to Tech Graduate Students taking classes full time at Tech.

• Opportunity to received dissertation research credits from the Graduate School, when available and appropriate, for Tech students engaged in dissertation research while participating in an internship at an FDA Center.

• Long-term commitment from the Graduate School to offer continued education, typical of what is provided to other Tech graduate students in good standing in their program, to Tech graduate students engaged in dissertation research while participating in an internship with FDA.

• Encouragement of graduate students to rotate through, and/or have short-term research opportunities in FDA laboratories.

 

Adjunct Faculty Appointments:

• Adjunct faculty appointments in relevant Tech programs or departments, based on available resources and consistent with standard Tech policies, for those FDA staff members working with Tech students, and/or assisting in teaching at Tech.

 

Education:

• FDA will be invited to participate in Tech distance learning for continuing education credit.

• Tech will invite FDA staff to be adjunct faculty.

 

IV. VT-CFNP's relationship with FDA.

Collaborative Research:

• Collaborative research in statistical analyses will be handled through appropriate federal documents such as Cooperative Research and Development Agreements (CRADAs).

 

Lectures:

• VT-CFNP will invite FDA to attend lecture series sponsored by VT-CFNP. FDA employees will be able to receive Continuing Education credit for attending in the lectures.

• VT-CFNP will invite FDA to participate in lecture series sponsored by VT-CFNP. Agency participation will be handled in accordance with federal law and Agency policy.

 

Education and Instruction:

• FDA individuals may consult with VT-CFNP on the development of their Masters of Public Policy degree program. FDA's availability to consult will be based on available resources, such as personnel and time. FDA will determine how the Agency can be of help. Furthermore, any commitment on behalf of FDA to permanently assist in the Master's program (e.g., curricula, research and design, faculty) will be handled in accordance with federal law and Agency policy.

• VT-CFNP will offer FDA adjunct faculty positions, should a Maters of Public Policy (MPP) degree program be developed. Graduate-level classes may include Food Safety and Regulatory Policy, Nutrition and Public Policy, Biotechnology and Public Policy, and Risk Analysis in Public Policy.

 

V. Coverance

Tech individuals participating in the MOU will be United States Citizens or Permanent Residents when their participation involves research subject to export controls restrictions, or select agents. Regarding the latter, all federal restrictions will be adhered to.

 

Patent, license, and other legal instruments will be prepared in accordance with federal law and Tech policy, and written notice referencing the policies will be provided to the individual prior to entering on duty with FDA. Tech and FDA may decide to enter into a Cooperative Research and Development Agreement (CRADA) at a future time to conduct collaborative research. The terms of such a CRADA will address Intellectual Property rights.

 

This MOU forms the basis for the initial relations between FDA and Tech for sabbaticals, research, and scientific education. However, as this collaborative effort progresses, it is expected that new and wider areas of mutual interest will evolve and be included in expansions of this document.

 

VI. Finances and Resources

Tech and FDA agree that this MOU does not commit either to make specific levels of financial or personnel support or to provide specific laboratory or office space for the programs and that the provision of such support will be based on available resources and provided in accordance with the rules, regulations, and laws under which FDA operates and the policies of Tech.

 

VII. Contact

The individual to whom all inquiries to FDA should be addressed is:

Eileen Parish, eileen.parish@fda.hhs.gov

 

The individual to whom all inquiries to Tech should be addressed is:

Dr. Leonard K. Peters, Vice Provost for Research peters@vt.edu

Approved and Accepted
for Virginia Polytechnic Institute and State University

Signed by: Maureen Storey, Ph.D.
Acting Director, Virginia Tech Center for Food and Nutrition Policy

Date: February 27, 2003

Approved and Accepted
for Virginia Polytechnic Institute and State University

Signed by: Charles W. Steger, Ph.D., President
Virginia Polytechnic Institute and State University

Date: March 5, 2003

Approved and Accepted
for the Food and Drug Administration

Signed by: Linda Arey Skladany, Esq.
Associate Commissioner for External Relations
Food and Drug Administration

Date: March 12, 2003

Approved and Accepted
for the Food and Drug Administration

Signed by: Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs

Date: March 13, 2003