MOU 225-17-022
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
HUMAN FOODS PROGRAM
AND
THE INDEPENDENT LABORATORIES INSTITUTE
I. Purpose
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.
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, 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 volunteer-driven. Established as a non-profit component of the American Council of Independent Laboratories (ACIL) in 1992, 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. Goals and Objectives
This MOU forms the basis for the development of scientific collaborations, outreach, educational initiatives, and intellectual partnerships between FDA and ILI. Objectives for this MOU include:
1. Provide opportunities to convene joint meetings/workshops for education and research, including training opportunities, and a forum for sharing information on analytical method needs;
2. Facilitate research cooperation/collaboration;
3. Promote collaboration on horizon scanning, method development, and validation activities and 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.
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. 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.
C. 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 with all applicable
D. This is an agreement between FDA and ILI and does not confer any rights or benefits to any person or Partners.
E. The Partners agree that this MOU is non-exclusive and nothing contained herein prevents either Partner from entering into similar agreements with any third party.
F. If any terms of this MOU are inconsistent with existing authorities or directives of either of the Partners entering this MOU, those portions of this MOU that are determined to be inconsistent shall be invalid; the remaining terms and conditions shall remain in full force and effect.
G. Nothing herein shall be construed to create any joint venture or similar relationship or to subject the Partners to any implied duties or obligations respecting the conduct of their affairs that are not expressly stated herein. Neither Partner shall have any right or authority to assume or create any obligation or responsibility, either expressed or implied, on behalf of or in the name of the other Partner, or to bind the other Partner in any matter whatsoever. Neither Partner shall be deemed to be an agent or principal of the other.
H. This MOU does not and is not intended to impose any legally binding requirements on the Partners. Each Partner will be responsible for its own acts and the results thereof and shall not be responsible for the acts of the other Partner and the results thereof.
V. Responsibilities
A. Develop and execute action plans to achieve the objectives of the MOU. B. Establish metrics to measure success of collaborations. C. Establish direct and consistent relationships at multiple organizational levels within Partners to document and share best practices. D. Serve as technical resources for each other. E. Notify the other Partner as soon as possible when issues of mutual concern become evident. F. Determine need for complementary and/or supplemental agreements and develop and execute, as necessary, to achieve the goals of this MOU. G. Institutions within FDA and ILI may decide to enter into Cooperative Research and Development Agreements (CRADAs), Research Cooperative Agreements (RCAs), or Material Transfer Agreements (MTAs) specific to particular collaborative projects. The terms of such agreements will address intellectual property rights. H. 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 policies.
VI. Information Sharing
a. The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including “confidential commercial or financial information” (21 C.F.R 20.61) or trade secret information (21 U.S.C. 360j(c)) obtained by or provided directly to FDA from a third party. Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements.
VII. Resource Obligations:
This MOU represents the broad outline of the FDA and ILl'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.
VIII. Liaison Officers:
a. For the Independent Laboratories Institute:
Individual's name: Richard Bright
Organization: Independent Laboratories Institute
Title: Chief Executive Officer
Address: 1300 I St NW, Ste 400E, Washington, DC 20005
Telephone No.: 202-887-5872
b. For the United States Food and Drug Administration:
Individual's name: Terri McConnell
Organization: Human Foods Program
Title: Director, Division of Science Program Coordination, Office of Regulatory Testing and Surveillance,
Office of Laboratory Operations and Applied Science
Address: 60 8th St NE, Atlanta, GA 30309
Telephone No.:404-253-1217
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.
IX. Term, Termination, and Modification:
This agreement will be effective on the date of the last signatory to the agreement 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 ninety (90) day advance written notice to the other. The Partners will review this agreement and goals annually. The Partners will make all reasonable attempts to meet, at a minimum annually, to discuss the current agreement, evaluate its usefulness, and make modifications, as needed. Any Partner on its initiative may submit a proposed amendment or modification in writing for review. Modifications and amendments will be tracked and documented throughout the duration of the agreement and will be reviewed at least annually during the annual review and maintained for historical purposes.
X. 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 wherein ILI operate.
APPROVED AND ACCEPTED FOR
INDEPENDENT LABORATORIES
INSTITUTE
By /s/
Richard Bright
Title: Chief Executive Officer, Independent Laboratories Institute
Date: 11/07/2024
APPROVED AND ACCEPTED FOR U.S.
FOOD AND DRUG ADMINISTRATION
By /s/
James J. Jones
Title: Deputy Commissioner for Human Foods
Date: 11/05/2024