Memorandum of Understanding Between U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Chief Scientist; and the University System of Maryland

I. Purpose

The United States Food and Drug Administration (FDA) and the University System of Maryland (USM)(the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine.The Parties also endorse scientific training for faculty, students and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. This Memorandum of Understanding (MOU)establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships

II.  Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with USM will greatly contribute to FDA's mission. FDA's Centers and Offices are described in Appendix A.

USM is one of Maryland's most valuable assets and adds immeasurably to the quality of life in the state and beyond. The nation's 12th largest university system, USM's network of 12 institutions (Appendix B) enrolls nearly 130,000 students worldwide in 600 degree programs delivered in classrooms, laboratories, education centers, and online. The USM's nationally ranked programs, leading-edge research collaborations, and innovative business partnerships provide an environment to support diverse multidisciplinary exchanges with FDA. The scientific, public health and policy expertise within FDA provide opportunities for collaborations that support the USM mission and strategic themes to provide access to high-quality education, research discovery, and knowledge based services responsive to both the promises and demands of the state and the nation in the new century.

III.  Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and USM. The types of activities expected to develop from this MOU include, but are not necessarily limited to, the following:

1. Identification and convening of a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives.
2. Personnel exchanges between university faculty and staff and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;
3. Opportunities to apply for a joint fellowship program at the FDA to advance student and faculty education. One mechanism to enroll students/post-doctoral trainees/residents from USM into a joint fellowship program at FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, FDA and the USM will adhere to the respective Agency Centers' ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of the appointment which will be outlined in an offer of appointment letter;
4. Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties' laboratories, classrooms, clinical settings and offices;
5. Opportunities for FDA personnel to serve as adjunct faculty, advisory board members, and dissertation advisors at USM;
6. Joint meetings for education and research;
7. Research collaborations;
8. Cooperative international activities including outreach;
9. Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors; and
10. Development of regular workshops where faculty from USM and FDA's scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.

A. FDA agrees to:

For programs agreed to in writing, and in advance by both parties, FDA may, as permitted by applicable statutes and regulations and subject to the availability of funds, and as it deems appropriate, offer USM the following:

1. Laboratory and/or office space in support of activities under this MOU.
2. Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party
3. Active participation in establishing collaborative research, education, extension and outreach efforts with faculty, students, and staff within USM institutions.
4. Willingness to participate in courses and seminars within USM, based on availability of resources.
5. Continuing and frequent communication with faculty and staff.
6. Openness and welcome to faculty, staff, and students wishing to visit FDA laboratories.
7. Promulgation and communication of identified collaborative efforts through appropriate means.

B.  University System of Maryland agrees to:

For programs agreed to in advance by both parties, USM may offer FDA the following:

1. Laboratory and/or office space in support of activities under this MOU at identified institutions.
2. Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party.
3. Active participation in establishing collaborative research, education, extension and outreach efforts with FDA scientists and staff.
4. Continuing and frequent communication with FDA scientists and staff.
5. Openness and welcome to FDA scientists and staff wishing to visit relevant USM programs and laboratories.
6. Promulgation and communication of identified collaborative efforts through appropriate means.
7. If permitted by, and consistent with USM and institutional policies and procedures, USM may offer faculty appointments for appropriate FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives of USM, and, as appropriate, of FDA. All terms and conditions of such appointments must comport with USM and institutional policies and procedures, and be consistent with laws and legal
requirements applicable to FDA employees.

C.  It is mutually agreed that:

In an effort to enhance collaborative interactions and communication between both institutions, FDA and USM will collaborate in the development of regular workshop where faculty from all the institutions within the USM and FDA scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.

IV. General Provisions:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations and USM policy.
2. Institutions within USM and FDA may decide to enter into supplemental agreements that may include contracts, grants or cooperative research and development agreements ("CRADA") between FDA and USM to the extent authorized by law and available appropriations. The terms of such supplemental agreements will address Intellectual Property rights. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations and USM policy, and shall be negotiated and executed by appropriate representatives of institutions within the USM and FDA.
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
4. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. USM individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations. FDA individuals participating in activities under this MOU on USM property will comply with all applicable Maryland statutes and regulations and USM and USM institutional policies, procedures and protocols.
5. It is recognized that from time to time FDA and institutions within USM will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements, as well as the requirements of the State of Maryland and of USM.

V. Resource Obligations:

This MOU represents the broad outline of the FDA and USM intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

VI. CONTACTS:

A. For the University System of Maryland

J. Thomas Sadowski
Vice Chancellor for Economic Development
University System of Maryland·
Columbus Center
701 East Pratt Street - Baltimore, MD 21202
Office: (410) 576-5742 Cell: (410) 688-0013
[email protected]

B.  For the Food and Drug Administration:

Khaled [email protected]

Each Party may designate new contacts at any time by notifying the other Party's contact in writing. If, at any time, an individual designated as a contact under this MOU becomes unavailable to fulfill those functions, the Parties will name a new contact within 2 weeks and notify the other Party through the designated contact.

VII.  Term, Termination, and Modification:

This MOU will be effective when accepted by all participating partners. This MOU may be modified or terminated by mutual written consent by the partners or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.

VIII. Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, USM, and the institutions within USM operate.

Approved and Accepted for the University System of Maryland

Robert L. Caret, PhD
USM Chancellor
/s/
March 29, 2018

Approved and Accepted for the U.S. Food and Drug Administration

RADM Denise Hinton
Acting Chief Scientist
/s/
April 2, 2018