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  1. FDA Memoranda of Understanding

MOU 225 -17-027

MOU 225 -17-027

Memorandum of Understanding Between the American College of Toxicology
and
The U.S. Food and Drug Administration, Department of Health and Human Services

I. PURPOSE

The United States Food and Drug Administration (FDA) and the American College of Toxicology (ACT) share interests in promoting scientific progress through exchange of scientific capital in the disciplines that directly and indirectly affect human and animal health and medicine. Both institutions foresee benefits from the mutual exchange of training and research expertise in the areas of innovative toxicity testing, regulatory science, education and training. 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. Throughout this document, FDA and ACT are referred to individually as a "Party" and collectively as the "Parties."

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, the FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. To accomplish its mission, the 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 ACT will greatly contribute to FDA's mission.

ACT is dedicated to providing an interactive forum for the advancement and exchange of scientific information in toxicology. ACT's mission is to educate, lead, and serve professionals in toxicology and related disciplines by promoting the exchange of information and perspectives on applied toxicology and safety assessment. The College provides educational opportunities through courses and symposia at its annual scientific meeting, as well as introductory and advanced courses and webinars held throughout the year.

III. SUBSTANCE OF THE AGREEMENT

FDA and ACT both agree to work collaboratively to promote best practices associated with regulatory science and toxicology. This will be accomplished by:

1. Collaborating on training that addresses emerging issues in toxicology including new methods and their qualification and alternatives to animal testing.
2. Facilitating dialogue between FDA scientists, academics, and industries on emerging issues and technologies.
3. Recommending, supporting and publicizing seminars, workshops, training and other activities to engage agency toxicologists in discussions of emerging issues in toxicology.
4. Supporting development of outreach and workshops to provide external stakeholders with FDA's perspectives on emerging issues in the field of toxicology.
5. Promoting professional development opportunities to advance education and research in regulatory toxicology.

Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information, except as required by law, and that they shall protect such information in accordance with the provisions of 21 U.S.C. 3310), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and the disclosure is permitted by applicable law.

IV. GENERAL PROVISIONS

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, and will comply with current U.S. Government patent regulations and any other applicable statutes and regulations.
2. Institutions within ACT and FDA may 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.  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.
4. 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. ACT individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. Under this MOU, joint efforts will be undertaken to support 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 supplemental agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate this MOU by reference. The terms and conditions of any such agreements will comply with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of ACT and FDA.

V.  RESOURCESOBLIGATIONS

This MOU represents the broad outline of the FDA and ACT'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 American College of Toxicology
Anthony Kiorpes, PhD, DVM, DABT, President
American College of Toxicology
11190 Sunrise Valley Drive, Suite 300
Reston, VA 20191
703-547-0875

B. For the Food and Drug Administration
RADM Denise Hinton
Food and Drug Administration
FDA Acting Chief Scientist
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-4880

Each Party may designate new liaisons by notifying the other Party’s administrative liaison in writing.  If, at any time, an individual as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

VII.  TERM, TERMINATION, AND MODIFICATION

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature and will continue in effect for 5 years and may be modified or terminated by mutual written consent the partners or may be terminated by either Partner(s) upon a 90-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, ACT and the institutions within ACT operate.

APPROVED AND ACCEPTED FOR
THE AMERICAN COLLEGE OF TOXICOLOGY

/s/
Anthony Kiorpes, ACT President
February 26, 2018

APPROVED AND ACCEPTED FOR
THE FOOD AND DRUG ADMINISTRATION

/s/
RADM Denise Hinton
Acting Chief Scientist, FDA

April 11, 2018