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  1. FDA Memoranda of Understanding

MOU 225-16-027

MOU 225-16-027

MEMORANDUM OF UNDERSTANDING
BETWEEN THE SOCIETY OF TOXICOLOGY
AND THE U.S. FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

 
I. PURPOSE
 
The Food and Drug Administration (FDA) and the Society of Toxicology (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 document sets forth a framework for an alliance between the FDA and SOT.   It is intended to describe their combined strengths, resources, and proximity for stimulating innovation in toxicity testing, regulatory science, ethics, and 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.
 
II. BACKGROUND
 
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. 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.
 
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.
 
Ill. 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:
  1. Collaborating on training that addresses new methods in toxicology and their qualification, as well as alternatives to animal testing.
  2. Facilitating dialogue between FDA scientists, academics, and industries on emerging technologies.
  3. Recommending, supporting and publicizing seminars, workshops, training and other activities to engage agency toxicologists in discussions of new toxicology methods and initiatives.
  4. 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.
  5. Supporting development of outreach and workshops, and, potentially, a cross-cutting FDA guidance to provide external stakeholders with FDA's perspectives on science-based approaches to qualified new methods to enable development for regulatory use.
  6. 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 and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 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 permitted by applicable law.
 
IV. INTELLECTUAL PROPERTY GUIDELINES
 
"Invention" refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of the MOU. "Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of the MOU.  Rights to Inventions or Intellectual Property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the Parties. lnventorship will be governed by the policies of the employer of the Invention. In joint lnventorship, ownership of Inventions will be jointly owned. Inventions made under a Federal grant or contract will be subject to the Bayh-Dole Act. No Party, by their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party.
 
V. RESOURCES
 
This MOU represents the broad outline of the Parties' present intent to enter specific agreements for collaborative efforts in areas of mutual interest to the FDA, subject to available personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the FDA and the SOT operate.
 
VI. CONTACTS

A. For the Society of Toxicology: 
John Morris, PhD
Society of Toxicology Title: President
1821 Michael Faraday Drive, Suite 300
Reston, VA 20190
Telephone Number: 703- 438-3115
 
B. For the Food and Drug Administration:
Luciana Borio, MD
Acting Chief Scientist
10903 New Hampshire
Silver Spring, MD 20993
Telephone Number: 301 796-4880
 
Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing.
 
VII. PERIOD OF AGREEMENT
 
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.
 
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.
 
SIGNATURES OF REPONSIBLE PARTIES
 
APPROVED AND ACCEPTED FOR
THE SOCIETY OF TOXICOLOGY 
John Morris, PhD, President
December 5, 2016
 
APPROVED AND ACCEPTED FOR
THE FOOD AND DRUG ADMINISTRATION 
Luciana Borio, MD
Acting Chief Scientist 
December 5, 2016