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  1. FDA Memoranda of Understanding

MOU 225-18-016

MOU 225-18-016

Memorandum of Understanding Between
The U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Chief Scientist, Office of Minority Health
The State University of New York at Buffalo

I.  Purpose

The United States Food and Drug Administration (FDA) and the State University of New York at Buffalo share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research. This Memorandum of Understanding (MOU) establishes the framework 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,promotes and protects the public health by ensuring the safety, efficacy, and security of drugs,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, 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 State University of New York at Buffalo will greatly contribute to FDA's mission.

The State University of New York at Buffalo is a public research university with campuses in Buffalo and Amherst, New York, United States. As of 2017, the university enrolls 30,648 students in 13 colleges. Among other schools, the university houses the largest state-operated medical school in the state of New York, a dental school,  and pharmacy school.

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and State University of New York at Buffalo. The types of initiatives expected to develop from this MOU include, but are not necessarily limited to, the following:

1. Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from State University of New York at Buffalo in the joint fellowship program at the FDA is through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may also be covered under ORISE. If prospective fellows or faculty members enter the program through the ORISE mechanism, FDA and State University of New York at Buffalo intend to adhere to the ORISE fellowship rules and regulations. Fellows or faculty members entering the program should be prepared to adhere to the term of appointment, which will be outlined in an offer of appointment letter.
2. Opportunities to convene joint meetings for education and research;
3. Research collaboration;
4. Cooperative international initiatives; and
5. Access to unique facilities, patient populations and equipment for scientific endeavors.

Under this MOU, FDA and State University of New York at Buffalo intend to 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 Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource-sharing. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.

IV. General Provisions: The Participants intend that:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. State University of New York at Buffalo and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary and/or nonpublic information may not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality and disclosure arrangements, or except to the extent that such disclosure is permitted by U.S. federal law without such arrangements.
4. Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities.  Either Participant may restrict or limit access to its property and facilities at any time and for any reason.  The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
5. It is recognized that from time to time, FDA and the State University of New York at Buffalo may share expenses and may request compensation to one Participant by the other. The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal requirements.

V.  Resource Obligations:

This MOU represents the broad outline of the intent of FDA and State University of New York at Buffalo to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Participant.  All activities that may be undertaken under this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU.

VI.  Liaison Officers:

A. For the State University of New York at Buffalo

Eric Streeter
Senior Academic Advisor, College of Arts and Sciences
275 Park Hall, University of Buffalo
Buffalo, New York 14260-4100

B. For the U.S. Food and Drug Administration

Katherine Bravo
Public Health Advisor
10903 New Hampshire Ave.
Silver Spring, MD 20993

Each Participant may designate new liaisons at any time by notifying the other Participant'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 Participant previously represented by that individual should name a new liaison within two (2) weeks and notify the other Participant through the designated administrative liaison.

VII.  Term, Termination, and Modification:

This MOU, when accepted by both Participants will be effective for five years upon the date of the last signature. It may be modified or terminated by mutual written consent of the Participants or may be terminated by either Participant upon 60-day written notice to the other.

VIII.  Statutes, Regulations, Rules, and Policies

This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within State University of New York at Buffalo operate.

Approved and Accepted for the State University Of New York at Buffalo

Erick Streeter
May 14, 2018

Approved and Accepted for the Food and Drug Administration

Richardae T. Araojo
Assistant Commissioner for Minority Health
May 14, 2018