MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
AND THE INDEPENDENT LABORATORIES INSTITUTE
The United States Food and Drug Administration (FDA) and The Independent Laboratories Institute (ILI) (the Parties) share interests in promoting scientific progress through exchange of scientific capital in analytical methods development and validation, as well as in educational initiatives. Both institutions foresee benefits from the mutual exchange of training and research expertise in food safety-related analytical sciences. 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 education and research.
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, medical devices and radiological products and the safety and security of foods, dietary supplements, 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, education and outreach partnerships within ILI will greatly contribute to FDA's mission.
ILI is a 501(c)(3) scientific educational organization that is multi-disciplined and member-driven. Established as a non-profit component of the American Council of Independent Laboratories (ACIL) in 1922 , ILI is organized to operate exclusively for educational, charitable, and research purposes. Their activities include, but are not limited to: conducting educational activities, such as seminars, conferences, and workshops, for the scientific/testing communities; developing and distributing educational materials, including research findings; and promoting, developing, and conducting research or review that is responsive to its member needs and concerns.
III. Substance of Agreement:
This MOU forms the basis for the development of scientific collaborations, outreach, educational initiatives, and intellectual partnerships between FDA and ILI. The types of initiatives expected to develop from this MOU include:
A. Opportunities to convene joint meetings/workshops for education and research, including training opportunities, and a forum for sharing information on analytical method needs;
B. Research cooperation/collaboration;
C. Collaboration on horizons canning, method development, and validation activities, and
D. Coordination/communication regarding new method implementation and expectations.
Under this MOU, FDA and ILI will 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 Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate, by reference, this MOU. FDA and ILI may enter into CRADAs or Research Collaboration Agreements, as mutually agreed upon by the Parties. Additionally, FDA may enter into a contract, grant, or cooperative agreement, with ILI to the extent authorized by law and available appropriations. The terms and conditions of any such awards wIll be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within FDA and ILI.
IV. General Provisions:
A. Rights to any inventions and intellectual property 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.
B. Institutions within FDA and ILI may decide to enter into Cooperative Research and Development Agreements (CRADA), Research Cooperative Agreements (RCA), or Material Transfer Agreements (MTA) specific to particular collaborative projects. The terms of such agreements will address intellectual property rights.
C. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by appropriate confidentiality disclosure agreements.
D. 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. ILI individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
E. It is recognized that from time to time FDA and ILI may 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.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and ILI's 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. Liaison Officers:
A. For the Independent Laboratories Institute:
Independent Laboratories Institute (ILI)
Chairman, Board of Directors, ILI
1875 I Street NW, Suite 500
Washington DC, 20006
B. For the Food and Drug Administration:
Palmer A. Orlandi, Jr., PhD
RADM, U.S. Public Health Service
Office of Foods and Veterinary Medicine
Chief Science Officer and Research Director
10903 New Hampshire Ave., WO 1, Rm 3202
Silver Spring, MD 20993
Each Party may designate new liaisons 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 Parties will name a new liaison within two (2) weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement will be effective when accepted by all participating partners and will continue in effect for five (5) years from the date of acceptance. This agreement may be modified or terminated by mutual written consent by the partners or may be terminated by either Partner(s) upon a 30 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, ILI, and the institutions within ILI operate.
APPROVED AND ACCEPTED FOR THE INDEPENDENT LABORATORIES INSTITUTE
Joe Konschnik, Chairman
Board of Directors
August 10, 2017
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Stephen Ostroff, M.D.
Deputy Commissioner Foods and Veterinary Medicine
August 10, 2017