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  1. FDA Memoranda of Understanding

MOU 225-14-023

MOU 225-14-023

MEMORANDUM OF UNDERSTANDING BETWEEN THE AMERICAN
INSTITUTE FOR MEDICAL AND BIOLOGICAL ENGINEERING
AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

 

I. Purpose
 
The United States Food and Drug Administration (“FDA”)’s Center for Devices and Radiological Health (“CDRH”) and the American Institute for Medical and Biological Engineering (“AIMBE”) share interests in promoting scientific progress, furthering public policy efforts, and translating innovation and discoveries into practice in the areas of medical and biological engineering. Both FDA and the AIMBE are referred to individually as a “Party” and collectively as the “Parties.” This Memorandum of Understanding (“MOU”) establishes the terms for collaboration to promote these shared interests, which may be pursued through a variety of programs including collaborative research, public outreach, extension activities, fellowship and internship opportunities, and disciplinary training.
 
II. Background
 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“the Act”) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. CDRH is responsible for assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. To accomplish its mission, FDA takes efforts to stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. 
 
AIMBE is an authoritative voice and advocate for the value of medical and biological engineering to society. It is an organization comprised of accomplished scientists, researchers, and academic, industrial, and clinical practice leaders in the fields of medical and biological engineering who are responsible for medical discovery and innovation. AIMBE works to advance greater translational research and innovation, promote inter-society relationships, as well as inspire the future leaders of the medical and biological engineering community.
 
III. Goals of Collaboration
 
FDA and the AIMBE share a mutual interest in exposing researchers and scientists to a policy environment, thereby expanding and enriching the field’s capacity for translational research and medical devices.   To achieve this end, FDA and AIMBE have developed the FDA Scholars Program, in which FDA intends to offer one-year public policy appointments to post-doctoral scholars with advanced training in medical and biomedical engineering.  Through this unique opportunity, scientists with doctorates in bioengineering may learn first-hand about FDA’s regulatory process. The scholars, in return, may provide important contributions to the FDA through their advanced training and background. The goals of the program are:

(1) To contribute to the effective use of scientific knowledge in developing public policy;
(2) To educate the scientific community about the development of public policy; and
(3) To establish a more effective liaison between scientists and policy-making mechanisms.
 
The program aims to grow the field of medical and biological engineers capable of bridging science and public policy. FDA intends to benefit from this partnership through access to highly trained interdisciplinary scientists who may participate in FDA’s research, evaluation, dissemination and interagency activities, bringing new perspectives and skills to the agency.
 
IV. Substance of the Agreement
 
This MOU forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives between FDA and AIMBE. The types of activities expected to develop from this MOU include, but are not necessarily limited to, the following:
 
1.       Sharing information to further medical device policy work; 
2.       Training researchers in medical device public policies;
3.       Exposure to the latest cutting-edge research technologies and innovations;
4.       Joint workshops and meetings for education and research; and
5.       Research collaborations in regulatory science.
 
Prior to the initiation or implementation of any specific collaboration, the Parties intend to identify priorities and topics of mutual interest, and develop separate written agreements (“Supplemental Agreements”) for each collaboration. The Supplemental Agreements will outline each Party’s financial commitments (if any) to the collaboration and the specific terms to govern the collaboration. Where applicable, these agreements will incorporate by reference the terms of this MOU.  The Supplemental Agreements may include contracts, grants or cooperative research and development agreements (“CRADAs”) between FDA and AIMBE 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 will be negotiated and executed by appropriate representatives of institutions within AIMBE and FDA.
 
V. General Provisions
 
A.      Data Sharing Guidelines: The Parties may enter into separate Confidential Disclosure Agreements (“CDAs”) pertaining to certain data and information shared pursuant to this MOU. In accordance with applicable disclosure statutes and FDA regulations, including, but not limited to, 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with AIMBE pursuant to this MOU. 
 
B.      Intellectual Property.  “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU.  “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU.  Ownership of and rights to Inventions or Intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement.  Inventions made under a Federal research and development grant or contract will be subject to the Bayh-Dole Act.  No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party. Neither Party will use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols or decorative designs of the other Party or any derivatives thereof without the prior written permission of the other Party. 
 
C.      Conflict of InterestIndividual participants in activities under this MOU who are not U.S. Government employees will abide by conflict of interest rules and policies as specified by FDA, and as set out in any Supplemental Agreement covering those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts or maintain employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided, in compliance with HHS/FDA requirements. If at any time prior to or during the performance of the activities under this MOU, the Parties believe that a potential or actual conflict exists, the Parties will notify the appropriate authorities within their respective institutions and contact the designated FDA liaison officer listed on this MOU. A determination will be made by FDA as to whether a conflict of interest exists and, if so, the necessary action/s to resolve or mitigate it. The Parties will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
 
D.      Security. Each Party will inform the other Party of its security policies and procedures regarding access to and use of facilities, and the other Party will comply with those policies.  Either Party may restrict or limit access to its property and facilities at any time and for any reason.  AIMBE representatives and experts participating in activities under this MOU on FDA’s property will comply with all applicable federal statutes and regulations.
 
VI. Resource Obligations
 
This MOU represents the broad outline of the FDA and AIMBE’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 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. This MOU does not create binding or enforceable obligations against any Party. 
 
VII. Liaison Officers
 
Liaison Officers:
 
CDRH
 
Anindita Saha
Director, External Expertise and Partnerships
10903 New Hampshire Avenue
White Oak Building 66, Room 5414
Silver Spring, MD 20993
Tel: (301) 796-2537
E-mail: Anindita.Saha@fda.hhs.gov
 
AIMBE
 
Sarah Mandell
Director, Research and Programming
1701 K Street NW, Suite 510
Washington, DC 20006
Tel: (202) 496-9661
Email: Smandell@aimbe.org 
 
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 Party affected will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
 
VIII. Term, Termination, and Modification
 
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years from the date of the latest signature. 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.
 
IX. 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 AIMBE operate.
 
IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed. This MOU may be executed in counterparts and each counterpart shall be deemed an original.
 
 APPROVED AND ACCEPTED FOR THE
AMERICAN INSTITUTE FOR MEDICAL AND BIOMEDICAL ENGINEERING 
 Milan P. Yager, Executive Director
 
APPROVED AND ACCEPTED FOR THE
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Jeffrey Shuren, M.D., J.D. Director
October 3, 2014