MOU 225-16-014
MEMORANDUM OF UNDERSTANDING
between the
UNITED STATES FOOD AND DRUG ADMINISTRATION
and
RUTGERS UNIVERSITY
I. Purpose
The United States Food and Drug Administration (FDA) and the University of Rutgers share interests in promoting scientific progress through exchange of scientific capital in training and research and foresee the benefits from the mutual exchange of this training and research expertise. This Memorandum of Understanding (MOU) establishes the term for collaboration to promote these shared interests, which can be pursued through information sharing in regulatory science research, training, sabbaticals, postdoctoral, recruitment opportunities, fellowships, and student internships.
II. Background
The 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, the FDA directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products. The agency regulates the safety and security of foods, dietary supplements, and cosmetics. The 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. The FDA has a primary role in advancing the translational/applied science that is needed to move promising new technologies into actual manufactured products in the most efficient manner possible while assuring the clinical safety and effectiveness of such products for patient care. 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 Rutgers will contribute to the FDA's mission. Rutgers has a longstanding history of interconnected education and research activities that involve collaborations among faculty and researchers in engineering, physical sciences, biological sciences, computational sciences, and social sciences. Rutgers research activities address a broad range of issues of crucial importance to the FDA in its efforts to advance regulatory science for positive public health impact. This includes Rutgers global stature in areas directly aligned to the FDA mission including food and health.
III. Substance of Agreement
This MOU is intended as a broad vehicle to promote programmatic interaction in the form of collaboration between FDA and Rutgers researchers, students, and personnel as well as joint development of relevant scientific research projects. Additionally, this MOU establishes the framework for collaborative graduate education to be completed concurrently at the Rutgers and FDA facilities.
Under this MOU, FDA and Rutgers will seek opportunities to participate together in collaborative research and training as permitted within appropriate statutory authority. Before any specific collaboration is initiated or implemented, the parties shall identify priorities and topics of mutual interest, and develop separate, written agreements for each collaboration that will outline each Party's financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU. These agreements may include contracts, grants, or cooperative research and development agreements ("CRADAs") between FDA and Rutgers to the extent authorized by law and available appropriations. The terms and conditions of any agreements will be in accordance with applicable federal law and regulations and shall be negotiated and executed by appropriate representatives of institutions within Rutgers and FDA.
- Joint training in educational programs. This includes but is not limited to graduate training to be conducted within the auspice of Rutgers programs and internships at FDA facilities.
- Joint research programs planned by scientists from the respective institutions. This research may be based on collaborative analysis of data from FDA files and the literature or experimental work. The partners will disseminate information and enhance the visibility of the work of the collaboration through mutually agreed upon vehicles including training activities, meetings, and symposia and journal publications. As specific topics for joint research are identified under this MOU, they will be conducted under the appropriate formal agreements.
- Joint participation and/or sponsorship of conferences, workshops, meetings, or seminars on areas of mutual interest.
- Joint training activities such as seminars, workshops, or short courses arising from complementary interests developed jointly by Rutgers and FDA and offered to FDA scientists and reviewers, Rutgers scientists, industry, and others as identified needs arise.
- Establishment and/or participation in public private partnerships with Rutgers, as an institution, serving as a neutral convener and/or intermediary to enable multi-stakeholder collaborations including government, industry, and academia.
IV. Participants
A wide range of faculty, graduate students and research staff from University Departments’ Schools of Engineering, Applied Sciences, Management, and Social Sciences. FDA participants from a variety of disciplinary fields would be potential participants. These individuals range from senior scientists and policy officials from the Commissioner's Office, as well as scientists and reviewers from the Product Centers and Offices of FDA. Other participants could include scientists and experts from industry, field laboratories, and other institutions identified for collaborative activities in the areas described above.
V. General Provisions
- 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.
- Institutions within Rutgers University and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- 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.
- 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. The Rutgers individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
VI. Resource Obligations
This MOU represents the broad outline of the FDA and Rutgers intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. 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.
VII. Liaison Officers
George Hamilton, Ph.D.
Professor and Chair
Rutgers, Department of Entomology
The State University of New Jersey
93 Lipman Drive
New Brunswick, NJ 08901
Hamilton@njaes.rutgers.edu
John Leazer, Ph.D.
Director, Northeast Food and Feed Laboratory
Food and Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
Phone: (718) 340-7093
John.Leazer@fda.hhs.gov
Each Party may designate new contacts at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party will name a new liaison within two (2) weeks and notify the other Party through the designated administrative liaison.
VIII. Period of Agreement
This MOU shall become effective upon the signature of all the Parties and will continue in effect for five (5) years. It may be extended by mutual written agreement of the Parties inwriting. It may be modified by mutual consent or terminated by either Party upon a 60-dayadvancenotice to the other party.
IX. Statutes, Regulations
This MOU and all associated agreements will be subject to all applicable federal and state laws and regulations.
APPROVED AND ACCEPTED FOR
RUTGERS UNIVERSITY
--/S/--
George Hamilton, Ph.D.
Professor and Chair
Entomology Department
Rutgers University
The State University of NJ
APPROVED AND ACCEPTED FOR
THE FOOD AND DRUG ADMINISTRATION
--/S/--
John Leazer, Ph.D.
Director, Northeast Food and Feed Laboratory
Food and Drug Administration
Date: April 14, 2021
MOU 225-16-014 Amendment Number 1
This is Amendment Number One (1) to the Memorandum of Understanding (MOU) 225-16-014 between the U.S. Department of Health and Human Services, Food and Drug Administration and Rutgers University, The State University of New Jersey (each a “party”, and together, the “parties”).
The purpose of this Amendment One is to extend the expiration date from January 26, 2021 to January 26, 2026. Execution of this amendment provides continuity to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information of mutual concern between the Parties. All other content, terms, and conditions stated in MOU Number: 225-16-014, made effective on January 26, 2016, will remain unchanged.
This Amendment One (1), when accepted by the undersigned, will be effective on the date of the last signature.
APPROVED AND ACCEPTED FOR
RUTGERS UNIVERSITY
--/S/--
George Hamilton, Ph.D.
Professor and Chair
Entomology Department
Rutgers University
The State University of NJ
APPROVED AND ACCEPTED FOR
THE FOOD AND DRUG ADMINISTRATION
--/S/--
John Leazer, Ph.D.
Director, Northeast Food and Feed Laboratory
Food and Drug Administration
Date: April 14, 2021