Memorandum Of Understanding
Between the Society of Toxicology and the
U.S. Department of Health and Human Services,
Food and Drug Administration

This Memorandum of Understanding (MOU) is made and entered into as of the [date of last signature] by and between the United States Food and Drug Administration (FDA) and the Society of Toxicology (“SOT”). FDA and SOT are referred to individually as a “Party” and collectively as “Parties.”

I.    PURPOSE

FDA and SOT share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine. The Parties endorse scientific training to foster a well-grounded foundation in interdisciplinary fields in which professional societies and government share mutual interest. This MOU establishes the terms for collaboration to promote these shared interests.

II.    BACKGROUND

A. 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, the FDA directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, biologics, 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, 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 education and outreach initiatives with SOT will complement FDA's mission.

B. SOT is committed to creating a safer and healthier world by advancing the science of toxicology. The Society promotes knowledge in toxicology, aids in protecting public health, and facilitates the development of the discipline. SOT has a strong commitment to education in toxicology and recruiting students and new members into the profession.

C. FDA and SOT desire to enter into this MOU to continue its working relationship. This MOU is intended to leverage the Parties’ combined strengths, resources, and proximity for stimulating innovation in toxicity testing, regulatory science, ethics, education, and training. The framework for this agreement is based on the scope of FDA's mission and the broad representation of the practice of toxicology from academic institutions, government, and industry in the United States and abroad.

III.    SUBSTANCE OF THE AGREEMENT

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

A. Collaborating on training that addresses new methods in toxicology and their qualification, as well as alternatives to animal testing.
B. Facilitating dialogue between FDA scientists, academics, and industries on emerging technologies.
C. Recommending, supporting, and publicizing seminars, workshops, training, and other activities to engage agency toxicologists in discussions of new toxicology methods and initiatives.
D. Creating, coordinating, and supporting workgroups on cardiac, renal, hepatic, nervous system, and other specific toxic endpoints to help define more predicative animal and non-animal models.
E. Supporting development of outreach and workshops regarding science-based approaches to qualified new methods to enable development for regulatory use.
F. Promoting professional development opportunities to advance education and research in regulatory toxicology.

IV.    GENERAL PROVISIONS

The Parties agree that:

A. Proprietary and/or non-public information will not be disclosed under this MOU unless such disclosure is governed by separate confidentiality disclosure agreements and to the extent that such disclosure is permitted by U.S. federal law.

B. Rights to any inventions resulting from collaborative research will be determined by separate written research arrangements governing the effort, based on U.S. government patent regulations and any other applicable statutes and regulations.

C. FDA and SOT may enter into cooperative research and development agreements (CRADAs) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights.

V.    CONTACTS/LIAISONS

Society of Toxicology

Myrtle Davis, DVM, PhD, ATS President
Society of Toxicology
11190 Sunrise Valley Drive, Suite 300
Reston, VA 20191
703.438.3115

Food and Drug Administration
 
Chad P. Nelson, Ph.D., M.S.P.H.
Senior Science Advisor (Toxicologist)
Office of the Chief Scientist
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
301.796.4643

Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing.

VI.    PERIOD OF AGREEMENT; TERMINATION

A. This agreement becomes effective upon acceptance by both parties and will continue in effect for five (5) years and may be modified upon mutual agreement of the parties in writing.
B. Either Party may terminate the MOU upon sixty (60) days written notice to the other Party.

VII.    RESOURCE OBLIGATIONS

This MOU represents the broad outline of the Parties' present intent to collaborate in areas of mutual interest, 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 into other agreements or arrangements related to this MOU.

VIII.    REGULATIONS

This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the FDA and SOT operate.

IX.    SIGNATURES OF RESPONSIBLE PARTIES

Approved and Accepted
for The Society of Toxicology

/s/
Myrtle Davis, DVM, PhD, ATS
Date: 03/11/2022
 

Approved and Accepted
for the Food and Drug Administration

/s/
Jacqueline A. O'Shaughnessy, Ph.D. Acting Chief Scientist, FDA
Date: 07/29/2022