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U.S. Department of Health and Human Services

About FDA

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MOU 225-07-8008


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 collaborativepartnership on mutually agreed activities in the scientific research and education fields. This Memorandum of Understanding {MOU) establishes the terms for collaboration to promotethese shared interests, which can be pursued through a variety of programs including collaborative education and research.
II..       Background
FDAis authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) asamended (21U.S.C. 301, et. seq.). In fulfillingits responsibilities under the Act, FDA, among other
things, directs its activities toward  promotingand protectingthe 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. FDAalso has responsibility for regulatingthe manufacturing, marketing, and distributionof tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDAmust 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 JohnsHopkins 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 throughoutits history. The National ScienceFoundation has ranked it the number one 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 divisionson campuses in Marylandand Washington, D.C. with international centers in Italy, China, Singapore, and Malaysia.
Ill.       Substance of Agreement:  
This MOU forms the basisfor development of scientificcollaborations, outreach and educational initiatives and intellectual partnerships between FDAand JHU. The types of activities expected to develop from this MOUinclude, but are not necessarily limited to, the following:
1. Identification and convening of a steering committee to guide a processfor scientific and intellectual collaborations, outreach, and education initiatives;
2. Personnel exchanges between universityfaculty, staff,and FDA 1s scientists and staff as permitted bythe IntergovernmentalPersonnel Act;
3. Opportunities to applyfor a joint fellowship program at the FDAto advance student and faculty education. One mechanism to enrollstudents/post., doctoral trainees/residents from JHU into a joint fellowship program at FDAmay be through the Oak RidgeInstitute for Science and Education (ORIS E)fellowship program. If prospective fellows or faculty enters the program through the CRISEfellowship mechanism, FDAand the JHU will adhere to the respective Agency Centers’ ORISE fellowship rulesand regulations. Fellowsor faculty members entering the program must agree to the CRISEterms of the appointment, which will be outlined inan offer of appointment  letter;
4. Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Partieslaboratories, classrooms,clinical settings and offices;
5. Opportunities for FDApersonnel who participate  in the appropriate JHU review and approval processes to serve as adjunct faculty, advisory board members, and dissertation advisorsat JHU;
6. Joint meetings for education and research; Research collaborations;
7. Cooperativeinternational activities includingoutreach;
8. Sharing of unique facilities and equipment for increased results and cost efficiencies for scientificendeavors; and
9. Development  of regular workshops  where faculty  from JHU and FDA's scientists and staff share informationabout  ongoing  research, education, extension, and outreach efforts of mutual interest.
A. 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.  Accessto 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 communicationof identifiedcollaborative efforts through appropriate means.
B.  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.  Accessto facilities and equipment, including necessary training and guidance, in so far as such use does not interferewith the primary mission of either party.
3.  Active participationin establishing collaborativeresearch, 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 communicationof identifiedcollaborative 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.
C. It is mutually agreed that:
In an effort to enhance collaborative interactions and communication between both institutions, FDAand JHUwill collaborate in the development of regular workshop where faculty from all the institutions  within the JHUand FDAscientists and staff share information about ongoing research,education, extension, and outreach
efforts of mutual interest.
IV.        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 JHU and FDAmay 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.
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.  EachParty will comply with the other Party's security procedures and policies regarding accessto and use of facilities. Either Party may restrict or limit accessto 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.
5.  It is recognized that from time to time FDAand 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 JHUoperate.
VI.        Liaison Officers
The individual to whom all inquiries to FDAshould be addressed is:
Eileen Parish,M.D.
Office of the Commissioner
Office of the Chief Scientist
10903 New Hampshire Avenue
Silver Spring, MD 20993
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
Each Party may designate new liaisons at any time by notifyingthe other Party's liaison officers in writing.If, at any time, an individual designated asa 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. Itmay be renewed by mutual written agreement of both Parties.It may be modified at anytime 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 applicablestatutes, regulations, rules, and policies under which FDA and JHU operate.



Alexandra Albinak McKeown, J.D

Associate Vice Provost

May 20, 2015




Lciana Borio, M.D.

Acting Chief Scientist

May 14, 2015