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  1. FDA Memoranda of Understanding

MOU 225-15-002

MOU 225-15-002


Memorandum of Understanding
Between the United States Food and
Drug Administration and University
of Massachusetts Amherst

I.      Purpose
The United States Food and Drug Administration (FDA) and the University of Massachusetts Amherst (UMA), through its UMass Innovation Institute, share interests in promoting scientific progress through exchange of scientific capital in training and research and foresee benefits from the mutual exchange of training and research expertise. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through information sharing in regulatory science research, training, sabbaticals, postdoctoral fellowships, and student internships.
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. FDA also has a primary role in advancing the translational/applied science that is needed to move promising new technologies into actual manufactured products in the most efficient manner possible while assuring the clinical safety and effectiveness of such products for patient care. 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 UMA will contribute to FDA’s mission. UMA has a longstanding history of interconnected education and research activities that involve collaborations among faculty and researchers in engineering, physical sciences, biological sciences, computational sciences, and social sciences, as well as with scientists/clinicians from academic medical centers and life science companies in the global biopharmaceutical and medical device industries. UMA research activities address a broad range of issues of crucial importance to the FDA in its efforts to advance regulatory science for positive public health impact. This includes UMA’s global stature in areas directly aligned to the FDA mission including food and health.


III.        Substance of Agreement
This MOU is intended as a broad vehicle to promote programmatic interaction in the form of joint collaboration between FDA and UMA researchers, students, and personnel as well as joint development of relevant scientific research projects. In addition, this MOU establishes the framework for collaborative graduate education to be completed concurrently at UMA and FDA facilities.
Under this MOU, FDA and UMA 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 and topics of mutual interest, and develop separate, written agreements for each collaboration that will outline each Party’s financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU. These agreements may include contracts, grants, or cooperative research and development agreements (“CRADAs”) between FDA and UMA to the extent authorized by law and available appropriations. The terms and conditions of any agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the UMA and FDA.
The initial area will be in the area of food microbiology safety and health, including but not limited to, microbiological surveillance, genome and microbial ecological sequencing and bioinformatics analyses, development and validation of biosensors, and general microbiology of food and associated pathogens. Activities in this area may focus on identifying and characterizing risks in the food supply and potential solutions. Collaboration in any of these, or additional identified areas of mutual interest, may take
a variety of forms, such as:
-- Joint training in educational programs. This includes, but is not limited to graduate training to be conducted under the auspice of UMA programs and internships at FDA facilities.
-- Joint research programs formed by scientists from the respective institutions.
This research may be based on collaborative analysis of data from FDA files and the literature, or experimental work. The partners will disseminate information and enhance the visibility of the work of the collaboration through mutually agreed upon vehicles including training activities, meetings, and symposia and journal publications. As specific topics for joint research are identified under this MOU, they will be conducted under the appropriate formal agreements as required by law.
-- Joint participation and/or sponsorship of conferences, workshops, meetings, or seminars on areas of mutual interest.

-- Joint training activities such as seminars, workshops, or short courses arising from complementary interests developed jointly by UMA and FDA and offered to FDA scientists and   
reviewers, UMA scientists, industry, and others as identified needs arise
-- Establishment and/or participation in public private partnerships with UMA, as an institution, serving as a neutral convener and/or intermediary to enable multi-stakeholder collaborations including government, industry, and academia. Examples of such existing public-private partnerships at UMA include the Dept. of Food Science Strategic Research Alliance (SRA), the Institute for Applied Life Sciences (IALS), Center for Bioactive Delivery (CBD), Personal Health Monitoring (PHM), Models to Medicine (M2M), UMass Innovation Institute (UMII).
IV.        Participants
A wide range of faculty, graduate students, and research staff from the Schools of Engineering, Science, Management, and Social Sciences, from a variety of disciplinary fields, would be potential participants from UMA. Senior scientists and policy officials from the Commissioner’s Office, and scientists and reviewers from the Product Centers and Offices of FDA would be participants from the FDA. Other participants could include scientists and experts from industry, field laboratories, and other institutions identified for collaborative activities in the areas described above.
V.         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 the UMA 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. The UMA individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.


agreements as appropriate and in compliance with all applicable federal requirements.
VI.        Resource Obligations
This MOU represents the broad outline of the FDA and UMA intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by 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 Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.
VII.       Liaison Officers
James D. Capistran
Executive Director
UMass Innovation Institute
715 North Pleasant St. Amherst, MA 01003
Phone (413) 577-1518 capistran@umass.edu
Brian L. Baker, P.E. WEAC Center Director
U.S. Food and Drug Administration
109 Holton Street
Winchester, MA 01890
Phone (781) 756-9701
Fax (781) 756-9757
Each Party may designate new contacts 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 Party will name a new liaison within two (2) weeks and notify the other Party through the designated administrative liaison.
VIII.      Period of Agreement
This MOU shall become effective upon the signature of all the Parties and will continue in effect for five (5) years. It may be extended by mutual written agreement of the


Parties in writing. It may be modified by mutual consent or terminated by either Party upon a 60-day advance notice to the other Party.
IX.        Statutes, Regulations
This MOU and all associated agreements will be subject to all applicable federal and state laws and regulations.
James D. Capistran
Executive Director
UMass Innovation Institute
September 2, 2014


Brian L. Baker, P.E. WEAC Center Director
U.S. Food and Drug Administration




September 2, 2014