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  1. FDA Memoranda of Understanding

MOU 225-07-8008-1

MOU 225-07-8008-1

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
AND JOHNS HOPKINS UNIVERSITY

 
I.  Purpose
 
The United States Food and Drug Administration (FDA) and Johns Hopkins University (JHU), by and through its various academic departments, share interests in promoting scientific progress through exchange of scientific capital. The purpose of this Memorandum of Understanding ("MOU") is to establish the framework for a collaborative partnership on mutually agreed activities in the scientific research and education fields. This Memorandum of Understanding {MOU) establishes the terms 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 (21U.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 ensuring 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. 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 within the Johns Hopkins University will greatly contribute to FDA's mission.
 
The Johns Hopkins University is a private research university in Baltimore, Maryland. The first research university in the Western Hemisphere and one of the founding members of the American Association of Universities, Johns Hopkins has ranked among the world's top universities throughout its history. The National Science Foundation has ranked it the number 1 university among U.S. academic institutions in total science, medical, and engineering research and development spanning for 31 consecutive years. Johns Hopkins is organized into ten divisions on campuses in Maryland and Washington, D.C. with international centers in Italy, China, Singapore, and Malaysia.
 
Ill. Substance of Agreement:  
 
A.      This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and JHU. The types of activities expected to develop from this MOU include, but are not necessarily limited to, the following:
 
1.      Identification and convening of a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives.
 
2.      Personnel exchanges between university faculty, staff, and FDA scientists and staff as permitted by the Intergovernmental Personnel Act.
 
3.      Opportunities to apply for a joint fellowship program at the FDA to advance student and faculty education. One mechanism to enroll students/post, doctoral trainees/residents from JHU into a joint fellowship program at FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enters the program through the ORISE fellowship mechanism, FDA and the JHU will adhere to the respective Agency Centers' ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the CRISE terms of the appointment, which will be outlined in an offer of appointment letter.
 
4.      Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties laboratories, classrooms, clinical settings, and offices.
 
5.      Opportunities for FDA personnel who participate  in the appropriate JHU review and approval processes to serve as adjunct faculty, advisory board members, and dissertation advisors at JHU.
 
6.      Joint meetings for education and research.
 
7.      Research collaborations.
 
8.      Cooperative international activities including outreach.
 
9.      Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors.
 
10.    Development  of regular workshops  where faculty  from JHU and FDA's scientists and staff share information about ongoing  research, education, extension, and outreach efforts of mutual interest.
 
B.      FDA agrees to:
 
For programs agreed to in writing, and in advance by both parties, FDA may, as permitted by applicable statutes and regulations and subject to the availability of funds, and as it deems appropriate, offer JHU the following.
 
1.      Laboratory and/or office space in support of activities under this agreement.
 
2.      Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party.
 
3.      Active participation in establishing collaborative research, education, extension, and outreach efforts with faculty, students, and staff within JHU institutions.
 
4.      Willingness to participate in courses and seminars within JHU, based on availability of resources.
 
5.      Continuing and frequent communication with faculty and staff.
 
6.      Openness to faculty, staff, and students wishing to visit FDA laboratories.
 
7.      Promulgation and communication of identified collaborative efforts through appropriate means.
 
C.     JHU agrees to:
 
For programs agreed to in advance by both parties, JHU may offer FDA the following:
  
1.      Laboratory and/or office space in support of activities under this agreement at identified institutions.
 
2.      Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party.
 
3.      Active participation in establishing collaborative research, education, extension, and outreach efforts with FDA scientists and staff.
 
4.      Continuing and frequent communication with FDA scientists and staff.
 
5.      Openness to FDA scientists and staff wishing to visit relevant JHU programs and laboratories.
 
6.      Promulgation and communication of identified collaborative efforts through appropriate means.
 
7.      Adjunct, affiliate and research faculty appointments for appropriate FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives of the parties as appropriate, and provided that such appointments comply with university policies on appointment of faculty/affiliates.
 
D.     It is mutually agreed that In an effort to enhance collaborative interactions and communication between both institutions, FDA and JHU will collaborate in the development of regular workshop where faculty from all the institutions within the JHU and FDA scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.
 
IV.        General Provisions:
 
A.         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 JHU and FD may decide to enter into supplemental agreements that may include contracts, grants, or cooperative research and development agreements ("CRADA") between FDA and JHU to the extent authorized by law and available appropriations. The terms of such supplemental agreements will address Intellectual Property rights. 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 the JHU and FDA.
 
B.         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.
 
C.         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. JHU individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
D.          It is recognized that from time to time FDA and institutions within JHU will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements.
 
V.         Resource Obligations
  
This MOU represents the broad outline of the FDA and JHU's 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 into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and JHU operate.
 
VI.        Liaison Officers
 
The individual to whom all inquiries to FDA should be addressed is:
Eileen Parish, M.D.
Office of the Commissioner
Office of the Chief Scientist
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-8522
 
The individuals to whom all inquiries to JHU should be addressed are:
 
Alexandra Albinak McKeown, J.D.
Associate Vice Provost for Research
Johns Hopkins University Research Administration
615 North Wolfe Street, W1600
Baltimore, Maryland  21205
410-614-1856
  
Each Party may designate new liaisons at any time by notifying the other Party's liaison officers in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill their functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
 
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. Either Party upon 60-day advance written notice to the other may terminate it, for any reason.
 
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 JHU operate.
 
 
APPROVED AND ACCEPTED
FOOD AND DRUG ADMINISTRATION
 
Luciana Borio, M.D.
Acting Chief Scientist
 
May 14, 2015
 
 
APPROVED AND ACCEPTED
JOHNS HOPKINS UNIVERSITY
 
Alexandra Albinak McKeown, J.D.
Associate Vice Provost for Research
Johns Hopkins University
 
May 20, 2015