MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
Center for Food Safety and Applied Nutrition
THE FACULTY OF MATHEMATICS, INFORMATICS, AND NATURAL SCIENCES (MIN),
THE HAMBURG SCHOOL OF FOOD SCIENCE,
UNIVERSITÄT HAMBURG, GERMANY
The United States Food and Drug Administration (FDA) and the Hamburg School of Food Science at Universität Hamburg, Germany (HSFS-UHH) (collectively, the Participants), share interests in promoting scientific progress through exchange of scientific capital by collaborating in areas of common interest and developing a common approach to analytical methods in support of food safety in relation to the protection of public health and international trade. Both institutions foresee benefits in the mutual exchange of training and research expertise in food safety and analytical methods development. 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 education and research.
It is anticipated that through the joint efforts of FDA and Universität Hamburg, new approaches can be identified and developed in the areas of analytical quality assurance and food safety, to the mutual benefit of both organizations and towards the achievement of their objectives. This more formal relationship between the Participants would promote the regular exchange of scientists, training, technology transfer and exchange of scientific literature.
II. Background and Authority
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA directs its activities toward, among other things, promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. 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 communication with stakeholders about complex scientific public health issues. Increased development of research, education, and outreach partnerships with the Hamburg School of Food Science, Universität Hamburg, Germany will greatly contribute to FDA’s mission.
Universität Hamburg, Germany, is Northern Germany’s largest and most diverse center of research and Germany’s fourth-largest university. The Faculty of Mathematics, Informatics, and Natural Sciences (MIN) is by far the biggest Faculty at Universität Hamburg. The HSFS-UHH is part of this Faculty. The central aim of the HSFS-UHH is the creation of an internationally competitive and visible platform for the enhancement of knowledge in the areas of food chemistry and related topics including food safety, nutrition, and health.
Since July 2011, the HSFS-UHH has coordinated the food science activities of Universität Hamburg. The work of HSFS-UHH covers a wide range of topics in research and teaching of food chemistry, biotechnology, microbiology, and packaging technology. It’s inclusion of the economic aspects of these topics allows a comprehensive view of food safety along the entire chain of production and marketing (“from farm to fork”).
III. Substance of Understanding
This MOU is intended to form the basis for development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and Universität Hamburg. The types of initiatives expected to develop from this MOU include:
1. Advancing student and postdoctoral education;
2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
3. Opportunities to convene joint meetings for education and research;
4. Research collaborations and exchange of technical staff for training;
5. Cooperative international initiatives;
6. Access to unique facilities and equipment for scientific endeavors;
7. Information exchange on priorities for future methods development;
8. Exchange of analytical protocols; and
9. Annual review of analytical methods at the senior staff level.
Under this MOU, FDA and Universität Hamburg intend to seek opportunities to participate together in collaborative research and training as permitted under appropriate statutory authorities. Before any specific collaboration is initiated or implemented, the Participants intend to identify priorities and topics of mutual interest, and develop separate, written arrangements for collaboration and sharing of resources. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU. The Participants have the option of entering into a contract, grant, or cooperative agreement to the extent authorized by the law of each Participant’s country and available appropriations. The Participants intend that the terms and conditions of any such arrangements will be in accordance with applicable law and regulations, and will be negotiated and executed by appropriate representatives of institutions within Universität Hamburg and FDA.
IV. General Provisions:
The Participants intend that:
1. Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current patent regulations and any other applicable statutes and regulations.
2. Institutions within Universität Hamburg and FDA will be able to decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. This MOU does not authorize the sharing of non-public information. Proprietary and/or nonpublic information will not be shared under this MOU, unless such disclosure is covered by appropriate confidentiality arrangements and only to the extent that the sharing Participant’s law permits such disclosure. FDA’s ability to share non-public information is governed by its disclosure regulations (21 CFR Part 20), restrictions under the Federal Food, Drug, and Cosmetic Act (e.g., 21 U.S.C. 331(j)), and other laws, including the Trade Secrets Act (18 U.S.C. 1905), the Privacy Act (5 U.S.C. 552a), and the Freedom of Information Act (5 U.S.C. 552).
4. Each Participant will comply with the other Participant’s security procedures and policies regarding access to and use of facilities. A Participant can either restrict or limit access to its property and facilities at any time and for any reason. Individuals participating in activities under this MOU on FDA property will comply with all applicable statutes and regulations.
5. It is recognized that from time to time FDA and institutions within Universität Hamburg may share expenses and may require compensation of one Participant by the other. It is intended that, as projects are developed, details of how costs are to be shared will be agreed to in advance under contractual or other mechanisms, as appropriate and in compliance with all applicable legal requirements.
6. Appropriate employees of a Participant will be free of conflicts of interest prior to entering into activities under this MOU. As required by the law or policies to which a Participant is subject, an individual will sign a Conflict of Interest Clearance agreement, pursuant to the Ethics in Government Act of 1978 and applicable laws of Germany, and the individual may be asked to file a financial disclosure report. The individual will be advised on any potential conflict so that a conflicting assignment can be avoided consistent with the U.S. Department of Health and Human Services/FDA requirements and the Universität Hamburg. If, at any time prior to or during the performance of activities under the MOU, an individual believes that a potential or actual conflict exists, the individual will notify the appropriate authorities within his/her institution and contact the designated FDA or Universität Hamburg official listed on the MOU so that the necessary actions can be undertaken. A determination will be made by FDA and the Universität Hamburg as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. Participants to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and Universität Hamburg’s intent to collaborate in areas of mutual interest. It is not intended to create obligations under international or other law. All activities that may be undertaken under this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future arrangements between the Participants and does not affect the ability of the Participants to enter other arrangements related to this MOU.
VI. Liaison Officers:
A. For the Universität Hamburg
Individual’s name: Prof. Dr. Markus Fischer
Organization: Universität Hamburg, Hamburg School of Food Science
Address: Grindelallee 117, D-20146 Hamburg, Germany
Telephone Number: 0049-40-428384359
B. For the Food and Drug Administration
Individual’s name: Eric Brown, Ph.D.
Organization: FDA/Center for Food Safety and Applied Nutrition
Title: Division of Microbiology
Address: 5100 Paint Branch Parkway, College Park, MD 20740
Telephone Number: 240-402-2020
Each Participant can designate a new liaison at any time by notifying the other Participant’s administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, that Participant will name a new liaison within two weeks and notify the other Participant through its designated administrative liaison.
VII. Term, Termination, and Modification:
The Participants intend that this MOU become effective when accepted by both Participants. It can be modified or terminated by mutual written consent by the Participants or can be terminated by either Participant(s) upon a 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and associated arrangements, if any, will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within Universität Hamburg operate.
APPROVED AND ACCEPTED FOR
Prof. Dr. Markus Fischer
Hamburg School of Food Science
August 26, 2013
APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG ADMINISTRATION
FOOD AND DRUG ADMINISTRATION
Michael M. Landa, J.D.
Center for Food Safety and Applied Nutrition
September 5, 2013
Prof. Dr. Heinrich Graener
Dean of the Faculty of Mathematics, Informatics and Natural Sciences
August 15, 2013