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  1. FDA Memoranda of Understanding

MOU 225-18-001

MOU 225-18-001

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION (FDA)
Center of Drug Evaluation and Research Office of Translational Sciences
AND
Vanderbilt University Medical Center (VUMC)

I. Purpose

The United States Food and Drug Administration (FDA) and Vanderbilt University Medical Center (VUMC) (the Parties) share interests in promoting scientific progress through exchange of scientific capital in the areas of public health and regulatory research. Both institutions foresee benefits from the mutual exchange of training and research expertise that will enhance the regulatory review and post-marketing surveillance processes at the FDA. 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.

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 the VUMC will greatly contribute to FDA's mission.

VUMC is one of the world's most important centers of research and at the same time is a distinctive and distinguished site of learning for undergraduates and graduate students in many fields, including medical research. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.

III. Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and VUMC. The types of initiatives expected to develop from this MOU include:

1. Advancing student education and matriculation into the statistics and biomedical science professions.

2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;

3. Opportunities to convene joint meetings for education and research;

4. Research collaborations;

5. Cooperative international initiatives; and

6. Access to unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and VUMC 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 may enter into a contract, grant or cooperative agreement with VUMC 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 VUMC and FDA.

IV. General Provisions:

1. Rights to any inventions 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.

2. Institutions within VUMC 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 governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.

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.  VUMC individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

5. It is recognized that from time to time FDA and institutions within VUMC will 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 VUMC'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 Vanderbilt University Medical Center (VUMC):

Individual's name: Amie Stephens
Organization: Institute for Medicine and Public Health Title: Associate Director for Research Management
Address: 2525 West End Ave, Suite 100 Nashville, TN 37203
Telephone Number: 615.875.2654
 
B. For the Food and Drug Administration:

Individual's name: Scott N. Goldie, Ph.D.
Organization: Center of Drug Evaluation and Research
Office of Translational Sciences
Title: Special Assistant for the Office of Biostatistics Address: 10903 New Hampshire Avenue,
Building 21 Room 3577, Silver Spring, MD 20993

Telephone Number: V: 301.796.2055 F: 301.796.9747

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 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. This agreement may be modified or terminated by mutual written consent by 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, Vanderbilt University Medical Center (VUMC), and the institutions within Vanderbilt University Medical Center (VUMC) operate.

APPROVED AND ACCEPTED FOR
Vanderbilt University Medical Center (VUMC)

/S/
By Libby D. Salberg
Title: Director, Office of Contracts Management
Date: 10/26/2017

APPROVED AND ACCEPTED FOR
Food and Drug Administration

/S/
By: Janet Woodcock, M.D.
Title: Director, CDER
Date: 10/30/2017

 

Recommended by: Frank Harrell