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  1. FDA Memoranda of Understanding

MOU 225-16-014

MOU 225-16-014

MEMORANDUM OF UNDERSTANDING
BETWEEN THE UNITED STATES FOOD
AND DRUG ADMINISTRATION
AND RUTGERS UNIVERSITY

I.                 Purpose
 
The UnitedStates Food and Drug Administration (FDA) and the Universityof Rutgers, share interestsin promoting scientific progress through exchange of scientific capital in trainingand research and foresee benefits from the mutual exchange of trainingand research expertise. This Memorandumof Understanding (MOU) establishes the terms for collaborationto promotethese shared interests, which can be pursued through information sharing in regulatory science research, training, sabbaticals, postdoctoral, recruitment opportunities, 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. 301et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting he 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 he 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 accomplishits 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 Rutgers will contribute to FDA'smission. Rutgers  has a long standing 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. Rutgers 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 Rutgers 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 Rutgers 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 the Rutgers and FDA facilities.
 
Under this MOU, FDA and Rutgers 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 (via the Liaison Officers) shall identify priorities, specific topics of mutual interest, and develop separate, written agreements (“Supplemental 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 some or all of the terms of this MOU. The Supplemental Agreements may include contracts, grants or cooperative research and development agreements (“CRADA”) between FDA and Rutgers to the extent authorized by law and available appropriations. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Rutgers and FDA.
  • Joint training in educational programs. This includes, but is not limited to graduate training to be conducted  under the auspice of Rutgers programs and internships at FDA facilities.
  • Joint research programs fanned 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.
  • 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 Rutgers and FDA and offered o FDA scientists and reviewers, Rutgers scientists, industry, and others as identified needs arise.
  • Establishment and/or participation in public private partnerships with Rutgers, 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 Rutgers.
IV.        Participants
 
A wide range of faculty, graduate student and research staff from the Schools of Engineering, Science, Management, and Social Sciences,from a variety of disciplinary  fields, would be potential participants from 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 determinedby 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 Rutgers and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative project. The termsof such CRADAs will address Intellectual Property rights.
 
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure s governed by appropriate confidentiality disclosure agreements or to the extent, such disclosureis permitted by law.
 
4. Each Party will comply with the other Party's security procedures and policiesregarding accessto and use of facilities.Either Party may restrictor limit access to its property and facilitiesat any time and for any reason. The Rutgers individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
5. As research projects are developed, details will be agreed to in advance under other agreementsas appropriate and in compliance with all applicable federal requirements.
 
VI.         Resource Obligations
 
This MOU represents the broad outline of the FDA and Rutgers intentto 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
 
George Hamilton, PHD Professor and Chair Departmentof Entomology
Rutgers, The State University of New Jersey
93 LipmanDrive
New Brunswick, NJ 08901
 
KentHennann,
Acting Director, NRL
Food and Drug Administration
15815 Liberty Avenue
Jamaica NY 11433
Phone(718) 340 7085
 
PaulaDavy
Director, Chemistry Branch
Food and Drug Administration
158-15 Liberty Avenue
Jamaica NY 11433
Phone (718) 340-7042
 
NazmulHassan
Director, Chemistry Branch II
Food and Drug Administration
158-15 Liberty Avenue
Jamaica,NY 11433
Phone(718) 662-5707
 
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.
                                                                                       
APPROVED AND ACCEPTED FOR:
RUTGERS UNIVERSITY
 
George Hamilton, PhD
 Professor and Chair
Department of Entomology
Rutgers, The State University of New Jersey
 
January 26, 2016
 
Cassandra Burrows
Assistant Director
Research and Sponsored Programs
Rutgers, The State University of New Jersey
 
January 26, 2016
 
APPROVED AND ACCEPTED FOR
U.S. FOOD AND DRUG ADMINISTRATION
 
Kent Hermann
Acting Director NRL
Food and Drug Administration
 
October 26, 2015