MOU 225-25-011
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES
OFFICE OF CLINICAL PHARMACOLOGY
AND
THE COLLEGE OF MEDICINE AND PUBLIC HEALTH OF FLINDERS UNIVERSITY
ADELAIDE, SA
I. Purpose
The United States Food and Drug Administration (FDA) and The College of Medicine and Public Health of Flinders University share interests in promoting scientific progress through knowledge exchange of scientific capital in Clinical Pharmacology and translational research with a view to optimizing drug dosing and safety, focusing on public health. This Memorandum of Understanding (MOU) establishes the framework for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and research.
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, promotes and protects 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 communicate with stakeholders about complex scientific and public health issues. Increased development of research and outreach partnerships with The College of Medicine and Public Health at Flinders University will significantly contribute to FDA's mission.
The College of Medicine and Public Health at Flinders University is a leading institution known for its innovative medical education, research, and healthcare services. It offers diverse programs across medicine and public health, combining clinical, population, and laboratory-based research. Research in Clinical Pharmacology broadly focuses on drug action, efficacy and safety. This includes factors (e.g., drug-drug interactions, disease states, pharmacogenetics/genomics) that alter the activities drug metabolizing enzymes and transporters, and how this influences drug exposure and response.
III. Substance of Agreement
This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and The College of Medicine and Public Health at Flinders University. As permitted by applicable laws and regulations the types of initiatives expected to develop from this MOU include:
a. Research collaborations.
b. Cooperative international initiatives.
c. Agreements to allow access to facilities and equipment for scientific endeavors.
d. Jointly authored scientific publications.
e. Opportunities to convene joint meetings for education and research including possible presentations at conferences and meetings.
f. Opportunities for advancing education and matriculation into the health and biomedical science professions may also be available. One of the mechanisms is for students/post-doctoral trainees/residents from The College of Medicine and Public Health at Flinders University to apply for the joint fellowship program at the FDA is through the Center for Drug Evaluation and Research's (CDER's) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may also be covered under ORISE. The existence of this MOU does not ensure that students/post-doctoral trainees/residents from the College of Medicine and Public Health at Flinders University will be selected. If prospective fellows or faculty members are selected for the program through the ORISE mechanism, the Office of Clinical Pharmacology and the College of Medicine and Public Health at Flinders University acknowledges that there will be CDER ORISE fellowship rules and regulations, including significant ethics requirements as well as security/background requirements, that will apply in conjunction with any ORISE offer of appointment letter. This program requires applicants to meet applicable security requirements including the completion of a background check. Completion of the background check requires individuals to have resided in the United States for a minimum of 3 of the past 5 years. For more information about the CDER ORISE fellowship program visit: Information for Applicants | Research Participation Program at the U.S. Food and Drug Administration.
Under this MOU, FDA and The College of Medicine and Public Health at Flinders University intend to seek opportunities to participate together in collaborative research and training, as permitted under appropriate statutory authority. 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 resource-sharing. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.
IV. General Provisions
The Participants intend that:
- Rights to any inventions resulting from collaborative research be determined by the separate written research arrangements governing the effort, based on current U.S. - Australian patent regulations and any other applicable statutes and regulations. For the avoidance of doubt, no intellectual property will be generated under this MOU and any background intellectual property shall remain the property of the party introducing the same.
- The College of Medicine and Public Health at Flinders University and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights and will be subject to negotiation and mutual agreement by the Participants.
- The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7 (c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5USC 552(v)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements.
- Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities. Either Participant may restrict or limit access to its property and facilities at any time and for any reason. The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
- It is recognized that from time-to-time FDA and The College of Medicine and Public Health at Flinders University may share expenses. The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. Federal and College of Medicine and Public Health at Flinders University requirements.
V. Resource Obligations
This MOU represents the broad outline of the intent of FDA and The College of Medicine and Public Health at Flinders University to collaborate in areas of mutual interest. This MOU is not legally binding, and it does not create binding, enforceable obligations against any Participant. 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 agreements or arrangements among the Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU.
VI. Liaison Officers
A. For the College of Medicine and Public Health at Flinders University
Professor John Miners, Ph.D., D.Sc.
Matthew Flinders Distinguished Emeritus Professor
Flinders University College of Medicine and Public Health
Discipline of Clinical Pharmacology
Flinders Medical Centre
Bedford Park
SA 5042, Australia
Email address: john.miners@flinders.edu.au
B. For the U.S. Food and Drug Administration:
Shiew-Mei Huang, Ph.D., Deputy Director
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: 301-796-1541 I Fax: 301-847-8720
Shiewmei.Huang@fda.hhs.gov
Each Participant may designate new liaisons 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, the Participant previously represented by that individual intends to name a new liaison within two weeks and notify the other Participant through the designated administrative liaison.
VII. Term, Termination, and Modification
This MOU, when accepted by both Participants, will be effective for three years starting on the date of the last signature. It may be modified or terminated by mutual written consent of the Participants or may be terminated by either Participant upon 60 days' written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within and The College of Medicine and Public Health of Flinders University operate.
APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION
/s/
By Dr. George Tidmarsh,
Director, Center for Drug Evaluation and Research (CDER)
Date: 09/24/2025
APPROVED AND ACCEPTED FOR THE COLLEGE OF MEDICINE AND PUBLIC HEALTH OF FLINDERS UNIVERSITY
/s/
By Simon Brennan
Chief Research Development Officer Flinders University
Email: simon.brennan@flinders.edu.au
Date: 09/30/2025