MEMORANDUM OF UNDERSTANDING
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
U.S. ARMY NATICK SOLDIER RESEARCH, DEVELOPMENT AND ENGINEERING CENTER
The United States Food and Drug Administration (FDA) and the Natick Soldier Research, Development and Engineering Center (NSRDEC) share interests in promoting scientific progress in food safety through exchange of scientific capital in training and research. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through information sharing in research, training, sabbaticals, postdoctoral fellowships, and student internships.
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 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 NSRDEC will contribute to FDA’s mission. NSRDEC has the dedicated mission to conduct research and development in order to maximize the survivability, sustainability, mobility, combat effectiveness and field quality of life of the Warfighter. The DOD Combat Feeding Directorate (CFD) is engaged in the research and engineering of all combat rations, field feeding equipment and combat feeding systems which support the unique feeding requirements of each military service. CFD efforts also protect Warfighter health through food safety and defense technology development in agent identification and detection, food safety risk analysis, and pathogen reduction.In part, the goals of the FDA and NSRDEC collaboration will focus on improved detection technologies sampling methodologies, and assay development and validation to meet current food safety needs. The common goal is to develop rapid, lightweight detection technologies and sampling strategies to detect pathogens in food. The collaborative effort will provide science-based information and methods for understanding the integration of nanomaterials and conductive polymer deposition processes as related to membrane sensor development. Initial research under the MOU will demonstrate the feasibility of using ultra small highly sensitive conductive polymer coated high surface area membranes for pathogen detection.
III. Substance of Agreement.
This MOU forms the basis for development of scientific collaborations and intellectual partnerships between FDA and the NSRDEC. The types of initiatives expected to develop from this MOU include:
- Opportunities to convene joint meetings for education and research;
- Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from NSRDEC into the joint fellowship program at the FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the FDA and NSRDEC will adhere to the ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the terms of appointment which will be outlined in an offer of appointment letter.
- Research collaborations;
- Cooperative international initiatives; and
- Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to support 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 collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within NSRDEC and FDA.
IV. General Provisions.
- 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.
- Institutions within the NSRDEC and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) with one or more non-Federal parties specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- 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.
- 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 anytime and for any reason. The NSRDEC individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations.
This MOU represents the broad outline of FDA and NSRDEC’s intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and NSRDEC.All activities undertaken pursuant to the 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 Partners. This MOU does not create binding, enforceable obligations against any Party.
VI. Agency Liaisons.
Patrick M. Regan Ph.D.
FDA Microbiology Supervisor
Winchester Engineering and Analytical Center
109 Holton St.
Winchester, MA 01890
W (781) 756-9707
C (339) 293-3460
Andre Senecal, Ph.D.
Advisor, Food Safety & Defense
Combat Feeding Directorate
Natick Soldier Research, Development and Engineering Center
15 Kansas St.
Natick, MA 01760
Each Party may designate new liaisons at any time by notifying the other Party's liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party previously represented by that individual will name a new liaison and notify the other Party within 2 weeks.
VII. Term, Termination, and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5)years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 60-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 and the NSRDEC operate.
Signed by:John P. Obusek, Sc.D. Director, Natick Soldier Research, Development and Engineering Center Date:04/12/2012 Signed by:Brian L. Baker P.E. Director, Winchester Engineering and Analytical Center Date:04/12/2012
APPROVED AND ACCEPTED FOR THE NATICK SOLDIER RESEARCH, DEVELOPMENT AND ENGINEERING CENTER
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Signed by:John P. Obusek, Sc.D. Director, Natick Soldier Research, Development and Engineering Center
Signed by:Brian L. Baker P.E. Director, Winchester Engineering and Analytical Center