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MOU 225-12-0029

MEMORANDUM OF UNDERSTANDING BETWEEN THE
MEHARRY MEDICAL COLLEGE
AND
THE FOOD AND DRUG ADMINISTRATION

 

I. Purpose:

The United States Food and Drug Administration (FDA) and Meharry Medical College (Meharry), share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research.  This Memorandum of Understanding (MOU) forms the basis for the initial relations between FDA and Meharry for sabbaticals, research and scientific education.
 

II. Background:

FDA identified the strategic goal to expand agency efforts to meet the needs of special populations.  FDA supports the premise that therapeutic breakthroughs and clear and timely public health information should be available to all Americans. There are numerous challenges to achieving this goal. For example, historically ethnic and racial minorities have been underrepresented in clinical trials, making it difficult to assess whether a medical product will be safe and effective for them.  Assuring that products are safe and effective for people with rare diseases is challenging, because the patient populations are too small to support standard clinical trials.  FDA is committed to addressing these issues through targeted scientific programs and culturally sensitive outreach efforts.

The Office of Minority Health (OMH) advances FDA’s regulatory mission in addressing the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all.  The Office provides leadership and direction in identifying agency actions that can help reduce health disparities, including the coordination of efforts across the Agency.  The Office of Minority Health serves as the principal advisor to the Commissioner on minority health and health disparities. 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.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 assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products.  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 Meharry will contribute to FDA’s mission.
Meharry Medical College’s mission is to eliminate health disparities.  Research at Meharry examines biological, behavioral and other factors that contribute to the disproportionate burden of poor health outcomes borne by minority and underserved populations.  Meharry’s research programs provide the venue for training programs in research.   Research Centers at Meharry are the umbrella structure for multi-investigator programs including research, training, and community outreach.  The Research Centers include:  1) Center for AIDS Health Disparities Research;2) Center for Women’s Health Research and, 3) Center for Molecular and Behavioral Neuroscience.
 

III. Substance of Agreement:
 

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives between FDA and Meharry to explore health disparities in regulatory science.  The types of initiatives expected to develop from this MOU include:

  1. Opportunity to apply for a joint fellowship program at the FDA to advance student and faculty education.  One of the mechanisms to enroll students/post-doctoral trainees/residents from the Meharry into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program.  If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, the Office of Minority Health and Meharry will adhere to the CDER ORISE Fellowship rules and regulations.  Fellows or faculty members entering the program must agree to the ORISE terms of appointment which will be outlined in an offer of appointment letter; 
  2. Opportunities for Meharry faculty training in the regulatory science pathways; 
  3. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
  4. Opportunities to convene joint meetings for education and research, and;
  5. Research and evaluation collaborations.
  6. Under this MOU, FDA and Meharry will seek opportunities to participate together in collaborative health disparities research and training as permitted under appropriate statutory authority.  In particular, collaboration will rely upon Meharry expertise in working with minority and underserved populations to further knowledge of health disparities in regulatory science.  Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, 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.  FDA may enter supplemental agreements with Meharry to the extent authorized by law and available appropriations.  The terms and conditions of any such agreements will be compliant with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Meharry and FDA.
     

IV. General Provisions:

  1. Confidentiality --  Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information.  No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless permitted by applicable law.
  2. Conflict of Interest -- Participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA.  This may require participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA.  The Parties will be advised of any potential conflict so conflicting assignments can be avoided consistent with the HHS/FDA requirements.  If before or while performing the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and, in the case of Meharry, contact the designated FDA officials listed on the MOU so the necessary actions can be undertaken.  A determination will be made by FDA on whether a conflict of interest exists and how to resolve or mitigate it.  Parties to the MOU will avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
  3. Intellectual Property Rights – Institutions within Meharry and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
  4. Security – 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.  Meharry 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 agreements as appropriate and in compliance with all applicable federal requirements.

V. Resource Obligations: 

This MOU represents the broad outline of the Partners’ intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and Meharry.  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.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Meharry operate.

VI. Liaison Officers:

The individual to whom all inquiries to Meharry should be  
addressed is:

A. For the Meharry College of Medicine:
Individual's name:  Wayne J. Riley, M.D., M.P.H., MBA, MACP, President and CEO
Organization:  Meharry Medical College
Address:  1005 Dr. D.B. Todd Jr., Blvd, Nashville, TN, 37208
   
Telephone Number:  615.327.6904
Email Address: wjriley@mmc.edu

FDA’s Office of Minority Health is the lead for this MOU.  The individual to whom all inquiries to FDA should be addressed is:

B. For the Food and Drug Administration: 
Individual's name:  Michelle Yeboah, DrPH
Organization: Office of Minority Health
Title: Acting Director
Address: 10903 New Hampshire Avenue, Silver Spring, MD 20993
Telephone Number: (301) 796-4649
Email Address: Michelle.Yeboah@fda.hhs.gov

Each Party may designate new liaisons by notifying the other Party's liaison officers in writing.  If an individual designated as a liaison under this agreement becomes unavailable to fulfill his or her functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated liaison.

VII. Term, Termination, and Modification:

This agreement will be effective when accepted by all participating parties.  This agreement may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60-day advance written notice to the other.

APPROVED AND ACCEPTED

FOR MEHARRY MEDICAL COLLEGE 

Signed by:President and CEO, Meharry Medical College 

Date: 6/21/2012
 

APPROVED AND ACCEPTED

FOR FOOD AND DRUG ADMINISTRATION

Signed by:Chief Scientist 

Date: 6/06/2012